(79 days)
BK-N Sealing Caps are intended for use as components of cardiac pacing systems. BK-N Sealing Caps provide a permanent barrier of silicone insulation between the electrical conductive elements of the implantable therapeutic device lead(s) or adapter(s) and the physiological environment. BK-N Sealing Caps are designed to accommodate lead diameters of 4F, 5F and 7F.
BIOTRONIK BK-N Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility. BK-N Sealing Caps are designed to be chronically implantable. The material of construction is Silopren LSR-4070.
I am sorry, but the provided text does not contain the specific information required to complete the table and answer all the questions regarding acceptance criteria and a study proving device performance.
The document is a 510(k) submission for the BIOTRONIK BK-N Sealing Cap, focusing on its substantial equivalence to previously marketed devices and changes in material. While it discusses the device's design, materials, and some testing, it does not present a detailed study with acceptance criteria and reported device performance in the format requested.
It mentions that "All production and biocompatibility test results were within specifications," but it does not elaborate on what those specifications (acceptance criteria) were or provide specific quantitative results of the tests.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Biocompatibility: "The material of construction is Silopren LSR-4070... thoroughly tested for biocompatibility, and is commonly used in many market-released Class III products..." | "Acute and chronic biocompatibility tests have been performed, as well as long-term implantation studies." "All production and biocompatibility test results were within specifications." |
| Ease of Use: (Implied) | Tested for ease of use. "All production... test results were within specifications." |
| Withstand Temperature Change: (Implied for sealed components) | Tested for ability to withstand temperature change. "All production... test results were within specifications." |
| Required Extraction Force of Lead (following ligature application): (Implied) | Tested for required extraction force of lead. "All production... test results were within specifications." |
| Electrical Insulation (following storage in warmed, aerated saline - in-vitro testing): (Implied for chronic implantable device) | Tested for electrical insulation. "All production... test results were within specifications." |
| ETO Residues: (Implied for sterilization) | Tested for ETO residues. "All production... test results were within specifications." |
| Packaging and Transportation Durability: (Implied for device integrity) | Tested for packaging and transportation durability. "All production... test results were within specifications." |
| Sterilization Validation: (Implied for sterility) | Performed for sterilization validation. "All production... test results were within specifications." |
Missing Information for the Table: No specific quantitative acceptance criteria or corresponding quantitative performance results are provided in the document for any of these tests. The document only broadly states that results were "within specifications."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified. The document mentions tests were performed by BIOTRONIK, suggesting internal testing, but details like location or whether it was retrospective/prospective are not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable to the type of testing described (material and functional engineering tests). This information is typically relevant for studies involving subjective human assessment (e.g., image interpretation).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for the type of testing described (material and functional engineering tests).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a TRMC comparative effectiveness study was not done. This type of study is not relevant for this device. The document describes engineering and biocompatibility testing for a physical implantable component, not a diagnostic AI system or a system requiring human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- A standalone performance assessment was done in the sense that the device itself was subjected to various tests (biocompatibility, electrical insulation, extraction force, etc.) without human interaction as part of its functional performance evaluation. However, this is not a "standalone algorithm performance" in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the tests mentioned (biocompatibility, electrical insulation, etc.) would be established by engineering specifications, industry standards, and regulatory requirements for such medical devices, along with validated laboratory test methods and equipment. For example, a successful biocompatibility test would mean the material elicited no unacceptable biological response according to established standards.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
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AUG 1 4 1997
1.2 Safety and Effectiveness Summary
BIOTRONIK BK-N Sealing Caps are single-component silicone devices, designed to be safe and effective through design functionality, simplicity and material biocompatibility.
BK-N Sealing Caps are designed to be chronically implantable. The material of construction is Silopren LSR-4070, which has been extensively used by BIOTRONIK in cardiac pacing lead designs. FDA has reviewed and cleared this material in the following submissions:
BK Series Sealing Caps 510(k) #K970204 Cleared April 29, 1997
Dromos DR and SR Pulse Generators PMA #P950037 Approved October 11, 1996
TIR and TIJ Endocardial Leads 510(k) #K953044 Cleared September 27, 1996
Physios CTM 01 Pulse Generator and ELC XX-UP Epicardial Lead IDE #G960045 Approved August 22, 1996.
Silopren LSR-4070 has been thoroughly tested for biocompatibility, and is commonly used in many market-released Class III products, including pacemaker and defibrillator leads and their accessories. Acute and chronic biocompatibility tests have been performed, as well as long-term implantation studies.
BK-N Sealing Caps are tested for ease of use, ability to withstand temperature change, required extraction force of lead (following ligature application), electrical insulation following storage in warmed, aerated saline (in-vitro testing), and ETO residues. Packaging and transportation durability as well as sterilization validation have been performed to ensure the quality and sterility of the delivered product.
All production and biocompatibility test results were within specifications; therefore, when the currently proposed BK-N Sealing Caps are in use, the patient will be exposed to no risks in excess of those experienced by patients using comparable competitor sealing caps distributed in the United States, or older model BIOTRONIK sealing caps. Complications arising from usage may include body rejection phenomena, fibrosis, displacement, infection, and erosion. BIOTRONIK is not aware of any other adverse safety and effectiveness data on these accessories.
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In accordance with the Safe Medical Device Act of 1990, a thorough literature search for adverse safety and effectiveness data on pacemaker lead sealing caps was performed. The search yielded no articles related to the safety of pacemaker lead sealing caps.
1.3 Previous 510(k) Submittals
In a letter dated August 9, 1991 (#K911142), FDA provided notification it had determined the BK Series Sealing Caps were Class III devices substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976. The BK-N Sealing Caps addressed in that 510(k) document were constructed of HTV silicone.
1.4 Summary of Proposed Changes
1.4.1 DEVICE CHANGES
BIOTRONIK is proposing the following changes to the BK-N Sealing Cap:
- MOC will be Silopren LSR-4070 .
- MOC change requires slight changes in sealing cap design .
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
AUG 1 4 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Kenneth P. Jensen Regulatory Affairs BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, Oregon 97035-5369
Re : K971930 BK-N Sealing Cap Regulatory Class: III (three) Product Code: DTD Dated: May 23, 1997 Received: May 27, 1997
Dear Mr. Jensen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Kenneth P. Jensen
obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulation.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to ------------conduct postmarket surveillance studies. FDA has identified under Section 522(a) (1) (A) the device cleared for marketing by this letter as requiring postmarket surveillance.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date or initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q) (1) (C) of the Act (21 U.S.C. 331 (q)(1)(C). Further, under section 502(t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of
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the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch-- ---at (301) 594-0639. "
In addition, on August 16, 1993, the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirement of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Walker.
Thomas JV Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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1.1.1 INDICATIONS FOR USE
BK-N Sealing Caps are intended for use as components of cardiac pacing systems. BK-N Sealing Caps provide a permanent barrier of silicone insulation between the electrical conductive elements of the implantable therapeutic device lead(s) or adapter(s) and the physiological BK-N Sealing Caps are designed to accommodate lead diameters of 4F, 5F and environment. 7F.
(Division Sign-Off) Division of Cardiovascular, and Neurological Device 510(k) Number .
§ 870.3620 Pacemaker lead adaptor.
(a)
Identification. A pacemaker lead adaptor is a device used to adapt a pacemaker lead so that it can be connected to a pacemaker pulse generator produced by a different manufacturer.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for the Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510(k) Submissions.”