The BIO-DETEK Modified Adult Multi-Function Electrode with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 500, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cables, for defibrillation, cardioversion, non-invasive pacing, and electrocardingraph monitoring.

Device Description

The BIO-DETEK Modified Adult Multi-Function Electrodes with Connector is indicated for use with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable, for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.

AI/ML Overview

The provided document does not contain information about specific acceptance criteria, device performance, a study conducted to demonstrate the device meets acceptance criteria, sample sizes, ground truth establishment, or human expert involvement.

Instead, this document is a 510(k) Premarket Notification Submission for the BIO-DETEK Modified Adult Multi-Function Electrodes with Connector. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (BIO-DETEK Adult Multi-Function Electrodes, K931801).

The core of this submission is to show that the new device has "operation and technological characteristics" that are sufficiently similar to the predicate device, not necessarily to present a study proving the new device meets specific, quantifiable performance acceptance criteria.

The information provided includes:

Device Name: BIO-DETEK Modified Adult Multi-Function Electrodes with Connector
Intended Use: For use with specific Medtronic Physio-Control Defibrillator Models (LIFEPAK 9, 10C, 11, 12, 20) with QUIK-COMBO Therapy Cables for defibrillation, cardioversion, non-invasive pacing, and electrocardiograph monitoring.
Predicate Device: BIO-DETEK Adult Multi-Function Electrodes (K931801)
Compliance with Standards: The device is designed to comply with applicable portions of IEC 60601-2-4, ANSI/AAMI/ISO DF39-1993, ANSI/AAMI EC53:1995, and 21 CFR Part 898. These standards would contain performance requirements that the device should meet, but the document does not explicitly state the acceptance criteria derived from these standards or present test results against them.
FDA Decision: The FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

Therefore, based on the provided text, I cannot complete the requested tables and information regarding acceptance criteria and performance study details. The document is a regulatory submission for substantial equivalence, not a detailed technical report of a performance study.

Summary

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BIO-DETEK Modified Adult Multi-Function Electrodes with Connector 510(k) Premarket Notification Submission

10.0 BIO-DETEK Modified Adult Multi-Function Electrodes with Connector 510(k) Summary

Company:

BIO-DETEK 525 Narragansett Park Drive Pawtucket, RI 02861-4323

Contact:

Robert Morse QA/QC Manager

Date Prepared:

December 1, 2003

Name of Device:

BIO-DETEK Adult Multi-Function Electrodes (#K931801)

Predicate Device:

BIO-DETEK Adult Multi-Function Electrodes

Device Description and Intended Use:

Technological Characteristics

The BIO-DETEK Modified Adult Multi-Function Electrodes with Connector is designed to comply with the applicable portions of the following standards:

IEC 60601-2-4 Medical Electrical Equipment .
ANSI/AAMI/ISO DF39-1993 .
ANSI/AAMI EC53:1995 .

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BIO-DETEK Modified Adult Multi-Function Electrodes with Connector 510(k) Premarket Notification Submission

21 CFR Part 898 Performance Standards for Electrode Lead Wires and Patient . Cables

Basis for Substantial Equivalence:

Operation and technological characteristics form the basis for the determination of substantial equivalence of The BIO-DETEK Modified Adult Multi-Function Electrodes with Connector with legally marketed predicate devices. Information supplied in this premarket notification includes descriptive information about the intended use, operation, and technological characteristics.

This information is provided pursuant to the requirements of the Safe Medical Devices Act of 1990 (SMDA).

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle is blank. In the center of the seal is an abstract image of an eagle.

FEB 27 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bio-Detek, Inc. c/o Mr. Robert Morse QA/QC Manager 525 Narragansett Park Drive Pawtucket, RI 02861-4323

Re: K033771

Trade Name: Bio-Detek Modified Adult Multi-Function Electrodes with Connector Regulation Number: 21 CFR 870,1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: 74 MKJ, MLN Dated: December, 08 2003 Received: December 09, 2003

Dear Mr. Morse:

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.

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Page 2 - Mr. Robert Morse

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 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) 594-4648. 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.

Dma R. Lochner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K033771

Device Name: BIQ-DETEK Modified Adult Multi-Function Electrode with Connector

Intended Use:

Prescription Use V (Pari 21 CFR 801 Subpan D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwing R. bodanes.

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K033771

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.