(210 days)
No
The device description and performance studies focus on mechanical and material properties, not data processing or algorithmic functions. The "automate the initial specimen diversion volume method" refers to a physical mechanism, not an AI/ML algorithm.
No.
The device is intended for collecting blood samples, not for treating any specific disease or condition.
No
Explanation: The device is a blood collection set used to obtain blood samples, not to analyze them for diagnostic purposes. Its function is limited to specimen collection.
No
The device description clearly details physical components like needles, tubing, holders, and a safety shield, and the performance studies focus on the physical properties and functionality of these hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain blood samples" for venipuncture. While these blood samples may be used for in vitro diagnostic testing later, the device itself is solely for the collection of the sample.
- Device Description: The description focuses on the mechanics of blood collection, needle safety, and compatibility with collection vials. It does not describe any components or processes that analyze the blood sample itself.
- Performance Studies: The performance studies listed are related to the physical characteristics and functionality of the collection device (sterilization, biocompatibility, needle performance, leakage, flow rate, safety mechanism, etc.). There are no studies related to the analysis of blood components or diagnostic results.
An IVD device is specifically designed to perform tests on samples taken from the human body (like blood) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is a tool for collecting the sample, not for performing the diagnostic test on the sample.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
JKA
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. (The blood collection holders were cleared in : K912563, K081229 and K950432)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following evaluations were conducted to support the 510(k) submission:
- Sterilization (product adoption per AAMI TIR 28)
- Biocompatibility
- Pyrogenicity
- Performance/Stability
- Needle Performance
- Stiffness test
- Resistance to breakage
- Resistance to corrosion
- Device Performance
- Functionality
- Leakage
- Flow Rate
- Needlestick Safety Mechanism
- Tensile Strength
- Packaging Integrity
- Visual Inspection
- Gross Leak (Bubble Emission)
- Dye Penetration
- Seal Strength (Peel)
- Needle Performance
- Performance related to blood collection holder and compatibility with blood culture bottles
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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
§ 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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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.
1
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 Road |
| Suite 111 | |
| San Diego, CA 92127 | |
| Company Phone: | (888) 963-9056 |
| Contact Person: | Bob Rogers |
| Chairman and CEO | |
| bobrogers@kurin.com | |
| Date: | February 3, 2020 |
Device Identification
| Device Trade Name: | Kurin Blood Culture Collection Set with Kurin Lock
Technology, Push-Button Needle |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Blood Collection Set |
| Product Models: | M-21221 - Kurin Blood Culture Collection Set with Kurin
Lock Technology, 21Ga Push Button Needle, Compatible
with BioMerieux Bottles
M-21223 - Kurin Blood Culture Collection Set with Kurin
Lock Technology, 23Ga Push Button Needle, Compatible
with BioMerieux Bottles
D-21221 - Kurin Blood Culture Collection Set with Kurin
Lock Technology, 21Ga Push Button Needle, Compatible
with BD & Thermo Fisher Long-Neck Bottles
D-21223 - Kurin Blood Culture Collection Set with Kurin
Lock Technology, 23Ga Push Button Needle, Compatible
with BD & Thermo Fisher Long-Neck Bottles
T-21221 - Kurin Blood Culture Collection Set with Kurin
Lock Technology, 21Ga Push Button Needle, Compatible
with Thermo Fisher Short-Neck Bottles
T-21223 - Kurin Blood Culture Collection Set with Kurin
Lock Technology, 23Ga Push Button Needle, Compatible
with Thermo Fisher Short-Neck Bottles |
| Classification Name(s): | Tubes, Vials, Systems, Serum Separators, Blood
Collection |
| 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 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. (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
| Comparison
| Feature | Subject Device | Predicate Device |
|---|---|---|
| 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. |
Note: The change in the terminology from | 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 safety
shield and apparatus for connection to
vacuum-based collection vials. |
| Comparison Table - Subject and Predicate Devices | | |
| Comparison
Feature | Subject Device | Predicate Device |
| | "safety shield and apparatus" to "blood
collection holder" in the device component
does not impact safety and effectiveness.
Both terms are referencing the same device
component. Three is no change in the
device component design. | |
| Infusion indication | No | No |
| Single-use | Yes | Yes |
| Sterile | Yes | Yes |
| Method of
sterilization, SAL | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL 10-6 |
| Needlestick
mechanism type | Active, semi-automatic (i.e., push button) -
Activation is achieved by depressing a
spring activated button
Note: The change from the Predicate does
not impact safety or effectiveness of the
device. The push-button design provides
protection prior to use with a needle tip | Active, manual (i.e. slide) - Activation is
achieved by manually sliding a shield over
the needle |
| | protector and covers the needle upon
activation after use. Performance testing in
the 510(k) submission supports its safety. | |
| | 21 & 23 | |
| Needle Gauge | Note: Not offering the 25 Ga needle
configuration does not impact the safety and
effectiveness. | 21, 23, & 25 |
| Needle Length | 0.75 Inch | 0.75 Inch |
| Device Length | 12 Inches | 12 Inches |
| Blood Collection
Holder | Saf-T Holder Device (MFG: Smith Medical)
Vacutainer One-Use Holder (MFG: BD)
Monoject Safety Collection Device (MFG:
Covidien)
Note: The additional blood collection holders
does not impact the safety or effectiveness.
Each blood collection holder works in the
same and interfaces with the standard
collection vial however each holder is
designed to interface specifically with its
manufacturer's culture collection bottle. All | Saf-T Holder Device (MFG: Smith Medical) |
| | holders are design with shielding to the
needle and are FDA cleared. | |
| Sterile barrier
packaging | Thermoform Tray/Tyvek Lidding Stock
Note: The change from the Predicate does
not impact safety or effectiveness. The tray
sterile barrier packaging was successfully
tested to same transportation and seal
integrity performance standards conducted | Tyvek/Poly Pouch |
| Comparison Table - Subject and Predicate Devices | | |
| Comparison
Feature | Subject Device | Predicate Device |
| | with the predicate. Results are incorporated
in the 510(k) submission and does not
impact safety or effectiveness. | |
| Principles of
operation | Venipuncture needle accesses the patient's
vascular system then blood flows up to the
blood lock mechanism where the first 0.15ml
of blood is held in a side chamber and then
blood is directed into the collection lumen.
The collection container is connected to a
blood collection holder where blood is
collected. Needlestick safety mechanism is
activated to protect against needlestick
injuries. | Venipuncture needle accesses the patient's
vascular system then blood flows up to the
blood lock mechanism where the first 0.15ml
of blood is held in a side chamber and then
blood is directed into the collection lumen.
The collection container is connected to a
blood collection holder where blood is
collected. Needlestick safety mechanism is
activated to protect against needlestick
injuries. |
| Shelf-Life | 6-month
Note: The difference in the shelf-life is not
based on performance There is not impact
to safety or effectiveness. | 1-year initially, currently 2-year |
Comparison Table - Subject and Predicate Devices
5
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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)
- o Needle Performance
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.