(29 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of lead extenders and adaptors, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an extender and adaptor kit for pacing lead systems, designed to connect pacing leads to pulse generators or extend their length. It does not directly provide therapeutic treatment itself but facilitates the function of a therapeutic device (the pacing system).
No
The device description indicates that the kits are designed to extend or adapt the length and connection type of pacing lead systems to pulse generators. There is no mention of the device being used to diagnose a medical condition or ailment.
No
The device description and performance studies clearly indicate that the device is a physical lead extender and adaptor kit, not a software product.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The descriptions clearly state that these devices are lead extenders and adaptors designed to connect pacing leads to pulse generators. They are components of an implantable cardiac pacing system.
- Intended Use: The intended use is to extend or adapt the connection of pacing leads, which are implanted in the body to deliver electrical impulses to the heart. This is an in-vivo application, not an in-vitro one.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, these devices are medical devices, but they fall under the category of implantable or accessory devices for cardiac pacing, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- 6981M Lead Extender Kit: The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard.
- 6984M Lead Extender Kit: The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard.
- 5866-24M Lead Adaptor Kit: The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
- 5866-38M Lead Adaptor Kit: The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
- 5866-40M Lead Adaptor Kit: The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings.
- 6986M Lead Extender Kit: The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.
Product codes
DTD
Device Description
- 6981M Lead Extender Kit: The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard.
- 6984M Lead Extender Kit: The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard.
- 5866-24M Lead Adaptor Kit: The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
- 5866-38M Lead Adaptor Kit: The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
- 5866-40M Lead Adaptor Kit: The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings.
- 6986M Lead Extender Kit: The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The assessment of the material change being made to the Lead Adaptor Kit and Lead Extender Kit products was carried out using Design Controls compliant to 21 CFR 820.30. The safety and effectiveness of the product has been ensured through performance testing. Verifications included:
Performance Testing
- Dielectric Withstanding Voltage Test .
- Saline Soak / Electrical Impedance .
- Fluid Leakage .
- . Composite Tensile Integrity
- Composite Tensile Strength .
- Lead Body Reverse Bend .
Biocompatibility Assessment - . Cytotoxicity
- Sensitization .
- Irritation or Intracutaneous Reactivity ●
- Systemic Toxicity ●
- Genotoxicity ●
- . Implantation
Sterilization Testing - Residual Testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
2.0 510(k) Summary
| Date Prepared: | June 28, 2013 | |
|---|---|---|
| Submitter: | Medtronic, Inc. | |
| Medtronic Cardiac Rhythm Disease Management | ||
| 8200 Coral Sea Street N.E. | ||
| Mounds View, MN 55112 | ||
| Establishment Registration Number: 2182208 | JUL 3 0 2013 | |
| Contact Person: | Michele L Machacek MS | |
| Senior Regulatory Affairs Specialist | ||
| Medtronic Cardiac Rhythm Disease Management | ||
| Phone: 763.526.2382 | ||
| Fax: 651.367.0603 | ||
| Email: michele.l.machacek@medtronic.com | ||
| Alternate Contact: | ||
| Wendy Saunders | ||
| Senior Regulatory Affairs Manager | ||
| Medtronic Cardiac Rhythm Disease Management | ||
| Phone: 763.526.8134 | ||
| Fax: 651.367.0603 | ||
| Email: wendy.a.saunders@medtronic.com | ||
| Device Name and Classification |
| Trade Name: | 6981M Lead Extender Kit |
|---|---|
| 6984M Lead Extender Kit | |
| 5866-24M Lead Adaptor Kit | |
| 5866-38M Lead Adaptor Kit | |
| 5866-40M Lead Adaptor Kit |
1
K132008
| Common Name: | 6986M Lead Extender Kit
Pacemaker Lead Adaptor |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 870.3620 |
| Product Code: | DTD |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
| Special Controls: | "Guidance for the Submission of Research and Marketing Applications for
Permanent Pacemaker Leads and for Pacemaker Lead Adaptor 510 (k)
Submissions" |
| Predicate Devices | |
| K911827 | 6981M Lead Extender Kit |
| K915724 | 6984M Lead Extender Kit |
| K911302 | 5866-24M Lead Adaptor Kit
5866-38M Lead Adaptor Kit
5866-40M Lead Adaptor Kit |
6986M Lead Extender Kit
Device Description/Indications for Use
| Model | Device Description/Indications for Use |
|---|---|
| 6981M Lead | |
| Extender Kit | The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), |
| the length of a pacing lead system with a unipolar connector that meets | |
| the (IS-1 UNI) standard. | |
| 6984M Lead | |
| Extender Kit | The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 |
| in.), the length of a pacing lead system with a bipolar connector that | |
| meets the (IS-1 BI) standard. | |
| 5866-24M Lead | |
| Adaptor Kit | The 5866-24M Lead adaptor kit is designed to connect a Medtronic |
| pacing lead with a bipolar connector (5mm bifurcated) to a pulse | |
| generator featuring a bipolar connector block which meets the (IS-1 BI) | |
| standard. | |
| 5866-38M Lead | |
| Adaptor Kit | The 5866-38M Lead adaptor kit is designed to connect two pacing leads |
| with unipolar connectors (IS-1 UNI) to a pulse generator featuring a | |
| bipolar connector block which meets the (IS-1 BI) standard. | |
| 5866-40M Lead | |
| Adaptor Kit | The Model 5866-40M Lead Adaptor Kit is designed to connect a |
| Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to | |
| a pulse generator featuring a bipolar connector block which meets the | |
| (1S-1 BI) standard and has a short-pin cavity and no sealing rings. |
:
2
| 6986M Lead
Extender Kit | The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm
(14.6 in.), the length of a 3.2 mm low-profile connector pacing lead
system and connect to a pulse generator featuring a bipolar connector
block that meets the (IS-1 BI) standard. |
| ---------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Comparison to Predicate Devices
When compared to the predicate devices (K911827, K915724 & K911302), the Medtronic Lead Adaptor Kit and Lead Extender Kit models presented in this submission have the following similarities:
- . Intended use
- Technological characteristics .
- Operating principle ●
- Design features ●
- . Performance
- Biological safety .
- Packaging materials .
- Sterilization and sterility assurance level �
- . Shelf life
Performance Testing
The assessment of the material change being made to the Lead Adaptor Kit and Lead Extender Kit products was carried out using Design Controls compliant to 21 CFR 820.30. The safety and effectiveness of the product has been ensured through performance testing. Verifications included:
Performance Testing
- Dielectric Withstanding Voltage Test .
- Saline Soak / Electrical Impedance .
- Fluid Leakage .
- . Composite Tensile Integrity
- Composite Tensile Strength .
- Lead Body Reverse Bend .
Biocompatibility Assessment
- . Cytotoxicity
- Sensitization .
- Irritation or Intracutaneous Reactivity ●
3
K132008
- Systemic Toxicity ●
- Genotoxicity ●
- . Implantation
Sterilization Testing
- Residual Testing .
Conclusion
Medtronic has demonstrated that the modifications made to the Lead Adaptor Kit and Lead Extender Kit products described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate device(s).
4
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with three arms or lines extending upwards, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2013
Medtronic, Inc. Michele Machacek 8200 Coral Sea Street NE Mounds View, MN 55112 US
Re: K132008
Trade/Device Name: 6981M, 6984M, 6986M Lead Extender Kits 5866-24M, 5866-38M, 5866-40M Lead Adaptors Regulation Number: 21 CFR 870.3620 Regulation Name: Pacemaker Lead Adaptor Regulatory Class: Class II Product Code: DTD Dated: June 28, 2013 Received: July 1. 2013
Dear Michele Machacek:
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.
ff 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.
5
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,
Owen P. Faris -S
- for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): K132008
Device Name:
6981M Lead Extender Kit
Indications for Use:
The 6981M Lead extender kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a unipolar connector that meets the (IS-1 UNI) standard.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
.
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Digitally signed by
Owen P. Faris -S
Date: 2013.07.30
10:24:22 -04'00'
7
510(k) Number (if known): K132008
Device Name:
6984M Lead Extender Kit
Indications for Use: The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6 in.), the length of a pacing lead system with a bipolar connector that meets the (IS-1 BI) standard.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
8
510(k) Number (if known): K132008
Device Name:
5866-24M Lead Adaptor Kit
Indications for Use: The 5866-24M Lead adaptor kit is designed to connect a Medtronic pacing lead with a bipolar connector (5mm bifurcated) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use
(21 CFR 807 Subpart C) |
|-------------------------------------------------|--------|------------------------------------------------|
| X | | |
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
9
510(k) Number (if known): K132008
Device Name:
5866-38M Lead Adaptor Kit
Indications for Use: The 5866-38M Lead adaptor kit is designed to connect two pacing leads with unipolar connectors (IS-1 UNI) to a pulse generator featuring a bipolar connector block which meets the (IS-I BI) standard.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
10
510(k) Number (if known): K132008
Device Name:
5866-40M Lead Adaptor Kit
Indications for Use: The Model 5866-40M Lead Adaptor Kit is designed to connect a Medtronic pacing lead with a bipolar connector (3.2 mm low-profile) to a pulse generator featuring a bipolar connector block which meets the (IS-1 BI) standard and has a short-pin cavity and no sealing rings.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
11
510(k) Number (if known): K132008
Device Name:
6986M Lead Extender Kit
Indications for Use:
The 6986M Lead adaptor/Extender kit is designed to extend, by 37 cm (14.6 in.), the length of a 3.2 mm low-profile connector pacing lead system and connect to a pulse generator featuring a bipolar connector block that meets the (IS-1 BI) standard.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)