Kurin Blood Culture Collection Set with Kurin Lock Technology

K220677 · Kurin, Inc. · JKA · Apr 28, 2023 · Clinical Chemistry

Device Facts

• Record ID: K220677
• Device Name: Kurin Blood Culture Collection Set with Kurin Lock Technology
• Applicant: Kurin, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Apr 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Kurin Blood Culture Collection Set is intended to obtain blood samples through the patient's vasculature via venipuncture or Peripheral IV (PIV) access. As it enters the Kurin Lock, blood initially fills a side channel then flows into the sample collection device (syringe or bottle) via an adjoining sampling channel to reduce blood culture contamination rates *. When supplied with a pressure-rated extension set, the pressure-rated extension set is intended to be utilized separately with infusions systems to administer IV fluids, medications, blood products into the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi. *The Kurin Blood Collection System is for use as a blood collection system and its Kurin Lock allows the specimen of blood from the patient to be sidelined prior to the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.

Device Story

Sterile, single-use blood collection set; includes vasculature connection (winged needle/luer), tubing, blood lock mechanism (Kurin Lock), and bottle holder. Operates via patient blood pressure; initial blood volume containing potential skin contaminants is passively diverted into a side channel; subsequent blood flow directed to collection container (syringe/bottle). Used in clinical settings by healthcare providers. Reduces blood culture contamination rates compared to standard draws. Pressure-rated extension set (when included) allows for separate IV infusion/medication administration and power injection up to 325 psi.

Clinical Evidence

No clinical data. Evidence consists of scientific literature review and bench testing. Literature (Arenas et al.) compared contamination rates between control, predicate, and subject device, demonstrating equivalent performance in contamination reduction. Bench testing evaluated particulate reduction and device functionality.

Technological Characteristics

Materials: biocompatible per ISO 10993-1. Components: winged needle (21/23G), flexible tubing, Kurin Lock diversion mechanism, bottle holder. Sterilization: Ethylene Oxide (ISO 11135). Connectivity: None. Standards: ISO 7864, ISO 1135-3, ISO 23908, ISO 9626, ISO 11607.

Indications for Use

Indicated for adult and pediatric patients requiring blood sample collection via venipuncture or Peripheral IV (PIV) access for blood culture testing. 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

• Steripath Micro Blood Collection System (K200661)

Submission Summary (Full Text)

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April 28, 2023

Kurin, Inc, Neal Hartman Regulatory Affairs/Quality Assurance 10840 Thornmint Road, Suite 111 San Diego, California 92012-7

Re: K220677

Trade/Device Name: Kurin Blood Culture Collection Set with Kurin Lock Technology Regulation Number: 21 CFR 862.1675 Regulation Name: Blood specimen collection device Regulatory Class: Class II Product Code: JKA, FPA Dated: March 27, 2023 Received: March 27, 2023

### 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.

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

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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 mediation-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,

David Walloschek

David Wolloscheck, Ph.D. Acting 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) K220677

#### Device Name

Kurin Blood Culture Collection Set with Kurin Lock Technology

#### Indications for Use (Describe)

The Kurin Blood Culture Collection Set is intended to obtain blood samples through the patient's vasculature via venipuncture or Peripheral IV (PIV) access. As it enters the Kurin Lock, blood initially fills a side channel then flows into the sample collection device (syringe or bottle) via an adjoining sampling channel to reduce blood culture contamination rates *.

When supplied with a pressure-rated extension set, the pressure-rated extension set is intended to be utilized separately with infusions systems to administer IV fluids, medications, blood products into the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi.

*The Kurin Blood Collection System is for use as a blood collection system and its Kurin Lock allows the specimen of blood from the patient to be sidelined prior to the test sample to reduce the frequency of blood culture contamination when contaminates are present in the initial blood sample compared to blood cultures drawn using standard practice without the Kurin Lock.

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

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

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# 510(K) SUMMARY - K220677

# Submitter Information

| Company Name: | Kurin, Inc. |
|------------------|--------------------------------------------------------------------------------|
| Company Address: | 10840 Thornmint Road<br>Suite 111<br>San Diego, CA 92127 |
| Company Phone: | [phone] |
| Contact Person: | Neal Hartman<br>Regulatory Affairs/ Quality Assurance<br>[e-mail] |
| Date: | April 27, 2023 |

### Device Identification

| Device Trade Name: | Kurin Blood Culture Collection Set with Kurin Lock<br>Technology |
|-------------------------------|------------------------------------------------------------------|
| Common Name: | Blood Collection Tubes, Vials, Systems, Serum Separators |
| Classification Name: | Blood specimen collection device |
| Classification Regulation(s): | 862.1675 |
| Device Class: | Class II |
| Primary Product Code: | JKA |
| Secondary Product Code: | FPA |
| Advisory Panel: | Clinical Chemistry |

# Identification of Predicate

| Type | Device Name | Regulation<br>No. | Product<br>Code | 510(K)<br>Number | Clearance Date |
|-----------|--------------------------------------------|-------------------|-----------------|------------------|-----------------|
| Predicate | Steripath Micro Blood Collection<br>System | 880.5440 | JKA, FPA | K200661 | October 8, 2020 |

# Purpose of Pre-Market Notification

To incorporate the blood culture contamination reduction claim in the indication for use statement.

# Device Description

The Kurin Blood Culture Collection Set is a sterile, single-use device that includes a vasculature connection (i.e., winged needle, male luer connection), flexible tubing, blood lock mechanism, and blood culture bottle holder (when supplied). The blood culture bottle holder varies between device models. Refer to the primary labeling for the compatible culture bottle.

The Subject Device is intended to be used with the adult and pediatric population. The main purpose of the Subject Device is to obtain blood samples by transferring from the patient to a culture bottle or collection container.

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Venipuncture sets incorporate a needle-safe feature that covers the needle prior to disposal to aid in the prevention of needlestick injury if activated after the blood draws. Venipuncture needles include 21 and 23 gauge.

Various Peripheral IV (PIV) sets incorporate a pressure-rated extension set with slide clamp that, when detached from the blood culture collection set, can be used for infusion purposes.

The unique technology with the Subject Device is the blood lock mechanism (i.e., Kurin Lock). Upon access to the patient's vasculature, the Subject Device uses the patient's blood pressure to push an initial portion of blood that could contain bacterial contaminants (e.g., skin plugs) into the side channel. After the side channel is filled, flow stops until a collection device (i.e., blood culture bottle, vacutainer tube, syringe) is attached. The attachment of a collection device draws additional blood through the Subject Device and into the collection device. The initial portion of blood in the side channel is not isolated from this additional incoming blood, the amount of contamination reaching the collection device is dramatically reduced.

| Product<br>Code | Device Configuration | Set<br>Length | Culture Bottle<br>Compatibility |
|-----------------|--------------------------------------------------------------------------------------------------------------|---------------|---------------------------------|
| D-11221 | 21Ga Standard Needle | 12" | BD |
| D-11223 | 23Ga Standard Needle | 12" | Thermo Fisher |
| D-21221 | 21Ga Push Button Needle | 12" | Long-Neck |
| D-21223 | 23Ga Push Button Needle | 12" | |
| D-PIV12 | Peripheral Intravascular (PIV) | 12" | |
| D-PIV18 | Peripheral Intravascular (PIV) with detachable, pressure-rated, 6"<br>(152mm) microbore extension set | 18" | |
| M-11221 | 21Ga Standard Needle | 12" | BioMerieux |
| M-11223 | 23Ga Standard Needle | 12" | |
| M-21221 | 21Ga Push Button Needle | 12" | |
| M-21223 | 23Ga Push Button Needle | 12" | |
| M-PIV12 | Peripheral Intravascular (PIV) | 12" | |
| M-PIV18 | Peripheral Intravascular (PIV) with detachable, pressure-rated, 6"<br>(152mm) microbore extension set | 18" | |
| S-PIV4 | Short Peripheral Intravascular (PIV) | 4" | None |
| S-PIV10 | Short Peripheral Intravascular (PIV) with detachable, pressure-<br>rated, 6" (152mm) microbore extension set | 10" | |
| T-11221 | 21Ga Standard Needle | 12" | Thermo Fisher |
| T-11223 | 23Ga Standard Needle | 12" | Short-Neck |
| T-21221 | 21Ga Push Button Needle | 12" | |
| T-1223 | 23Ga Push Button Needle | 12" | |
| T-PIV12 | Peripheral Intravascular (PIV) | 12" | |
| T-PIV18 | Peripheral Intravascular (PIV) with detachable, pressure-rated, 6"<br>(152mm) microbore extension set | 18" | |

The following table includes the product codes associated to the Subject Device:

# Indications for Use

The Kurin Blood Culture Collection Set is intended to obtain blood samples through the patient's vasculature via venipuncture or Peripheral IV (PIV) access. As it enters the Kurin Lock, blood initially fills a side channel the sample collection device (syringe or bottle) via an adjoining sampling channel to reduce blood culture contamination rates*.

When supplied with a pressure-rated extension set, the pressure-rated extension set is intended to be utilized separately with infusions systems to administer IV fluids, medications, blood and

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blood products into the patient's vascular system and may be safely used with power injectors at pressures up to 325 psi.

*The Kurin Blood Collection System is for use as a blood collection system and its Kurin Lock allows the initial specimen of blood from the patient to be sidelined prior to the collection of the test sample to reduce the frequency of blood culture contamination compared to blood cultures drawn using standard practice without the Kurin Lock.

## Substantial Equivalence Discussion

| Comparison - Subject & Predicate Devices | | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison<br>Feature | Subject Device | Predicate Device | Comparison Comments |
| 510(k) No | K220677 | K200661 | N/A |
| Manufacturer | Kurin, Inc. | Magnolia Medical Technologies Inc | N/A |
| Device Name | Kurin Blood Culture Collection<br>Set with Kurin Lock Technology | Steripath Micro Blood Collection<br>System | N/A |
| Common<br>Name | Blood Collection Set | Blood Collection Set | Identical |
| Indication for<br>Use | The Kurin Blood Culture<br>Collection Set is intended to<br>obtain blood samples through the<br>patient's vasculature via<br>venipuncture or Peripheral IV<br>(PIV) access. As it enters the<br>Kurin Lock, blood initially fills a<br>side channel then flows into the<br>sample collection device (syringe<br>or bottle) via an adjoining<br>sampling channel to reduce<br>blood culture contamination<br>rates*.<br>When supplied with a pressure-<br>rated extension set, the pressure-<br>rated extension set is intended to<br>be utilized separately with<br>infusions systems to administer<br>IV fluids, medications, blood and<br>blood products into the patient's<br>vascular system and may be<br>safely used with power injectors<br>at pressures up to 325 psi.<br>*The Kurin Blood Collection<br>System is for use as a blood<br>collection system and its Kurin<br>Lock allows the initial specimen<br>of blood from the patient to be<br>sidelined prior to the collection of<br>the test sample to reduce the<br>frequency of blood culture<br>contamination compared to blood<br>cultures drawn using standard<br>practice without the Kurin Lock. | The Steripath Micro Blood<br>Collection System is a system to<br>draw blood for in vitro diagnostic<br>testing.<br>The Steripath Micro Blood<br>Collection System is indicated for<br>use as a blood collection system<br>that diverts and sequesters the<br>initial specimen prior to collection of<br>a subsequent test sample to reduce<br>the frequency of blood culture<br>contamination when contaminants<br>are present in the initial blood<br>sample compared to blood cultures<br>drawn with standard procedure<br>without manual diversion.<br>Additionally, components of the<br>system may be used for infusion<br>following sample collection after<br>disconnection of the Initial<br>Specimen Diversion Device®<br>(ISDD). | The indication for use<br>statements is generally<br>identical in nature,<br>however the Subject<br>Device provides<br>additional details, which<br>are associated to various<br>product configurations.<br>All information included in<br>the Subject Device's<br>indication for use<br>statement, except for the<br>blood culture<br>contamination reduction<br>claim, have been cleared<br>in other 510(k)<br>submissions (K191832,<br>K181895). The blood<br>culture contamination<br>reduction claim is<br>supported with literature<br>review and bench testing<br>(particulate reduction)<br>evaluated in this 510(k)<br>review. |
| Infusion<br>indication | Yes, only with the detached<br>pressure-rated extension set | Yes | Identical |
| Comparison - Subject & Predicate Devices | | | |
| Comparison<br>Feature | Subject Device | Predicate Device | Comparison Comments |
| Single-use | Yes | Yes | Identical |
| Sterile | Yes | Yes | Identical |
| Method of<br>sterilization,<br>SAL | Ethylene Oxide, 10-6 | Gamma, 10-6 | The sterilization methods<br>are different, Subject<br>Device was validated to<br>ISO 11135. Safety was<br>demonstrated through<br>the sterilization<br>validation. |
| Non-pyrogenic | Yes | Yes | Identical |
| Needle Gauge | 21, 23 (with associated product<br>configurations) | None | Performance associated<br>with venipuncture<br>needles was verified in<br>K191832, which<br>performance testing was<br>conducted per ISO 7864,<br>ISO-1135-3, and ISO-<br>23908. Testing<br>demonstrated the Subject<br>Device's safety. |
| Needle Length | 0.75 inch (with associated<br>product configurations) | N/A | |
| Initial draw of<br>blood sidelined | 0.15 ml | 0.6-0.9 ml | The Subject Device<br>sidelined blood volume is<br>less than the predicate<br>device. The adequacy of<br>the volume sidelined was<br>reviewed in this 510(k)<br>submission with peer<br>reviewed articles that<br>demonstrated blood<br>culture contamination<br>reductions with the<br>Subject Device. Bench<br>testing (particulate<br>reduction) was also<br>conducted to<br>demonstrate the<br>performance of the blood<br>lock mechanism. |
| Blood<br>Collection<br>Holder | Saf-T Holder Device (MFG:<br>Smith Medical)<br>Vacutainer One-Use Holder<br>(MFG: BD)<br>Monoject Safety Collection<br>Device (MFG: Covidien) | Custom | The Subject Device<br>provides different<br>configurations of blood<br>collection holders to<br>accommodate the<br>various culture bottles on<br>the market. Compatibility<br>and functionality were<br>confirmed with simulated<br>used functional<br>evaluations.<br>Effectiveness was<br>demonstrated through<br>these evaluations. |

Comparison of Technological Characteristics with Predicate Devices

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# Summary of Evaluations Performed

The following evaluations were conducted to support the blood culture contamination claim for the Subject Device in this submission:

- Scientific Literature Review
- "Innovation for Reducing Blood Culture Contamination: Initial Specimen Diversion O Technique" Richard G. Patton
- Diversion devices were not utilized in the documented study ■
- . Provides information on skin/tissue fragments created during venipuncture contain microbial contaminants that are present in initial specimen volume
- . Does not identify the absolute minimum effective volume for blood contamination rates reduction
- I Significant improvement in contamination with a volume of ≥0.5, ≤2 ml was with a 16-gauge needle, which has approximately 5 times greater volume than a 21-GA needle: one should expect less contamination with the smaller 21-GA needle.
- "Asynchronous Testing Of 2 Specimen diversion Devices to Reduce Blood O Culture Contamination: A Single-Site Product Supply Quality Improvement Proiect" Monica Arenas
- . Conducted at Central Texas Veterans Health Care System (CTVHCS) between November 2017 to February 2019, where a total of 4300 blood samples were taken between the control and two (2) blood culturediversion devices. Device A is manufactured by Magnolia Medical Technologies and isolates the first 1-2 mL of blood and Device B is manufactured by Kurin. Inc. and passively diverts less than 0.15 mL of blood. The control was blood sampling without a blood culture-diversion device.
- Model estimated that the mean incidence of contaminated draws per month in the device A group was 0.29 (0.14-0.55) times the incidence of contaminated draws in the control group. The estimated mean incidence of contaminated draws in device B group was 0.23 (0.13-0.37) times the incidence of contaminated draws in the control group.
- Evaluation demonstrates equivalent performance between the Magnolia's . diversion device and the Subject Device, as it relates to blood contamination rate reduction.
- Performance
- o Particle Reduction through Device (T=0. T=2 Year)

Safety and performance evaluation for the Subject Device were performed in the previous submissions (K191832, K181895). Evaluations assessed include the following:

- Sterilization (ISO 11135, ISO 10993-7) .
- . Biocompatibility (ISO 10993-1, Venipuncture Configuration - Externally communicating medical device with circulating blood contact for limited exposure; Extension Set Configuration - Externally communicating medical device with indirect blood path contact for prolona exposure)
- o Cytotoxicity
- Sensitization o
- Irritation or Intracutaneous reactivity O

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- Systemic toxicity O
- Hemocompatibility O
- Material Mediated Pyrogen o
- Performance/Stability ●
- Needle Performance (ISO 9626) O
- Stiffness test ■
- 트 Resistance to breakage
- . Resistance to corrosion
- o Device Performance (ISO 1135-3, ISO 23908, ISO 7864, ISO 8536-9)
- Functionality ■
- . Leakage
- 트 Flow Rate
- Needlestick Safety Mechanism (ISO 23908) .
- Tensile
- 트 Burst Pressure
- o Packaging Integrity (ISO 11607)
- Visual Inspection ■
- . Gross Leak (Bubble Emission)
- Dye Penetration I
- . Seal Strength (Peel)
- Human Factors (FDA Guidance, Applying Human Factors & Usability Engineering to . Medical Devices)

The following guidance documents and recognized performance standards were utilized to support the Subject Device for this submission:

- AAMI/ANSI/ISO 15223-1:2016 Medical devices symbols to be used with medical ● devices labels, labeling, and information to be supplied - part 1: general requirements
- 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)

Clinical Testing - Not applicable

# Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Subject Device is substantially equivalent to the commercially available predicate.