(87 days)
Not Found
No
The summary describes a set of reusable surgical instruments for hip arthroscopy and does not mention any AI or ML capabilities.
No
The device is described as reusable instrumentation for visualization and surgical procedures (resection, removal of loose bodies) within the hip joint. It is a surgical tool, not a device that provides a therapeutic effect on its own.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies."
No
The device description explicitly states it is composed of reusable instruments made of surgical stainless steel and rigid telescopic arthroscopes, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure involving accessing, illuminating, and visualizing the hip joint for operative and diagnostic purposes. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside the body, typically on biological samples).
- Device Description: The device description details reusable surgical instruments like arthroscopes and manual surgical instruments. These are tools used directly on the patient during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Stryker Hip Arthroscopy Set is a surgical device used for in vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Hip Arthroscopy Set is used for illumination and visualization of the deep confines of the hip joint. The Hip Arthroscopy Set is made size/length appropriate, and is indicated for use in approaching the hip joint for diagnostic evaluation and resection of various diseased soft tissues, debridement of cartilaginous tissues, and the removal of loose and foreign bodies in the hip joint.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Stryker Hip Arthroscopy Set is composed of reusable instruments including: extended length rigid telescopic arthroscopes and accessories with 30° and 70° oblique view angles, extended length manual surgical instruments made of surgical stainless steel. The instruments are maintained in a hardened plastic tray that accommodate repeat sterilization of the devices. The set is to be used in combination with various styles of Stryker disposable Hip Rotary Surgical Blades.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
stryker
OCT 2 1998
2590 Walsh Avenue Santa Clara, CA 95051
982375
(408) 567-9100 408) 567-2505 Fax
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (REVISED)
Stryker Endos Joy
Applicant:
2590 Walsh Avenue Santa Clara, CA 95051 (408) 567-9100
Device Identification:
Common Name: Arthroscope and Accessories
Trade Name: Stryker Hip Arthroscopy Set
Contact:
Baltazar Acosta Hip Project Coordinator (408) 567-2433
Carlos Gonzalez Regulatory Affairs (408) 567-2179
Device Description: The Stryker Hip Arthroscopy Set is composed of reusable instruments including: extended length rigid telescopic arthroscopes and accessories with 30° and 70° oblique view angles, extended length manual surgical instruments made of surgical stainless steel. The instruments are maintained in a hardened plastic tray that accommodate repeat sterilization of the devices. The set is to be used in combination with various styles of Stryker disposable Hip Rotary Surgical Blades.
Indications: The Hip Arthroscopy Set is used for illumination and visualization of the deep confines of the hip joint. The Hip Arthroscopy Set is made size/length appropriate, and is indicated for use in approaching the hip joint for diagnostic evaluation and resection of various diseased soft tissues, debridement of cartilaginous tissues, and the removal of loose and foreign bodies in the hip joint.
Substantial Equivalence Statement: Stryker hip arthroscopes are claimed substantially equivalent (SE) to commercially available arthroscopes made by Karl Storz and cleared under K963524. Stryker hip manual instruments are claimed SE to commercially available devices made by Smith & Nephew, Karl Stroz, and Arthrex, cleared under K971253, K963524, and K926212 respectively.
Safety and Effectiveness: The Hip Arthroscopy Set is made size length appropriate, reflecting desirable characteristics as described by orthopedic surgeons now performing various hip arthroscopic procedures. The Stryker Hip Arthroscopy Set introduces no new risks to health as compared with existing commercially available devices.
Signed: Baltazar Acosta
Baltazar Acosta
Hip Project Coordinator
Signed: Carlos Gonzalez
Carlos Gonzalez
Regulatory Affairs
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1998
Baltazar Acosta Hip Project Coordinator Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
Re: K982375 Trade Name: Stryker Hip Arthoroscopy Set Regulatory Class: II Product Code: HRX Dated: June 2, 1998 Received: July 7, 1998
Dear Mr. Acosta:
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 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). 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 requirements, 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 - Baltazar Acosta
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/dsma/dsmamain.html".
Sincerely yours,
C. Sadie McWitter, 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
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Page 1 of 1
510(k) Number: K982375
Device Name: Stryker Hip Arthroscopy Set
Revised Indications For Use: (Revised)
The Stryker Hip Arthroscopy Set, consisting of reusable instrumentation to access, illuminate and visualize the confines of the hip joint, is indicated for operative and diagnostic arthroscopic procedures of hip joint pathology including evaluation and the removal of loose bodies. Resection of soft, osseous and cartilaginous tissues is possible when used in conjunction with Stryker sterile disposable Rotary Hip Surgical Blades.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801 109) |
OR
| Over the Counter Use | ________________ |
|---|---|
| ---------------------- | ------------------ |
| (Optional Format 1-2-96) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | 1982375 |