The PROSTIM 1000/2000 is used for the symptomatic relief and management of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain. This is a prescription device and should be used under continued medical supervision.

Device Description

The PROSTIM 1000/2000 are battery operated TENS units for pain control. User driven the units feature a wide array of output combinations. The user may set the timer for 15 minutes to 30 minutes or a continuous mode. They also feature three modes: B (Burst), N (Normal), and M (Modulation). The pulse rate, pulse width, and amplitude are adjustable.

The devices are supplied with electrodes and electrode leads(K 042301) and electrode leads, battery case and 9V battery, Instruction manual and carrying case.

AI/ML Overview

This 510(k) summary describes a Transcutaneous Electrical Nerve Stimulator (TENS) device called PROSTIM 1000/2000. For such devices, acceptance criteria and detailed performance studies are typically focused on electrical safety, electromagnetic compatibility (EMC), and functional performance specifications rather than clinical efficacy studies with human subjects or AI performance metrics.

Based on the provided text, the device's acceptance criteria are primarily met by demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards. There is no clinical study involving human patients or AI performance metrics within this submission.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance
Intended Use Equivalence	Similar intended use as predicate devices	The PROSTIM 1000/2000 is used for symptomatic relief and management of chronic intractable pain and adjunctive treatment of post-surgical or post-traumatic acute pain, similar to predicate devices.
Technology Equivalence	Similar technology as predicate devices	The PROSTIM 1000/2000 has similar technology to predicate devices (battery-operated TENS units with adjustable pulse rate, pulse width, and amplitude; B, N, M modes; timer).
Operating Principles & Modes Equivalence	Similar operating principles and modes as predicate devices	The PROSTIM 1000/2000 has similar operating principles and modes as predicate devices.
Electrical Safety Standard	IEC 60601-1: 1988	Compliance with this standard indicates the device meets general requirements for safety of medical electrical equipment. (Compliance is asserted by the submission, but no specific test results are provided in this summary.)
EMC Standard	IEC 60601-1-2: 2001	Compliance with this standard indicates the device meets requirements for electromagnetic compatibility. (Compliance is asserted by the submission, but no specific test results are provided in this summary.)
Specific Safety Standard for Nerve Stimulators	IEC 60601-2-10: 2001	Compliance with this standard indicates the device meets particular requirements for nerve and muscle stimulators. (Compliance is asserted by the submission, but no specific test results are provided in this summary.)

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This submission does not describe a test set or clinical study involving human data. The assessment is based on comparison to predicate devices and adherence to safety standards.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable. No ground truth for a test set was established as no clinical study or human data evaluation is described.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable. No test set requiring adjudication is described.

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

MRMC Study: No. This is a TENS device, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-related effectiveness assessment was performed or presented in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: No. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable. The "ground truth" in this context refers to the established safety requirements and the functional parameters of the predicate devices. There is no clinical ground truth established from patient outcomes, pathology, or expert consensus described for a study.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI device.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. This is not an AI device.

In summary: The PROSTIM 1000/2000 received 510(k) clearance by demonstrating substantial equivalence to previously legally marketed predicate TENS devices in terms of intended use, technology, operating principles, and by complying with recognized electrical safety and EMC standards. This type of submission does not typically involve clinical performance studies with human subjects or AI performance evaluations as described in your prompt.

Summary

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510(k) Summary

Bio Protech, Inc.

1720-26, Taejang 2-Dong, Wonju Medical Instrument Park Woonju-Si, Gangwon-Do, Republic of Korea

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ប្រជាជនជាតិ នៅរ 7 . .

Date: September 6, 2007

Contact: Mr. Kevin Han Bio Protech USA, Inc. 17962 Sky Park Circle Suite G · Irvine, CA 92614 Phone: 1-949-250-9950 Fax: 1-949-250-9925

Trade Name: PROSTIM 1000/2000

Common Name: TENS

Classification Name: Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief

Predicate Device Identification: CFR21:882.5890 Product Code: GZJ Device Class: II

Legally Marketed Device:

Company	Product	510(k) #
Biomedical Life Systems, Inc.	Electro-Nerve Stimulator TENS	K061476
Theratech, Inc.	TTech Model 200E+TENS	K021436
Johari Digital Healthcare Ltd.	Infrex	K060240

Description:

The devices are supplied with electrodes and electrode leads(K 042301) and electrode leads, battery case and 9V battery, Instruction manual and carrying case.

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Intended Use:

Comparison to Predicate Devices

The PROSTIM 1000 and PROSTIM 2000 TENS units have similar intended use, technology, operating principles and modes of operations. Based on the predicate product comparison Bio Protech has determined that no new issues of safety and effectiveness have been raised with this 510(k) submission.

Safety Standards:

IEC 60601-1-2: 2001

IEC 60601-2-10: 2001

IEC 60601-1: 1988

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

FEB 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bio Protech, Inc. % Underwriters Laboratories, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062-2096

Re: K073438

Trade/Device Name: PROSTIM 1000/2000 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stmulator for pain relief Regulatory Class: II Product Code: GZJ Dated: January 22, 2008 Received: January 23, 2008

Dear Mr. Devine:

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 general controls provisions 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.

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.

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Page 2 - Mr. Ned Devine

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Mellema

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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Indications for Use

510(k) Number (if known): K073438

Device Name: PROSTIM 1000/2000

Indications for Use:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ision Sign-Off) (DA Division of General, Restorative. and Neurological D

510(k) Numbe

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).