(60 days)
The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.
The Steelex Electrode Set comprises a stainless steel 316L braided wire (ASTM-F138), with a plastic isolating cover (Polyethylene). One end of the wire is armed with a stainless steel 420 (ASTM-F899) ½ circle or 3% circle round-bodied needle and the other end is armed with a stainless steel (ASTM-F899) straight needle (break-off). The straight break-off needle also serves as the connection to the generator. The needle sizes for Steelex Electrode Set are available in the USP sizes 302, 420 or 420F, 0, 1-0, 2-0 and 3-0.
The provided text is a 510(k) summary for the Steelex Electrode Set. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it explicitly states that "No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices." This means there are no formal acceptance criteria or a study proving the device meets them in the traditional sense of a clinical performance study with specific metrics.
Instead, the FDA's decision to clear this device via 510(k) is based on substantial equivalence to already approved predicate devices. This regulatory pathway means the new device is considered as safe and effective as a legally marketed device if it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics and the information submitted to FDA does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device.
Therefore, for this particular submission, the answers to your questions will reflect this regulatory approach rather than a traditional performance study.
Here's the information based on the provided text, while noting the absence of a specific performance study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safe and effective for temporary cardiac pacing or monitoring | Considered as safe and effective as the predicate devices: Ethicon, Inc.; Temporary Cardiac Pacing Wire (K980503)Medtronic; Model 6494 Unipolar Temporary Myocardial Pacing Wire (K012459) |
| Same intended use as predicate devices | Intended for use in temporary cardiac pacing or monitoring, identical to the common use of predicate devices. |
| Similar technological characteristics to predicate devices | Comprises stainless steel 316L braided wire (ASTM-F138) with plastic isolating cover (Polyethylene); armed with stainless steel 420 (ASTM-F899) needles (½ circle or 3/8 circle round-bodied and straight break-off). Needle sizes include USP sizes 3-0, 2-0, 1-0, 0, 4-20, 4-20F, 3-0. This falls within the typical design of temporary pacing electrodes. |
| Does not raise new questions of safety or effectiveness | No new questions of safety or effectiveness were raised, allowing clearance based on equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No specific "test set" was used for a performance study as described. The determination of substantial equivalence relies on comparing the device's design, materials, and intended use against already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No specific ground truth was established by experts for a test set in the context of a performance study. The FDA's review panel (Cardiovascular) and Office of Device Evaluation (ODE) experts assess the submitted documentation for substantial equivalence to predicates.
4. Adjudication Method for the Test Set
Not applicable. No test set adjudication method is mentioned as there was no performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a temporary pacing electrode, not an AI-assisted diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance for human readers was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this context is the safety and effectiveness profile of the predicate devices (Ethicon, Inc.; Temporary Cardiac Pacing Wire (K980503) and Medtronic; Model 6494 Unipolar Temporary Myocardial pacing Wire (K012459)) as established through their prior FDA clearances. The new device is deemed safe and effective because it is substantially equivalent to these already approved devices.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
APR 22 2003
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [in Accordance with SMDA of 1990]
Steelex Electrode Set
February 20, 2003
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| Establishment Registration Number: 2916714 | |
| CONTACT: | Georg Keller800-258-1946 x 5073 (phone)610-791-6882 (fax) |
| TRADE NAME: | Steelex Electrode Set |
| COMMON NAME: | Temporary Pacing Electrode |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | 74LDF |
| CLASSIFICATION: | 870.3680 - Electrode, Pacemaker, Temporary |
| REVIEW PANEL: | Cardiovascular |
INDICATIONS FOR USE
The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.
DEVICE DESCRIPTION
The Steelex Electrode Set comprises a stainless steel 316L braided wire (ASTM-F138), with a plastic isolating cover (Polyethylene). One end of the wire is armed with a stainless steel 420 (ASTM-F899) ½ circle or 3% circle round-bodied needle and the other end is armed with a stainless steel (ASTM-F899) straight needle (break-off). The straight break-off needle also serves as the connection to the generator. The needle sizes for Steelex Electrode Set are available in the USP sizes 302, 420 or 420F, 0, 1-0, 2-0 and 3-0.
PURPOSE FOR SUBMISSION
This submission seeks marketing clearance for Aesculap's Steelex Electrode Set.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices.
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Steelex Electrode Set is substantially equivalent to:
- Ethicon, Inc .; Temporary Cardiac Pacing Wire (K980503) ●
- Medtronic; Model 6494 Unipolar Temporary Myocardial pacing Wire (K012459) ●
{1}------------------------------------------------
Image /page/1/Picture/2 description: The image shows a logo for the Department of Health. The logo features a stylized human profile with three faces overlapping each other. The text "DEPARTMENT OF HEALTH" is arranged vertically along the left side of the logo, curving to follow the shape of the profile. The logo is black and white.
Food and Drug Administrati 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2003
Aesculap®, Inc. c/o Mr. Georg Keller Regulatory Affairs Manager 3773 Corporate Parkway Center Valley, PA 18034
Re: K030556
Trade Name: Steelex Electrode Set Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode Regulatory Class: Class II (two) Product Code: LDF Dated: February 20, 2003 Received: February 21, 2003
Dear Mr. Keller:
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
{2}------------------------------------------------
Page 2 - Mr. Georg Keller
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,
QedrTh
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
B. INDICATIONS FOR USE STATEMENT
Page 1 of 1
510(k) Number: K030556
Steelex Electrode Set Device Name:
Indication for Use:
The Steelex Electrode Set 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)
Prescription Use
or Over-the-Counter Use
(per 21 CFR 801.109)
V. Deaton
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030556
§ 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.