(63 days)
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 not appropriate for bone biopsies.
Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy.
Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue. 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. The Breast localization cannulas/ needles are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. This device is not indicated for use under MR based imaging technologies, such as MRI.
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.
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.
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.
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.
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.
For better depth control, the interventional micro-cannula features graduated collars at intervals of 1 cm.
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.
Pajunks breast localization cannulas can be used in Mammographic procedures to obtain breast lesion tissue.
The provided document is a 510(k) Premarket Notification Submission for various soft tissue biopsy, puncture, and aspiration cannulas and needles. It is a submission seeking substantial equivalence to a predicate device, rather than a study demonstrating that a device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement is not present in this type of regulatory document.
However, based on the information provided, here's what can be inferred and what is explicitly stated:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or a performance study with reported metrics. The submission is a claim of "substantial equivalence" to a predicate device, meaning it asserts that the new device is as safe and effective as a legally marketed device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) premarket notification for substantial equivalence, not a clinical study. The submission relies on a comparison to a predicate device and bench testing (e.g., sterilization, biocompatibility, packaging) rather than a clinical trial with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set requiring expert ground truth is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical instrument (cannulas and needles), not an AI-powered diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is typically the established safety and effectiveness of the predicate device (K980211 Manan MRI Chiba, spinal, breast localization etc.). The new device aims to be substantially equivalent to this standard.
8. The sample size for the training set
Not applicable. This is a physical medical instrument, not an AI model.
9. How the ground truth for the training set was established
Not applicable.
Summary based on the provided document:
The submission explicitly states its approach:
- Acceptance Criteria (Implied): The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to the predicate device (Manan Medical's cannulas and needles, cleared under K980211). This means showing the new device is as safe and effective as the predicate.
- Study Proving Device Meets Acceptance Criteria: The "study" is a comparative analysis documented in Section 12 of the submission (not provided here).
- Basis of Comparison: The submission states, "The comparison between the predicate devices and the proposed device in section 12 of this submission demonstrates that the proposed device is safe and effective, as well as substantially equivalent to the predicate devices."
- Key points of the comparison for substantial equivalence:
- Identical Indications for Use: The predicate device and the proposed device share "identical indications for use" for their respective categories (e.g., breast localization, soft tissue biopsy).
- Same Technical Specification: The proposed device has the "same technical specification in materials and grinding" as the predicate device.
- Biocompatibility: All materials are medical grade steel and plastic, which have been cleared in previous 510(k) applications (K040965 for Anesthesia conduction, spinal and epidural) and are "deemed to be biocompatible." Testing according to ISO 10993 has been conducted successfully using identical materials.
- Sterilization: The device uses Ethylene Oxide (EO) sterilization to a Sterility Assurance Level (SAL) of < 10⁻⁶, performed by a contract sterilizer (Sterigenics) and process that is "the same as that one used for all further Pajunk products already cleared for market in the USA." This process is "recurrently evaluated for suitability and effectiveness and the results are acceptable."
- Packaging and Labeling: "The same validations, in-process-controls, procedures and materials" are used as for Pajunk's previously cleared disposable anesthesia conducting cannulas/needles.
- Standards: Applicable sections of FDA's "GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR BIOPSY DEVICES USED IN GASTROENTEROLOGY AND UROLOGY" were considered, and a declaration of conformity with applicable standards is mentioned in Section 9.0 (not provided).
In essence, the "study" for this 510(k) is a technical and regulatory argument demonstrating that the new device does not raise new questions of safety or effectiveness when compared to a previously cleared device. It relies on shared design principles, materials, manufacturing processes, and established regulatory standards.
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s 1 of 4
្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 andaspiration cannulas and needles | |
| Classification Name: Gastroenterology-urology biopsy instrumentHandheld biopsy instrument | |
| Classification Reference: 21 CFR § 876.1075, April 1st, 200621 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. |
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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 < 10°. After manufacture the cannulas are arranged in a foil bag which is sealed. EO sterilization is accomplished with exposure to 100% EO in accordance with AAMI/ISO 10993-7.
Packaging and Labeling
The cannulas and needles subject to this premarket notification are packed and labeled employing the same validations, in-process-controls, procedures and materials as Pajunks disposable anesthesia conducting cannulas/ needles already cleared for market.
A process descriptions for labeling and packaging can be found in section 13.0 of this submission.
Biocompatibility status
All materials employed in the manufacturing process that may come in contact with blood, tissue or fluids to be injected have been cleared in Pajunks former 510(k) applications. Therefore they are deemed to be biocompatible. Testing according to ISO 10993 has been conducted successfully employing cannulas/ needles that consists of identical materials.
Furthermore these materials are long term proven materials for the use with medical devices.
PMN
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pg 4 of 4
MEDIZINTECHNOLOGIE
Standards
There are no special standards applicable for the cannulas and needles. Applicable sections of FDA´s GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR BIOPSY DEVICES USED IN GASTROENTEROLOGY AND UROLOGY have been taken into regard.
A list of all standsrds applicable as well as a declaration of conformity with this standards can be found in section 9.0 of this submission.
Conclusion:
The comparison between the predicate devices and the proposed device in section 12 of this submission demonstrates that the proposed device is safe and effective, as well as substantially equivalent to the predicate devices.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines forming the snake and staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pajunk GmbH % Christian Quass Director Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany
FEB 1 4 2007
Re: K063697
Trade/Device Name: Soft Tissue Biopsy, Puncture and Aspiration Cannulas and Needles Initial puncture cannula/needle Special puncture cannula with atraumatic Sprotte tip Aspiration puncture cannula type Chiba Special Aspiration puncture cannula type Chiba with beveled tip Interventional micro cannula Chiba type Soft tissue puncture and aspiration kit acc. Steinhoff Breast localization cannulas/needles Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: KNW. FCG Dated: December 9, 2006 Received: December 13, 2006
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.
{5}------------------------------------------------
Page 2 - Christian Quass
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.
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 legal/y 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may ohtain other general information on your responsibilities under the Act from the Division of Swall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
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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g l ots
Image /page/6/Picture/3 description: The image shows the word "PAJUNK" in large, bold, white letters. Below this word is the word "MEDIZINTECHNOLOGIE" in smaller, black letters. The background of the image is a textured pattern.
Indications for use
510(k) Number:
Device Name:
Soft Tissue Biopsy, Puncture and Aspiration Cannulas and Needles Initial puncture cannula/ needle Special puncture cannula with atraumatic Sprotte tip Aspiration puncture cannula type Chiba Special Aspiration puncture cannula type Chiba with beveled tip Interventional micro cannula Chiba type
Indications for Use:
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 not appropriate for bone biopsies.
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 CDRA, Office of Device Evaluation (ODE)
P. Mo
(Division Sign-Of Division of General, Rest prative, and Neurological Devices
510(k) Number /K06362
Page 1 of 1
AK063697.doc
{7}------------------------------------------------
pg 2 of 3
Image /page/7/Picture/3 description: The image contains the word "PAJUNK" in large, bold, white letters. Below "PAJUNK" is the word "MEDIZINTECHNOLOGIE" in smaller, thinner letters. The background of the image is a grainy, dark texture, which contrasts with the white text.
Indications for use
| 510(k) Number: | K063697 |
|---|---|
| Device Name: | Soft tissue puncture and aspiration kit acc. Steinhoff |
| Indications for Use: |
Pajunks soft tissue puncture and aspiration Kit acc. Steinhoff is intended for use in puncturing and aspiring for soft tissue biopsy.
Prescription UseX
(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)
{8}------------------------------------------------
Indications for use
| 510(k) Number: |
|---|
| ---------------- |
Device Name:
Breast localization cannulas/ needles
Indications for Use:
Pajunks breast localization cannulas/ needles can be used in Mammographic procedures to obtain breast lesion tissue.
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.
The Breast localization cannulas/ needles are indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
This device is not indicated for use under MR based imaging technologies, such as MRI.
Prescription Use X
(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)
Page 1 of 1
§ 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.