TROCASYS

K063528 · PAJUNK GmbH Medizintechnologie · GCJ · Jan 17, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063528
• Device Name: TROCASYS
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Device Story

TrocaSys is a manually operated surgical system consisting of disposable trocar sleeves, trocars, obturators, valves, and Hasson cones. Used by physicians in clinical settings to create incisions for endoscope and accessory insertion during general endoscopic and laparoscopic procedures. The device functions as a mechanical access port; the trocar/obturator punctures the body wall, then is removed to allow instrument passage through the sleeve. The system is a disposable version of the previously cleared reusable Pajunk trocar system. It facilitates minimally invasive surgery by providing a stable, sealed entry point for endoscopic tools.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarity to the predicate device.

Technological Characteristics

Manually operated surgical trocar system. Components include disposable trocar sleeves, trocars, obturators, valves, and Hasson cones. Materials and design are identical to the predicate reusable system (K012771). Sterilization via ethylene oxide (EO) at a contract facility.

Indications for Use

Indicated for patients undergoing general endoscopic and laparoscopic procedures requiring incision for the insertion of endoscopes and endoscopic accessories.

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

• Pajunks reusable Trocars, trocar sleeves, dilation balloons and trocar Systems (K012771)

Submission Summary (Full Text)

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# Premarket Notification Submission

# TrocaSys

Image /page/0/Picture/2 description: The image shows the number K063528 at the top. Below that is the word PAJUNK in a bold, sans-serif font. Underneath that is the word MEDIZINTECHNOLOGIE in a smaller, sans-serif font.

# 510(k) Premarket Notification Submission:

#### Summary of Safety and Effectiveness

#### Date of Preparation: November 6th 2006

#### Submitter Information/ production site:

Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: [phone] Fax: [phone]

#### Contact:

Christian Quass, Regulatory Affairs Fon: [phone] Fax: [phone] E-Mail: [e-mail]

Establishment Registration Number:

9611612

#### Device Information:

| Device Name: | Disposable Trocar System |
|------------------------------------|-----------------------------------------------------------------------------------------|
| Trade Names: | TrocaSys |
| Common Name: | Laparoscope, General and Plastic surgery |
| Classification Name: | Endoscope and accessories |
| Classification Reference: | 21 CFR §876.1500, April 1, 2005 |
| Establishment Registration Number: | 9611612 |
| Classification: | Regulatory Class: II |
| Product Code: | GCJ |
| Panel: | General & Plastic Surgery |
| Predicate Devices: | K012771: Pajunks reusable Trocars, trocar sleeves, dilation balloons and trocar Systems |

Contract Sterilizer:

SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Moerfelden-Walldorf Germany

JAN 1 7 2007

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# Premarket Notification Submission

# TrocaSys

MEDIZINTECHNOLOGIE

## Device Description:

The Pajunk TrocaSys consists of disposable trocar sleeves, disposable trocars and obturators and disposable valves (i.e. TrocaTec, TrocaPort, Hasson system for example for insufflation). The system is based on Pajunks reusable Trokars, Trokar sleeves and Accessories already cleared in K012771. The technical description remains unchanged.

The systems and its accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and end propio accessories during general endoscopic and laparoscopic procedures.

The devices follow the FDA Draft Guidance for the Content of Premarket Notifications for Endoscopes used in Gastroenterology and Urology, dated 3/17/95.

The trocars and obturators are used together with the trocar sleeves for puncture of the patient's body. After having made the incision, the trocar is removed to allow insertion of end scope and endoscopic accessories.

The Disposable Hasson Cone, Disposable obturators/ trocars, Disposable Trocar valve, Disposable TrocaTec and Disposable TrocaPort are available seperately.

For a detalied device description please refer to section 11.0 of this submission.

## Disposable TrocaPort

The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient´s body to allow the insertion of endoscopes and endoscopic accessories around general endoscopic and laparoscopic procedures. The TracePort is a component of the system available seperately.

## Disposable TrocaTec

IThe Pajunk TrocaSys is a manually operated surgical! device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures. The TrocaTec is a component of the system available seperately.

## Disposable Trocar valve

The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories aring general endoscopic and laparoscopic procedures. The disposable Trocar value is a component of the system available seperately. It may be used with Pajunks dilation balloon systems also.

## Disposable obturators/ trocars

The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures. The obturators and trocars are components of the system available seperately. They may be used with Pajunks dilation balloon systems also.

## Disposable Hasson Cone

PMN

The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparosiser enable procedures. The Hasson Cone is a component of the system available seperately.

K063582

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" written around the perimeter. Inside the circle is a stylized image of a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 7 2007

Pajunk GmbH Medizintechnologie % Christian Quass Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany

Re: K063528

Trade/Device Name: TrocaSys disposable Trocar System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: January 4, 2007 Received: January 8, 2006

Dear Christian Quass:

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 - Christian Quass

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 yours,

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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# Premarket Notification Submission

### TrocaSys

MEDIZINTECHNOLOGIE

#### Indications for use

510(k) Number:

Device Name:

TrocaSys disposable Trocar System

Indications for Use:

The Pajunk TrocaSys is a manually operated surgicall device intended for making incisions into the patient's body to allow the insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Prescription Use (Per 21 CFR 801.109) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** /<063528

Page 1 of 1

K063582

PMN