(187 days)
No
The document describes a mechanical biopsy system with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is intended for obtaining biopsies for diagnostic purposes, not for treating a condition or disease.
No
This device is used to obtain biopsies, which are samples of tissue. Biopsies are then analyzed diagnostically, but the device itself is a tool for obtaining the sample, not for performing the diagnosis.
No
The device description explicitly details physical components: a reusable biopsy gun and a disposable cannula. It describes mechanical actions (spring-loaded, adjustable penetration depths, triggers, shooting out of cannulas) and physical characteristics (sterile, non-sterile, various diameters and lengths). There is no mention of software as a component or function of the device.
Based on the provided text, the PAJUNK DeltaCut biopsy system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The PAJUNK DeltaCut system is a device used to obtain the tissue sample (biopsy) from the body. It is a tool for collecting the specimen, not for analyzing it.
The text clearly describes the device as a "biopsy system" and "biopsy cannulas" intended for "obtaining biopsies from soft tissues and soft tissue tumors." This is a procedure performed in vivo (within the body) to collect a sample for subsequent in vitro analysis (which would be done using IVD devices).
N/A
Intended Use / Indications for Use
The PAJUNK DeltaCut biopsy system is intended for obtaining biopsies from soft tissues and soft tissue tumors. It is not appropriate for bone biopsies.
The PAJUNK DeltaCut biopsy system consists of a gun and a disposable cannula. It is intended for obtaining biopsies from soft tissues and soft tissue tumors. It is not appropriate for bone biopsies.
The Pajunk DeltaCut biopsy cannulas are single use sterile devices. They are intended for obtaining biopsies from soft tissues and soft tissue tumors. They are only to be used in combination with the DeltaCut biopsy gun, but they are available separately. It is not appropriate for bone biopsies.
Product codes (comma separated list FDA assigned to the subject device)
KNW
Device Description
DeltaCut consist of a non-sterile biopsy gun and a sterile biopsy cannula.
The PAJUNK DettaCut biopsy gun is a reusable, spring-loaded, core biopsy device. It features adjustable penetration depths of 15 mm to 22 mm and is sold non-sterlie (see directions for cleaning, sterilization and lubrication).
The Pajunk DeltaCut biopsy needle is a disposable needle intended for single use with the Pajunk DeltaCut biopsy gun. The DeltaCut biopsy needle is packaged individually and sterile. It is available in various diameters and lengths. For single patient use. Do not reuse. Do not resterilize.
DeltaCut is a cannula system made by Pajunk®, which was developed specifically for the extraction of biopsies from soft tissue.
The device is equipped with a visual and mechanical safety-system. Two triggers permit ergonomic handling for right and lefthanded application, regardless of the position of the extraction location. The puncture depth can be adjusted variable on a scale from 15 to 22 mm.
The biopsy extraction is carried out in two steps and takes only seconds:
- First, the inner cannula shoots out forwards and is filled with tissue.
2 Then the cutting cannula instantaneously sildes over it, thereby closing the biopsy chamber and protecting the biopsy material from contamination,
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues and soft tissue tumors
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K883469 Bard® Aspiration Biopsy System ("Magnum")
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K911221, K911202, K911260, K043130, K033018
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
DeltaCut Biopsy system Premarket Notification Submission
Image /page/0/Picture/2 description: The image shows the word "PAJUNK" in large, bold letters. Below that, the word "MEDIZINTECHNOLOGIE" is written in a smaller font. The background of the image is a textured pattern.
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: October 16th, 2006
APR 3 0 2007
Submitter Information/ production site:
Pajunk GmbH Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-0 Fax: +49(0)7704-9291-610 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 FDA-ERN: 3002807090
Device Information:
| Trade Names: | DeltaCut® Biopsy System (Gun and Cannula) |
|---|---|
| Common Name: | Biopsy cannulas and biopsy gun |
| Classification Name: | Instrument, biopsy |
| Classification Reference: | 21 CFR §876.1075, April 1, 2005 |
| Additional Classification: | Guide, needle, surgery |
| Additional Classification | |
| Reference: | 21CFR§876.1075, April 1, 2005 |
| Proposed Classification: | Regulatory Class II |
| Proposed Product | |
| Classification Code: | KNW |
| Classification Panel: | Gastroenterology/ Urology |
| Additional Review | |
| Advisory Committee: | General & Plastic Surgery |
| Predicate Devices: | 1. K883469 Bard® Aspiration Biopsy System ("Magnum") |
1
DeltaCut Blopsy system
Premarket Notification Submission
Image /page/1/Picture/2 description: The image shows the logo for PAJUNK MEDIZINTECHNOLOGIE. The word "PAJUNK" is in large, bold, white letters. Below that, the word "MEDIZINTECHNOLOGIE" is in smaller, black letters.
Indications for use
The PAJUNK DeltaCut blopsy system is intended for obtaining biopsies from soft tissues ans soft tissue tumors.
It is not appropriate for bone blopsies.
The single use, sterile, seperately packaged DeltaCut cannulas are available seperately.
Device Description/ Technology Characteristics
DeltaCut consist of a non-sterile biopsy gun and a sterile biopsy cannula.
The PAJUNK DettaCut biopsy gun is a reusable, spring-loaded, core biopsy device. It features adjustable penetration depths of 15 mm to 22 mm and is sold non-sterlie (see directions for cleaning, sterilization and lubrication).
The Pajunk DeltaCut biopsy needle is a disposable needle intended for single use with the Pajunk DeltaCut biopsy gun. The DeltaCut biopsy needle is packaged individually and sterile. It is available in various diameters and lengths. For single patient use. Do not reuse. Do not resterilize.
Device Description: DeltaCut® Blopsy System (Gun and Cannula)
DeltaCut is a cannula system made by Pajunk®, which was developed specifically for the extraction of biopsies from soft tissue.
The device is equipped with a visual and mechanical safety-system. Two triggers permit ergonomic handling for right and lefthanded application, regardless of the position of the extraction location. The puncture depth can be adjusted variable on a scale from 15 to 22 mm.
The biopsy extraction is carried out in two steps and takes only seconds:
-
- First, the inner cannula shoots out forwards and is filled with tissue.
- 2 Then the cutting cannula instantaneously sildes over it, thereby closing the biopsy chamber and protecting the biopsy material from contamination,
Predicate Devices:
Predicate Device for Pajunks DeltaCut system is the Bard® Magnum Biopsy system cleared and marketed under K883469. Both, the Pajunk System and the Bard system consist of a springload gun supplied non-sterile and a special designed biosy cannula marketed sterile.
The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.
Sterilization
The reusable DeltaCut Biopsy gun is supplied non-sterile and has to be cleaned and sterilized before each use.
The DeltaCut cannula is supplied seperately packed in a blister. It is a single-use, sterile, pyrogenfree and latex free disposable cannula only to be used with the DeltaCut gun.
The contract sterilizer and the sterilizing process at Sterigenics is the same as that one used for all further Pajunk products already cleared for market in the USA. The DeltaCut cannula is not the worst-case-product which indeed is the Sprotte (K911221, K911202, K911260) and the StimuLong Kit (K043130, K033018) within Pajunks sterilization process. The cannulas are very similar in dimensions and materials.
2
DeltaCut Biopsy system
Premarket Notification Submission
Image /page/2/Picture/2 description: The image shows the word "PAJUNK" in large, bold, white letters against a dark, textured background. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, less bold letters. The text appears to be a logo or heading, possibly for a medical technology company.
Sterilization of Pajunk's DeltaCut Blopsy cannulas at Sterigenics is being done according to a documented process. This Ethylene Oxide sterillzation process is recurrently evaluated for suitability and effectiveness and the results are acceptable.
Sterilization of the Blopsy cannulas is accomplished using Ethylene Oxide (EO) sterilization to a Sterility Assurance Level (SAL) of