PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM

K080674 · PAJUNK GmbH Medizintechnologie · MJG · May 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080674
• Device Name: PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: MJG · General, Plastic Surgery
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

PAJUNK®'s PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.

Device Story

PrimoCut is a sterile, single-use, semi-automated, spring-loaded biopsy cannula system. Designed for soft tissue tumor biopsy, it features an integrated activating mechanism within the connecting hub. The device offers two dissecting lengths (6 mm or 15 mm) for variable biopsy sample sizes. It is disposed of entirely after a single use. The device is operated by clinicians to extract tissue samples; the output is the physical biopsy specimen retrieved for diagnostic evaluation. It serves as an economical, disposable alternative to multi-use systems.

Clinical Evidence

Bench testing and bench marking were conducted to validate the device. No clinical data was required or presented; efficacy was proven through bench testing and biocompatibility evaluation.

Technological Characteristics

Semi-automated, spring-loaded, sterile disposable biopsy cannula. Features integrated activating mechanism in the connecting hub. Available in 6 mm or 15 mm dissecting lengths. Sterilized via EtO.

Indications for Use

Indicated for soft tissue biopsy in patients requiring tissue sampling.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Predicate Devices

• Manan BioCut soft tissue Biopsy needle (K052802)
• TEMNO® semi automated biopsy device, Allegiance (K024120)

Submission Summary (Full Text)

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K080674

# 510(k) Premarket Notification Submission: MAY – 9 2008

# Summary of Safety and Effectiveness

Date of Preparation: March 6th 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

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# Device Information:

| Device Name: | PAJUNK®'s PrimoCut Disposable Biopsy system |
|---------------------------------------|-------------------------------------------------------------------------------------------------|
| Trade Names: | PrimoCut |
| Common Name: | Biopsy cannula, Instrument/ Needle, Kit, Biopsy |
| Classification Name: | Gastroenterology-urology biopsy instrument |
| Classification Reference: | 21 CFR §876.1075, April 1, 2007 |
| Establishment Registration<br>Number: | 9611612 |
| Regulatory Class: | II |
| Product Code: | KNW |
| Panel: | Gastroenterology/Urology |
| Predicate Devices: | 1. K052802 Manan BioCut soft tissue Biopsy needl<br>2. K024120 TEMNO® semi automated biopsy dev |

Allegiance

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# Indications for use:

# PAJUNK®'s PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.

## Device Description:

With PrimoCut. PAJUNK® has developed a disposable cannula system which was especially designed for the extraction of biopsies from soft tissue tumors. Depending on the size of the biopsy material desired, there are two different dissecting lengths to choose from: 6 mm, or 15 mm. Different from the multiple-use biopsy system DeltaCut, the activating mechanism of the PrimoCut is directly integrated in the connecting hub of the cannula. This more economical alternative is disposed of completely after use.

## Predicate Devices:

Predicate devices with identical indications of use are:

- 3. K052802 Manan BioCut soft tissue Biopsy needle
- 4. K024120 TEMNO® semi automated biopsy device, Allegiance

The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.

## Sterilization

The device is single use, sterilized with EtO. The contract sterilizer and the sterilizing process is the same as that used for all Pajunk Products already cleared for market.

## Technology Characteristics:

The PrimoCut is a semi-automated, spring loaded, sterile disposable device for soft tissue biopsies.

## Conclusion:

The comparison between the predicate devices and the subject device in section 12 of this submission as well as the validated sterilization process and the results of the bench testing and bench marking demonstrates that the proposed devices are substantially equivalent to the predicate devices and identical in technical description to devices already cleared for market and therefore demonstrated to be safe and effective. Based on the clinical evaluation, the biocompatibility testing and the bench testing conducted the efficacy of PAJUNK®'s PrimoCut is proven.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY - 9 ZUUG

Re: K080674

Trade/Device Name: PAJUNK®'s PrimoCut Disposable Biopsy System Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: MJG 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 10gally marketed predicate device results in a classification for your device and thus, perrorts your cevrice 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 Riometric'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 N Mulhusen

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: Device Name:

KOBOX 74 PAJUNK®'s PrimoCut Disposable Biopsy system

Indications for Use:

PAJUNK®'s PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.

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)

Neil R. Doyle for mtm
**Division Sign-Off**

Division of General, Restorative and Neurological Devices

**510(k) Number** K080674