(63 days)
Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses solely on the intended use and anatomical sites for a standard endoscope.
No.
The device is indicated for visualization and aiding in the search and removal of material, which are diagnostic and procedural assistance functions, not therapeutic.
No
Explanation: The device is an endoscope used for visualization and aiding in the search and removal of material. It is a surgical tool, not a diagnostic device that interprets data for diagnosis.
No
The 510(k) summary describes an "Endoscope," which is a hardware device used for visualization. There is no mention of software as the primary or sole component.
Based on the provided information, the METRx™ Endoscope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for visualization and aiding in the removal of material within the body (herniated disc material, nucleus material, within joints). This is a direct interaction with the patient's anatomy for diagnostic and therapeutic purposes.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body (in vitro).
- Device Type: An endoscope is a device used to look inside the body. This is an in vivo (within the living body) procedure, not an in vitro procedure.
The information provided clearly indicates the device is used for internal visualization and procedures, which is characteristic of an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The METRx™ Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the scarch and removal of nucleus material. It is intended for use in the lumbar spinc. The endoscope is also indicated for use in the knec, shoulder, wrist and temporomandibular joint (TMJ).
Product codes
HRX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, knee, shoulder, wrist, temporomandibular joint (TMJ)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
StealthStation® System - Indications Modification
Date Summary Prepared: October 26, 1999
- Contact: Roger N. White Company: 1. Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Product Trade Name: METRx™ System ll. Common or usual name: Arthroscope Classification name: Arthroscope and Accessories (HRX per 21 CFR 888.1100)
- The above device is substantially equivalent to the Endoscopes cleared in III. K943356, K946087, and K955471. This submission describes a change to the indications for use and minor design changes.
- This submission describes a modification to the METRx™ System indications for IV. use to provide for use of the endoscope in the cervical spine.
- The indications for use for the METRx™ System arc as follows: V.
The METRx TM Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the search and removal of nucleus material. It is intended for use in the lumbar spine. The endoscope is also indicated for use in the knee, shoulder, wrist and temporomandibular joint (TMJ).
- The technological characteristics of the device are the same as or similar to those VI. for the predicate devices. A comparison of technological characteristics and literature references support the claim of substantial equivalence.
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.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Mr. Roger N. White Group Director, Quality Systems and Regulatory Affairs Surgical Navigation Technologies 530 Compton Street Broomfield, Colorado 80020
K993021 Re:
Trade Name: METRx™ Endoscope Regulatory Class: II Product Code: HRX Dated: September 3, 1999 Received: September 8, 1999
Dear Mr. White:
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. Roger N. White
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,
Colin M. Wittwer, Ph.D., M.D.
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): K993021
Device Name: METRx™ Endoscope - Indications Modification
Indications For Usc:
The METRx™ Endoscope is Indicated for visualization of herniated disc material, visualization of the circumferential decompression of the nerve roots, and aiding in the scarch and removal of nucleus material. It is intended for use in the lumbar spinc. The endoscope is also indicated for use in the knec, shoulder, wrist and temporomandibular joint (TMJ).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NIEDED)
| Concurrence of CDRH, Office Of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K993021 |
Prescription Use_X
OR
Over-The-Counter Usc_
(Pcr 21 CFR 801.109)
(Optional Format 1-2-96)