(56 days)
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No
The description focuses on mechanical and fluid dynamics for wound cleansing and debridement, with no mention of AI or ML capabilities.
No
The device is intended for wound debridement and cleansing, which are procedures to remove damaged tissue or foreign matter, not directly to treat a disease, injury or condition.
No
The device is used for debridement and cleansing of wounds/sites, not for diagnosing medical conditions.
No
The device description explicitly details physical components like a handpiece, tubing, tips, and splash shields, and mentions battery operation, indicating it is a hardware device.
Based on the provided information, the Stryker InterPulse Lavage System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for wound debridement, soft tissue debridement, and cleansing of surgical or medical/clinical sites. This involves direct interaction with the patient's body and tissues for therapeutic and cleansing purposes.
- Device Description: The device is a physical system for delivering irrigation and suction. It does not involve the examination of specimens (like blood, urine, or tissue samples) outside of the body to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Stryker InterPulse Lavage System's function is entirely focused on physical cleansing and debridement of wounds and surgical sites.
N/A
Intended Use / Indications for Use
The Stryker InterPulse Lavage System is intended for wound debridement, soft tissue I he birgher meets and cleansing of a medical, clinical, or surgical site. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin on burn wounds, and cleansing wounds incurred from trauma.
Product codes
FQH
Device Description
The Stryker InterPulse System is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields.
The Stryker InterPulse Handpiece is operated by batteries which are either located and sealed within the handpiece housing or in an external battery pack. The flow of irrigation is variable between approximately 100ml/min and 1500ml/min depending on which irrigation tip is attached to the handpiece as well as the amount of displacement of the handpiece trigger.
The InterPulse system includes an assortment of tips which provide a variation in irrigant flow rate and irrigation flow pattern. Tips that are indicated for wound and soft tissue debridement do not exceed a pressure of 15 psi at the wound site. A Protective Plug allows the user to reuse the InterPulse handpiece on the same patient for subsequent hydrodebridement of chronic wounds. A lighted irrigation tip provides illumination of the irrigating site. This tip has a bulb that is illuminated by batteries located within the tip.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(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.
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Stryker
INSTRUMENTS
mazoo MI 4 6) 323-7700 (800) 253-3210
JUL 29 1997
Device Name:
Regulatory Class:
| Classification Name: | Jet Lavage: 21CFR 880.5475, Class II |
|---|---|
| Common/Usual Name: | Pulsed Lavage |
| Proprietary Name: | Stryker InterPulse Lavage System |
| Device Sponsor: | Stryker Corporation |
| Instruments Division | |
| 4100 E. Milham | |
| Kalamazoo, MI 49001 | |
| Registration No: 1811755 |
Class II
Summary of Safety and Effectiveness:
The Stryker InterPulse Lavage System is a pulsed lavage system intended for wound debridement, soft tissue debridement, and cleansing of the surgical or medical/clinical site.
The Stryker InterPulse System is a single patient use, sterile, disposable, pulsed lavage device. The system consists of an irrigation handpiece, irrigation tubing, irrigation tips, suction tips, suction tubing, and splash shields.
The Stryker InterPulse Handpiece is operated by batteries which are either located and sealed within the handpiece housing or in an external battery pack. The flow of irrigation is variable between approximately 100ml/min and 1500ml/min depending on which irrigation tip is attached to the handpiece as well as the amount of displacement of the handpiece trigger.
The InterPulse system includes an assortment of tips which provide a variation in irrigant flow rate and irrigation flow pattern. Tips that are indicated for wound and soft
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tissue debridement do not exceed a pressure of 15 psi at the wound site. A Protective Plug allows the user to reuse the InterPulse handpiece on the same patient for subsequent hydrodebridement of chronic wounds. A lighted irrigation tip provides illumination of the irrigating site. This tip has a bulb that is illuminated by batteries located within the tip.
The Stryker InterPulse Lavage System is equivalent to existing marketed products by companies such as Davol and Davis+Geck. Power modality, intended use, and safety risks are all substantially equivalent.
The Stryker InterPulse System does not raise any new safety and efficacy concerns when compared to similar legally marketed devices.
Therefore, the Stryker InterPulse System is substantially equivalent to these existing devices.
Tammy Lounds Associate Manager, Regulatory Affairs Stryker Instruments
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tammy Lounds Associate Manager, Regulatory Affairs Stryker® Instruments …………………… 4100 East Milham Avenue Kalamazoo, Michigan 49001-6197
JUL 2 9 1997
K972069 Re: Trade Name: Stryker InterPulse System Regulatory Class: II Product Code: FQH Dated: May 29, 1997 Received: June 3, 1997
Dear Ms. Lounds:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the
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Page 2 - Ms. Tammy Lounds
Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. .
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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|--|--|
K972069 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: InterPulse System
Indications For Use:
The Stryker InterPulse Lavage System is intended for wound debridement, soft tissue I he birgher meets and cleansing of a medical, clinical, or surgical site. This includes cleansing of bone in surgical procedures, hydrodebridement of chronic wounds, debridement of loose skin on burn wounds, and cleansing wounds incurred from trauma
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The- Counter Use _ Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)