(29 days)
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
This appears to be a 510(k) summary for a medical device (lead extender and adaptor kits), not a study evaluating software or AI performance. Therefore, many of the requested categories for AI/software studies are not applicable.
Here's an analysis based on the provided text, focusing on the available information regarding acceptance criteria and performance testing for these hardware devices:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | Safety and effectiveness ensured through device design controls | Verification Included: |
| Dielectric Withstanding Voltage Test | Not explicitly stated what the passing criteria are, but implied to meet standards for safety. | Passed through performance testing. |
| Saline Soak / Electrical Impedance | Not explicitly stated what the passing criteria are, but implied to meet standards for safety. | Passed through performance testing. |
| Fluid Leakage | Not explicitly stated what the passing criteria are, but implied to meet standards for safety. | Passed through performance testing. |
| Composite Tensile Integrity | Not explicitly stated what the passing criteria are, but implied to meet standards for physical durability. | Passed through performance testing. |
| Composite Tensile Strength | Not explicitly stated what the passing criteria are, but implied to meet standards for physical durability. | Passed through performance testing. |
| Lead Body Reverse Bend | Not explicitly stated what the passing criteria are, but implied to meet standards for physical durability and lead integrity. | Passed through performance testing. |
| Biocompatibility Assessment | Not explicitly stated, but implied to meet standards for patient safety and biological compatibility. | Verification Included: |
| Cytotoxicity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Sensitization | Not explicitly stated. | Passed through biocompatibility assessment. |
| Irritation or Intracutaneous Reactivity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Systemic Toxicity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Genotoxicity | Not explicitly stated. | Passed through biocompatibility assessment. |
| Implantation | Not explicitly stated. | Passed through biocompatibility assessment. |
| Sterilization Testing | Not explicitly stated, but implied to meet standards for ensuring a sterile product. | Verification Included: |
| Residual Testing | Not explicitly stated. | Passed through sterilization testing. |
Study Proving Device Meets Acceptance Criteria:
The document describes a "Performance Testing" section which details verification tests conducted on the modified Lead Adaptor Kit and Lead Extender Kit products. The study explicitly states: "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."
The conclusion states: "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)."
This implies that the study proving the device meets the acceptance criteria is the comprehensive set of verification tests (Performance, Biocompatibility, Sterilization) conducted under Design Controls (21 CFR 820.30) to establish substantial equivalence to predicate devices. The specific results for each test are not numerical but are reported as "verified" or "passed."
Regarding the AI/Software specific questions (not applicable to this device submission):
This submission is for physical medical devices (lead extenders and adaptors), not a software or AI-driven device. Therefore, the following information is not present and is not relevant to this type of 510(k) submission:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a hardware device. No "data" in the AI sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for hardware performance is established by engineering standards and objective measurements.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For these hardware devices, the ground truth is based on engineering specifications, material properties, and regulatory standards for safety and performance (e.g., electrical impedance measurements, tensile strength, biocompatibility tests).
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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2.0 510(k) Summary
| Date Prepared: | June 28, 2013 | |
|---|---|---|
| Submitter: | Medtronic, Inc.Medtronic Cardiac Rhythm Disease Management8200 Coral Sea Street N.E.Mounds View, MN 55112Establishment Registration Number: 2182208 | JUL 3 0 2013 |
| Contact Person: | Michele L Machacek MSSenior Regulatory Affairs SpecialistMedtronic Cardiac Rhythm Disease ManagementPhone: 763.526.2382Fax: 651.367.0603Email: michele.l.machacek@medtronic.com | |
| Alternate Contact:Wendy SaundersSenior Regulatory Affairs ManagerMedtronic Cardiac Rhythm Disease ManagementPhone: 763.526.8134Fax: 651.367.0603Email: 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 |
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K132008
| Common Name: | 6986M Lead Extender KitPacemaker 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 forPermanent 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 Kit5866-38M Lead Adaptor Kit5866-40M Lead Adaptor Kit |
6986M Lead Extender Kit
Device Description/Indications for Use
| Model | Device Description/Indications for Use |
|---|---|
| 6981M LeadExtender 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 meetsthe (IS-1 UNI) standard. |
| 6984M LeadExtender Kit | The 6984M Lead Extender Kit is designed to extend, by 37 cm (14.6in.), the length of a pacing lead system with a bipolar connector thatmeets the (IS-1 BI) standard. |
| 5866-24M LeadAdaptor Kit | The 5866-24M Lead adaptor kit is designed to connect a Medtronicpacing lead with a bipolar connector (5mm bifurcated) to a pulsegenerator featuring a bipolar connector block which meets the (IS-1 BI)standard. |
| 5866-38M LeadAdaptor Kit | The 5866-38M Lead adaptor kit is designed to connect two pacing leadswith unipolar connectors (IS-1 UNI) to a pulse generator featuring abipolar connector block which meets the (IS-1 BI) standard. |
| 5866-40M LeadAdaptor Kit | The Model 5866-40M Lead Adaptor Kit is designed to connect aMedtronic pacing lead with a bipolar connector (3.2 mm low-profile) toa pulse generator featuring a bipolar connector block which meets the(1S-1 BI) standard and has a short-pin cavity and no sealing rings. |
:
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| 6986M LeadExtender 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 leadsystem and connect to a pulse generator featuring a bipolar connectorblock 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 ●
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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).
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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.
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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
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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'
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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)
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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)
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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)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
§ 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.”