(186 days)
No
The device description focuses on mechanical components and fluid dynamics for blood collection and infusion, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as administering IV fluids, medications, and blood products to the patient's vascular system, which are therapeutic actions.
No.
The device is intended for blood collection and administration of fluids, medications, and blood products, not for diagnosing a condition. While blood collection can be a part of diagnostic procedures, the device itself performs the collection, not the diagnosis.
No
The device description clearly outlines a physical, sterile, single-use device consisting of a pressure-rated extension set and a blood culture collection set with various hardware components like luer connections, tubing, a blood lock mechanism, and a blood collection holder. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is to obtain an initial blood draw and then function as a pressure-rated extension set for administering fluids, medications, and blood products to the patient's vascular system. While it collects blood, the purpose of the collection is for a blood culture sample, which is then analyzed externally using other devices (the blood culture bottles and vials). The device itself does not perform any diagnostic testing on the blood sample.
- Device Description: The description details the mechanics of blood collection and the subsequent use of the extension set for infusion. It mentions the blood culture collection set and how it interfaces with blood culture bottles, but it does not describe any components or processes within the device that analyze the blood for diagnostic purposes.
- Lack of Diagnostic Function: The device facilitates the collection of a sample for a diagnostic test (blood culture), but it is not the diagnostic test itself. The diagnostic analysis happens in the blood culture bottle and potentially in a laboratory setting.
- Predicate Devices: The predicate devices listed (K092382 and K162233) are also not IVDs. K092382 is a pressure-rated extension set, and K162233 is a blood culture collection set. These are devices used in the process of obtaining samples or administering substances, not for performing diagnostic tests.
- Reference Devices: The reference devices (K912563, K950432, K081229) are blood collection holders, which are accessories for collecting blood samples, not IVDs.
In summary, this device is a medical device used for blood collection and fluid administration. It is a tool used in the process that may lead to an in vitro diagnostic test (the blood culture), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.
Product codes
FPA, JKA
Device Description
The Subject device is a sterile, single-use device that consist of a pressure-rated extension set and the blood culture collection set. The blood culture collection set incorporates a luer connection, flexible tubing, blood lock mechanism, and blood collection holder. The pressure-rated extension set is connected to the blood collection set via the luer connection. The Subject device is provided to the healthcare facility in this configuration.
The Peripheral IV (PIV) catheter is connected to the pressure-rated extension set via luer connection. Blood travels through the lumen of the Subject device into the blood lock mechanism where the initial draw of blood (approximately 1ml) is diverted and sequestered. The purpose of the sequestration is to automate the discard volume method (DVM). Once the sequestered volume is diverted and retained, the blood continues travel to the blood collection holder where the blood culture sample is obtained.
Once the blood draw process is completed, the blood collection set of the Subject device is disconnected from the pressure-rated extension set and discarded. The pressure-rated extension set is utilized as an infusion system to administer IV fluids, medications, blood and blood products to the patient's vascular system. The pressure-rated extension set is rated to 325 PSI.
Various blood collection holders are incorporated with the Subject device to interfaces with marketed blood culture bottles and vails. These blood collection holders are cleared under K912563 (Biomerieux Shield), K950432 (BD Vacutainer), and K081229 (Short Saf-T Holder). The blood collection holder incorporates a needle that is covered by elastomer boot. The culture bottle is inserted into the blood collection holder where the needle punctures the elastomer cap and provides a pathway for the blood to traveling into the culture bottle. The vacuum of the culture bottle pulls the blood. Once completed, the culture bottle is removed and the elastomer boot covers the needle and seals to fluid path.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's vascular system
Indicated Patient Age Range
Not Found
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)
Summary of Non-Clinical Tests Performed
- Sterilization
- Sterilization Product Adoptions
- Sterilization Cycle Comparison
- Shelf-Life (Accelerated Aging)
- Visual Inspection
- Gross Leak (Bubble Emission)
- Peel Seal Strength
- Performance/Functionality
- Blood collection portion of Subject device
- Performance/Functionality for pressure-rated extension set
- Tensile Strength
- Burst Pressure
Conclusion: The Subject device has demonstrated through performance testing that it is substantially equivalent to the commercially available predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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January 18, 2019
Kurin, Inc % Neal Hartman Independent Consultant 892 Summer Moon Road San Marcos, California 92078
Re: K181895
Trade/Device Name: Kurin PIV18 Blood Culture Collection Set with Kurin Lock Technology, includes detachable, pressure-rated, 6" (152mm) microbore extension set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA, JKA Dated: December 14, 2018 Received: December 17, 2018
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/cfpmp/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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181895
Device Name
Kurin PIV18 Blood Culture Collection Set with Kurin Lock Technology, includes detachable, pressure-rated, 6" (152mm) microbore extension set
Indications for Use (Describe)
Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood collection portion of the device, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.
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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K181895 – 510(K) SUMMARY
Submitter Information
| Company Name: | Kurin, Inc. |
|---|---|
| Company Address: | 10840 Thornmint Road |
| Suite 111 | |
| San Diego, CA 92127 | |
| Company Phone: | (760) 612-6090 |
| Contact Person: | Bob Rogers |
| Chairman and CEO | |
| bobrogers@kurin.com | |
| Date: | January 17, 2019 |
| Device Identification | |
| Device Trade Name: | Kurin PIV18 Blood Culture Collection Set with Kurin |
| Lock Technology, includes detachable, pressure- | |
| rated, 6" (152mm) microbore extension set | |
| Common Name: | Intravascular Administration Set/ Blood Collection |
| Set | |
| Product Models: | M-PIV18 - Kurin PIV18 Blood Culture Collection Set |
| with Kurin Lock Technology, includes detachable, | |
| pressure-rated, 6" (152mm) microbore extension set | |
| (with Biomerieux Shield Blood Collection Holder) | |
| D-PIV18 – Kurin PIV18 Blood Culture Collection Set | |
| with Kurin Lock Technology, includes detachable, | |
| pressure-rated, 6" (152mm) microbore extension set | |
| (with BD Vacutainer Blood Collection Holder) | |
| T-PIV18 - Kurin PIV18 Blood Culture Collection Set | |
| with Kurin Lock Technology, includes detachable, | |
| pressure-rated, 6" (152mm) microbore extension set | |
| (with Short Saf-T Blood Collection Holder) | |
| Classification Name(s): | Intravascular Administration Set |
| Classification Regulation(s): | 880-5440 |
| Device Class: | Class II |
| Product Code(s): | FPA, JKA |
| Advisory Panel: | General Hospital |
4
Identification of Predicate Device
| Predicate
Identifier | Device Name | Regulation No. | Product
Code | 510(K)
Number | Clearance
Date |
|-------------------------|----------------------------------------|--------------------------------------------------------------------------|-----------------|------------------|----------------------|
| Primary | Nexus Pressure Rated
Extension Sets | 880.5440
Intravascular Administration
Set | FPA | K092382 | April 26,
2010 |
| Secondary | Kurin Blood Culture
Collection Set | 862.1675
Tubes, Vials, Systems, Serum
Separators, Blood Collection | JKA | K162233 | December
23, 2016 |
Device Description
The Subject device is a sterile, single-use device that consist of a pressure-rated extension set and the blood culture collection set. The blood culture collection set incorporates a luer connection, flexible tubing, blood lock mechanism, and blood collection holder. The pressurerated extension set is connected to the blood collection set via the luer connection. The Subject device is provided to the healthcare facility in this configuration.
The Peripheral IV (PIV) catheter is connected to the pressure-rated extension set via luer connection. Blood travels through the lumen of the Subject device into the blood lock mechanism where the initial draw of blood (approximately 1ml) is diverted and sequestered. The purpose of the sequestration is to automate the discard volume method (DVM). Once the sequestered volume is diverted and retained, the blood continues travel to the blood collection holder where the blood culture sample is obtained.
Once the blood draw process is completed, the blood collection set of the Subject device is disconnected from the pressure-rated extension set and discarded. The pressure-rated extension set is utilized as an infusion system to administer IV fluids, medications, blood and blood products to the patient's vascular system. The pressure-rated extension set is rated to 325 PSI.
Various blood collection holders are incorporated with the Subject device to interfaces with marketed blood culture bottles and vails. These blood collection holders are cleared under K912563 (Biomerieux Shield), K950432 (BD Vacutainer), and K081229 (Short Saf-T Holder). The blood collection holder incorporates a needle that is covered by elastomer boot. The culture bottle is inserted into the blood collection holder where the needle punctures the elastomer cap and provides a pathway for the blood to traveling into the culture bottle. The vacuum of the culture bottle pulls the blood. Once completed, the culture bottle is removed and the elastomer boot covers the needle and seals to fluid path.
Indications for Use
Intended to connect to short peripheral catheter to obtain initial blood draw and when disconnected from the blood culture collection set, the pressure-rated extension set is intended to be utilized with infusions systems to administer IV fluids, medications, blood and blood products to the patient's vascular system and may be safety used with power injectors at pressures up to 325 psi.
| Comparison
Feature | Subject Device | Primary Predicate Device
(K092382) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Device Name | Kurin PIV18 Blood Culture Collection Set with
Kurin Lock Technology, includes detachable,
pressure-rated, 6" (152mm) microbore
extension set | Nexus Pressure Rated Extension Set |
Comparison of Technological Characteristics with Primary Predicate Device
5
| Comparison
Feature | Subject Device | Primary Predicate Device
(K092382) |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation No. | 880.5540 | 880.5540 |
| | Intravascular Administration Set | Intravascular Administration Set |
| Product Code | FPA | FPA |
| Indications for
Use | Intended to connect to short peripheral
catheter to obtain initial blood draw and when
disconnected from the blood culture collection
set, the pressure-rated extension set is
intended to be utilized with infusions systems
to administer IV fluids, mediations, blood and
blood products to the patient's vascular
system and may be safety used with power
injectors at pressures up to 325 psi. | The Nexus Pressure Rated Extension Sets are
intended for the use in today's growing
professional healthcare environment, including
healthcare facilities that utilize infusion
systems to administer IV fluids, mediations,
blood and blood products to the patient's
vascular system and may be safety used with
power injectors at pressures up to 325 psi. |
| Infusion Use? | Yes, Extension Set Only | Yes |
| Includes Blood
Collection
Capabilities | Yes | No |
| Shelf-Life | 2 Years | 5 Years |
| Pressure
Rating,
Extension Set | 325 PSI | 325 PSI |
| Maximum Flow
Rate,
Extension Set | 10 mL/second | 10 mL/second |
| Priming
Volume,
Extension Set | 0.25 mL | 0.25 mL |
| Single-Use? | Yes | Yes |
| Prescription
Use? | Yes | Yes |
| Sterile? | Yes, EO | Yes, EO |
The Pressure-Rated Extension Set on the Subject device is actually the predicate device thus the materials, constructions, and manufacturing processes are identical. Based on this, the Subject device is substantial equivalent to the predicated device from the fluid administration standpoint. In addition, the Subject device provides the ability for conduct initial blood draw prior to fluid administration.
The differences in the indication for use statement between the Subject device and the predicate device are not critical and does not affect the safety and effectiveness of the indication for the Pressure-Rated Extension Set is the same however the Subject device is specific to the connection to a short peripheral catheter and its use in blood draws. The predicate device is connected to such devices and can be used in blood draws.
The blood collection technology was cleared under 510(k) K162233 (Secondary Predicate). Refer to the following table for a comparison with the Subject Device:
| Comparison
Feature | Subject Device | Secondary Predicate Device
(K162233) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Device Name | Kurin PIV18 Blood Culture Collection Set with
Kurin Lock Technology, includes detachable,
pressure-rated, 6" (152mm) microbore
extension set | Kurin Blood Culture Collection Set |
| Regulation No. | 880.5540
Intravascular Administration Set | 862.1675 |
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| Comparison
Feature | Subject Device | Secondary Predicate Device
(K162233) |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FPA, JKA | JKA |
| Indications for
Use | Intended to connect to short peripheral
catheter to obtain initial blood draw and when
disconnected from the blood culture collection
set, the pressure-rated extension set is
intended to be utilized with infusions systems
to administer IV fluids, mediations, blood and
blood products to the patient's vascular
system and may be safety used with power
injectors at pressures up to 325 psi. | 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 prevention of
needlestick injury if manually activated after
blood draw. For blood collection, the set also
includes a safety shield and apparatus for
connection to vacuum based collection vials |
| Infusion Use? | Yes, Extension Set Only | No |
| Blood Collection
Capabilities | Yes, the Kurin blood lock mechanism
sequesters the initial sample of blood and the
blood collection holder is used to interface
with a vacuum tube or culture bottle. There is
no energy source, the device fills with blood
by differences in pressure gradient. | Yes, the winged needle is used to access the
patient's blood stream, the safety shield is
used cover the needle after collection, the
blood lock mechanism sequesters the initial
sample of blood and the blood collection
holder is used to interface with a vacuum tube
or culture bottle. There is no energy source,
the device fills with blood by differences in
pressure gradient. |
| Venipuncture
needle | No, luer connector | Yes |
| Pressure
Rating,
Extension Set | 325 PSI | N/A |
| Maximum Flow
Rate,
Extension Set | 10 mL/second | N/A |
| Priming
Volume,
Extension Set | 0.25 mL | N/A |
| Single-Use? | Yes | Yes |
| Prescription
Use? | Yes | Yes |
| Sterile? | Yes, EO | Yes, EO |
| Shelf-Life | 2 Years | 2 Years |
The main differences between the Subject Device and the Secondary Predicate is the Secondary Predicate includes a venipuncture needle and it is strictly used for blood collection. The Subject Device does not include a venipuncture needle, includes a pressure-rated extension set, and is intended to be used with peripheral catheters for blood collection and the extension set is intended to be used with infusion systems. The Subject Device and Secondary predicate are made of the same materials.
Summary of Non-Clinical Tests Performed
- . Sterilization
- Sterilization Product Adoptions o
- Sterilization Cycle Comparison o
-
Shelf-Life (Accelerated Aging)
7
- Visual Inspection .
- Gross Leak (Bubble Emission) .
- . Peel Seal Strength
- o Performance/Functionality
- Blood collection portion of Subject device .
- Performance/Functionality for pressure-rated extension set .
- Tensile Strength o
- Burst Pressure O
Conclusion
The Subject device has demonstrated through performance testing that it is substantially equivalent to the commercially available predicate.