Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on a mechanical blood lock mechanism and does not mention any computational or learning components.

Therapeutic

No

Explanation: The device is intended for blood sample collection and to reduce contamination during this process. It does not provide any treatment or therapy.

Diagnostic

No

The device is a blood sampling and collection system intended to reduce contamination during blood culture collection, not a device that analyzes or interprets blood samples for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as needles, tubing, a blood lock mechanism, and a bottle holder. It is a hardware device for blood collection.

IVD (In Vitro Diagnostic)

Based on the provided information, the Kurin Blood Culture Collection Set is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The primary intended use is to obtain blood samples and reduce blood culture contamination rates during the collection process. It is a tool for collecting the sample, not for performing a test on the sample itself.
Device Description: The description focuses on the mechanism for collecting blood and diverting the initial portion to reduce contamination. It does not describe any components or functions related to analyzing the blood sample or providing diagnostic information.
Lack of Diagnostic Function: The device's function is purely mechanical and related to sample collection and handling. It does not perform any chemical, biological, or immunological tests on the blood.
Performance Studies: The performance studies described focus on the device's ability to reduce contamination during collection, not on the accuracy or reliability of any diagnostic test performed on the collected blood.

While the collected blood is intended for blood culture, which is an in vitro diagnostic test, the Kurin Blood Culture Collection Set itself is a sample collection device, not the diagnostic test itself. It facilitates the collection of a sample that will then be used in an IVD test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 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.

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 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.

Product codes (comma separated list FDA assigned to the subject device)

JKA, FPA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vasculature

Indicated Patient Age Range

The Subject Device is intended to be used with the adult and pediatric population.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Scientific Literature Review
- "Innovation for Reducing Blood Culture Contamination: Initial Specimen Diversion O Technique" Richard G. Patton
  - 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
  - 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 culture-diversion 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
- 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)
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous reactivity
- Systemic toxicity
- Hemocompatibility
- Material Mediated Pyrogen
Performance/Stability
- Needle Performance (ISO 9626)
  - Stiffness test
  - Resistance to breakage
  - Resistance to corrosion
- Device Performance (ISO 1135-3, ISO 23908, ISO 7864, ISO 8536-9)
  - Functionality
  - Leakage
  - Flow Rate
  - Needlestick Safety Mechanism (ISO 23908)
  - Tensile
  - Burst Pressure
- Packaging Integrity (ISO 11607)
  - Visual Inspection
  - Gross Leak (Bubble Emission)
  - Dye Penetration
  - Seal Strength (Peel)
Human Factors (FDA Guidance, Applying Human Factors & Usability Engineering to Medical Devices)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K200661

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K191832, K181895

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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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

1

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

2

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)

☑ 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 Road
Suite 111
San Diego, CA 92127
Company Phone:	(888) 963-9056
Contact Person:	Neal Hartman
Regulatory Affairs/ Quality Assurance
nealhartman@kurin.com
Date:	April 27, 2023

Device Identification

| Device Trade Name: | Kurin Blood Culture Collection Set with Kurin Lock
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
No. | Product
Code | 510(K)
Number | Clearance Date |
|-----------|--------------------------------------------|-------------------|-----------------|------------------|-----------------|
| Predicate | Steripath Micro Blood Collection
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.

4

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

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

5

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
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
Set with Kurin Lock Technology	Steripath Micro Blood Collection
System	N/A
Common
Name	Blood Collection Set	Blood Collection Set	Identical
Indication 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 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 and
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.	The Steripath Micro Blood
Collection System is a system to
draw blood for in vitro diagnostic
testing.
The Steripath Micro Blood
Collection System is indicated for
use as a blood collection system
that diverts and sequesters the
initial specimen prior to collection of
a subsequent test sample to reduce
the frequency of blood culture
contamination when contaminants
are present in the initial blood
sample compared to blood cultures
drawn with standard procedure
without manual diversion.
Additionally, components of the
system may be used for infusion
following sample collection after
disconnection of the Initial
Specimen Diversion Device®
(ISDD).	The indication for use
statements is generally
identical in nature,
however the Subject
Device provides
additional details, which
are associated to various
product configurations.
All information included in
the Subject Device's
indication for use
statement, except for the
blood culture
contamination reduction
claim, have been cleared
in other 510(k)
submissions (K191832,
K181895). The blood
culture contamination
reduction claim is
supported with literature
review and bench testing
(particulate reduction)
evaluated in this 510(k)
review.
Infusion
indication	Yes, only with the detached
pressure-rated extension set	Yes	Identical
Comparison - Subject & Predicate Devices
Comparison
Feature	Subject Device	Predicate Device	Comparison Comments
Single-use	Yes	Yes	Identical
Sterile	Yes	Yes	Identical
Method of
sterilization,
SAL	Ethylene Oxide, 10-6	Gamma, 10-6	The sterilization methods
are different, Subject
Device was validated to
ISO 11135. Safety was
demonstrated through
the sterilization
validation.
Non-pyrogenic	Yes	Yes	Identical
Needle Gauge	21, 23 (with associated product
configurations)	None	Performance associated
with venipuncture
needles was verified in
K191832, which
performance testing was
conducted per ISO 7864,
ISO-1135-3, and ISO-

Testing
demonstrated the Subject
Device's safety. |
| Needle Length | 0.75 inch (with associated
product configurations) | N/A | |
| Initial draw of
blood sidelined | 0.15 ml | 0.6-0.9 ml | The Subject Device
sidelined blood volume is
less than the predicate
device. The adequacy of
the volume sidelined was
reviewed in this 510(k)
submission with peer
reviewed articles that
demonstrated blood
culture contamination
reductions with the
Subject Device. Bench
testing (particulate
reduction) was also
conducted to
demonstrate the
performance of the blood
lock mechanism. |
| Blood
Collection
Holder | Saf-T Holder Device (MFG:
Smith Medical)
Vacutainer One-Use Holder
(MFG: BD)
Monoject Safety Collection
Device (MFG: Covidien) | Custom | The Subject Device
provides different
configurations of blood
collection holders to
accommodate the
various culture bottles on
the market. Compatibility
and functionality were
confirmed with simulated
used functional
evaluations.
Effectiveness was
demonstrated through
these evaluations. |

Comparison of Technological Characteristics with Predicate Devices

6

7

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

8

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.