(60 days)
No
The device description and performance studies focus on mechanical function and equivalence to existing non-AI/ML devices. There is no mention of AI, ML, image processing, or data sets for training/testing.
No
The device is described as a biopsy system used for the extraction of tissue, which is a diagnostic procedure, not a therapeutic treatment.
No
The device is described as a biopsy system used for the extraction of tissue samples, which are then typically sent to a lab for diagnostic analysis. The device itself is for sample collection, not for performing the diagnostic analysis or providing a diagnosis.
No
The device description clearly describes a physical, disposable cannula system with an integrated activating mechanism, indicating it is a hardware device for soft tissue biopsy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The PAJUNK® PrimoCut Disposable Biopsy system is a device used to extract a tissue sample from the body. It is a tool for obtaining the sample, not for analyzing it or performing a diagnostic test on it.
- Intended Use: The intended use is "for soft tissue biopsy," which means obtaining a tissue sample. It does not mention any analysis or testing of the sample within the device itself.
The device is a surgical instrument used to collect a sample that could then be used for an in vitro diagnostic test (e.g., a pathology examination of the tissue). However, the device itself is not performing the diagnostic test.
N/A
Intended Use / Indications for Use
PAJUNK®'s PrimoCut Disposable Biopsy system is indicated for soft tissue biopsy.
Product codes
KNW, MJG
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.
The PrimoCut is a semi-automated, spring loaded, sterile disposable device for soft tissue biopsies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4800 Manual surgical instrument for general use.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612
Contact:
Christian Quass, Director Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com
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: stefan.dayagi@pajunk-usa.com
Contract Sterilizer: STERIGENICS GERMANY GMBH Rheingaustrasse 190-196 65203 Wiesbaden, GERMANY Registration Number: 3002807090 Operations: Contract Sterilizer Status: Active
ce,
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 | |
| Number: | 9611612 |
| Regulatory Class: | II |
| Product Code: | KNW |
| Panel: | Gastroenterology/Urology |
| Predicate Devices: | 1. K052802 Manan BioCut soft tissue Biopsy needl |
- K024120 TEMNO® semi automated biopsy dev |
Allegiance
1
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:
-
- K052802 Manan BioCut soft tissue Biopsy needle
-
- 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.
2
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.
3
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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
4
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