(105 days)
No
The summary describes a reusable electrode belt for ECG monitoring and does not mention any AI or ML capabilities.
No.
It is an electrode system for ECG monitoring, which is a diagnostic procedure, not a therapeutic one. The device's function is to collect electrical signals from the heart for diagnostic purposes, not to treat a condition.
No
The device is described as an "electrode system" used for "ECG monitoring" and is "compatible for use with most ECG instruments on the market." It acts as a component for obtaining ECG data rather than interpreting or diagnosing based on that data. Its function is to facilitate the acquisition of physiological signals, which are then used by other ECG instruments for monitoring, and potentially for diagnosis by a physician. The "Indications for Use" state it's for "general electrocardiograph procedures where ECG monitoring is deemed necessary," which focuses on data collection, not diagnosis.
No
The device description explicitly states it is a "reusable electrode system consisting of an electrode assembly, an elastic chest belt, and a connectorized cable," which are all hardware components.
Based on the provided information, the AccuHeart™ Electrode Belt is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- AccuHeart™ Function: The AccuHeart™ Electrode Belt is a device that is placed on the surface of the body (chest) to acquire electrical signals from the heart (ECG). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "general electrocardiograph procedures where ECG monitoring is deemed necessary." This is a procedure performed on the patient, not on a sample from the patient.
Therefore, the AccuHeart™ Electrode Belt falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AccuHeart™ Electrode Belt is a reusable electrode system intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician. The AccuHeart™ Electrode Belt is compatible for use with most ECG instruments on the market.
Product codes
74 DRX, DRX
Device Description
The AccuHeart" " Electrode Belt is a reusable electrode system consisting of an electrode assembly, an elastic chest bett, I ho necarized - Electron a routered Medectrodes are positioned against the skin with light pressure, using the elastic chest belt. The AccuHeart™ Electrode Belt is designed to be used without electrolytic gels and without adhesives on unprepared skin, i.e., without the requirements for shaving, abrading or other skin preparations.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
0
MAR 2 2 2005
510(k) Summary
AccuHeart™ ELECTRODE BELT
K K043361
| Submitter: | Advanced Bioelectric Corporation |
|---|---|
| 21 Park Street, 2nd. Floor, Suite B | |
| Gatineau, Quebec, J9H 4J6 | |
| CANADA | |
| Telephone: 819-682-0505 | |
| Fax: 819-682-4738 | |
| Contact person: Alastair R. B. Samson | |
| President and CEO | |
| Date of preparation: | 2004/12/01 |
| Device Name: | Proprietary Name: AccuHeart TM Electrode Belt |
| Common Name: | Electrocardiograph Electrode |
| Classification Name: | Electrocardiograph Electrode |
| Regulatory Classification: | |
| Class: | 2 |
| Medical Specialty Panel: | Cardiovascular |
| Product Code: | 74 DRX |
| Devices to Which Substantial Equivalence is Claimed: | |
| Device Name: | Medi-Trace 200 and Medi-Trace 200-30 ECG Electrodes |
| 510(k) Number: | K960968 |
| Device Name: | ECG Electrodes Apron |
| 510(k) Number: | K982470 |
| Device Description: |
Device Description:
The AccuHeart" " Electrode Belt is a reusable electrode system consisting of an electrode assembly, an elastic chest bett, I ho necarized - Electron a routered Medectrodes are positioned against the skin with light pressure, using the elastic chest belt. The AccuHeart™ Electrode Belt is designed to be used without electrolytic gels and without adhesives on unprepared skin, i.e., without the requirements for shaving, abrading or other skin preparations.
Intended Use:
The Accul Part " Electrode Belt is a reusable electrode system intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician. The AccuHearl™ Electrode Belt is compatible for use with most ECG instruments on the market.
Substantial Equivalence:
The AccuHeart™ Electrode Belt is substantially equivalent to the Medi-Trace 200 and Medi-Trace 200-30 ECG Electrodes (K960968) and to the ECG Electrodes Apron (K982470).
1
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 consists of a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
MAR 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Bioelectric Corporation c/o Mr. Alaistair R. B. Samson President & CEO 1 resident Street, 2nd Floor, Suite B Gatineau, Quebec, J9H 4J6 CANADA
Re: K043361
Trade Name: AccuHeart™ Electrode Belt Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: March 08, 2005 Received: March 09, 2005
Dear Mr. Samson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 910(s) presidentially equivalent (for the indications
referenced above and have determined the device is substantially interests a for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to tegary mancess province in the Medical Device Ameral Food. Drug commerce prior to May 20, 1978, the enations of the provisions of the Federal Food, Drug, devices that have been recalismou in acceracy al of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosment Act (Act) that to not require appen the general controls provisions of the Act. The You may, therefore, market the devreet, salered to the go
general controls provisions of the Act include requirements for annual registration, listing of the general controls provisions of the 110 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 If your device is classified (see aborto) into Existing major regulations affecting your device can may be subject to such additional controller is notions, the 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peacharter concerning your device in the Federal Register.
2
Page 2 -- Mr. Alaistair R. B. Samson
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a substance or other requirements of the Act
that FDA has made a determination that your device complies . You must that FDA has made a decermination that your are be other Federal agencies. You must or any Federal statules and regulations administered of registration and listing (21 )
comply with all the Act's requirements, including, but not limited to: ret comply with all the Act s requirements, including, but internuring practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); gractice requirements as set CFR Part 807); labeling (21 CFR Part 800); good manart 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000); 11 CFR 1000 1050 forth in the quality systems (Q5) regulation (21-542 of the Acct); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Acction S product radiation control provisions (Scctions 95 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will anow you to begin makemig your article quivalence of your device to a legally premarket notification. The FDA midnig of substantial equiveness on 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
rst of the many of the many of 10, 2019 - Alaxy places retor the requilatio If you desire specific advice for your ac not the can and the regulation entitled, the regulation entitled, contact the Office of Collipilance at (240) 270 of (210) Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). Your may of "Misbranding by reference to premarkst nontheation (1) 6 of from the Division of Small
other general information on your responsibilities under the Act from worker (800) 638other general information on your responsibilities ander at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-fremain ht Manufacturers, International and Consumer Presservedrh/dsma/dsmamain.html
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html
Sincerely yours,
B. Silliman fa
Bran D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
Applicant: ADVANCED BIOELECTRIC CORPORATION
510(k) Number (if known):
Device Name: AccuHeart™ Electrode Belt
Indications For Use:
The AccuHeart™ Electrode Belt is a reusable electrode system intended for use in general electrocardiograph procedures where ECG monitoring is deemed necessary and is ordered by a physician. The AccuHeart™ Electrode Belt is compatible for use with most ECG instruments on the market.
X Prescription Use Per 21 CFR 801.109
OR
Over-the-counter
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Alummo
ivision Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number