(60 days)
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.
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.
The provided document K980503 is a 510(k) summary for a Temporary Cardiac Pacing Wire with wave. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria in the way a new, novel device might. Therefore, the information requested regarding a study proving acceptance criteria is largely not applicable in the typical sense for this submission type.
However, I can extract the information that is present and explain why some of the requested points are not explicitly detailed in a 510(k) for a substantially equivalent device.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use: Temporary cardiac pacing or monitoring | The modified device has the same intended use as the predicate device (Temporary Cardiac Pacing Wire (TPW)). |
| Technological Characteristics: Same material, insulated coating, electrical resistance as predicate device. | The modified device has the same technological characteristics. "There is no change in material, insulated coating or electrical resistance." |
| Safety and Effectiveness: At least as safe and effective as the predicate device. | Nonclinical laboratory testing showed "increased resistance to pullout force after it is inserted into the myocardium when compared to the predicate device." This suggests an improvement in a safety/performance aspect. |
Explanation: For a 510(k) submission, the primary "acceptance criterion" is often substantial equivalence to a predicate device. This means the new device shares the same intended use and technological characteristics as the predicate, or if there are differences, they do not raise new questions of safety or effectiveness and can be demonstrated to be as safe and effective as the legally marketed predicate. Specific numerical acceptance criteria are typically not provided as they would be for a de novo or PMA submission.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Nonclinical laboratory testing was performed to determine pullout force after implantation." It does not specify the number of wires tested.
- Data Provenance: The testing appears to be nonclinical laboratory testing, likely performed by the manufacturer, ETHICON, Inc. The document does not specify country of origin for the data or whether it was retrospective or prospective. Given it's nonclinical lab testing, it's typically prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For nonclinical laboratory testing like pullout force, "ground truth" is established by direct physical measurement using validated testing protocols, not through expert consensus or interpretation of clinical data. Therefore, no experts were involved in establishing ground truth for this specific lab test.
4. Adjudication method for the test set
- Not Applicable. As the "ground truth" for the pullout force test is a direct physical measurement, there is no need for adjudication by experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size
- No. This is not a diagnostic device that involves human interpretation of results, but rather a medical device for temporary cardiac pacing. Therefore, an MRMC study is not relevant or required for this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used
- For the reported performance data (pullout force), the ground truth was established by direct physical measurement during nonclinical laboratory testing.
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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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.
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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
:
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510(k) SUMMARY, Continued
| Intended Use | The Temporary Cardiac Pacing Wire with wave is intended foruse in temporary cardiac pacing or monitoring.The Temporary Cardiac Pacing Wire with wave has the sameintended use as predicate device Temporary Cardiac PacingWire (TPW). |
|---|---|
| Indications Statement | The Temporary Cardiac Pacing Wire with wave is intended foruse in temporary cardiac pacing or monitoring. |
| TechnologicalCharacteristics | The modified device has the same technologicalcharacteristics as the predicate device. There is no change inmaterial, insulated coating or electrical resistance. |
| Performance Data | Nonclinical laboratory testing was performed to determinepullout force after implantation. It was determined that theTemporary Cardiac Pacing Wire with wave has an increasedresistance to pullout force after it is inserted into themyocardium when compared to the predicate device. |
| Conclusions | Based on the 510(k) summaries and 510(k) statements (21 CFR807) and the information provided herein, we conclude that thenew device is substantially equivalent to the Predicate Deviceunder the Federal Food, Drug, and Cosmetic Act. |
| Contact | Gregory R. JonesDirector, Regulatory AffairsETHICON, Inc.Rt. #22, WestSomerville, NJ 08876-0151 |
| Date | February 6, 1998 |
Temporary Cardiac Pacing Wire with wave
ETHICON, Inc.
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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
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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
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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.
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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.