(260 days)
The Medtronic Model 6416 Temporary. Transvenous Pacing Lead System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording.
The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile.
The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector.
The Model 6416 lead consists of a small distal active fixation helix, tip and ring electrodes, an insulated coaxial conductor, and two staggered pin, low-profile bifurcation connectors. The Model 6416 system also includes a guiding catheter which is used for percutaneous lead introduction and placement in the heart. After implantation of the lead, the catheter is removed, and the lead's connectors are attached to an external pulse generator for a contemplated implant duration of up to 7 days. After completion of therapy, the lead is removed by counter-rotation and gentle traction. No part of the device remains in the body.
The provided text describes a 510(k) summary for the Medtronic Model 6416 Bipolar Temporary Transvenous Pacing Lead. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel performance criteria through a clinical study with acceptance criteria in the typical sense of new device development.
Therefore, the information you're requesting regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically found for algorithms or diagnostic devices making claims about accuracy or effectiveness, is not present in this type of submission. This 510(k) is about device integrity and comparison to a predicate, not clinical performance measures like sensitivity, specificity, or reader improvement with AI.
However, I can extract the "performance" data that is usually presented in these types of submissions, which relates to device integrity testing.
Here's a summary of what's available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission like this are generally that the new device meets its own internal specifications and is substantially equivalent to a predicate device. The "device performance" in this context refers to the results of engineering and integrity testing.
| Acceptance Criteria (Implicit: Met specified requirements) | Reported Device Performance |
|---|---|
| Visual verification to specified requirements | All test results met specified requirements. |
| Dimensional verification to specified requirements | All test results met specified requirements. |
| Electrical verification to specified requirements | All test results met specified requirements. |
| Flex life verification to specified requirements | All test results met specified requirements. |
| Pull strength verification to specified requirements | All test results met specified requirements. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "device integrity testing" which implies a set of physical devices were tested, but the number is not provided.
- Data Provenance: Not applicable in the sense of patient data. The provenance is from internal Medtronic engineering testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. The "ground truth" for these tests are engineering specifications and measurements, not clinical expert consensus.
- Qualifications of Experts: Not applicable. The tests are industrial engineering and quality control tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Results are based on measurable physical and electrical properties compared to predefined specifications.
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
- MRMC Study: No. This is a medical device (pacing lead), not a diagnostic algorithm. Therefore, an MRMC study and AI-assisted performance metrics are not relevant or performed for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: No. This is not an algorithm; it is a physical medical device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Engineering specifications and physical/electrical measurement standards.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is not an AI/ML model that requires a training set. The device design is based on engineering principles and previous device models.
9. How the Ground Truth for the Training Set was Established
- Establishment of Ground Truth for Training Set: Not applicable. There is no training set in the context of this device. The design and validation are based on established engineering and manufacturing standards.
In summary: The provided text is a 510(k) summary for a physical medical device, not a diagnostic algorithm or a device requiring clinical performance claims in the traditional statistical sense. The "studies" performed relate to ensuring the device meets its own engineering specifications and demonstrating substantial equivalence to predicate devices, which is the primary requirement for 510(k) clearance.
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MAY 2 6 1998
Model 6416 Bipolar Temporary Transvenous Pa 510(k) Summary
510(k) Summary
| 1. SUBMITTER'S NAME& ADDRESS | Susan Noddin, Product Regulation ManagerMedtronic, Inc.7000 Central Avenue NEMinneapolis, MN 55432Phone: (612) 514-6191Fax: (612) 514-6424 | |
|---|---|---|
| 2. TRADE NAME: | Bipolar transvenous temporary pacing lead, Model 6416 | |
| Common Name: | Temporary Pacing Lead | |
| Classification Name: | Temporary Pacemaker Electrode | |
| Classification | This device has been classified by the Circulatory Systems DevicePanel into Class II, (21 CFR 870.3680(a)). | |
| 3. SUBSTANTIALLYEQUIVALENT DEVICE(S) | Temporary Transvenous Pacing Lead, Medtronic Model 6704,marketed via K772103, K790261Medtronic Vector X Guiding Catheter, marketed via K950179 | |
| 4. DEVICE DESCRIPTION | The Model 6416 lead consists of a small distal active fixation helix, tipand ring electrodes, an insulated coaxial conductor, and two staggeredpin, low-profile bifurcation connectors. The Model 6416 system alsoincludes a guiding catheter which is used for percutaneous leadintroduction and placement in the heart. After implantation of the lead,the catheter is removed, and the lead's connectors are attached to anexternal pulse generator for a contemplated implant duration of up to 7days. After completion of therapy, the lead is removed by counter-rotation and gentle traction. No part of the device remains in the body. | |
| 5. INDICATIONS FOR USE | The Medtronic Model 6416 Temporary, Transvenous Pacing LeadSystem features an active fixation, bipolar lead and a soft-tippedlubricated guide catheter. The system is designed for temporaryintracardiac pacing and/or EGM recording. The system is disposable,for temporary single patient use with a contemplated implant duration of7 days or less. The lead and accessories are supplied sterile. The leadis introduced transvenously using the guide catheter. Once within theappropriate chamber, the helical tip electrode of the lead is actively fixedinto the endocardium. After lead placement, the guide catheter isremoved by sliding it over the lead's bifurcated connector. | |
| 6. TECHNOLOGICALCHARACTERISTICCOMPARISONS | The bipolar transvenous temporary pacing lead system, Model 6416 issubstantially equivalent to the following products:Bipolar temporary transvenous pacing lead, Medtronic Temptron Model6704 (K772103, K790261).Medtronic Vector X Guiding Catheter (K950179).The table that follows contains a comparison of the similarities anddifferences of the Model 6416 to the predicate devices to which it issubstantially equivalent. Similarities between the Model 6416 and thecomparison devices are noted. | |
| Feature | Model 6416 Lead | Model 6704 Lead |
| Lead Type | Temporary, single-use | Same |
| Intended use (including anatomicalsite) | Transvenous atrial and ventricularbipolar pacing | Transvenous ventricular bipolarpacing |
| Lead Introduction Method | Percutaneous, assisted bydisposable guiding catheter | Percutaneous, assisted bydisposable introducer |
| (Minimum) Device Compatability | Medtronic external cardiacstimulators and cable accessories | Same |
| Distal configuration | Straight with fixation helix | Straight, no fixation |
| Lead Body | 3.5 French coaxial wire16-wire braid with 3 innerconductors | 4 French coaxial wire16-wire braid with 3 innerconductors |
| Ring and Tip Electrodes | 316L stainless steel | 316 / 304 stainless steel |
| Electrode surface area | Tip: 4.3 mm²Ring: 17 mm² | Tip: 12 ± 1 mm²Ring: 20 ± 2 mm² |
| Electrode ring:tip ratio | 4:1 | 1.6:1 |
| Electrode spacing | 1 centimeter | Same |
| Outer Insulation material | Polyethylene | Same |
| Inner insulation material | FEP | Nylon |
| Lead length | 100, 140, & 200 cm | 110 cm |
| Connector type | Staggered pin, low profilebifurcation | In-line connector with separatebifurcation assembly |
| Connector polarity markings | Long (-) & short (+) wires | Molded (+) and (-) on connectors |
| Included accessories | Catheter, hemostasis valve/ cap,torque tool | Bifurcation assy/ introducer set |
| Sterilization Method | 100% EtO | Same |
| Packaging | 5 sterile packages per carton | Same |
| Feature | Model 6416 Guiding Catheter | Vector X Guiding Catheter |
| Guiding Catheter | Radiopaque marker bands | No marker bands |
| All other features | Same | Same |
| 7. SUMMARY OF STUDIES | Medtronic, Inc. performed device integrity testing to support the Model6416 is substantially equivalent to the predicate devices.Device integrity testing included: | |
| Visual verification | Dimensional verification | |
| Electrical verificationFlex life verification | Pull strength 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 6416. |
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MAY 26 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Susan Noddin Product Regulation Manager Medtronic, Inc. 7000 Central Avenue, N.E. Minneapolis, MN 55432-3576
Re : K973360 Trade Name: Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead System Requlatory Class: II Product Code: LDF Dated: March 19, 1998 Received: March 20, 1998
Dear Ms. Noddin:
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 A substantially equivalent determination assumes compliance with 895. 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 assumptions. 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
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Page 2 - Ms. Susan Noddin
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 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 (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahon
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 Medtronic Model 6416 Temporary. Transvenous Pacing Lead System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording.
The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile.
The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector.
(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 | K973360 |
| Prescription Use | / |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use |
|---|
| (Optional Format 1-2-96) |
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§ 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.