OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D

K991718 · Richard Wolf Medical Instruments Corp. · GCJ · Aug 12, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991718
• Device Name: OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The operating laparoscopes are used for viewing the interior of the patient through surgically produced accesses: for examination, diagnosis and / or therapy in connection with endoscopic accessories for laparoscopy.

Device Story

Operating laparoscopes are rigid endoscopes featuring a working channel for the passage of endoscopic accessories. The device provides a distortion-free optical view of the patient's interior. It includes a detachable instrument port with an automatic valve or insertion cock, which can be replaced by a laser coupler for CO2 laser procedures. Used in clinical settings by physicians, the device is connected to external light sources, light cables, and imaging systems (video or reflex cameras). It facilitates minimally invasive examination, diagnosis, and therapy by allowing the surgeon to visualize the surgical site and manipulate tissues or perform procedures using accessories like trocar sleeves, forceps, and electrodes. The device is steam-sterilizable (autoclavable).

Clinical Evidence

No clinical tests performed. Bench testing only.

Technological Characteristics

Rigid endoscope with working channel; distortion-free optics; detachable instrument port with insertion cock; detachable laser coupler for CO2 laser; steam-sterilizable (autoclavable at 134°C / 273°F). Conforms to IEC 601-1 and IEC 601-2-18.

Indications for Use

Indicated for patients requiring endoscopic examination, diagnosis, or therapy of the interior of the body via surgically produced access points. Used in conjunction with endoscopic accessories for laparoscopy.

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Operating Peritoneoscope 4937 (pre-enact.)

Submission Summary (Full Text)

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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: [phone] Fax: [phone]

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Image /page/0/Picture/2 description: The image shows the name "RICHARD WOLF" in bold, black, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The letters are evenly spaced and the overall composition is simple and clear.

MEDICAL INSTRUMENTS C

K991718

# 510(k) Summary of Safety and Effectiveness

| Date of Preparation: | May 18, 1999 |
|----------------------------------------|----------------------------------------|
| FDA establishment registration number: | 1418479 |
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Phone number (include area code): | [phone] |
| FAX number (include area code): | [phone] |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |

Product Information:

| Trade name: | Operating Laparoscopes |
|----------------------|----------------------------------------------|
| Model number: | 8912.402, 8914.402, 8915.402 and accessories |
| Common name: | Laparoscopes with working channel |
| Classification name: | Laparoscopes |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|------------------------------------|----------------|
| 1 pre-enact. | 1 Operating Peritoneoscope 4937 | 1 Richard Wolf |
| 2 | 2 | 2 |

## 1.0 Description

The operating laparoscopes are endoscopes with working channels. The optic of the endoscopes is distortion-free. The instrument ports with automatic valves or insertion cocks are detachable and can be replaced by a laser coupler. The submitted laparoscopes are steam-sterilizable.

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### 2.0 Intended Use

The operating laparoscopes are used for viewing the interior of the patient through surgically produced accesses: for examination, diagnosis and / or therapy in connection with endoscopic accessories for laparoscopy.

### Technological Characteristics 3.0

- = distortion free
- autoclavable 134°C / 273°F
- = detachable instrument port with insertion cock
- detachable laser coupler for CO2 laser

#### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing devices sold by Richard Wolf.

#### 5.0 Performance Data

The devices conform to IEC 601-1 and IEC 601-2-18, and to the relevant provisions of European Device Directive 93/42/EEC.

#### 6.0 Clinical Tests

No clinical tests performed.

### 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.

By: Ret Hassan

Robert L. Casarsa Quality Assurance Manager

Date: May 18,99

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 12 1999

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

Re: K991718

> Trade Name: Laparoscopes Models 8912.402, 8914.402, and 8915.402 Regulatory Class: II Product Code: GCJ Dated: May 18, 1999 Received: May 20, 1999

Dear Mr. Casarsa:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirement, as set forth in the Quality System Regulation (OS) 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 devices 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. Robert L. Casarsa

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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,

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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**Indications for Use**

| 510(k) Number (if known): | K991171 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:__________________________________________________________________________________________________________________________________________________________________ Operating Laparoscopes

# Intended Use:

The operating laparoscopes are used for viewing the interior of the patient through surgically produced accesses; for examination, diagnosis and / or therapy in connection with endoscopic accessories for laparoscopy.

# Combinations:

The laparoscopes are used in connection with light sources and flexible light cables, video cameras, or reflex cameras and objectives lenses, as well as accessories for endoscopic use (e.g. trocar sleeves, forceps, electrodes).

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(Division Sign-Off)
Division of General Restorative Devices K991718
510(k) Number

Prescription Use
Per 21 CFR 801.109

OR

Over-The Counter_