(298 days)
No
The device description and performance studies focus on the physical and electrical properties of a temporary pacing lead, with no mention of AI or ML capabilities.
Yes
The device is designed for temporary atrial and ventricular pacing and sensing, which are therapeutic interventions to support cardiac function.
No
This device is a temporary pacing lead designed for stimulating the heart, not for diagnosing conditions. Its primary function is to deliver electrical impulses for pacing and sensing, not to identify or characterize a disease or condition.
No
The device description clearly details physical components like electrodes, conductors, needles, and a connector ring, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Model 6495 bipolar temporary myocardial pacing lead is a device that is inserted into the body (in vivo) to directly stimulate the heart muscle for pacing and sensing. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "temporary atrial and ventricular pacing and sensing," which is a direct intervention on the body, not an in vitro test.
Therefore, based on the provided information, the Model 6495 is a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The bipolar temporary myocardial pacing wire, Model 6495 is designed for temporary atrial and ventricular pacing and sensing, for a maximum of the days, during and after cardiac surgery. The Model 6495 is intended for single use only.
The Model 6495 bipolar temporary myocardial pacing lead is designed for temporary atrial and ventricular pacing and sensing, for a maximum of 7 days, during and after cardiac surgery. The Model 6495 bipolar temporary myocardial pacing lead is intended for SINGLE USE ONLY.
Product codes
LDF
Device Description
The bipolar temporary myocardial pacing wire, Model 6495 consists of a distal electrode, and a coaxial conductor which are crimped together. A blue polypropylene fiber proximally coiled (flattered coil) for fixation of the lead is attached to the distal electrode and terminated in an atraumatic curved needle. An atraumatic breakaway chest needle at the other end of the conductor wire permits running the lead through the chest wall. Proximal to the chest needle is a connector ring crimped to the conductor wire.
After removal of the pacing wire, which is performed by gentle traction, no part of the wire remains in the body.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Medtronic, Inc. performed device integrity testing to support the bipolar temporary myocardial pacing wire, Model 6495 is substantially equivalent to the predicate devices.
Device integrity testing included:
- Visual verification
- X-ray & Dimensional verification
- Electrical verification
- Pull strength verification
- Flex life verification
- Connector compatibility
- Break moment of thorax needle .
All device integrity test results for the bipolar temporary myocardial pacing wire, Model 6495 met specified requirements.
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
§ 870.3680 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
MEDTRONIC CONFIDENTIAL
G: 510(K) SUMMARY
1. SUBMITTER'S NAME, ADDRESS
Susan M. Noddin Associate Product Regulation Manager Medtronic, Inc. 7000 Central Avenue NE Minneapolis, MN 55432 Phone: (612) 574-6191 Fax: (612) 574-6424
JUL 22 1997
| 2. TRADE NAME: | Bipolar temporary myocardial pacing wire, Model 6495 |
|---|---|
| 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 Myocardial Pacing Wire, Medtronic Model |
| 6500, marketed via K944957 | |
| Bipolar temporary Myocardial Heart Wire, Oscor Model | |
| TME 65 C, marketed via K850622 |
4. DEVICE DESCRIPTION
The bipolar temporary myocardial pacing wire, Model 6495 consists of a distal electrode, and a coaxial conductor which are crimped together. A blue polypropylene fiber proximally coiled (flattered coil) for fixation of the lead is attached to the distal electrode and terminated in an atraumatic curved needle. An atraumatic breakaway chest needle at the other end of the conductor wire permits running the lead through the chest wall. Proximal to the chest needle is a connector ring crimped to the conductor wire.
After removal of the pacing wire, which is performed by gentle traction, no part of the wire remains in the body.
5. INDICATIONS FOR USE
The bipolar temporary myocardial pacing wire, Model 6495 is designed for temporary atrial and ventricular pacing and sensing, for a maximum of the days, during and after cardiac surgery. The Model 6495 is intended for single use only.
6. TECHNOLOGICAL CHARACTERISTIC COMPARISONS
The bipolar temporary myocardial pacing wire, Model 6495 is substantially equivalent to the following products:
- Unipolar temporary myocardial pacing wire, Medtronic Model 6500, marketed via K944957 .
- Bipolar temporary myocardial heart wire, Oscor Medical Corporation Model TME 65 C, marketed via ● K850622
1
MEDTRONIC CONFIDENTIAL
The table below contains a comparison of the similarities and differences of the Model 6495 to the predicate devices to which it is substantially equivalent. Similarities between the Model 6495 and the comparison devices are noted.
The bipolar temporary myocardial pacing wire, Model 6495 contains technologies comparable to Medtronic, Inc. temporary myocardial pacing lead, Model 6500. The proximal end of the Model 6495 ends in a straight chest needle, similar to the Model 6500. The conductor wire material is stainless steel, identical to that of the Model 6500 and the Oscor Model TME 65 C. The insulation materials for the Model 6495 are identical to the Model 6500 and the Model TME 65 C. The distal end is identical to the Model 6500, and similar to the Model TME 65 C. The Model 6495 utilizes the double pouch package configuration, identical to that utilized by the Model 6500. The Model 6495 uses the same 100% EtO sterilization process as the Model 6500. The Model 6495 is a bipolar heartwire, as is the Model TME 65 C myocardial heartwire.
| Manufacturer | Medtronic | Oscor Medical | Medtronic |
|---|---|---|---|
| Model No. | 6495 | TME 65 C | 6500 |
| 510(k) Number | K850622 | K944957 | |
| Intended Use | Temporary | ||
| Myocardial Pacing | |||
| and Sensing | Same | Same | |
| Bipolar | Bipolar | Unipolar | |
| Electrode | Two discrete | ||
| electrodes | Ring electrode and | ||
| wire | Tip | ||
| Electrode and | |||
| Conductor Material | Stainless Steel | Same | Same |
| Fixation Mode | "Pigtail" Coil | Zigzag and suturing | "Pigtail" Coil |
| Outer Insulation | |||
| Material | Polyethylene | Same | Same |
| Insulated Wire | |||
| Diameter (nominal) | 0.7mm | 0.45 mm | 0.7mm |
| Proximal Needle | |||
| Shape and | |||
| Breakaway Feature | |||
| Size (nominal) | Straight | ||
| Breakaway | |||
| L = 88mm | |||
| D = 1.0mm | Slightly curved | ||
| L= 80mm | |||
| D = 1.12 mm | Straight | ||
| Breakaway | |||
| L = 90 mm | |||
| D = 1.0 mm | |||
| Distal Needle | |||
| Shape | |||
| Size (nominal) | 3/8 | ||
| Curved | |||
| L = 32mm | |||
| D = 0.38mm | 1/2 | ||
| Curved | |||
| L=16mm | |||
| D = 0.52 mm | 3/8 | ||
| Curved | |||
| L = 25mm | |||
| D = 0.66mm | |||
| Sterile Package | |||
| Configuration | Blister/Pouch | Pouch/Pouch | Blister/Pouch |
| Sterile Packaging | |||
| Materials | spunbounded | ||
| olefin-PE/Polyester | not known | spunbounded olefin | |
| -PE/Polyester | |||
| Sterilization & | |||
| Aeration Process | 100% EtO | not known | 100% EtO |
2
MEDTRONIC CONFIDENTIAL
7. SUMMARY OF STUDIES
Medtronic, Inc. performed device integrity testing to support the bipolar temporary myocardial pacing wire, Model 6495 is substantially equivalent to the predicate devices.
Device integrity testing included:
- Visual verification ●
- X-ray & Dimensional verification .
- Electrical verification .
- Pull strength verification .
- Flex life verification
- Connector compatibility
- Break moment of thorax needle .
All device integrity test results for the bipolar temporary myocardial pacing wire, Model 6495 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 bipolar temporary myocardial pacing wire, Model 6495.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Ms. Susan Noddin Product Regulation Manager Medtronic, Inc. Mediconic, The .
7000 Central Avenue, N.E. . . . . . JUL 2 2 1997 Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minneapolis, Minn
Re: K963898 Model 6495 Bipolar Temporary Pacing Lead Regulatory Class: III (three) Product Code: LDF Dated: April 24, 1997 Received: April 25, 1997
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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this 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.
4
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) 594-4648. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Medtronic Confidential
Indications For Use
INDICATIONS FOR USE
The Model 6495 bipolar temporary myocardial pacing lead is designed for temporary atrial and ventricular pacing and sensing, for a maximum of 7 days, during and after cardiac surgery. The Model 6495 bipolar temporary myocardial pacing lead is intended for SINGLE USE ONLY.
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(Division Sign-Off) Division of Cardiovascular, Respirato and Neurological Devices 4963898 510(k) Number_
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