Stryker CrossFlow Integrated Arthroscopy Pump

K191259 · Stryker Corp. · HRX · Jul 12, 2019 · Orthopedic

Device Facts

• Record ID: K191259
• Device Name: Stryker CrossFlow Integrated Arthroscopy Pump
• Applicant: Stryker Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Jul 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Stryker CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle, and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

Device Story

Microprocessor-controlled dual peristaltic pump system; provides fluid distension, irrigation, and aspiration for arthroscopic procedures. Inputs include user-set pressure parameters; system uses pressure-sensing algorithm to maintain joint cavity pressure. New software modification adds temperature estimation algorithm and GUI update; algorithm analyzes data features to estimate in-joint temperature and triggers mitigating actions to prevent high temperatures. Operated by surgeons/nurses in clinical settings via touch-screen, remote hand, or foot controls. Output includes real-time pressure and temperature status on display. Benefits include maintained joint distension and reduced risk of high-temperature fluid injury.

Clinical Evidence

No clinical or animal testing was conducted. Evidence consists of bench performance testing, software verification, and simulated-use validation. Bench testing confirmed temperature estimation algorithm accuracy and effectiveness in reducing high fluid temperatures. Simulated-use testing with surgeons and nurses validated GUI usability.

Technological Characteristics

Dual peristaltic pump system; console housing, power supply, three pinch valves, touch-screen display. Software-controlled via microelectronics. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-18 (endoscopic equipment).

Indications for Use

Indicated for patients undergoing diagnostic or operative arthroscopic procedures of the knee, shoulder, hip, elbow, ankle, or wrist requiring fluid distension, irrigation, and suction.

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

• Stryker CrossFlow Integrated Arthroscopy Pump (K123441)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the full name written out to the right of it.

July 12, 2019

Stryker Endoscopy Mr. Justin Florence Regulatory Affairs Specialist 5900 Optical Court San Jose. California 95138

Re: K191259

Trade/Device Name: Stryker CrossFlow Integrated Arthroscopy Pump Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: May 9, 2019 Received: May 10, 2019

Dear Mr. Florence:

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.

{1}------------------------------------------------

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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation & Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K191259

Device Name

Stryker CrossFlow Integrated Arthroscopy Pump

Indications for Use (Describe)

The Stryker CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Stryker logo in black, with the text "K191259 page 1 of 5" above and to the right of the logo. The logo is a stylized version of the company name, with bold, sans-serif letters. The text above the logo indicates that this is page 1 of a 5-page document with the identifier K191259. The overall impression is that this is a document header or title page from Stryker.

#### I. SUBMITTER

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138

Phone: [phone] Email: [e-mail]

Contact Person: Justin Florence Date Prepared: May 9, 2019

- II. DEVICE
Name of Device: Stryker CrossFlow Integrated Arthroscopy Pump Common or Usual Name: Arthroscopic Pump, Tubing Sets and Accessories Classification Name: Arthroscope (21 CFR 888.1100) Regulatory Class: II Product Code: HRX

#### III. PREDICATE DEVICE

Stryker CrossFlow Integrated Arthroscopy Pump, K123441 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The Stryker CrossFlow Integrated Arthroscopy Pump (CrossFlow) is a microprocessorcontrolled dual (inflow and outflow) pump system designed to provide liquid distention and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. Both the irrigation and aspiration pump of the device function according to the peristaltic principle. The Stryker CrossFlow Integrated Arthroscopy Pump consists of the following main components: console housing, power supply, two peristaltic pumps, three pinch valves, and a touch-screen display panel. The device is to be used with specially designed irrigation and aspiration tube sets and can be operated by remote hand and foot controls. A constantly-performed pressure sensing algorithm controls the value of the actual pressure in the joint cavity as compared to the set pressure determined by the user.

The proposed software modification consists of a graphical user interface (GUI) aesthetic update and the addition of a temperature estimation algorithm and on-screen indicator.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase and black. The word is centered in the image and the background is white.

The algorithm analyzes data features to estimate the in-joint temperature and implements mitigating actions to reduce the likelihood of high temperatures.

- INTENDED USE/INDICATIONS FOR USE V.
The Stryker CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle, and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

| Characteristic | Subject Device | Predicate Device |
|--------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Stryker CrossFlow Integrated<br>Arthroscopy Pump | Stryker CrossFlow Integrated<br>Arthroscopy Pump (K123441) |
| Intended<br>Use/Indications for Use<br>Statement | Same as predicate device. | The Stryker CrossFlow Integrated<br>Arthroscopy Pump is a dual<br>arthroscopic pump system intended to<br>provide fluid distension and irrigation<br>of the knee, shoulder, hip, elbow, ankle<br>and wrist joint cavities and fluid<br>suction during diagnostic and operative<br>arthroscopic procedures. |
| Contraindications | Same as predicate device. | The use of the Stryker CrossFlow<br>Integrated Arthroscopy Pump is<br>prohibited whenever arthroscopy is<br>contraindicated. |
| Product Code(s) | Same as predicate device. | HRX |
| Pump Mechanism | Same as predicate device. | Peristaltic |
| Pump Type | Same as predicate device. | Inflow/Outflow, Inflow Only |
| Operating Principle | Same as predicate device. | The device is controlled by software<br>and microelectronics that execute<br>control algorithms that ensure the set<br>pressure is being achieved within the<br>patient's joint. |
| Roller Wheel | Same as predicate device. | The device has internally-mounted<br>roller wheels that interface with<br>cassettes that are part of the<br>disposable, single-use tube sets. |
| EMC/Electrical | Same as predicate device. | IEC 60601-1-2<br>IEC 60601-1<br>IEC 60601-2-18 |

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all connected, giving the word a solid, block-like appearance. The color of the text is black, and the background is white, creating a high contrast.

| Design | Same as predicate device. | Pump consists of the following main components:<br>- console housing<br>- power supply<br>- two peristaltic pumps<br>- three pinch valves<br>- touch-screen display panel |
|---------------|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Energy Source | Same as predicate device. | Supply voltage provided to the console is that of a typical business or hospital environment. |

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters.

### Discussion of Similarities and Differences

The core functionality of the Stryker CrossFlow Integrated Arthroscopy Pump, as cleared per K123441, remains unchanged. Similarly, the indications for use and intended use remain unchanged.

The changes described in this premarket notification are entirely contained within the software. No hardware changes are being implemented. The proposed software modification implements a graphical user interface (GUI) aesthetic update and the addition of a temperature estimation algorithm and on-screen indicator.

#### VII. PERFRMANCE DATA/NON-CLINICAL TESTING

Design verification and validation testing were performed on the Stryker CrossFlow Integrated Arthroscopy Pump as a result of the risk analysis and product requirements. Testing included software verification testing, bench performance testing as well as design validation. Software verification testing was conducted to ensure the newly added temperature estimation algorithm and resulting mitigating actions performed according to specification. Bench performance testing was conducted to ensure the temperature estimation algorithm meets accuracy specifications and reduces the occurrence of high fluid temperature. Design validation testing was conducted in a simulated-use environment by surgeon and nurse users. Users were successfully able to navigate the updated GUI and use the CrossFlow as intended.

### Software testing

Software testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to be of "moderate" level of concern since a failure or latent flaw in the software could result in minor injury to the patient or user of the device.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are black and the background is white. The word is written in all lowercase letters.

## Mechanical testing

Mechanical functionality testing included the following to ensure the device design meets user needs in the environment of use:

- -Temperature accuracy testing
- Temperature limit testing -
- Simulated-use testing -

## Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Stryker CrossFlow Integrated Arthroscopy Pump and results provided as part of the original 510(k) submission, K123441. The CrossFlow complies with the IEC 60601-1 standard for safety, the IEC 60601-1-2 standard for EMC, and the IEC 60601-2-18 standard for safety of endoscopic equipment.

### Animal Study

No animal testing was conducted to determine the safety and effectiveness of the Stryker CrossFlow Integrated Arthroscopy Pump.

### Clinical Studies

No human clinical testing was conducted to determine the safety and effectiveness of the Stryker CrossFlow Integrated Arthroscopy Pump.

#### VIII. CONCLUSIONS

The technological characteristics and intended use of the Stryker CrossFlow Integrated Arthroscopy Pump remains unchanged and therefore is substantially equivalent to the predicate – the Stryker CrossFlow Integrated Arthroscopy Pump (K123441). The proposed software modification does not raise different questions of safety and effectiveness of CrossFlow. The results of the non-clinical testing conducted supports the safety of the device and demonstrates that CrossFlow performs as intended in the specified use conditions.