Kurin PIV Blood Collection Set with High Pressure

K181895 · Kurin, Inc. · JKA · Jan 18, 2019 · Clinical Chemistry

Device Facts

• Record ID: K181895
• Device Name: Kurin PIV Blood Collection Set with High Pressure
• Applicant: Kurin, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Jan 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.

Device Story

Sterile, single-use blood culture collection set with integrated pressure-rated extension set; connects to existing short peripheral IV (PIV) catheter. Device features Kurin Lock technology; diverts and sequesters initial ~1ml of blood to automate discard volume method (DVM); prevents contamination of blood culture samples. Blood flows via pressure gradient into collection holder for vacuum-based culture bottles. Post-collection, blood collection set is disconnected and discarded; pressure-rated extension set remains attached to PIV for infusion of fluids, medications, or blood products. Rated for power injection up to 325 psi. Used in clinical settings by healthcare providers. Benefits include reduced blood culture contamination and streamlined workflow by combining collection and infusion access.

Clinical Evidence

Bench testing only. Testing included sterilization validation, shelf-life (accelerated aging), visual inspection, gross leak (bubble emission), peel seal strength, and performance/functionality testing for both the blood collection portion and the pressure-rated extension set (tensile strength, burst pressure).

Technological Characteristics

Sterile, single-use intravascular administration set. Components: luer connection, flexible tubing, blood lock mechanism, blood collection holder. Pressure-rated extension set (325 PSI, 10 mL/sec flow rate, 0.25 mL priming volume). Sterilization: Ethylene Oxide (EO). No energy source; operates via pressure gradient.

Indications for Use

Indicated for patients requiring blood collection via short peripheral catheter and subsequent IV infusion therapy. No specific age or gender restrictions noted. Contraindications not specified.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• Nexus Pressure Rated Extension Sets (K092382)
• Kurin Blood Culture Collection Set (K162233)

Reference Devices

• Biomerieux Shield (K912563)
• BD Vacutainer (K950432)
• Short Saf-T Holder (K081229)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue.

January 18, 2019

Kurin, Inc % Neal Hartman Independent Consultant 892 Summer Moon Road San Marcos, California 92078

Re: K181895

Trade/Device Name: Kurin PIV18 Blood Culture Collection Set with Kurin Lock Technology, includes detachable, pressure-rated, 6" (152mm) microbore extension set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, JKA Dated: December 14, 2018 Received: December 17, 2018

Dear Neal Hartman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K181895

#### Device Name

Kurin PIV18 Blood Culture Collection Set with Kurin Lock Technology, includes detachable, pressure-rated, 6" (152mm) microbore extension set

#### Indications for Use (Describe)

Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.

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

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "kurin" in bold, black font. Above the "i" is a pink teardrop shape. The background is white.

# K181895 – 510(K) SUMMARY

# Submitter Information

| Company Name: | Kurin, Inc. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Address: | 10840 Thornmint Road<br>Suite 111<br>San Diego, CA 92127 |
| Company Phone: | [phone] |
| Contact Person: | Bob Rogers<br>Chairman and CEO<br>[e-mail] |
| Date: | January 17, 2019 |
| <b>Device Identification</b> | |
| Device Trade Name: | Kurin PIV18 Blood Culture Collection Set with Kurin<br>Lock Technology, includes detachable, pressure-<br>rated, 6" (152mm) microbore extension set |
| Common Name: | Intravascular Administration Set/ Blood Collection<br>Set |
| Product Models: | M-PIV18 - Kurin PIV18 Blood Culture Collection Set<br>with Kurin Lock Technology, includes detachable,<br>pressure-rated, 6" (152mm) microbore extension set<br>(with Biomerieux Shield Blood Collection Holder)<br>D-PIV18 – Kurin PIV18 Blood Culture Collection Set<br>with Kurin Lock Technology, includes detachable,<br>pressure-rated, 6" (152mm) microbore extension set<br>(with BD Vacutainer Blood Collection Holder)<br>T-PIV18 - Kurin PIV18 Blood Culture Collection Set<br>with Kurin Lock Technology, includes detachable,<br>pressure-rated, 6" (152mm) microbore extension set<br>(with Short Saf-T Blood Collection Holder) |
| Classification Name(s): | Intravascular Administration Set |
| Classification Regulation(s): | 880-5440 |
| Device Class: | Class II |
| Product Code(s): | FPA, JKA |
| Advisory Panel: | General Hospital |

{4}------------------------------------------------

## Identification of Predicate Device

| Predicate<br>Identifier | Device Name | Regulation No. | Product<br>Code | 510(K)<br>Number | Clearance<br>Date |
|-------------------------|----------------------------------------|--------------------------------------------------------------------------|-----------------|------------------|----------------------|
| Primary | Nexus Pressure Rated<br>Extension Sets | 880.5440<br>Intravascular Administration<br>Set | FPA | K092382 | April 26,<br>2010 |
| Secondary | Kurin Blood Culture<br>Collection Set | 862.1675<br>Tubes, Vials, Systems, Serum<br>Separators, Blood Collection | JKA | K162233 | December<br>23, 2016 |

## Device Description

The Subject device is a sterile, single-use device that consist of a pressure-rated extension set and the blood culture collection set. The blood culture collection set incorporates a luer connection, flexible tubing, blood lock mechanism, and blood collection holder. The pressurerated extension set is connected to the blood collection set via the luer connection. The Subject device is provided to the healthcare facility in this configuration.

The Peripheral IV (PIV) catheter is connected to the pressure-rated extension set via luer connection. Blood travels through the lumen of the Subject device into the blood lock mechanism where the initial draw of blood (approximately 1ml) is diverted and sequestered. The purpose of the sequestration is to automate the discard volume method (DVM). Once the sequestered volume is diverted and retained, the blood continues travel to the blood collection holder where the blood culture sample is obtained.

Once the blood draw process is completed, the blood collection set of the Subject device is disconnected from the pressure-rated extension set and discarded. The pressure-rated extension set is utilized as an infusion system to administer IV fluids, medications, blood and blood products to the patient's vascular system. The pressure-rated extension set is rated to 325 PSI.

Various blood collection holders are incorporated with the Subject device to interfaces with marketed blood culture bottles and vails. These blood collection holders are cleared under K912563 (Biomerieux Shield), K950432 (BD Vacutainer), and K081229 (Short Saf-T Holder). The blood collection holder incorporates a needle that is covered by elastomer boot. The culture bottle is inserted into the blood collection holder where the needle punctures the elastomer cap and provides a pathway for the blood to traveling into the culture bottle. The vacuum of the culture bottle pulls the blood. Once completed, the culture bottle is removed and the elastomer boot covers the needle and seals to fluid path.

## Indications for Use

Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood culture collection set, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood and blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.

| Comparison<br>Feature | Subject Device | Primary Predicate Device<br>(K092382) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Device Name | Kurin PIV18 Blood Culture Collection Set with<br>Kurin Lock Technology, includes detachable,<br>pressure-rated, 6" (152mm) microbore<br>extension set | Nexus Pressure Rated Extension Set |

## Comparison of Technological Characteristics with Primary Predicate Device

{5}------------------------------------------------

| Comparison<br>Feature | Subject Device | Primary Predicate Device<br>(K092382) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation No. | 880.5540 | 880.5540 |
| | Intravascular Administration Set | Intravascular Administration Set |
| Product Code | FPA | FPA |
| Indications for<br>Use | Intended to connect to short peripheral<br>catheter to obtain initial blood draw and when<br>disconnected from the blood culture collection<br>set, the pressure-rated extension set is<br>intended to be utilized with infusions systems<br>to administer IV fluids, mediations, blood and<br>blood products to the patient's vascular<br>system and may be safety used with power<br>injectors at pressures up to 325 psi. | The Nexus Pressure Rated Extension Sets are<br>intended for the use in today's growing<br>professional healthcare environment, including<br>healthcare facilities that utilize infusion<br>systems to administer IV fluids, mediations,<br>blood and blood products to the patient's<br>vascular system and may be safety used with<br>power injectors at pressures up to 325 psi. |
| Infusion Use? | Yes, Extension Set Only | Yes |
| Includes Blood<br>Collection<br>Capabilities | Yes | No |
| Shelf-Life | 2 Years | 5 Years |
| Pressure<br>Rating,<br>Extension Set | 325 PSI | 325 PSI |
| Maximum Flow<br>Rate,<br>Extension Set | 10 mL/second | 10 mL/second |
| Priming<br>Volume,<br>Extension Set | 0.25 mL | 0.25 mL |
| Single-Use? | Yes | Yes |
| Prescription<br>Use? | Yes | Yes |
| Sterile? | Yes, EO | Yes, EO |

The Pressure-Rated Extension Set on the Subject device is actually the predicate device thus the materials, constructions, and manufacturing processes are identical. Based on this, the Subject device is substantial equivalent to the predicated device from the fluid administration standpoint. In addition, the Subject device provides the ability for conduct initial blood draw prior to fluid administration.

The differences in the indication for use statement between the Subject device and the predicate device are not critical and does not affect the safety and effectiveness of the indication for the Pressure-Rated Extension Set is the same however the Subject device is specific to the connection to a short peripheral catheter and its use in blood draws. The predicate device is connected to such devices and can be used in blood draws.

The blood collection technology was cleared under 510(k) K162233 (Secondary Predicate). Refer to the following table for a comparison with the Subject Device:

| Comparison<br>Feature | Subject Device | Secondary Predicate Device<br>(K162233) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Device Name | Kurin PIV18 Blood Culture Collection Set with<br>Kurin Lock Technology, includes detachable,<br>pressure-rated, 6" (152mm) microbore<br>extension set | Kurin Blood Culture Collection Set |
| Regulation No. | 880.5540<br>Intravascular Administration Set | 862.1675 |

{6}------------------------------------------------

| Comparison<br>Feature | Subject Device | Secondary Predicate Device<br>(K162233) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FPA, JKA | JKA |
| Indications for<br>Use | Intended to connect to short peripheral<br>catheter to obtain initial blood draw and when<br>disconnected from the blood culture collection<br>set, the pressure-rated extension set is<br>intended to be utilized with infusions systems<br>to administer IV fluids, mediations, blood and<br>blood products to the patient's vascular<br>system and may be safety used with power<br>injectors at pressures up to 325 psi. | The Kurin Blood Culture Collection Set is a<br>winged blood collection needle with flexible<br>tubing intended for venipuncture to obtain<br>blood samples. It is provided with a safety<br>shield for covering the used venipuncture<br>needle prior to disposal to aid in prevention of<br>needlestick injury if manually activated after<br>blood draw. For blood collection, the set also<br>includes a safety shield and apparatus for<br>connection to vacuum based collection vials |
| Infusion Use? | Yes, Extension Set Only | No |
| Blood Collection<br>Capabilities | Yes, the Kurin blood lock mechanism<br>sequesters the initial sample of blood and the<br>blood collection holder is used to interface<br>with a vacuum tube or culture bottle. There is<br>no energy source, the device fills with blood<br>by differences in pressure gradient. | Yes, the winged needle is used to access the<br>patient's blood stream, the safety shield is<br>used cover the needle after collection, the<br>blood lock mechanism sequesters the initial<br>sample of blood and the blood collection<br>holder is used to interface with a vacuum tube<br>or culture bottle. There is no energy source,<br>the device fills with blood by differences in<br>pressure gradient. |
| Venipuncture<br>needle | No, luer connector | Yes |
| Pressure<br>Rating,<br>Extension Set | 325 PSI | N/A |
| Maximum Flow<br>Rate,<br>Extension Set | 10 mL/second | N/A |
| Priming<br>Volume,<br>Extension Set | 0.25 mL | N/A |
| Single-Use? | Yes | Yes |
| Prescription<br>Use? | Yes | Yes |
| Sterile? | Yes, EO | Yes, EO |
| Shelf-Life | 2 Years | 2 Years |

The main differences between the Subject Device and the Secondary Predicate is the Secondary Predicate includes a venipuncture needle and it is strictly used for blood collection. The Subject Device does not include a venipuncture needle, includes a pressure-rated extension set, and is intended to be used with peripheral catheters for blood collection and the extension set is intended to be used with infusion systems. The Subject Device and Secondary predicate are made of the same materials.

## Summary of Non-Clinical Tests Performed

- . Sterilization
- Sterilization Product Adoptions o
- Sterilization Cycle Comparison o
- Shelf-Life (Accelerated Aging)
-

{7}------------------------------------------------

- Visual Inspection .
- Gross Leak (Bubble Emission) .
- . Peel Seal Strength
- o Performance/Functionality
- Blood collection portion of Subject device .
- Performance/Functionality for pressure-rated extension set .
- Tensile Strength o
- Burst Pressure O

## Conclusion

The Subject device has demonstrated through performance testing that it is substantially equivalent to the commercially available predicate.