MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS

K991928 · Allegiance Healthcare Corp. · GCJ · Jun 25, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991928
• Device Name: MODULAR LAPAROSCOPIC GRASPING FORCEPS, SCISSORS, NEEDLE HOLDERS & DISSECTORS
• Applicant: Allegiance Healthcare Corp.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 25, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Allegiance Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors and Needle Holders are used as accessories in general laparoscopic diagnostic and surgical procedures for manipulating tissue (grasping, cutting, dissecting coagulating and suturing).

Device Story

Modular laparoscopic instruments consisting of reusable handle/shaft assembly and removable tip assembly; designed for manipulation of soft tissue structures during laparoscopic diagnostic and surgical procedures. Operated by surgeons in clinical/OR settings. Device facilitates grasping, cutting, dissecting, coagulating, and suturing. Benefits include modularity for instrument reuse and maintenance.

Clinical Evidence

Bench testing only. Performance and physical tests conducted to evaluate safety, effectiveness, and reliability; all results acceptable.

Technological Characteristics

Modular design with reusable handle/shaft assembly and removable tip assembly. Materials and design identical to predicate. Manual operation; no energy source or software.

Indications for Use

Indicated for use as accessories in general laparoscopic diagnostic and surgical procedures for tissue manipulation, including grasping, cutting, dissecting, coagulating, and suturing.

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

• Resposable Grasping Forceps/ Scissors/ Needle Holder/ Dissectors (K931340)

Submission Summary (Full Text)

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Allegiance Healthcare Corporation

1500 Waukegan Road McGaw Park, IL 60085

847.473.1500 FAX: [phone]

JUN 25 1999

K 991928

## SUMMARY OF SAFETY AND EFFECTIVENESS Attachment G

| Manufacturer: | Allegiance Healthcare Corporation<br>V. Mueller Business Unit<br>1430 Waukegan Road<br>McGaw Park, IL 60085 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Affairs Contact | Patricia Sharpe-Gregg<br>1500 Waukegan Road<br>McGaw Park, Illinois 60085 |
| Telephone: | [phone] |
| Date Summary Prepared: | June 1, 1999 |
| Product Trade Name: | Modular Endoscopy Laparoscopic Scissors,<br>Grasping Forceps, Dissectors and Needle Holders |
| Common Name: | Laparoscopic Scissors, Grasping Forceps,<br>Dissectors & Needle Holders |
| Classification: | Gynecologic Laparoscope and Accessories |
| Predicate Device:<br>(K931340) | "Resposable" Grasping Forceps/ Scissors/<br>Needle Holder/ Dissectors |
| Description: | The Allegiance Modular Endoscopy<br>Laparoscopic Scissors, Grasping Forceps,<br>Dissectors and Needle Holders are composed<br>of a reusable handle and shaft assembly and a<br>removable tip assembly. These instruments<br>are designed and manufactured specifically for<br>the purpose of manipulating soft tissue<br>structures. |

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| Intended Use: | The Allegiance Modular Endoscopy<br>Laparoscopic Scissors, Grasping Forceps,<br>Dissectors and Needle Holders are used as<br>accessories in general laparoscopic diagnostic<br>and surgical procedures for manipulating<br>tissue (grasping, cutting, dissecting<br>coagulating and suturing). |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence: | The Modular Endoscopy Laparoscopic<br>Scissors, Grasping Forceps, Dissectors and<br>Needle Holders are substantially equivalent to<br>the Allegiance the "Resposable" Grasping<br>Forceps/ Scissors/ Needle Holder/ Dissectors,<br>in that:<br>• Intended use is the same<br>• Performance attributes are the same<br>• Materials and basic design are the same |
| Summary of Testing: | All materials used in the composition of the<br>Modular Endoscopy Laparoscopic Scissors,<br>Grasping Forceps, Dissectors and Needle<br>Holders were subjected to performance and<br>physical tests to evaluate the safety,<br>effectiveness and reliability of the device. All<br>test results were acceptable. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with three lines representing arms or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 25 1999

Ms. Patricia Sharpe-Gregg Manager, Regulatory Affairs Allegiance Healthcare Corp. 1500 Waukegan Road William Merz Building McGaw Park, Illinois 60085

K991928 Re:

Trade Name: Modular Endoscopy Laparoscopic Scissors, Grasping Forceps, Dissectors, and Needle Holders

Regulatory Class: II Product Code: GCJ Dated: June 7, 1999 Received: June 8, 1999

Dear Ms. Sharpe-Gregg:

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. Patricia Sharpe-Gregg

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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Allegiance

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085 USA 847-578-3636 FAX: [phone]

Special 510(k) Device Modification: Laparoscopic Grasping Forceps, Scissors, Needle Holders & Dissectors V. Mueller Business Unit Page 1 of 1

kg91928 510(k) Number (if known): Unknown Laparoscopic Grasping Forceps, Scissors, Needle Device Name: Holders and Dissectors Used as accessories in general laparoscopic Indications For Use: diagnostic and surgical procedures for manipulating tissue (grasping, cutting, coagulating, dissecting and suturing).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---------------------------------------|----------------------|
| or | Over-The Counter Use |

(Division Sign-Off)
Division of General Restorative Devices

| 510(k) Number | K991228 |
|---------------|---------|
|---------------|---------|