VASCULAR SONO

K113196 · PAJUNK GmbH Medizintechnologie · DYB · Feb 6, 2012 · Cardiovascular

Device Facts

• Record ID: K113196
• Device Name: VASCULAR SONO
• Applicant: PAJUNK GmbH Medizintechnologie
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

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 Story

Vascular Sono is a single-use, sterile, non-pyrogenic introducer cannula/needle designed for percutaneous access to veins or arteries. The device features enhanced ultrasound visibility (Cornerstone-technique) to assist clinicians in needle placement under ultrasound guidance. It consists of a stainless steel cannula, polycarbonate hub, and epoxy resin glue; an optional polymeric NanoLine coating is available. The device is used by clinicians in clinical settings to facilitate the insertion of intravascular devices. It does not include safety mechanisms or tear-away features found in some predicate devices. Performance is verified through bench testing, including bending stability, hub-to-needle bonding, breakage resistance, and insertion force. The device provides improved visualization during ultrasound-guided procedures, potentially increasing accuracy and reducing complications during vascular access.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including packaging integrity (DIN EN 868-5, ASTM E 515-05, ASTM F 1929-98), sterilization validation (EtO residuals per ISO 10993-7), and mechanical performance testing (bending rigidity, hub-to-needle bonding, breakage resistance, and insertion force). Biocompatibility is established via compliance with ISO 10993-1 and equivalence to previously cleared Pajunk devices (K040965, K000722, K053283).

Technological Characteristics

Materials: stainless steel tubing, polycarbonate hub, epoxy resin, optional polymeric NanoLine coating. Sensing: enhanced ultrasound visibility (Cornerstone-technique). Energy: none (manual). Connectivity: none. Sterilization: Ethylene Oxide (EtO). Standards: ISO 10993-1 (biocompatibility), ISO 10993-7 (EtO residuals), DIN EN 868-5 (packaging).

Indications for Use

Indicated for use as a catheter introducer to facilitate the placement of intravascular or intravenous devices for diagnostic or interventional procedures through the skin into a vein or artery.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• BD Introsyte Precision Introducer (K020834)
• Safety Introducer Needle (K030135)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] 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: [e-mail]

### Contact:

Christian G. H. Quass Director Regulatory Affairs, Safety Official Patricia Weisbrod, Regulatory Affairs Fon: [phone] Fax: [phone] E-Mail: [e-mail] E-Mail: [e-mail]

### Contact

Richard Fischer MD President Fon: +01(0)770-493-6832 Ext 111 Fax: [phone] E-Mail: [e-mail]

## 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 facilitate<br>placing a catheter through the skin into a vein or artery. |
| Establishment Registration<br>Number: | 9611612 |
| Regulatory Class: | II |
| Product Code: | DYB, OFC, OFD, OEX |
| Panel: | Cardiovascular |
| Predicate Devices: | 1. K020834 BD Introsyte Precision Introducer, BD Medical Systems<br>2. 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
- 2. 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 -<br>Part 5: Sealable pouches and reels of porous materials and plastic film construction -<br>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 [phone] or [phone] 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

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.

| Prescription Use<br>(Per 21 CFR 801.109) | <b>X</b> |
|------------------------------------------|------------------------------------------------|
| AND/OR | Over-The-Counter Use<br>(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

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