INSUFFLATION NEEDLE- 120MM, MODEL 900-200

K993625 · Genicon, LC · HIF · Jun 20, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993625
• Device Name: INSUFFLATION NEEDLE- 120MM, MODEL 900-200
• Applicant: Genicon, LC
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jun 20, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The GeniCon Pnuemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

Device Story

GeniCon Pneumo-Needle is a sterile, disposable 120mm Veress needle used in laparoscopic surgery. Device features spring-loaded, round-tipped obturator for safety during insertion; integrated slide switch for gas flow control; proximal male luer lock connector for CO2 line attachment. Operated by surgeons in clinical settings to establish pneumoperitoneum. Device facilitates safe peritoneal access, allowing subsequent trocar placement. Performance verified via tip pull, switch operation, spring obturator function, and needle puncture force testing.

Clinical Evidence

Bench testing only. Performance testing included tip pull test, switch operation, spring obturator operation, and needle puncture force test.

Technological Characteristics

Sterile, disposable 120mm Veress needle. Features spring-loaded, round-tipped obturator, slide switch for gas flow control, and male luer lock connector. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients undergoing laparoscopic procedures requiring percutaneous insertion into the peritoneal cavity for carbon dioxide insufflation to establish pneumoperitoneum prior to trocar placement.

Regulatory Classification

Identification

A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Predicate Devices

• Apple Medical's Pneumo-Matic Insufflation Needle

Submission Summary (Full Text)

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JUN 2 0 2000

Section II. 510(k) Summary

Page: II-1

GeniCon L.C. Contact: Gary Haberland 573 Waterscape Way Orlando, FL 32828 Phone: [phone] Fax: [phone]

Date Prepared: October 19, 1999

Trade Name: GeniCon Pneumo-Needle Common Name: Veress Needle Classification Name: According to Section 513 of the Federal Food, Drug and Cosmetic Act, the device classification is Class II, Performance Standards (21 CFR 884.1730).

| Predicate Device: | Apple Medical's Pneumo-Matic Insufflation Needle |
|-------------------|--------------------------------------------------|
| | 580 Main Street |
| | Bolton, MA 01740 |

## Product Description:

The GeniCon, Pneumo-Needle is a sterile, disposable Veress needle which is available in 120mm length. The device is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a malue luer lock connector for secure CO2 gas line connection.

### Indications for Use:

The GeniCon Pnuemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

### Performance:

A series performance tests were performed on the GeniCon Pneumo-Needle to inspect such areas as:

- Tip Pull Test 1.
- 2. Switch Operation
- Spring Obturator Operation 3.
- 4. Needle Puncture Force Test

## Conclusion:

Based on the indications for use, technological characteristics and performance testing, the GeniCon Pneumo-Needle has been shown to be effective for its intended use and substantially equivalent to the predicate device.

Image /page/0/Picture/20 description: The image shows the logo for GeniCon, a company that provides new ideas for modern health care. The logo features the company name in a bold, sans-serif font, with the "C" in "Con" replaced by a circle with two surgical instruments inside. Below the logo is the tagline "New Ideas for Modern Health Care" in a smaller, serif font. The logo is simple and professional, and it conveys the company's focus on innovation and healthcare.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 2 0 2000

Mr. Gary Haberland Product Manager GeniCon L.C. 573 Waterscape Way Orlando, FL 32828

Dear Mr. Haberland:

Re: K993625 GeniCon Pneumo-Needle Dated: March 31, 2000 Received: April 3, 2000 Regulatory Class: II 21 CFR §884.1730/Procode: 85 HIF

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 legally marketed predicate 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 Cosmelic 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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, Tille 21, Parts 800 to 895. A substantially equivation assumes compliance with the Ourrent 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 vour device in the Federal Register. Please note: this response to your premarket not ification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 predication for your device and thus, permits your device to proceed to the market.

If you desre specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnosic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html"

Sincerely yours,

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Section I. Indications for Use

K993625 510 (k) Number: unassigned neumo - Needle Device Name:

Indications for Use:

The GeniCon Pnutemo - Needle is intended for percutaneous insertion into the peritoneal cavity for the purspose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

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Prescription Use
✓

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

David A. Nyarron

(Division Sign-Off)

(Division of Reproductive, Abdominal, ENT) and Radiological Devices 510(k) Number

Image /page/2/Picture/11 description: The image shows the logo for GeniCon, a company that provides new ideas for modern healthcare. The logo features the company name in a bold, sans-serif font, with a stylized image of surgical instruments forming the "C" in "Con". Below the company name is the tagline "New Ideas for Modern Health Care".

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