(63 days)
No
The device description focuses on the physical components and materials of biopsy and localization needles/cannulas. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The 'Intended Use / Indications for Use' section explicitly states, "Pajunks Breast localization cannulas/ needles are intended for diagnostic sampling of breast tissue during breast biopsy procedures. They are to be used for diagnostic purposes only and are not intended for therapeutic uses."
Yes
The text explicitly states, "Pajunks Breast localization cannulas/ needles are intended for diagnostic sampling of breast tissue during breast biopsy procedures. They are to be used for diagnostic purposes only..." and "The Breast localization cannulas/ needles are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities." This clearly indicates a diagnostic purpose.
No
The device description explicitly details physical components made of medical grade steel and plastic, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the devices are for obtaining biopsies, puncturing, and aspiration from soft tissues. This is a procedure performed on the patient's body to collect a sample.
- Device Description: The description details physical instruments (cannulas, needles, stylets, hubs, depth stops, etc.) used for the physical act of obtaining tissue samples.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device's function is to collect the specimen, not to analyze it.
The device is a tool used in a diagnostic procedure (biopsy), but it is not the diagnostic test itself. The collected tissue sample would then likely be sent to a laboratory for in vitro analysis (e.g., histology), which would be performed using IVD devices and procedures.
N/A
Intended Use / Indications for Use
Breast localization cannulas/ needles
Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue.
Soft tissue puncture and aspiration kit acc. Steinhoff
Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy.
Soft tissue biopsy needle/ cannula, Soft tissue puncture cannula/ needle, Initial Puncture Cannula/ needle, Soft tissue aspiration cannula/ needle, Chiba needle for soft tissue biopsy, puncture and aspiration
Chiba Special tip grinding cannulal needle for soft tissue biopsy, puncture and aspiration
Special Sprotte tip cannula/ needle for aspiration, puncture and biopsy
Pajunks soft tissue biopsy, puncture and aspiration cannulas and needles listed above are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are EO-sterilized, latex-free devices for single use.
It is not appropriate for bone biopsies.
Product codes (comma separated list FDA assigned to the subject device)
KNW, FCG
Device Description
Soft Tissue Biopsy, Puncture and Aspiration Cannulas and Needles
The cannulas and needles consist of medical grade steel, plastic luer hub and stylet (stabilizing mandrin inside cannula). For safety reasons, the graduated puncture cannula also has an additional depthstop installed at the shaft of the cannula.
Aspiration puncture cannula type Chiba Special
The cannula Type Chiba Special has been developed by PAJUNK® with an approx. 1 cm matted finish of the cannula tip and three additional ring-markings.
Aspiration puncture cannula type Chiba with beveled tip
For safety reasons, the graduated puncture cannula/ needle has an additional depth-stop installed at the shaft. As a standard, the cannulas/ needles with beveled tip are normally equipped with a handle plate and a depth stop.
Initial puncture cannula
This universally usable puncture cannula/ needle made of high-grade stainless steel is suitable for all percutaneous punctures with guidance wires. It is available in a 2-parted and in a 3-parted version, with and without graduation. The outer cannula has a rounded, blunt tip, and it is designed to match the inside stylet-cannula.
Special puncture cannula with atraumatic Sprotte tip
This cannula with a Special Sprotte tip is intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. It is an EO-sterilized, latex-free device for single use.
Interventinal micro cannula Chiba type
For better depth control, the interventional micro-cannula features graduated collars at intervals of 1 cm.
Aspiration-puncture cannula with injecting tube acc. Steinhoff
The puncture kit according Dr. Steinhoff contains a Chiba-type puncture cannula/ needle with a cannula rider and a flexible tube. The millimeter-precise introduction of the puncture needle by means of the cannula rider is facilitated with the aid of the centimeter-graduation and the corresponding markings at intervals of 5 mm. Thereby, the needle can be quided safely, without lacking the necessary flexibility.
Breast Localization cannulas
Pajunks breast localization cannulas can be used in Mammographic procedures to obtain breast lesion tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast, soft tissues
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.
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.
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
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្រុងប្រទេស MEDIZINTECHNOLOGIE
510(k) Premarket Notification Submission:
Summary of Safety and Effectiveness
Date of Preparation: November 29th, 2006
FEB 1 4 2007
| Submitter Information/ production site: | USA Contact: |
|---|---|
| Pajunk GmbH | Pajunk Medical Systems |
| Karl-Hall-Strasse 01 | German American Trade Center |
| 78187 Geisingen | 5126 South Royal Atlanta Drive |
| Germany | 30084 Tucker, Georgia |
| Fon: +49(0)7704-9291-586 | USA |
| Fax: +49(0)7704-9291-605 | |
| Establishment Registration Number: 9611612 | |
| Contact: | Contact |
| Christian Quass, Director Regulatory Affairs | Stefan Dayagi |
| Fon: +49(0)7704-9291-586 | Fon: +01(0)770-493-9305 |
| Fax: +49(0)7704-9291-605 | |
| E-Mail: christian.quass@pajunk.com | E-Mail: stefan.dayagi@pajunk-usa.com |
| Contract Sterilizer: | |
| Sterigenics SteriPro Lab & EO Facility | |
| Dreieichstrasse 7 | |
| 64546 Moerfelden | |
| RN: 3002807090 | |
| Device Information: | |
| Trade Names: Chiba, Chiba Special, Special Sprotte, Kit acc. | |
| Dr. Steinhoff, Initial Puncture needle/ cannula, | |
| Breast Localization cannula/ needle | |
| Common Name: Pajunks soft tissue biopsy, puncture and | |
| aspiration cannulas and needles | |
| Classification Name: Gastroenterology-urology biopsy instrument | |
| Handheld biopsy instrument | |
| Classification Reference: 21 CFR § 876.1075, April 1st, 2006 | |
| 21 CFR § 878.4800, April 1st 2006 | |
| Additional Classification: Kit, Needle, Biopsy | |
| Additional Classification Reference: Gastroenterology-urology biopsy instrument. | |
| Poposed Classification: Regulatory Class II | |
| Product Classification Code: KNW | |
| Additional Product Classification Code: FCG | |
| Classification Panel: Gastroenterology/ Urology | |
| Additional Review Advisory Committee: General & Plastic Surgery | |
| Predicate Devices: | 1. K980211 Manan MRI Chiba, spinal, |
| breast localization etc. |
1
pg 2 of 4
DIZINTECHNOLOGIE
Indications for use
Breast localization cannulas/ needles
Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue.
Soft tissue puncture and aspiration kit acc. Steinhoff
Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy.
Soft tissue biopsy needle/ cannula, Soft tissue puncture cannula/ needle, Initial Puncture Cannula/ needle, Soft tissue aspiration cannula/ needle, Chiba needle for soft tissue biopsy, puncture and aspiration
Chiba Special tip grinding cannulal needle for soft tissue biopsy, puncture and aspiration
Special Sprotte tip cannula/ needle for aspiration, puncture and biopsy
Pajunks soft tissue biopsy, puncture and aspiration cannulas and needles listed above are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. They are EO-sterilized, latex-free devices for single use.
It is not appropriate for bone biopsies.
Device Description
Soft Tissue Biopsy, Puncture and Aspiration Cannulas and Needles
The cannulas and needles consist of medical grade steel, plastic luer hub and stylet (stabilizing mandrin inside cannula). For safety reasons, the graduated puncture cannula also has an additional depthstop installed at the shaft of the cannula.
Aspiration puncture cannula type Chiba Special
The cannula Type Chiba Special has been developed by PAJUNK® with an approx. 1 cm matted finish of the cannula tip and three additional ring-markings.
Aspiration puncture cannula type Chiba with beveled tip
For safety reasons, the graduated puncture cannula/ needle has an additional depth-stop installed at the shaft. As a standard, the cannulas/ needles with beveled tip are normally equipped with a handle plate and a depth stop.
Initial puncture cannula
This universally usable puncture cannula/ needle made of high-grade stainless steel is suitable for all percutaneous punctures with guidance wires. It is available in a 2-parted and in a 3-parted version, with and without graduation. The outer cannula has a rounded, blunt tip, and it is designed to match the inside stylet-cannula.
Special puncture cannula with atraumatic Sprotte tip
This cannula with a Special Sprotte tip is intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration. It is an EO-sterilized, latex-free device for single use.
Interventinal micro cannula Chiba type
For better depth control, the interventional micro-cannula features graduated collars at intervals of 1 cm.
2
pg 3 of 4
MEDIZINTECHNOLOGIE
Aspiration-puncture cannula with injecting tube acc. Steinhoff
The puncture kit according Dr. Steinhoff contains a Chiba-type puncture cannula/ needle with a cannula rider and a flexible tube. The millimeter-precise introduction of the puncture needle by means of the cannula rider is facilitated with the aid of the centimeter-graduation and the corresponding markings at intervals of 5 mm. Thereby, the needle can be quided safely, without lacking the necessary flexibility.
Breast Localization cannulas
Pajunks breast localization cannulas can be used in Mammographic procedures to obtain breast lesion tissue.
Predicate Devices:
Predicate Device for Pajunks soft tissue biopsy and aspiration cannulas and needles are the cannulas and needles cleared for market by Manan in K980211. These devices have identical indications for use and the same technical specification in materials and grinding as Pajunks cannulas.
Pajunks Chiba cannulas/ needles are already cleared for a different intended use (anesthesia conduction, spinal and epidural) in K040965.
The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.
Sterilization
Pajunks soft tissue biopsy and aspiration cannulas and needles are supplied packed in a blister as single-use, sterile, pyrogenfree and latex free disposable cannulas.
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. All cannulas are very similar in dimensions and materials.
Sterilization of Pajunks soft tissue biopsy and aspiration cannulas and needles at Sterigenics is being done according to a documented process. This Ethylene Oxide sterilization process is recurrently evaluated for suitability and effectiveness and the results are acceptable.
Sterilization of the Pajunks soft tissue biopsy and aspiration cannulas and needles is accomplished using Ethylene Oxide (EO) sterilization to a Sterility Assurance Level (SAL) of