(78 days)
Not Found
No
The description focuses on the optical and mechanical components of the arthroscope and does not mention any AI/ML capabilities for image processing or analysis. The "processing and display" refers to standard video processing, not AI/ML.
Yes.
The device's intended use explicitly states it is used for "therapy" in arthroscopic procedures.
Yes
The device is explicitly stated to be used for "examination, diagnosis, and/or therapy" and for providing an "internal view or image of the interior of a joint for examination, diagnosis, and therapy." This indicates its role in obtaining information crucial for diagnosing medical conditions.
No
The device description clearly states it is a tubular optical instrument with lenses and physical components, indicating it is a hardware device, not software-only.
Based on the provided information, the Stryker Arthroscopes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Stryker Arthroscopes' Intended Use: The intended use clearly states that the device is used within the patient's body to provide an internal view or image of a joint. It is used for examination, diagnosis, and therapy during arthroscopic procedures.
- Device Description: The description reinforces that it's a tubular optical instrument used to view internal anatomy.
The device is an endoscopic device used for direct visualization within the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Stryker Arthroscopes are endoscopic devices into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
Stryker Arthroscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during arthroscopic procedures. The devices are available in a variety of outer diameters and working lengths.
The arthroscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process the device for initial use, as well as to reprocess the device after each use. The devices are available in an evepiece and a C-Mount design. The evepiece arthroscopes connect to the camera system through a separate coupler; the C-Mount arthroscopes connect directly to the camera system through an integrated coupler.
Stryker's arthroscopes achieve their intended use by guiding light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display by a separate camera system. The arthroscopes' optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release)
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)
The following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1, IEC 60601-2-18 | PASS |
| Packaging | ASTM D4169 | PASS |
| Visual Inspection | ISO 8600-1 | PASS |
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 | PASS |
| Cleaning and Disinfection | AAMI TIR 12, AAMI TIR 30, ISO 15883-5, ISO 15883-2 | PASS |
| Sterilization | AAMI ST79, AAMI ST58, ISO 17665-1, ISO 14937 | PASS |
| Performance - Bench | Needle Torque, Needle Torque - Dynamic Torque, Focus Ring Torque | PASS |
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
December 1, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Stryker Endoscopy Christie Samsa Principal Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138
Re: K202659
Trade/Device Name: Stryker Arthroscopes Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 30, 2020 Received: November 2, 2020
Dear Ms. Samsa:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 misleading.
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
K202659 - Christie Samsa
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202659
Device Name Stryker Arthroscopes
Indications for Use (Describe)
Stryker Arthroscopes are endoscopic devices into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
Submitter:
| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Christie Samsa, ME, RAC
Principle Regulatory Affairs Specialist
Phone: (978) 500-1303
Email: christie.samsa@stryker.com |
| Date Prepared | September 11, 2020 |
Subject Device:
| Name of Device | Stryker Arthroscopes |
|---|---|
| Common or Usual Name | Stryker Arthroscopes |
| Classification Name | Arthroscope, 21 CFR 888.1100 |
| Regulatory Class | Class II |
| Product Code | HRX |
Predicate Device:
| Name of Device | Precision Ideal Eyes® 4K Arthroscopes, K093677 & K183470 |
|---|---|
| ---------------- | ---------------------------------------------------------- |
Note: The predicate device has not been subject to a design-related recall.
Device Description:
Stryker Arthroscopes are tubular optical instruments used to provide a view of internal patient anatomy for examination, diagnosis, and therapy during arthroscopic procedures. The devices are available in a variety of outer diameters and working lengths.
The arthroscopes are reusable devices initially supplied as non-sterile to the user and requiring the user to process the device for initial use, as well as to reprocess the device after each use. The devices are available in an evepiece and a C-Mount design. The evepiece arthroscopes connect to the camera system through a separate coupler; the C-Mount arthroscopes connect directly to the camera system through an integrated coupler.
Stryker's arthroscopes achieve their intended use by guiding light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display by a separate camera system. The arthroscopes' optical system consists of a series of lenses, which includes an objective lens to image the intended object, a relay rod lens system to transmit the image along the working length, and an ocular lens to form the final image size.
4
Indications for Use:
Stryker Arthroscopes are endoscopic devices introduced into a patient to provide an internal view or image of the interior of a joint for examination, diagnosis, and/or therapy. Arthroscopes are indicated for use in arthroscopic procedures performed in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle elbow, and feet (plantar fascia release).
| Feature | Subject Device
Stryker Arthroscopes | Predicate Device
Stryker Arthroscopes |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Submission Reference | Current Submission | K093677 |
| Indications for Use
Statement | Stryker arthroscopes are endoscopic
devices introduced into a patient to
provide an internal view or image of
the interior of a joint for examination,
diagnosis, and/or therapy.
Arthroscopes are indicated for use in
arthroscopic procedures performed in
the hip, knee, shoulder, wrist (carpal
tunnel syndrome), temporal
mandibular joint, ankle elbow, and
feet (plantar fascia release). | Same as subject device |
| Operating principles | Transmission of light to illuminate
and image an arthroscopic joint, then
relaying the image out of the surgical
site for processing and display. | Same as subject device |
| Outer diameter | 4mm, 2.9mm, 2.7mm, 2.4mm, 1.9mm | Same as subject device |
| Working Length | 200mm, 165mm, 140mm, 120mm,
75mm, 72mm, 58mm | Same as subject device |
| DOV | 0°, 30°, 45°, 70°, and 30° reverse cant | Same as subject device |
| FOV | 105°, 80°, 65° | Same as subject device |
| C-mount coupler seal | U-cup seal | Quad ring seal |
| Key Patient-Contacting
Materials | Stainless Steel, Optical Glass,
Glass Fibers | Same as subject device |
| Single Use or Reusable | Reusable | Same as subject device |
| Cleaning | Manual and Automated | Same as subject device |
| Disinfection | Manual and Automated | Same as subject device |
| Sterilization
Methods | Autoclave, Steris VPRO, APS Sterrad | Same as subject device |
| Sterility Assurance
Level | 10-6 | Same as subject device |
| Comparison of Technological Characteristics with the Predicate Device: | |||||
|---|---|---|---|---|---|
5
Performance Testing:
The following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
|---|---|---|
| Electrical Safety | IEC 60601-1 | PASS |
| IEC 60601-2-18 | ||
| Packaging | ASTM D4169 | PASS |
| Visual Inspection | ISO 8600-1 | PASS |
| Biocompatibility | ISO 10993-1 | PASS |
| ISO 10993-5 | ||
| ISO 10993-10 | ||
| ISO 10993-11 | ||
| Cleaning and Disinfection | AAMI TIR 12 | PASS |
| AAMI TIR 30 | ||
| ISO 15883-5 | ||
| ISO 15883-2 | ||
| Sterilization | AAMI ST79 | PASS |
| AAMI ST58 | ||
| ISO 17665-1 | ||
| ISO 14937 | ||
| Performance - Bench | Needle Torque | PASS |
| Needle Torque - Dynamic Torque | PASS | |
| Focus Ring Torque | PASS |
Conclusions:
The Stryker Arthroscope is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the Stryker Arthroscope when used as instructed.