(60 days)
Not Found
No
The device description and intended use are purely mechanical/electrical components for pacing/monitoring, with no mention of data processing or analysis that would typically involve AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is described as being "intended for use in temporary cardiac pacing," which directly implies a therapeutic function by providing electrical stimulation to the heart to regulate its rhythm.
No
The device is intended for temporary cardiac pacing or monitoring, which are therapeutic and observational functions, not diagnostic.
No
The device description explicitly details physical components made of stainless steel and plastic, indicating it is a hardware device, not software-only.
Based on the provided information, the Steelex Electrode Set is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "temporary cardiac pacing or monitoring." This involves direct interaction with the patient's body for therapeutic (pacing) or diagnostic (monitoring electrical activity) purposes.
- Device Description: The description details a physical device with needles and wires designed to be inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The Steelex Electrode Set does not perform this function.
Therefore, the Steelex Electrode Set is a medical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.
Product codes
74LDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
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)
No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices.
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
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 Parkway
Center Valley, PA 18034 |
|-----------------|----------------------------------------------------------------------|
| | Establishment Registration Number: 2916714 |
| CONTACT: | Georg Keller
800-258-1946 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