K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)

K973259 · Medical Creative Technologies, Inc. · OCZ · Sep 10, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K973259
• Device Name: K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)
• Applicant: Medical Creative Technologies, Inc.
• Product Code: OCZ · Gastroenterology, Urology
• Decision Date: Sep 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in endoscopic surgical procedures through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.

Device Story

K&W 2-Piece Take-Apart Instruments are reusable endoscopic surgical tools. System consists of interchangeable jaw inserts and reusable handles (insulated or noninsulated). Jaws perform cutting, grasping, dissecting, retracting, and manipulating. Device is used endoscopically through cannulae; jaws are rotated via a handle knob. Features include a flushing port for cleaning and a push-button detented locking mechanism to secure the shaft to the handle. Operated by surgeons in clinical/OR settings. Provides mechanical tissue interaction to facilitate surgical procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Reusable endoscopic instruments; insulated and noninsulated handles; interchangeable jaw inserts; 360-degree rotation; integrated flushing port for cleaning; push-button detented locking mechanism for shaft-to-handle connection.

Indications for Use

Indicated for patients undergoing endoscopic surgical procedures requiring cutting, grasping, dissecting, retracting, or manipulating of tissue via cannulae.

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

• Karl Storz Endoscopy America, Inc. (K952149)

Submission Summary (Full Text)

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SEP 1 0 1997

973259 Page 1 of 3

# 510(k) Summary

#### Submitter's Name, Address and Telephone Number, and Contact Person: 1.

Perk Crook Medical Creative Technologies, Inc. 2950-N Advance Lane Colmar, PA 18915

Telephone: [phone]

Contact Person: Perk Crook

#### 2. Name of the Device, including the trade or proprietary name if applicable, and the common name, and the classification name, if known:

Trade Name: K&W 2-Piece Take-Apart Instruments

Endoscopic Forceps/Graspers/Scissors Common Name:

Classification Name: Endoscopic and Accessories

### 3. Identification of the legally marketed device that the submitter claims equivalence:

The devices in consideration are substantially equivalent to the devices currently marketed by Karl Storz Endoscopy America, Inc., under 510(k) K952149.

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## A description of the device that is the subject of the premarket notification 4. submission, such as might be found in the labeling or the promotional material of the device:

The K&W 2-Piece Take-Apart Instrumentation are endoscopic instruments which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the iaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle.

#### A statement of the intended use of the device that is the subject of the 5. premarket notification:

The K&W 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.

- lf the device has the same technological characteristics as the predicate 6. device identified in paragraph (a)(3) of this section, a summary of the technological characteristics of new device in comparision to those of the predicate device; if the device has different technological characteristics from the predicate device, a summary of how the technological characteristics of the device compare to the legally marketed device:
The intended uses of the K&W 2-Piece Take-Apart Instrumentation and the Karl Storz Endoscopy America, Inc. Devices under K952149 have the same intended use, and that is for endoscov proceures through cannulae for cutting, grasping, dissecting, retracting, and manipulating.

The devices have reusable handles that accommodate inserts, that can be rotated 360 degrees during use.

Both devices include insulated and noninsulated handles, and accommodating shafts.

In the K&W device there is included flushing port to facilitate cleaning. This port

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is not present on the Karl Storz devices.

All K&W device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral port of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button. In some of the Storz instruments, security is achieved by a one-quarter turn into the outer tube and then connecting into the outer tube handle. The rest of the Storz instruments are the same as K&W.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1997

Ms. Perk Crook Official Correspondent Medical Creative Technologies, Inc. 2950-N Advance Lane Colmar, Pennsylvania 18915-9727

Re: K973259 K&W Two-Piece Take-Apart Instrumentation Dated: August 26, 1997 Received: August 29, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG

Dear Ms. Crook:

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 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 misbranion.

If your device is classified (see above) into either 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 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 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,

h.7liau Yu
Lillian Yin, Ph.D.

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

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Page_ 1_of_1__

510(k) Number (if known): _

Device Name: 2-Piece Take-Apart Instruments

Indications For Use:

(Per 21 CFR 801.109)

For use in endoscopic surgical procedures through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Rober 7 (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Device 510(k) Number . Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR Prescription Use_v

(Optional Format 1-2-96)