(90 days)
The Stryker Cassette Pump is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. This device provides sterile irrigant solution, serves as a conduit for suction, and functions as a cannula for accessory instrumentation, including electrosurgical devices.
The Stryker Cassette Pump is a modification of the currently marketed Stryker Strykeflow Suction Irrigator in that the batteries are rechargeable and relocated with the motor to a re-usable pump console. The single use tube set is equivalent to the Stryker Strykeflow Suction Irrigator.
The provided text is a 510(k) summary for the Stryker Cassette Pump, demonstrating its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance results. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
However, I can provide what is stated and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | Conforms to voluntary safety standards (IEC 60601-1, IEC 60601-1-1, etc.) |
| Effectiveness | Equivalent to predicate devices (Stryker Strykeflow K954726, Davol® X-Stream" K003790) |
| Conformity to relevant voluntary safety and performance standards | Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60529, ISO 10993, ANSI/AAMIHF-18 2003 |
Missing: Specific quantitative acceptance criteria (e.g., maximum flow rate, minimum suction pressure, battery life, seal integrity) and the exact measured performance values for the Stryker Cassette Pump are not detailed. The document only states that "Laboratory and performance testing demonstrate that the characteristics of the Stryker Cassette Pump are equivalent in Safety and Effectiveness to the referenced predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
Missing: The document does not specify any sample sizes for a "test set" in the context of device performance. The entire submission is about demonstrating substantial equivalence, not a standalone clinical or experimental study with a defined test set. Data provenance (country of origin, retrospective/prospective) is not applicable here as it's a device submission, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Missing: As there is no "test set" and ground truth in the context of an AI/human performance study, this information is not applicable. The assessment here is based on engineering and performance testing against established standards and predicate devices.
4. Adjudication Method for the Test Set:
Missing: Not applicable for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Missing: No MRMC study was done or mentioned. This is a medical device approval document, not related to AI comparative effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Missing: This is not applicable as the device is a physical pump, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to the established safety and performance characteristics of the predicate devices and the compliance with recognized voluntary standards.
- Established Predicate Device Performance: The functional specifications, safety profiles, and clinical indications of the Strykeflow Suction Irrigator (K954726) and Davol® X-Stream" Laparoscopic Irrigation System (K003790) serve as benchmarks.
- Voluntary Safety and Performance Standards: The device's adherence to standards such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60529, ISO 10993, and ANSI/AAMIHF-18 2003 forms the basis of its "ground truth" for safety and general performance.
8. The Sample Size for the Training Set:
Missing: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Missing: Not applicable.
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DEC = 9 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
| Proprietary Name: | Stryker Cassette Pump |
|---|---|
| Common and Usual Name: | Suction Irrigator |
| Classification Name: | Vacuum-powered Body Fluid Suction Apparatus,Irrigation Device, Gynecologic Laparoscope andAccessories, Powered Nasal Irrigator,Gastroenteroloy-urology evacuator |
The Stryker Cassette Pump is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the Strykeflow Suction Irrigator (K954726) and the Davol® X-Stream" Laparoscopic Irrigation System (K003790).
The Stryker Cassette Pump is a modification of the currently marketed Stryker Strykeflow Suction Irrigator in that the batteries are rechargeable and relocated with the motor to a re-usable pump console. The single use tube set is equivalent to the Stryker Strykeflow Suction Irrigator.
The Stryker Cassette Pump is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. This device provides sterile irrigant solution, serves as a conduit for suction, and functions as a cannula for accessory instrumentation, including electrosurgical devices.
The Stryker Cassette Pump will conform to the following voluntary safety and performance standards including: IEC 60601-1 Medical Electrical Equipment General Requirements for Safety, IEC 60601-1-1 Collateral Standard: Medical Electrical Systems, IEC 60601-1-2 Collateral Standard: Electromagnetic Compatibility, IEC 60601-1-4 Collateral Standard: Programmable Electrical Medical, IEC 60529 Degrees of Protection Provided by Enclosure, and ISO 10993 Biological Evaluation of Medical Devices, ANSI/AAMIHF-18 2003 Electrosurgical Devices.
Laboratory and performance testing demonstrate that the characteristics of the Stryker Cassette Pump are equivalent in Safety and Effectiveness to the referenced predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Mr. Christopher L. Cook Regulatory Supervisor Stryker Endoscopy 5900 Optical Court San Jose, California 95138
Re: K042454
Trade/Device Name: Stryker Cassette Pump Regulation Number: 21 CFR 880.6740 Regulation Name: Vacuum-powered body fluid suction apparatus Regulatory Class: II Product Code: GCX, HET, KQT Dated: September 9, 2004 Received: September 10, 2004
Dear Mr. Cook:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please in you deems specific an earning at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Stryker Cassette Pump
Indications For Use:
The Stryker Cassette Pump is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. This device provides sterile irrigant solution, serves as a conduit for suction, and functions as a cannula for accessory instrumentation, including electrosurgical devices.
メ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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)
| (Division Sign-Off) | for emw |
|---|---|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K042454 |
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§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.