Stryker Arthroscope

K202659 · Stryker · HRX · Dec 1, 2020 · Orthopedic

Device Facts

• Record ID: K202659
• Device Name: Stryker Arthroscope
• Applicant: Stryker
• Product Code: HRX · Orthopedic
• Decision Date: Dec 1, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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).

Device Story

Stryker Arthroscopes are reusable tubular optical instruments used in arthroscopic surgery. The device functions by guiding light to illuminate the interior of a joint and relaying the resulting image out of the surgical site via an internal lens system (objective, relay rod, and ocular lenses). The device connects to a separate camera system either via an eyepiece with a coupler or a direct C-Mount integrated coupler. Operated by surgeons in clinical settings, the device provides visual feedback to the physician, enabling real-time visualization of internal anatomy to guide diagnostic and therapeutic interventions. The device is supplied non-sterile and requires reprocessing (cleaning, disinfection, and sterilization) between uses.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1, IEC 60601-2-18), packaging (ASTM D4169), visual inspection (ISO 8600-1), biocompatibility (ISO 10993 series), cleaning/disinfection (AAMI TIR 12/30, ISO 15883 series), sterilization (AAMI ST79/ST58, ISO 17665-1, ISO 14937), and mechanical performance (needle and focus ring torque). All tests passed.

Technological Characteristics

Reusable tubular optical endoscope. Materials: Stainless steel, optical glass, glass fibers. Optical system: Objective lens, relay rod lens, ocular lens. Connectivity: Eyepiece or C-Mount interface to external camera. Sterilization: Autoclave, Steris VPRO, APS Sterrad. Standards: ISO 8600-1, ISO 10993, IEC 60601-1.

Indications for Use

Indicated for patients undergoing arthroscopic procedures in the hip, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle, elbow, and feet (plantar fascia release) for examination, diagnosis, or therapy.

Regulatory Classification

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.

Predicate Devices

• Precision Ideal Eyes® 4K Arthroscopes (K093677 & K183470)

Submission Summary (Full Text)

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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

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# 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 ([e-mail]) or phone [phone] 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

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# 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 100%;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

## Submitter:

| Applicant | Stryker Endoscopy<br>5900 Optical Court<br>San Jose, CA 95138 |
|----------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Christie Samsa, ME, RAC<br>Principle Regulatory Affairs Specialist<br>Phone: [phone]<br>Email: [e-mail] |
| 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.

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# 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<br>Stryker Arthroscopes | Predicate Device<br>Stryker Arthroscopes |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Submission Reference | Current Submission | K093677 |
| Indications for Use<br>Statement | Stryker arthroscopes are endoscopic<br>devices introduced into a patient to<br>provide an internal view or image of<br>the interior of a joint for examination,<br>diagnosis, and/or therapy.<br>Arthroscopes are indicated for use in<br>arthroscopic procedures performed in<br>the hip, knee, shoulder, wrist (carpal<br>tunnel syndrome), temporal<br>mandibular joint, ankle elbow, and<br>feet (plantar fascia release). | Same as subject device |
| Operating principles | Transmission of light to illuminate<br>and image an arthroscopic joint, then<br>relaying the image out of the surgical<br>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,<br>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<br>Materials | Stainless Steel, Optical Glass,<br>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<br>Methods | Autoclave, Steris VPRO, APS Sterrad | Same as subject device |
| Sterility Assurance<br>Level | 10-6 | Same as subject device |

| | | | Comparison of Technological Characteristics with the Predicate Device: | | |
|--|--|--|------------------------------------------------------------------------|--|--|
| | | | | | |

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# 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.