REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS

K022748 · Medical Device Services · HET · Oct 9, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K022748
• Device Name: REPROCSSED USED DISPOSABLE ENDOSCOPIC SCISSORS AND GRASPERS
• Applicant: Medical Device Services
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Endoscopic scissors and graspers are instruments that have a 5 to 10 mm diameter insulated shaft designed for use through surgical trocars. Endoscopic scissors and graspers, in conjunction with trocars, are used in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissections and transection of tissue.

Device Story

Reprocessed single-use endoscopic scissors and graspers; originally manufactured as disposable devices. AMI collects used devices from hospitals; subjects them to cleaning, inspection, and sterilization per protocol 40011; returns to hospital for reuse. Devices feature 5-10mm insulated shafts; optional electrocautery and rotation capabilities. Used in minimally invasive surgery via trocar cannula. Physician operates device to manipulate tissue. Reprocessing restores device to patient-ready state; non-conforming devices rejected. Benefits include extended utility of surgical instruments.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and validation of the reprocessing protocol to ensure the device meets original specifications.

Technological Characteristics

Manual endoscopic surgical instruments; 5-10mm diameter insulated shafts; optional electrocautery and rotation. Materials and design identical to original disposable predicate. Sterilization performed as part of the validated reprocessing protocol.

Indications for Use

Indicated for use in patients undergoing minimally invasive surgical procedures requiring grasping, mobilization, dissection, or transection of tissue via endoscopic access.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Ethicon Endo-surgery Disposable Endoscopic Scissors and Graspers (K960933)

Submission Summary (Full Text)

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K022748

Image /page/0/Picture/1 description: The image shows the text "Adven Medical, Inc." in a serif font. The text is black and the background is white. A black line is underneath the text.

1001 Slaton Hwv. Lubbock, Texas 79404

Tel: [phone] Fax: [phone] OCT 0 9 2002

## 510(k) SUMMARY

## Adven Medical, Incorporated Reference: Section 510(k) Notification Reprocessed Used Disposable Endoscopic Scissors and Graspers

Classification name:

Common/Usual Name: Proprietary Name:

79GCJ. Manual Laparoscopic Surgical Instruments 79GEI, Endoscopic Electrosurgical Instruments Laparoscopic/Endoscopic Surgical Instruments Reprocessed Used Disposable Endoscopic Scissors and Graspers

Establishment Registration Number: 1649663

AMI intends to market Endoscopic Scissors and Graspers that have been reprocessed. Reprocessing Endoscopic Scissors and Graspers is performed by AMI to AMI protocol Number 40011. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready (Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals.

Endoscopic Scissors and Graspers are sold new by the original manufacturers to the hospital. The hospital uses the Endoscopic Scissors and Graspers, collects them and ships them to AMI for reprocessing. Endoscopic Scissors and Graspers are reprocessed by AMI as described in our reprocessing protocol Control Document Number 400011, and returned to the hospital to be reused as a single-use device again.

Endoscopic Scissors and Graspers that do not meet the AMI protocol are rejected. Rejection may occur during the first reprocessing (in which the device is not reprocessed at all) or anytime during subsequent reprocessings.

Endoscopic Surgical Scissors and Graspers are hand-manipulated devices, with and without electrocautery capability; and with and without rotation capability. They are designed for use during minimally invasive surgical procedures and are equipped with elongated shafts to fit through the surgical trocar cannula.

Adven Medical, Inc., Reprocessed Endoscopic Scissors and Graspers are substantially equivalent to Ethicon Endo-surgery Disposable Endoscopic Scissors and Graspers, currently marketed new by Ethicon under 510(k) Number K960933.

000008

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Device Services c/o Mr. Mark W. Aldana President Adven Medical, Inc. 1001 Slaton Highway Lubbock, Texas 79404

Re: K022748

Trade/Device Name: Reprocessed Disposable Endoscopic Scissors and Graspers Regulation Number: 884.1720, 878.4800

Regulation Name: Gynecological laparoscope and accessories, Manual surgical instruments for general use.

Regulatory Class: II Product Code: HET, MDM Dated: August 9, 2002 Received: august 19, 2002

Dear Mr. Aldana:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Mr. Mark W. Aldana

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stupt Rurder
Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K022748

Reprocessed Used, Disposable Endoscopic Scissors and Graspers Device Name:

Indications For Use:

Endoscopic scissors and graspers are instruments that have a 5 to 10 mm diameter insulated shaft designed for use through surgical trocars. Endoscopic scissors and graspers, in conjunction with trocars, are used in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissections and transection of tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stupt Rhode
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number___KO2274 8

Prescription Use _ (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)