OPTICAL FORCEPS

K990561 · Pilling Weck Surgical · JEK · May 14, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K990561
• Device Name: OPTICAL FORCEPS
• Applicant: Pilling Weck Surgical
• Product Code: JEK · Ear, Nose, Throat
• Decision Date: May 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes

Device Story

Optical Forcep consists of a telescope and a biopsy forcep. Used by physicians during endoscopic procedures to visualize and perform foreign body removal or tissue biopsy in the tracheobronchial or esophageal tracts. Device is inserted through rigid scopes (bronchoscopes, esophagoscopes, laryngoscopes, mediastinoscopes). Provides direct visualization to assist the clinician in targeting the biopsy site or foreign object; facilitates mechanical retrieval or sampling. Benefits include improved procedural accuracy and access to anatomical sites during minimally invasive interventions.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

Consists of a telescope and biopsy forcep assembly. Designed for use through rigid endoscopic instrumentation (bronchoscopes, esophagoscopes, laryngoscopes, mediastinoscopes). Mechanical device; no electronic or software components.

Indications for Use

Indicated for patients requiring tracheobronchial or esophageal foreign body removal or biopsy procedures via rigid scopes (bronchoscopes, esophagoscopes, laryngoscopes, and mediastinoscopes).

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Storz Vocal Cord Stripping Instrument

Submission Summary (Full Text)

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MAY 1 4 1939

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## 510(K) Summary

# 1990561

#### 1. Submitter Name, Address, and Date of Submission.

Elizabeth Lazaro Pilling Weck Surgical 420 Delaware Drive Fort Washington, PA 19034

[phone] Telephone Number [phone] Fax

Contact: Same as above.

#### 2. Name of the Device, Common, Proprietary (if known), and Classification.

- Biopsy Forcep and Telescope Classification Name: Common Name: Optical Forcep Pilling Weck Surgical Optical Forcep Proprietary Name:
- 3. Identification of the legally marketed device to which the submitter claims equivalence.

Pilling Weck Surgical Optical Forcep is substantially equivalent to Storz Vocal Cord Stripping Instrument

#### 4. Description of the Device.

The Optical Forcep consists of two components

- a. Telescope
- b. Biopsy Forcep

#### 5. Intended Use of the Device.

The Optical Forcep is to be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures.

#### 6. Summary of Technological Characteristics.

The technological characteristics are the same as, or equivalent to, predicate devices by Storz Vocal Cord Stripping Instruments.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 1999

Ms. Elizabeth Lazaro Regulatory Affairs Associate Pilling Weck Surgical 420 Delaware Drive Fort Washington, Pennsylvania 19034

K990561 Re: Trade Name: Optical Forcep Regulatory Class: II Product Code: JEK, EOX, and EWY Dated: February 17, 1999 Received: February 22, 1999

Dear Ms. Lazaro:

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 requirement, 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 – Ms. Elizabeth Lazaro

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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510(K) Number (if known):

Device Name: Pilling Weck Surgical Optical Forcep

Indications for Use:

To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K99056
510(k) Number.

Prescription Use \\$\times\$ or Over-
The-Counter Use *_*_

(Per 21 CFR 801.1 09)