12 LEAD GLOVE

K100315 · I Needmd, Inc. · DRX · Apr 23, 2010 · Cardiovascular

Device Facts

• Record ID: K100315
• Device Name: 12 LEAD GLOVE
• Applicant: I Needmd, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Apr 23, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.

Device Story

12 Lead Glove is a wearable accessory designed to standardize ECG electrode placement. It integrates multiple ECG electrodes into a single, glove-like unit to facilitate consistent electrode positioning on the patient's chest. The device is intended for use by healthcare professionals during standard electrocardiogram procedures. By ensuring correct and repeatable electrode placement, the device aims to improve the accuracy and reliability of ECG signal acquisition. It is used in clinical settings where ECG monitoring is required. The output is a standard 12-lead ECG signal, which is processed by a connected electrocardiograph machine to assist clinicians in diagnosing cardiac conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device consists of a glove-like assembly housing multiple ECG electrodes. It is designed to maintain a conventional ECG electrode configuration. It is a passive accessory used with standard electrocardiograph equipment. No specific materials, energy sources, or software algorithms are described.

Indications for Use

Indicated for patients with a chest girth of 97-104 cm requiring an electrocardiogram (ECG) procedure.

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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

## APR 2 3 2010

INeedMD, Inc. c/o Mr. Irving Wiesen Law Offices of Irving L. Wiesen, Esq. 420 Lexington Avenue, Suite 2400 New York, NY 10170

Re: K100315

> Trade/Device Name: 12 Lead Glove Regulatory Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: 74 DRX Dated: March 26, 2010 Received: March 29, 2010

Dear Mr. Wiesen:

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 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. Irving Wiesen

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

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): _ K100315

Device Name: __________12 Lead Glove

Indications For Use:

The 12 lead glove is designed to configure ECG electrodes in a single unit using a conventional ECG electrode configuration for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 97 - 104 cm.

Prescription Use ONLY X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801

Subparı C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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W.W.S.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K100315

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