(370 days)
Ambu® White Sensor electrode is for multipurpose ECG monitoring. The ECG electrode 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. The electrode is for single patient use only.
Ambu® White Sensor CFM/CFL are non-sterile, self adhesive, multifunction ECG electrodes. Ambu® White Sensor CFM/CFL should only be used by or on the order of a physician. Ambu® White Sensor CFM/CFL are single patient use disposable devices. Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydrogel, foam with medical adhesive and a polymer topfilm.
The provided 510(k) summary (K052944) for the Ambu® White Sensor CFM/CFL describes the device's technical characteristics and performance testing. However, it does not describe a study that involves typical "acceptance criteria" and "device performance" in the way one would for an AI/ML medical device, which is implied by several of your questions (e.g., number of experts, ground truth, MRMC study).
This document pertains to a disposable ECG electrode, which is a physical medical device, not a software algorithm. Therefore, many of your questions related to AI/ML device testing methodologies are not applicable to this submission.
Here's a breakdown of the available information adapted to your request, with an explanation of why certain questions cannot be answered from this specific submission:
Acceptance Criteria and Study for Ambu® White Sensor CFM/CFL
The Ambu® White Sensor CFM/CFL is a disposable ECG electrode. The "study" described is a series of non-clinical laboratory tests and biocompatibility assessments to ensure the device meets established performance standards for ECG electrodes.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ANSI/AAMI EC12:2000 - Disposable ECG Electrodes) | Reported Device Performance |
|---|---|
| Electrical functionality (as per standard) | Meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000. Equivalent electrical functionality as predicate devices. |
| Mechanical functionality (as per standard) | Meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000. Equivalent mechanical functionality as predicate devices. |
| Biocompatibility (as per ISO 10993-1) | Biological safety assured through material selection. Biocompatibility established. |
| Aging test performance | Passed aging test. |
| Comparison to predicate devices | Equivalent electrical and mechanical functionality as predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of data or images. Instead, it refers to laboratory tests performed on the physical ECG electrode devices themselves. Therefore, details regarding sample size for a "test set" for data and data provenance (country of origin, retrospective/prospective) are not applicable and not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. For a physical ECG electrode, "ground truth" would relate to its physical and electrical properties, evaluated by standard laboratory methods and equipment, not by interpretation from human experts.
4. Adjudication Method for the Test Set
This information is not applicable, as there is no "test set" of data requiring expert adjudication.
5. 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
No. An MRMC comparative effectiveness study is designed for evaluating AI/ML algorithms that assist human readers in tasks like image interpretation. This submission is for a physical ECG electrode and does not involve AI or human readers in that capacity.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This submission is for a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
For the physical electrode:
- Electrical and Mechanical Functionality: Ground truth is established by objective measurements against the performance standards defined in ANSI/AAMI EC12:2000.
- Biocompatibility: Ground truth is established by material selection and testing based on ISO 10993-1.
8. The Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of device.
In summary: The K052944 submission details the non-clinical testing and biocompatibility assessment of a disposable ECG electrode to demonstrate its equivalence to predicate devices and adherence to relevant performance standards. It does not involve any AI/ML components or clinical data-based studies typically associated with "acceptance criteria" for software or interpretation devices.
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510(k) Summary
| 1. 510(k) owner:Ambu A/SBaltorpbakken 132750 BallerupDenmarkTel.: +45 72252000Fax.: +45 72252050 | OCT 25 2006 |
|---|---|
| Contact person:Poul OttosenCorporate Quality Manager | |
| Preparation date of the 510(k) summary: | 10 October 2005 |
| 2. Name of device:Device Common name: | Disposable ECG electrode |
| Device Trade name: | Ambu® White Sensor CFMAmbu® White Sensor CFL |
| Classification Name: | Electrode, Electrocardiograph.21 CFR 870.2360 |
| Product Code: | DRX |
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- Identifies the legally marketed device to which equivalence is claimed
| Manufacturer | Trade Name | Productcode |
|---|---|---|
| Ambu A/S | Ambu® Disposable ECGElectrode | DRX |
| 3M | Red Dot 2560 | DRX |
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- Description of device
Ambu® White Sensor CFM/CFL are non-sterile, self adhesive, multifunction ECG electrodes. Ambu® White Sensor CFM/CFL should only be used by or on the order of a physician.
- Description of device
Ambu® White Sensor CFM/CFL are single patient use disposable devices.
Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydrogel, foam with medical adhesive and a polymer topfilm.
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- The intended use Ambu® White Sensor CFM/CFL are for multipurpose ECG monitoring.
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- Summary of the technological Characteristics The technological characteristics of Ambu® White Sensor CFM/CFL are identical to the predicate devices. Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydroqel, foam with medical adhesive and a polymer topfilm.
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- Brief discussion of the nonclinical tests submitted The non-clinical tests performed are laboratory tests to ensure the electrical and mechanical functionality of the electrode meets the standard ANSI/AAMI EC12:2000 - Disposable ECG Electrodes.
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- Brief discussion of the clinical tests submitted No clinical tests are performed
9. Biocompatibility testing
The biological safety of the Ambu® White Sensor CFM/CFL have been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. Tests were selected on the basis of ISO 10993-1 - Biological evaluation of Medical Devices.
10.Conclusions drawn from the nonclinical, clinical and biocompatibility tests Aging test of Ambu® White Sensor CFM/CFL and comparison test to predicate devices have been performed. From the results it has been concluded that the Ambu® White Sensor CFM/CFL have equivalent electrical and mechanical functionality as the predicate devices.
The Ambu® White Sensor CFM/CFL meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000 - Disposable ECG electrodes.
The biocompatibility of the Ambu® White Sensor CFM/CFL have been established.
It is concluded that Ambu® White Sensor CFM/CFL are safe and effective electrodes and comparable to the predicate devices.
E-Z
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2006
Ambu Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs 6740 Baymeadow Dr. Glen Burnie, MD 21060
Re: K052944
Trade Name: Ambu® White Sensor CFM & Ambu® White Sensor CFL Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: September 26, 2006 Received: September 29, 20()6
Dear Mr. Parikh:
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 – Mr. Sanjay Parikh
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 (OS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
B/bimmimar for
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 (if known):
Device Name: Ambu® White Sensor Indications For Use:
Ambu® White Sensor electrode is for multipurpose ECG monitoring. The ECG electrode 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. The electrode is for single patient use only.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Blomman
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K052944
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§ 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.