(113 days)
No
The device description and performance studies focus on mechanical and electrical integrity, with no mention of AI or ML technologies.
No
The device is described as an adaptor for connecting pacing leads to a pulse generator, serving a mechanical and electrical connection purpose rather than directly providing a therapeutic effect.
No
Explanation: The device is described as a lead adaptor kit designed to connect pacing leads to a pulse generator, and its purpose is validated through device integrity testing, not diagnostic performance metrics. It facilitates the function of another device (pulse generator) rather than diagnosing a condition.
No
The device description explicitly details physical components made of stainless steel, MP35N, and silicone rubber, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect pacing leads to a pulse generator. This is a direct connection to an implanted medical device, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The components (stainless steel connectors, conductor coils, silicone rubber insulation) are consistent with an implantable medical device component, not a diagnostic reagent or instrument used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, the Model 2872 Lead Adaptor Kit is a component of an implantable medical device system, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
74DTD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Implanted in a pacemaker pocket;
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Medtronic, Inc. performed device integrity testing to support the Model 2872 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
510(k) Summary
| 1. SUBMITTER'S NAME
& ADDRESS | Brian Edwards, Product Regulation Manager
Medtronic, Inc.
7000 Central Avenue NE
Minneapolis, MN 55432
Phone: (612) 514-3962
Fax: (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 Device
Panel into Class III, (21 CFR 870.3680(a)). | | |
| 3. SUBSTANTIALLY
EQUIVALENT 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 packaged
in the kit are wrench / setscrew assemblies, and a tube of medical
grade adhesive. | | |
| 5. INDICATIONS FOR USE | The Model 2872 Lead Adaptor Kit is designed to connect two pacing
leads with bipolar connectors (IS-1 BI) to a pulse generator featuring a
bipolar connector block which meets the IS-1 BI standard. | | |
| 6. TECHNOLOGICAL
CHARACTERISTIC
COMPARISONS | The Model 2872 Bipolar Lead Adaptor Kit is substantially equivalent to
the following product:
Medtronic Model 5866-38M Lead Adaptor Kit (K911302)
The table that follows contains a comparison of the similarities and
differences of the Model 2872 to the predicate devices to which it is
substantially equivalent. Similarities between the Model 2872 and the
comparison device are noted. | | |
| Feature | Model 2872 Lead Adaptor | Model 5866-38M Lead
Adaptor (K911302) | |
| Lead Adaptor Type | Bipolar | | |
| Intended use (including
anatomical site) | Implanted in a pacemaker pocket;
intended to connect two pacing
leads with bipolar connectors (IS-1
BI)* to a pulse generator featuring
a bipolar connector block which
meets the IS-1 BI* standard | Implanted in a pacemaker
pocket; intended to connect two
pacing leads with unipolar
connectors (IS-1UNI)* to a pulse
generator featuring a bipolar
connector block which meets the
(IS-1 BI)* standard. | |
| Application | Permanent Implantable bipolar
lead adaptor kit | | |
| | | | |
| (Minimum) Device Compatability | Medtronic pulse generators
featuring a bipolar connector block
which 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 block
Ring / ring connector block | maximum 200Ω
maximum 200Ω | maximum 15Ω
maximum 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 Model
2872 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 (STATEMENT
OF 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 | | |
1
26
2
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
3
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
4
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'.