(88 days)
The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring.
The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only.
The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.
Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes
This document (K012218) is an FDA 510(k) clearance letter for the Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information about specific acceptance criteria or details of a study (clinical or otherwise) that proves the device meets such criteria.
The letter focuses on the regulatory determination of substantial equivalence based on the device's indications for use and classification. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for any test set.
- Information about multi-reader multi-case comparative effectiveness studies, standalone algorithm performance, or ground truth types.
- Details on training sets or how their ground truth was established.
Therefore, I cannot fulfill your request for these specifics based solely on the provided document. The 510(k) clearance process primarily relies on demonstrating substantial equivalence to a predicate device, which may involve referencing performance data or design specifications of the predicate, but the details of such assessments are typically found in the full 510(k) submission, not in the clearance letter itself.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 2 2001
Ms. Kathleen M. Tremblay The Ludlow Company LP Two Ludlow Park Drive Chicopee, MA 01022
Re: K012218
Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes Regulation Number: 870.5550 Regulation Name: External Transcutaneous Cardiac Pacemaker (Noninvasive) Regulatory Class: II (two) Product Code: 74 DRO Dated: July 11, 2001 Received: July 16, 2001
Dear Mr. Tremblay:
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 or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 - Ms. Kathleen M. Tremblay
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
O. V. TEN
nes H. Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrodes
Indications for Use:
The Ludlow Gradient Edge Adult & Pediatric Multifunctional Electrode is intended for use in defibrillation procedures, cardioversion, pacing, and ECG monitoring.
The Ludlow Gradient Edge Adult Multifunctional Electrode is for use on adults (an adult is defined as a patient weighing over 10 Kg). The Ludlow Gradient Edge Adult Multifunctional Electrode is not intended for use on children or infants. The device is non-sterile and single-use only.
The Ludlow Gradient Edge Pediatric Multifunctional Electrode is for use on pediatrics (a pediatric is defined as a patient weighing less than 10 Kg). The device is non-sterile and single-use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Deletel
Division of Cardiovascular & Respiratory Devices
510(k) Number: K08418
✓
Prescription Use (Per 21 CFR 801.109)
(Optional Format 3-10-98)
§ 870.5550 External transcutaneous cardiac pacemaker (noninvasive).
(a)
Identification. An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.(b)
Classification. Class II. The special controls for this device are:(1) “American National Standards Institute/American Association for Medical Instrumentation's DF-21 ‘Cardiac Defibrillator Devices’ ” 2d ed., 1996, and
(2) “The maximum pulse amplitude should not exceed 200 milliamperes. The maximum pulse duration should not exceed 50 milliseconds.”