LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE

K972984 · Lerner Medical, Inc. · GCJ · Oct 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972984
• Device Name: LERNER MEDICAL, INC. AUTOCLAVABLE 10 MM LAPAROSCOPE
• Applicant: Lerner Medical, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Lerner Medical, Inc. Autoclavable 10MM Laparoscope is intended to be used for visualization of the abdominal cavity during general and thoracic surgery.

Device Story

The Lerner Medical, Inc. Autoclavable 10MM Laparoscope is a 10mm diameter optical instrument used for visualization of the abdominal cavity during diagnostic and operative laparoscopic procedures. It is intended for use by surgeons in clinical settings such as the operating room. The device provides direct visualization of internal anatomy to assist in surgical decision-making and procedural guidance. It is compatible with high-level disinfection, ethylene oxide gas sterilization, or steam autoclaving. The device is a passive optical tool; it does not process data or provide automated outputs.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

10mm diameter rigid laparoscope. Optical visualization system. Compatible with high-level disinfection, ethylene oxide gas, and steam autoclave sterilization. Standalone mechanical device.

Indications for Use

Indicated for general surgery (laparoscopic cholecystectomy, hernia repair, appendectomy, Nissen fundoplication, diagnosis and management of acute abdomen) and thoracic surgery (pericardiectomy, pneumonectomy, evaluation of pulmonary nodule, biopsy, pleurodesis).

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

• Cuda Products Corporation Autoclavable Laparoscope (K935818)

Submission Summary (Full Text)

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OCT 2 9 1997

## 510(k) Notification: Lerner Medical, Inc. Autoclavable 10MM Diagnostic Laparoscope

## SUMMARY OF SAFETY AND FIFFECTIVENESS Lerner Medical, Inc. Autoclavable 10MM Laparoscope

1. Name and Address of Applicant Lerner Medical, Inc. 840 West Main Street Lansdale, PA 19446 Contact: Michael Pollack President

2. Device Name and Classification

| Product Nomenclature | Classification<br>Number | Class | Regulation<br>Number |
|-----------------------------------------------|--------------------------|-------|----------------------|
| Laparoscope, General and<br>Plastic Surgery | 78GCJ | II | 21 CFR<br>§876.1500 |
| Laparoscope, Gynecological<br>and Accessories | 85HET | II | 21 CFR<br>§884.1720 |

Common/Usual Name:

Autoclavable I.aparoscopc

Trade/Proprictary Name:

Lerner Medical, Inc. Autoclavable 10MM

- 3. Identification of Predicate Devices
Marketed Devices Used for Substantial Equivalence:

The Lerner Medical, Inc. Autoclavable Laparoscope is substantially equivalcat to autoclavable laparoscopes marketed after May 28, 1976 and were determined as substantially equivalent by the US FDA. The Lemer Medical, Inc. Autoclavable 10MM Laparoscope is substantially equivalent to the following device; the Cuda Products Corporation Autoclavable Laparoscope (510(r): K935818)

4. Device Description:

The Lemer Medical. Inc. Autoclavable 10MM Laparoscope System is a 10MM diameter laparoscope which may be used during diagnostic and operative laparoscopy procedures for visualization of the abouninal cavity. The laparoscope may be disinfected using bigh level disinfectants or sterilized using ethylene oxide gas or steam autoclave.

S. Intended Use of the Marketed Device:

The I emer Medical, Inc. Autoclavable 10MM Laparoscope is intended to be used for visualization of the abdominal cavity during general and thoracic surgery.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Pollack President Lerner LMI Medical, Inc. 840 West Main Street Lansdale, Pennsylvania 19446

OCT 29 1997

Re: K972984

> Trade Name: Lerner Medical, Inc. Autoclavable 10 MM Laparoscope Regulatory Class: II ........ Product Code: GCJ Dated: August 4, 1997 Received: August 11, 1997

Dear Mr. Pollack:

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 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 your device in the Federal Register. Please note: this response to your premarket notification submission does 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.

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Page 2 - Mr. Michael Pollack

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.

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 your device, please contact the Office of Compliance at [phone]. 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 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/dsmamain.html".

Sincerely yours,

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Pagc ( പ

510(k) Number (if known): _

Device Name: I cracr Medical, Inc. Autoclavable 10MM Laparoscope

Indications For Usc:

General Surgery

- Laparoscopic cholecystectorny, liernia repair, Appendcctomy, Nissen fundal plication, . Diagnosis and Management of acute abdomen
Thoracic Surgery

- Pericardiectorny, Pneumonectomy, Evaluation of pulmonary nodule, Biopsy, Pleurodosis ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K972984 |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(Uplional Format 1-2-96)