Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

K191832 · Kurin, Inc. · JKA · Feb 4, 2020 · Clinical Chemistry

Device Facts

• Record ID: K191832
• Device Name: Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)
• Applicant: Kurin, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Feb 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood draw. For blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials.

Device Story

Sterile, single-use blood collection set; includes winged venipuncture needle, flexible tubing, blood lock mechanism, and blood collection holder. Needle inserted into peripheral vascular system; blood flows through lumen to blood lock mechanism; side chamber diverts/retains initial ~0.15 ml blood (automated initial specimen diversion volume method). Remaining blood flows to vacuum-based collection vial. Features active, semi-automatic push-button safety shield to cover needle tip post-use. Used by clinicians in clinical settings. Benefits include reduction of needlestick injuries and potential reduction of blood culture contamination via initial specimen diversion.

Clinical Evidence

Bench testing only. Evaluations included sterilization validation (AAMI TIR 28), biocompatibility, pyrogenicity, and performance/stability testing (needle stiffness, breakage, corrosion resistance). Device functionality testing covered leakage, flow rate, needlestick safety mechanism activation, and tensile strength. Packaging integrity was verified via visual inspection, bubble emission, dye penetration, and seal strength testing. Compatibility with various blood culture bottles was confirmed.

Technological Characteristics

Materials: Stainless steel needle tubing (ISO 9626), silicone-coated. Energy: None (manual/vacuum-driven). Dimensions: 21Ga/23Ga, 0.75-inch needle, 12-inch tubing. Connectivity: None. Sterilization: Ethylene Oxide (SAL 10^-6). Packaging: Thermoform tray/Tyvek lidding. Safety: Active, semi-automatic push-button needle shield (ISO 23908).

Indications for Use

Indicated for venipuncture to obtain blood samples in patients requiring blood culture collection. Contraindications: None stated.

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

• Kurin Blood Culture Collection Set (K162233)

Reference Devices

• Saf-T Holder Device (K912563)
• Vacutainer One-Use Holder (K081229)
• Monoject Safety Collection Device (K950432)

Submission Summary (Full Text)

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February 4, 2020

Kurin, Inc Neal Hartman VP, Regulatory Affairs/Quality Assurance 10840 Thornmint Road, Suite 111 San Diego, California 92127

Re: K191832

Trade/Device Name: Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: January 3, 2020 Received: January 6, 2020

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/cfpmn/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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Geeta Pamidimukkala Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K191832

#### Device Name

Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223)

#### Indications for Use (Describe)

The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needle stick injury if manually activated after the blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials.

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

| <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY – K191832

## 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: | February 3, 2020 |

## Device Identification

| Device Trade Name: | Kurin Blood Culture Collection Set with Kurin Lock<br>Technology, Push-Button Needle |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Collection Set |
| Product Models: | M-21221 - Kurin Blood Culture Collection Set with Kurin<br>Lock Technology, 21Ga Push Button Needle, Compatible<br>with BioMerieux Bottles<br>M-21223 - Kurin Blood Culture Collection Set with Kurin<br>Lock Technology, 23Ga Push Button Needle, Compatible<br>with BioMerieux Bottles<br>D-21221 - Kurin Blood Culture Collection Set with Kurin<br>Lock Technology, 21Ga Push Button Needle, Compatible<br>with BD & Thermo Fisher Long-Neck Bottles<br>D-21223 - Kurin Blood Culture Collection Set with Kurin<br>Lock Technology, 23Ga Push Button Needle, Compatible<br>with BD & Thermo Fisher Long-Neck Bottles<br>T-21221 - Kurin Blood Culture Collection Set with Kurin<br>Lock Technology, 21Ga Push Button Needle, Compatible<br>with Thermo Fisher Short-Neck Bottles<br>T-21223 - Kurin Blood Culture Collection Set with Kurin<br>Lock Technology, 23Ga Push Button Needle, Compatible<br>with Thermo Fisher Short-Neck Bottles |
| Classification Name(s): | Tubes, Vials, Systems, Serum Separators, Blood<br>Collection |
| Classification Regulation(s): | 862.1675 |
| Device Class: | Class II |
| Product Code(s): | JKA |
| Advisory Panel: | Clinical Chemistry |

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| Predicate Device | | | | | |
|------------------------------------|----------------------------------------------------------------------|--------------|---------------|----------------|--|
| Device Name | Regulation No. | Product Code | 510(K) Number | Clearance Date | |
| Kurin Blood Culture Collection Set | 862.1675 - Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | K162233 | 12/23/2016 | |

#### Device Description

The Subject Device is a sterile, single-use blood culture collection set. The blood collection set incorporates a venipuncture needle assembly that is connected with flexible tubing to a blood lock mechanism that is connected by flexible tubing to a blood collection holder. Blood collection is accomplished by inserting the venipuncture needle into the patient's peripheral vascular system. Blood will travel up the lumen into the blood lock mechanism where the initial draw of blood (approximately 0.15 ml) is held in a side chamber. The purpose of the side chamber is to automate the initial specimen diversion volume method (ISDVM). Once the side chamber volume is retained, the blood upon connection to a vacuum bottle continues to travel up the lumen to the blood collection holder into the attached blood culture bottle/vial.

The Subject Device's venipuncture needle assembly incorporates an active, semi-automatic needlestick safety design where the safety mechanism is activated via a button on the needle hub. When the safety mechanism is activated, a protective shield is deployed. It advances distally to cover the entire length, including the distal tip, of the venipuncture needle. The protective shield is locked in this position protecting the clinician/patient from needlestick injuries. Silicone coating is applied to the outside of the venipuncture needle, which aids in the insertion into the peripheral vascular system.

The Subject Device incorporates various blood collection holders to interact with various types of vacuum-based collection vials. (The blood collection holders were cleared in : K912563, K081229 and K950432)

#### Indications for Use

The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood draw. For blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials.

## Comparison of Technological Characteristics with Predicate Device

| Comparison<br>Feature | Subject Device | Predicate Device |
|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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 the<br>prevention of needlestick injury if manually<br>activated after the blood draw. For blood<br>collection, the set also includes a blood<br>collection holder for connection to vacuum-<br>based collection vials.<br><br>Note: The change in the terminology from | 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 the<br>prevention of needlestick injury if manually<br>activated after the blood draw. For blood<br>collection, the set also includes a safety<br>shield and apparatus for connection to<br>vacuum-based collection vials. |
| Comparison Table - Subject and Predicate Devices | | |
| Comparison<br>Feature | Subject Device | Predicate Device |
| | "safety shield and apparatus" to "blood<br>collection holder" in the device component<br>does not impact safety and effectiveness.<br>Both terms are referencing the same device<br>component. Three is no change in the<br>device component design. | |
| Infusion indication | No | No |
| Single-use | Yes | Yes |
| Sterile | Yes | Yes |
| Method of<br>sterilization, SAL | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL 10-6 |
| Needlestick<br>mechanism type | Active, semi-automatic (i.e., push button) -<br>Activation is achieved by depressing a<br>spring activated button<br>Note: The change from the Predicate does<br>not impact safety or effectiveness of the<br>device. The push-button design provides<br>protection prior to use with a needle tip | Active, manual (i.e. slide) - Activation is<br>achieved by manually sliding a shield over<br>the needle |
| | protector and covers the needle upon<br>activation after use. Performance testing in<br>the 510(k) submission supports its safety. | |
| | 21 & 23 | |
| Needle Gauge | Note: Not offering the 25 Ga needle<br>configuration does not impact the safety and<br>effectiveness. | 21, 23, & 25 |
| Needle Length | 0.75 Inch | 0.75 Inch |
| Device Length | 12 Inches | 12 Inches |
| Blood Collection<br>Holder | Saf-T Holder Device (MFG: Smith Medical)<br>Vacutainer One-Use Holder (MFG: BD)<br>Monoject Safety Collection Device (MFG:<br>Covidien)<br>Note: The additional blood collection holders<br>does not impact the safety or effectiveness.<br>Each blood collection holder works in the<br>same and interfaces with the standard<br>collection vial however each holder is<br>designed to interface specifically with its<br>manufacturer's culture collection bottle. All | Saf-T Holder Device (MFG: Smith Medical) |
| | holders are design with shielding to the<br>needle and are FDA cleared. | |
| Sterile barrier<br>packaging | Thermoform Tray/Tyvek Lidding Stock<br>Note: The change from the Predicate does<br>not impact safety or effectiveness. The tray<br>sterile barrier packaging was successfully<br>tested to same transportation and seal<br>integrity performance standards conducted | Tyvek/Poly Pouch |
| Comparison Table - Subject and Predicate Devices | | |
| Comparison<br>Feature | Subject Device | Predicate Device |
| | with the predicate. Results are incorporated<br>in the 510(k) submission and does not<br>impact safety or effectiveness. | |
| Principles of<br>operation | Venipuncture needle accesses the patient's<br>vascular system then blood flows up to the<br>blood lock mechanism where the first 0.15ml<br>of blood is held in a side chamber and then<br>blood is directed into the collection lumen.<br>The collection container is connected to a<br>blood collection holder where blood is<br>collected. Needlestick safety mechanism is<br>activated to protect against needlestick<br>injuries. | Venipuncture needle accesses the patient's<br>vascular system then blood flows up to the<br>blood lock mechanism where the first 0.15ml<br>of blood is held in a side chamber and then<br>blood is directed into the collection lumen.<br>The collection container is connected to a<br>blood collection holder where blood is<br>collected. Needlestick safety mechanism is<br>activated to protect against needlestick<br>injuries. |
| Shelf-Life | 6-month<br>Note: The difference in the shelf-life is not<br>based on performance There is not impact<br>to safety or effectiveness. | 1-year initially, currently 2-year |

#### Comparison Table - Subject and Predicate Devices

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## Summary of Evaluations Performed

The following evaluations were conducted to support the 510(k) submission:

- Sterilization (product adoption per AAMI TIR 28) ●
- . Biocompatibility
- Pyrogenicity .
- Performance/Stability ●
- o Needle Performance
- . Stiffness test
- . Resistance to breakage
- I Resistance to corrosion
- o Device Performance
- " Functionality
- . Leakage
- . Flow Rate
- I Needlestick Safety Mechanism
- " Tensile Strength
- o Packaging Integrity
- Visual Inspection
- I Gross Leak (Bubble Emission)
- . Dye Penetration
- . Seal Strength (Peel)

Performance related to blood collection holder and compatibility with blood culture bottles

The following guidance documents and recognized performance standards were utilized in the development of the subject device:

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- . ISO 10993-1:2018 - Biological evaluation of medical devices - Part 1: Evaluation & testing within a risk process
- ISO 1135-3: 2016 Transfusion Equipment for medical use Part 3: Blood-taking sets . for single use
- . ISO 7864:2016 - Sterile hypodermic needles for single use - Requirements and test methods
- . ISO 9626:2016 -- Stainless steel needle tubing for the manufacture of medical devices -Requirements and test methods
- . ISO 23908:2011 - Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters, and needles used for blood sampling
- ISO 11135:2014 Sterilization of health-care products Ethylene oxide . Requirements for the development, validation and routine control of a sterilization process for medical devices
- . ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- FDA Guidance Medical Devices with Sharps Injury Prevention Features (8/9/2005) ●
- FDA Guidance Submission and Review of Sterility Information in Premarket . Notification (510(k)) Submissions for Devices Labeled as Sterile (1/21/2016)

## Conclusion

The Subject Device has demonstrated it is substantially equivalent to the commercially available predicate device based on the intended use and performance testing conducted on the subject device.