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Timestamp: 2018-06-24 18:40:48
Document Index: 688967386

Matched Legal Cases: ['arts 800', 'art 807', 'art 80', 'art 820', 'art 801', 'art 807', 'art 803']

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Food and Drug Administration 10903 Newv Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Cochlear Amenicas d/o Monica Montanez, MS RS, RAC Senior Regulatory Specialist 13059 East Peak-view Avenue Centennial, CO 801 11
JUL 1 32010
Re: K100360 Trade/Device Name: Cochlear Baha® Auditory Osseointegrated Implant System: Model BI 300 Implant and Model BA300 Abutment Regulation Number: 21 CER 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: LXB Dated: June 22, 201 0 Received: June 23, 201 0 Dear Ms. Montanez: We have reviewed your Section 5 10(k) prernarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal. Regulations, Title 2 1, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2 - Monica Montanez, MS RS, RAC Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 80]); medical-device reporting (reporting-of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CER Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm I I15809.hitm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, &quot;Misbranding by reference to premarket notification&quot; (2ICFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.g~ov/Medical Devices/Safetv/ReportaProblem/default.htm for the CDRH 's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default~htm. Sincerely yours,
Malvina B. Eydelman, M.D. Director 1 Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure
Indications for Use 510(k) Number (if known): K100360
Device Name: Cochlear Baha® auditory osseointegrated implant system using model B31300 implant and model BA300 abutment Indications For Use: The Cochlear Baha®f auditory osseointegrated implant system using model B1300 implant and model BA300 abutment is intended for the following patients and indications for use: * * Patients aged 5 and older. Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL for use with the BPI 00 sound processor, 55 dB HL for use with the Intenso sound processor, and 65 dB HL for use with the Cordelle LI sound processor. Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1,2, and 3 kHz), or less than a 15 dB difference at individual frequencies. Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness; SSDTM). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL. Baha for SSD is also indicated for any patient who is indicated for an air conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CR05.
(21 CER 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) I Division of Ophthalmic, Neurological and Ear,
Nose and Troat Devices
5iD(k)Number