Vesco Medical NRFit Tip Syringes

K170218 · Vesco Medical, LLC · FMF · Feb 24, 2017 · General Hospital

Device Facts

• Record ID: K170218
• Device Name: Vesco Medical NRFit Tip Syringes
• Applicant: Vesco Medical, LLC
• Product Code: FMF · General Hospital
• Decision Date: Feb 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.

Device Story

Sterile, single-use piston syringe; consists of polypropylene barrel and plunger with synthetic rubber gasket. Features NRFit ISO 80369-6 compliant tip to facilitate neuraxial-specific connections and prevent misconnections to non-neuraxial devices. Used in hospital settings by medical professionals and trained caregivers. Operates by manual aspiration or compression to inject/withdraw fluids. Provides visual volume measurement via graduated markings on barrel. Benefits patient by reducing risk of medical errors associated with tubing/connector misconnections.

Clinical Evidence

No clinical data. Performance established via non-clinical bench testing, including ISO 80369-6/20 and BS EN ISO 7886-1 compliance, risk analysis, and Design FMEA.

Technological Characteristics

Materials: Polypropylene (barrel/plunger), synthetic rubber (gasket), polydimethylsiloxane (lubricant). Connector: ISO 80369-6 compliant NRFit. Standards: ISO 80369-6:2016, ISO 80369-20:2016, BS EN ISO 7886-1:1997. Sterilization: Ethylene Oxide (EtO). Form factor: Manual piston syringe (3mL, 10mL, 20mL).

Indications for Use

Indicated for patients over 1 year of age requiring fluid injection or withdrawal via neuraxial applications.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Syringes With or Without Needles (K113091)
• Sterile Hypodermic Syringe for Single Use, With or Without Needle (K112057)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 24, 2017

Vesco Medical, LLC % Mark Job Official Correspondent Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K170218

Trade/Device Name: Vesco Medical NRFit Tip Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 23, 2017 Received: January 25, 2017

Dear Mark Job:

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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, 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 (if known)

Device Name

Vesco Medical NRFit™ Tip Syringes

Indications for Use (Describe) The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## TAB 6 510(k) Summary

#### Submitter I.

| Official Contact | Name: Chris O'Keefe<br>Title: VP Product Development and Innovation<br>Email: [e-mail] |
|---------------------|--------------------------------------------------------------------------------------------------------|
| | Vesco Medical<br>Address: 692 N. High Street, Suite 205ef<br>Columbus, Ohio 43215 |
| | Phone: [phone]<br>Fax: [phone] |
| Date of Preparation | November 04, 2016 |

#### II. Device

| Name of Device: | Vesco Medical NRFitTM Tip Syringes |
|---------------------------------------|-------------------------------------------------------------------|
| Common/Usual Name: | Syringe, Piston |
| Device Classification: | Class II |
| Classification Name/<br>Product Code: | General Hospital and Personal Use Devices (21 CFR 880.5860) / FMF |

#### Legally Marketed Predicate Devices III.

- Jiangyin Caina Technology Co., Ltd (Caina) Syringes With or Without Needles (Luer Slip/Lock) were cleared under notification K113091.
- Shanghai Kindly Enterprises Sterile Hypodermic Syringe for Single Use, With or WithoutNeedle (Luer Slip/Lock) were cleared under notification K112057.

#### Device Description IV.

The Vesco Medical NRFit Tip Syringes are sterile, single use devices consisting of rigid polypropylene barrels and plungers with a synthetic rubber gasket. The tips of the syringe barrels are NRFit ISO 80369-6 compliant. The NRFit tip allows for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe barrel is printed with graduated markings indicating, in milliliters, the volume of liquid inside the syringe barrel. The proposed models are listed in Table 6.1.

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| Vesco Medical NRFit Tip Syringes | |
|----------------------------------|--------|
| Model # | Volume |
| VND-603EO | 3 mL |
| VND-610EO | 10 mL |
| VND-620EO | 20 mL |

Table 6.1: Proposed models of Vesco Medical NRFit Tip Syringes

#### Intended Use V.

The Vesco Medical NRFit™ Tip Syringes are intended to inject fluids into or withdraw fluids from the body.

## VI. Comparison of Technological Characteristics with the Predicate

## Device

The proposed Vesco Medical NRFit Tip Syringes and the predicate devices are all intended to injectfluids into or withdraw fluids from the body. These products have similar intended uses, technological characteristics, manufacturing methods, and operating principles. There are no significant differences that would affect the performance of the Vesco Medical NRFit Tip Syringes as compared to the predicate devices. Table 6.2 lists the comparisons of the proposed device to the predicate devices.

Table 6.2: Comparison of Vesco Medical NRFit Tip Syringes to predicate devices regarding substantial equivalence રાજ્યના વાંતિત

| Design Features<br>/ Function | Syringes With or<br>Without Needles<br>K113091<br>(Primary Predicate) | Sterile Hypodermic<br>Syringe for Single<br>Use, With or Without<br>Needle K112057<br>(Secondary<br>Predicate) | Vesco Medical<br>NRFit™ Tip<br>Syringes<br>(Proposed) | Substantial<br>Equivalence |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Syringes with or<br>without needle are<br>intended to inject<br>fluids into or withdraw<br>fluids from the body. | The Sterile<br>Hypodermic Syringe<br>for Single Use with /<br>without needle is<br>intended to be used for<br>medical purposes to<br>inject fluid into or<br>withdraw fluid from<br>body. | The Vesco Medical<br>NRFit™ Tip<br>Syringes are<br>intended to inject<br>fluids into or<br>withdraw fluids from<br>the body. | Substantially<br>equivalent. |
| Intended Use | Syringes with or<br>without needle are<br>intended to inject<br>fluids into or withdraw<br>fluids from the body. | The Sterile<br>Hypodermic Syringe<br>for Single Use with /<br>without needle is<br>intended to be used for<br>medical purposes to<br>inject fluid into or<br>withdraw fluid from<br>body. | The Vesco Medical<br>NRFit™ Tip<br>Syringes are<br>intended to inject<br>fluids into or<br>withdraw fluids from<br>the body. | Substantially<br>equivalent. |
| Environment of<br>Use | Unspecified, hospital<br>use implied | Unspecified, hospital<br>use implied | Hospital | Similar to both. |
| Traditional 510(k) Vesco Medical NRFitTM Tip Syringes | | | | |
| Design Features / Function | Syringes With or Without Needles K113091 (Primary Predicate) | Sterile Hypodermic Syringe for Single Use, With or Without Needle K112057 (Secondary Predicate) | Vesco Medical NRFitTM Tip Syringes (Proposed) | Substantial Equivalence |
| Intended Users | Trained Clinicians (implied) | Trained Clinicians (implied) | Medical Professionals and trained care givers | Similar to both. There are no differences in intended users that would impact equivalence. |
| Patient Population | RX only | RX only | RX only, patients over 1 year | Similar to both. There are no differences in patient population that would impact equivalence. |
| Single Use | Yes | Yes | Yes | Substantially equivalent. |
| Sterility Condition | Sterile (EtO) and non-pyrogenic | Sterile (method unspecified) | Sterile (EtO) and non-pyrogenic | Substantially equivalent. |
| Type of placement | Used with catheter or needle | Used with catheter or needle | Used with catheter or needle with Neuraxial compliant connector | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| NRFit Connector | No; Luer Slip/Lock connector. | No; Luer Slip/Lock connector. | Yes; compliant with ISO 80369-6. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Syringe Barrel and Plunger Material | Polypropylene | Polypropylene | Polypropylene | Substantially equivalent. |
| Syringe Piston Material | Synthetic Rubber | Synthetic Rubber | Synthetic Rubber | Substantially equivalent. |
| Syringe Piston Lube Coating | Polydimethylsiloxane, Silanol Terminated | Medical Grade Silicone | Polydimethylsiloxane Silanol Terminated | Substantially equivalent. |
| Traditional 510(k)<br>Design Features / Function | Syringes With or Without Needles K113091 (Primary Predicate) | Sterile Hypodermic Syringe for Single Use, With or Without Needle K112057 (Secondary Predicate) | Vesco Medical NRFit™ Tip Syringes (Proposed) | Substantial Equivalence |
| Markings on Syringe for Measuring Liquid Volume | TAMPAPUR TPU | Black Medical Grade | TAMPAPUR TPU | Substantially equivalent. |
| Volumes | Various volume sizes based upon customer request | 1 mL, 2 mL, 3 mL, 5 mL, 10 mL, 20 mL, 30 mL, 35 mL, 50 mL | 3 mL, 10 mL, 20 mL | Similar to both. 3, 10 and 20 mL are a subset of sizes cleared under both. |
| Biocompatibility | Biocompatibility testing has demonstrated that this device meets guidelines presented in ISO 10993-1:2009, with the FDA modified matrix presented in General Program Memorandum # G95-1 | Biocompatibility testing has demonstrated that this device meets guidelines presented in ISO 10993-1:2009, with the FDA modified matrix presented in General Program Memorandum # G95-1 | Same materials, manufacturer, manufacturing materials as primary predicate | Substantially equivalent. |
| Piston/Plunger Assembly Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use | Substantially equivalent. |
| Dead Space Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Substantially equivalent. |
| Air Leakage Past Syringe Piston During Aspiration Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Substantially equivalent. |
| Liquid Leakage Past Syringe Piston Under Compression Testing | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Tested and met standards of ISO 7886-1:1997 Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use | Substantially equivalent. |
| Traditional 510(k)<br>Vesco Medical NRFit TM Tip Syringes | | | | |
| Design Features<br>/ Function | Syringes With or<br>Without Needles<br>K113091<br>(Primary Predicate) | Sterile Hypodermic<br>Syringe for Single<br>Use, With or Without<br>Needle K112057<br>(Secondary<br>Predicate) | Vesco Medical<br>NRFit™ Tip<br>Syringes<br>(Proposed) | Substantial<br>Equivalence |
| Fluid Leakage:<br>Connector | Not Applicable; no<br>NRFit Connector | Not Applicable; no<br>NRFit Connector | Tested per ISO<br>80369-20 and met<br>the standards of ISO<br>80369-6 for positive<br>pressure fluid<br>leakage. | The NRFit<br>connector does<br>not change the<br>intended use or<br>function of the<br>proposed device.<br>From the Risk<br>Analysis and<br>DFMEA, it was<br>found that the<br>NRFit connector<br>helps reduce the<br>residual risk of<br>misconnections. |
| Air Leakage:<br>Connector | Not Applicable; no<br>NRFit Connector | Not Applicable; no<br>NRFit Connector | Tested per ISO<br>80369-20 and met<br>the standards of ISO<br>80369-6 for sub<br>atmospheric<br>pressure air leakage. | The NRFit<br>connector does<br>not change the<br>intended use or<br>function of the<br>proposed device.<br>From the Risk<br>Analysis and<br>DFMEA, it was<br>found that the<br>NRFit connector<br>helps reduce the<br>residual risk of<br>misconnections. |
| Stress Cracking:<br>Connector | Not Applicable; no<br>NRFit Connector | Not Applicable; no<br>NRFit Connector | Tested per ISO<br>80369-20 and met<br>the standards of ISO<br>80369-6 for stress<br>cracking. | The NRFit<br>connector does<br>not change the<br>intended use or<br>function of the<br>proposed device.<br>From the Risk<br>Analysis and<br>DFMEA, it was<br>found that the<br>NRFit connector<br>helps reduce the<br>residual risk of<br>misconnections. |
| Traditional 510(k)<br>Vesco Medical NRFit TM Tip Syringes | | | | |
| Design Features / Function | Syringes With or Without Needles K113091 (Primary Predicate) | Sterile Hypodermic Syringe for Single Use, With or Without Needle K112057 (Secondary Predicate) | Vesco Medical NRFit™ Tip Syringes (Proposed) | Substantial Equivalence |
| Resistance to separation from axial load: connector | Not Applicable; no NRFit Connector | Not Applicable; no NRFit Connector | Tested per ISO 80369-20 and met the standards of ISO 80369-6 Resistance to separation from axial load. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to separation from unscrewing: connector | Not Applicable; no NRFit Connector | Not Applicable; no NRFit Connector | Tested per ISO 80369-20 and met the standards of ISO 80369-6 for Resistance to separation from unscrewing. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Resistance to overriding: connector | Not Applicable; no NRFit Connector | Not Applicable; no NRFit Connector | Tested per ISO 80369-20 and met the standards of ISO 80369-6 for Resistance to overriding. | The NRFit connector does not change the intended use or function of the proposed device. From the Risk Analysis and DFMEA, it was found that the NRFit connector helps reduce the residual risk of misconnections. |
| Design Features<br>/ Function | Syringes With or<br>Without Needles<br>K113091<br>(Primary Predicate) | Sterile Hypodermic<br>Syringe for Single<br>Use, With or Without<br>Needle K112057<br>(Secondary<br>Predicate) | Vesco Medical<br>NRFit™ Tip<br>Syringes<br>(Proposed) | Substantial<br>Equivalence |
| NRFit<br>Dimensional<br>Verification | Not Applicable; no<br>NRFit Connector | Not Applicable; no<br>NRFit Connector | Evaluated per ISO<br>80369-20 and met<br>the standards of ISO<br>80369-6 for NRFit<br>dimensional<br>verification. | The NRFit<br>connector does<br>not change the<br>intended use or<br>function of the<br>proposed device.<br>From the Risk<br>Analysis and<br>DFMEA, it was<br>found that the<br>NRFit connector<br>helps reduce the<br>residual risk of<br>misconnections |

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#### VII. Performance Data:

## Non-Clinical Tests

Verification and validation Testing was performed with the Vesco Medical NRFit Tip Syringes. It was found that Vesco Medical NRFit Tip Svringes are in compliance with design and performance requirements according to ISO 80369-6:2016 "Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications," ISO 80369-20:2016 "Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common Test Methods, "and BS EN ISO 7886-1:1997 "Sterile Hypodermic Syringes For Single Use – Part 1: Syringes For Manual Use." A risk analysis and a Design FMEA were conducted on the Vesco Medical NRFit™ Tip Syringes; both yielded acceptable results.

The following testing was conducted on the Vesco Medical NRFit Tip Syringes:

- Basic Syringe Functions per BS EN ISO 7886-1:1997 performed by Jiangyin CainaTechnology 1. Co., Ltd and Vesco Medical
- Determination of Dead Space per BS EN ISO 7886-1:1997 performed by Jiangyin Caina 2. Technology Co., Ltd and Vesco Medical
- 3. Liquid Leakage at Syringe Piston Under Compression per BS EN ISO 7886-1:1997 performed by Jiangyin Caina Technology Co., Ltd and Vesco Medical
- 4. Air Leakage Past Syringe Piston During Aspiration and for Separation of Piston and Plunger per BS EN ISO 7886-1:1997 performed by Jiangyin Caina Technology Co., Ltd and VescoMedical
- Fluid Leakage per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd 5.
- Stress Cracking per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd 6.
- Resistance to separation from axial load per ISO 80369-20:2015, performed by Jiangyin Caina 7. Technology Co., Ltd
- 8. Resistance to separation from unscrewing per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd
- 9. Resistance to overriding per ISO 80369-20:2015, performed by Jiangyin Caina TechnologyCo., Ltd Disconnection by unscrewing per ISO 80369-20:2015, performed by Jiangyin Caina Technology Co., Ltd
- 10. NRFit dimensional verification per ISO 80369-6:2016, performed by Jiangyin Caina Technology Co., Ltd

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## Clinical Tests

Clinical tests were not required to demonstrate performance of Vesco Medical NRFitTM Tip Syringes. Product functionality has been adequately assessed by non-clinical tests.

## Animal Tests

Animal tests were not required to demonstrate the performance of Vesco Medical NRFit Tip Syringes. Product functionality has been adequately assessed by non-animal tests.

## VIII. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Vesco Medical NRFit Tip Syringes are as safe, as effective, and perform as well as or better than the legally marketed devices identified in part III, "Legally Marketed Predicate Devices" of this section.

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