(143 days)
The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.
Not Found
This is a 510(k) premarket notification for an ECG Electrode and not a clinical study report. Therefore, the detailed information requested regarding acceptance criteria, device performance, and study methodology is not available in the provided text. The document primarily concerns the FDA's determination of substantial equivalence for marketing the device.
However, based on the information provided, we can infer some general aspects:
- Device: ECG Electrode for Anaesthesia use
- Purpose: To transmit electrical signals from the body surface to a processor for producing an electrocardiogram or vectorcardiogram.
The FDA's review in a 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use and the same technological characteristics as the predicate, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This often relies on performance data comparing the new device to the predicate, but specific acceptance criteria and detailed study designs are usually found in the sponsor's submission, not the FDA's decision letter itself.
No study is described in this document that proves the device meets specific acceptance criteria as if it were a novel, higher-risk device requiring extensive clinical trials. The FDA's letter indicates a finding of "substantial equivalence" to a predicate device.
Given the limitations of the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document is an FDA clearance letter, not a study report. For an ECG electrode, general performance criteria would relate to signal quality, impedance, adhesion, biocompatibility, and electrical safety, usually benchmarked against a predicate device.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for an ECG electrode's 510(k) clearance, as "ground truth" in this context would likely refer to the accuracy of ECG signal transmission, not diagnostic interpretation by experts.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrode, not an AI-powered diagnostic system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrode, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For an ECG electrode, "ground truth" would generally refer to the accurate and clear transmission of the heart's electrical activity, often verified against established physiological standards and predicate device performance. Specific methodologies are not detailed here.
- The sample size for the training set: Not available (training sets are more relevant for AI/machine learning models).
- How the ground truth for the training set was established: Not applicable.
Summary based on available information:
The provided text is an FDA 510(k) clearance letter for an ECG electrode. It states that the device is "substantially equivalent" to legally marketed predicate devices. This means the manufacturer submitted information (likely including performance data) demonstrating that the ECG electrode for anesthesia use is as safe and effective as a previously cleared device. However, the specific details of that submitted data, including acceptance criteria, study design, sample sizes, and expert involvement, are not contained within this document.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 8 2002
Medicotest, A/S c/o Ms. Emalee G. Murphy Kirkpatrick & Lockhart LLP 1800 Massachusetts Avenue, NW Suite 200 Washington, DC 20036-1221
Re: K020382
Trade Name: ECG Electrode for Anesthesia use Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II (two) Product Code: DRX Dated: May 3, 2002 Received: May 6, 2002
Dear Ms. Murphy:
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 - Ms. Emalee G. Murphy
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Donna-Bea Tillman, Ph.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices
and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K020382
Page of ﻠﺴﻨﺎ 1
K020382 510 (k) Number (if known):
Device Name: ECG Electrode for Anaesthesia use
Indications For Use:
The ECG electrodes is applied to surface of the body to transmit the electrical signal at the body surface to a processor that produce an electrocardiogram or vectorcardiogram. For single patient use only. The electrode is designed for measuring ECG under Anaesthesia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off)Division of Cardiovascularand Respiratory Devices | |
| 510(k) Number | K020382 |
| Prescription Use(Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | --- |
| OR |
|---|
| ---- |
| Over-The-Counter Use(Optional format 1-2-96) | |
|---|---|
| -------------------------------------------------- | -- |
§ 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.