(246 days)
The Lifecare HC-88 Series Conductive Garments are cutaneous electrodes to be used with legally marketed electrical stimulators (such as powered muscle stimulators and transcutaneous electrical nerve stimulators).
The knitted garment electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.
These body parts include hands (gloves), feet (socks), wrists / elbows (wristlets / elbow guards) and knees (kneecaps).
The single-patient reusable and non-sterile Lifecare HC-88 Series Conductive Garments are cutaneous. flexible, conductive garment/fabric electrodes.
They are passive devices acting as interface between electrical stimulators (such as powered muscle stimulators, interferential devices, galvanic device and transcutaneous electrical nerve stimulators) and a patient's skin. The signal is transmitted from the conductive knob through the cloth of conductive garment to the surface of the patient's skin.
The Lifecare HC-88 Series Conductive Garments are used in conjunction with electrical stimulators both in the home and physical therapy setting, and can stimulate large or multiple. They are knitted in different shapes, as gloves, socks, kneecaps and wristlets/elbow guards, and in different sizes.
The Lifecare HC-88 Series Conductive Garments are constructed with four basic components (materials): a metal conductive snap terminal; cloth knitted together with Spandex and Stainless-steel yarns that twisted and composed by Stainless-steel and Nylon fibers. The garments are not packaged with lead wire.
Impedance testing evaluated by the "Resistance meter of electronic multimeter" to measure the impedances of all conductive garments are below 5 ohms between each centimeter and evaluated by the "oscilloscope measuring circuit" to measure the total impedance of all conductive garments are below 50 ohms" . Even after over 20 times washing, the impedance of Lifecare HC-88 Series Conductive Garments are still within specification.
The garments are not compatible with MRI spectrometry.
The provided document is a 510(k) summary for the Lifecare HC-88 Series Conductive Garments. This device is a passive cutaneous electrode used with electrical stimulators. The document focuses on demonstrating substantial equivalence to a predicate device and addresses safety aspects like biocompatibility and impedance.
However, the 510(k) summary does not contain information about a study proving device performance against acceptance criteria in the context of diagnostic or AI-assisted medical devices. It is a report for a passive, non-AI medical device (conductive garments).
Therefore, it is not possible to extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types/establishment for training/test sets) because these concepts are generally applicable to studies for diagnostic devices with specific performance metrics or AI/ML-enabled devices, not a simple conductive garment.
Here's a breakdown of why the requested information cannot be provided from the given document:
- Acceptance Criteria & Reported Performance: The document provides impedance specifications, but these are specifications for the physical product, not performance criteria for a diagnostic or AI algorithm. It states "Impedance testing evaluated by the "Resistance meter of electronic multimeter" to measure the impedances of all conductive garments are below 5 ohms between each centimeter and evaluated by the "oscilloscope measuring circuit" to measure the total impedance of all conductive garments are below 50 ohms"." This is a design specification verification, not a clinical performance study.
- Sample Size (Test Set) & Data Provenance: Not applicable. There is no "test set" in the context of evaluating a diagnostic algorithm's performance.
- Number of Experts & Qualifications / Adjudication Method: Not applicable. These relate to establishing ground truth for diagnostic studies, which is not relevant for a conductive garment.
- MRMC Comparative Effectiveness Study: Not applicable. This type of study evaluates human reader performance, often with and without AI assistance, which isn't relevant for a passive garment.
- Standalone Performance: Not applicable. A conductive garment doesn't have "standalone performance" in the way an AI algorithm does.
- Type of Ground Truth: Not applicable. There is no diagnostic ground truth needed for this device.
- Sample Size (Training Set) & How Ground Truth for Training Set was Established: Not applicable. This refers to AI/ML development, which is not relevant here.
In summary, the provided text describes a 510(k) submission for a medical device (conductive garments) that is considered safe and effective based on substantial equivalence to a predicate device and adherence to manufacturing and biocompatibility standards, not through a performance study against specific acceptance criteria for a diagnostic or AI-enabled function.
{0}------------------------------------------------
510(k) Summary As Required by 21 section 807.92 ( c )
Everyway Medical Instruments Co., Ltd. 1-Submitter Name:
2-Address:
3 FL., No.5, LANE 155, Sec. 3, Peishen Rd Shen Keng Hsiang. 222 Taipei Hsien. Taiwan (ROC)
3-Phone: (886) 2 2662 0038
4-Fax: (886) 2 2664 5566
5-Contact Person: Mr. Robert Tu (General Manager)
6-Date summary prepared: July 15", 2011
7 - Official Correspondent: Mansour Consulting LLC
8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA
9- Phone: 678-908-8180
10- Fax: 678-623-3765
11- Contact Person: Jav Mansour, President
12-Device Trade or Proprietary Name: Lifecare HC-88 Series Conductive Garments
13-Device Common or usual name: Lifecare HC-88 Series Conductive Garments
14-Device Classification Name: Cutaneous electrode
15-Substantial Equivalency is claimed against the following device:
TheraKnit Garment Cutaneous Electrodes from Neurotron Medical, Inc. 510k# K053214 16-Description of the Device:
The single-patient reusable and non-sterile Lifecare HC-88 Series Conductive Garments are cutaneous. flexible, conductive garment/fabric electrodes.
They are passive devices acting as interface between electrical stimulators (such as powered muscle stimulators, interferential devices, galvanic device and transcutaneous electrical nerve stimulators) and a patient's skin. The signal is transmitted from the conductive knob through the cloth of conductive garment to the surface of the patient's skin.
The Lifecare HC-88 Series Conductive Garments are used in conjunction with electrical stimulators both in the home and physical therapy setting, and can stimulate large or multiple. They are knitted in different shapes, as gloves, socks, kneecaps and wristlets/elbow guards, and in different sizes.
The Lifecare HC-88 Series Conductive Garments are constructed with four basic components (materials): a metal conductive snap terminal; cloth knitted together with Spandex and Stainless-steel yarns that twisted and composed by Stainless-steel and Nylon fibers. The garments are not packaged with lead wire.
Impedance testing evaluated by the "Resistance meter of electronic multimeter" to measure the impedances of all conductive garments are below 5 ohms between each centimeter and evaluated by the "oscilloscope measuring circuit" to measure the total impedance of all conductive garments are below 50 ohms" . Even after over 20 times washing, the impedance of Lifecare HC-88 Series Conductive Garments are still within specification.
The garments are not compatible with MRI spectrometry.
17-Intended use of the device: (refer to FDA form attached)
The Lifecare HC-88 Series Conductive Garments are used in conjunction with electrical stimulators both in the home and physical therapy setting, and can stimulate large or multiple. They are knitted in different shapes, as gloves, socks, kneecaps and wristlets/elbow guards, and in different sizes.
18-Safety and Effectiveness of the device:
This device is safe and effective as the predicate devices cited above as detailed within this submission. This type of device has been marketed and used in US for several years as Prescription use and proven to be safe and effective without side effects or complications generated from the use of the device itself.
19-Biocompatibility of material:
The material of Lifecare HC-88 Series Conductive Garments were evaluated and passed the evaluation of biocompatibility testing by SGS Taiwan Ltd.
- Cytotoxicity test (ISO 10993-5, SGS report No.UB/2010/50533), -
- । Skin irritation test (ISO 10993-10, SGS report No. UB/2010/50533A-01) and
- Skin sensitization test (ISO 10993-10, SGS report No. UB/2010/50533A-02)
AUG 2 4 2011
{1}------------------------------------------------
20-Approximate surface area of each garment model:
| REF.NO | SIZE | SURFACE AREA | Type |
|---|---|---|---|
| HC-884A | M(L21cm) | 450cm² | Glove |
| HC-885A | L(L24cm) | 580cm² | Glove |
| HC-886A | S(L18cm) | 330cm² | Glove |
| REF.NO | SIZE | SURFACE AREA | Type |
| HC-883 | (L33xW9cm) | 600cm² | Sock |
| REF.NO | SIZE | SURFACE AREA | Type |
| HC-881A | M(L18xW11cm) | 400cm² | Wristlet/Elbow |
| HC-881-1A | S(L18xW10cm) | 360cm² | Wristlet/Elbow |
| REF.NO | SIZE | SURFACE AREA | Type |
| HC-882A | M(L27xW14cm) | 760cm² | Kneecaps |
719
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Everyway Medical Instruments Co., Ltd. c/o Mr. Jay Mansour Mansour Consulting, LLC 845 Aronson Lake Court Roswell, GA 30075
AUG 2 4. 2011
Re: K103719
Trade/Device Name: Lifecare HC 88-Series Conductive Garments Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: August 1, 2011 Received: August 5, 2011
Dear Mr. Mạnsour:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) promation 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 encrosule) to tegally manoves personal perice Ameridae, or to commerce prof to way 20, 1970, the classified in accordance with the provisions of the Federal Food, Drug, devices that have been recursed in accordance was a premarket approval approval application (PMA). and Cosment Act (Act) that do not roques approvinces in controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provision You may, merelote, market the device, saljers to the gents for annual registration, listing of the general Controls provisions of the vice is a prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note. CDITI docs how verse labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or classica on be II your device is classifica (see above) Existing major regulations affecting your device can be may be subject to additional controlly "Linziting Collections, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I occar 105g ming your device in the Federal Register,
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 of the Act one of our must oomn that FDA has made a determination that Jour cered by other Federal agencies. You must comply of any Pederal statutes and regulations administered of the registration and listing (2) CFR Patt With an the Act s requiremons; areasing, a with the reporting of medical device-related
{3}------------------------------------------------
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the adverse events) (21 CFR 805); good manufacture production in electronic product
quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product quality systems (QS) regulation (21 CFR 100 SE6), 21 CFR 1000-1050.
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
r (1580), please and 15 (1) (15) (1)PRIVOR (CDRUCCDRUCC) If you desire specific advice for your device of our laborary copanese (
go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml (5809.html for go to http://www.tda.gov/AboutFDACEmers/crices/Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH) s (CDRH) stopperket notification" ( the Center for Devices and Radiological ricallis systemarks notification" (21CFR Patt
note the regulation entitled, "Misbranding by reference sunder the MDR regulation (2 note the regulation entitled, "Misoraliung of relected to promation
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.html for the CDRH's Office ntlp://www.ida.gov.nice.etrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general inormational and Consumer Assistance at its toll-free number
Division of Small Manufacturers, International and Consumer Assistance at its toll-f (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 638-2041 of (501) 790-7100 of at its career)
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/3/Picture/7 description: The image shows the handwritten word "for" in cursive. The "f" has a large loop extending below the baseline, and the "o" and "r" are connected with a smooth curve. The writing style is fluid and elegant, with a slight slant to the right.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Lifecare HC-88 Series Conductive Garments
Indications For Use:
The Lifecare HC-88 Series Conductive Garments are cutaneous electrodes to be used with legally marketed electrical stimulators (such as powered muscle stimulators and transcutaneous electrical nerve stimulators).
The knitted garment electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.
These body parts include hands (gloves), feet (socks), wrists / elbows (wristlets / elbow guards) and knees (kneecaps).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of
510(k) Number
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).