RIGID FIBER OPTIC LAPAROSCOPE

K962246 · Health Care International Assoc. · HET · Feb 7, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K962246
• Device Name: RIGID FIBER OPTIC LAPAROSCOPE
• Applicant: Health Care International Assoc.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Feb 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Saber’s Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

Device Story

Rigid fiber optic laparoscope; small diameter endoscope; stainless steel jacket; fiber optic imaging and illumination fibers. Light source transmits light via detachable cable to target; distal lens focuses image onto fiber bundle; image transmitted to proximal eyepiece for direct viewing or connection to video system via standard coupler. Used in clinical settings by physicians for abdominal/gynecologic procedures. Enables minimally invasive visualization of peritoneal organs; facilitates diagnostic and surgical interventions.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Stainless steel jacket; fiber optic imaging and illumination bundles; optical eyepiece; standard endoscopic video coupler interface. Reusable; sterilizable. Rigid form factor.

Indications for Use

Indicated for patients requiring diagnostic or surgical procedures within the peritoneal cavity via direct visualization.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• MicroLap™ Laparoscope (K944079)
• Mini Laparoscope for General Surgery (K950278)
• OptiMIS® Series 300 Rigid Fiber Optic Laparoscopes (K921883, K926597)

Submission Summary (Full Text)

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FEB - 7 1997
K962246
P192

# 510(k) Summary: #K962246

1) **Submitter:** Saber Endoscopy, L.L.C.
6191 Atlantic Blvd., Suite 5
Norcross, GA 30071

**Contact:** Dr. Ronald J. Ehmsen
[phone]

**Date Prepared:** November 14, 1996

2) **Name of Device:** Rigid Fiber Optic Laparoscope
**Proprietary/Trade Name:** (Not yet determined)
**Common/Usual Name:** Laparoscope
**Classification:** Class II (21 CFR §884.1720)
**Classification Name:** Laparoscope, Gynecologic

3) **Name of Predicate or Legally Marketed Devices:**

Saber’s Rigid Fiber Optic Laparoscopes are substantially equivalent to the following predicate devices:

- Imagyn Medical, Inc.
MicroLap™ Laparoscope
Approved by FDA for marketing on 20-Jan-95 under 510(k) # K944079.

- Olympus America, Inc.
Mini Laparoscope for General Surgery
Approved by FDA for marketing on 01-Feb-95 under 510(k) #K950278.

- Optimed Technologies, Inc.
OptiMIS® Series 300 Rigid Fiber Optic Laparoscopes
Approved by FDA for marketing on 23-Nov-92 under 510(k) #K921883 for abdominal laparoscopy and other indicated uses, and on 12-Jul-94 under 510(k) #K926597 for gynecologic laparoscopy.

4) **Description of Device:**

Saber Endoscopy’s Rigid Fiber Optic Laparoscopes are small diameter endoscopes which consist of fiber optic imaging fibers and illumination fibers contained within a stainless steel jacket. Light from a high intensity light source is transmitted to the scope by a detachable light carrying cable. The light is then carried by the illumination fibers to the target. A distal lens focuses an image of the target onto the image fiber bundle. The image is transmitted to the proximal end of the scope, where it is magnified and focused by an optical eyepiece. The image may be viewed directly through the eyepiece, or the scope may be connected to a video system via a standard endoscopic video coupler.

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K962246
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510(k) Summary: #K962246
Saber Endoscopy, L.L.C.
Rigid Fiber Optic Laparoscopes
November 14, 1996
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## 5) Intended Use of Device:

Saber’s Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

## 6) Comparison of Technological Characteristics:

Saber’s Rigid Fiber Optic Laparoscopes are substantially equivalent¹ to the predicate or legally marketed Imagyn MicroLap Laparoscope, Olympus Mini Laparoscope for General Surgery, and Optimed Series 300 Rigid Fiber Optic Laparoscopes. Saber’s scopes employ the same design considerations and operating principles as the predicate devices, and each can be sterilized and reused. Any differences between the Saber, Imagyn, Olympus and Optimed laparoscopes do not raise new questions regarding safety or effectiveness.

¹The term, "substantially equivalent," is intended to reflect a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act, and relates to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to have any bearing on matters relating to patents.