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 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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the Kurin Blood Culture Collection Set with Kurin Lock Technology. It details the device's purpose, design, and a comparison to a predicate device, focusing on the justification for a blood culture contamination reduction claim.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text, structured according to your request:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion seems to be demonstrating non-inferiority or equivalent performance in reducing blood culture contamination rates compared to a predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance
Reduce blood culture contamination rates when contaminants are present in the initial blood sample, compared to blood cultures drawn using standard practice without the Kurin Lock. (Derived from the "Indications for Use" statement and the "Purpose of Pre-Market Notification")	A scientific literature review, specifically the study "Asynchronous Testing Of 2 Specimen Diversion Devices to Reduce Blood Culture Contamination: A Single-Site Product Supply Quality Improvement Project" by Monica Arenas, demonstrated that the Kurin device (Device B) had a mean incidence of contaminated draws that was 0.23 (0.13-0.37) times the incidence of contaminated draws in the control group. This evaluation "demonstrates equivalent performance between the Magnolia's diversion device (Predicate) and the Subject Device, as it relates to blood contamination rate reduction." The predicate device (Device A) had a mean incidence of contaminated draws that was 0.29 (0.14-0.55) times the incidence of the control group. This implies that the Kurin device performed marginally better in reducing contamination.
Adequacy of volume sidelined (0.15 mL for Kurin vs. 0.6-0.9 mL for the predicate) for contamination reduction. (Derived from the "Comparison - Subject & Predicate Devices" table)	The 0.15 mL sidelined blood volume for the Subject Device was reviewed with "peer reviewed articles that demonstrated blood culture contamination reductions with the Subject Device." Additionally, "Bench testing (particulate reduction) was also conducted to demonstrate the performance of the blood lock mechanism." The document explicitly states that the lesser volume "does not raise any new or different questions of safety or effectiveness."

Acceptance Criterion (Implicit)

Reported Device Performance

Reduce blood culture contamination rates when contaminants are present in the initial blood sample, compared to blood cultures drawn using standard practice without the Kurin Lock. (Derived from the "Indications for Use" statement and the "Purpose of Pre-Market Notification")

A scientific literature review, specifically the study "Asynchronous Testing Of 2 Specimen Diversion Devices to Reduce Blood Culture Contamination: A Single-Site Product Supply Quality Improvement Project" by Monica Arenas, demonstrated that the Kurin device (Device B) had a mean incidence of contaminated draws that was 0.23 (0.13-0.37) times the incidence of contaminated draws in the control group. This evaluation "demonstrates equivalent performance between the Magnolia's diversion device (Predicate) and the Subject Device, as it relates to blood contamination rate reduction." The predicate device (Device A) had a mean incidence of contaminated draws that was 0.29 (0.14-0.55) times the incidence of the control group. This implies that the Kurin device performed marginally better in reducing contamination.

Adequacy of volume sidelined (0.15 mL for Kurin vs. 0.6-0.9 mL for the predicate) for contamination reduction. (Derived from the "Comparison - Subject & Predicate Devices" table)

The 0.15 mL sidelined blood volume for the Subject Device was reviewed with "peer reviewed articles that demonstrated blood culture contamination reductions with the Subject Device." Additionally, "Bench testing (particulate reduction) was also conducted to demonstrate the performance of the blood lock mechanism." The document explicitly states that the lesser volume "does not raise any new or different questions of safety or effectiveness."

Study Details

The primary evidence provided for the blood culture contamination reduction claim is a scientific literature review, specifically citing a particular study.

Sample Size and Data Provenance:
- The cited study, "Asynchronous Testing Of 2 Specimen diversion Devices to Reduce Blood Culture Contamination: A Single-Site Product Supply Quality Improvement Project" by Monica Arenas, was conducted at the Central Texas Veterans Health Care System (CTVHCS) in the USA.
- The study period was between November 2017 to February 2019.
- A total of 4300 blood samples were taken, divided between a control group and two blood culture diversion devices (Device A, manufactured by Magnolia Medical Technologies, the predicate; and Device B, manufactured by Kurin, Inc., the subject device).
- The study appears to be retrospective or a prospective quality improvement project rather than a typical randomized controlled clinical trial, given the description "Single-Site Product Supply Quality Improvement Project" and the "mean incidence of contaminated draws per month". However, the exact design (prospective/retrospective) isn't explicitly stated but inferred.
Number of Experts and Qualifications:
- The document does not provide information on the number of experts used to establish ground truth or their specific qualifications for the Monica Arenas study. This information would typically be found in the full study publication rather than a 510(k) summary.
Adjudication Method:
- The document does not specify any adjudication method for the test set in the Monica Arenas study. Ground truth was likely established by the bacterial culture results themselves (positive/negative for contamination).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not conducted. This device is a blood collection system, not an AI or imaging diagnostic device that would typically involve human readers. Therefore, there is no information on how human readers improve with AI vs. without AI assistance.
Standalone Performance:
- Yes, the performance tested (reduction in contamination rates) is essentially a standalone performance of the device's mechanism (the Kurin Lock) in preventing contaminants from reaching the blood collection. The "algorithm" here is the physical mechanism of diverting initial blood. The reported performance refers to the device's function directly.
Type of Ground Truth Used:
- The ground truth for the contamination rate reduction claim was bacterial culture results from the collected blood samples, indicating the presence or absence of contamination.
Sample Size for Training Set:
- The text does not mention a "training set" in the context of machine learning, as this is a medical device clearance focusing on its physical mechanism and clinical performance via literature review and bench testing, not an AI model.
How Ground Truth for Training Set was Established:
- Not applicable, as no training set for an AI model is described. The relevant "ground truth" (bacterial culture results) was established by standard laboratory procedures in the clinical study.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K220677

Submitter Information

Company Name:	Kurin, Inc.
Company Address:	10840 Thornmint RoadSuite 111San Diego, CA 92127
Company Phone:	(888) 963-9056
Contact Person:	Neal HartmanRegulatory Affairs/ Quality Assurancenealhartman@kurin.com
Date:	April 27, 2023

Device Identification

Device Trade Name:	Kurin Blood Culture Collection Set with Kurin LockTechnology
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	RegulationNo.	ProductCode	510(K)Number	Clearance Date
Predicate	Steripath Micro Blood CollectionSystem	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

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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.

ProductCode	Device Configuration	SetLength	Culture BottleCompatibility
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"(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"(152mm) microbore extension set	18"
S-PIV4	Short Peripheral Intravascular (PIV)	4"	None
S-PIV10	Short Peripheral Intravascular (PIV) with detachable, pressure-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"(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
ComparisonFeature	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 CollectionSet with Kurin Lock Technology	Steripath Micro Blood CollectionSystem	N/A
CommonName	Blood Collection Set	Blood Collection Set	Identical
Indication forUse	The Kurin Blood CultureCollection Set is intended toobtain blood samples through thepatient's vasculature viavenipuncture or Peripheral IV(PIV) access. As it enters theKurin Lock, blood initially fills aside channel then flows into thesample collection device (syringeor bottle) via an adjoiningsampling channel to reduceblood culture contaminationrates.When supplied with a pressure-rated extension set, the pressure-rated extension set is intended tobe utilized separately withinfusions systems to administerIV fluids, medications, blood andblood products into the patient'svascular system and may besafely used with power injectorsat pressures up to 325 psi.The Kurin Blood CollectionSystem is for use as a bloodcollection system and its KurinLock allows the initial specimenof blood from the patient to besidelined prior to the collection ofthe test sample to reduce thefrequency of blood culturecontamination compared to bloodcultures drawn using standardpractice without the Kurin Lock.	The Steripath Micro BloodCollection System is a system todraw blood for in vitro diagnostictesting.The Steripath Micro BloodCollection System is indicated foruse as a blood collection systemthat diverts and sequesters theinitial specimen prior to collection ofa subsequent test sample to reducethe frequency of blood culturecontamination when contaminantsare present in the initial bloodsample compared to blood culturesdrawn with standard procedurewithout manual diversion.Additionally, components of thesystem may be used for infusionfollowing sample collection afterdisconnection of the InitialSpecimen Diversion Device®(ISDD).	The indication for usestatements is generallyidentical in nature,however the SubjectDevice providesadditional details, whichare associated to variousproduct configurations.All information included inthe Subject Device'sindication for usestatement, except for theblood culturecontamination reductionclaim, have been clearedin other 510(k)submissions (K191832,K181895). The bloodculture contaminationreduction claim issupported with literaturereview and bench testing(particulate reduction)evaluated in this 510(k)review.
Infusionindication	Yes, only with the detachedpressure-rated extension set	Yes	Identical
Comparison - Subject & Predicate Devices
ComparisonFeature	Subject Device	Predicate Device	Comparison Comments
Single-use	Yes	Yes	Identical
Sterile	Yes	Yes	Identical
Method ofsterilization,SAL	Ethylene Oxide, 10-6	Gamma, 10-6	The sterilization methodsare different, SubjectDevice was validated toISO 11135. Safety wasdemonstrated throughthe sterilizationvalidation.
Non-pyrogenic	Yes	Yes	Identical
Needle Gauge	21, 23 (with associated productconfigurations)	None	Performance associatedwith venipunctureneedles was verified inK191832, whichperformance testing wasconducted per ISO 7864,ISO-1135-3, and ISO-23908. Testingdemonstrated the SubjectDevice's safety.
Needle Length	0.75 inch (with associatedproduct configurations)	N/A
Initial draw ofblood sidelined	0.15 ml	0.6-0.9 ml	The Subject Devicesidelined blood volume isless than the predicatedevice. The adequacy ofthe volume sidelined wasreviewed in this 510(k)submission with peerreviewed articles thatdemonstrated bloodculture contaminationreductions with theSubject Device. Benchtesting (particulatereduction) was alsoconducted todemonstrate theperformance of the bloodlock mechanism.
BloodCollectionHolder	Saf-T Holder Device (MFG:Smith Medical)Vacutainer One-Use Holder(MFG: BD)Monoject Safety CollectionDevice (MFG: Covidien)	Custom	The Subject Deviceprovides differentconfigurations of bloodcollection holders toaccommodate thevarious culture bottles onthe market. Compatibilityand functionality wereconfirmed with simulatedused functionalevaluations.Effectiveness wasdemonstrated throughthese 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.

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
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.(b)
Classification. Class II.