ACTAEON PROBE

K013429 · Osteobiologics, Inc. · NGR · Jan 11, 2002 · Orthopedic

Device Facts

• Record ID: K013429
• Device Name: ACTAEON PROBE
• Applicant: Osteobiologics, Inc.
• Product Code: NGR · Orthopedic
• Decision Date: Jan 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic in vivo point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.

Device Story

Hand-held arthroscopic cartilage stiffness tester; measures reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by a disposable tip. Used by surgeons during arthroscopic or open joint procedures to assess cartilage integrity. Provides quantitative stiffness data to assist clinical decision-making regarding cartilage health.

Clinical Evidence

Bench testing only; device designed to comply with IEC 60601 standards.

Technological Characteristics

Hand-held mechanical probe; disposable indenting tip; measures reaction force/resistance; complies with IEC 60601 safety standards.

Indications for Use

Indicated for in vivo point measurement of articular cartilage stiffness in humans during arthroscopic or open joint procedures.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Artscan 200 Arthroscopic Cartilage Stiffness Tester (Artscan Oy)

Submission Summary (Full Text)

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## JAN 1 1 2002

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Act of 1990 and 21 CFR 807.92, In accordance with the requirements of the 510(K) Summary of Safety and OstooDiologics, 210. Inc. 25 accory Probe, 510(k) Number______________________________________________________________________________________________________________________

| Submitter: | OsteoBiologics, Inc.<br>University Business Park<br>12500 Network, Suite 112<br>San Antonio, TX 78249-3308<br>Tel: [phone] Fax: [phone] |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mark Q. Niederauer, Ph.D., Director of Operations |
| Date (summary prepared): | October 15, 2001 |
| Trade Name: | ACTAEON™ Probe |
| Common Name: | Arthroscopic Cartilage Stiffness Tester |
| Description of Device: | The ACTAEON™ Probe is a hand-held device which<br>when activated by the user measures the reaction force<br>(resistance) of articular cartilage against a known rate<br>and force of indentation applied by the disposable<br>indenting tip of the device. |
| Indications for Use: | The ACTAEON™ Probe arthroscopic cartilage stiffness<br>tester is indicated for an arthroscopic in vivo point<br>measurement of articular cartilage stiffness in humans.<br>The ACTAEON™ Probe can be used arthroscopically<br>or in open joint procedures. |
| Testing Summary: | The ACTAEON™ Probe is designed to meet and<br>comply with all sections of IEC 60601. |
| Predicate Device: | Artscan 200 Arthroscopic Cartilage Stiffness Tester<br>Artscan Oy. Helsinki. Finland |

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 1 2002

OsteoBiologics, Inc. Mark Q. Niederauer, Ph.D. Director of Operations University Business Park 12500 Network, Suite 112 San Antonio, Texas 78249-3308

Re: K013429

Trade Name: ACTAEONTM Probe Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: NGR Dated: October 15, 2001 Received: October 16, 2001

Dear Dr. Niederauer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Dr. Mark Niederauer:

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 [phone]. 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 vours,

Sincerely yours,

Mark A. Mulkern

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 (FORM) 2.4

INDICATIONS FOR USE

510(k) Number (if known): (not known) `K013429`
Device Name: `ACTAEON™ Probe`

Indications For Use:

The ACTAEON™ Probe arthroscopic cartilage stiffness tester is indicated for an arthroscopic *in vivo* point measurement of articular cartilage stiffness in humans. The ACTAEON™ Probe can be used arthroscopically or in open joint procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for *Mark N Melber*
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number `K013429`

Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)