(33 days)
The TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS and NMES stimulating devices. The knitted garments deliver the stimulation signals generated by the stimulator to the body parts with which they are in contact. These body parts include hands, feet, arms, legs, shoulder, back (pads).
The TheraKnit Garment Electrodes are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, sleeves and flat fabric used for pads. The conductivity is derived from the silver content of the Nylon yarn. The garment electrodes are available in a variety of sizes ranging from small to extra large for gloves and small to large for socks and sleeves. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The devices can be used dry or wet when in contact with the skin. The entire surface of each garment electrode is very conductive having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
Acceptance Criteria and Device Performance Study for TheraKnit Garment Electrodes
The provided 510(k) summary for the TheraKnit Garment Electrodes (K053214) outlines its claims of substantial equivalence to predicate devices, but it does not explicitly state quantitative acceptance criteria or detailed results of a study designed to prove the device meets specific performance thresholds.
Instead, the submission focuses on demonstrating equivalence through shared technological characteristics and general bench testing, which is common for devices seeking 510(k) clearance based on substantial equivalence.
Here's an analysis based on the provided text, addressing your specific points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Inferred) | Reported Device Performance (from text) |
|---|---|
| Electrical Resistance (Conductivity) | Less than 7 ohms per inch. (Stated for both TheraKnit and predicate devices). This is critical for uniform current distribution and low current density. |
| Material Composition | Knitted from a continuous silver-coated Nylon yarn. |
| Form Factor | Garments (gloves, socks, sleeves, flat fabric for pads). |
| Intended Use | To deliver stimulation current for pain relief with TENS/NMES devices. |
| Target Population | Patients needing pain relief via electrostimulation on hands, feet, arms, legs, low back, and shoulder. |
| Washability | Washable with conventional detergents without adverse effect on conductivity. |
| Fit/Skin Contact | Provides a snug elastic fit. |
| Biocompatibility/Safety | Not explicitly stated, but implied by regulatory clearance and similarity to predicate devices. |
| Compatibility with TENS/NMES devices | Receives electrostimulation signal from legally marketed TENS/NMES devices via a lead wire and snap connector. |
| Overall Design Requirements | Device meets design controls and design requirements. |
| Equivalence to Predicate Devices | TheraKnit is "substantially equivalent" to predicate devices. |
Study Proving Acceptance Criteria:
The study proving these (mostly implied) acceptance criteria is described as "Bench testing" and "Comparative testing":
- Bench testing: "Bench testing has been done with this device demonstrating that it meets design controls." This is a general statement indicating the device underwent internal testing to ensure it functions as designed, but specific results or quantitative criteria met are not detailed.
- Comparative testing: "Comparative testing was done between the TheraKnit garments and the predicate devices for resistance measurement and comparison." This directly addresses the electrical resistance criterion and aims to show similarity to the legally marketed predicate devices. The text states that "The resistance of the knitted garment for both TheraKnit and the predicate devices are less than 7 ohms/inch," indicating this comparative testing confirmed the TheraKnit's conductivity is within the same range as the predicates.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document does not provide any numbers for the test set used during bench or comparative testing.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given it's bench and comparative testing relating to physical properties, it would most likely be prospective laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. The study described focuses on technical performance characteristics (like resistance) and design controls of the device itself, rather than diagnostic accuracy or clinical outcomes that would require expert ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. As the testing was technical/bench-based, there would be no need for an adjudication method typically used for clinical or image-based studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. An MRMC study was not done. The device is a cutaneous electrode, not a diagnostic imaging or AI-assisted interpretation tool that would typically involve human readers. The comparative effectiveness focused on technical specifications rather than human performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not Applicable (in the conventional sense). This device is not an algorithm or AI system. Its performance (e.g., conductivity) is standalone in the sense that the device itself performs this function, but the context of "standalone performance" usually refers to AI systems. Its intended use is with human-operated TENS/NMES devices.
7. The Type of Ground Truth Used
- Calibration/Measurement Standards and Predicate Device Performance. For the resistance measurements, the ground truth would be established through calibrated measuring equipment providing an objective standard for "ohms/inch." For the comparative testing, the performance of the legally marketed predicate devices served as a de facto "ground truth" or benchmark against which the TheraKnit's performance was compared to demonstrate equivalence.
8. The Sample Size for the Training Set
- Not Applicable. The device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. The device is not an AI/ML model.
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K0532/4
OEC 2 0 2005
510(k) Summary
Trade Name: TheraKnit
Common/Classification Name: Electrode, Cutaneous (84GXY) 21 CFR 882.1320
Neurotron Medical, Inc. 800 Silvia Street West Trenton, NJ 08628 800-367-1238
Contact: Jack Guldalian, President
Prepared: August 24, 2005
LEGALLY MARKETED PREDICATE DEVICES A.
K932299 Electro-Mesh Glove Electrode Prizm Medical, Inc.
K944487 Electro-Mesh Sock, Wrap and Sleeve Electrodes Prizm Medical, Inc.
K943009 SMD Glove, Sock and Sleeve Electrodes Scientific Medical Devices, Inc.
DEVICE DESCRIPTION B.
The TheraKnit Garment Electrodes are conductive garments knitted from a continuous silver coated Nylon yarn into the form of gloves, socks, sleeves and flat fabric used for pads. The conductivity is derived from the silver content of the Nylon yarn. The garment electrodes are available in a variety of sizes ranging from small to extra large for gloves and small to large for socks and sleeves. The elongation property of the nylon yarn provides some elasticity which ensures firm skin contact. The devices can be used dry or wet when in contact with the skin. The entire surface of each garment electrode is very conductive having a resistance of less than 7 ohms per inch. This low resistance provides low current density with uniform current distribution.
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INTENDED USE C.
TheraKnit garment cutaneous electrodes as glove, socks, sleeves and pads are intended for use with legally marketed electrostimulation devices such as TENS and NMES to deliver stimulation current for pain relief. They can be used on body parts such as hands, feet, arms, legs, low back and shoulder for pain relief using electrostimulation.
SUBSTANTIAL EQUIVALENCE SUMMARY D.
The TheraKnit Garment Electrode is a medical device that has the same indication, intended use and target population as the legally marketed predicate devices.
TheraKnit has the same technological characteristics as the predicate rneraKhit hab the stheraKnit and the predicate devices are made with a silver plated nylon yarn. The resistance of the knitted garment for both TheraKnit and the predicate devices are less than 7 ohms/inch which is very low relative to the delivery of the stimulation current.
Both TheraKnit and the predicate devices receive the electrostimulation signal from a legally marketed TENS or NEMS device through a lead wire signal from a logally markets connected to a snap connector on the knitted garment device.
Both TheraKnit and the predicate devices are washable and intended for single patient use.
TECHNOLOGICAL CHARACTERISTICS E.
The TheraKnit garment electrodes are made from a silver plated nylon rne Therakhit gurment elections process. The fabric is highly conductive yarri asing a comments ohms resistance per inch. The device can be and provides less and interestive polarity, a second electrode is used with element the stimulator current to the target tissue and necessary to direct the samalator of e device is washable using conventional complete the clecencal circuit.
detergents without adverse effect on the conductivity of the device.
The garment electrodes provide a snug elastic fit based upon the 37% The garment characteristic of the yarn used in the construction.
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F. TESTING
ﻪ
Bench testing has been done with this device demonstrating that it meets design controls.
Comparative testing was done between the TheraKnit garments and the predicate devices for resistance measurement and comparison.
CONCLUSIONS G.
Design specifications, comparison to predicate device specifications and testing has demonstrated that this TheraKnit device meets design requirements and is equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2005
Neurotron Medical, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo Minnesota 55313
Re: K053214/S1
Trade/Device Name: Theraknit Garments Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: December 2, 2005 Received: December 5, 2005
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 910(t) premance is substantially equivalent (for the ndications for referenced above and have decemined the ac-10 in the east and the starter and courses that use stated in the enclosure) to tegally management date of the Amendments, or to devices that prob to May 26, 1976, the chacinent auto of the Federal Food, Drug, and Cosmetic have been reclassified in accordance will atte por head. In and possible at on the Act . The consember Act (Act) that do not require apple for the general controls provisions of the Act. The general therefore, market the device, subject to the expirements for annual registration, listing of devices, good controls provisions of the nechade requibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classined (see ao roy mite existing major regulations affecting your device can be may be subject to such additional controls. Exhould may - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 1 found in the Oods of concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that Please be advised mat 1 DX 3 losained of aevice complies with other requirements of the Act or any FDA has made a decemination that your development. You must comply with all rederal statutes and regulations as annuws t limited to: registration and listing (21 CFR Part 807): the ree s requirements, and manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and 1f applicable, the electronic form in the quality bytellio (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your deversite vaux develop premarket nothleation. The IDA midnig of sactantial vice and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Patt 801), please If you desire specific advice for your do riou on our can and one mote the regulation entitled, and Comact the Office of Compliance at (210) 21 0 0 0 0 0 7.97). You may obtain other "Misbranding by telefence to premation (2) & From the Division of Small Manufacturers, general miormation on your responsionales and its tool-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KOS3214
Device Name: TheraKnit
Indications For Use:
The TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed The The Therant Garment Electrodes are each over the stimulation signals TENS Sumblating device. The knitted garniers with which they are in contact. These body parts generated by the stimulator to the body behace man har har heg, shoulder, back (pads).
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
2
(Division St. Oor
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_Kos フェバイ
§ 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).