(260 days)
Not Found
No
The document describes a temporary pacing lead system and its mechanical and electrical properties, with no mention of AI or ML in its function, description, or testing.
Yes
The device is designed for "temporary intracardiac pacing," which is a therapeutic intervention for heart rhythm disorders.
No
The device is primarily designed for temporary intracardiac pacing, which is a therapeutic function. While it also mentions "EGM recording," this is a secondary function used to confirm placement or monitor cardiac activity in support of the pacing therapy, rather than being the primary purpose of diagnosing a condition.
No
The device description clearly outlines physical components (lead, electrodes, conductor, connectors, guide catheter) and describes a physical implantation and removal process, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Medtronic Model 6416 Temporary Transvenous Pacing Lead System is an implantable medical device used for temporary electrical stimulation of the heart (pacing) and/or recording of electrical signals from the heart (EGM recording). It is introduced directly into the body.
- Intended Use: The intended use clearly states "temporary intracardiac pacing and/or EGM recording." This involves direct interaction with the patient's internal organs, not the analysis of samples outside the body.
Therefore, this device falls under the category of an implantable or invasive medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LDF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transvenous intracardiac
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Medtronic, Inc. performed device integrity testing to support the Model 6416 is substantially equivalent to the predicate devices. 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Manager
Medtronic, Inc.
7000 Central Avenue NE
Minneapolis, MN 55432
Phone: (612) 514-6191
Fax: (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 Device
Panel into Class II, (21 CFR 870.3680(a)). | |
| 3. SUBSTANTIALLY
EQUIVALENT DEVICE(S) | Temporary Transvenous Pacing Lead, Medtronic Model 6704,
marketed via K772103, K790261
Medtronic Vector X Guiding Catheter, marketed via K950179 | |
| 4. DEVICE DESCRIPTION | 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. | |
| 5. 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. | |
| 6. TECHNOLOGICAL
CHARACTERISTIC
COMPARISONS | The bipolar transvenous temporary pacing lead system, Model 6416 is
substantially equivalent to the following products:
Bipolar temporary transvenous pacing lead, Medtronic Temptron Model
6704 (K772103, K790261).
Medtronic Vector X Guiding Catheter (K950179).
The table that follows contains a comparison of the similarities and
differences of the Model 6416 to the predicate devices to which it is
substantially equivalent. Similarities between the Model 6416 and the
comparison devices are noted. | |
| Feature | Model 6416 Lead | Model 6704 Lead |
| Lead Type | Temporary, single-use | Same |
| Intended use (including anatomical
site) | Transvenous atrial and ventricular
bipolar pacing | Transvenous ventricular bipolar
pacing |
| Lead Introduction Method | Percutaneous, assisted by
disposable guiding catheter | Percutaneous, assisted by
disposable introducer |
| (Minimum) Device Compatability | Medtronic external cardiac
stimulators and cable accessories | Same |
| Distal configuration | Straight with fixation helix | Straight, no fixation |
| Lead Body | 3.5 French coaxial wire
16-wire braid with 3 inner
conductors | 4 French coaxial wire
16-wire braid with 3 inner
conductors |
| Ring and Tip Electrodes | 316L stainless steel | 316 / 304 stainless steel |
| Electrode surface area | Tip: 4.3 mm²
Ring: 17 mm² | Tip: 12 ± 1 mm²
Ring: 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 profile
bifurcation | In-line connector with separate
bifurcation 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 Model
6416 is substantially equivalent to the predicate devices.
Device integrity testing included: | |
| | Visual verification | Dimensional verification |
| | Electrical verification
Flex life verification | Pull strength 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 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
4
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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