(48 days)
973814
Not Found
No
The device description details a purely mechanical system for suction and irrigation control, with no mention of AI, ML, or any computational processing.
No.
The device facilitates surgical procedures by providing suction and irrigation but does not directly treat a disease or condition in a therapeutic manner.
No
The device's intended use is to provide suction and irrigation during laparoscopic procedures, which are therapeutic actions, not diagnostic.
No
The device description explicitly details physical components such as a main body, tubing, a "Y" connector, branch tubes, spikes with guards, clamps, and an adapter, indicating it is a hardware device with mechanical functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide suction and irrigation during laparoscopic surgical procedures. This is a direct intervention on a patient during surgery, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device components (main body, tubing, connectors, spikes, clamps, adapter) are all designed for physical manipulation and fluid management within the surgical field. There is no mention of reagents, test strips, or any components typically associated with in vitro testing.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of analytes, or diagnostic purposes.
In summary, this device is a surgical instrument used for suction and irrigation during laparoscopic procedures, which falls under the category of medical devices used for treatment or intervention, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
This device intends to provide pinpoint suction and irrigation to the surgical site during laparoscopic procedures. It is to be used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, legally-marketed suction source, and a laparoscopic probe.
Product codes
GCJ
Device Description
This device consists of the following parts already connected to each other:
-
Main Body to control suction and irrigation. A pool suction tip may be connected to the body
-
10 ft Twin tubing to allow for suction and irrigation. The blue color tube allows for irrigation and the clean color tube allows for suction.
A "Y" connector connects the blue tube to two branch tubes (clear color, 12" each). Each branch ends with spike with guard, allowing connection to saline bags. Also, each branch includes a clamp intended to avoid back-flow to the disconnected branch. Clamps may not be used if both branches are simultaneously connected.
An adapter at the end of the other clear color tube allows connection to a suction machine.
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)
510k 973814
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
3 2000 FEB
510(k) Summary As Required by 21 section 807.92 ( c )
| 1-Submitter Name: | A & A Medical, Inc. |
|---|---|
| 2-Address: | 9370 Industrial Trace |
| Alpharetta, GA 30004 | |
| 3-Phone: | (770) 343- 8400 |
| 4-Fax: | (770) 343- 8985 |
| 5-Contact Person: | Jihad Mansour |
| 6-Date summary prepared: | December 16th, 1999 |
| 7-Device Trade or Proprietary Name: | Suction Irrigation Trumpet valve set |
| 8-Device Common or usual name: | Suction Irrigation Handpiece |
| 9-Device Classification Name: | Laparoscope, general and plastic surgery |
| 10-Substantial Equivalency is claimed against the following device: |
- Trump-It II and Magnum 250 ڊيم 172 م �
11-Description of the Device:
This device consists of the following parts already connected to each other:
-
Main Body to control suction and irrigation. A pool suction tip may be connected to the body
-
10 ft Twin tubing to allow for suction and irrigation. The blue color tube allows for irrigation and the clean color tube allows for suction.
A "Y" connector connects the blue tube to two branch tubes (clear color, 12" each). Each branch ends with spike with guard, allowing connection to saline bags. Also, each branch includes a clamp intended to avoid back-flow to the disconnected branch. Clamps may not be used if both branches are simultaneously connected.
An adapter at the end of the other clear color tube allows connection to a suction machine.
12-Intended use of the device:
This device intends to provide pinpoint suction and irrigation to the surgical site during laparoscopic procedures. It is to be used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, legally-marketed suction source, and a laparoscopic probe.
13-Safety and Effectiveness of the device:
This device (Suction Irrigation Trumpet valve set) is safe and effective as the other predicate device cited above.
This is better expressed in the tabulated comparison ( Paragraph 14 below )
1
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that Suction Irrigation Trumpet Valve set is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.
| FDA file reference number | 510k 973814 |
|---|---|
| Attachments inside notification submission file | 510k summary as downloaded from www.fda.gov |
| TECHNOLOGICAL | |
| CHARACTERISTICS | Comparison result |
| Indications for use | Equivalent |
| Target population | Equivalent |
| Design | Equivalent |
| Materials | Equivalent |
| Performance | Equivalent |
| Sterility | Similar |
| Biocompatibility | Equivalent |
| Mechanical safety | Equivalent |
| Chemical safety | Equivalent |
| Anatomical sites | Equivalent |
| Human factors | Equivalent |
| Energy used and/or delivered | Equivalent |
| Compatibility with environment and other devices | Equivalent |
| Where used | Equivalent |
| Standards met | Equivalent |
| Electrical safety | Equivalent (not applicable) |
| Thermal safety | Equivalent (not applicable) |
| Radiation safety | Equivalent (not applicable) |
F. 2.)
2
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 depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird symbol in a circular fashion.
Public Health Service
3 2000 FizB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jihad Mansour Quality & Regulatory Manager A&A Medical. Inc. 9370 Industrial Trace Alpharetta, Georgia 30004
Re: K994256
Trade Name: Suction Irrigation Trumpet Valve Set, Model Q65-823 Regulatory Class: II Product Code: GCJ Dated: December 16, 1999 Received: December 17, 1999
Dear Mr. Mansour:
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 requirement, 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 Federal Register. Please note: this response to your premarket notification submission docs 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.
3
Page 2 – Mr. Jihad Mansour
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 Compliance and please contact the Office of Compliance at (31) 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 obtainsd 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,
ill.ell.l/7-
Sar James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page | 06 -
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: SUL-110 J 188164 1100 TRUBILT VALUE SET Indications For Use: PATIENTS ﻟﺮ ﺍ For USE INDICATED DEVICE ાં ર THIS
LAPAROSCOPIC TREATMENT VIA GENERAL ELIGIBLE
SURGICAL PROCEDURES
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ahmed/Liyan
(Division Sign-Off)
Division of General Restorative Devices K 994256 510(k) Number.
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
(Optional Formal 1-2-96)