(406 days)
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.
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.
Unfortunately, the provided document, the "IneedMD - ILC Dover 12-Lead Glove 510(k) Summary," primarily focuses on the device's description, component materials, and regulatory clearance (510(k)) based on substantial equivalence to predicate devices. It does not contain details about acceptance criteria or a study proving the device meets specific performance criteria, which would typically include performance metrics like sensitivity, specificity, accuracy, or details about clinical trials.
The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have 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)." This indicates the device received clearance based on demonstrating equivalence to existing devices, rather than through a study specifically designed to establish and meet novel acceptance criteria for its performance.
Therefore, I cannot extract the requested information (points 1-9) from the provided text, as it is not present. The summary focuses on material biocompatibility and comparison to predicate device materials, not clinical performance metrics.
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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(Predicate Device and/or510K if available) |
|---|---|---|---|
| - multi-layered glovelike sheath- incidental contactwith patient's skin- direct contact withoperator's skin | - 100% polypropylenefiber- spunbondnonwoven fabric- manufacturedwithoutlubricants/finishes- latex and powderfree | - layers thermally weld tocreate the glove-likestructure | currently used pre-approved devices,- Class I Hygienicproducts(incontinent pads,adult/infant diapers,tampons)- Class II ProtectiveApparel (gowns,surgicalfacemasks*)- USP Class VIImplantable 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.
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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(Predicate Device and/or510K if available) |
|---|---|---|---|
| Electrodes | |||
| Kendall MediTrace230 (ECGConductiveAdhesiveElectrodes) | conductive hydrogeladhesive-backedfoamsnap attachment | electrode is affixed(crimped) to glovesheathsnap 70/30 brass,nickel plated, 0.005"thickhas no contact withpatient | Medi-Trace 200 andMedi-Trace 200-30*K960968 |
| Electrode Backers | |||
| Scapa BioFlex®RX416VSa | white polyethylenefoamdouble coated witha medical-gradeacrylic pressuresensitive adhesive | affixed underneaththe electrode toprovide stability ofthe electrode forease of placementdoes not contact thepatient nor theoperator's skin | product safety sheetlists the Class IItests performed andpassed-cytotoxicityprimary skinirritationsensitization-also contains nonatural latexproteins |
- 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(Predicate Device and/or510K if available) |
|---|---|---|---|
| Flexible Circuit Substrate | |||
| flexible substrate, 3-6 mils thick | 100% polyestersubstrateconductive silverink, topped withcarbon ink toexpose pads andtraces covered withdielectric(insulating) ink | the pre-printedcircuit receives noadditionalprocessing and ispositioned within thelayers of the gloveand away fromdirect contact withthe patient | Uni-Lead™ SensorArrays K932903 |
| Pre-printed Conductive Tracings | |||
| pre-printed andcured conductivetracings | pre-printed andcured circuitryconductivesilver inkcarbon inkinsulating ink | manufacture of theend-item does notchange or affect thepre-printed tracings | Uni-Lead™ SensorArrays K932903 |
| Extendable Limb Leads | |||
| three extendablelimb leads are madefrom the samematerials found inthe flex circuit | 100% polyestersubstratepre-printed circuitryconductivesilver inkcarbon inkinsulating film | the extendableleads are positionedwithin the layers ofthe glove when notin operation andpulled into use foroperation. Directskin contact ispossible | Uni-Lead™ SensorArrays 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/or510K if available) |
|---|---|---|---|
| Medical Cables, Inc.connecting cablewith an ABSconnector K002781 | 10 conductorshielded cablePVC insulatedConnector willcontain a rigidcircuit board | the ECG connectorcable is notattached duringmanufacture andtherefore notaffected by anyprocessingmeasures | Kendall TronomateK952659Merit IndustriesK942321 |
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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 (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
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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
Page 1 of __ 1 __
§ 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.