MAHLER ABDOMINAL WALL ELEVATOR

K960878 · Cook Urological, Inc. · GCJ · Mar 15, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960878
• Device Name: MAHLER ABDOMINAL WALL ELEVATOR
• Applicant: Cook Urological, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Mar 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures. The device is intended to be used after the establishment of a pneumoperitoneum.

Device Story

Stainless steel abdominal wall elevator; used for retraction during low-pressure laparoscopic procedures. Device deployed after pneumoperitoneum establishment to provide surgical access. Operated by surgeons in clinical/OR settings. Provides mechanical elevation of abdominal wall; facilitates visualization and instrument maneuverability. Benefits include reduced intra-abdominal pressure requirements during laparoscopy.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established via material and design comparison to predicate.

Technological Characteristics

Material: Stainless steel. Form factor: Mechanical abdominal wall elevator. Energy source: None (manual). Sterilization: Not specified.

Indications for Use

Indicated for patients undergoing laparoscopic procedures requiring abdominal wall elevation or retraction following pneumoperitoneum establishment.

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

• Mediflex® Bookler® A.W.E.L.™ Abdominal Wall Elevator (K943614)

Submission Summary (Full Text)

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510(k) Premarket Notification
Maher Abdominal Wall Elevator
Cook Urological, Incorporated and COOK OB/GYN®
k960878

## J. 510(k) Summary of Safety and Effectiveness

### Submitted By:

Rick Lykins
Cook Urological, Incorporated and COOK OB/GYN®
1100 West Morgan Street
Spencer, Indiana 47460
[phone]
March 1, 1996

MAR 15 1996

### Device:

**Trade Name:** Maher Abdominal Wall Elevator
**Proposed Classification Name:** Laparoscope, General and Plastic Surgery 79 GCJ

### Predicate Devices:

The Maher Abdominal Wall Elevator is substantially equivalent to predicate abdominal wall elevators in terms of indications for use, design, construction and materials equivalence. Specifically, this device is similar to the Mediflex® Bookler® A.W.E.L.™ Abdominal Wall Elevator (K943614) manufactured by Mediflex, 250 Gibbs Road, Islandia, NY 11722.

### Device Description:

The Maher Abdominal Wall Elevator is used to elevate/retract the abdominal wall for low pressure laparoscopic procedures. The device is intended to be used after the establishment of a pneumoperitoneum. The device is manufactured entirely from stainless steel. Stainless steel is widely used in the medical field and biocompatibility is assured.

### Substantial Equivalence:

This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by Cook Urological, Incorporated and COOK OB/GYN®. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.