(90 days)
No
The summary describes a suction/irrigation pump and its modifications, focusing on hardware and function. There is no mention of AI, ML, image processing, or data-driven decision making.
No.
The device is described as a general-purpose suction and/or irrigation device used during surgical procedures, not for treating a disease or condition itself.
No
Explanation: The device description states its intended use is for suction, irrigation, and as a conduit for accessory instrumentation during surgery, not for diagnosing medical conditions.
No
The device description explicitly mentions hardware components such as a re-usable pump console, motor, and single-use tube set, indicating it is not software-only.
Based on the provided information, the Stryker Cassette Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes the device as a general purpose suction and/or irrigation device for use in various surgical procedures. This involves direct interaction with the patient's body during surgery, not the examination of specimens taken from the body.
- Device Description: The description focuses on the mechanical function of the pump and tube set for suction and irrigation.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Stryker Cassette Pump's function is to assist in surgical procedures through suction and irrigation, which is a different category of medical device.
N/A
Intended Use / 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.
Product codes
GCX, HET, KQT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Laboratory and performance testing demonstrate that the characteristics of the Stryker Cassette Pump are equivalent in Safety and Effectiveness to the referenced predicate devices.
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
§ 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.
0
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 and | |
| Accessories, 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.
1
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.
2
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
3
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 |
Page 1 of 1