The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.

Device Description

5.1 Digital Hand Dynamometer(SH5003)
In health care environment, accurate and objective data is required for reimbursable rehabilitation services, making the SAEHAN Digital Hand Dynamometer an indispensable tool.
Ideal for routine screening of grip strength and initial and ongoing evaluation of clients with hand trauma and dysfunction.
Virtually leak-proof hydraulics and isometric design ensure accurate, reproducible results and years of reliable service.
A shock-resistant rubber cap protects the stainless steel gauge and a wrist strap prevents accidental damage if dropped.
The SAEHAN Digital Hand Dynamometer combines Precision with convenient features:
-Dual-scale readout displays isometric grip force from 0-300 lbs.(0-136 Kg)
-Peak-hold needle automatically retains the highest reading until reset.
-Handle easily adjusts to five grip position, from 1 3/8" -3 3/8", in half-inch increments.
5.2 Digital Pinch Gauge(SH5006)
Unlike conventional pinch gauges, The SAEHAN Digital Pinch Gauge's unique design frees the client to perform a true pinch pattern because the therapist, not the client, supports the weight of the gauge.
A highly accurate pinch-force measurement, devoid of artifact, is the result. Red indicator needle remains at maximum reading until reset.
Measures pinch force to 601bs. includes instructions, handy carrying case.

AI/ML Overview

The provided 510(k) summary for the SH5003 Digital Hand Dynamometer & SH5006 Digital Pinch Gauge focuses on demonstrating substantial equivalence to a predicate device and safety/performance based on compliance with electrical and EMC standards. It does not contain information about formal acceptance criteria for a study proving device performance in terms of clinical accuracy, sensitivity, specificity, etc., nor does it describe a study involving human subjects or AI.

Therefore, many of the requested categories cannot be filled from the provided text.

Here's a breakdown based on the available information:

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria	Reported Device Performance
Accuracy/Clinical Performance Metrics:	Not specified in the provided document. The submission focuses on substantial equivalence based on safety and compliance with standards.
Electrical Safety (EN/IEC 60601-1)	Satisfactory
Mechanical Safety (EN/IEC 60601-1)	Satisfactory
Environmental Safety (EN/IEC 60601-1)	Satisfactory
Performance Testing (EN/IEC 60601-1)	Satisfactory
EMC (EN/IEC 60601-1-2)	Satisfactory

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

Not applicable. The document describes compliance with electrical and EMC standards, not a clinical study with a test set of human subjects or data.

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

Not applicable. No clinical ground truth was established in a study described here.

4. Adjudication method for the test set:

Not applicable. No clinical study with adjudication was 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:

Not applicable. This device is a digital hand dynamometer and pinch gauge, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a measurement tool; it does not involve an algorithm generating independent diagnoses.

7. The type of ground truth used:

For the "study" (i.e., testing for safety and performance standards), the "ground truth" would be the specifications and requirements of the EN/IEC 60601-1 and EN/IEC 60601-1-2 standards.

8. The sample size for the training set:

Not applicable. No algorithm training was performed or described.

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

Not applicable. No algorithm training was performed or described.

Summary of the Study Mentioned:

The "study" referenced in the 510(k) summary is not a clinical performance or comparative effectiveness study as might be expected for an AI device. Instead, it refers to regulatory compliance testing:

Study Purpose: To demonstrate the electrical, mechanical, environmental safety, and overall performance of the SH5003 Digital Hand Dynamometer and SH5006 Digital Pinch Gauge, and electromagnetic compatibility (EMC).
Methodology: Testing was conducted according to international standards:
- EN/IEC 60601-1 (1990) for electrical, mechanical, environmental safety, and general performance.
- EN/IEC 60601-1-2 (2001) for electromagnetic compatibility (EMC).
Results: "All test results were satisfactory." This indicates that the device met the requirements specified in these standards.
Conclusion: Based on these tests and a comparison to a predicate device (Dynamometer (FCE Series) of Ametek, Inc. K042889), Saehan Corp. concluded that the SH5003 & SH5006 devices are safe, effective, and substantially equivalent to the predicate device.

Summary

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Ka52309 p/2

SEP 2 7 2005

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Jul 16, 2005

1. Company and Correspondent making the submission:
  Name - Saehan Corp. Address - 973, Yangdeok-Dong, Masan-City, Kyungsangnam-Do, Korea Telephone - +82-55-294-0381 Fax - +82-55-293-5019 Contact - Mrs. Tae Sun, Byun / Manager Internet - saehancorp@korea.com
1. Device :
  : SH5003 Digital Hand Dynamometer Trade/proprietary name SH5006 Digital Pinch Gauge : DC-powered dynamometer Common Name : DC-powered dynamometer Classification Name
1. Predicate Devices :

Manufacturer	: Ametek, Inc.
Device	: Dynamometer(FCE Series)
510(k) Number	: K042889(Decision Date-Nov. 16. 2004)

1. Classifications Names & Citations :
  21CFR 888.1240, LBB, DC-powered dynamometer, Class2
1. Description :
  5.1 Digital Hand Dynamometer(SH5003)

In health care environment, accurate and objective data is required for reimbursable the SAEHAN Digital Hand Dynamometer an rehabilitation services, making

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indispensable tool.

I. Heal for routine screening of grip strength and initial and ongoing evaluation of clients with hand trauma and dysfunction.

Virtually leak-proof hydraulics and isometric design ensure accurate, reproducible results and years of reliable service.

and your of a shock-resistant rubber cap protects the stainless steel gauge and a wrist strap prevent s accidental damage if dropped.

The SAEHAN Digital Hand Dynamometer combines Precision with convenient features:

-Dual-scale readout displays isometric grip force from 0-300 lbs.(0-136 Kg)

-Peak-hold needle automatically retains the highest reading until reset.

-Handle easily adjusts to five grip position, from 1 3/8" -3 3/8", in half-inch increments.

5.2 Digital Pinch Gauge(SH5006)
Unlike conventional pinch gauges, The SAEHAN Digital Pinch Gauge's unique design frees the client to perform a true pinch pattern because the therapist, not the client, supports he weight of the gauge.

A highly accurate pinch-force measurement, devoid of artifact, is the result. Red indicator needle remains at maximum reading until reset.

Measures pinch force to 601bs. includes instructions, handy carrying case.

1. Indication for use :
  The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.
1. Comparison with predicate device :
  Saehan Corp. believes that the SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge is substantially equivalent to Dynamometer(FCE Series) of Ametek, Inc..
1. Safety, EMC and Performance Data :
  Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1(1990) was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory.

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9. Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Sachan Corp. concludes that the SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge is safe and effective and substantially equivalent to predicate devices as described herein.

1. Sachan Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
  END

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol that resembles a stylized caduceus or a representation of human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol. The symbol itself consists of four abstract shapes that could be interpreted as human figures or stylized elements representing health and well-being.

Public Health Service

SEP 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sachan Corporation c/o Mr. Charlie Mack, PE Prinicipal Engineer International Regulatory Consultants 340 Shady Grove Road Flintville, Tennessee 37335

Re: K052309

KU52309
Trade/Device Name: SH5003 Digital Hand Dynamometer & SH5006 Digital Pinch Gauge Regulation Number: 21 CFR 888.1240 Regulation Name: AC-powered dynamometer Regulatory Class: II Product Code: LBB Dated: August 20, 2005 Received: August 24, 2005

Dear Mr. Mack:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 9 ro(t) premained is substantially equivalent (for in indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for legally manatiment po the Medical Device Amendments, or to commerce print to May 20, 1978, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration. Ilisting of general controls provisions of the Piet 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 classified (see above) the existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition. FDA may be found in the Outs neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase be advised that I DA : Issuance of a vaced and other requirements of the Act that I DA has made a determination an administered by other Federal agencies. You must or any I cuttar statutes and regarations and limited to: registration and listing (21 Comply with an the Her 3 requirements (21) and manufacturing practice requirements as set a CI K Part 607); adomig (21 CFR Part 820); and if applicable. the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Charlic Mack, PE

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin mailing of substantial equivalence of your device to a legally prematice notification "Thesults 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 If you desire specific aurile 10. Jour 2010) 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 other general mionnational 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/dsma/dsmamain.html

Sincerely yours,
Mark A. Milliken

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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not a consultant for the 510(k) submitter]

Indications for Use

510(k) Number(if known):

Device Name: SH5003 Digital Hand Dynamometer & SH5006 Digital Pinch Gauge

Indications for Use:

The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for rne Criocol or Orient.
performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.

tion Use

✓

Prescription Use_ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ AND/OR

(Part 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)

Mark A. Millman

Page 1 of _1

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number

Regulation Number and Section

§ 888.1240 AC-powered dynamometer.

(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.