reduction in the rate of PBCs compared to the use of Tego connector plus Curos cap in
hemodialysis patients with catheters. See Table 3 below.
Table 3. Randomized Clinical Study Results Primary Analysis:
PBC rates of ClearGuard HD vs. Tego+Curos on a Per-Event Basis

Variable

ResultPBC Rate, ClearGuard HD

0.28 per 1,000 CVC-days

PBC Rate, Tego+Curos

0.75 per 1,000 CVC-days

Incidence Rate Ratio (IRR)

0.37

Reduction in PBC Rate

63%

P value

0.0001www.icumed.com/symbols-glossary
Blue Lock

The exploratory ad-hoc CLABSI analysis was conducted to explore the possible reductionof a more clinically meaningful outcome than PBC rates. However, this analysis was not
pre-specified in the protocol and may have limitations (see Note below).
For a PBC to be classified as a CLABSI in this study per the NHSN surveillance definition, it must have been a Laboratory-Confirmed Bloodstream Infection (LCBI)2 as
follows: LCBI1) a recognized pathogen (an organism not included on the NHSN common
commensal list) identified from one or more blood specimens obtained by blood culture
microbiologic testing and the organism(s) identified in the blood must not be related to an
infection at another site (as indicated by the “vascular access” box being checked as thesuspected source of the PBC on the Dialysis Event (DE) form)3, OR an LCBI2) the same
NHSN common commensal identified by blood culture microbiologic testing from two or
more blood specimens drawn on the same day, the organism(s) identified in blood mustnot be related to an infection at another site (as indicated by the “vascular access” box
being checked as the suspected source of the PBC on the DE form), and the subject had
at least one of the following symptoms: fever, chills, or hypotension (as indicated on the
DE form). Also, the CLABSI analysis was conducted on a per-subject basis (i.e., censoredthe patient after the first CLABSI event to prevent potentially double counting the same
infection). All cultures were processed by a single clinical laboratory. Note: CLABSI was
defined as a positive blood culture (PBC) not related to an alternative source of infection
per the National Healthcare Safety Network (NHSN) surveillance definition. Alternative
sources were excluded if dialysis sites attributed the PBC to vascular access on the
dialysis event form. The actual reduction in CLABSI rates may be less substantial as the

Figure 1

CLABSI Rate, Tego+Curos

0.50 per 1,000 CVC-days

Incidence Rate Ratio (IRR)

0.34

Reduction in CLABSI Rate

66%

There was no formal safety endpoint associated with this clinical study. There were no
device-associated adverse events reported via the FDA’s medical device reporting (MDR)
during this study or in a previous study4.
CONCLUSIONS
Results of design verification and validation testing demonstrate that 1) the ClearGuard
HD Antimicrobial Barrier Cap is safe for its intended use as an end cap for hemodialysis
catheters and 2) the chlorhexidine antimicrobial agent effectively reduces the number ofmicroorganisms in hemodialysis catheter hubs following three years of real time ambient
aging. The risk assessment results, together with the results of design verification and vali

One ClearGuard HD Cap Removed from the Shield

INTENDED USE / INDICATIONS FOR USE
ClearGuard HD Antimicrobial Barrier Cap is indicated for use with hemodialysis catheter
hubs.
Using in vitro methods, the antimicrobial treatment on the ClearGuard HD Antimicrobial
Barrier Cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE),
Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus
aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown
to be effective against Candida paratropicalis and Klebsiella pneumoniae.
Using post-market clinical surveillance data, use of the ClearGuard HD Antimicrobial Barrier Cap has been shown to reduce the incidence of central-line associated bloodstream
infections (CLABSI) in hemodialysis patients with catheters. Note: CLABSI was defined
as a positive blood culture (PBC) not related to an alternative source of infection per the
National Healthcare Safety Network (NHSN) surveillance definition. Alternative sourceswere excluded if dialysis sites attributed the PBC to vascular access on the dialysis event
form. The actual reduction in CLABSI rates may be less substantial as the evaluation foralternative PBC sources was not pre-specified, nor standardized between patients andclinical sites, and supplemental data evaluating for alternative sources were not available
for review.
The subject device is not intended to be used for the treatment of existing infections. The
antimicrobial is only present within the hub of the catheter and does not migrate to distal
portions of the catheter.

Result0.17 per 1,000 CVC-days

Red Lock

DESCRIPTION
The ClearGuard™ HD Antimicrobial Barrier Cap (also referred to as the ClearGuard HDcap) is a cap for use with hemodialysis catheters. It has the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads.
Each package contains two ClearGuard HD caps assembled in a shield (Figure 1). The total amount of chlorhexidine acetate on a pair of devices is not more than 2.53 mg, and the
maximum amount that is available to be released to the patient is 0.6 mg per device pair.

Table 4. Randomized Clinical Study Results Exploratory Analysis:
CLABSI Rates of ClearGuard HD vs. Tego+Curos on a Per-Subject Basis

CLABSI Rate, ClearGuard HD

RodShieldevaluation for alternative PBC sources was not pre-specified, nor standardized between patients and clinical sites,and supplemental data evaluating for alternative sources were not available for review.
The CLABSI analysis demonstrated that using ClearGuard HD Antimicrobial Barrier Caps resulted in a reduction in
the rate of CLABSIs compared to the control (Table 4).

Variable

ClearGuard™ HD

dation testing presented in this submission, confirm that the ClearGuard HD Antimicrobial
Barrier Cap raised no new questions of safety or effectiveness compared to the predicate
device. The ClearGuard HD Antimicrobial Barrier Cap has, therefore, been shown to be
substantially equivalent to a legally marketed device for the purpose of 510(k) clearance.
The post-market clinical study demonstrated a reduction in the rate of CLABSIs with useof the device, thus supporting the expanded indications for use.

CONTRAINDICATIONS
Do not use the ClearGuard HD cap for the following:• Patients who are allergic to chlorhexidine.
• Patients who are allergic to nylon or polypropylene.
• Catheters that are dimensionally incompatible with the ClearGuard HD caps.

IFU0000385 REV 03 (11/22)

• Catheters with hubs that allow the ClearGuard HD rod to extend beyond the hub
within reach of the extension line pinch clamp.
• Catheters that have antimicrobial agents eluting from their inner lumens.
WARNINGS• Do not use if the package has been opened or is damaged, or if the expiration datehas passed.
• Do not reuse any component of the ClearGuard HD cap. The ClearGuard HD cap
is intended for single use only and should never be re-used. Reuse or reprocessing
including resterilization may compromise the device integrity and may also create arisk of contamination of the device and/or cause recipient infection.
• Do not close extension line pinch clamp on ClearGuard HD rod.
• The ClearGuard HD cap has not been evaluated for safety in Magnetic ResonanceImaging (MRI).
• Do not allow the ClearGuard HD rod or luer to contact non-sterile items; touching therod or luer with non-sterile items may lead to a bloodstream infection.
• Do not touch the rod with gloved hands.
• The ClearGuard HD cap should be discarded if the rod contacts non-sterile items or
gloved hands.
CAUTIONS• This product contains chlorhexidine acetate.
• Carefully read and follow all instructions prior to use.
• Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
• Only qualified dialysis center personnel or healthcare practitioners should place,manipulate or remove the ClearGuard HD caps.
PRECAUTIONS• Follow universal precautions when inserting and maintaining the ClearGuard HD
caps.
• Do not allow the ClearGuard HD rod to contact non-sterile items.
• Take care not to damage the ClearGuard HD cap during placement.
POTENTIAL COMPLICATIONS• Allergic/anaphylactic/pyrogenic reaction• Injury/pain/death• Device failure (device cracking, breaking, leaking, splitting or disconnecting potentiallyrequiring device intervention, removal or replacement)• Embolism (air or device)• Incompatibility with administered fluids or sanitizing agent.
• Incompatibility with connecting device/difficulty connecting• Infection (local, bacteremia, endocarditis, sepsis)• Sensitization• Toxicity
PLACING A ClearGuard HD END CAP ON A HEMODIALYSIS CATHETER
1. Use the standard facility or industry recommended aseptic technique when accessing the catheter. A mask is to be worn by the caregiver and patient covering the noseand mouth. The caregiver’s hands are to be cleaned and gloved.
PRECAUTION: Use aseptic technique to avoid contaminating the end cap andcatheter.
2. Use the standard facility and industry recommended practices to flush the catheter and to instill locking solution into the catheter prior to placing the ClearGuard
HD cap. Ensure that the catheter extension tubing pinch clamp is closed, that thelock solution completely fills the extension tube and catheter hub, and the syringe
remains attached to the catheter.
3. Remove the pair of ClearGuard HD caps that are contained in a shield from the foil
pouch.
4. While holding the shield and a catheter hub in one hand, remove the syringe fromthe hub and discard syringe. Do not allow the hub to touch non-sterile surfaces.

5. Remove a single ClearGuard HD cap (red or blue), by rotating the lock ring counterclockwise, taking care to only handle the lock ring; do not touch the rod.
WARNING: Do not allow the ClearGuard HD rod or luer to contact non-sterile items;
touching the rod or luer with non- sterile items may lead to a bloodstream infection.
Discard the ClearGuard HD cap if the rod or luer contacts non-sterile items or gloved
hands.
6. Carefully insert the ClearGuard HD rod into the catheter hub and, using a simultaneous push and twist motion, tighten by rotating clockwise.
NOTE: As the ClearGuard HD rod enters the hub, it will displace some of the locksolution; this is desirable as it can wet the antimicrobial on the ClearGuard HD cap
threads.
7. Repeat with the other ClearGuard HD cap and dispose of the shield and foil pouch.
REMOVING THE ClearGuard HD CAP FROM A HEMODIALYSIS CATHETER
1. Use the standard facility or industry recommended aseptic technique when accessing the catheter. A mask is to be worn by the caregiver and patient covering the noseand mouth. The caregiver’s hands are to be cleaned and gloved.
PRECAUTION: Use aseptic technique to avoid contaminating the cap and catheter.
2. Use the facility’s standard cap and hub cleaning procedures.
3. Ensure that the extension tubing pinch clamp is closed.
4. Carefully support catheter hub with one hand and, using other hand, loosen ClearGuard HD cap by rotating counter-clockwise.
5. Remove the ClearGuard HD cap and dispose of the used device in accordance withfacility protocol (see DEVICE DISPOSAL, below). The caps must be discarded after
removal.
PRECAUTION: Caps must never be reused or reconnected to the catheter hub once
removed or contamination of the catheter may occur.
6. Attach sterile syringe to catheter and aspirate the lock solution from the catheter
using your facility’s standard practices.
WARNING: After removing the ClearGuard HD cap from the catheter, aspirate aminimum of 5 mL of fluid from the catheter. This will prevent lock solution and antimicrobial agent from entering the bloodstream.
7. Use the catheter using standard facility and industry recommended practices.
MAXIMUM USE TIME
The recommended maximum use time is three days.
STERILITY & PACKAGING
The ClearGuard HD cap is provided sterile in a single sterile barrier foil package and isgamma sterilized. The device should be stored at room temperature and protected from
UV exposure and moisture.
DEVICE DISPOSAL
ClearGuard HD caps that have been in contact with body fluids are a potential biohazard.
Handle and dispose of the device and its components with acceptable medical practiceand applicable local, state, and federal laws and regulations.
SAFETY AND EFFECTIVENESS DATAThe ClearGuard HD caps have been found to be safe and effective for their intended use.
The ClearGuard HD caps have been subjected to biocompatibility testing in compliance with EN ISO 10993-1 and found to be non-hemolytic, non-cytotoxic, non-irritating,non-sensitizing, non-mutagenic, non-toxic and non- pyrogenic under intended use conditions. They have also been found to be sterile with a SAL ≤ 10-6. The ClearGuard caps
have also met their requirements for luers, chemical resistance, assembly and disassembly torque and attachment strength.
The ClearGuard HD end cap effectiveness has been assessed using the following in vitro
test method:• Heparin lock solution, which was inoculated with microorganism strains that are
known to cause catheter related blood stream infections, was injected into the hub
region of a catheter.
• Equal numbers of ClearGuard HD end caps and uncoated control devices were thenplaced on the test catheter systems and allowed to remain in place for two to threedays.

• For both the ClearGuard HD end cap and the uncoated control device, the number ofsurviving microorganisms were determined.
• The ClearGuard HD end cap was deemed to be effective against a microorganism if it
produced at least a 4 log10 reduction (99.99% reduction), when compared to uncoated control device.
• Please see indications for use for a summary of results.
• The ClearGuard HD cap safety and effectiveness has been assessed in a post market
clinical trial.
CLINICAL TRIAL RESULTS
A 13-month, prospective, cluster-randomized, multi-arm, unblinded clinical study with acontrol was conducted at 40 dialysis facilities throughout the United States only. Facilities
were pair-matched and randomly assigned to treatment or control group. The treatmentgroup received the ClearGuard HD Antimicrobial Barrier Cap and the control group
received the Tego™ Connector with the Curos™ Disinfecting Cap. The primary study
endpoint was PBC rate. There were no other primary study endpoints but an ad hoc exploratory analysis of CLABSI was also conducted. 1,671 subjects participated in the study
during the primary and exploratory analyses, accruing approximately 183,000 CVC-daysin the primary
analysis1. The subject enrollment is shown in Table 1 and the subject demographics areshown in Table 2
Table 1. Subject Enrollment During the Intervention Period

Investigation
Device Arm(ClearGuard HD)

Control Device
Arm(Tego+Curos)

Total in Both
Arms

Subjects enrolled

951

960

1911

Subjects excluded for history of heparin allergy

9

0

9

Subjects receiving treatment

942

960

1902

Subjects excluded due to treatment ≤21 days

116

115

231

Subjects in primary and exploratory analyses

826

845

1671

Stage

Table 2. Subject Demographics During the Intervention Period

Characteristic

Treatment
Group

All

ControlGroup

P-Value

No. of Facilities

40

20

20

No. of CVC Subjects

1671

826

845

Age, y62.8 ± 14.9

63.7 ± 14.4

62.0 ± 15.3

0.02

Gender (% Male)

856 (51)421 (51)435 (51)

0.8

Race
Caucasion
African American
Hispanic
Other
Missing

778 (47)621 (37)
171 (10)98 (6)3 (0)414 (50)267 (32)
83 (10)60 (7)2 (0)364 (43)354 (42)88 (10)38 (5)
1 (0)Diabetes

998 (60)477 (58)521 (62)

0.1

Dialysis vintage, y

1.7 ± 3.2

1.6 ± 3.3

1.8 ± 3.2

0.2

<0.001

Note: Values for categorical variables are given as number (percentage); values for continuous variables, asmean ± standard deviation.
As is standard policy at the participating facilities, blood culture results were reported into
the electronic health record in automated fashion and to the National Healthcare Safety
Network (NHSN) Dialysis Event (DE) Form, from which they were abstracted for analysis.
The pre-specified primary study endpoint was PBC rate. This study demonstrated that useof the ClearGuard HD Antimicrobial Barrier Caps resulted in a statistically significant