PAJUNK®s soft tissue biopsy, puncture and aspiration cannulas and needles are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration.

They are not appropriate for bone biopsies.

Device Description

Chiba SONO cannulas/ needles enhanced for ultrasound visibility are single use sterile and nonpyrogenic devices used to gain entry or puncture the tissue and aspirate soft tissue for biopsy purposes. The needles/ cannulas may be used during all biopsy and puncturing procedures according to the physician´s indication. Additionally fluids for example for fluoroscopy may be injected.

Cannulas/ needles enhanced for ultrasound visibility are standard cannulas/ needles equipped with CornerStone reflectors (cleared in K111374 - SonoPlex STIM) in order to significantly enhance ultrasound visibility.

The cannulas basically consist of stainless steel tubing and an epoxy glued polycarbonate hub.

In order to enhance ultrasound visibility the cannulas are equipped with a special reflector pattern named "CornerStone" imprinted to the cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) Summary of Safety and Effectiveness for a medical device (Chiba SONO cannulas/needles). This type of document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed, rigorous study proving new performance claims against explicit acceptance criteria in the way one might expect for a novel, high-risk AI-powered device. Therefore, some of the requested information (especially around AI-specific elements like MRMC studies, training set details, or complex ground truthing) is not applicable or not provided in this type of submission.

Acceptance Criteria and Device Performance

The document does not explicitly list numerical "acceptance criteria" and "reported device performance" in a quantitative table for, for example, diagnostic accuracy (sensitivity, specificity, etc.), because it's a submission for a biopsy needle based on substantial equivalence to existing devices, not a new diagnostic algorithm.

Instead, the "acceptance criteria" are implied by the requirements for substantial equivalence and the performance of the predicate devices. The "reported device performance" is a qualitative affirmation that the device meets these implied criteria by being substantially equivalent and passing standard industry tests.

Here's an interpretation based on the provided text:

Acceptance Criteria (Implied)	Reported Device Performance
Safety:
Biocompatibility (ISO 10993-1 compliance)	"All cannulas comply with ISO 10993-1, 20d and 3rd edition." Components (stainless steel, polycarbonate hub, epoxy resin glue, optional NanoLine coating) are identical in formulation, processing, and sterilization to those in cleared predicate devices (K063697, K053283), with no added chemicals.
Sterility (SAL of 10^-6) and freedom from chemical/bio/pyroburden	"Cleaning and Sterilization method, which ensures an SAL of 10^-6 as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and EtO-residuals as well as shelf life have been validated and are safe and effective." The contract sterilizer and process are identical to those used for other cleared PAJUNK® devices.
Effectiveness/Functionality:
Mechanical Integrity (bending stability, breaking resistance)	"The needles/ cannulas have been subjected to standard testing applicable for all cannulas. Standard testing consists of bending stability and breaking resistance testing as well as of hub-to-needle-bondage testing." "Due to technological equivalence the subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie. There are no special testing requirements defined, neither in incoming and in-process inspection routines nor in final testing."
Maintains Performance over Shelf Life	"Efficacy of sterile product's lifecycle has been validated for a period of 10 years now. Shelf life is set to 5 years." "Shelf life and impact of sterilization and storage on the devices has been proven and found to be safe and effective."
Ultrasound Visibility Enhancement (CornerStone Technology)	Demonstrated as safe and effective through comparison to predicate and bench testing. "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, safety and effectiveness as well as efficacy of the Cornerstone -technique is demonstrated for each type of cannula."
Substantial Equivalence to Predicate Device	"We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." (FDA statement)

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes "bench testing" for mechanical properties and "bench marking" for general performance. It does not specify a "test set" in the context of patient data or images.
- The "CornerStone" reflectors' efficacy is stated to be "demonstrated for each type of cannula" based on "clinical evaluation, the biocompatibility testing and the bench testing." However, details of this "clinical evaluation" (e.g., sample size, design) are not provided in this summary. Instead, the focus is on the device's technical and material equivalence to previously cleared devices.
- Data provenance: Not specified for any "clinical evaluation." Bench testing would be internal to the manufacturer (Germany).
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 as no specific "test set" requiring expert ground truth in a diagnostic sense is described. The evaluation is based on engineering tests and comparison to predicates.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- No. This device is a physical medical instrument (a biopsy needle), not an AI-powered diagnostic system. Therefore, an MRMC study is not relevant or described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm; it's a physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility, the ground truth is compliance with ISO 10993-1 and material composition identical to cleared devices.
- For sterility, the ground truth is an SAL of 10^-6 and compliance with specific limits, validated by standard methods.
- For mechanical properties, the ground truth is adherence to internal "standard testing" requirements for bending stability, breaking resistance, and hub-to-needle bonding.
- The primary "ground truth" for marketing clearance is substantial equivalence to an existing predicate device based on material composition, intended use, and similar technological characteristics.
The sample size for the training set:
- Not applicable. There is no AI model or "training set" for this physical device.
How the ground truth for the training set was established:
- Not applicable.

Summary

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NOV 2 1 2011

K113209

Page 1 of 3

ﻨﻪ

Summary of Safety and Effectiveness

Date of Preparation: October 27th 2011

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 G. H. Quass Director Regulatory Affairs, Safety Official Patricia Weisbrod, Regulatory Affairs Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com E-Mail: patricia.weisbrod@pajunk.com

USA Contact:

PAJUNK MEDICAL SYSTEMS 6611 Bay Circle, Suite 100 Norcross, GA 30071 Phone: (770) 493 - 6832 ext.111 (678) 514 - 3388 Fax: Cell: (770) 330 - 2724 richard.fischer@pajunk-usa.com

Contact

Richard Fischer MD President Fon: +01(0)770-493-6832 Ext 111 Fax: 678 5143388 E-Mail: Richard.fischer@pajunk-usa.com

Device Information: Device Name: Trade Names:

Common Name:

Classification Name Classification Reference Product Code: Subsequent Product code Establishment Registration Number: Regulatory Class: Panel: Predicate Device:

Contract Sterilizer:

Ethylene Oxide; External service provider, validated procedure.

Needle for puncture/ aspiration/ biopsy Chiba SONO, SONO-Series

Soft tissue puncture, aspiration and biopsy instrument

Gastroenterology-urology biopsy instrument 21 CFR §876.1075, April 1, 2011

KNW

FCG

9611612

Gastroenterology/Urology

K063697 SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT PAJUNK® GmbH Medizintechnologie, Geisingen

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K11 3209

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Indications for use

PAJUNK®s soft tissue biopsy, puncture and aspiration cannulas and needles are intended for obtaining biopsies from soft tissues, for use in puncturing and for aspiration.

They are not appropriate for bone biopsies.

Device Description:

The cannulas basically consist of stainless steel tubing and an epoxy glued polycarbonate hub.

Predicate Devices:

Predicate device with identical indications of use are: - - -------

1. K063697 SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT PAJUNK® GmbH Medizintechnologie, Geisingen
  The detailed discussion of substantial equivalence can be found in Section 12 of this submission.

Sterilization

The contract sterilizer and the sterilizing process are identical to the process and sterilizer used for all PAJUNK® - manufactured and purchased devices which are already cleared for market or exempt. CornerStone-technique does neither influence sterilization process nor shelf life properties.

Cleaning and Sterilization method, which ensures an SAL of 10th as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and EtO-residuals as well as shelf life have been validated and are safe and effective.

Efficacy of sterile product's lifecycle has been validated for a period of 10 years now. Shelf life is set to 5 years.

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K11 3209

Page 3 of 3

Biocompatibility:

All cannulas comply with ISO 10993-1, 20d and 3rd edition.

The stainless steel tubing of the Sono-needles/cannulas is identical to stainless steel tubing of the needles/cannulas as they were cleared for market in K063697 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).

The polycarbonate hub of the Sono-needles/cannulas is identical to the polycarbonate hub of the needles/cannulas as they were cleared for market in K063697 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).

The epoxy resin glue of the Sono-needles/cannulas is identical to the epoxy resin glue of the needles/cannulas as they were cleared for market in K063697 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).

The optional polymeric NanoLine coating of the Sono-needles/cannulas is identical to the polymeric NanoLine coating of the NanoLine-needles/cannulas as they were cleared for market in K053283 in formulation, processing, and sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).

Technology Characteristics:

The components are listed in a table in section 11 of this submission. Shelf life and impact of sterilization and storage on the devices has been proven and found to be safe and effective.

Performance Testing

The needles/ cannulas have been subjected to standard testing applicable for all cannulas. Standard testing consists of bending stability and breaking resistance testing as well as of hubto-needle-bondage testing. Due to technological equivalence the subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie. There are no special testing requirements defined, neither in incoming and in-process inspection routines nor in final testing.

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, safety and effectiveness as well as efficacy of the Cornerstone -technique is demonstrated for each type of cannula.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 2 1 2011

Pajunk GmbH % Mr. Christian G.H. Quass Director, Regulatory Affairs Karl-Hall-Strasse 01 78187 Geisingen, Germany

Re: K113209

Trade/Device Name: Chiba SONO Cannulas/Needles Enhance for Ultrasound Visibility Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW, FCG Dated: October 27, 2011 Received: October 31, 2011

Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Mr. Christian G.H. Quass

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kii 3209

Indications for use

510(k) Number:
Device Name:
Indications for Use:	Indications for Use:

Chiba SONO cannulas/ needles enhanced for ultrasound visibility

PAJUNK®s soft tissue biopsy, puncture and aspiration cannulas and needles 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 CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogden for xm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113209

Page 1 of 1

Regulation Number and Section

§ 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.