FLEXTIP GRASPER

K972450 · Endius, Inc. · EOB · Nov 21, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K972450
• Device Name: FLEXTIP GRASPER
• Applicant: Endius, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Nov 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.

Device Story

FlexTip™ Grasper is a manual surgical instrument for tissue grasping, dissecting, and cutting. Device features a pistol-grip handle, a shaft, a series of nested high-density polycarbonate vertebrae joints, and a high-density polyethylene radius control sheath. The vertebrae joints allow the tip to articulate 110° above or below the shaft plane, enabling adjustable angulation. The radius control sheath manages the curvature of the flexible tip. Operated by a surgeon in OR settings for sinus, arthroscopic, or microdiscectomy procedures. The articulation mechanism eliminates the need for multiple instruments with fixed tip angles. Output is mechanical manipulation of tissue via biting or through-cut jaws.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual surgical instrument. Materials: high-density polycarbonate (vertebrae joints), high-density polyethylene (radius control sheath), stainless steel. Articulation: 110° above/below shaft plane via nested vertebrae. Jaw configuration: biting or through-cut. Handle: pistol-grip. Non-powered, mechanical operation.

Indications for Use

Indicated for tissue grasping, dissecting, and cutting during surgical or endoscopic sinus procedures, arthroscopic orthopedic surgery, and microdiscectomy. For prescription use only.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Predicate Devices

• Endo-bend™ Grasper (Aust & Taylor Medical Corp.)
• Precisor Disposable Forceps (Smith & Nephew Dyonics, Inc.)
• Reusable Graspers (Smith & Nephew Dyonics, Inc.)
• AMD™ System (Smith & Nephew Dyonics, Inc.)

Submission Summary (Full Text)

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K972450

## 510(k) Summary FlexTip™ Grasper

### SUBMITTER NAME AND ADDRESS 1.

# NOV 2 1 1997

Endius Incorporated 23 West Bacon Street Plainville, MA 02762 Telephone: [phone] [phone] Telefax:

Thomas W. Davison, Ph.D. Contact:

#### DEVICE NAME 2.

| Proprietary Name: | FlexTip™ Grasper |
|----------------------|-----------------------------------------------------------------------------------|
| Common/Usual Name: | Forceps |
| Classification Name: | Ear, nose and throat manual surgical instrument<br>manual arthroscopic instrument |

#### PREDICATE DEVICES 3.

- Endo-bend™ Grasper (Aust & Taylor Medical Corp.) .
- Precisor Disposable Forceps and Graspers Reusable Graspers (Smith & . Nephew Dyonics, Inc.)
- AMD™ System (Smith & Nephew Dyonics, Inc.). .

#### 4. INTENDED USE

The FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.

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#### DEVICE DESCRIPTION ട.

The Endius Incorporated FlexTip™ Grasper is composed of:

- · a tissue engaging tip of either a through cut or biting design
- · a series of nested high density polycarbonate vertebra joints which allow articulation of the grasper tip
- a shaft section which connects the flexible end to the handle .
- · a radius control sheath used to control the radius of curvature of the flexible tip
- · a pistol grip handle containing the control mechanism for the grasper tip.

#### TECHNOLOGICAL CHARACTERISTICS 6.

The Endius Incorporated FlexTip™ Grasper and the substantially equivalent devices are all used for grasping, holding, manipulating or removal of tissue during surgical procedures. Tissue grasping is accomplished using a pivoting jaw configuration.

The Smith & Nephew Dyonics, Inc. devices all have rigid shafts with jaws either straight or at a specified angle. The proposed FlexTip™ Grasper and the Endobend™ Grasper have a flexible shaft due to the presence of a series of nested vertebrae joints, which allow adjustable shaft angulation. The Endo-bend™ Grasper can curve upward to 180°. The FlexTip™ Grasper can articulate 110° either above or below the plane of the shaft. A high density polyethylene radius control sheath slides over the stainless steel vertebrae to control the radius of curvature of the tip. The articulation feature of the FlexTip™ Grasper eliminates the need for numerous instruments with different tip angles.

The jaws of the Aust & Taylor Medical Corp. Endo-bend™ Grasper are of a biting forceps design. The proposed device and the Smith & Nephew Dyonics, Inc. disposable and reusable graspers and forceps have biting forcep and through cut jaw configurations in a variety of sizes.

The Smith & Nephew Dyonics, Inc. predicate devices use a scissor handle to open and close the jaws of the instrument. The Aust & Taylor device uses a trigger handle for jaw operation which is equivalent in design to that used in the proposed FlexTip™ Grasper.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal is circular and features the department's name around the perimeter. In the center of the seal is a stylized image of a bird-like figure, which is a common symbol associated with HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cynthia J. M. Nolte, Ph.D. Associate Regulatory Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re:

K972450 FlexTip™ Grasper Dated: October 14, 1997 Received: October 15, 1997 Regulatory class: II 21 CFR 874.4760/Procode: 77 EOB 21 CFR 888.1100/Procode: 87 HRX NOV 2 1 1997

Dear Dr. Nolte:

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, 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 (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 Radiation Control provisions, or other Federal laws or regulations.

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 question 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.

W. Kiau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K972450

Device Name: FlexTip™ Grasper

Indications For Use:

The FlexTip™ Grasper is a manual instrument intended for use in tissue grasping, dissecting and cutting in surgical or endoscopic sinus procedures and arthroscopic orthopedic and microdiscectomy surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K972450

Prescription Use _V (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)