Inspirstar IS02 Microcurrent Stimulator is a Microcurrent TENS device intended to be used for the symptomatic relief of chronic intractable pain. This product can generate low current intensity pulses at microampere level and frequency of pulses. The unit supports five pre-defined therapy programs. The current intensity, frequency, time, etc. are programmable by doctors.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Inspirstar IS02 Microcurrent Stimulator, a TENS device intended for symptomatic relief of chronic intractable pain. This type of submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than conducting new clinical trials to establish de novo effectiveness against specific acceptance criteria.

Therefore, the document does not contain information on acceptance criteria for a novel device performance study, nor a study proving the device meets such criteria. Instead, its "performance data" section focuses on compliance with general safety and electromagnetic compatibility standards and software verification.

However, I can extract the information relevant to the substantial equivalence process which implicitly defines the "acceptance criteria" for a 510(k) submission and how the device "meets" them:

1. Table of Acceptance Criteria and Reported Device Performance (as applied to Substantial Equivalence):

Acceptance Criteria (based on Predicate Device Equivalence)	Reported Device Performance (Inspirstar IS02)
Indications for Use: Same as legally marketed predicate device.	"Inspirstar IS02 Microcurrent Stimulator has the same indications for use as the legally marketed predicate device." (Section 6) Indications for Use: "symptomatic relief of chronic intractable pain." (Section 4)
Technological Characteristics: Same or comparable to predicate device without raising new questions of safety or effectiveness.	"Inspirstar IS02 Microcurrent Stimulator has the same technological characteristics as all of the predicate devices. All are battery-powered, current source pulse generator devices with two output channels." (Section 7) "Inspirstar IS02 Microcurrent Stimulator has very close waveforms and output characteristics including frequency, current intensity, wave slope, etc with Precision Micro ('THERASTIM') and has comparable waveforms and output characteristics with Alpha-Stim 100('ALPHA-STIM CS')." (Section 7) "The user operating interfaces to setup values of frequency, current intensity, etc have some differences... But these differences do not affect the technology and do not affect the safety and effectiveness." (Section 7)
Safety and Effectiveness: Demonstrated through compliance with recognized standards and software verification (where applicable).	"Inspirstar IS02 Microcurrent Stimulator conforms to applicable voluntary standards IEC 60601-1 for safety requirement, and IEC60601-1-2 for electromagnetic compatibility requirement. In addition, the software verification has been carried out according to FDA software guidance." (Section 8)

The following information is NOT applicable or NOT available in the provided document, as it pertains to a different type of device evaluation (e.g., a clinical study with novel performance claims, not a substantial equivalence submission):

2. Sample size used for the test set and the data provenance: Not applicable. No test set for a performance study is described. The "test" is a comparison to predicate devices based on design and technical specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for a performance test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a TENS unit, not an AI-assisted diagnostic tool requiring human reader performance studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" in a 510(k) is the established safety and effectiveness of the predicate device(s).
8. The sample size for the training set: Not applicable. Not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (Substantial Equivalence Demonstration):

The "study" undertaken for the Inspirstar IS02 Microcurrent Stimulator was a 510(k) premarket notification to the FDA. This regulatory pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device.

Nature of the "Study": A comparison of the new device's indications for use, technological characteristics, and performance data (safety and EMC standards, software verification) against one or more predicate devices.
"Acceptance Criteria" for this "Study": The FDA's criteria for substantial equivalence, primarily:
- Same intended use as the predicate device(s).
- Same technological characteristics, OR
- Different technological characteristics that do not raise new questions of safety or effectiveness and are supported by appropriate data (e.g., performance testing as per standards).
Conclusion: The FDA reviewed the submission and found the Inspirstar IS02 Microcurrent Stimulator to be substantially equivalent to the predicate devices (Precision Micro / THERASTIM and ALPHA-STIM CS). This determination allows the device to be legally marketed.

Summary

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L060368

Section 5

510(k) Summary

Inspirstar IS02 Microcurrent Stimulator - TENS Device

1. 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:	January 20, 2006

2. Device Identification

a. Common Name:	Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief
b. Trade Name:	Inspirstar IS02 Microcurrent Stimulator
	Note: There might be two-letter suffix added to the model name
	"IS02" during marketing, like IS02AA, IS02AB. The names with different suffix are only for marketing and destination purpose and are the same products.
c. Classification:	Class II

Product Code: d. GZJ
Regulation Number:882.5890 e.

3. Device Description

1. Intended Use
  Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.
1. Legally Marketed Predicate Devices
  Inspirstar IS02 Microcurrent Stimulator is substantially equivalent to the following predicate device. See Table 5-1 Predicate Devices.

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Device Name	Manufacturer	510(k) No.	Date Cleared
THERASTIM (also knownas "Precision Micro")	Precision Electronics,Ltd.	K914813	12/31/1991
"ALPHA-STIM CS"("Alpha-Stim 100" isregistered as update.)	ElectromedicalProducts, Inc.	K896948	02/23/1990

Table 5-1 Predicate Devices

1. Substantial Equivalence Summary
  Inspirstar IS02 Microcurrent Stimulator has the same indications for use as the legally marketed predicate device. Inspirstar IS02 Microcurrent Stimulator has same or comparable technological characteristics as the predicate device. Inspirstar IS02 Microcurrent Stimulator is substantially equivalent to legally marketed predicate devices.
1. Technological Characteristics
  Inspirstar IS02 Microcurrent Stimulator has the same technological characteristics as all of the predicate devices. All are battery-powered, current source pulse generator devices with two output channels. Inspirstar IS02 Microcurrent Stimulator has very close waveforms and output characteristics including frequency, current intensity, wave slope, etc with Precision Micro ("THERASTIM") and has comparable waveforms and output characteristics with Alpha-Stim 100("ALPHA-STIM CS"). Inspirstar IS02 Microcurrent Stimulator and Alpha-Stim 100 are both software controlled. The user operating interfaces to setup values of frequency, current intensity, etc have some differences for three devices. But these differences do not affect the technology and do not affect the safety and effectiveness.
1. Performance Data
  Inspirstar IS02 Microcurrent Stimulator conforms to applicable voluntary standards IEC 60601-1 for safety requirement, and IEC60601-1-2 for electromagnetic compatibility requirement. In addition, the software verification has been carried out according to FDA software guidance.
1. Conclusions
  Inspirstar IS02 Microcurrent Stimulator is substantial equivalent to legally marketed predicative devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2006

Inspirstar Incorporated c/o Regulatory Technology Services LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K060368

Trade/Device Name: Inspirstar IS02 Microcurrent Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: March 2, 2006 Received: March 3, 2006

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou mayy ato s provisions of the Act include requirements for annual registration, listing of general vonaron 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 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.

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 any 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 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.

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Page 2 - Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html

Sincerely yours,

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Fiealth

Enclosure

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Section 4

Indications for Use

K060368 510(k) Number (if known):

Device Name: Inspirstar IS02 Microcurrent Stimulator

Indications for Use:

Inspirstar IS02 Microcurrent Stimulator is intended to be used for the symptomatic relief of chronic intractable pain.

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	K060368
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INSPIRSTAR INC.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).