(28 days)
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No
The device description details a standard strain gauge load cell and microprocessor for force measurement and display, with no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No
The device is a diagnostic tool used for evaluating muscle strength (a measurement device), not to provide treatment or therapy.
Yes
The device description states, "The Chatillon FCE and MSC series dynamometers are diagnostic devices used for evaluating muscle strength." and the intended use is for "manual muscle testing to measure muscle strength."
No
The device description explicitly details hardware components such as a rechargeable battery, strain gauge load cell, analog-to-digital converter, microprocessor, and graphical display. It is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Chatillon FCE and MSC series dynamometers measure muscle strength by applying force externally to the body. They do not analyze samples taken from the body.
- Intended Use: The intended use is for "performing manual muscle testing to measure muscle strength," which is a physical assessment, not an in vitro test.
- Device Description: The description details the internal workings related to force measurement (strain gauge, load cell, microprocessor) and external attachments for physical testing. It does not mention any components or processes related to analyzing biological samples.
Therefore, the Chatillon FCE and MSC series dynamometers fall under the category of medical devices used for physical assessment and measurement, not In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LBB
Device Description
The Chatillon FCE and MSC series dynamometers are diagnostic devices used for 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 sports medicine. These medical dynamometers are a repackaged version of the industrial force measurement instruments and are designed with special medical attachments that are appropriate for performing manual muscle testing and ergonomic analysis.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
muscle
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
504-2889
NOV 1 6 2004
Image /page/0/Picture/2 description: The image shows the word "AMETEK" in a bold, sans-serif font. The letters are black against a white background. The word appears to be a logo or brand name.
TEST AND CALIBRATION INSTRUMENTS DIVISION
8600 SOMERSET DRIVE, LARGO FLORIDA 33773
TELEPHONE: PAX
- 530-7310 (Purchasing 7 532-3329 (Engineering
SUMMARY 510 (k)
-
- 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 Philip.lachance@ametek.com Title - Engineering Manager
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- 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 ●
-
- Predictive Devices (manufactured by Ametek, Inc):
- CSD200 -- 500 LBF Capacity .
- CSD300 -- 500 LBF Capacity .
- CSD500 -- 500 LBF Capacity ●
-
- 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.
Image /page/0/Picture/20 description: The image shows a logo with the letters "UL" inside a circle. The text "A471.5" is on the left side of the circle, and the text "ISO 9001" is on the right side of the circle. Below the circle, the text "Test and Calibration Instruments Division" is written in a smaller font.
Image /page/0/Picture/21 description: The image shows the letters TQM in a stylized font, with the Q appearing to be a leaf. Below the letters, the phrase "Teamwork Makes it Happen" is written in a smaller, sans-serif font. The text is centered below the letters TQM. The image appears to be a logo or emblem.
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Image /page/1/Picture/1 description: The image is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized eagle-like symbol with three wing-like shapes stacked on top of each other. The symbol is black and the background is white.
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 (800) 638-2041 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
3
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 |
510 (k) Number.
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