DUAL HOOK FIBEROPTIC DELIVERY SYSTEM

K970069 · Ihd, Inc. · GEX · Jul 17, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K970069
• Device Name: DUAL HOOK FIBEROPTIC DELIVERY SYSTEM
• Applicant: Ihd, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dual Hook Scalpel, fiberoptic delivery system is indicated for use in cutting, and coagulation of soft tissues encountered in general surgical applications. This includes incision, excision, or coagulation of tissue.

Device Story

Dual Hook Scalpel is a fiberoptic delivery system designed for general surgical applications. Device utilizes fiber optics to deliver energy for cutting and coagulation of soft tissues. Operated by surgeons in clinical/surgical settings to perform incisions, excisions, or tissue coagulation. Provides visual or functional access to tissue sites via fiberoptic delivery. Benefits include precise tissue management during surgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fiberoptic delivery system for surgical energy application. Form factor: Scalpel with dual hook configuration. Intended for soft tissue cutting and coagulation.

Indications for Use

Indicated for cutting, incision, excision, and coagulation of soft tissues in general surgical applications.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL 17 1998

Innovative Healthcare Devices, Inc.
c/o Mr. Wayne Dillender
4675 Cornell Road, Suite 180
Cincinnati, Ohio 45241

Re: K970069
Trade Name: Dual Hook Scalpel (Fiber Optic Delivery System)
Regulatory Class: II
Product Code: GEX
Dated: May 1, 1998
Received: May 1, 1998

Dear Mr. Dillender:

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 - Mr. Wayne Dillender

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,


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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07/14/98 TUE 17:21 FAX [phone]
bioMerieux Vitek
002

510(k) Number (if known): K970069

Device name: Dual Hook Scalpel (fiberoptic delivery system)

Indications for Use:

The Dual Hook Scalpel, fiberoptic delivery system is indicated for use in cutting, and coagulation of soft tissues encountered in general surgical applications. This includes incision, excision, or coagulation of tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K970069
(Optional Format 1-2-96)
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