(16 days)
Inspirstar Glove Electrode is intended to for use with legally marketed electrostimulation devices such as TENS to deliver stimulation current for pain relief.
Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.
Inspirstar Glove Electrode is the conductive glove knitted from a continuous silver coated nylon yarn into the form of the glove. The conductivity is derived from the silver material of nylon yarn. Nylon yarn provides elasticity which can ensure skin contact. Inspirstar Glove Electrode has the same conductivity for dry or wet usage. The entire glove electrode is conductive having the resistance of less than 7 ohms per inch consistently.
The provided document is a 510(k) summary for the Inspirstar Glove Electrode, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert involvement, and ground truth establishment is not present in this filing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The filing does not explicitly define "acceptance criteria" in a quantitative, measurable sense for the glove electrode's performance as a medical device. Instead, it focuses on demonstrating technological characteristics similar to a predicate device. The primary performance characteristic mentioned is conductivity.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conductivity (resistance per inch) | Less than 7 ohms per inch consistently (for the entire glove) |
| Ability to deliver stimulation current | Functions as a conductive electrode for TENS devices |
| Substantial equivalence to predicate device | Deemed substantially equivalent in indications for use, technological characteristics, conductivity performance, connector interface, and use/care characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Inspirstar Glove Electrode is tested to verify the device meets the design requirement. Predicate devices are also tested to support substantial equivalence." However, it does not specify the sample size of glove electrodes that were tested, nor does it detail the specific tests conducted beyond mentioning resistance measurement.
- Sample Size (Test Set): Not specified.
- Data Provenance: The document does not provide details on the specific data provenance (e.g., country of origin, prospective or retrospective) for the testing. It's implied the testing was conducted by or for Inspirstar Inc. for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/not provided in this type of 510(k) submission for a device like a glove electrode. Establishing "ground truth" with human experts is typically relevant for diagnostic devices that interpret complex data (e.g., medical images, physiological signals), where clinical consensus or pathology reports serve as the gold standard. For a conductive glove, the "ground truth" is based on physical property measurements and functional testing.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for the reasons stated above. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies in expert interpretation, which is not relevant for the performance assessment of a conductive glove.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable/not provided. MRMC studies are typically used for diagnostic imaging or equivalent interpretation devices to assess human-in-the-loop performance and usually involve multiple human readers interpreting cases with and without AI assistance. This device is a conductive electrode, not an AI or diagnostic interpretation device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is a physical electrode, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. The Type of Ground Truth Used
For the Inspirstar Glove Electrode, the "ground truth" for its performance is based on physical property measurements, specifically:
- Resistance measurement: The resistance of the silver-coated nylon yarn (less than 7 ohms per inch).
- Functional performance: Its ability to act as a conductive electrode to deliver stimulation current when connected to a legally marketed TENS device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The Inspirstar Glove Electrode is a manufactured medical device, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of device.
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Image /page/0/Picture/2 description: The image shows the logo for InspirStar. The logo features a stylized letter "i" with a star at the top, followed by the word "INSPIRSTAR" in bold, uppercase letters. A horizontal line is present under the word "INSPIRSTAR".
Section 5
510(k) Summary
Inspirstar Glove Electrode
MAY 3 1 2006
-
- Submitters Identification
| a. Company Name: | Inspirstar Inc. |
|---|---|
| b. Company Address: | 891 N. Naples Dr.Chandler, AZ 85226, USA |
| c. Contact Person: | Ning Wu, Vice President |
| d. Date of Summary Preparation: | April 15, 2006 |
2. Device Identification
- Common Name: Electrode, Cutaneous a.
- Inspirstar Glove Electrode Trade Name: b.
- Class II C. Classification:
- d. Product Code: GXY
- Regulation Number: 882.1320 e.
3. Device Description
Inspirstar Glove Electrode is the conductive glove knitted from a continuous silver coated nylon yarn into the form of the glove. The conductivity is derived from the silver material of nylon yarn. Nylon yarn provides elasticity which can ensure skin contact. Inspirstar Glove Electrode has the same conductivity for dry or wet usage. The entire glove electrode is conductive having the resistance of less than 7 ohms per inch consistently.
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- Intended Use
Inspirstar Glove Electrode is intended to for use with legally marketed electrostimulation devices such as TENS to deliver stimulation current for pain relief.
- Intended Use
-
- Legally Marketed Predicate Devices
Inspirstar Glove Electrode is substantially equivalent to the following predicate device. See Table 5-1 Predicate Device.
- Legally Marketed Predicate Devices
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Section 5
Table 5-1 Predicate Device
| Device Name | Manufacturer | 510(k) No. | Date Cleared |
|---|---|---|---|
| TheraKnit GarmentElectrode | Neurotron Medical,Inc | K053214 | 12/20/2005 |
6. Substantial Equivalence Summary
Inspirstar Glove Electrode has the same indications for use as the legally marketed predicate device. Inspirstar Glove Electrode has same technological characteristics, the same conductivity performance, the similar connector interface and similar use and care characteristics as the predicate device. Overall, Inspirstar IS02 Microcurrent Stimulator is substantially equivalent to legally marketed predicate devices.
-
- Technological Characteristics
Inspirstar Glove Electrode is knitted by traditional knitting process from a continuous silver coated nylon yarn into the form of the glove. The conductivity is derived from the silver material of nylon yarn. The resistance measurement on the glove is less than 7 ohms per inch. Inspirstar Glove Electrode can be used as one electrode, positive or negative polarity, on the current path of circuit. Another Inspirstar Glove Electrode or other electrode can be used as opposite polarity on the current path. Nylon yarn provides elasticity which can ensure skin contact.
- Technological Characteristics
-
- Testing
Inspirstar Glove Electrode is tested to verify the device meets the design requirement. Predicate devices are also tested to support substantial equivalence.
- Testing
-
- Conclusions
Inspirstar Glove Electrode is substantial equivalent to legally marketed predicative devices.
- Conclusions
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2006
Inspirstar Inc.
c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
Re: K061343
Trade/Device Name: Inspirstar Glove Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode, Regulatory Class: Class II Product Code: GXY Dated: May 11, 2006 Received: May 15, 2006
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premised 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 encreate) to regard) the enactment date of the Medical Device Amendments, or to commence price to May 20, 1978, the eccordance with the provisions of the Federal Food, Drug, de necs that have boon receise at require approval of a premarket approval application (PMA). alla Cosmetic rior (110.) that as novely subject to the general controls provisions of the Act. The Tourmaly, mercersions of the Act include requirements for annual registration, listing of general voltable provision 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 If your device is elassinod (tional controls. Existing major regulations affecting your device can may or subject to been 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.
- 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 or and I 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
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Page 2 - Mr. Mark Job
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 240-276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the word "INSPIRSTAR" in a stylized font. The "I" in "INSPIRSTAR" is stylized with a star at the top and a curved line extending from the bottom. A horizontal line is present under the word "INSPIRSTAR".
Section 4
Indications for Use
510(k) Number (if known):
Device Name: Inspirstar Glove Electrode
Indications for Use:
Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.
Prescription Use X (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 IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K061343
Page 1 of 1
§ 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).