PNEUMO-MATIC INSUFFLATION NEEDLE

K970788 · Apple Medical Corp. · FHO · Mar 27, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970788
• Device Name: PNEUMO-MATIC INSUFFLATION NEEDLE
• Applicant: Apple Medical Corp.
• Product Code: FHO · Gastroenterology, Urology
• Decision Date: Mar 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

Device Story

Sterile, disposable 14-gauge Veress needle; 120mm or 150mm lengths. Features spring-loaded, round-tipped obturator; proximal handle with visual indicator window for abdominal wall penetration confirmation; slide switch for gas flow control; male luer lock connector. Used by surgeons in clinical/OR settings to establish pneumoperitoneum via CO2 insufflation prior to trocar placement. Visual indicator provides immediate feedback on needle position, aiding safe entry and reducing risk of injury during abdominal access.

Clinical Evidence

Bench testing only. Biocompatibility testing included cytotoxicity, USP systemic toxicity (mouse), USP intracutaneous toxicity (rabbit), and hemolysis. Safety and performance testing included tip pull test, switch operation, spring obturator operation, and needle puncture test.

Technological Characteristics

14-gauge stainless steel needle; spring-loaded obturator mechanism; proximal handle with visual indicator and slide switch; male luer lock connector. Sterile, disposable. Class II device (21 CFR 884.1730).

Indications for Use

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

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

• Dexide, Inc. Pneumo-Needle

Submission Summary (Full Text)

{0}

Apple Medical Corp.
510(k) Premarket Notification
MAR 27 1997
February 20, 1997
Pneumo-Matic Insufflation Needle

# 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Apple Medical Corp. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Apple Medical chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

**Trade Name:** Pneumo-Matic Insufflation Needle

**Owner/Operator:** Apple Medical Corporation
580 Main Street
Bolton, MA 01740
Registration # 1221923

**Manufacturing Site:** GEOTEC
2800 Post Road, Unit #3
Warwick, RI 02886

**Device Generic Name:** Spring-loaded pneumoperitoneum needle

**Classification:** 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:** Dexide, Inc. Pneumo-Needle
Manufactured and Distributed by:
Dexide, Inc.
7509 Flagstone Drive
Fort Worth, TX 76181

## Product Description:

The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a “window” and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a “slide switch” which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.

## Indications for Use:

The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

121

{1}

Apple Medical Corp.
510(k) Premarket Notification
February 20, 1997
Pneumo-Matic Insufflation Needle

## Biocompatibility:

The following biocompatibility tests were performed on the Pneumo-Matic Insufflation Needle:

1. Cytotoxicity Test
2. USP Systemic Toxicity in the Mouse
3. USP Intracutaneous Toxicity Study in the Rabbit
4. Hemolysis Test

## Safety and Performance:

The following safety and performance tests were performed on the Pneumo-Matic Insufflation Needle:

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

## Conclusion:

Based on the indications for use, technological characteristics and performance testing, the Apple Medical Pneumo-Matic Insufflation Needle has been shown to be safe and effective for its intended use.