(30 days)
The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated.
The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing. The lead's screw-in electrode is designed to be secured to the myocardium with two clockwise turns. A polyester mesh allows fibrous ingrowth for additional fixation. The lead requires no stab wounds or sutures for electrode placement and fixation. Tissue damage from electrode insertion may be compared to the insertion of a 15guage needle. The lead features a MP35N nickel alloy conductor, silicone rubber insulation, and an IS-1 Unipolar (UNI) lead connector.
The provided document is a 510(k) summary for the Medtronic Model 5071 Myocardial Pacing Lead, seeking substantial equivalence to an already marketed predicate device (the original Model 5071 Lead). This type of submission focuses on demonstrating that a modified device is as safe and effective as a legally marketed predicate device, rather than proving efficacy from scratch with a new device.
Therefore, the document does not contain information typically found in studies designed to prove a device meets specific performance acceptance criteria through clinical trials or detailed standalone algorithm performance evaluations. Instead, it relies on bench testing and material characterization to show that the modified device is still substantially equivalent to the predicate device.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting when the information is not applicable or present for a 510(k) submission of this nature:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. A 510(k) Special submission for minor modifications typically focuses on showing that the modifications do not affect the safety or effectiveness, often by referencing existing predicate device performance and material equivalency. Specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy for an AI device) are not part of this submission type for a pacing lead.
2. Sample size used for the test set and the data provenance
The document mentions "bench test results for lead Models 5568, 5024M, and 5524M and the MED-4719 material characterization and biocompatibility testing," but does not specify sample sizes for these tests nor the data provenance (e.g., country of origin, retrospective/prospective). These are likely internal engineering tests rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes bench testing and material characterization for a pacing lead, not a device requiring expert interpretation of diagnostic output (like an AI imaging device). Ground truth for a pacing lead would involve physical integrity, electrical performance, and biocompatibility, typically assessed through engineering standards and laboratory analyses.
4. Adjudication method for the test set
This information is not applicable for the same reasons as point 3.
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 information is not applicable. The device is a myocardial pacing lead, not an AI-powered diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical implant (pacing lead), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Summary of Studies," the "ground truth" implicitly refers to engineering standards, material specifications, and validated characterization methods for the lead and insulation material. For example, biocompatibility testing would compare against established safety profiles for materials in contact with human tissue.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of a physical medical device like a pacing lead. This concept applies to AI/machine learning algorithms.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
In summary:
The provided K031274 document is a 510(k) submission for a modification to a myocardial pacing lead, focusing on demonstrating substantial equivalence to a predicate device. It primarily relies on bench test results and material characterization to support this claim, rather than clinical studies with human subjects or AI algorithm performance evaluations. As such, most of the requested information pertains to study designs not relevant to this specific regulatory submission for this type of product.
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Model 5071 Lead
ATTACHMENT C MAY 22 2003 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE
Submitter
Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432
Contact: Tina Benoit, Regulatory Affairs Specialist Telephone: (763) 514-4112 Fax: (763) 514-6424 E-Mail: tina.benoit(a)medtronic.com
Date Prepared: April 21, 2003
Name of Device
| Device Name: | Medtronic® Model 5071 Myocardial Pacing Lead |
|---|---|
| Device Classification: | Cardiovascular Permanent Pacemaker ElectrodeClass III, 21 CFR, Part 870.3680 |
| Classification Panel: | Cardiovascular |
| Product Code: | DTB |
Predicate Devices
The predicate device for the Model 5071 Lead is the currently market released Model 5071 Lead.
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Device Description
The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing
The lead's screw-in electrode is designed to be secured to the myocardium with two clockwise turns. A polyester mesh allows fibrous ingrowth for additional fixation.
The lead requires no stab wounds or sutures for electrode placement and fixation. Tissue damage from electrode insertion may be compared to the insertion of a 15guage needle.
The lead features a MP35N nickel alloy conductor, silicone rubber insulation, and an IS-1 Unipolar (UNI) lead connector.
Packaging
The packaging configuration of the modified Model 5071 Lead has not changed from the market release configuration of the Model 5071 Lead (510(k) Document Control Number K902002, cleared 09/26/90, and K915736, cleared 12/03/92).
Intended Use
The Medtronic Model 5071 sutureless. unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated.
Technological Characteristics
The technology used with the Model 5071 Lead has is the same technological characteristics as the predicate device.
Summary of Studies
Based on the bench test results for lead Models 5568, 5024M, and 5524M and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as an insulation material in Model 5071.
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Sterilization Validation
The Model 5071 Lead is sterilized using a 100% Ethylene Oxide (EtO) sterilization process.
Conclusion
Through data and information presented, numerous similarities support a determination of substantial equivalence and show the device modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. Market clearance of the Model 5071 Lead is supported through this Special 510(k) Premarket Notification.
Tma D Benoit
Tina L. Benoit Regulatory Affairs Specialist Medtronic. Inc.
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INDICATIONS FOR USE
| 510(k) Number (ifknown): | K031274 |
|---|---|
| Device Name: | Medtronic† Model 5071 Myocardial Pacing Lead |
| Indications For Use: | The Medtronic Model 5071 sutureless, unipolar,myocardial, screw-in lead is designed for ventricularpacing and sensing. The lead has application wherepermanent ventricular or dual-chamber pacing systems areindicated. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
Image /page/3/Picture/9 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image on the left and the word "Medtronic" in bold, black letters. The word "Confidential" is in a smaller font size and is located to the right of the Medtronic logo. The image is likely a header or footer from a document.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that appears to be three stylized human profiles facing to the right, with flowing lines connecting them. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2003
Medtronic, Inc. c/o Ms. Tina L. Benoit Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432-3576
Re: K031274
Trade Name: Model 5071 Myocardial Pacing Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Pacemaker leads Regulatory Class: Class III (three) Product Code: DTB Dated: April 17, 2003 Received: April 23, 2003
Dear Ms. Benoit:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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Page 2 - Ms. Tina L. Benoit
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); 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(k) Number (if known): | K031274 |
|---|---|
| Device Name: | Medtronic® Model 5071 Myocardial Pacing Lead |
| Indications For Use: | The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-95) Delbert Th
51
Confidential
12
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.