(100 days)
4740
No
The document describes a pneumatic pulse lavage device with no mention of AI or ML capabilities.
No
The device is used to debride a surgical site by flushing it with sterile fluids to remove blood and debris. While it assists in cleaning the wound, it does not directly treat or restore the function of an affected body part or system, which is characteristic of a therapeutic device. It's an instrument used during surgery for cleaning, not for therapy in itself.
No
The device is described as a pulse lavage system used for debridement (removing blood and debris from a surgical site), which is a treatment or preparation for treatment, not a diagnostic function.
No
The device description explicitly states it is a "pneumatic instrument" and describes physical components like a "cradle" and "hatch," indicating it is a hardware device.
Based on the provided information, the Tava Surgical Instruments' L31 Series H.V. Pulse Lavage is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for debridement of the surgical site during surgery to remove blood and debris. This is a direct surgical intervention on the patient's body.
- Device Description: The device is a pneumatic instrument that pulsates sterile fluids into the surgical site. This is a physical action performed on the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical instrument used for cleaning and debridement during a surgical procedure, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Tava Surgical Instruments' L31 Series H.V. Pulse Lavage is intended to be utilized in the debridement of the surgical site during trauma cases, hip and knee arthroplasty cases and soft tissue surgery.
Product codes
FOH
Device Description
Tava Surgical Instruments' L31 H.V. Pulse Lavage is an ergonomically designed pneumatic instrument. The hatch of the cradle is raised in order to insert single-use sterile pump sets which isolates the sterile fluids from the instrument. Activation of the instrument causes engagement of the pump set and pulsates the sterile fluids into the surgical site to remove blood and debris.
Similar to the MicroAire® Hi Speed Pulse Lavage 4740, the instrument is powered by compressed, dry air or nitrogen. Activation of the instrument is accomplished by depressing the lever located in the handle of the instrument. Air flow into the instrument causes the rotary motor to drive the pulsating action of the pump.
Pulse Lavage systems currently on the market are used in conjunction with a pump set in order to achieve the necessary pulsation of the sterile fluids. The L31 H.V. Pulse Lavage engages the single-use pump set in a pumping action to introduce sterile fluids to the surgical sight in a pulsation. The pulsation of the sterile fluids brings debridement to the surface and removes it from the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MicroAire® Hi Speed Pulse Lavage 4740
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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510(k) Summary
JUN 20 1997
Global Medical Products, Inc. d/b/a Tava Surgical Instruments 1725 S. Rainbow Blvd., Suite 25 Las Vegas, Nevada 89102 Telephone: 702-228-1193; Fax: 702-228-1197
Contact Person: Tonya Balaban, Quality Assurance/Regulatory Affairs
Trade Name: Tava Surgical Instruments L31 H.V. Pulse Lavage Common Name: Pulse Lavage Classification Name: Lavage, Jet
Tava Surgical Instruments' L31 H.V. Pulse Lavage is substantially equivalent to like devices in commercial distribution. The Tava L31 Pulse Lavage utilizes the same pump set as its predecessor, the L20 Pulse Lavage, with a similar drive mechanism of the MicroAire® Hi Speed Pulse Lavage 4740.
Tava Surgical Instruments' L31 H.V. Pulse Lavage is an ergonomically designed pneumatic instrument. The hatch of the cradle is raised in order to insert single-use sterile pump sets which isolates the sterile fluids from the instrument. Activation of the instrument causes engagement of the pump set and pulsates the sterile fluids into the surgical site to remove blood and debris.
The L31 H.V. Pulse Lavage is utilized in trauma cases, hip and knee replacement surgery and other soft tissue procedures. The pulsation of sterile fluids into the surgical site facilitates removal of blood and debris by moving it to the surface.
Similar to the MicroAire® Hi Speed Pulse Lavage 4740, the instrument is powered by compressed, dry air or nitrogen. Activation of the instrument is accomplished by depressing the lever located in the handle of the instrument. Air flow into the instrument causes the rotary motor to drive the pulsating action of the pump.
Pulse Lavage systems currently on the market are used in conjunction with a pump set in order to achieve the necessary pulsation of the sterile fluids. The L31 H.V. Pulse Lavage engages the single-use pump set in a pumping action to introduce sterile fluids to the surgical sight in a pulsation. The pulsation of the sterile fluids brings debridement to the surface and removes it from the surgical site.
The L31 H.V. Pulse Lavage and similar devices have components that are of similar materials that are well known and extensively used by medical device manufacturers. In addition, the Tava Surgical Instruments L31 H.V. Pulse Lavage utilizes current and recognized technology. Therefore, the L31 H.V. Pulse Lavage is as safe and effective as it equivalent the MicroAire® Hi Speed Pulse Lavage 4740 and does not raise additional questions concerning safety and effectiveness.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird-like figure in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 1997
Ms. Tonya Balaban Quality Assurance/Regulatory Affairs Global Medical Products, Incorporated 1725 South Rainbow Boulevard, #25 Las Vegas, Nevada 89102
Re : K970916 H.V. Pulse Lavage (L31 Series) Trade Name: Requlatory Class: II Product Code: FOH Dated: April 7, 1997 Received: April 11, 1997
Dear Ms. Balaban:
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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.
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Page 2 - Ms. Balaban
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 at (301) 443-6597.
Sincerely yours,
Susan Runnex
Timothy A. Ulatowski Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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K4704/6/51
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Indications for Use of the Tava Surgical Instruments L31 Series H.V. Pulse Lavage
Tava Surgical Instruments' L31 Series H.V. Pulse Lavage is intended to be utilized in the debridement of the surgical site during trauma cases, hip and knee arthroplasty cases and soft tissue surgery.