(191 days)
Not Found
No
The summary describes a passive electrode and does not mention any computational or analytical capabilities beyond signal acquisition.
No
The device is an electrode used for monitoring ECG, not for providing therapeutic treatment.
No
This device is an ECG electrode designed for monitoring, not for diagnosing a condition or disease. It provides data (ECG tracings) which can then be interpreted by a healthcare professional for diagnostic purposes, but the device itself does not perform the diagnosis.
No
The device description clearly outlines a physical electrode patch with wires and a silicone base, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The HMicro Wired C-Patch ECG Electrode is an external electrode designed to be placed on the skin to measure electrical activity of the heart (ECG monitoring). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "for short-term, adult ECG monitoring at rest." This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the device described is a medical device for physiological monitoring, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left upper chest or center chest
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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: 408.981.4889
Email: 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).
1
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 | |
| electrode, color coded, single use, | ||
| non-sterile. | Pre-wired (radiolucent), hydrogel electrode, | |
| color coded affixed to 3 inch patch, single | ||
| use, non-sterile. | ||
| Materials | Electrode backing includes a | |
| laminated conductive adhesive | ||
| and silver/silver chloride sensing | ||
| unit. | Electrode backing includes a laminated | |
| conductive adhesive and silver/silver | ||
| chloride sensing unit; electrodes affixed to a | ||
| 3 inch round silicone sheet patch using | ||
| medical grade adhesives. | ||
| Energy source | The wires must be connected to | |
| an ECG patient cable which is in | ||
| turn connected to an ECG monitor. | The wires must be connected to an ECG | |
| patient cable which is in turn connected to | ||
| 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.
2
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
3
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
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
4
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)
Image /page/4/Picture/7 description: The image shows a stamp with the text "Mark Jellison" and "for" on the left side. On the right side, the stamp includes the date "2014.07.24", the time "15:32:00", and the timezone offset "-04'00'". The stamp appears to be an official mark or seal, possibly indicating approval or verification.