(90 days)
Not Found
No
The document describes a standard visualization device with a camera and monitor, and there is no mention of AI, ML, or advanced image processing that would suggest the use of such technologies.
No
The device is described as a "Visualization Device" used for providing "illumination and visualization" during diagnostic and operative procedures. It does not perform any therapeutic function (e.g., treatment, repair, or modification of tissue).
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in diagnostic and operative arthroscopic and endoscopic procedures."
No
The device description explicitly details hardware components such as an integrated LCD monitor, probe, electronics, LED light source, CMOS camera, and fiber optic lighting.
Based on the provided information, the Axis Surgical Technologies C-MOR Visualization Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- C-MOR Device Function: The C-MOR Visualization Device is used for direct visualization of the interior of the body during surgical or diagnostic procedures. It provides real-time images from a camera inserted into the body. This is an in vivo (within the living body) application, not an in vitro one.
- Intended Use: The intended use clearly states "to provide illumination and visualization of an interior cavity of the body". This aligns with an endoscopic or arthroscopic device, not an IVD.
Therefore, the C-MOR Visualization Device falls under the category of a surgical or endoscopic visualization device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Axis Surgical Technologies C-MOR Visualization Device is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
Product codes
HRX
Device Description
The C-MOR Visualization Device is a battery operated, portable, visualization device including an integrated LCD monitor and probe. The C-MOR Visualization Device is easily handled in one hand and includes a user interface, electronics, user controls, and LED light source. The LCD monitor displays real-time images from the probe and is flexibly mounted on the handle - allowing adjustment of the LCD viewing angle. The probe extends from the handle as a rigid shaft seating a CMOS camera and fiber optic lighting located at the distal tip.
The overall length of the C-MOR Device 342 mm (approx. 13.5 inches); including the probe portion and handle. The probe length, extending from the handle, is 150 mm (approx. 6 inches). The entire unit weighs less than 300 grams (approx. 0.67 lbs.).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Interior cavity of the body through either a natural or surgical opening.
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
Not Found
Key Metrics
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
Premarket Notification December 1, 2009
K0937+7
SECTION 5 - 510(K) SUMMARY
Axis Surgical Technologies, Inc.
Submitter / Holder:
MAR - 2 2010
Axis Surgical Technologies, Inc. 325 E. Middlefield Road Mountain View, CA 94043
Contact Person:
James Farnworth RA/QA Tel: 650-968-3800 x5610 Fax: 650-968-3803 Email: jfarnworth@axissurgical.com
Date prepared:
December 1, 2009
Device Information:
| Trade name: | C-MOR Visualization System |
|---|---|
| Common name: | Arthroscope |
| Classification name: | Arthroscope |
| Panel: | Orthopedic |
| Product Code: | HRX |
| Device Class: | Class 2 |
Predicate Devices:
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K082293 | Surgview integrated visualization system | Biovision Technologies, |
| LLC | ||
| K043395 | S&N Video Arthroscope | Smith & Nephew |
| K072879 | InnerVue Diagnostic Scope System | Biomet |
Intended Use / Indications for Use:
The Axis Surgical Technologies C-MOR Visualization Device is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
1
Device Description:
The C-MOR Visualization Device is a battery operated, portable, visualization device including an integrated LCD monitor and probe. The C-MOR Visualization Device is easily handled in one hand and includes a user interface, electronics, user controls, and LED light source. The LCD monitor displays real-time images from the probe and is flexibly mounted on the handle - allowing adjustment of the LCD viewing angle. The probe extends from the handle as a rigid shaft seating a CMOS camera and fiber optic lighting located at the distal tip.
The overall length of the C-MOR Device 342 mm (approx. 13.5 inches); including the probe portion and handle. The probe length, extending from the handle, is 150 mm (approx. 6 inches). The entire unit weighs less than 300 grams (approx. 0.67 lbs.).
Substantial Equivalence:
The C-MOR Visualization Device has the same indications and intended use as the predicate devices. The subject and predicate devices utilize the same basic technology and the same operating principles. Performance data supporting the claim of substantial equivalence is included in the body of the premarket notification.
Performance:
The C-MOR Visualization Device complies with the international standards for EMC, Medical Device Electrical Safety and biocompatibility.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird, with its wings forming a human profile.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Axis Surgical Technologies, Inc. % Mr. James Farnworth Director, RA/QA 325 E. Middlefield Road Mountain View, California 94043
MAR - 2 2010
Re: K093717
Trade/Device Name: C-MOR Visualization System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 28, 2010 Received: January 29, 2010
Dear Mr. Farnworth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not mislcading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. James Farnworth
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
Mark A. Milkean
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Axis Surgical Technologies, Inc. C-MOR Visualization Device
SECTION 4 - INDICATIONS FOR USE STATEMENT
Indications for Use
K093717 510(k) Number (if known):
Device Name: C-MOR Visualization System
Indications For Use:
The Axis Surgical Technologies C-MOR Visualization Device is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use 21 CFR 801 Subpart C)
(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 Surgical, Orthopedic, Page 1 of and Restorative Devices
510(k) Number K093717 Page 9
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