The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility -Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono - are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.

Device Description

The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles/ cannulas may be used during all anaesthetic and analgetic procedures according to the physicians indication. Cannulas/ needles for anesthesia and analgesia 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. The tubing is optionally coated for better insertion properties with NanoLine, a copolymeric coating cleared for market in K053283. 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

The provided document is a 510(k) summary for a medical device (cannulas/needles enhanced for ultrasound visibility). It describes the device, its intended use, technological characteristics, and comparison to predicate devices, ultimately concluding substantial equivalence. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by the structure of the request.

The request's format (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)") strongly suggests it's looking for information related to the performance validation of an AI/Machine Learning device, where accuracy metrics, ground truth establishment, and test set details are critical.

The provided document describes a physical medical device (needles), and its validation revolves around:

Bench Testing: Bending stability, breaking resistance, hub-to-needle-bondage.
Biocompatibility: Compliance with ISO 10993-1.
Sterilization: Validation of cleaning and sterilization process, shelf life.
Technological Equivalence: Comparing dimensions, materials, and manufacturing processes to previously cleared predicate devices.

Therefore, I cannot fulfill the request as phrased because the provided document does not contain the type of AI/algorithm performance data, acceptance criteria, or study details that the prompt is asking for.

If the intent was to understand the acceptance criteria for a physical medical device as described in the document, here's a conceptual answer based on the document's content, reinterpreting "acceptance criteria" as the grounds for demonstrating "substantial equivalence":

Based on the provided document, the "acceptance criteria" and "study" are interpreted in the context of demonstrating substantial equivalence for a physical medical device (ultrasound-enhanced needles) rather than an AI/algorithm. No specific quantitative performance acceptance criteria in terms of accuracy, sensitivity, or specificity are mentioned, as this is not an AI/diagnostic device.

Here's an attempt to map the request's structure to the available information, noting significant gaps:

1. A table of acceptance criteria and the reported device performance:

Area of Performance	Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance / Evidence
Mechanical Integrity	Bending stability must be adequate. Breaking resistance must be adequate. Hub-to-needle-bondage must be secure.	"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." (No specific quantitative results are provided in the summary).
Material Biocompatibility	Must comply with ISO 10993-1. Materials must be identical to cleared predicate devices in formulation, processing, and sterilization.	"All cannulas comply with ISO 10993-1, 2nd and 30 edition." "The stainless steel tubing... polycarbonate hub... epoxy resin glue... polymeric NanoLine coating... is identical to... as they were cleared for market in K040965, K000722 and K053283 in formulation, processing, and sterilization, and no other chemicals have been added."
Sterilization & Shelf Life	Must achieve SAL of 10^-6. Must comply with limits for chemical burden, bioburden, pyroburden (LAL), and EtO residuals. Shelf life must be validated.	"Cleaning and Sterilization method, which ensures an SAL of 10^-6 as well 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."
Ultrasound Visibility Enhancement (Key new feature)	Demonstrated efficacy of the "CornerStone"-technique for enhancing visibility.	"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." (Details of what "clinical evaluation" or "efficacy demonstrated" means in terms of specific metrics/studies for ultrasound visibility are not provided in this summary).
Dimensions (Lengths & Diameters)	Must be identical to predicate devices.	Lengths and Diameters tables confirm identity to predicate devices (e.g., Tuohy SONO: 20mm-180mm, 16G-26G, identical to predicate).

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated for any of the "standard testing" (bending, breaking, bonding). The document implies routine internal testing for "each cannula" or "all cannulas," but not a specific study sample size for validation.
Data Provenance: The testing is implied to be internal testing by PAJUNK® GmbH Medizintechnologie in Germany. No mention of retrospective or prospective study types in the context of device performance validation beyond "bench testing" and "biocompatibility testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

N/A. This question is relevant for AI/diagnostic devices where expert labeling establishes ground truth. For this physical device, "ground truth" refers to engineering specifications, material properties, and physical performance against established standards (e.g., ISO, internal company standards). No human "experts" are cited for establishing ground truth in the document's validation section.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

N/A. This is relevant for AI-assisted image interpretation or similar diagnostic tasks. Not applicable to the physical validation of a needle.

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:

N/A. This is specific to AI/diagnostic devices. The device described here is a physical medical needle.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

N/A. Not an algorithm-only device.

7. The type of ground truth used:

For Mechanical Performance: Engineering specifications, physical measurements, and compliance with internal (PAJUNK®) and potentially industry standards for bending, breaking, and bonding.
For Biocompatibility: Compliance with ISO 10993-1 standards and material specifications.
For Sterilization: Measured sterility assurance level (SAL), residual limits, and validated shelf life.
For Ultrasound Visibility: Implied to be assessed in "clinical evaluation" (details not provided) and implicitly by the design ("CornerStone reflectors designed to optimally reflect ultrasound waves"). No explicit 'ground truth' definition like pathology or outcomes data is mentioned; it's a functional claim validated via unspecified means.

8. The sample size for the training set:

N/A. No training set is involved as this is not an AI/Machine Learning device.

9. How the ground truth for the training set was established:

N/A. No training set for an AI model.

In summary, the document details the substantial equivalence of a physical medical device (ultrasound-enhanced needles) to predicate devices through bench testing, biocompatibility, and sterilization validation, rather than the performance validation of an AI/algorithm.

Summary

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汇||3207 ! 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 Requlatory 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 Fax: (678) 514 - 3388 (770) 330 - 2724 Cell: richard.fischer@pajunk-usa.com

Contact

Contract Sterilizer:

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:

Establishment Registration Number:

Regulatory Class:

Panel:

Predicate Device:

Ethylene Oxide: External service provider, validated procedure.

cannulas/ needles enhanced for ultrasound visibility for anesthesia and analgesia

Tuohy Sono, SonoTAP, Quincke Sono, Chiba Sono and Crawford Sono

Anaesthesia conduction needles/ cannulas

needle, conduction, anesthetic (w/wo introducer)

21 CFR §868.5150, April 1, 2011

BSP

9611612

Anesthesiology

K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES PAJUNK® GmbH Medizintechnologie, Geisingen

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Indications for use

The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility -Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono, Sono and Crawford Sono - are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.

Device Description:

Cannulas/ needles for anesthesia and analgesia 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. The tubing is optionally coated for better insertion properties with NanoLine, a copolymeric coating cleared for market in K053283.

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.

Brand names of the original file as well as the corresponding brand names of the are:

Predicate: Tuohy	Subject: Tuohy SONO
Predicate: Quincke	Subject: Quincke SONO, SonoTAP
Predicate: Crawford	Subject: Crawford SONO
Predicate: Chiba (Facette)	Subject: Chiba SONO

Predicate Devices:

Predicate device with identical or at least partial identical indications of use are:

1. K040965 PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES PAJUNK® GmbH Medizintechnologie, Geisingen
  The detailed discussion of substantial equivalence can be found in Section 12 of this

submission.

Technological Characteristics:

Tip Specifications

The tips of the needles/ cannulas covered by this 510(k) are identical to the tips of the original predicate devices submission: Tuohy tip, Beveled tip (which is synonymously used with Chiba tip and facette tip), Crawford tip and Quincke tip (SonoTAP).

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Length

The length of the needles/ cannulas subject to this 510(k) submission are identical to the lengths of the cannulas covered by the predicate device submission.

Tuohy:	20mm-180mm
Quincke:	20mm-180mm
Chiba:	20mm-180mm
Crawford:	20mm-180mm
Tuohy SONO:	20mm-180mm
Sono TAP, Quincke SONO:	20mm-180mm
Chiba SONO:	20mm-180mm
Crawford SONO:	20mm-180mm

Diameters

The diameters of the needles/ cannulas subject to this 510(k) submission are identical to the diameters of the cannulas covered by the predicate device submission.

Tuohy: 16G - 26G	Tuohy SONO: 16G - 26G
Quincke: 16G - 26G	Quincke SONO: 16G - 26G
Chiba: 16G - 26G	Sono TAP, Chiba SONO: 16G - 26G
Crawford: 16G - 26G	Crawford SONO: 16G - 26G

Technical specifications

The material of the cannulas/ needles tubing and hub of the predicate devices is identical to the material of the cannulas/ needles tubing and hub of the subject device. So are the glue connections. Both, subject device and predicate device are glued to the hub.

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 well as compliance with limits for chemical burden, bioburden, pyroburden (i.e. LAL) and EtC-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.

Biocompatibility:

All cannulas comply with ISO 10993-1, 2nd and 30 edition.

The stainless steel tubing of the Sono-needles/cannulas is identical to stainless steel tubing of the NanoLine-needles/cannulas as they were cleared for market in K040965, K000722 and 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.).

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 K040965, K000722 and 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.).

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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 K040965, K000722 and 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.).

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 - cannulas for anaesthesia conduction: Tuohy, Quincke. Crawford. Chiba - and the subject device - cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility - 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Public Health Service

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

Mr. Christian G.H. Quass Director Regulatory Affairs Pajunk GmbH Karl-Hall-Strasse 1 Geisingen GERMANY D-78187

FEB 2 9 2012

Re: K113207

Trade/Device Name: Cannulas/ Needles for Anesthesia and Analgesia Enhanced For Ultrasound Visibility

Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: February 15, 2012 Received: February 21, 2012

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.

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Page 2 - Mr. 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); 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

510(k) Number:

Device Name:

Cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility

Brand name:

Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono

Indications for Use:

The cannulas/ needles for anesthesia and analgesia enhanced for ultrasound visibility -Tuohy Sono, Sono TAP, Quincke Sono, Chiba Sono and Crawford Sono – are intended for the transient delivery of anesthetics to provide regional anesthesia and analgesia or to facilitate placement of a catheter.

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)

L. Schult

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesional, Dental Devices Division of Anesthoolors

510(k) Number. K113207

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).