(62 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 is a microprocessor-controlled 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 Stryker CrossFlow Integrated Arthroscopy Pump is a medical device, and the provided 510(k) summary focuses on demonstrating its substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove its performance in the same way one would for a diagnostic AI device.
Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are generally not applicable or not explicitly provided in the context of this 510(k) submission for a physical pump system.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics in the provided document. Instead, the "acceptance criteria" are related to conformance with design specifications and voluntary external standards.
- Reported Device Performance: The document states that "bench performance testing performed on the Stryker CrossFlow Integrated Arthroscopy Pump verifies that the device satisfies design specifications and their acceptance criteria." However, specific numerical performance results (e.g., flow rates, pressure accuracy, ranges) are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Provided. This type of information is typically for studies involving clinical data or imaging for AI/diagnostic devices. The testing mentioned in the document is bench testing of the physical pump system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. Ground truth established by experts is relevant for diagnostic or AI systems. For a physical pump, "ground truth" would relate to engineering specifications and measurements.
4. Adjudication method for the test set
- Not Applicable/Not Provided. Adjudication methods are used in clinical studies, particularly for interpreting ambiguous cases or establishing ground truth from multiple expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable/Not Provided. This is a type of study specifically for AI-assisted diagnostic or interpretative tasks. The Stryker CrossFlow is a surgical pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. This is relevant for AI algorithms. The "algorithm" in this device controls the pump's mechanical function, and its performance is assessed as part of the overall device's bench testing.
7. The type of ground truth used
- Not Applicable/Not Provided (in the AI/clinical sense). For this device, the "ground truth" for performance would be objective measurements against engineering specifications and validated test methods (e.g., pressure sensors, flow meters).
8. The sample size for the training set
- Not Applicable/Not Provided. This applies to AI/machine learning models.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. This applies to AI/machine learning models.
Summary of relevant information from the document related to "acceptance criteria" and "study":
The document highlights the following performance testing:
-
Bench Performance Testing: "Bench performance testing performed on the Stryker CrossFlow Integrated Arthroscopy Pump verifies that the device satisfies design specifications and their acceptance criteria."
- Nature of "Acceptance Criteria": These relate to the device's adherence to its design specifications (e.g., maintaining set pressure, achieving specified flow rates, proper functioning of peristaltic pumps, pinch valves, software controls, etc.). Specific numerical values for these criteria are not disclosed in this summary.
- Nature of "Study/Testing": This refers to internal bench testing. Details about the methodology, exact test protocols, or raw data are not provided in this 510(k) summary. These would reside in the full 510(k) submission.
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Conformance to Voluntary External Standards:
- Biocompatibility: Verified per ISO 10993-1:2009/Cor 1:2010 for patient contacting materials.
- Software: Developed, tested, and verified per FDA guidance documents and IEC 62304:2006.
- Electrical Safety: Tested to IEC 60601-1:1988/A1:1991/A2:1995.
- Electromagnetic Compatibility: Verified by testing to IEC 60601-1-2:2007.
Conclusion stated by Stryker:
"The submitted information in this premarket notification is complete, and based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the Stryker CrossFlow Integrated Arthroscopy Pump raises no new questions of safety and effectiveness. The proposed device is substantially equivalent to the predicate device."
In essence, for this specific device and document, the "study" is the described bench performance testing and conformance to recognized standards, and the "acceptance criteria" are the device's internal design specifications and requirements of those standards. This is typical for a premarket notification (510(k)) for a device like an arthroscopic pump, which is demonstrating substantial equivalence to a predicate device based on similar technology and performance. It does not involve the elaborate clinical validation studies, expert ground truth establishment, or AI-specific metrics you've outlined, which are more common for diagnostic software or AI devices.
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5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521 www.stryker.com
tryker®
Endoscopy
510(k) SUMMARY, PER 21 CFR 807.92
JAN 0 9 2013
510(k) Owner/Sponsor: Address:
Establishment Number: Telephone Number: Contact Person: Email Address:
Proposed Device:
Common/Usual Name: Product Code: FDA Regulation Number: Device Classification:
Predicate Device:
Common/Usual Name: Product Code: FDA Regulation Number: Device Classification: Premarket Notification:
Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 2936485 (408) 754-2701 Kevin Potgieter, RAC; Senior Regulatory Affairs Analyst kevin.potgieter@stryker.com
Stryker CrossFlow Integrated Arthroscopy Pump Arthroscopic Pump, Tubing Sets and Accessories HRX 21 CFR 888.1100 - Arthroscope and accessories Class II
World of Medicine Arthroscopy Pump A107 Arthroscopic Pump, Tubing Sets and Accessories HRX 21 CFR 888.1100 - Arthroscope and accessories Class II K030402
Device Description
The Stryker CrossFlow Integrated Arthroscopy Pump is a microprocessor-controlled 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.
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,
Stryker CrossFlow Integrated Arthroscopy Pump 510(k) Submission
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5900 Ontical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 252 1 www.stryker.com
Endoscopy
ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.
Technological Comparison
The Stryker CrossFlow Integrated Arthroscopy Pump employs the same technological characteristics as the predicate device. Both devices operate on the peristaltic principle where roller wheels are spun against soft tubing, thus creating flow of fluid within the tubing. One roller wheel controls the inflow (irrigation) side of the pump and the other roller wheel controls the outflow (aspiration) side. Both pumps are controlled by software and microelectronics that execute control algorithms that ensure that the set pressure is being achieved within the patient's joint.
The Stryker CrossFlow Integrated Arthroscopy Pump and the WOM A107 employ different designs in terms of how the tube sets interface with the roller wheels of the pump. The proposed Stryker design utilizes internally-mounted roller wheels that interface with cassettes that are part of the disposable, single-use tube sets. The predicate device uses externally-mounted roller wheels.
The device described in this notification is similar in design and technical characteristics to the predicate device. The differences between the Stryker CrossFlow Integrated Arthroscopy Pump and the WOM A107 Arthroscopy Pump are minor and raise no new questions of safety and effectiveness. Stryker believes that the Stryker CrossFlow Integrated Arthroscopy Pump is substantially equivalent to the predicate device currently on the market.
Performance Testing
The Stryker CrossFlow Integrated Arthroscopy Pump's performance was tested in accordance with design specifications and with voluntary external standards. FDA has not established Recognized Consensus Standards for product code HRX. However the CrossFlow system is designed to conform to the following voluntary safety and performance standards. Biocompatibility was verified per ISO 10993-1:2009/Cor 1:2010 for patient contacting materials. Software was developed, tested, and verified per FDA guidance documents as well as IEC 62304:2006. Electrical Safety is being tested to IEC 60601-1:1988/A1:1991/A2:1995. Electromagnetic Compatibility is verified by testing to and IEC 60601-1-2:2007.
In addition to the above, bench performance testing performed on the Stryker CrossFlow Integrated Arthroscopy Pump verifies that the device satisfies design specifications and their acceptance criteria.
2013
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K12344
5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521 www.stryker.com
stryker®
Conclusion
Endoscopy
The submitted information in this premarket notification is complete, and based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the Stryker CrossFlow Integrated Arthroscopy Pump raises no new questions of safety and effectiveness. The proposed device is substantially equivalent to the predicate device.
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Stryker CrossFlow Integrated Arthroscopy Pump 510(k) Submission
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: January 9, 2013
Stryker, Endosopy % Underwriters Laboratories, Incorporated Mr. Jeff Rongero Senior Project Engineer 12 Laboratory Drive Research Triangle, North Carolina 27709
Re: K123441
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: December 21, 2012 Received: December 31, 2012
Dear Mr. Rongero:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jeff Rongero
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801); please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Endoscopy
Device Name: Stryker CrossFlow Integrated Arthroscopy Pump
510(k) Number if known:
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.
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Krishna Asundi, PhD Division of Orthopedic Devices
Stryker CrossFlow Integrated Arthroscopy Pump 510(k) Submission
§ 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.