(406 days)
No
The description focuses on the physical design and functionality of the electrode placement device, with no mention of data analysis or interpretation using AI/ML.
No
The device is described as assisting in conducting an electrocardiogram (ECG) and taking recordings. It is used to obtain diagnostic information and does not treat or alleviate a disease, nor does it restore, modify, or correct body function. Therefore, it is not a therapeutic device.
Yes
The device is designed to obtain an electrocardiogram (ECG), which is a diagnostic tool used to assess heart function and diagnose cardiac conditions.
No
The device description clearly details a physical glove with pre-positioned electrodes, conductive circuitry, and a cable connection, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The 12-Lead Glove is used to acquire an electrocardiogram (ECG). An ECG is a recording of the electrical activity of the heart, which is a physiological measurement taken directly from the patient's body. It does not involve analyzing samples taken from the body.
The device is a tool for acquiring a physiological signal from the patient, not for performing a diagnostic test on a biological sample.
N/A
Intended Use / 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.
Product codes
DRX
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.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
(Predicate Device and/or
510K if available) |
|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| - multi-layered glove
like sheath
- incidental contact
with patient's skin - direct contact with
operator's skin | - 100% polypropylene
fiber - spunbond
nonwoven fabric - manufactured
without
lubricants/finishes - latex and powder
free | - layers thermally weld to
create the glove-like
structure | currently used pre-
approved devices, - Class I Hygienic
products
(incontinent pads,
adult/infant diapers,
tampons) - Class II Protective
Apparel (gowns,
surgical
facemasks*) - USP Class VI
Implantable Devices
(hernia repair mesh,
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.
1
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
(Predicate Device and/or
510K if available) |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrodes | | | |
| Kendall MediTrace
230 (ECG
Conductive
Adhesive
Electrodes) | conductive hydrogel
adhesive-backed
foam
snap attachment | electrode is affixed
(crimped) to glove
sheath
snap 70/30 brass,
nickel plated, 0.005"
thick
has no contact with
patient | Medi-Trace 200 and
Medi-Trace 200-30*
K960968 |
| Electrode Backers | | | |
| Scapa BioFlex®
RX416VSa | white polyethylene
foam
double coated with
a medical-grade
acrylic pressure
sensitive adhesive | affixed underneath
the electrode to
provide stability of
the electrode for
ease of placement
does not contact the
patient nor the
operator's skin | product safety sheet
lists the Class II
tests performed and
passed
cytotoxicity
primary skin
irritation
sensitization
also contains no
natural latex
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.
2
Flex-Circuit Layer
| Component Description | Material(s) | End-Product Processing | Acceptability for Use
(Predicate Device and/or
510K if available) |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Flexible Circuit Substrate | | | |
| flexible substrate, 3-
6 mils thick | 100% polyester
substrate
conductive silver
ink, topped with
carbon ink to
expose pads and
traces covered with
dielectric
(insulating) ink | the pre-printed
circuit receives no
additional
processing and is
positioned within the
layers of the glove
and away from
direct contact with
the patient | Uni-Lead™ Sensor
Arrays K932903 |
| Pre-printed Conductive Tracings | | | |
| pre-printed and
cured conductive
tracings | pre-printed and
cured circuitry
conductive
silver ink
carbon ink
insulating ink | manufacture of the
end-item does not
change or affect the
pre-printed tracings | Uni-Lead™ Sensor
Arrays K932903 |
| Extendable Limb Leads | | | |
| three extendable
limb leads are made
from the same
materials found in
the flex circuit | 100% polyester
substrate
pre-printed circuitry
conductive
silver ink
carbon ink
insulating film | the extendable
leads are positioned
within the layers of
the glove when not
in operation and
pulled into use for
operation. Direct
skin contact is
possible | Uni-Lead™ Sensor
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
(Predicate Device and/or
510K if available) |
|------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Medical Cables, Inc.
connecting cable
with an ABS
connector K002781 | 10 conductor
shielded cable
PVC insulated
Connector will
contain a rigid
circuit board | the ECG connector
cable is not
attached during
manufacture and
therefore not
affected by any
processing
measures | Kendall Tronomate
K952659
Merit Industries
K942321 |
3
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.
4
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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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
5
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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