(86 days)
Not Found
Not Found
No
The summary describes a multi-function electrode for use with defibrillators and does not mention any AI or ML capabilities.
Yes
The device is indicated for therapeutic uses such as defibrillation, cardioversion, and non-invasive pacing.
Yes
The device is used for "electrocardiograph monitoring," which is a diagnostic function used to detect and record the electrical activity of the heart.
No
The device description explicitly states it is an "electrode with connector," which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for external use with defibrillators for procedures like defibrillation, cardioversion, pacing, and ECG monitoring. These are all procedures performed directly on the patient's body, not on samples taken from the body.
- Device Description: The description reinforces the intended use with defibrillators for direct patient contact procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances or markers, or providing diagnostic information based on laboratory analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on delivering electrical therapy and monitoring electrical activity directly on the patient.
N/A
Intended Use / Indications for Use
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.
Product codes
74 MKJ, MLN
Device Description
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 .
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
Adult
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
BIO-DETEK Adult Multi-Function Electrodes
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 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:
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.
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 .
1
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).
2
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.
3
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
4
Indications for Use
510(k) Number: K033771
Device Name: BIQ-DETEK Modified Adult Multi-Function Electrode with Connector
Intended Use:
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.
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