(87 days)
Not Found
Not Found
No
The summary describes a mechanical device that measures force and resistance. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies.
No.
The device is a diagnostic tool that measures cartilage stiffness, not one that directly treats or provides therapy.
Yes
The device measures a physical property (stiffness) of articular cartilage, which is then used to assess the condition of the cartilage. This assessment contributes to diagnosing the state of the tissue.
No
The device description clearly states it is a "hand-held device" that measures "reaction force" and has a "disposable indenting tip," indicating it is a physical hardware device, not software only.
Based on the provided information, the ACTAEON™ Probe 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.
- ACTAEON™ Probe Function: The ACTAEON™ Probe is described as a device that performs an "arthroscopic in vivo point measurement of articular cartilage stiffness in humans." This means it is used inside the body (in vivo) during a procedure, not on a sample taken from the body (in vitro).
- Measurement Method: The device measures the "reaction force (resistance) of articular cartilage against a known rate and force of indentation." This is a mechanical measurement performed directly on the tissue within the joint.
Therefore, the ACTAEON™ Probe falls under the category of a medical device used for direct measurement within the body, not an in vitro diagnostic test.
N/A
Intended Use / 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.
Product codes
NGR
Device Description
The ACTAEON™ Probe is a hand-held device which when activated by the user measures the reaction force (resistance) of articular cartilage against a known rate and force of indentation applied by the disposable indenting tip of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
articular cartilage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The ACTAEON™ Probe is designed to meet and comply with all sections of IEC 60601.
Key Metrics
Not Found
Predicate Device(s)
Artscan 200 Arthroscopic Cartilage Stiffness Tester
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
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.
University Business Park
12500 Network, Suite 112
San Antonio, TX 78249-3308
Tel: (210) 690-2131 Fax: (210) 690-2559 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
when activated by the user measures the reaction force
(resistance) of articular cartilage against a known rate
and force of indentation applied by the disposable
indenting tip of the device. |
| 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. |
| Testing Summary: | The ACTAEON™ Probe is designed to meet and
comply with all sections of IEC 60601. |
| Predicate Device: | Artscan 200 Arthroscopic Cartilage Stiffness Tester
Artscan Oy. Helsinki. Finland |
1
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.
2
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 (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 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
3
INDICATIONS FOR USE (FORM) 2.4
INDICATIONS FOR USE
510(k) Number (if known): (not known) [K013429](https://510k.innolitics.com/search/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](https://510k.innolitics.com/search/K013429)
Prescription Use X OR Over-The-Counter Use
(Per 21 CFR 801.109)