KADANCE 2000

K012492 · Kada Research, Inc. · LBB · Nov 2, 2001 · Orthopedic

Device Facts

• Record ID: K012492
• Device Name: KADANCE 2000
• Applicant: Kada Research, Inc.
• Product Code: LBB · Orthopedic
• Decision Date: Nov 2, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1240
• Device Class: Class 2

Intended 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.

Device Story

KaDance 2000 is a force measurement system for identifying fine motor performance issues (e.g., median nerve entrapment). Device measures forces exerted by thumb, index, and little fingers during repetitive exercises; sampling rate up to 500Hz (every 2ms). System comprises hand sensor, data control module, and laptop running KaDance 2000 software. Operated by test director/medical practitioner in clinical or industrial settings. Data displayed as force-over-time; transmitted via modem/high-speed connection to central location for analysis. Hard copies produced for review. Interpretation and diagnosis performed by medical practitioner. Benefits include objective quantification of grip/pinch strength for clinical evaluation and workplace job-matching.

Clinical Evidence

No clinical data provided. Device underwent extensive safety, performance, and validation testing prior to release to ensure functional requirements and safety standards were met.

Technological Characteristics

AC-powered dynamometer. System includes hand sensor, data control module, and laptop computer. Measures force as a function of time for three digits simultaneously. Connectivity via modem or high-speed data transmission for remote reporting. Software-driven menu operation.

Indications for Use

Indicated for individuals requiring evaluation of hand grip or pinch strength due to injury or disease, and for pre-employment screening or industrial strength testing. Contraindicated for subjects with burns, open wounds, rashes, or fractures. Use with caution if hands are sensitive to pain.

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

• Digit-grip with LCD (K981730)

Submission Summary (Full Text)

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# 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.

- 1. Company making the submission:

| | Company | or | Correspondent (contract): |
|-------------------|-----------------------------------------------------------------------------------|----|-----------------------------------------------------------------------------------|
| Name:<br>Address: | KaDa Research, Inc.<br>10701 Corporate Drive<br>Ste. 100<br>Stafford, Texas 77477 | | Delphi Consulting Group<br>11874 South Evelyn Circle<br>Houston, Texas 77071-3404 |
| Telephone: | 281-437-9119 voice<br>281-240-7122 fax | | 713-723-4080 voice<br>208-694-6953 fax |
| Contact: | William C. Paske, Ph.D.<br>President & CEO | | J. Harvey Knauss<br>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.

6. 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.

8. 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.

9. 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.

10. 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 #

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# 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

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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.

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### 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 [phone]. 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 [phone] or [phone] 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

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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

K012492

(Optional Format 1-2-96)