12-LEAD GLOVE

K033559 · Ineedmd · DRX · Dec 22, 2004 · Cardiovascular

Device Facts

• Record ID: K033559
• Device Name: 12-LEAD GLOVE
• Applicant: Ineedmd
• Product Code: DRX · Cardiovascular
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Traditional
• 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

The 12-Lead Glove is a wearable sheath containing pre-positioned electrodes and conductive circuitry on a flexible substrate. It simplifies ECG setup by consolidating multiple electrodes into a single unit. The operator connects the glove to a standard ECG monitor via a multi-conductor cable, wears the glove, and positions their hand on the patient's chest to attach the electrodes. Three extendable limb leads are also provided. The device is intended for use by healthcare professionals to obtain a 12-lead ECG tracing. By pre-positioning electrodes, the device reduces setup time, eliminates cable confusion, and minimizes erroneous readings compared to traditional individual electrode placement. It benefits patients by facilitating faster, more reliable diagnostic data collection.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per AAMI/ISO 10993-5 (Cytotoxicity) and AAMI/ISO 10993-10 (Primary Dermal Irritation). Electrodes comply with EC12-1991 AAMI standards.

Technological Characteristics

Multi-layered polypropylene fiber glove sheath; conductive hydrogel adhesive electrodes; polyester-based flexible circuit with silver/carbon conductive inks. Connectivity via multi-conductor cable to standard ECG monitors. Biocompatibility per ISO 10993. Non-sterile.

Indications for Use

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

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

• Uni-Lead™ Sensor Arrays (K932903)
• Medi-Trace 200 and Medi-Trace 200-30 (K960968)
• Kendall Tronomate (K952659)
• Merit Industries (K942321)

Submission Summary (Full Text)

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### IneedMD - ILC Dover 12-Lead Glove 510(k) Summary

#### Scope

The scope of this document is limited to the IneedMD 12-Lead Glove, a Class II medical device.

#### Device Description

The 12-Lead Glove has been designed to obtain an electrocardiogram (ECG) with pre-positioned electrodes affixed to the underside of a glove-like sheath. The pre-printed conductive circuity is contained within the sheath (or shell) on a flexible substrate. To obtain the tracing, the operator need only connect the glove via a single (multi-conductor) cable connected to the ECC monitor, slip on the glove, position their hand on the patient's chest, and attach three extendable electrodes which will provide a full 12-Lead recording. The 12-Lead Glove saves valuable time required for set-up compared to the standard approach with multiple electrode placements. It eliminates the confusion of working with the standard cables and eliminates erroneous ECG readings.

## Component/Materia! Descriptions

The 12-Lead Glove is made up of several components, or sub-assemblies. They include:

- the shell, or the glove-like sheath which has indirect contact with the patient's skin .
- the electrodes (and electrode foam backers) which are embedded within the shell and has . direct contact with the patient's skin
- . the pre-printed conductive flex-circuit (and extendable limb leads), have no contact with the patient's skin
- the ECG Connector Cable to transmit the electrical impulses to an ECG machine .

The following tables delineate all materials used in the 12-Lead Glove, and demonstrate their safety and acceptability for use in this device. Most materials used either have predicate device history or are currently used in pre-approved medical devices.

#### Shell

| Component Description | Material(s) | End-Product Processing | Acceptability for Use<br>(Predicate Device and/or<br>510K if available) |
|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - multi-layered glove<br>like sheath<br>- incidental contact<br>with patient's skin<br>- direct contact with<br>operator's skin | - 100% polypropylene<br>fiber<br>- spunbond<br>nonwoven fabric<br>- manufactured<br>without<br>lubricants/finishes<br>- latex and powder<br>free | - layers thermally weld to<br>create the glove-like<br>structure | currently used pre-<br>approved devices,<br>- Class I Hygienic<br>products<br>(incontinent pads,<br>adult/infant diapers,<br>tampons)<br>- Class II Protective<br>Apparel (gowns,<br>surgical<br>facemasks*)<br>- USP Class VI<br>Implantable Devices<br>(hernia repair mesh,<br>sutures K002999) |

Guidance for Industry and FDA Staff; Surgical Masks – Premarket Notification (5109k)) Submissions, Document Issued 3/5/2004Center for Devices and Radiological Health, page 6.

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Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of numbers and letters. The first line reads 'K033559', and the second line reads 'p.2/3'. The handwriting is somewhat rough, but the characters are generally legible.

The polypropylene fabric has demonstrated exceptional performance in biocompatibility tests, AAM/ISO 10993-5, Cytotoxicity - Agar Diffusion and AAM/ISO 10993-10, Primary Dermal Irritation in Rabbits.

Test Results are included in Attachment I of this document.

#### Electrodes and Electrode Backers

| Component Description | Material(s) | End-Product Processing | Acceptability for Use<br>(Predicate Device and/or<br>510K if available) |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Electrodes</b> | | | |
| Kendall MediTrace<br>230 (ECG<br>Conductive<br>Adhesive<br>Electrodes) | conductive hydrogel<br>adhesive-backed<br>foam<br>snap attachment | electrode is affixed<br>(crimped) to glove<br>sheath<br>snap 70/30 brass,<br>nickel plated, 0.005"<br>thick<br>has no contact with<br>patient | Medi-Trace 200 and<br>Medi-Trace 200-30*<br>K960968 |
| <b>Electrode Backers</b> | | | |
| Scapa BioFlex®<br>RX416VSa | white polyethylene<br>foam<br>double coated with<br>a medical-grade<br>acrylic pressure<br>sensitive adhesive | affixed underneath<br>the electrode to<br>provide stability of<br>the electrode for<br>ease of placement<br>does not contact the<br>patient nor the<br>operator's skin | product safety sheet<br>lists the Class II<br>tests performed and<br>passed<br>-<br>cytotoxicity<br>primary skin<br>irritation<br>sensitization<br>-<br>also contains no<br>natural latex<br>proteins |

* Each of the pre-approved electrodes have received FDA approved biocompaibility and EC12-1991 and EC12-1991 AAMi Standards.

The electrodes are installed to the glove sheath by crimping. They function through contact with the printed conducting pad of the flex-circuit.

## Figure 1: Schematic of the electrode affixed to the sheath

Image /page/1/Figure/8 description: This image shows a diagram of a sensor with a male snap, two female snaps, a polypropylene sheath, a backer, and a flex circuit layer. The sensor with the male snap is located at the top of the diagram. The two female snaps are located in the middle of the diagram. The polypropylene sheath is located at the top and bottom of the diagram. The flex circuit layer is located at the bottom of the diagram.

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# Flex-Circuit Layer

| Component Description | Material(s) | End-Product Processing | Acceptability for Use<br>(Predicate Device and/or<br>510K if available) |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Flexible Circuit Substrate | | | |
| flexible substrate, 3-<br>6 mils thick | 100% polyester<br>substrate<br>conductive silver<br>ink, topped with<br>carbon ink to<br>expose pads and<br>traces covered with<br>dielectric<br>(insulating) ink | the pre-printed<br>circuit receives no<br>additional<br>processing and is<br>positioned within the<br>layers of the glove<br>and away from<br>direct contact with<br>the patient | Uni-Lead™ Sensor<br>Arrays K932903 |
| Pre-printed Conductive Tracings | | | |
| pre-printed and<br>cured conductive<br>tracings | pre-printed and<br>cured circuitry<br>conductive<br>silver ink<br>carbon ink<br>insulating ink | manufacture of the<br>end-item does not<br>change or affect the<br>pre-printed tracings | Uni-Lead™ Sensor<br>Arrays K932903 |
| Extendable Limb Leads | | | |
| three extendable<br>limb leads are made<br>from the same<br>materials found in<br>the flex circuit | 100% polyester<br>substrate<br>pre-printed circuitry<br>conductive<br>silver ink<br>carbon ink<br>insulating film | the extendable<br>leads are positioned<br>within the layers of<br>the glove when not<br>in operation and<br>pulled into use for<br>operation. Direct<br>skin contact is<br>possible | Uni-Lead™ Sensor<br>Arrays K932903 |

Attached to this document in Attachment II, are comparisons schematic drawing/photo of the proposed and predicate flex-circuits.

# ECG Cable and Connector

| Component Description | Material(s) | End-Product Processing | Acceptability for Use<br>(Predicate Device and/or<br>510K if available) |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Medical Cables, Inc.<br>connecting cable<br>with an ABS<br>connector K002781 | 10 conductor<br>shielded cable<br>PVC insulated<br>Connector will<br>contain a rigid<br>circuit board | the ECG connector<br>cable is not<br>attached during<br>manufacture and<br>therefore not<br>affected by any<br>processing<br>measures | Kendall Tronomate<br>K952659<br>Merit Industries<br>K942321 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEC 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

INeedMD c/o Irving Wiesen, Esq. Law Offices of Irving L. Wiesen 860 Canal Street Stamford, CT 06902

Re: K033559 Trade Name: 12-Lead Glove Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: II (two) Product Code: DRX Dated: September 22, 2004 Received: September 24, 2003

Dear Mr. Wiesen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered proc to May 20, 1978, 11:15
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmotion For (110) in the device, subject to the general controls provisions of the Act. The r our may, merelore, mains 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.

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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); 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Megasmer

Bram B. 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): K033559

#### 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 _____________________________________________________________________________________________________________________________________________________________

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nllepak Moun

Sign-On
Division of Cardiovascular Devices
510(k) Number 16033 554

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