(186 days)
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.
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.
The provided document is a 510(k) summary for the Kurin PIV18 Blood Culture Collection Set with Kurin Lock Technology. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. While it summarizes non-clinical tests performed, it does not include acceptance criteria or a study proving that the device meets specific performance criteria related to diagnostic accuracy, sensitivity, or specificity in the way an AI/ML device study would.
The document details engineering and performance tests relevant to the device's function as a blood collection and infusion system. It confirms that these tests demonstrate substantial equivalence to predicate devices, but it does not present acceptance criteria for diagnostic performance or present a study to meet those criteria.
Therefore, the requested information specifically about acceptance criteria and a study proving achievement of those for a diagnostic device cannot be extracted from this document, as this is a physical medical device clearance, not an AI/ML diagnostic software clearance. Many of the requested fields are not applicable or cannot be found within this document.
However, I can extract information related to the non-clinical tests performed to demonstrate safety and performance of the physical device to establish substantial equivalence.
Here's an attempt to answer the questions based on the available information, noting where information is not present or not applicable for this type of device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format for all tests, nor does it detail the specific reported device performance values for each test, other than qualitative statements of substantial equivalence. It lists the types of tests performed.
| Test Performed | Acceptance Criteria (Not explicitly stated as numerical values in the document) | Reported Device Performance (Summary statement) |
|---|---|---|
| Sterilization (Product Adoptions, Cycle Comparison) | Not explicitly stated (Implied to meet ISO or other recognized standards) | Device is sterile (Yes, EO) |
| Shelf-Life (Accelerated Aging) | Not explicitly stated (Implied to meet shelf-life claim of 2 years) | Complies, supporting 2 years shelf-life. |
| Visual Inspection | Not explicitly stated (Implied to meet manufacturing quality standards) | Implied to pass (no defects reported) |
| Gross Leak (Bubble Emission) | Not explicitly stated (Implied to ensure system integrity) | Implied to pass (no leaks reported) |
| Peel Seal Strength | Not explicitly stated (Implied to ensure sterile barrier integrity) | Implied to pass |
| Performance/Functionality (Blood collection portion) | Not explicitly stated (Implied to successfully collect blood and divert discard volume) | Demonstrated substantial equivalence to secondary predicate (K162233) for blood collection capabilities. |
| Performance/Functionality (Pressure-rated extension set) | Pressure rating of 325 PSI, Maximum flow rate of 10 mL/second, Priming volume of 0.25 mL (These are design specifications that the device must meet). | Meets 325 PSI pressure rating, 10 mL/second maximum flow rate, and 0.25 mL priming volume. Demonstrates substantial equivalence to primary predicate (K092382). |
| Tensile Strength | Not explicitly stated (Implied to meet mechanical integrity standards) | Implied to pass |
| Burst Pressure | Not explicitly stated (Implied to meet mechanical integrity standards) | Implied to pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The document describes "non-clinical tests" which typically refer to bench or lab testing, not patient-based studies. Therefore, data provenance such as country of origin or retrospective/prospective is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a physical medical device (blood collection and infusion set), not a diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of bench and performance testing described for this physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as this is a physical medical device, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and established performance standards that the device needs to meet (e.g., sterilization efficacy, mechanical strength, flow rates). These are not expert consensus, pathology, or outcomes data, but rather measurable physical properties.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device, not an AI/ML device.
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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
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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
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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 RoadSuite 111San Diego, CA 92127 |
| Company Phone: | (760) 612-6090 |
| Contact Person: | Bob RogersChairman and CEObobrogers@kurin.com |
| Date: | January 17, 2019 |
| Device Identification | |
| Device Trade Name: | Kurin PIV18 Blood Culture Collection Set with KurinLock Technology, includes detachable, pressure-rated, 6" (152mm) microbore extension set |
| Common Name: | Intravascular Administration Set/ Blood CollectionSet |
| Product Models: | M-PIV18 - Kurin PIV18 Blood Culture Collection Setwith 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 Setwith 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 Setwith 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 |
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Identification of Predicate Device
| PredicateIdentifier | Device Name | Regulation No. | ProductCode | 510(K)Number | ClearanceDate |
|---|---|---|---|---|---|
| Primary | Nexus Pressure RatedExtension Sets | 880.5440Intravascular AdministrationSet | FPA | K092382 | April 26,2010 |
| Secondary | Kurin Blood CultureCollection Set | 862.1675Tubes, Vials, Systems, SerumSeparators, Blood Collection | JKA | K162233 | December23, 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.
| ComparisonFeature | Subject Device | Primary Predicate Device(K092382) |
|---|---|---|
| Device Name | Kurin PIV18 Blood Culture Collection Set withKurin Lock Technology, includes detachable,pressure-rated, 6" (152mm) microboreextension set | Nexus Pressure Rated Extension Set |
Comparison of Technological Characteristics with Primary Predicate Device
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| ComparisonFeature | Subject Device | Primary Predicate Device(K092382) |
|---|---|---|
| Regulation No. | 880.5540 | 880.5540 |
| Intravascular Administration Set | Intravascular Administration Set | |
| Product Code | FPA | FPA |
| Indications forUse | Intended to connect to short peripheralcatheter to obtain initial blood draw and whendisconnected from the blood culture collectionset, the pressure-rated extension set isintended to be utilized with infusions systemsto administer IV fluids, mediations, blood andblood products to the patient's vascularsystem and may be safety used with powerinjectors at pressures up to 325 psi. | The Nexus Pressure Rated Extension Sets areintended for the use in today's growingprofessional healthcare environment, includinghealthcare facilities that utilize infusionsystems to administer IV fluids, mediations,blood and blood products to the patient'svascular system and may be safety used withpower injectors at pressures up to 325 psi. |
| Infusion Use? | Yes, Extension Set Only | Yes |
| Includes BloodCollectionCapabilities | Yes | No |
| Shelf-Life | 2 Years | 5 Years |
| PressureRating,Extension Set | 325 PSI | 325 PSI |
| Maximum FlowRate,Extension Set | 10 mL/second | 10 mL/second |
| PrimingVolume,Extension Set | 0.25 mL | 0.25 mL |
| Single-Use? | Yes | Yes |
| PrescriptionUse? | 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:
| ComparisonFeature | Subject Device | Secondary Predicate Device(K162233) |
|---|---|---|
| Device Name | Kurin PIV18 Blood Culture Collection Set withKurin Lock Technology, includes detachable,pressure-rated, 6" (152mm) microboreextension set | Kurin Blood Culture Collection Set |
| Regulation No. | 880.5540Intravascular Administration Set | 862.1675 |
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| ComparisonFeature | Subject Device | Secondary Predicate Device(K162233) |
|---|---|---|
| Product Code | FPA, JKA | JKA |
| Indications forUse | Intended to connect to short peripheralcatheter to obtain initial blood draw and whendisconnected from the blood culture collectionset, the pressure-rated extension set isintended to be utilized with infusions systemsto administer IV fluids, mediations, blood andblood products to the patient's vascularsystem and may be safety used with powerinjectors at pressures up to 325 psi. | 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 prevention ofneedlestick injury if manually activated afterblood draw. For blood collection, the set alsoincludes a safety shield and apparatus forconnection to vacuum based collection vials |
| Infusion Use? | Yes, Extension Set Only | No |
| Blood CollectionCapabilities | Yes, the Kurin blood lock mechanismsequesters the initial sample of blood and theblood collection holder is used to interfacewith a vacuum tube or culture bottle. There isno energy source, the device fills with bloodby differences in pressure gradient. | Yes, the winged needle is used to access thepatient's blood stream, the safety shield isused cover the needle after collection, theblood lock mechanism sequesters the initialsample of blood and the blood collectionholder is used to interface with a vacuum tubeor culture bottle. There is no energy source,the device fills with blood by differences inpressure gradient. |
| Venipunctureneedle | No, luer connector | Yes |
| PressureRating,Extension Set | 325 PSI | N/A |
| Maximum FlowRate,Extension Set | 10 mL/second | N/A |
| PrimingVolume,Extension Set | 0.25 mL | N/A |
| Single-Use? | Yes | Yes |
| PrescriptionUse? | 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)
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- 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.
§ 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.