MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS

K080257 · Medtronic Xomed, Inc. · GCJ · May 22, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080257
• Device Name: MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS
• Applicant: Medtronic Xomed, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Manual surgical instruments are intended for use in a wide variety of surgical procedures including various laparoscopic and endoscopic procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures.

Device Story

MicroFrance Laparoscopic Manual Surgical Instruments are reusable, manual surgical tools designed for laparoscopic and endoscopic procedures. The device line includes forceps, probes, needle holders, clamps, dissectors, scissors, knives, hooks, knot guides, retractors, and blades. Instruments are available in both dismantable and non-dismantable configurations, with or without insulation, and in diameters ranging from 3mm to 12mm. These instruments are used by surgeons in clinical settings to physically manipulate, dissect, or remove internal tissue. The devices are distributed non-sterile and require sterilization by the user before use. They function as mechanical extensions of the surgeon's hands, providing the necessary reach and precision for minimally invasive surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Stainless steel, tungsten (needle holders), and insulation material. Dimensions: 3mm to 12mm diameter; 25cm to 60cm length. Reusable, manual mechanical instruments. Distributed non-sterile; requires user sterilization. No energy source or software components.

Indications for Use

Indicated for use in surgical procedures, including laparoscopic and endoscopic procedures, for scraping, cutting, grasping, holding, removing, or manipulating tissue or structures in patients requiring such surgical intervention.

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

• GIMMI ALPHA Gastro-Urology, & Laparoscopic Endoscopes, Endoscopic Accessories (K012660)
• Modular Laparoscopic Grasping Forceps, Scissors (K991928)
• MicroFrance Electrosurgical Instruments (K993655)
• MicroFrance Laparoscopic Manual Surgical Instruments for gynecological use

Submission Summary (Full Text)

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K080257

# MAY 22 2008

### 510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS FOR

## MicroFrance Laparoscopic Manual Surgical Instruments, various

| 510(k) Owner | Medtronic Xomed, Inc. |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 6743 Southpoint Drive North |
| | Jacksonville, Florida 32216-0980 USA |
| | 904-296-9600 |
| | 904-296-2386 (FAX) |
| Contact Name | Jayme Wilson |
| | Senior Regulatory Affairs Specialist |
| | Medtronic Xomed, Inc. |
| Date Summary Prepared | January 30, 2008 |
| Proprietary Name | MicroFrance Laparoscopic Instruments, various |
| Common Name | Laparoscopic Instruments, General and Plastic Surgery |
| Classification Name | Laparoscope accessories, Endoscopic procedures<br>(21 CFR 876.1500, Product Code GCJ, Class II)<br>Laparoscope accessories, Gynecologic procedures<br>(21 CFR 884.1720, Product Code HET, Class I) |

#### Marketed device claiming equivalence to

MicroFrance Laparoscopic Instruments are equivalent to Geister Medizintechnik GMBH GIMMI ALPHA Gastro-Urology, & Laparoscopic Endoscopes, Endoscopic Accessories - K012660, Allegiance Healthcare Corp Modular Laparoscopic Grasping Forceps, Scissors - K991928, MicroFrance Electrosurgical Instruments - K993655, and MicroFrance Laparoscopic Manual Surgical Instruments for gynecological use.

### Device Description

The subject instruments include a full line of laparoscopic manual surgical instruments and accessories for various laparoscopic intended uses.

#### Intended Use

Manual surgical instruments are intended for use in a wide variety of surgical procedures including various laparoscopic and endoscopic procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures.

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| | | Comparison to Marketed Devices | | | |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Medtronic Xomed, Inc.<br>MicroFrance Laparoscopic Manual Surgical Instruments, various<br>PROPOSED | Medtronic Xomed, Inc.<br>MicroFrance Laparoscopic Manual Surgical Instruments for Gynecologic Use<br>(Class I exempt) | MicroFrance Electrosurgical Instruments, Various<br>K993655 | Geister Medizintechnik GMBH GIMMI ALPHA Gastro-Urology, & Laparoscopic Endoscopes, Endoscopic Accessories<br>K012660 | Allegiance Healthcare Corp Modular Laparoscopic Grasping Forceps, Scissors<br>K991928. |
| Intended Use | Manual surgical instruments are intended for use in a wide variety of surgical procedures including various laparoscopic and endoscopic procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures | The manual surgical instruments are intended for use in various Gynecological laparoscopic procedures. The instruments enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, or cut internal tissue or organs. | The electrosurgical instruments are intended to remove tissue and control bleeding. The instruments consist of scissors, forceps, and probes available in configurations for laparoscopic/ endoscopic access and open field surgery. | Intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting, and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic closed and minimally invasive procedures. | 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). |
| Material | Stainless Steel<br>Tungsten (Needle Holders)<br>Insulation material | Stainless Steel<br>Insulation material | Stainless Steel<br>Insulation material | Stainless Steel<br>Insulation material | Stainless Steel<br>Insulation material |
| Diameter<br>Lengths | 3mm to 12mm<br>Tube, various from 25cm to 60cm | 3mm, 5mm, 10mm<br>Tube, various from 25cm to 45cm | 3mm, 5mm, 10mm<br>Tube, various from 25cm to 45cm | 5mm<br>Tube, various, from 25cm to 38cm | 3mm, 5mm, 10mm, 11mm<br>Tube various, 32cm to 45cm |
| Types of Devices | Dismantable and Non-dismantable<br>Insulated and non-insulated<br>Forceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knives, Hooks, Knot Guides, Retractors, and Blades | Dismantable and Non-dismantable<br>Insulated and non-insulated<br>Forceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Hook, Knot Guide, and Blades | Dismantable and Non-dismantable Insulated scissors, forceps, and probes | Dismantable and Non-dismantable<br>Insulated and non-insulated<br>Forceps, Probes, Needle Holders, Clamps, Dissectors, Scissors, Knife, Hook, Knot Guide, Retractors, Divers and Blades | Modular and Non-Take Apart<br>Insulated and non-insulated<br>Dissectors, Forceps, Graspers, Scissors, Needle Holders, Retractors |
| Sterility | Distributed non-sterile | Distributed non-sterile | Distributed non-sterile | Distributed non-sterile | Distributed non-sterile |
| Reusable | Yes | Yes | Yes | Yes | Yes |

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Image /page/2/Picture/1 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 double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2008

Medtronic Xomed, Inc. % Jayme Wilson Senior Regulatory Afairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K080257

Trade/Device Name: MicroFrance Laparoscopic Manual Surgical Instruments, various Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET, GCJ Dated: April 17, 2008 Received: May 6, 2008

Dear Jayme Wilson:

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 - Jayme Wilson

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours.

Mark N Mullison

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

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): K080257/S1

Device Name: MicroFrance Laparoscopic Manual Surgical Instruments, various

Manual surgical instruments are intended for use in a wide variety of surgical procedures including various laparoscopic and endoscopic procedures. The instruments are intended to scrape, cut, grasp, hold, remove, or manipulate tissue or structures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nephrol for man

Division of General, Restorative, and Neurological Devices

510(k) Number K080257