(113 days)
The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 Bl)* to a pulse generator featuring a bipolar connector block which meets the IS-1 Bl* standard.
*IS-1 refers to an International Connector Standard (ISO 5841-3; 1992) whereby pulse generators and leads so designated are assured of a basic mechanical fit.
The Model 2872 lead adaptor consists of stainless steel connectors, MP35N conductor coils, and silicone rubber insulation. Also packaged in the kit are wrench / setscrew assemblies, and a tube of medical grade adhesive.
Here's an analysis of the provided K982220 510(k) summary, detailing the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The K982220 submission is for a medical device (Bipolar Lead Adaptor Kit) and the "acceptance criteria" are essentially the performance requirements and specifications that the new device (Model 2872) had to meet to demonstrate substantial equivalence to its predicate device (Medtronic Model 5866-38M Lead Adaptor Kit). The "reported device performance" refers to the results of the tests conducted on the Model 2872.
It's important to note that for this type of device, the "acceptance criteria" are primarily engineering specifications and not diagnostic performance metrics like sensitivity/specificity.
| Feature / Acceptance Criteria | Reported Device Performance (Model 2872) | Comments |
|---|---|---|
| Visual verification | Met specified requirements | Performed |
| Dimensional verification | Met specified requirements | Performed |
| Electrical verification | Met specified requirements | Performed |
| Pull strength verification | Met specified requirements | Performed |
| Flex life verification | Met specified requirements | Performed |
| Resistance: Tip / tip connector block | maximum 200Ω | Specified maximum allowed resistance |
| Resistance: Ring / ring connector block | maximum 200Ω | Specified maximum allowed resistance |
Note on Resistance Criteria: The summary explicitly lists the maximum allowed resistance for the new device as 200Ω for both tip/tip connector block and ring/ring connector block. When comparing to the predicate device, it states the predicate had a maximum of 15Ω for both. This difference is listed as a feature difference, but the submission indicates the new device met its specified requirements, implying the 200Ω was the target for the new device and it achieved it. This suggests a different electrical performance target or design for the new device compared to the predicate, but it was deemed acceptable by Medtronic for substantial equivalence.
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary does not explicitly state the sample sizes for the device integrity testing (visual, dimensional, electrical, pull strength, flex life verification). It simply states that "Medtronic, Inc. performed device integrity testing" and "All test results for the device met specified requirements."
Given the nature of bench testing for a lead adaptor, samples would typically consist of a statistically significant number of manufactured units or prototypes to ensure reliability and consistency. However, the exact number is not provided in this summary.
Data Provenance: The studies were performed by Medtronic, Inc., which implies an internal, prospective bench testing approach during the device development and validation process. The country of origin of the data would be the United States, where Medtronic, Inc. is based and where the testing was presumably conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this 510(k) submission. For a device like a pacemaker lead adaptor, "ground truth" doesn't involve expert medical interpretation or diagnosis. Instead, the "ground truth" is established by:
- Engineering specifications and standards: The device must meet predefined electrical, mechanical, and material properties.
- International standards: The device must adhere to standards like ISO 5841-3; 1992 (IS-1).
- Comparison to a legally marketed predicate device: The new device must demonstrate "substantial equivalence" to a device already on the market through performance testing.
Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set. The validation relies on technical specifications and engineering testing.
4. Adjudication Method for the Test Set
This is not applicable to this 510(k) submission. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple experts evaluate patient data (e.g., medical images) and their discrepancies need to be resolved. For bench testing of a device's physical and electrical properties, there's typically no need for such an adjudication process. Test results are either within specification or not.
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
This is not applicable to this 510(k) submission. This device is a passive, implantable medical component (a lead adaptor), not an AI-powered diagnostic tool or a system that involves human readers interpreting data. Therefore, an MRMC study and AI-related performance metrics are irrelevant for this type of device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable to this 510(k) submission. There is no algorithm involved in the function of a pacemaker lead adaptor. It is a physical connector.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Engineering specifications and performance standards: The device must meet predefined thresholds for resistance, pull strength, flex life, and dimensional accuracy.
- Compliance with international standards: Specifically, the IS-1 standard (ISO 5841-3; 1992) for basic mechanical fit of pacemaker components.
- Demonstration of substantial equivalence to a predicate device: The predicate (Medtronic Model 5866-38M) serves as the benchmark for acceptable performance and safety.
8. The Sample Size for the Training Set
This is not applicable to this 510(k) submission. The device is not based on a machine learning algorithm; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above (no training set for a non-AI device).
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510(k) Summary
| 1. SUBMITTER'S NAME& ADDRESS | Brian Edwards, Product Regulation ManagerMedtronic, Inc.7000 Central Avenue NEMinneapolis, MN 55432Phone: (612) 514-3962Fax: (612) 514-6424 | ||
|---|---|---|---|
| 2. TRADE NAME: | Bipolar lead adaptor kit, Model 2872 | ||
| Common Name: | Pacemaker Lead Adaptor | ||
| Classification Name: | Adaptor, Lead, Pacemaker 74DTD | ||
| Classification | This device has been classified by the Circulatory Systems DevicePanel into Class III, (21 CFR 870.3680(a)). | ||
| 3. SUBSTANTIALLYEQUIVALENT DEVICE(S) | Medtronic Model 5866-38M Lead Adaptor Kit, marketed via K911302 | ||
| 4. DEVICE DESCRIPTION | The Model 2872 lead adaptor consists of stainless steel connectors,MP35N conductor coils, and silicone rubber insulation. Also packagedin the kit are wrench / setscrew assemblies, and a tube of medicalgrade adhesive. | ||
| 5. INDICATIONS FOR USE | The Model 2872 Lead Adaptor Kit is designed to connect two pacingleads with bipolar connectors (IS-1 BI) to a pulse generator featuring abipolar connector block which meets the IS-1 BI standard. | ||
| 6. TECHNOLOGICALCHARACTERISTICCOMPARISONS | The Model 2872 Bipolar Lead Adaptor Kit is substantially equivalent tothe following product:Medtronic Model 5866-38M Lead Adaptor Kit (K911302)The table that follows contains a comparison of the similarities anddifferences of the Model 2872 to the predicate devices to which it issubstantially equivalent. Similarities between the Model 2872 and thecomparison device are noted. | ||
| Feature | Model 2872 Lead Adaptor | Model 5866-38M LeadAdaptor (K911302) | |
| Lead Adaptor Type | Bipolar | ||
| Intended use (includinganatomical site) | Implanted in a pacemaker pocket;intended to connect two pacingleads with bipolar connectors (IS-1BI)* to a pulse generator featuringa bipolar connector block whichmeets the IS-1 BI* standard | Implanted in a pacemakerpocket; intended to connect twopacing leads with unipolarconnectors (IS-1UNI)* to a pulsegenerator featuring a bipolarconnector block which meets the(IS-1 BI)* standard. | |
| Application | Permanent Implantable bipolarlead adaptor kit | ||
| (Minimum) Device Compatability | Medtronic pulse generatorsfeaturing a bipolar connector blockwhich meets the IS-1BI standard | ||
| Conductor Material | MP35N conductor coils | ||
| Outer Insulation material | Silicone rubber | ||
| Connector Material | Stainless Steel | ||
| Lead adaptor length | 130 mm | 139.7 mm | |
| Lead adaptor body diameter | 2.31mm | ||
| Resistance:Tip / tip connector blockRing / ring connector block | maximum 200Ωmaximum 200Ω | maximum 15Ωmaximum 15Ω | |
| Connector type | IS-1BI | ||
| Included accessories | Wrench and setscrew assemblies,tube of medical adhesive | ||
| Sterilization Method | 100% EtO | ||
| Packaging materials | Spunbonded olefin tray and pouch | ||
| 7. SUMMARY OF STUDIES | Medtronic, Inc. performed device integrity testing to support the Model2872 is substantially equivalent to the predicate device.Device integrity testing included: | ||
| Visual verification | Dimensional verification | ||
| Electrical verification | Pull strength verification | ||
| Flex life verification | |||
| All test results for the device met specified requirements. | |||
| 8. CONCLUSION (STATEMENTOF EQUIVALENCE) | Through the data and information provided in this submission,numerous similarities support a substantial equivalence determination,and, therefore, clearance of the 510(k) notification for the Model 2872 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
OCT 1 5 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian J. Edwards, M.S. Product Regulation Manager Medtronic, Inc. 7000 Central Avenue NE Minneapolis, MN 5543 2-3576
Re: K982220 Model 2872 Bipolar Lead Adaptor Kit Trade Name: Regulatory Class: III Product Code: DTD Dated: October 1, 1998 Received: October 2, 1998
Dear Mr. Edwards:
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 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). 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.
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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such accumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 obligation you might have under sections 531 through 542 of the Act
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Page 2 - Mr. Brian J. Edwards
for devices under the Electronic Product Radiation Control provisions,
or other Federal laws or requiations or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) promarket 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotions of Compliance advertising of your device, please contact the office of Compliance at (301) 594-4639. Also, please note the regulation entitle of Co.
"Misbranding by reference the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97) . 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 (101) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. CallaHan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
The Model 2872 Lead Adaptor Kit is designed to connect two pacing leads with bipolar connectors (IS-1 Bl)* to a pulse generator featuring a bipolar connector block which meets the IS-1 Bl* standard.
*IS-1 refers to an International Connector Standard (ISO 5841-3; 1992) whereby pulse generators and leads so designated are assured of a basic mechanical fit.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K982220
Prescription Use
OR
Over-The-Counter
Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Image /page/4/Picture/7 description: The image shows a handwritten symbol that appears to be a stylized number '3' with a small superscript '+1' to its upper right. The number '3' is drawn with curved lines, giving it a somewhat abstract appearance. The '+1' is smaller in size and positioned slightly above and to the right of the '3'.
§ 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.”