(63 days)
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.
The Stryker CrossFlow Integrated Arthroscopy Pump (CrossFlow) is a microprocessorcontrolled dual (inflow and outflow) pump system designed to provide liquid distension 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.
The provided document is an FDA 510(k) clearance letter for the Stryker CrossFlow Integrated Arthroscopy Pump, with a focus on a software modification (GUI aesthetic update and addition of a temperature estimation algorithm with an on-screen indicator).
This document does not contain the detailed, quantitative acceptance criteria and study results typically found for AI/ML-driven diagnostic or prognositic devices that require extensive performance data demonstrating accuracy in the context of human interpretation, such as sensitivity, specificity, AUC, or reader studies.
The device discussed here, the Stryker CrossFlow Integrated Arthroscopy Pump, is a medical device with a software component, not primarily an AI/ML-driven diagnostic/prognostic algorithm. The software modification is focused on estimating in-joint temperature and implementing mitigating actions to reduce high temperatures, and a GUI aesthetic update. The performance testing is engineering-centric, verifying that the temperature estimation algorithm meets accuracy specifications and reduces the occurrence of high fluid temperature.
Therefore, a significant portion of the requested information regarding AI/ML study specifics (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training ground truth establishment) is not applicable or not present in this type of 510(k) submission for this specific device.
However, I can extract and infer information based on the document related to the software modification's performance data:
Acceptance Criteria and Device Performance for Stryker CrossFlow Integrated Arthroscopy Pump (Software Modification)
Given the nature of the device as an arthroscopic pump with a new temperature estimation algorithm, the "acceptance criteria" discussed are largely functional and performance-based for the new software feature, rather than diagnostic accuracy metrics common for AI/ML image analysis.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Software Testing" and "Mechanical Testing") | Reported Device Performance (Inferred from "Software Testing" and "Bench Performance Testing" sections) |
|---|---|
| Temperature estimation algorithm performs according to specification. | Software verification testing confirmed the algorithm and resulting mitigating actions performed according to specification. |
| Temperature estimation algorithm meets accuracy specifications. | Bench performance testing confirmed the temperature estimation algorithm meets accuracy specifications. |
| Algorithm reduces the occurrence of high fluid temperature. | Bench performance testing confirmed the algorithm reduces the occurrence of high fluid temperature. |
| Updated GUI allows users to successfully navigate and use the device as intended. | Design validation testing in a simulated-use environment showed surgeon and nurse users were successfully able to navigate the updated GUI and use the CrossFlow as intended. |
2. Sample size used for the test set and data provenance:
- Sample Size: Not explicitly stated as a number of "cases" or "patients" in the context of an algorithm evaluation study. Performance testing involved "software verification testing" and "bench performance testing," and "design validation testing" in a "simulated-use environment." The sample size refers to the number of tests performed or configurations evaluated, not a patient cohort. No specific numbers are provided beyond that these tests were conducted.
- Data Provenance: Not applicable. This is not a study derived from patient data in the sense of image analysis. The "data" tested are simulated or real-time measurements within the pump system during bench and simulated-use testing. It is implicitly prospective testing done in a lab/simulated environment. No country of origin for data is relevant as it's not a clinical data set.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of Experts: Not explicitly stated for generating "ground truth" as it would be for diagnostic imaging. For "Design validation testing," it states it was conducted by "surgeon and nurse users." This implies clinical experts.
- Qualifications: "Surgeon and nurse users." No specific years of experience or board certifications are mentioned. Their role was to assess usability of the GUI and intended use, not to establish data-driven ground truth for temperature estimation. For the temperature estimation accuracy, the ground truth is likely established by precise measurement instruments in a lab setting, not human experts.
4. Adjudication method for the test set:
- Method: Not applicable. This is not a study requiring adjudication of human expert interpretations. The validation of the temperature algorithm would rely on objective physical measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Done?: No. This type of study (comparative effectiveness of human readers with/without AI assistance) is not applicable to an arthroscopic pump's temperature estimation algorithm and GUI update.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Done?: Yes, to a degree. The "Software verification testing" and "Bench performance testing" of the "temperature estimation algorithm" are effectively standalone performance tests, ensuring the algorithm itself calculates and acts on temperature data correctly, independently of user interaction beyond setting parameters. The results state it "performed according to specification" and "meets accuracy specifications."
7. The type of ground truth used:
- Type:
- For the temperature estimation algorithm: Objective measurements from calibrated physical sensors during bench testing.
- For the GUI user experience: User feedback/success criteria from "surgeon and nurse users" in a "simulated-use environment."
8. The sample size for the training set:
- Sample Size: Not applicable/not disclosed. This is a software modification (algorithm update + GUI change) to an existing device, not an AI/ML system that undergoes traditional training on large datasets in the way a diagnostic image analysis algorithm would. The algorithm's parameters and logic would be developed and refined using engineering principles and calibration data, not a "training set" in the common AI/ML sense.
9. How the ground truth for the training set was established:
- Method: Not applicable. Given the nature of the device's software update, there isn't a "training set" with established "ground truth" in the manner of AI/ML diagnostic tools. The development of the temperature estimation algorithm would involve engineering design, thermodynamic modeling, and empirical calibration using temperature sensors, not a ground truth derived from clinical experts on a patient dataset.
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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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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.
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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 IntegratedArthroscopy Pump | Stryker CrossFlow IntegratedArthroscopy Pump (K123441) | |
| IntendedUse/Indications for UseStatement | Same as predicate device. | The Stryker CrossFlow IntegratedArthroscopy Pump is a dualarthroscopic pump system intended toprovide fluid distension and irrigationof the knee, shoulder, hip, elbow, ankleand wrist joint cavities and fluidsuction during diagnostic and operativearthroscopic procedures. |
| Contraindications | Same as predicate device. | The use of the Stryker CrossFlowIntegrated Arthroscopy Pump isprohibited whenever arthroscopy iscontraindicated. |
| 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 softwareand microelectronics that executecontrol algorithms that ensure the setpressure is being achieved within thepatient's joint. |
| Roller Wheel | Same as predicate device. | The device has internally-mountedroller wheels that interface withcassettes that are part of thedisposable, single-use tube sets. |
| EMC/Electrical | Same as predicate device. | IEC 60601-1-2IEC 60601-1IEC 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.
§ 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.