(133 days)
Not Found
None
No
The summary describes a basic arthroscope/endoscope for viewing surgical sites and makes no mention of AI, ML, image processing, or any related technologies.
No
The device is described as an arthroscope/endoscope used for viewing surgical sites in joints, not for treating any condition. Its intended use is diagnostic or for surgical visualization, not therapeutic intervention.
No
Explanation: The device is described as an "Arthroscope" or "Endoscope" intended for viewing surgical sites. Its purpose is to visualize anatomical structures during surgery, not to diagnose a disease or condition. It is a surgical viewing instrument rather than a diagnostic tool.
No
The device description and intended use clearly describe a physical arthroscope/endoscope, which is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for viewing the surgical site within joints. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description (Implied): While the description is "Not Found," the intended use as an arthroscope/endoscope for viewing joints strongly suggests a device used directly on the patient's body.
- Anatomical Site: The specified anatomical sites (joints) are within the human body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing laboratory tests, or providing diagnostic information based on such analysis.
Therefore, the Micro Arthroscope/Endoscope described is a surgical viewing instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Micro Arthroscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints in conjunction with cameras.
Micro Endoscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints of the wrists, ankles, elbows, knees, or shoulders in conjunction with cameras.
Product codes
HXR
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and large joints, wrists, ankles, elbows, knees, or shoulders
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Surgical site
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Galileo Arthroscope
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
SUMMARY OF SAFETY AND EFFECTIVENESS MICRO MEDICAL DEVICES, INC. MICRO ENDOSCOPE
The Summary of Safety and Effectiveness on Micro Endoscope reflects data available and presented at the time the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
Micro Arthroscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints in conjunction with cameras.
Caution
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
Contraindication
Bending or prying with scope will damage optics.
Precautions
- Surgical laser and mechanical cutting instruments can damage the scope. ●
- Do not allow the arthroscope tip to come into contact with hard or sharp objects. .
- Use this device only with a xenon light source (maximum 300 watts) and Micro Medical . Devices, Inc camera.
Substantial Equivalency Information
The Micro Arthroscope is similar to the Galileo Arthroscope currently offered by Galileo Electro-Optics Corporation.
| Materials | Galileo
Stainless Steel | Micro Medical
Stainless Steel
Polyimide |
|---------------|----------------------------|-----------------------------------------------|
| Sterilization | Reusable: EO and
Steris | Single Use: EO
SAL 10-6 |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Micro Medical Endoscope is comparable to that of the Galileo Electro-Optics Corporation Arthroscope
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 1999
Mr. Jim Ohneck General Manger Micro Medical Devices, Inc. 11000 Cedar Avenue Suite 445 Cleveland, Ohio 44106
Re: K983882 Trade Name: Micro Endoscope Regulatory Class: II Product Code: HXR Dated: February 3, 1999 Received: February 5, 1999
Dear Mr. Ohneck:
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.
2
Page 2 - Mr. Jim Ohneck
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):_
Micro Endoscope
983882
Devicc Namc:_______
Indications For Use:
Micro Endoscope is intended for insertion into a small incision or puncture (through a cannula) to view the surgical site of small and large joints of the wrists, ankles, elbows, knees, or shoulders in conjunction with cameras.
CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
CONTRAINDICATIONS: Bending or prying with scope will damage optics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) -
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K983882 |
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)