HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE

K140096 · Hmicro, Inc. · DRX · Jul 24, 2014 · Cardiovascular

Device Facts

• Record ID: K140096
• Device Name: HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE
• Applicant: Hmicro, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Jul 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Indications for 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.

Device Story

The HMicro Wired C-Patch is a single-use, disposable, radiolucent ECG electrode patch; features five pre-wired electrodes affixed to a 3-inch silicone patch. Designed for short-term adult ECG monitoring at rest; applied to the upper left or center chest. The device functions as a single-patch alternative to traditional distributed electrode configurations. Wires from the patch connect to standard patient monitoring cables and ECG monitors. The healthcare provider applies the patch to the patient; the monitor processes the electrical signals to provide ECG tracings for clinical assessment. The device simplifies electrode placement while maintaining signal quality comparable to standard distributed electrodes, facilitating patient monitoring in clinical settings.

Clinical Evidence

Bench testing only. An engineering usability study compared the HMicro patch to 3M Red Dot electrodes in 15 volunteers. Data from 13 volunteers (26 HMicro patches vs 13 predicate sets) showed 85% (11/13) similarity in ECG tracing quality between the subject and predicate devices. The study concluded the device provides usable ECG data comparable to the predicate.

Technological Characteristics

Single-use, non-sterile, radiolucent 3-inch silicone patch. Contains five hydrogel electrodes with silver/silver chloride sensing elements. Laminated conductive adhesive. Connects to standard ECG patient cables. No internal software or active electronics; passive sensing device.

Indications for Use

Indicated for ECG monitoring of adults at rest when the upper left chest or center chest is available for patch placement.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 3M Red Dot ECG electrodes (K000690)

Submission Summary (Full Text)

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510(k) Summary

## 510(k) Summary for HMicro Wired C-Patch Electrode Page 1 of 2

| Company name: | HMicro, Inc.<br>39355 California St. Ste 303, Fremont, CA 94538 | |
|-----------------------|-----------------------------------------------------------------|--|
| Contact: | Kim Tompkins, VP Regulatory and Clinical Affairs | |
| | Mobile: [phone]<br>Email: [e-mail] | |
| 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), hydrogel<br>electrode, color coded, single use,<br>non-sterile. | Pre-wired (radiolucent), hydrogel electrode,<br>color coded affixed to 3 inch patch, single<br>use, non-sterile. |
| Materials | Electrode backing includes a<br>laminated conductive adhesive<br>and silver/silver chloride sensing<br>unit. | Electrode backing includes a laminated<br>conductive adhesive and silver/silver<br>chloride sensing unit; electrodes affixed to a<br>3 inch round silicone sheet patch using<br>medical grade adhesives. |
| Energy source | The wires must be connected to<br>an ECG patient cable which is in<br>turn connected to an ECG monitor. | The wires must be connected to an ECG<br>patient cable which is in turn connected to<br>an 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three curved lines representing its wings and body. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

Image /page/3/Picture/8 description: The image shows a logo with the letters FDA in a square shape on the left and a triangle shape on the right. There is a signature in the middle of the logo. The logo is black and white and has a pixelated appearance.

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) |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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