As provided in Sec. 870.1340 the PAJUNK®s Vascular Sono cannula/needle is an introducer used to facilitate placing an intravascular or intravenous device for diagnostically or interventional use through the skin into a vein or artery.

Device Description

The Vascular Sono intravenous introducer cannula/needle is a single use sterile and nonpvrogenic medical device used to gain entry or puncture arteries and veins.

AI/ML Overview

The provided text describes a 510(k) summary for the PAJUNK® Vascular Sono vascular introducer cannula/needle, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating that the new device performs similarly to existing, cleared devices for the specified functions, primarily via bench testing and biocompatibility assessments, rather than clinical efficacy studies.

Here's an analysis based on your requested information:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test. Instead, it describes "standard testing applicable for all cannulas" and concludes that the device is "safe and effective" and "substantially equivalent" to predicate devices. The "reported device performance" is a general statement of compliance rather than specific measured values against thresholds.

However, we can infer the types of criteria based on the tests conducted and the overall conclusion of substantial equivalence.

Acceptance Criteria (Inferred from tests and claims of equivalence)	Reported Device Performance
Packaging Integrity:
DIN EN 868-5:2009-09 compliance (materials, test methods)	Implied compliance to standard requirements.
ASTM E 515-05 4a (Bubble Emission test) for seal integrity	Packaging passed this test.
DIN 868-1 and ASTM F 1929-98 (Rhodamin-B-Test, DYE-Test)	Packaging passed this test.
868-10:2009-09 Annex C (Peel-Test)	Packaging passed this test, ensuring sterility can be maintained and packaging can be opened effectively.
Microbiology/Particulates:
LAL-Testing (Pyrogens) compliance	Passed to ensure non-pyrogenic.
Bioburden levels compliance	Passed.
Chemical Burden levels compliance	Passed.
Ethylene-Oxide Residuals acc. 10993-7 compliance	Passed.
Sterility (per batch)	Passed to ensure an SAL of 10^-6, with efficacy proven for a 10-year period (shelf life set to 5 years).
Performance (Mechanical/Physical):
Bending Rigidity/Bending Stability requirements	Device passed these tests, demonstrating structural integrity during use. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie."
Hub to needle bonding strength requirements	Device passed this test, ensuring the hub remains securely attached to the needle. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie."
Breakage resistance requirements	Device passed this test, indicating durability. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie."
Insertion force at point of entry requirements	Device passed this test, ensuring appropriate ease of insertion. "Subject device is tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie."
Biocompatibility:
ISO 10993-1 compliance	All cannulas comply with ISO 10993-1, 20d and 3rd edition. Components (stainless steel tubing, polycarbonate hub, epoxy resin glue, optional polymeric NanoLine coating) are identical to those cleared in previous 510(k)s (K040965, K000722, K053283) in formulation, processing, and sterilization, with no added chemicals, implying existing biocompatibility.
Ultrasound Visibility:	The device is "provided with enhanced ultrasound visibility," similar to a predicate manufactured by BBraun. This is a characteristic, not a performance metric with specific acceptance criteria in this document.
Sterilization Process:
Validated sterilization process	Sterilization process is "identical to the process and sterilizer used for all PAJUNK® - manufactured and purchased devices which are already cleared for market or exempt." Validated to ensure an SAL of 10^-6 and compliance with limits for chemical burden, bioburden, and EtO-residuals. Efficacy of sterile product's lifecycle proven for 10 years; shelf life set to 5 years.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for individual performance tests (bending, bonding, breakage, insertion force, packaging). It refers to "standard testing applicable for all cannulas" and mentions that the device is "tested the same way as each cannula is tested at PAJUNK® GmbH Medizintechnologie." For sterility, it mentions "test for sterility (per batch)."
Data Provenance: The testing was conducted by PAJUNK® GmbH Medizintechnologie, located in Geisingen, Germany. This is a prospective evaluation of newly manufactured devices against established internal standards and relevant international standards (ISO, ASTM, DIN).

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)

This type of information (number and qualification of clinical experts for ground truth) is not applicable to this submission. This 510(k) summary focuses on demonstrating mechanical, material, and sterilization equivalence to existing devices through bench testing and biocompatibility assessments, not on clinical performance or diagnostic accuracy that would require expert-established ground truths on patient data.

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

Not applicable. Adjudication methods are typically used in clinical studies or image-based diagnostic device evaluations where there might be disagreements among expert readers/observers. The tests described here are bench tests with predefined methods and objective measurements (e.g., force, bending angle, chemical levels), which do not require expert adjudication.

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

No. A multi-reader multi-case (MRMC) comparative effectiveness study is designed for evaluating diagnostic or interpretive devices, often involving human readers and AI. This device is a physical medical instrument (introducer cannula/needle), not a diagnostic tool or an AI-assisted system. Therefore, this type of study was not conducted and is not relevant to this submission.

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

No. Standalone algorithm performance is relevant for AI/software as a medical device. The Vascular Sono is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance and material tests, the "ground truth" is implied by the established standards and specifications (e.g., ISO 10993-1 for biocompatibility, DIN and ASTM standards for packaging and sterility, and internal PAJUNK® Medizintechnologie testing standards for mechanical properties). The device's performance is compared against the requirements specified in these standards or the performance of the predicate device.

8. The sample size for the training set

Not applicable. This device submission does not involve machine learning or AI, and therefore, there is no "training set."

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

Not applicable. As there is no training set involved.

Summary

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510(k) Summary

K113196

Date of Preparation: October 27th 2011

Submitter Information/ production site:

Paiunk GmbH Karl-Hall-Strasse 01 78187 Geisingen Germany Fon: +49(0)7704-9291-586 Fax: +49(0)7704-9291-605 Establishment Registration Number: 9611612

USA Contact:

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

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.guass@pajunk.com E-Mail: patricia.weisbrod@pajunk.com

Contact

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

Contract Sterilizer:

External service provider located in Europe

Device Information:

Device Name:	Vascular Sono vascular introducer cannula/needle
Trade Names:	Vascular Sono
Common Name:	Introducer
Classification Name:	Catheter introducer
Classification Reference:	21 CFR § 870.1340 April 1, 2011
	PART 870 -- CARDIOVASCULAR DEVICES
	Subpart B--Cardiovascular Diagnostic Devices
	Sec. 870.1340 Catheter introducer
	(a) Identification. A catheter introducer is a sheath used to facilitateplacing a catheter through the skin into a vein or artery.
Establishment RegistrationNumber:	9611612
Regulatory Class:	II
Product Code:	DYB, OFC, OFD, OEX
Panel:	Cardiovascular
Predicate Devices:	1. K020834 BD Introsyte Precision Introducer, BD Medical Systems2. K030135 Safety Introducer Needle, BBraun Medical, Allentown

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Indications for use

As provided in Sec. 870.1340 the PAJUNK®s Vascular Sono cannula/needle is an introducer used to facilitate placing an intravenous device for diagnostical or interventional use through the skin into a vein or artery.

Device Description:

The Vascular Sono intravenous introducer cannula/needle is a single use sterile and nonpvrogenic medical device used to gain entry or puncture arteries and veins.

Predicate Devices:

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

1. K020834 BD Introsvte Precision Introducer, BD Medical Systems
1. K030135 Safety Introducer Needle, BBraun Medical, Allentown

Predicate Devices are marketed with additional equipment like safety mechanism and tear-away cannula. Basically, the introducer cannula of the predicate devices and the subject device is made from stainless steel.

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. The 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 (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 proven for a period of 10 years now. Shelf life is set to 5 years.

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 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.).

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.).

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Technology Characteristics:

The Vascular Sono is provided with enhanced ultrasound visibility. So is the predicate manufactured by BBraun. Additional Safety features like BBraun and BD offer are not part of the equipment. BD in Addition does provide a tear away cannula.

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-stability 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.

Test Description
Packaging: DIN EN 868-5:2009-09 Packaging for terminally sterilized medical devices -Part 5: Sealable pouches and reels of porous materials and plastic film construction -Requirements and test methods
Packaging: "Bubble Emission test" acc. To ASTM E 515-05 4a
Packaging: Rhodamin-B-Test, DYE-Test acc. To DIN 868-1 and ASTM F 1929-98
Packaging: Peel-Test acc. To 868-10:2009-09 Annex C
Microbiology/Particles: LAL-Testing (Pyrogene)
Microbiology/Particles: Bioburden
Microbiology/Particles: Chemical Burden
Microbiology/Particles: Ethylene-Oxide Residuals acc. 10993-7
Microbiology/Particles: Test for sterility (per batch)
Performance: Bending Rigidity/ Bending Stability
Performance: Hub to needle bonding
Performance: Breakage resistance
Performance: Insertion force at point of entry

Summary of testing conducted on the Vascular SONO

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/ Sono-technique is proven for each type of cannula.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

PAJUNK GmbH C/O Mr. Christian G.H. Quass Director Regulatory Affairs, Safety Official Karl-Hall-Strasse 01 78187 Geisingen Germany

FEB - 6 2012

Re: K113196/S001

Trade/Device Name: Vascular Sono vascular introducer cannula Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: January 9, 2012 Received: January 12, 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.

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 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

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Page 2 - Mr. Christian G.H. Quass

(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 (OS) 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M. A. Hilleben

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for use

510(k) Number:

KII 3196

Device Name: Indications for Use:

Vascular Sono vascular introducer cannula

Prescription Use(Per 21 CFR 801.109)	X
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)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_1(318) كلك الكارك الكارك الكارك الكارك الكارك الكارك الكارك ا

Page 1 of 1

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).