(62 days)
Not Found
No
The description mentions a "constantly-performed pressure sensing algorithm," which is a deterministic control algorithm, not indicative of AI/ML. There are no mentions of AI, ML, deep learning, training data, or performance metrics typically associated with AI/ML models.
No
The device is used to distend, irrigate, and aspirate fluid during arthroscopic procedures, which are diagnostic and operative, but it does not directly treat a disease or condition itself.
No
Explanation: The device description clearly states its purpose is to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures. While it's used during diagnostic procedures, the device itself does not perform any diagnostic analysis or produce diagnostic information. It's a tool that facilitates the visualization and manipulation of the joint during such 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, indicating it is a physical device with integrated software, not a software-only device.
Based on the provided information, the Stryker CrossFlow Integrated Arthroscopy Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing fluid distension, irrigation, and suction within joint cavities during diagnostic and operative arthroscopic procedures. This involves direct interaction with the patient's body during a surgical procedure.
- Device Description: The description details a pump system designed to manage fluids within the joint cavity. It describes components like peristaltic pumps, pinch valves, and pressure sensing, all related to controlling fluid flow during surgery.
- Lack of IVD Characteristics: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. The Stryker CrossFlow pump does not perform any such tests on samples. It is a surgical tool used during a procedure.
In summary, the Stryker CrossFlow Integrated Arthroscopy Pump is a surgical device used for fluid management during arthroscopic procedures, not a device for performing diagnostic tests on in vitro samples.
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
HRX
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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
1
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
2
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.
જુન
p.
2
Stryker CrossFlow Integrated Arthroscopy Pump 510(k) Submission
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
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
4
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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5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521 www.stryker.com
Image /page/5/Picture/1 description: The image contains the word "stryker" in bold, black font. The letters are closely spaced together, and the word appears to be a logo or brand name. There is a small circle or dot above and to the right of the letter 'r'.
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