(105 days)
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.
The AccuHeart™ Electrode Belt is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and a connectorized cable. The electrode assembly contains multiple dry electrodes. The electrodes 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.
The provided 510(k) summary for the AccuHeart™ Electrode Belt (K043361) does not contain information regarding detailed acceptance criteria or a specific study proving the device meets those criteria with performance metrics, sample sizes, or ground truth details.
The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive de novo clinical trials with predefined performance metrics and acceptance criteria.
Based on the provided text, here's what can be inferred and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated. The core "acceptance criteria" for a 510(k) submission is typically demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is not the same as a quantitative performance standard with defined thresholds.
- Reported Device Performance: Not explicitly stated in quantitative terms tied to specific performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, etc.). The summary describes the device's design (reusable electrode system, elastic chest belt, no gels/adhesives, no skin prep) and intended use, implying that its performance is comparable to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not mentioned. It's likely that performance data, if collected, was part of a non-clinical evaluation comparing the AccuHeart™ to the predicate devices, but the size of any such test set is not provided.
- Data Provenance (country of origin, retrospective/prospective): Not mentioned.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Given that this is an electrode belt, "ground truth" might refer to expert assessment of ECG signal quality or clinical utility, but no details are provided.
4. Adjudication Method:
- Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not done/not mentioned. MRMC studies are typically for image-based diagnostic devices where reader interpretation is a key variable. This device is an ECG electrode belt, so such a study would not be applicable in the traditional sense. The emphasis is on the physical and electrical performance of the electrodes themselves.
6. Standalone Performance Study (Algorithm Only):
- Not applicable/not mentioned. This device does not involve an "algorithm" in the sense of AI/ML. It is a physical medical device (electrode belt). Its performance is inherently tied to its physical characteristics and ability to acquire ECG signals.
7. Type of Ground Truth Used:
- Not explicitly stated in the document. For an ECG electrode, "ground truth" would likely involve objective measures like impedance, noise levels, signal quality from a known ECG source, and potentially comparative clinical data demonstrating equivalent signal quality to predicate devices. The document implies equivalence to established ECG electrode performance.
8. Sample Size for the Training Set:
- Not applicable/not mentioned. There is no "training set" in the context of AI/ML for this device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/not mentioned.
Summary of what the document focuses on instead:
The 510(k) summary for the AccuHeart™ Electrode Belt focuses on demonstrating substantial equivalence to the following predicate devices:
This is achieved by stating that the AccuHeart™ Electrode Belt:
- Has the same intended use (general electrocardiograph procedures, ECG monitoring).
- Has similar technological characteristics (reusable electrode system, elastic chest belt, electrodes positioned against the skin with light pressure, compatible with most ECG instruments).
- Offers advantages like being used without electrolytic gels, adhesives, or skin preparation (shaving, abrading), which would be considered efficiency/usability improvements rather than a fundamental change in performance.
The FDA's decision letter (K043361) confirms that they found the device "substantially equivalent" for the stated indications for use. This means the FDA concluded that the device is as safe and effective as the predicate devices, based on the information provided in the 510(k) submission, without requiring a detailed performance study with explicit acceptance criteria as would be expected for novel or high-risk devices or AI/ML products.
{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
§ 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.