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 collection, the set also includes a blood collection holder for connection to vacuum-based collection vials.

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.

AI/ML Overview

The Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle, has undergone various evaluations to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a formal table of specific, quantified acceptance criteria for each test. Instead, it lists the types of evaluations performed and implies that the performance met acceptable standards for demonstrating substantial equivalence. The "Reported Device Performance" column below is based on the conclusion stated in the document that the device "has demonstrated it is substantially equivalent... based on the intended use and performance testing conducted."

Acceptance Criteria Category	Reported Device Performance
Sterilization (product adoption per AAMI TIR 28)	Successfully met requirements for Ethylene Oxide sterilization (SAL 10-6).
Biocompatibility	Successfully met biocompatibility requirements.
Pyrogenicity	Successfully met pyrogenicity requirements.
Needle Performance (Stiffness, Resistance to Breakage, Corrosion)	Successfully met performance standards for stiffness, resistance to breakage, and resistance to corrosion.
Device Performance (Functionality, Leakage, Flow Rate, Needlestick Safety Mechanism, Tensile Strength)	Demonstrated proper functionality, no leakage, acceptable flow rate, effective needlestick safety mechanism, and adequate tensile strength.
Packaging Integrity (Visual Inspection, Gross Leak, Dye Penetration, Seal Strength Batch)	Successfully maintained packaging integrity through visual inspection, gross leak (bubble emission), dye penetration, and seal strength (peel) tests.
Blood Collection Holder and Compatibility with Blood Culture Bottles	Demonstrated compatibility with various blood culture bottles and established blood collection holders.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of devices or tests performed) for each individual test conducted to support the 510(k) submission. It broadly states that "evaluations were conducted."

The data provenance is implicit: the tests were conducted by Kurin, Inc. to support their premarket notification. Therefore, this would be considered prospective data collected specifically for regulatory submission. There is no information provided about the country of origin for the data collection, but given the company's address in San Diego, California, it is reasonable to infer the testing was likely conducted in the United States or under conditions compliant with U.S. regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information (number and qualifications of experts for ground truth establishment) is typically not applicable to the evaluation of mechanical or material performance of a blood collection device, which relies on standardized engineering and biological tests rather than expert interpretation of complex clinical data. The "ground truth" for these tests is defined by the passing criteria of the relevant ISO standards and FDA guidance documents.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are usually relevant for studies involving human interpretation or clinical outcomes where discrepancies need to be resolved. For the types of performance and material tests described for this device, which are objective and quantitative, an adjudication method is not applicable. The results are typically pass/fail based on pre-defined criteria from recognized standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or mentioned in the provided text. MRMC studies are typically employed for diagnostic imaging devices or algorithms where the performance of human readers (with and without AI assistance) is compared. This device is a blood specimen collection device, not an imaging or diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) performance study was not done or mentioned. This device is a physical medical device for blood collection, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for the various evaluations conducted for this device was established based on recognized industrial standards, international standards (ISO), and FDA guidance documents.

Examples of ground truth sources include:

AAMI TIR 28 for sterilization.
ISO 10993-1:2018 for biocompatibility.
ISO 1135-3:2016 for blood-taking sets.
ISO 7864:2016 and ISO 9626:2016 for sterile hypodermic needles.
ISO 23908:2011 for sharps injury protection.
ISO 11135:2014 for ethylene oxide sterilization.
ISO 11607-1:2006 for packaging integrity.
FDA Guidance documents (e.g., Medical Devices with Sharps Injury Prevention Features).

The outcomes of these tests are objective measurements against the specified criteria within these standards.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to the evaluation of this medical device. Training sets are used in machine learning and AI development. The evaluations performed here are for a physical product and its constituent materials and mechanisms.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of device evaluation, this question is not applicable.

Summary

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ 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 RoadSuite 111San Diego, CA 92127
Company Phone:	(888) 963-9056
Contact Person:	Bob RogersChairman and CEObobrogers@kurin.com
Date:	February 3, 2020

Device Identification

Device Trade Name:	Kurin Blood Culture Collection Set with Kurin LockTechnology, Push-Button Needle
Common Name:	Blood Collection Set
Product Models:	M-21221 - Kurin Blood Culture Collection Set with KurinLock Technology, 21Ga Push Button Needle, Compatiblewith BioMerieux BottlesM-21223 - Kurin Blood Culture Collection Set with KurinLock Technology, 23Ga Push Button Needle, Compatiblewith BioMerieux BottlesD-21221 - Kurin Blood Culture Collection Set with KurinLock Technology, 21Ga Push Button Needle, Compatiblewith BD & Thermo Fisher Long-Neck BottlesD-21223 - Kurin Blood Culture Collection Set with KurinLock Technology, 23Ga Push Button Needle, Compatiblewith BD & Thermo Fisher Long-Neck BottlesT-21221 - Kurin Blood Culture Collection Set with KurinLock Technology, 21Ga Push Button Needle, Compatiblewith Thermo Fisher Short-Neck BottlesT-21223 - Kurin Blood Culture Collection Set with KurinLock Technology, 23Ga Push Button Needle, Compatiblewith Thermo Fisher Short-Neck Bottles
Classification Name(s):	Tubes, Vials, Systems, Serum Separators, BloodCollection
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 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

ComparisonFeature	Subject Device	Predicate Device
Indications for Use	The Kurin Blood Culture Collection Set is awinged blood collection needle with flexibletubing intended for venipuncture to obtainblood samples. It is provided with a safetyshield for covering the used venipunctureneedle prior to disposal to aid in theprevention of needlestick injury if manuallyactivated after the blood draw. For bloodcollection, the set also includes a bloodcollection holder for connection to vacuum-based collection vials.Note: The change in the terminology from	The Kurin Blood Culture Collection Set is awinged blood collection needle with flexibletubing intended for venipuncture to obtainblood samples. It is provided with a safetyshield for covering the used venipunctureneedle prior to disposal to aid in theprevention of needlestick injury if manuallyactivated after the blood draw. For bloodcollection, the set also includes a safetyshield and apparatus for connection tovacuum-based collection vials.
Comparison Table - Subject and Predicate Devices
ComparisonFeature	Subject Device	Predicate Device
	"safety shield and apparatus" to "bloodcollection holder" in the device componentdoes not impact safety and effectiveness.Both terms are referencing the same devicecomponent. Three is no change in thedevice component design.
Infusion indication	No	No
Single-use	Yes	Yes
Sterile	Yes	Yes
Method ofsterilization, SAL	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL 10-6
Needlestickmechanism type	Active, semi-automatic (i.e., push button) -Activation is achieved by depressing aspring activated buttonNote: The change from the Predicate doesnot impact safety or effectiveness of thedevice. The push-button design providesprotection prior to use with a needle tip	Active, manual (i.e. slide) - Activation isachieved by manually sliding a shield overthe needle
	protector and covers the needle uponactivation after use. Performance testing inthe 510(k) submission supports its safety.
	21 & 23
Needle Gauge	Note: Not offering the 25 Ga needleconfiguration does not impact the safety andeffectiveness.	21, 23, & 25
Needle Length	0.75 Inch	0.75 Inch
Device Length	12 Inches	12 Inches
Blood CollectionHolder	Saf-T Holder Device (MFG: Smith Medical)Vacutainer One-Use Holder (MFG: BD)Monoject Safety Collection Device (MFG:Covidien)Note: The additional blood collection holdersdoes not impact the safety or effectiveness.Each blood collection holder works in thesame and interfaces with the standardcollection vial however each holder isdesigned to interface specifically with itsmanufacturer's culture collection bottle. All	Saf-T Holder Device (MFG: Smith Medical)
	holders are design with shielding to theneedle and are FDA cleared.
Sterile barrierpackaging	Thermoform Tray/Tyvek Lidding StockNote: The change from the Predicate doesnot impact safety or effectiveness. The traysterile barrier packaging was successfullytested to same transportation and sealintegrity performance standards conducted	Tyvek/Poly Pouch
Comparison Table - Subject and Predicate Devices
ComparisonFeature	Subject Device	Predicate Device
	with the predicate. Results are incorporatedin the 510(k) submission and does notimpact safety or effectiveness.
Principles ofoperation	Venipuncture needle accesses the patient'svascular system then blood flows up to theblood lock mechanism where the first 0.15mlof blood is held in a side chamber and thenblood is directed into the collection lumen.The collection container is connected to ablood collection holder where blood iscollected. Needlestick safety mechanism isactivated to protect against needlestickinjuries.	Venipuncture needle accesses the patient'svascular system then blood flows up to theblood lock mechanism where the first 0.15mlof blood is held in a side chamber and thenblood is directed into the collection lumen.The collection container is connected to ablood collection holder where blood iscollected. Needlestick safety mechanism isactivated to protect against needlestickinjuries.
Shelf-Life	6-monthNote: The difference in the shelf-life is notbased on performance There is not impactto 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.

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.