(89 days)
Not Found
Not Found
No
The summary describes a device for acquiring ECG signals and software for recording them. There is no mention of AI, ML, or any algorithms that would process the ECG data using such techniques. The performance studies focus on electrical safety and comparison to standard ECG cables, not on algorithmic performance.
No
The device is used for recording diagnostic 12-lead ECGs, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as "for use in recording diagnostic 12-lead ECGs," which indicates its role in diagnosis.
No
The device description explicitly states it is a "glove that incorporates a system of Ag/AgCI electrodes" and "terminates in a standard 15-pin mini D-type connector," indicating it is a hardware device. While it is intended to be used with software, the device itself is not software-only.
Based on the provided information, 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. They are used to examine these samples outside of the body.
- Device Function: The description clearly states that the device is a "glove that incorporates a system of Ag/AgCI electrodes for use in recording ECGs." An ECG (Electrocardiogram) is a test that measures the electrical activity of the heart directly from the body surface.
- Intended Use: The intended use is "for the purpose of conducting an electrocardiogram," which is a non-invasive procedure performed on the patient's body.
The device is a medical device used for physiological measurement in vivo (within the living body), not for analyzing samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms).
Product codes (comma separated list FDA assigned to the subject device)
DRX
Device Description
The PhysioGlove is a glove that incorporates a system of Ag/AgCI electrodes for use in recording ECGs. The glove terminates in a standard 15-pin mini D-type connector.
The PhysioGlove is intended to be used with the cleared PhysioGlove ES-1 software, for recording diagnostic 12-lead ECGs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest
Indicated Patient Age Range
Not Found
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)
The device was tested according to the following performance standards: IEC 60601-2-25, EC53 and EC 11. In addition, clinical testing was done to demonstrate the efficacy of the PhysioGlove compared to a standard 12-lead ECG cable. In all instances, the device functioned as intended,
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.
Not Found
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
K083677 Pl/2
510(k) SUMMARY
MAR 1 0 2009
COMMWELL LTD.'s PHYSIOGLOVE
A. General Information Submitter's Name: 1. Commwell Ltd. 2. Address: Rechov Yad Harutzim 4 Kfar Saba, Israel 44641 Telephone Number: 3. 9729-766-8094 4. Fax number: 9729-766-8099 5. Contact Person: Irving Levy 6. Date Prepared: December 11, 2008 Name of Device and Name/Address of Sponsor: B.
PhysioGlove
Commwell Ltd. Rechov Yad Harutzim 4 Kfar Saba, Israel 44641
C. Device
- Trade Name:
-
- Common Name:
- Classification Name: 3.
- Product Code: 4.
-
- Class:
- ర్. CFR Reference:
D. Predicate devices
| 1. Name: | Tapuz Medical Technology's ECG Electrodes Apron |
|---|---|
| 1. Date Cleared: | June 1, 2003 and Oct. 14, 1998 respectively |
- Name IneedMD 12-Lead Glove Date Cleared: Dec 22, 2004
\\DC - 080866/000001 - 2823607 v1
PHYSIOGLOVE 12-Lead Diagnostic ECG glove Electrocardiograph glove DRX II
21 CFR 870.2360
I.
1
E. Intended Use / Indications for Use
The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms).
F. Technological Characteristics - Components and Safety Features
The PhysioGlove is a glove that incorporates a system of Ag/AgCI electrodes for use in recording ECGs. The glove terminates in a standard 15-pin mini D-type connector.
The PhysioGlove is intended to be used with the cleared PhysioGlove ES-1 software, for recording diagnostic 12-lead ECGs.
G. Performance Data
·
The device was tested according to the following performance standards: IEC 60601-2-25, EC53 and EC 11. In addition, clinical testing was done to demonstrate the efficacy of the PhysioGlove compared to a standard 12-lead ECG cable.
In all instances, the device functioned as intended,
H. Substantial Equivalence
The PhysioGlove is as safe and effective as the Tapuz ECG Electrodes Apron and the IneedMD 12-Lead Glove. The PhysioGlove has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the PhysioGlove and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the PhysioGlove is as safe and effective as the Tapuz ECG Electrodes Apron and the IncedMD 12-Lead Glove. Thus, the PhysioGlove is substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
MAR I 0 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Commwell Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004
Re: K083677
Trade/Device Name: PhysioGlove Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II Product Codes: DRX Dated: December 11, 2008 Received: December 11, 2008
Dear Mr. Kahan:
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.
3
Page 2 - Mr. Jonathan S. Kahan
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,
7 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K083677
Device Name: PhysioGlove
Indications for Use:
The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 33.5 - 46.5 inches. (85 - 118 cms).
Prescription Use イ (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Zuckerman
(Division Sign-Off) 3/14/09 Division of Cardiovascular Devices 510(k) Number K083677