(67 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and optical capabilities of a rigid arthroscope, with no mention of AI or ML technologies.
No
The device is described as providing illumination and visualization for diagnostic and operative arthroscopic procedures, which are investigative and interventional procedures, but the device itself does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in diagnostic and operative arthroscopic procedures" and mentions "arthroscopic diagnostic procedures" and "Hip diagnostic procedures."
No
The device description clearly states it is a rigid, fixed arthroscope with surgical stainless steel shafts and lens housings, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "diagnostic and operative arthroscopic procedures to provide illumination and visualization" within various joints. This describes a surgical tool used for direct visualization within the body, not for testing samples (like blood, urine, or tissue) in vitro (outside the body).
- Device Description: The description details a rigid arthroscope with optical components for visualization. This aligns with a surgical instrument, not a device designed for laboratory testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Arthrex Arthroscopes are surgical instruments used for visualization during procedures performed in vivo (within the body), not IVDs.
N/A
Intended Use / Indications for Use
The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
Hip diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondromatosis Unresolved hip pain Labral tears
Product codes
HRX
Device Description
Arthrex Arthroscopes are rigid, fixed arthroscopes with a wide-angle view. Arthrex Arthroscopes have surgical stainless steel shafts and lens housings for durability and are available with a 30 or 70 degree angle view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surqical site and surgeon preference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, knee, elbow, ankle, wrist, jaw, hip joint
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)
Not Found
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
MAR 1 8 2003
PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS Arthrex Arthroscopes
| NAME OF SPONSOR: | Arthrex, Inc.
2885 S. Horseshoe Drive
Naples, Florida 34104 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) CONTACT: | Sally Foust, RAC
Regulatory Affairs Specialist
Arthrex, Inc.
Telephone: (239) 643-5553 extension 1251
FAX: (239) 430-3494 |
| TRADE NAME: | Arthrex Arthroscopes |
| COMMON NAME: | Arthroscope |
| CLASSIFICATION: | Arthroscope
21 CFR 888.1100 |
| DEVICE PRODUCT CODE: | HRX |
DEVICE DESCRIPTION AND INTENDED USE:
Arthrex Arthroscopes are rigid, fixed arthroscopes with a wide-angle view. Arthrex Arthroscopes have surgical stainless steel shafts and lens housings for durability and are available with a 30 or 70 degree angle view. The optical components are sealed to provide a durable focusing mechanism. The arthroscopes may be attached to a video camera and are available in various sizes, diameters and lengths, to provide for differences in arthroscopic surqical site and surgeon preference.
The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
SAFETY AND EFFECTIVENESS
The Arthrex, Inc. Arthroscopes are similar to the predicate devices in design, materials, and intended use and as such are considered by Arthrex, Inc. to be substantially equivalent to devices currently available in U.S. distribution. The expansion of the indications of the Arthrex, Inc. Arthroscopes to include elbow and hip, those of the Smith & Nephew predicate device, does not raise new issues of safety and effectiveness.
000007
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2003
Ms. Sally Foust, RAC Regulatory Affairs Specialist Arthrex, Inc. 2885 S. Horsehoe Drive Naples, Florida 34104
Re: K030096
Trade/Device Name: Arthrex Arthroscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscopes and accessories Regulatory Class: II Product Code: HRX Dated: January 9, 2003 Received: January 10, 2003
Dear Ms. Foust:
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.
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 - Ms. Sally Foust, RAC
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), 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) you may obtain. 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 yours,
uriam C. Provost
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
510(k) Number (if known)
INDICATIONS FOR USE:
The Arthrex Arthroscopes are indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of the shoulder, knee, elbow, ankle, wrist, and jaw, and also to provide illumination and visualization during arthroscopic diagnostic procedures and removal of loose bodies and soft tissue within the hip joint as size/length appropriate.
Hip diagnostic procedures may include: Staging of avascular necrosis Chondral injuries Joint sepsis Synovial chondromatosis Unresolved hip pain Labral tears
| 新闻网易新闻网址新闻网 新疆新闻网 新闻总裁总裁总裁总裁员参加会议相继续参加会议员参加会议员会议会议 利来国际网络网络网络网 |
|---|
| ancurrance of CDBH Office of Davice Evaluation |
Prescription Use
_ OR
Over-The-Counter
Use
(Per 21 CFR 801.109)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________