Ponto bone anchored hearing system

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 23, 2015 Oticon Medical AB Ms. Carolina Wessling Quality Assurance and Regulatory Affairs Manager Datavägen 37B SE-436 32 Askim Sweden Re: K152067 Trade/Device Name: Ponto Bone Anchored Hearing System Regulation Number: 21 CFR 874.3300 Regulation Name: Hearing Aid Regulatory Class: Class II Product Code: MAH Dated: October 27, 2015 Received: October 30, 2015 Dear Ms. Wessling: We have reviewed your Section 510(k) premarket 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 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.gov/MedicalDevices/Safety/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 Industry and Consumer Education 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. # Eric A. Mann -S for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known):__K152067 Device Name: Ponto Bone Anchored Hearing System Indications for Use: The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications: - . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors. - . Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 dB at individual frequencies. - Patients who have a profound sensorineural hearing loss in one ear and normal hearing in ● the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). - 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 CROS. The placement of a bone anchored implant is contraindicated for patient below the age of 5. The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models). | Prescription Use X | AND/OR | Over-The-Counter Use | |-------------------------------|--------|-------------------------------| | (Per 21 C.F.R. 801 Subpart D) | | (Per 21 C.F.R. 807 Subpart C) | (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of Center for Devices and Radiological Health (CDRH) Page 1 of {3}------------------------------------------------ # 510(k) SUMMARY # Oticon Medical AB's Ponto bone anchored hearing system Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared | Submitter: | Oticon Medical AB<br>Datavägen 37B<br>SE-436 32 Askim<br>Sweden | | |-----------------|-----------------------------------------------------------------|--| | | Phone: +46 31 748 6100<br>Facsimile: +46 (0) 31 68 77 56 | | | Contact Person: | Carolina Anker Wessling<br>Phone: +46 76 168 63 32 | | | Date Prepared: | October 6, 2015 | | | Name of Device: | Ponto bone anchored hearing system | | Common or Usual Name: Hearing Aid, Bone Conduction Classification Name: Hearing Aid, Bone Conduction, Implanted Predicate Devices Primary predicate device: | 510(k) | Device name | Manufacturer | |---------|----------------------------------|-------------------| | K112053 | OBC Bone Anchored Hearing System | Oticon Medical AB | Additional predicate devices: | K142678 | Ponto Bone Anchored Hearing system/ Abutment, 14mm. | Oticon Medical AB | |---------|-----------------------------------------------------|-------------------| | K121228 | Ponto Bone Anchored Hearing System | Oticon Medical AB | ## Purpose of the 510(k) notice The scope of this 510(k) submission is a modification to the 4.5 mm diameter Ponto implant, introducing Ponto BHX implants with a modified surface topography on parts of the implant. The purpose of the modification is to enhance osseointegration properties of the implant. In addition, minor modifications have been made to surgical instruments for a less invasive surgical approach, i.e. Minimally Invasive Ponto Surgery (MIPS). {4}------------------------------------------------ # Intended Use The Ponto bone anchored hearing system intended use is for improvement of hearing for patients with conductive and mixed hearing losses, bilateral fitting and single-sided deafness. # Indications for Use The Ponto bone anchored hearing system (Ponto sound processors and implant system) is intended for the following patients and indications: - . Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto, Ponto Pro and Ponto Plus sound processors, 55 dB HL for use with Ponto Pro Power and Ponto Plus Power sound processors. - . Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 db on average measured at 0.5, 1, 2 and 4 kHz, or less than 15 db at individual frequencies. - . Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. single sided deafness or "SSD"). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). - . 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 CROS. The placement of a bone anchored implant is contraindicated for patient below the age of 5. The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models). # Technological Characteristics The Ponto bone anchored hearing system consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. The technological characteristics of the Ponto bone anchored hearing system remain substantially unchanged from the original design. A modification has been made to the 4.5 mm diameter implant, introducing Ponto BHX implants with a rougher surface topography on parts of the implant. The purpose of the modification is to enhance osseointegration properties of the implant. In addition, minor modifications have been made to surgical instruments for a less invasive surgical approach, Minimally Invasive Ponto Surgery (MIPS), for installation of Ponto implants. Instead of a linear incision, a single circular incision is created by means of a biopsy punch equivalent in size to the implant/abutment, enabling access for placement of the implant in the bone. {5}------------------------------------------------ #### Performance Data The modified device has been tested in comparison to the previously cleared device to verify the performance to support safety and effectiveness. Surface characterization and performance data including drill performance and cutting ability and bone anchorage of the implant show that the modified device is as safe and effective as the previously cleared device. #### Substantial Equivalence The modified Ponto bone anchored hearing system has the same intended use and indications, the same principles of operation, and the same technological characteristics as the previously cleared Ponto bone anchored hearing system (K112053, K121228, K142678). The only difference is the rougher implant surface topography on parts of the Ponto BHX implants, and the modified surgical instruments used for installation of Ponto implants through Minimally invasive Ponto surgery. Performance data demonstrates that the modified device is as safe and effective as the previously cleared Ponto bone anchored hearing system and that the system will perform as intended during use. Thus, the modified Ponto bone anchored hearing system is substantially equivalent to its predicate device.