**Before the**

**Federal Communications Commission**

**Washington, D.C. 20554**

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| In the matter of                 | * | FCC Identifier PG6BA0T        |
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| Biotronik, Inc.                  | ) |                               |
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| Equipment Authorization for the  | * |                               |
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| Implant Communications Service   | * |                               |
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**MEMORANDUM OPINION AND ORDER**

**Adopted: February 12, 2003 Released: February 25, 2003**

By the Commission:

I.  **INTRODUCTION**

1\. On April 23, 2001, the Commission's Office of Engineering and
Technology (OET) granted an application for equipment authorization to
Biotronik, Inc. (Biotronik) for its medical implant device, Philos
DR-t.[^1] This device is a low-power implanted transmitter that operates
in conjunction with a medical pacemaker to facilitate data (non-voice)
communication from the device to a doctor. The device is designed to
communicate data in the event of certain changes in the patient\'s
condition or through manual activation, and also at regular intervals
for periodic monitoring of the patient's condition.

2\. This grant was challenged by the manufacturer of another medical
implant device, Medtronic, Inc. (Medtronic), and was modified by OET to
disallow regular periodic transmissions.[^2] Biotronik seeks
reconsideration of that decision, arguing for restoration of the
automatic transmission function by rule interpretation or by waiver.
Medtronic seeks review of OET's determination to leave the equipment
grant in place, albeit with certain restrictions, arguing that any
operation of the device fails to comply with our rules. For the reasons
stated below, we deny Biotronik's petition for reconsideration or waiver
and deny Medtronic's application for review.

II. **BACKGROUND**

3\. The Commission initiated the Medical Implant Communications Service
(MICS) in 1999,[^3] in response to a petition for rule making by
Medtronic to permit use of a mobile radio device, implanted in a
patient, for transmitting data in support of the diagnostic and/or
therapeutic functions associated with an

implanted medical device.[^4] This technology represented a significant
advancement in communications with implanted medical devices in a manner
that would be far more efficient, useful and safe than current
systems.[^5] The Commission determined that the 402--405 MHz band was
particularly well suited for this service, due to the signal propagation
characteristics in the human body, the relative dearth of other users of
the band, the compatibility of a MICS service with the incumbent users
of the band, and its use internationally for this purpose.[^6]

4\. In order to allow use of this newly-developed, life-saving medical
technology without harming other users of the frequency band, MICS was
provided a secondary allocation. At the time of this decision, the
402-405 MHz band was primarily allocated to Federal Government uses,
including Meteorological Aids Service (Metaids), the Meteorological
Satellite Service, and the Earth Exploration Satellite Service.[^7] We
adopted technical rules specifically designed to protect these incumbent
Federal services and to ensure compatibility among multiple MICS devices
and users.[^8] These rules establish 10 channels of 300 kHz each for
this service within the allotted bandwidth (47 C.F.R. § 95.628(c) (d)),
provide for frequency sharing and cooperation in the selection and use
of channels (47 C.F.R. § 95.1211), and establish specific guidelines for
frequency monitoring prior to transmission by implant programmer/control
transmitters (47 C.F.R. § 95.625(a)). We also provided that a MICS
device could transmit without prior frequency monitoring, pursuant to a
non-radio frequency actuation signal generated by a device external to
the body (manual activation) (47 C.F.R. § 95.1209(b)), or in response to
a medical implant event (47 C.F.R. §§ 95.628(b), 95.1209(b)). Given
these protections, the National Telecommunications and Information
Administration (NTIA), representing the incumbent Federal user entitled
to exclusive use of this band, interposed no objection to this
allocation.[^9]

5\. Under these newly adopted provisions, OET issued a Grant of
Equipment Authorization to Biotronik to permit marketing and importation
in the United States of its Philos DR-t model under the MICS rules.
Whereas the Medtronic technology that served as the original instigation
of this service and the basic model for our service rules is an external
device that communicates with implanted equipment, the Biotronik device
is an ultra-low power, non-broadcast transmitter that is implanted into
the body with and operates in conjunction with a medical pacemaker. Its
simpler function is to provide data (non-voice) communications to
doctors regarding a patient's condition and its own performance. The
device relays data for a doctor (typically to a data collection point)
via a telephone (typically a cellular phone) that is in close proximity
to the patient. As submitted to the Commission, the device could be
activated manually by the patient using a magnetic wand, by certain
changes in the patient's condition, or automatically on a schedule set
by the doctor. These automatic/periodic transmissions are used to assist
doctors in identifying trends in a patient's condition in order to
refine medical diagnosis and treat the patient.

6\. Medtronic filed a Petition for Reconsideration of the Grant of
Equipment Authorization. Medtronic contended that the one-way,
single-frequency design of the Biotronik device is at odds with the
basic MICS requirement to "share" frequencies among MICS users, citing
the "cooperation" provision of Section 95.1211 of our rules. Medtronic
argued that only devices that are frequency agile and that monitor
frequency use prior to transmission, as provided in Section 95.628(a) of
our rules, comply with this requirement. Medtronic also contended that,
even under the medical implant event exception of Section 95.628(b), our
rules require a "communications session," and that this requirement
implies a two-way communication with multiple messages. Finally,
Medtronic asserted that operation of Biotronik's device would pose an
interference risk to other medical communications devices.

7\. OET granted Medtronic's Petition for Reconsideration in part. OET
determined that the Biotronik transmitter was in compliance with our
rules and regulations except for the automatic transmissions that it
incorporated. It determined that periodic operations of the equipment is
not within the letter of the Commission's rules and accordingly modified
Biotronik's Equipment Authorization to eliminate the provision for
automatic transmission.[^10]

8\. Biotronik filed the instant Petition for Reconsideration of the OET
reconsideration decision that limits their authorization by prohibiting
automatic transmissions from the implanted device.[^11] Biotronik argues
that the automatic transmission provision is consistent with the MICS
rules and should be reinstated. Biotronik alternatively seeks a
waiver[^12] of the Commission's rules to allow for automatic monitoring
of a patient's condition, claiming that the short duration of the
transmissions and the limited power employed during these transmissions
obviate the risk of interference to other communications service or
other medical devices.[^13] Biotronik submits several letters from the
medical community attesting to the value of the Biotronik device as a
medical tool for diagnosis of cardiac problems. Medtronic filed in
opposition to Biotronik's petition and alternative waiver request, and
also filed the instant Application for Review of the determination to
permit the more limited authorization.[^14] Medtronic continues to
contend that the Philos DR-t, even as limited in OET's most recent
decision, is not in conformance with the MICS rules.

III. **DISCUSSION**

[Medtronic Application for Review]{.underline}

9\. In its Application for Review seeking complete rejection of all
aspects of the Philos DR-t, Medtronic contends that MICS was created
with the intention that users be frequency agile, monitoring the band
and conducting the equivalent of an electronic handshake prior to
operation, even in situations involving a medical emergency. Medtronic
cites Section 95.1211(b), which requires "cooperat\[ion\] in the
selection and use of channels." It further elaborates that the MICS
rules, at Section 95.628(a), lay out monitoring and transmission
provisions designed to ensure that the limited MICS spectrum is shared
equitably among all users and that the potential of interference to
other MICS devices be minimized. It contends that the MICS rules intend
that transmissions occur between the medical implant transmitter and an
external medical implant programmer/control transmitter, which would
coordinate frequency usage. The Philos DR-t does not employ a
programmer/control transmitter, but contains only a medical implant
transmitter and thus is not capable of this coordination. This,
according to Medtronic means the Biotronik device is more likely to
cause interference to other MICS devices, and is not contemplated by the
rules in any mode of operation. Medtornic elaborates on its earlier
arguments by contending that all MICS devices must have these
capabilities, even though certain rule sections provide exceptions to
this mode of operation. Finally, Medtronic argues that the very low
power output on which OET based its determination of the lack of
interference potential causes its receivers to be overly susceptible to
interference from others, thus inhibiting the use of other MICS systems
and of Part 15 devices.

10\. We find that most of these arguments were fully considered and all
were properly disposed of by OET. While the Philos DR-t may not perform
in the manner of devices contemplated by Medtronic when Medtronic
instigated a rule making for MICS, that service was not authorized for
the limited purpose of accommodating only Medtronic's product or those
that closely mimic its design. Biotronik has designed an apparently
simpler utilitarian device whose functions are more limited but also
provide a valuable medical tool. This device is consistent with the
purposes of that service and fully comports with our rules as adopted
when it is operated in the manner permitted by OET in its most recent
decision. As OET has already pointed out, while a handshake/monitoring
function is contemplated to minimize the interference potential of a
MICS controller/transmitter that is not the only permissible mode of
operation. The rules clearly contemplate a transmitter that is distinct
and separate from its activation device, as here, and they state that
*for an activation device that is a controller/transmitter*, certain
protocols must be followed.[^15] The Biotronik transmitter is not and
does not include a controller/transmitter for its activation. Sections
95.628(b) and 95.1209(b) of our rules provide an exception to the
monitoring requirement for transmissions that are initiated by a
"medical implant event" (47 C.F.R. §§ 95.628(b), 95.1209(b)), and manual
activation of a transmitter is not restricted by the transmission
protocols governing activation by a controller/transmitter (47 C.F.R.
§ 95.1209(b)). In the case of a device such as the Philos DR-t that
would operate only under the exceptions, as limited by OET's subject
decision, it would be unnecessarily onerous for the Commission, as urged
by Medtronic, to require a device to include a capability that would not
be utilized - in this case a monitoring/handshake function - and we will
not interpret our rules in such a manner.[^16]

11\. Medtronic also reiterates its earlier argument that the Commission
based its MICS decision and rules on International Telecommunications
Union (ITU) recommendations for such a service, and that OET failed to
adequately consider the ITU recommendations that support its position.
We find that OET was correct in discounting this argument. The ITU
recommendation for MICS in this band provided additional impetus for
this Commission to make a domestic MICS allocation at these frequencies,
and provided guidance for appropriate operational parameters for
controller/transmitters. However, as correctly observed by OET, the
rules adopted do not mimic the provisions of the ITU recommendation, and
we have distinguished between an implanted transmitter and its actuation
device. Accordingly, we affirm OET's decision to authorize the Philos
DR-t to operate manually and in the case of a medical implant event.

[Biotronik Petition for Reconsideration.]{.underline}

12\. In its Petition for Reconsideration, Biotronik argues that the
"scheduled event" that was disallowed in OET's decision, is a medical
implant event as contemplated by the exemption of Section 95.628(b),
even though the transmission is programmed to occur on a regular
schedule. The rules define a medical implant event as an event
recognized by a medical implant device, or a duly authorized health care
professional, that requires the transmission of data from the medical
implant transmitter in order to protect the safety or well--being of the
person in whom the medical implant transmitter has been implanted.
(47 C.F.R. App. 1 to subpart E of Part 95.)  Biotronik insists that OET
misunderstood the nature of the information included in the device's
transmissions, asserting that the Philos DR-t transmissions include
critical information regarding a patient's condition and reaction to
pacemaker settings. According to Biotronik, the physician makes the
determination as to a selected time and interval for the transmissions
that are deemed medically necessary to assess the patient's medical
condition and the proper operation or setting for a pacemaker. The
physician or other qualified medical personnel programs (and can
reprogram) the pacemaker to alter its function and to set the time
interval for the Philos DR-t transmissions. Biotronik argues that only
by reading this data and seeing trends can the physician appropriately
observe the patient and intervene as needed.

13\. Several physicians and health care facilities filed comments in
support of Biotronik's petition. They contend that allowing doctors to
collect cardiac data that is automatically transmitted at regular
intervals is essential to observing patients' changing condition on a
semi-real-time basis, and is invaluable as a diagnostic tool. They
assert that never before have pacemakers been capable of automatically
transmitting diagnostic cardiac data on a scheduled basis with such
frequency and resolution. They contend that OET's reconsideration
decision[^17] was not consistent with the rule making and they seek to
have the Commission grant Biotronik's petition for reconsideration and
allow for these automatic transmissions on the basis that they are
medically necessary and desirable for the purpose of patient care.

14\. Medtronic counters that in establishing MICS, the Commission
intended for MICS to be broadly applicable and intended to accommodate
large numbers and numerous types of implantable therapies from many
manufacturers. Accordingly, it argues, the Commission intended to
provide a flexible framework, such that these devices could self-manage
spectrum use, so as to facilitate sharing of the band, through
electronic coordination, to avoid interference and without placing a
burden on health care professionals.

15\. While Medtronic's arguments here essentially echo those it raises
in its Application for Review, discussed above, they are more compelling
in the context of regular, preprogrammed transmissions. While OET may
not have been fully apprised of the therapeutic functions of the regular
monitoring transmissions when it made its subject decision, its
technical analysis was correct. Channel scanning to avoid interference
given and received was a key issue in our negotiations with the NTIA,
and we clearly contemplated a two-way electronic handshake to occur
before most automatic transmissions. We provided, with NTIA assent,
exceptions for urgent situations and those individually controlled by
manual operation. There is a difference between occasional transmissions
instigated by an emergency situation or a change in a patient's
condition recognized by the device or by the patient, and periodic
transmissions that can be accommodated less urgently and in a way as to
avoid conflict with other signals. To interpret the "medical implant
event" exception as urged by Biotronik, to permit regular and
potentially frequent transmissions with no specific instigation, would
effectively eviscerate the protective provisions of the rules, and we
cannot interpret our rules such that they have no effect. Accordingly,
we affirm OET's decision that preprogrammed, regularly scheduled
transmissions on a single channel without prior frequency monitoring, do
not comport with the rules established for MICS.[^18]

[Biotronik Petition for Waiver.]{.underline}

16\. Biotronik alternatively asks that if its device's preprogrammed
periodic transmission function is not found in compliance with our MICS
rules, it be granted a waiver of those rules to permit such
monitoring/diagnostic operations by the device as originally submitted
to the Commission for approval. Biotronik argues that the interference
potential of such operations is *de minimis*, due to the very low power
and short duration of the transmissions, and that only one channel is
impacted. It states that the level of emissions are well below the
allowable MICS level and are no more than we allow for computers and
other digital devices, and are thus within limits the Commission has
determined in the past to be relatively risk free of causing
interference. It contends that a waiver would serve the underlying
purpose of the rules by making diagnostic and therapeutic benefits
available to the public while avoiding interference, and thus can and
should be granted, citing *WAIT Radio*. [^19]

17\. Medtronic opposes this argument, contending that Biotronik has not
met the burden for a waiver of our rules by failing to demonstrate a
need for a waiver. Medtronic argues that Biotronik should not be allowed
to circumvent the rules by using a waiver; that the device may be used
in a variety of venues and as such may cause interference; and that
granting the waiver would encourage other similar waiver requests.

18\. We deny Biotronik's waiver request. While Biotronik argues that a
waiver would not undercut the interests served by the rules, it has not
even attempted to demonstrate that there is a hardship or burden in
complying with them, or that a compliant device could not just as
effectively serve patient needs.[^20] We also note that while the
interference potential from the Philos DR-t appears to be *de minimis*,
as already recognized by OET, there appears to be a potential for
interference to the device,[^21] which could unreasonably impact other
users of this band. Additionally, this spectrum is primarily allocated
for Federal use (Metaids) and we give considerable deference to the NTIA
in determining its potential impact on Federal use. Indeed, NTIA played
a significant role in setting the service rules. In this case, NTIA does
not agree that a waiver of the rules is appropriate for the Philos DR-t
as presently formatted.[^22]

**IV. ORDERING CLAUSES**

19\. Accordingly, IT IS ORDERED that, pursuant to Sections 1, 4(i) and 4
(j) of the Communications Act of 1934, as amended, 47 U.S.C. §§ 151,
154(i), 154 (j), the Application for Review filed by Medtronic is
DENIED.

20\. IT IS FURTHER ORDERED that, pursuant to Sections 1, 4(i) and 4 (j)
of the Communications Act of 1934, as amended, 47 U.S.C. §§ 151, 154(i),
154 (j), the Petition for Reconsideration or Waiver filed by Biotronik
is DENIED.

FEDERAL COMMUNICATIONS COMMISSION

Marlene H. Dortch

Secretary

# 

[^1]: FCC ID: PG6BAOT.

[^2]: Letter to David E. Hilliard (Medtronic) and Mark Johnson
    (Biotronik) from Bruce A. Franca, Deputy Chief, Office of
    Engineering and Technology, FCC, March 28, 2002 (OET Letter).

[^3]: *Report and Order* in WT Docket No. 99-66 ("*MICS Order*"), 14 FCC
    Rcd 21,040 (1999).

[^4]: This technology not only permits the reporting of the condition of
    the patient and the implanted pacemaker or other device, but also
    permits the doctor to reset certain parameters of the pacemaker's
    operation without the need to retrieve the device from the patient's
    body and have the device provide data back to report the results of
    the adjustments. See *Notice of Proposed Rule Making* in WT Docket
    No. 99-66 ("*MICS Notice"*), 14 FCC Rcd 3659, 3660 (1999).

[^5]: *Id.,* at 3661.

[^6]: *MICS Order, supra* at 21,042 -- 43.

[^7]: In this band, Metaids currently operates radiosondes, which are
    automatic transmitters, usually carried on an aircraft, free
    balloon, kite, or parachute, which transmit meteorological data
    during their journey through the atmosphere. (See 47 C.F.R. § 2.1.)

[^8]: *Id.* at 21,046.

[^9]: NTIA is responsible for managing the Government portion of the
    Table of Frequency Allocations. In bands shared between Federal and
    non-Federal Government services, the Commission and NTIA operate
    under a long-standing coordination agreement. *See NTIA Manual,
    Basic Coordination Arrangement Between IRAC and the FCC*, at p.
    8-39.

[^10]: OET Letter, *supra* at p. 3.

[^11]: "Biotronik, Inc. Petition for Reconsideration or Waiver," April
    8, 2002

[^12]: *Id.*

[^13]: The Philos DR-t would typically transmit for less than one-half
    second per day, in the early morning hours.

[^14]: "Opposition of Medtronic, Inc.," April 23, 2002; "Application for
    Review," filed by Medtronic, Inc., April 8, 2002.

[^15]: "...no medical implant *transmitter* shall transmit except in
    response to a ... medical implant programmer *control transmitter*
    or a non-radio frequency actuation signal ...." (emphasis added)
    47 C.F.R. § 95.1209(b).

[^16]: Medtronic's citation of the Wireless Telecommunications Bureau
    website discussion of MICS is unavailing. While website information
    is intended to provide useful information to persons outside the
    Commission, it does not have binding authority. (We note that the
    website information has been modified recently to better reflect
    Commission decisions in this area.)

[^17]: OET Letter, *supra*.

[^18]: Philos Dr-t devices that have already been implanted in patients
    are grandfathered, and can continue to be operated as originally
    configured and approved.

[^19]: *WAIT Radio v. FCC*, 418 F.2d 1153 (D.C.Cir. 1969); *cert.
    denied* 409 U.S. 1027 (1972).

[^20]: See *Northeast Cellular v. FCC*, 897 F.2d 1164, 1166 (D.C. Cir.,
    1990).

[^21]: OET Letter at 2.

[^22]: *See* Letter from Frederick R. Wentland to Edmond J. Thomas,
    November 5, 2002.