(91 days)
Not Found
No
The description focuses on measuring and displaying force over time, with no mention of AI/ML for analysis or interpretation.
No
The device is described as aiding in the identification of fine motor performance issues through measurement, not for treating or preventing a disease or condition. Its purpose is evaluative and diagnostic rather than therapeutic.
Yes
Explanation: The device is described as aiding in the "identification of fine motor performance issues" and "measuring grip or pinch strength," which are diagnostic activities used to evaluate a person with an injury or disease. The "Intended Use / Indications for Use" explicitly states its use in the "evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s)."
No
The device description explicitly states the system consists of a hand sensor and a data control module in addition to the software and computer, indicating it includes hardware components.
Based on the provided information, the KaDance 2000 system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The KaDance 2000 system measures physical forces exerted by the hand (grip and pinch strength) directly from the patient. It does not analyze blood, urine, tissue, or any other biological specimen.
- The intended use and device description focus on physical measurement. The system is designed to measure grip and pinch strength and how digits maintain a grip over time. This is a biomechanical measurement, not a diagnostic test performed on a biological sample.
- The predicate device is a grip strength measurement device. The predicate device (K981730 Digit-grip with LCD) is also a device for measuring grip strength, which further supports the classification of the KaDance 2000 as a physical measurement device rather than an IVD.
Therefore, the KaDance 2000 system falls under the category of a physical measurement or rehabilitation device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- Any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s).
- To measure grip or pinch strength in an injured and uninjured hand.
- To conduct pre-employment screening for physically demanding job activities.
- To establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace.
Product codes (comma separated list FDA assigned to the subject device)
LBB
Device Description
The KaDance 2000 system is designed to aid in the identification of fine motor performance issues, (median nerve entrapment), which may be present in either or both hands of a human. The system is non-invasive. This is accomplished by measuring how the thumb (digit 1), index finger (digit 2) and little finger (digit 5) maintain a grip throughout several repetitive exercisers. The applied forces exerted by the digits measured as a function of time. Measurements may be made as rapidly as once every 2 ms for all three digits simultaneously.
The system consists of 1) hand sensor, 2) a data control module and laptop computer, 3) KaDaLink™ computer with KaDance 2000 software running. Data is displayed as force over time.
Operation of the system is menu driven from the laptop computer. When a subject test without errors has been completed, the data is transmitted to a central location via modem or other hi-speed data transmission means and hard copies are produced. Data is returned to test director by whatever means as directed. Interpretation of data and any diagnosis resides with the test director or other medical practitioner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand(s)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Test director or other medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The KaDance device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complicable industry and safety standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Digit-grip with LCD K981730
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.
Not Found
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).
Not Found
§ 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
510(k) Submission, New, KaDance 2000
KaDa Research, Inc., Stafford, Texas 77477
NOV 02 2001
K012492
10F3
Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.
-
- Company making the submission:
| Company | or | Correspondent (contract): | |
|---|---|---|---|
| Name: | |||
| Address: | KaDa Research, Inc. | ||
| 10701 Corporate Drive | |||
| Ste. 100 | |||
| Stafford, Texas 77477 | Delphi Consulting Group | ||
| 11874 South Evelyn Circle | |||
| Houston, Texas 77071-3404 | |||
| Telephone: | 281-437-9119 voice | ||
| 281-240-7122 fax | 713-723-4080 voice | ||
| 208-694-6953 fax | |||
| Contact: | William C. Paske, Ph.D. | ||
| President & CEO | J. Harvey Knauss | ||
| Consultant |
2. Device:
| Proprietary Name: | KaDance Hand Sensor System |
|---|---|
| Common Name: | Force measurement device |
| Classification Name: | AC-powered dynamometer |
3. Predicate Devices;
Digit-grip with LCD K981730
4. Classifications Names & Citations:
21 CFR 888.1240 AC-powered dynamometer, Class II, LLB, 87 Orthopedics.
5. Description:
The KaDance 2000 system is designed to aid in the identification of fine motor performance issues, (median nerve entrapment), which may be present in either or both hands of a human. The system is non-invasive. This is accomplished by measuring how the thumb (digit 1), index finger (digit 2) and little finger (digit 5) maintain a grip throughout several repetitive exercisers. inger (againe) and intil migor (aally the applied forces exerted by the digits measured as a function of time. Measurements may be made as rapidly as once every 2 ms for all three digits
simultaneously.
1
510(k) Submission, New, KaDance 2000
KaDa Research, Inc., Stafford, Texas 77477
The system consists of 1) hand sensor, 2) a data control module and laptop computer, 3) KaDaLink™ computer with KaDance 2000 software running. Data is displayed as force over time.
Operation of the system is menu driven from the laptop computer. When a subject test without errors has been completed, the data is transmitted to a central location via modem or other hispeed data transmission means and hard copies are produced. Data is returned to test director by whatever means as directed. Interpretation of data and any diagnosis resides with the test director or other medical practitioner.
- Indications for use:
- Any situation where the hand grip or pinch strength would be a valuable piece of data in ● the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s).
- . To measure grip or pinch strength in an injured and uninjured hand.
- To conduct pre-employment screening for physically demanding job activities. .
- To establish an industrial strength testing program in general, and to match the strength . of workers to the strength demands of specific job duties in the workplace.
7. Contra-indications:
Should not be use on a subject with burns, open wound, rash or fracture. Use with caution when subject hands are sensitive to pain. Do not counter accepted clinical practice or institution guidelines.
- Comparison:
The KaDance™ device has the same device characteristics as the predicate devices, except the predicate devices do not have the capability to transmit data to a distance location.
- Test Data:
The KaDance device has been subjected to extensive safety, performance, and validations prior to release. Final testing for the systems includes various performance tests designed to ensure that the device meets all of its functional requirements and performance specifications. Safety tests have further been performed to ensure the device complicable industry and safety standards.
- Literature Review:
A review of literature pertaining to the safety and effectiveness has been conducted. Appropriate safequards have been incorporated in the design of the KaDance™ device.
Section 5 Page 3 510(k) Submission Page #
2
510(k) Submission, New, KaDance 2000
KaDa Research, Inc., Stafford, Texas 77477
1012492
3 OF 3
11. Conclusions:
The conclusion drawn from these tests is that the KaDance device is equivalent in safety and efficacy to its predicated devices.
Section 5 Page 4
3
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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
NOV 02 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
KaDa Research, Inc. c/o Mr. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, Texas 77071
Re: K012492
Trade/Device Name: KaDance 2000 Hand Sensor System Regulation Number: 21 CFR 888.1240 Regulation Name: AC-powered dynamometer Regulatory Class: Class II Product Code: LBB Dated: July 31, 2001 Received: August 3, 2001
Dear Mr. Paske:
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.
4
Page 2 - Mr. Harvey Knauss
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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.
Sincerely yours,
Mark N. Millikan
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
5
510(k) Number K_ 012 492
Device Name: KaDance 2000 Hand Sensor System
Indications for use:
- Any situation where the hand grip or pinch strength would be a valuable I piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s).
- To measure grip or pinch strength in an injured and uninjured hand. 트
- To conduct pre-employment screening for physically demanding job 트 activities.
- To establish an industrial strength testing program in general, and to 회 match the strength of workers to the strength demands of specific job duties in the workplace.
Prescription Device: NO
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use $\checkmark$
(Per 21 CFR 801.109)
510(k) Number
O. Mark N. Mullersen
storative
(Optional Format 1-2-96)