(203 days)
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No
The summary only describes a rigid arthroscope for illumination and visualization, with no mention of AI, ML, image processing, or any other features indicative of AI/ML technology.
No
The device is described as providing illumination and visualization for diagnostic and operative arthroscopic procedures, which points to it being a diagnostic or surgical tool rather than directly therapeutic.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for "Diagnostic and operative arthroscope procedures."
No
The device is described as a rigid arthroscope, which is a physical medical device used for visualization. The summary does not mention any software component as the primary or sole function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Diagnostic and operative arthroscope procedures." This involves visualizing structures within the body (in vivo) during a medical procedure.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis based on laboratory tests.
Arthroscopes are medical devices used for direct visualization of joints during surgical or diagnostic procedures, which is an in vivo application, not an in vitro one.
N/A
Intended Use / Indications for Use
The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in: · Diagnostic and operative arthroscope procedures.
Product codes
HRX
Device Description
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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
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 2 1999
Ms. Gayle M. Butler Compliance Office National Advanced Endoscopy Devices, Inc. 10801 National Boulevard, Suite 603 Los Angeles, California 90064
Re: K991656 Trade Name: AED Arthroscope Regulatory Class: II Product Code: HRX Dated: September 1, 1999 Received: September 7, 1999
Dear Ms. Butler:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Gayle M. Butler
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
Mark M. Milkersm
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K991626 Device Name: AED Arthroscope
INDICATIONS FOR USE:
The AED line of rigid Arthroscopes is indicated to provide illumination and visualization in:
· Diagnostic and operative arthroscope procedures.
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| Concurrence of CDHR, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Mark N. Mikkelsen for BD (Division Sign-Off) Division of General Restorative Devices 510(k) Number K991656 | ||
| Prescription Use | X | Over-The-Counter Use _ |