(191 days)
The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity.
The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.
The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.
Here's the information about the acceptance criteria and the study for the HMicro Wired C-Patch Electrode, extracted from the provided text:
Acceptance Criteria and Device Performance Study for HMicro Wired C-Patch Electrode
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to provide usable ECG tracings as often as a commercially available predicate. | 85% (11/13) of volunteer data was similar between the two HMicro Patches (left chest and center chest placements) and the respective control (3M Red Dot electrodes). |
2. Sample size used for the test set and the data provenance
- Sample Size: 15 volunteers (netting usable ECG tracings data from 13 volunteers).
- Data Provenance: The document does not explicitly state the country of origin. It was an engineering study involving volunteers, implying a prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a ground truth or their qualifications. The study focused on the usability of data by comparing ECG tracings from the subject device to a predicate device.
4. Adjudication method for the test set
The document does not describe an adjudication method involving experts for the test set. The comparison appears to have been based on similarity of ECG tracings.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an electrode, not an AI-powered diagnostic system, so the concept of human readers improving with AI assistance is not applicable here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is an ECG electrode, not an algorithm. The study evaluated the ability of the electrode to produce usable ECG data.
7. The type of ground truth used
The "ground truth" in this context was established by:
- Comparison to a predicate device: The 3M Red Dot electrodes, a commercially available and legally marketed device, served as the comparative standard.
- Usable ECG tracings: The primary outcome measured was the similarity of the ECG tracings produced by the HMicro C-Patch to those from the predicate device.
8. The sample size for the training set
This is not applicable. The device is hardware (an ECG electrode), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo for HMicro. The logo consists of a cube-like shape on the left, followed by the text "HMicro" in a bold, sans-serif font. The letters are all capitalized except for the "icro" portion of the word. There is a trademark symbol to the right of the word.
510(k) Summary
510(k) Summary for HMicro Wired C-Patch Electrode Page 1 of 2
| Company name: | HMicro, Inc.39355 California St. Ste 303, Fremont, CA 94538 | |
|---|---|---|
| Contact: | Kim Tompkins, VP Regulatory and Clinical Affairs | |
| Mobile: 408.981.4889Email: kim@hmicro.com | ||
| Date prepared: | June 24, 2014 | |
| Trade Name: | HMicro Wired C-Patch Electrode, trade name subject to change | |
| Common Name: | ECG Electrodes | |
| Classification Name: | Electrocardiograph electrodes (21 CFR 870.2360, pro code DRX) | |
| Class: | 2 | |
| Panel Identification: | Cardiovascular | |
| Predicate device: | 3M Red Dot ECG electrodes (K000690, SE 5.17.2000) |
Device description:
The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on the left upper chest or center chest and used for ECG monitoring. It is disposable and single use. It has five pre-wired electrodes affixed to a 3-inch silicone patch, where wires from the electrodes are pulled through the silicone patch for connecting into the patient monitoring cable.
Intended use:
The HMicro Wired C-Patch ECG Electrode is a single patient use, disposable, radiolucent wired ECG electrode with a silver/silver chloride sensing element designed for short-term, adult ECG monitoring at rest. It is designed to provide a single patch alternative to distributed electrodes. It has been tested using the GE Marquette Eagle 4000 ECG monitor and patient cable and should be used with monitors with equivalent or better sensitivity.
Substantial Equivalence:
The HMicro Wired C-Patch is similar to 3M Red Dot electrodes with respect to technological characteristics (see Table 1). Engineering justifications demonstrate substantial equivalence to the 3M Red Dot electrodes with respect to biocompatibility, electrical safety, and adhesion of patch to body performance. Shelf life testing demonstrated patch functionality through the sponsor requested expiration dating.
The key design difference between the subject and predicate device is that the subject device is a single 3 inch patch that is applied to the upper left or center chest and the predicate device is placed in the standard distributed configuration on the body (left arm, right arm, and left leg).
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Image /page/1/Picture/0 description: The image shows the logo for HMicro. The logo consists of a cube-like shape on the left, followed by the text "HMicro" in a bold, sans-serif font. A small "TM" symbol is located to the upper right of the word "HMicro". The logo appears to be in black and white.
510(k) Summary for HMicro Wired C-Patch Electrode Page 2 of 2
An engineering study was completed to evaluate the usability of data from the subject and predicate device. Fifteen volunteers were enrolled and three tracings obtained: 3M electrodes, HMicro patch placed on the left chest and HMicro patch placed on the center chest. The study netted usable ECG tracings data from 13 volunteers for a total of 26 HMicro Wired C-Patches and 13 3M Red Dot electrode sets for evaluation. Eighty-five percent (11/13) of the volunteer data was similar between the two HMicro Patches and the respective control. For the two remaining volunteers, only one ECG tracing was usable--one for the control and the other for the HMicro Wired C-Patch. This study demonstrated that the HMicro is expected to provide usable ECG data as often as the commercially available predicate when used as indicated.
| Characteristic | Predicate Device: 3M Red Dot | Subject Device: HMicro Wired C-Patch |
|---|---|---|
| Design | Pre-wired (radiolucent), hydrogelelectrode, color coded, single use,non-sterile. | Pre-wired (radiolucent), hydrogel electrode,color coded affixed to 3 inch patch, singleuse, non-sterile. |
| Materials | Electrode backing includes alaminated conductive adhesiveand silver/silver chloride sensingunit. | Electrode backing includes a laminatedconductive adhesive and silver/silverchloride sensing unit; electrodes affixed to a3 inch round silicone sheet patch usingmedical grade adhesives. |
| Energy source | The wires must be connected toan ECG patient cable which is inturn connected to an ECG monitor. | The wires must be connected to an ECGpatient cable which is in turn connected toan ECG monitor. |
Conclusion:
The HMicro Wired C-Patch is similar to the predicate 3M Red Dot electrodes predicate with respect to design, materials and energy source and as such is substantially equivalent.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2014
HMicro, Inc. Kim Tompkins VP Regulatory/Clinical 39355 California St. Ste 303 Fremont, CA 94538
Re: K140096
Trade/Device Name: Wired C-Patch EKG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: Class II Product Code: DRX Dated: June 25, 2014 Received: June 26, 2014
Dear Ms. Kim Tompkins,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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Page 2 - Ms. Kim Tompkins
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely your
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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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510(k) Number (if known): K140096
Device Name:
Indications for Use:
The HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available to place the patch.
| Prescription Use X | AND/OR | Over-The-Counter Use ___ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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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.