REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS

K012625 · Alliance Medical Corp. · GEI · Oct 22, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012625
• Device Name: REPROCESSED UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS
• Applicant: Alliance Medical Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed unipolar laparoscopic/endoscopic instruments, including scissors, dissectors, and graspers are intended for use in minimally invasive surgical procedures.

Device Story

Reprocessed unipolar laparoscopic/endoscopic instruments consist of rigid plastic handpiece with loop handles connected to distal end effector jaws via insulated shaft. Jaws include scissors, dissectors, or graspers. Device used in minimally invasive surgery; operated by surgeon. Unipolar cautery current enters through handpiece connector, travels down shaft to jaws for tissue cauterization/coagulation. Reprocessing involves removal of visible soil and decontamination. Performance verified via electrical continuity testing and mechanical function testing (cutting/grasping).

Clinical Evidence

Bench testing only. No clinical data provided. Performance demonstrated through electrical continuity testing and mechanical functional testing of scissors, graspers, and dissectors to confirm performance matches original intended use.

Technological Characteristics

Rigid plastic handpiece, insulated barrel/shaft, metal end effector jaws. Unipolar electrosurgical energy source. Manual operation via loop handles. Reprocessing includes cleaning, decontamination, and functional testing. No specific ASTM standards cited.

Indications for Use

Indicated for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Ethicon Endopath® Endoscopic Instrument (K984240)
• Ethicon Endopath® Endoscopic Electrosurgical Forceps (K934784)
• Ethicon Endopath® Endoscopic Surgical Instruments (K930933)

Submission Summary (Full Text)

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OCT 22 2001

# PART B: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:

KO 12625 Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Contact:

Don Selvey Vice President, Regulatory Affairs and Quality Assurance [phone]

Date of preparation:

August 10, 2001

Name of device:

Trade/Proprietary Name: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments

Common or Usual Name: Unipolar Laparoscopic/Endoscopic Instruments

Classification Name: Endoscope and Accessories and/or Electrosurgical Cutting and Coagulation Device and Accessories

#### Reprocessed devices:

| Manufacturer | Description | Model |
|--------------|------------------------------------|-------|
| Ethicon | Endopath ® Endo Metzenbaum Scissor | BMS10 |
| Ethicon | Endopath ® Curved Scissor | DCS12 |
| Ethicon | Endopath ® Hook Scissor | DHS14 |
| Ethicon | Endopath ® Micro-Scissor | DMS15 |
| Ethicon | Endopath ® Curved Scissor | 5DCS |
| Ethicon | Endopath ® Curved Scissor, Short | SCS12 |
| Ethicon | Endopath ® Straight Grasper | DSG22 |
| Ethicon | Endopath ® Modified Allis Grasper | DSG23 |
| Ethicon | Endopath ® Ratchet Grasper | 5DSG |
| Ethicon | Endopath ® Claw Extractor | DEX41 |
| Ethicon | Endopath ® Curved Dissector | DCD32 |
| Ethicon | Endopath ® Straight Dissector | DSD33 |
| Ethicon | Endopath ® Curved Dissector | 5DCD |
| Ethicon | Endopath ® Curved Dissector | SCD32 |

Predicate device(s):

| K# | Device Description | Procode |
|---------|------------------------------------------|---------|
| K984240 | Ethicon Endopath ® Endoscopic Instrument | GEI |
| | Ethicon Endopath ® Endoscopic | |
| K934784 | Electrosurgical Forceps | GEI |
| | Ethicon Endopath ® Endoscopic Surgical | |
| K930933 | Instruments | GCJ |

#### Alliance Medical Corporation Reprocessed Laparoscopic/Endoscopic Instruments Traditional 510(k)

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| Device<br>description: | Unipolar laparoscopic/endoscopic instruments are electrosurgical<br>instruments consisting of a rigid plastic handpiece with loop handles<br>connected to the distal end effector jaw by an elongated, narrow-<br>diameter insulated barrel or shaft. The devices are designed to be<br>inserted through an appropriately sized trocar sleeve or cannula. The<br>jaws are operated by the handpiece loop handles and may be shaped<br>as scissors, dissectors or graspers. The jaws of some models may be<br>rotated by manipulating controls on the handpiece. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The blades or jaws of unipolar laparoscopic/endoscopic instruments can<br>deliver a cauterizing current that enters the instrument through the<br>unipolar cautery connector on the handpiece, runs down the insulated<br>shaft and through the tissue in the blades or jaws. |
| Intended use: | Reprocessed unipolar laparoscopic/endoscopic instruments, including<br>scissors, dissectors, and graspers are intended for use in minimally<br>invasive surgical procedures. |
| Indications<br>statement: | Reprocessed unipolar laparoscopic/endoscopic instruments, including<br>scissors, dissectors, and graspers, are to be used for patients requiring<br>minimally invasive surgical procedures to manipulate and manage<br>internal soft tissue by grasping, cutting, dissecting, cauterizing, or<br>coagulating tissue. |
| Technological<br>characteristics: | The intended use and technological features of the reprocessed devices do<br>not differ from the legally marketed predicate device(s). Both the<br>reprocessed device(s) and the predicate device(s) have the same materials<br>and product design. The technological characteristics of the reprocessed<br>unipolar laparoscopic/endoscopic scissors, dissectors, and graspers are the<br>same as those of the legally marketed predicate devices. |
| | Alliance Medical Corporation's reprocessing of unipolar<br>laparoscopic/endoscopic instruments includes removal of adherent visible<br>soil and decontamination. All unipolar laparoscopic/endoscopic instruments<br>are tested for electrical continuity. Unipolar laparoscopic/endoscopic<br>scissors are tested for cutting function. Graspers and dissectors are tested<br>for the ability of the jaws to grasp appropriately. |
| Performance<br>data: | Performance data demonstrates that Reprocessed Unipolar<br>Laparoscopic/Endoscopic Instruments perform as originally intended. |
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act, 21<br>CFR Part 807 and based on the information provided in this<br>premarket notification, Alliance Medical Corporation concludes that<br>the modified device (Reprocessed Unipolar Laparoscopic/Endoscopic<br>Instruments) is safe, effective and substantially equivalent to the<br>predicate devices as described herein. |

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a triple helix design representing the interconnectedness of health, science, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.

OCT 22 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Don Selvey Vice President, Regulatory Affairs and Ouality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044

Re: K012625

Trade/Device Name: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 10, 2001 Received: August 13, 2001

Dear Mr. Selvey:

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. Don Selvey

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letter will and my Journe FDA finding of substantial equivalence of your device to a legally premated notification " 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 Oixision 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,

Susan Walker, us

Image /page/3/Picture/5 description: The image contains a handwritten symbol or character. It appears to be a cursive letter, possibly an 'h' or a stylized 'l', with a small flourish or stroke extending to the right. The character is drawn with thick lines, suggesting it was written with a marker or pen with a broad tip.

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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## II. Indications for Use Statement

### K012625 510(k) Number (if known):

Device Name: Alliance Medical Corporation Reprocessed Unipolar Laparoscopic/Endoscopic Instruments

Indications for Use: Reprocessed Unipolar Laparoscopic/Endoscopic Instruments, including scissors, dissectors, and graspers, are to be used for patients requiring minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, dissecting, cauterizing, or coagulating tissue.

| Manufacturer | Description | Model |
|--------------|-----------------------------------|-------|
| Ethicon | Endopath® Endo Metzenbaum Scissor | BMS10 |
| Ethicon | Endopath® Curved Scissor | DCS12 |
| Ethicon | Endopath® Hook Scissor | DHS14 |
| Ethicon | Endopath® Micro-Scissor | DMS15 |
| Ethicon | Endopath® Curved Scissor | 5DCS |
| Ethicon | Endopath® Curved Scissor, Short | SCS12 |
| Ethicon | Endopath® Straight Grasper | DSG22 |
| Ethicon | Endopath® Modified Allis Grasper | DSG23 |
| Ethicon | Endopath® Ratchet Grasper | 5DSG |
| Ethicon | Endopath® Claw Extractor | DEX41 |
| Ethicon | Endopath® Curved Dissector | DCD32 |
| Ethicon | Endopath® Straight Dissector | DSD33 |
| Ethicon | Endopath® Curved Dissector | 5DCD |
| Ethicon | Endopath® Curved Dissector | SCD32 |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

(Division Sign-Off)

General, Restorative

510(k) Number K012625

CONFIDENTIAL

Alliance Medical Corporation Reprocessed Laparoscopic/Endoscopic Instruments Traditional 510(k)

or