(60 days)
Not Found
Not Found
No
The document describes a physical medical device (a pacing wire) and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "temporary cardiac pacing," which indicates it is used for treatment by providing pacing to the heart.
Yes
The device is described as being for "temporary cardiac pacing or monitoring." Monitoring involves observing or checking the state of something, which in a medical context often includes gathering information to assess a patient's condition, making it a diagnostic activity.
No
The device description clearly details physical components like wires, needles, and insulation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "temporary cardiac pacing or monitoring." This involves direct interaction with the patient's body (myocardium) for therapeutic or monitoring purposes.
- Device Description: The device is a wire lead designed to be inserted into the myocardium. This is an invasive procedure.
- Anatomical Site: The anatomical site is the "myocardium," which is heart muscle tissue within the living body.
- Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on specimens.
The device is clearly intended for direct clinical use within the patient's body, which is characteristic of a medical device used for treatment or monitoring, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Temporary Cardiac Pacing Wire with wave is intended for use in temporary cardiac pacing or monitoring.
The Temporary Cardiac Pacing Wire with wave has the same intended use as predicate device Temporary Cardiac Pacing Wire (TPW).
The Temporary Cardiac Pacing Wire is intended for use in temporary cardiac pacing or monitoring.
Product codes (comma separated list FDA assigned to the subject device)
LDF
Device Description
The Temporary Cardiac Pacing Wire with wave is a lead that consists of an uninsulated multifilament stainless steel wire electrode and an insulated multifilament conductor coated with blue polyethylene attached to a straight Keith needle. There is no exposed wire at the point of the swage to the straight Keith needle. The Keith needle is scored eliminating the need to cut the needle. The Keith needle is connected to an external temporary cardiac pacing or monitoring device. A 'wave' is preformed into the uninsulated distal end, then attached to a curved needle.
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)
Nonclinical laboratory testing was performed to determine pullout force after implantation. It was determined that the Temporary Cardiac Pacing Wire with wave has an increased resistance to pullout force after it is inserted into the myocardium when compared to the predicate device.
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.
Temporary Cardiac Pacing Wire (TPW)
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
APR 1 0 1998
SECTION 7
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
MODIFIED DEVICE NAME: Temporary Cardiac Pacing Wire
PREDICATE DEVICE NAME: Temporary Cardiac Pacing Wire
510(k) SUMMARY
Device Description
The Temporary Cardiac Pacing Wire with wave is a lead that consists of an uninsulated multifilament stainless steel wire electrode and an insulated multifilament conductor coated with blue polyethylene attached to a straight Keith needle. There is no exposed wire at the point of the swage to the straight Keith needle. The Keith needle is scored eliminating the need to cut the needle. The Keith needle is connected to an external temporary cardiac pacing or monitoring device. A 'wave' is preformed into the uninsulated distal end, then attached to a curved needle.
Continued on next page
Temporary Cardiac Pacing Wire with wave ETHICON, Inc.
1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
:
な
?
510(k) SUMMARY, Continued
| Intended Use | The Temporary Cardiac Pacing Wire with wave is intended for
use in temporary cardiac pacing or monitoring.
The Temporary Cardiac Pacing Wire with wave has the same
intended use as predicate device Temporary Cardiac Pacing
Wire (TPW). |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications Statement | The Temporary Cardiac Pacing Wire with wave is intended for
use in temporary cardiac pacing or monitoring. |
| Technological
Characteristics | The modified device has the same technological
characteristics as the predicate device. There is no change in
material, insulated coating or electrical resistance. |
| Performance Data | Nonclinical laboratory testing was performed to determine
pullout force after implantation. It was determined that the
Temporary Cardiac Pacing Wire with wave has an increased
resistance to pullout force after it is inserted into the
myocardium when compared to the predicate device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR
807) and the information provided herein, we conclude that the
new device is substantially equivalent to the Predicate Device
under the Federal Food, Drug, and Cosmetic Act. |
| Contact | Gregory R. Jones
Director, Regulatory Affairs
ETHICON, Inc.
Rt. #22, West
Somerville, NJ 08876-0151 |
| Date | February 6, 1998 |
Temporary Cardiac Pacing Wire with wave
ETHICON, Inc.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 1998
Mr. Gregory R. Jones Director, Requlatory Affairs Ethicon, Incorporated P.O. Box 151 Somerville, NJ 08876-0151
Re: K980503 Temporary Cardiac Pacing Wire Trade Name: Regulatory Class: II Product Code: LDF Dated: February 6, 1998 February 9, 1998 Received:
Dear Mr. Jones:
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 leqally 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 Reqister. Please note: this response to your premarket notification submission does not affect any
3
Page 2 - Mr. Gregory R. Jones
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 requlations.
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" (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/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
INDICATION FOR USE
4980503 510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name:
Temporary Cardiac Pacing Wire
Indications for Use:
The Temporary Cardiac Pacing Wire is intended for use in temporary cardiac pacing or monitoring.
(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 Devices510(k) NumberK980 503 | (Division Sign-Off) | Division of Cardiovascular, Respiratory, and Neurological Devices | 510(k) Number | K980 503 | |||
| (Division Sign-Off) | |||||||
| Division of Cardiovascular, Respiratory, and Neurological Devices | |||||||
| 510(k) Number | K980 503 | ||||||
| Prescription Use (Per 21 CFR 801.109) | |||||||
| OR | Over-The Counter Use | ||||||
| (Optional Format 1-2-9G) |
Temporary Cardiac Pacing Wire with wave ETHICON, Inc.
(