(66 days)
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No
The description details a traditional force measurement device using a strain gauge, A/D converter, and microprocessor for signal processing and display. There is no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is described as a "diagnostic device used for quantitatively evaluating muscle strength" and is solely for measurement, not for treating any condition.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that "The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively evaluating muscle strength."
No
The device description explicitly details hardware components including a rechargeable battery, strain gage load cell, A/D converter, microprocessor, and LCD, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided text, the Chatillon CSD Series Dynamometers are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "quantitatively evaluating muscle strength." This is a measurement of a physical characteristic of the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details a device that measures force applied to a load cell. This is a mechanical measurement, not a chemical, biological, or immunological analysis of a sample.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information about a disease state based on sample analysis.
The device is described as a "diagnostic device" in the context of evaluating muscle strength, which is a form of physical diagnosis, but it does not fit the regulatory definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively evaluating muscle strength. The person being tested (patient) is told to push or pull against the instrument using a particular muscle group. The physician/therapist performing the test (operator) resists the push or pull for a predetermined time period. The instrument measures the instantaneous push or pull force produced by the patient and stores the maximum value of the force during a single test in memory.
Product codes
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Device Description
The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively evaluating muscle strength. These instruments are powered by a rechargeable battery (7.5 Vdc) which supplies a regulated 5 Vdc excitation voltage to a strain gage load cell. The output from the load cell passes through an A/D converter which produces a digital signal that is directly proportional to the applied force. This signal is then sent to a microprocessor which converts the signal to a force value that is stored in memory and/or displayed on an LCD. This basic design has been used for many years in industrial force measuring instruments that have found their way into hospitals, clinics and other similar facilities through industrial distributors. The instrument submitted herewith is a repackaged version of the industrial instrument with attachments that are more appropriate for performing manual muscle testing. The predicate device utilizes a load cell as the force measuring element, a printed circuit board to process the signal produced by the load cell and a display (LCD) to indicate the results. The design accuracy of this instrument is ± 0.5% of full scale, + one least significant count which translates to + 0.6 lb. Each individual instrument is calibrated and then checked for accuracy using weights that are checked annually by the State of North Carolina, certified and traceable to N.I.S.T. The instrument is mounted in a test fixture and a 20 lb. weight is applied. Additional 20 lb. weights are applied until the full capacity of the instrument, 100 lb., is reached. This five point calibration ensures the accuracy of the instrument over its full operating range. The unit is then inspected using a different set of weights to verify that the readings do not vary by more than + 0.6 lb. at the five calibration points.
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
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Indicated Patient Age Range
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Intended User / Care Setting
Physician/therapist performing the test (operator) in hospitals, clinics and other similar facilities.
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
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Key Metrics
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Predicate Device(s)
John Chatillon & Sons, Inc. Model CSD200 Dynamometer
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Future developments anticipated for these instruments will only involve the number of test results that can be stored in memory, manipulation of the data within the microprocessor or possibly a change in the physical size and/or shape of the case that encloses the instruments. Any change in the basic technology used in the instruments will be the subject of a separate submittal.
§ 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
JAN 27 1997
510(k) Summary
Submitter's Information: 1. John Chatillon & Sons, Inc. 7609 Business Park Drive Greensboro, NC 27409-9301 Contact - Mr. Joe Troy 1-800-367-0244 Ext. 3120 or (910) 668-0841
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Classification Name: 2. Common/Usual Name: Proprietary Name:
Dynamometer Dynamometer Dynamometer - Model CSD200MT -
Predicate Device: 3. John Chatillon & Sons, Inc. Model CSD200 Dynamometer
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The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively 4. evaluating muscle strength. These instruments are powered by a rechargeable battery (7.5 Vdc) which supplies a regulated 5 Vdc excitation voltage to a strain gage load cell. The output from the load cell passes through an A/D converter which produces a digital signal that is directly proportional to the applied force. This signal is then sent to a microprocessor which converts the signal to a force value that is stored in memory and/or displayed on an LCD. This basic design has been used for many years in industrial force measuring instruments that have found their way into hospitals, clinics and other similar facilities through industrial distributors. The instrument submitted herewith is a repackages version of the industrial instrument with attachments that are more appropriate for performing manual muscle testing.
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This new Chatillon Model CSD200MT Dynamometer is one more diagnostic ર. device to be added to the existing familar devices previously approved. The person being tested (patient) is told to push or pull against the instrument using a particular muscle group. The physician/therapist performing the test (operator) resists the push or pull for a predetermined time period. The instrument measures the instantaneous push or pull force produced by the patient and stores the maximum value of the force during a single test in memory. The results of each test must be manually recorded.
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The predicate device utilizes a load cell as the force measuring element, a printed ર. circuit board to process the signal produced by the load cell and a display (LCD) to indicate the results.
1
510(k) Summary of Safety and Effectiveness
- This new Chatillon Model CSD200MT Dynamometer is one more diagnostic device to be 】. added to the existing familar devices previously approved. The person being tested (patient) is told to push or pull against the instrument using a particular muscle group. The physician/therapist performing the test (operator) resists the push or pull for a predetermined time period. The instrument measures the instantaneous push or pull force produced by the patient and stores the maximum value of the force during a single test in memory. The operator can then recall the peak push/pull force that occurred during the test using the keypad. The results of each test must be manually recorded.
- These instruments are powered by a rechargeable battery (7.5 Vdc) which supplies a 2. regulated 5 Vdc excitation voltage to a strain gage load cell. The output from the load cell passes through an A/D converter which produces a digital signal that is directly proportional to the applied force. This signal is then sent to a microprocessor which converts the signal to a force value that is stored in memory and/or displayed on an LCD. This basic design has been used for many years in industrial force measuring instruments that have found their way into hospitals, clinics and other similar facilities through industrial distributors. The instrument submitted herewith is a repackaged version of the industrial instrument with attachments that are more appropriate for performing manual muscle testing.
- The design accuracy of this instrument is ± 0.5% of full scale, + one least significant count 3. which translates to + 0.6 lb.
- Each individual instrument is calibrated and then checked for accuracy using weights that 4. are checked annually by the State of North Carolina, certified and traceable to N.I.S.T. The instrument is mounted in a test fixture and a 20 lb. weight is applied. Additional 20 lb. weights are applied until the full capacity of the instrument, 100 lb., is reached. This five point calibration ensures the accuracy of the instrument over its full operating range. The unit is then inspected using a different set of weights to verify that the readings do not vary by more than + 0.6 lb. at the five calibration points.
Based on the above, the risk of personal injury that could be caused by the use of this instrument is considered negligible. If a patient's threshold of pain is reached, a test can immediately be terminated by the operator without relying on any action but relaxing the resistance applied.
The use of a 7.5 Vdc rechargeable battery as the power source removes any potential for shock or other electrical involvement.
Future developments anticipated for these instruments will only involve the number of test results that can be stored in memory, manipulation of the data within the microprocessor or possibly a change in the physical size and/or shape of the case that encloses the instruments. Any change in the basic technology used in the instruments will be the subject of a separate submittal.