DYNAMOMETER - MODEL FCE AND MODEL MSC

K042889 · Ametek · LBB · Nov 16, 2004 · Orthopedic

Device Facts

• Record ID: K042889
• Device Name: DYNAMOMETER - MODEL FCE AND MODEL MSC
• Applicant: Ametek
• Product Code: LBB · Orthopedic
• Decision Date: Nov 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1240
• Device Class: Class 2

Intended Use

The intended use of the Chatillon FCE and MSC series dynamometers is for performing manual muscle testing to measure muscle strength. The target population for this product is individuals recovering from physical injury or for sports medicine applications.

Device Story

Chatillon FCE and MSC series dynamometers are diagnostic instruments for manual muscle testing; used in physical therapy, occupational medicine, and sports medicine. Device utilizes rechargeable battery (4.8 VDC) to provide 2.5 VDC excitation to strain gauge load cell. Analog load cell output (2 mV/V) converted to digital signal proportional to applied force; microprocessor calculates force value for storage and graphical display. Designed as repackaged industrial force measurement instruments with specialized medical attachments for ergonomic analysis and muscle testing. Operated by clinicians to evaluate patient strength; output provides objective force data to assist in clinical assessment of recovery or athletic performance.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

DC-powered dynamometer; 4.8 VDC rechargeable battery; strain gauge load cell sensing; microprocessor-based signal processing; graphical display; medical-specific attachments for manual muscle testing; industrial-grade force measurement architecture.

Indications for Use

Indicated for individuals recovering from physical injury or for sports medicine applications requiring manual muscle strength testing.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Chatillon CSD200 (K964685)
• Chatillon CSD300 (K964685)
• Chatillon CSD500 (K964685)

Submission Summary (Full Text)

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504-2889

NOV 1 6 2004

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TEST AND CALIBRATION INSTRUMENTS DIVISION
8600 SOMERSET DRIVE, LARGO FLORIDA 33773

TELEPHONE: PAX

27) 530-7310 (Purchasing 7 532-3329 (Engineering

## SUMMARY 510 (k)

- 1. Submitter's Information: Ametek, Inc. 8600 Somerset Drive Largo, FL 33773 Contact - Philip LaChance Tele # 727-536-7831 Ext 3384 Cell # 727-543-4894 Email [e-mail] Title - Engineering Manager
- 2. Classification Name: DC Powered Dynamometer Common/Usual Name: Dynamometer Proprietary Names:
- FCE-100 100 LBF (50 KGF, 500 N) Capacity 4
- FCE-200 200 LBF (100 KGF, 1000 N) Capacity �
- FCE-500 500 LBF (250 KGF, 2500 N) Capacity .
- MSC-100 100 LBF (50 KGF, 500 N) Capacity .
- MSC-200 200 LBF (100 KGF, 1000 N) Capacity .
- MSC-500 500 LBF (250 KGF, 2500 N) Capacity ●
- 3. Predictive Devices (manufactured by Ametek, Inc):
- CSD200 -- 500 LBF Capacity .
- CSD300 -- 500 LBF Capacity .
- CSD500 -- 500 LBF Capacity ●
- 4. The Chatillon FCE and MSC series dynamometers are diagnostic devices used for The ontained evaluating muscle strength. These instruments are powered by a rechargeable battery (4.8 VDC) which supplied a regulated 2.5 VDC excitation voltage to a strain gauge load cell. The analog output from the load cell (2 mV/V) is then converted to a digital signal that is directly proportional to the applied force. This digital signal is then sent to a microprocessor, which converts the signal to a force value that is stored in memory and/or displayed on the dynamometer graphical display. This design has been used for many years in industrial force measuring instruments and has been also used for physical therapy, occupational medicine and These medical dynamometers are a repackaged version of the sports medicine. industrial force measurement instruments and are designed with special medical attachments that are appropriate for performing manual muscle testing and ergonomic analysis.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2004

Mr. Phillip LaChance Engineering Manager Ametek 8600 Somerset Drive Largo, Florida 33773

Re: K042889

K042889
Trade/Device Name: New Device – Chatillon FCE and MSC Series Dynamometer New Device – Chatillon CSD Series Dynamometer Regulation Number: 21 CFR 888.1240 Regulation Name: AC-powered Dynamometer Regulatory Class: II Product Code: LBB Dated: October 5, 2004 Received: October 19, 2004

Dear Mr. LaChance:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 310(x) premier is substantially equivalent (for the indications felerenced above and nave decembers and marketed predicate devices marketed in interstate for use stated in the enclosure) is tegans atment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the ensordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). alle Cosmetic Act (71ct) that do not requent office to the general controls provisions of the Act. The I ou may, mercere, manse of the Act include requirements for annual registration, listing of general controls provisions of the rice, 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 (tional controls. Existing major regulations affecting your device can may be subject to back acceral 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Driver Internances and regulations administered by other Federal agencies. You must of any i edelar statutes and submitted to: registration and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF N Fatt 607), accems (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. Phillip LaChance

This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin hankemily of substantial equivalence of your device to a legally premarket notification. The PDA mining of Subscanalian of 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 advice for your ac not one on one one one the regulation entitled, and Colliact the Office of Comphalled at (21 %) = if = = = = 807.97). You may obtain Misoranuing by reference to premainters in the Act from the Division of Small other general information on your response at its toll-free number [phone] or Manufacturers, International and Ovess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Wilkerson

Celia M. Witten, Ph.D., M.D. 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): K964685-

Device Name: New Device – Chatillon FCE and MSC Series Dynamometer : New Device - Chatillon POL Life M.
Predictive Device - Chatillon CSD Series Dynamometer

Indications For Use:

The intended use of the Chatillon FCE and MSC series dynamometers is for The intended use of the Criation i Oct and measure strength. The target performing manufal muscle testing to measure massile with of
population for this product is individuals recovering from physical injury or for sports medicine applications.

Prescription Use _ Yes (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) |
|--------------------------------------------------------|
| (Division Sign-Off) |
| Division of General, Restorative, |
| and Neurological Devices |

K042889

510 (k) Number.

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