SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823

K994256 · A & A Medical, Inc. · GCJ · Feb 3, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994256
• Device Name: SUCTION IRRIGATION TRUMPET VALVE SET, MODEL Q65-823
• Applicant: A & A Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 3, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Device consists of a main body with a trumpet valve to control suction and irrigation, connected to twin tubing (irrigation and suction lines). A Y-connector with clamps allows connection to two saline bags for irrigation; an adapter connects the suction line to a suction machine. A pool suction tip may be attached to the main body. Used in laparoscopic surgery by surgeons to provide pinpoint suction and irrigation at the surgical site. Operates by manual control of the trumpet valve to manage fluid delivery and aspiration. Benefits include improved visualization and site management during minimally invasive procedures.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and performance comparisons to legally marketed predicate devices.

Technological Characteristics

Manual trumpet valve handpiece; twin tubing for suction and irrigation; Y-connector with clamps for dual saline bag connection; suction machine adapter. Materials and design are equivalent to predicate devices. Non-powered, mechanical device.

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring suction and irrigation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Trump-It II (K973814)
• Magnum 250 (K973814)

Submission Summary (Full Text)

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K994256

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<br>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 )

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## 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<br>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.)

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#### 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.

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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 [phone]. 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 [phone] or [phone] 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

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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)