(63 days)
No reference devices were used in this submission.
No
The document describes a microprocessor-controlled pump system with a pressure sensing algorithm and a temperature estimation algorithm. While these involve algorithms, there is no mention of AI, ML, or any learning capabilities. The algorithms described appear to be deterministic and based on pre-defined logic rather than learned patterns.
Yes
The device is intended to provide fluid distension and irrigation of joint cavities and fluid suction during diagnostic and operative arthroscopic procedures, which are medical treatments or procedures, qualifying it as a therapeutic device.
Yes
The Intended Use / Indications for Use section states that the device is intended for "fluid suction during diagnostic and operative arthroscopic procedures."
No
The device description explicitly lists hardware components such as a console housing, power supply, peristaltic pumps, pinch valves, and a touch-screen display panel. The software modification is an update to the GUI and the addition of an algorithm, but it operates within a hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures." This describes a device used during a surgical procedure to manage fluids within a joint.
- Device Description: The description details a pump system that controls fluid flow and pressure within a joint cavity. It does not mention any analysis of biological samples (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform such analysis.
The device is an arthroscopic pump, which is a surgical instrument used to facilitate arthroscopic procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, elbow, ankle and wrist joint cavities
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)
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 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.
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 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.
No animal testing was conducted. No human clinical testing was conducted.
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.
No reference devices were used in this submission.
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.
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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.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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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: 408-620-8312 Email: justin.florence@stryker.com
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.
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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 | ||
| Arthroscopy Pump | Stryker CrossFlow Integrated | |
| Arthroscopy Pump (K123441) | ||
| Intended | ||
| Use/Indications for Use | ||
| Statement | Same as predicate device. | 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. | ||
| Contraindications | Same as predicate device. | The use of the Stryker CrossFlow |
| Integrated Arthroscopy Pump is | ||
| prohibited whenever arthroscopy is | ||
| 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 |
| and microelectronics that execute | ||
| control algorithms that ensure the set | ||
| pressure is being achieved within the | ||
| patient's joint. | ||
| Roller Wheel | Same as predicate device. | The device has internally-mounted |
| roller wheels that interface with | ||
| cassettes that are part of the | ||
| disposable, single-use tube sets. | ||
| EMC/Electrical | Same as predicate device. | IEC 60601-1-2 |
| IEC 60601-1 | ||
| IEC 60601-2-18 |
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| Design | Same as predicate device. | Pump consists of the following main components:
- console housing
- power supply
- two peristaltic pumps
- three pinch valves
- 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. |
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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.
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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.