(115 days)
No
The summary describes a purely mechanical suction-irrigator device with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is a surgical tool used for suction and irrigation during laparoscopic procedures, not for treating a disease or condition itself. Its function is to facilitate the surgical procedure, not to provide therapy.
No
The device description indicates it is a "suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site," which are therapeutic or surgical functionalities, not diagnostic. There is no mention of it being used to diagnose a condition or collect information for diagnosis.
No
The device description clearly states it is a "hand-held trumpet valve suction-irrigator," which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing suction and irrigation during general laparoscopic surgical procedures. This is a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The description details a hand-held surgical instrument for suction and irrigation.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for clinical diagnosis. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Candidate Device is intended for use in the treatment of disease conditions via general laparoscopic surgical procedures. The Candidate Device is indicated for use in patient populations eligible for treatment via general laparoscopic surgical procedures. The device is indicated for use in patients eligible for treatment via general laparoscopic surgical procedures.
Product codes
GCJ
Device Description
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, and legally-marketed suction source, the Candidate Device provides suction and irrigation to the surgical site during general laparoscopic procedures. Provides pinpoint suction and irrigation to the surgical site during laparoscopic procedures by combining a hand-held trumpet valve suctionirrigator and laparoscopic probe. Sterile, disposable. For single use only. The materials from which this device is constructed are proprietary. The Candidate Device consists of a hand-held trumpet valve suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site during general laparoscopic procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, and legallymarketed suction sources.
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)
Not Found
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS VIII. Submitter's Name A.
-
- Address
Valley West, Inc.
- Address
P. O. Box 678
Highway 6 North
Meridian, TX 76665
-
- Phone Number
(254) 435-2306
- Phone Number
-
- Contact Person
C. Kenneth French, President
- Contact Person
- Summary Preparation Date
January 13, 1998
B. Device Name
-
- Trade/Proprietary Name Trump-It II™
and
- Trade/Proprietary Name Trump-It II™
Magnum 250
-
- Common/Usual Name
Trumpet Valve Suction-Irrigation Handpiece
- Common/Usual Name
-
- Classification Name(s)
General and Plastic Surgery Laparoscope and Accessories
- Classification Name(s)
1973814
1
Food and Drug Admin. Center for Devices & Radiological Health (HFZ-401) 01/13/98 Amendment A
C. Predicate Device(s)
:
In terms of safety, effectiveness, and intended use, the Candidate Device is substantially-equivalent to the following legally-marketed device ("Predicate Device"):
| Device Name: | Nezhat-Dorsey Hydro-Dissection
System & Accessories |
|-------------------------------|--------------------------------------------------------|
| Manufacturer: | American Hydro-Surgical Instruments,
Inc. |
| 510(k) Number: | K951086 |
| Substantial Equivalence Date: | 3/16/95 |
D. Device Description
1. Function
When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, and legally-marketed suction source, the Candidate Device provides suction and irrigation to the surgical site during general laparoscopic procedures.
2. Scientific Basis
Provides pinpoint suction and irrigation to the surgical site during laparoscopic procedures by combining a hand-held trumpet valve suctionirrigator and laparoscopic probe.
3. Significant Physical/Performance Characteristics
- a) Design
Sterile, disposable. For single use only.
2
Food and Drug Admin. Center for Devices & Radiological Health (HFZ-401) 01/13/98 Amendment A
-
Materials b)
The materials from which this device is constructed are proprietary. -
Physical Properties c)
Not Applicable.
Intended Use Statement E.
1. Disease/Conditions
The Candidate Device is intended for use in the treatment of disease conditions via general laparoscopic surgical procedures.
2. Patient Population
The Candidate Device is indicated for use in patient populations eligible for treatment via general laparoscopic surgical procedures.
Technological Characteristics Summary F.
The Candidate Device consists of a hand-held trumpet valve suction-irrigator designed to provide pinpoint suction and irrigation to the surgical site during general laparoscopic procedures. This device is designed for use with legally-marketed irrigation pumps, irrigant bags and bottles, and legallymarketed suction sources.
" Trademark of American Surgical Specialties Company
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a simple, minimalist composition consisting of a series of small, dark dots or dashes arranged in a horizontal line across a white background. The dots are spaced irregularly, with varying distances between them. The overall impression is one of sparseness and simplicity, with the dots appearing almost like a faint trail or a series of isolated marks.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. IAN 3 0 1998
Ms. Julie H. Byerly Regulatory Affairs Consultant Valley West, Incorporated C/O Accureg, Incorporated 300 NW 82nd Avenue, Suite 402 Plantation, Florida 33324
Re: K973814
Trade Name: Trump-It II and Magnum 250 Regulatory Class: II Product Code: GCJ Dated: January 13, 1998 Received: January 15, 1998
Dear Ms. Byerly:
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 (OS) 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 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
4
Page 2 - Ms. Byerly
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-freenumber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
J. Collez
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
5
IX. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K973814 Device Name: Trump-It II™ or Magnum 250
Indications for Use:
The device is indicated for use in patients eligible for treatment via general laparoscopic surgical procedures.
""Trademark of American Surgical Specialties Company
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices |
| 510(k) Number | K973814 |
|---|---|
| --------------- | --------- |
| Prescription Use | XX |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)