K Number
K040056
Device Name
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
Manufacturer
Date Cleared
2004-04-09

(87 days)

Product Code
Regulation Number
870.5310
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIO-DETEK Electrode Adapter is indicated for use with ZOLL CPR-D, stat-padz™ and statepadz II™ Electrodes for connection with Medtronic Physio-Control Defibrillator and data: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable.
Device Description
The BIO-DETEK Electrode Adaptor is made of rigid thermoplastic and conductive material. The adaptor will be provided as a reusable stand-alone accessory to be used in conjunction with ZOLL CPR-D, Stat*padz, and Stat*padz II Electrodes.
More Information

K#984286

Not Found

No
The 510(k) summary describes a simple electrode adapter made of rigid thermoplastic and conductive material. There is no mention of any software, algorithms, or data processing capabilities that would indicate the presence of AI or ML. The device's function is purely mechanical/electrical adaptation.

No
The device is described as an adapter for connecting electrodes to defibrillators. It does not directly provide therapy but facilitates the connection of therapeutic devices.

No
The device is described as an "electrode adapter" for connecting electrotherapy electrodes to defibrillators, which are therapeutic devices. Its function is to facilitate the delivery of electrical therapy, not to diagnose a condition.

No

The device description explicitly states the device is made of "rigid thermoplastic and conductive material," indicating it is a physical hardware component.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as an adapter for connecting defibrillator electrodes to different defibrillator models. This is a function related to delivering electrical therapy, not performing diagnostic tests on biological samples in vitro (outside the body).
  • Device Description: The description mentions rigid thermoplastic and conductive material, consistent with an electrical adapter. It doesn't mention any components or functions related to analyzing biological samples.
  • Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing diagnostic information based on laboratory tests

The device's function is to facilitate the connection of electrodes for defibrillation, which is a therapeutic procedure, not a diagnostic one.

N/A

Intended Use / Indications for Use

The BIO-DETEK Electrode Adaptor is indicated for use with ZOLL CPR-D, Statpadz, and Statpadz II Electrodes for connection with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO™ Therapy Cable.

Product codes

MLN

Device Description

The BIO-DETEK Electrode Adaptor is made of rigid thermoplastic and conductive material. The adaptor will be provided as a reusable stand-alone accessory to be used in conjunction with ZOLL CPR-D, Statpadz, and Statpadz II Electrodes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Heartstream Electrode Adaptor K#984286

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

BIO-DETEK Electrode Adaptor 510(k) Premarket-Notification Submission

8.0 BIO-DETEK Electrode Adaptor 510(k) Summary

| Company: | BIO-DETEK
525 Narragansett Park Drive
Pawtucket, RI 02861-4323 |
|-------------------|----------------------------------------------------------------------|
| Contact: | Robert Morse
QA/QC Manager |
| Date Prepared: | January 12, 2004 |
| Name of Device: | BIO-DETEK Electrode Adaptor |
| Predicate Device: | Heartstream Electrode Adaptor K#984286 |

Device Description and Intended Use:

The BIO-DETEK Electrode Adaptor is indicated for use with ZOLL CPR-D, Statpadz, and Statpadz II Electrodes for connection with Medtronic Physio-Control Defibrillator Models: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO™ Therapy Cable.

The BIO-DETEK Electrode Adaptor is made of rigid thermoplastic and conductive material. The adaptor will be provided as a reusable stand-alone accessory to be used in conjunction with ZOLL CPR-D, Statpadz, and Statpadz II Electrodes.

Technological Characteristics

The BIO-DETEK Electrode Adaptor is designed to comply with the applicable portions of the following standards:

  • 9 IEC 60601-2-4 Medical Electrical Equipment
  • 트 ANSI/AAMI/ISO DF39-1993
  • 지 ANSI/AAMI EC53:1995
  • 21 CFR Par 898 Performance Standards for Electrode Lead Wires and Patient Cables

1

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

APR = 9 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: K040056 Trade Name: BIO-DETEK Electrode Adaptor Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: III (three) Product Codc: MLN Dated: January 12, 2004 Received: January 13, 2004

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 prodicate 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 aporoval 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 adultcration.

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.

2

Page 2 - Mr. Robert Morse

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has intact and regulations administered by other Federal agencies. You must or uny vith 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. product taxialled on and begin marketing your device as described in your Section 510(k) I mis letter will and my and one of substantial equivalence of your device to a legally premarket netilicated 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 if you desire specific as not as (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,

Dina R. Vahner

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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: K040056

Device Name: BIO-DETEK Electrode Adapter

Intended Use:

The BIO-DETEK Electrode Adapter is indicated for use with ZOLL CPR-D, stat-padz™ and statepadz II™ Electrodes for connection with Medtronic Physio-Control Defibrillator and dala: LIFEPAK 9, LIFEPAK 10C, LIFEPAK 11, LIFEPAK 12, and LIFEPAK 20, all fitted with QUIK-COMBO Therapy Cable ..

Prescription Use ﺮ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana R. Vachner
(Division Sign-off)

Division of Cardiovascular Devices

E NUMBER K040056