(29 days)
Not Found
No
The summary describes a passive pacing lead with no mention of computational or adaptive capabilities typically associated with AI/ML.
Yes
The device is a lead specifically designed for pacing and sensing, which are therapeutic functions for an implantable pacing system, used to treat conditions like arrhythmias by regulating heart rhythm.
No
The device is described as a lead designed for "pacing and sensing" within an implantable pacing system, indicating a therapeutic rather than diagnostic function. While it performs sensing, this is for the purpose of pacing, not for diagnosing a condition in itself.
No
The device description clearly details physical components like an electrode, barbed tip, suture holes, conductor, insulation, and connector, 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 the body (in vitro).
- Device Function: The Medtronic Model 4951M Myocardial Lead is an implantable device designed for pacing and sensing within the heart (atrium or ventricle). It is surgically placed inside the body.
- Intended Use: The intended use clearly states it's for pacing and sensing in an implantable pacing system. This is a therapeutic and diagnostic function performed in vivo (within the living body).
The description focuses on the physical characteristics of the lead and its function within the heart, not on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.
Product codes (comma separated list FDA assigned to the subject device)
DTB
Device Description
The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated. Two leads may be used for bipolar pacing.
The lead features a platinized electrode that can be secured to the heart by gently pushing the barbed tip into the epicardium and securing it in myocardial tissue. Suture holes in the polyurethane base pad are provided for greater security. A polyester mesh allows for fibrous ingrowth for additional fixation. The lead also features an MP35N nickel alloy conductor, polyurethane insulation, and an IS-1 Unipolar (UNI) lead connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrium or ventricle (heart)
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)
Based on the bench test results for lead Model 4073 and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as a strain relief material in Model 4951M.
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.
Not Found (The text states "The predicate device for the Model 4951M Lead is the currently market released Model 4951M Lead." but does not provide a K/DEN number for this predicate.)
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.
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
Special 510(k) Premarket Notification Attachment C: 510(k) Summary of Substantial Equivalence Model 4951M Lead
MAY 1 6 2003
ATTACHMENT C 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 (763) 514-6424 Fax: E-Mail: tina.benoit@medtronic.com
Date Prepared: April 15, 2003
Name of Device
| Device Name: | Medtronic® Model 4951M Myocardial, Unipolar
Lead |
|-----------------------|----------------------------------------------------------------------------------|
| Device Classification | Cardiovascular Permanent Pacemaker Electrode
Class III, 21 CFR, Part 870.3680 |
| Classification Panel | Cardiovascular |
| Product Code: | DTB |
Image /page/0/Picture/11 description: The image shows the Medtronic logo. The logo consists of a symbol on the left and the word "Medtronic" in bold, black letters. To the right of the word "Medtronic" is the word "Confidential" in a smaller, non-bold font.
1
Predicate Devices
The predicate device for the Model 4951M Lead is the currently market released Model 4951M Lead.
Device Description
The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated. Two leads may be used for bipolar pacing.
The lead features a platinized electrode that can be secured to the heart by gently pushing the barbed tip into the epicardium and securing it in myocardial tissue. Suture holes in the polyurethane base pad are provided for greater security. A polyester mesh allows for fibrous ingrowth for additional fixation. The lead also features an MP35N nickel alloy conductor, polyurethane insulation, and an IS-1 Unipolar (UNI) lead connector.
Intended Use
The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.
Technological Characteristics
The technology used with the Model 4951M Lead has is the same technological characteristics as the predicate device.
Summary of Studies
Based on the bench test results for lead Model 4073 and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as a strain relief material in Model 4951M.
Image /page/1/Picture/13 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image of a person inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.
2
Packaging
The packaging configuration of the modified Model 4951M Myocardial Unipolar Lead has not changed from the market released configuration of the Model 4951 M Myocardial Unipolar Lead (510(k) Document Control Number K894040, cleared 07/14/89, and K913288, cleared 10/17/91).
Sterilization Validation
The Model 4951M Lead is sterilized using a 100% Ethylenc 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 4951M Lead is supported through this Special 510(k) Premarket Notification.
Image /page/2/Picture/8 description: The image shows the Medtronic logo and the word "Confidential" to the right of the logo. The Medtronic logo consists of a stylized human figure inside a circle with radiating lines. The word "Medtronic" is in a bold, sans-serif font. The word "Confidential" is in a smaller, lighter font.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Druci Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2003
Medtronic, Inc. c/o Ms. Tina Benoit Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432
Re: K031210
Trade Name: Medtronic® Model 4951M Myocardial, Unipolar Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode Regulatory Class: Class III (three) Product Code: DTB Dated: April 16, 2003 Received: April 17, 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
4
Page 2 - Ms. Tina 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
N. Oelletuh
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
| 510(k) Number (if
| known): | K031210 |
|---|---|
| Device Name: | Medtronic® Model 4951M Myocardial, Unipolar Lead |
| Indications For Use: | The Medtronic Model 4951M Myocardial, IS-1 Unipolar |
| Lead is designed for pacing and sensing in either the | |
| atrium or ventricle. The lead has application where an | |
| implantable atrial, ventricular or dual-chamber pacing | |
| system is 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 1-2-96)
Kacatur
510(k)