PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY

K080654 · PAJUNK GmbH Medizintechnologie · GCJ · May 8, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K080654
• Device Name: PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

PAJUNK®'s Kit for balloon aided laparoscopy is intended for making incisions into the patients body to allow insertion of endoscopes and endoscopic accessories during general and minimal invasive surgical procedures.

Device Story

Kit provides access for minimal invasive surgery; includes common port with trocar and valve closure, plus rigid balloon guidance with obturator and filling syringe. Device facilitates insertion of endoscopic visualization tools. No pneumoperitoneum insufflation required due to balloon guidance length. Port may remain in place for up to 30 days. Used in clinical settings for diagnostics and aftercare. Healthcare providers use the device to create access points for endoscopes; allows manual interventions under visual guidance. Benefits include enhanced safety and effectiveness for monitoring and diagnostic procedures.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, validated sterilization processes, and biocompatibility data.

Technological Characteristics

Kit components: port, trocar, seal closure trocar, balloon guidance, obturator, and 30ml filling syringe. Sterile, single-use. Balloon-based guidance system. No electronic components or software.

Indications for Use

Indicated for patients undergoing general and minimal invasive surgical procedures requiring incision for endoscope and accessory insertion; specifically intended for diagnostics and aftercare.

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

• Trocar Sleeve and accessories – PAJUNK® (K012771)
• TrokaSys – PAJUNK® (K063528)

Submission Summary (Full Text)

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K080654

# 510(k) Premarket Notification Submission:

ﻢ . . . . . . . . .

MAY - 8 2008

# Summary of Safety and Effectiveness for PAJUNK®'s Kit for balloon aided laparoscopy

# Date of Preparation: April 12th 2008

#### Submitter Information/ production site:

Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: [phone] Fax: [phone] Establishment Registration Number: 9611612 Contact:

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

#### USA Contact:

Pajunk Medical Systems German American Trade Center 5126 South Royal Atlanta Drive 30084 Tucker, Georgia USA

# Contact

Stefan Dayagi Fon: +01(0)770-493-9305

E-Mail: [e-mail] Contract Sterilizer:

STERIGENICS GERMANY GMBH Rheingaustrasse 190-196 65203 Wiesbaden, GERMANY Registration Number: 3002807090 Operations: Contract Sterilizer Status: Active

# Device Information:

| Device Name: | PAJUNK®'s Kit for balloon aided laparoscopy |
|------------------------------------|-------------------------------------------------------------------------------------|
| Trade Names: | Balloon Laparoscopes |
| Common Name: | Kit, balloon, trocar, port |
| Classification Name: | Endoscope and accessories |
| Classification Reference: | 21 CFR §876.1500, April 1, 2007 |
| Establishment Registration Number: | 9611612 |
| Regulatory Class: | II |
| Product Code: | GCJ |
| Panel: | Gastroenterology/Urology |
| Predicate Devices: | 1. K012771 Trocar Sleeve and accessories – PAJUNK®<br>2. K063528 TrokaSys – PAJUNK® |

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#### Device Description:

The kit provides a common port with trocar and valve closure (for gaining acces for minimal invasive surgery) packed in a separate bag within the sterilized unit and a rigid balloon guidance with obturator and filling syringe (for insertion of the endoscopic visualisation device) packed in another separate bag. Both units are available seperately and as a procedure unit.

It is especially intended for diagnostics and aftercare in minimal invasive procedures.

Due to the length of the balloon quidance and the clinical practice there is no need to create a pneumoperitoneum via insufflation

The port may be left in place for up to 10 days with the seal closure trocar in place.

The kit is sterile and intended for single use.

#### Indications for use:

PAJUNK®'s Kit for balloon aided laparoscopy is intended for making incisions into the patients body to allow insertion of endoscopes and endoscopic accessories during general and minimal invasive surgical procedures.

#### Additional Claims

It is especially intended for diagnostics and aftercare.

Due to the length of the balloon guidance and the clinical practice there is no need to create a pneumoperitoneum via insufflation.

The port may be left in place for up to 30 days.

### Predicate Devices:

PAJUNK®'s Kit for balloon aided laparoscopy, the subject device of this submission, combines technical features of PAJUNK®'s devices already approved for market. Predicate devices with identical or at least similar indications of use are:

- 1. K012771 Trocar Sleeve and accessories (balloon systems), PAJUNK®
- 2. K063528 TrokaSys, PAJUNK®

While the predicate devices are indicated for minimal invasive procedures the subject device is indicated for inserting and guiding optical endoscopes for aftercare and diagnostics. The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.

#### Sterilization

The sterilization process is the same as that used for all PAJUNK® Products already cleared for market. It has been validated for double-bag packages with the balloon systems and the disposable trocars TrokaSys, predicate devices of this submission.

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## Technology Characteristics:

The Kit consists of the following components arranged in two bags for two steps in procedure:

| Bag 01 | Port |
|--------|------------------------|
| | Trocar |
| | Seal closure trocar |
| Bag 02 | Balloon guidance |
| | Obturator |
| | Filling syringe (30ml) |

### Conclusion:

The comparison between the predicate devices and the proposed devices in section 12 of this submission as well as the validated sterilization process and biocompatibility data demonstrates that the proposed Kit is substantially equivalent to the predicate devices and safe and effective. The optional use of optical devices (image giving endoscopes) in order to monitor the procedure and to conduct manually operated interventions under sight/ view are at least as safe and effective as common techniques are, actually this is intended to enhance safety and effectiveness ..

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol of intertwined ribbons or streams.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 8 2008

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

Re: K080654

Trade/Device Name: PAJUNK®'s Kit for balloon aided laparoscopy Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 21, 2008 Received: April 23, 2008

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 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 yours,

Mark M. Millman

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

K080054

510(k) Number:

Device Name:

PAJUNK®'s Kit for balloon aided laparoscopy

Indications for Use:

PAJUNK®'s Kit for balloon aided laparoscopy is intended for making incisions into the patients body to allow insertion of endoscopes and endoscopic accessories during general and minimal invasive surgical 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)

Nil R.P. Oyal for xxx

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

**510(k) Number** K080654