(137 days)
The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a safety shield and apparatus for connection to vacuum based collection vials.
The Kurin device is a sterile, single use blood culture collection set. The Kurin includes a winged needle with flexible tubing and an attached vial adapter intended for venipuncture to obtain blood culture samples. Kurin is identical in every way to existing sets used to collect blood culture samples except for the insertion into the tubing of the Kurin blood capture chamber. The Kurin blood capture device sequesters the initial draw of blood upon initial venipuncture. The set is provided with a safety shield for covering the used needle prior to disposal. The amount of blood diverted is very small, estimated at a fraction of 1 ml.
The provided document is a 510(k) premarket notification for a medical device called the "Kurin Blood Culture Collection Set." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than proving performance against specific acceptance criteria for diagnostic accuracy or effectiveness in a clinical context. Therefore, the information typically found in acceptance criteria and detailed study descriptions for AI/ML medical devices (like sensitivity, specificity, F1 score, sample size for test sets, expert qualifications, etc.) is not present in this document.
However, I can extract the non-clinical testing performed and present them as "acceptance criteria" and "reported performance" based on how they are described in the document as meeting specifications.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Sterilization: Compliance with ISO 11135-1:2006 for Ethylene Oxide sterilization. | The Kurin device is sterilized using a validated EO sterilization process which complies with ISO 11135-1:2006. |
| Aging/Shelf Life: Achieve a 1-year shelf life for sterility and performance. Protocols for up to 3 years. | The Kurin device was validated to achieve 1-year shelf life with protocols for up to 3 years of shelf life for sterility and performance. |
| Functional, Leakage, and Tensile Test: No compromise to the function of the blood collection device, no leakage, and passing tensile testing in accordance with ISO 1135-3 sections 5.2 and 5.3. | The Kurin set confirmed the addition of the Kurin device shows no compromise to the function of the blood collection device in regards to functionality. With the addition of the device, the product does not leak and passed tensile testing in accordance with sections 5.2 and 5.3 of ISO 1135-3. |
| Packaging Integrity and Shipping Test: Compliance with ISO 11607 and ASTM D4169-14. | This test was completed, and the Kurin device passed all tests in accordance with ISO 11607 and ASTM D4169-14. |
| Biocompatibility Tests: No leachables (MEM Elution Test), no adverse effect on blood constituents (IVH Blood Count Test). | The Kurin device passed two types of biocompatibility tests: the MEM Elution Test demonstrated that no leachables are present from the system, and the IVH Blood Count Test which demonstrated that the blood path did not adversely affect the constituents of blood exposed to the systems fluid path. |
| User Verification Test: Instructions for use are easy to understand, and device functionality is acceptable. | Testing was conducted to evaluate if the instructions for use were easy to understand and the functionality of the device. (Implied success as it "passed") |
| Flow Rate Test: Addition of the Kurin Device does not change the flow rate of liquid compared to the predicate. | Testing verified that the addition of the Kurin Device into the tubing of the FDA cleared BD Vacutainer® brand blood collection set and Safety-Lok™ Blood Collection set did not change the flow rate of liquid passing through the device. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical engineering and bench testing, not a clinical test set with patient data. No specific sample sizes for these tests (e.g., number of devices tested for flow rate, leakage, etc.) are provided in the summary. Data provenance is not applicable in the context of clinical populations as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this document describes non-clinical, bench testing, and engineering verification, not a study evaluating expert performance or ground truth established by experts. The "ground truth" here is determined by the specifications of the standards (e.g., ISO, ASTM) and the physical properties of the device.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.
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
Not applicable. This device is a blood collection set, not an AI/ML diagnostic tool, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm, and its performance is assessed via non-clinical testing.
7. The type of ground truth used
The "ground truth" for the non-clinical tests described in this document is based on engineering specifications, compliance with international standards (ISO, ASTM), and predefined performance benchmarks (e.g., no leakage, specific flow rates, successful sterilization).
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2016
Pathway LLC. c/o Mark Job Regulatory Technology Services LLC 1394 25th Street North West Buffalo, MN 55313
Re: K162233
Trade/Device Name: Kurin Blood Culture Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Set Regulatory Class: Class II Product Code: JKA Dated: December 1, 2016 Received: December 8, 2016
Dear Mr. Mark Job:
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. 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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH 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) K162233
Device Name Kurin Blood Culture Collection Set
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 needlestick injury if manually activated after the blood collection, the set also includes a safety shield and apparatus 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
| A. Submitter: | Pathway LLC, on behalf of Calliope Solutions, Inc. |
|---|---|
| B. Date Prepared: | September 7, 2016 |
| C. Address: | 8779 Cottonwood Ave, Suite 105, Santee CA 92071 |
| D. Corporate Contact: | David Stroup |
| E. Submission Contact: | Emily Davis, Quality ConsultantPathway LLC8779 Cottonwood AveSuite 105Santee CA 92071Ph: 949.636.4621Email: erbakersd@gmail.com |
| F. Trade Name: | Kurin Blood Culture Collection Set |
| G. Predicate Device(s): | (1) BD Vacutainer Blood collection set and Safety-Lok bloodcollection set (K980414)(2) Smith Medical Saf-T Holder Adapter (K923090) |
| H. Common Name: | Venous Blood Collection Device |
| I. Classification: | Class II |
| RegulationNumber | ProductCode | Classification Name | DeviceClass |
|---|---|---|---|
| 862.1675 | JKA | Blood Specimen Collection Device | II |
J. Device Description
The Kurin device is a sterile, single use blood culture collection set. The Kurin includes a winged needle with flexible tubing and an attached vial adapter intended for venipuncture to obtain blood culture samples. Kurin is identical in every way to existing sets used to collect blood culture samples except for the insertion into the tubing of the Kurin blood capture chamber. The Kurin blood capture device sequesters the initial draw of blood upon initial venipuncture. The set is provided with a safety shield for covering the used needle prior to disposal. The amount of blood diverted is very small, estimated at a fraction of 1 ml.
Below is a table with the three models and sizes of the subject device's that intend to be marketed.
| Measurement (mm) | ||||||
|---|---|---|---|---|---|---|
| Model | H | D | W | Weight (g) | Tubing | Gauge |
| K-11221 | 31mm | 13mm | 6.45mm | 15.7g | 12 in | 21 Gauge |
| K-11223 | 31mm | 13mm | 6.45mm | 15.7g | 12 in | 23 Gauge |
| K-11225 | 31mm | 13mm | 6.45mm | 15.7g | 12 in | 25 Gauge |
K. Intended 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
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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.
L. Predicate Device(s)
The Kurin device is substantially equivalent to the following FDA cleared predicate devices:
| Predicate #1 | |
|---|---|
| 510(k) Number: | K980414 |
| Trade Name: | Vacutainer Brand Safety-Lok Blood Collection SetModel Multiple |
| Manufacturer: | Becton Dickinson |
| Common/Usual Name: | Accessory to: Tubes, Vials, Systems, SerumSeparators, Blood Collection |
| Regulation Number: | 862.1675 |
| Product Codes: | JKA |
| Classification: | II |
| Predicate #2 | |
| 510(k) Number: | K923090 |
| Trade Name: | Saf-T Holder Multi Sample Luer Adapter |
| Manufacturer: | Smiths Medical |
| Common/Usual Name: | Tubes, Vials, Systems, Serum Separators, BloodCollection |
| Regulation Number: | 862.1675 |
| Product Codes: | JKA |
| Classification: | II |
M. Substantial Equivalence
| Feature | Proposed DeviceThe "Kurin" | VACUTAINER BRAND SAFETY-LOKBLOOD COLLECTION SET MODELMULTIPLEK980414 | SAF-T HOLDER MULTISAMPLE LUER ADAPTER W/BLOODK923090 |
|---|---|---|---|
| Indications forUse | The Kurin Blood CultureCollection Set is a wingedblood collection needle withflexible tubing intended forvenipuncture to obtain bloodsamples. It is provided with asafety shield for covering theused venipuncture needleprior to disposal to aid in theprevention of needlestickinjury if manually activatedafter the blood draw. Forblood collection, the set alsoincludes a safety shield andapparatus for connection tovacuum based collectionvials. | The VACUTAINER® brand bloodcollection sets and Safety-Lok™ bloodcollection set is a winged bloodcollection needle and flexible tubingfor venipuncture to collect bloodspecimens from patients or monitoringblood pressure. The Safety-Lok™ bloodcollection set also contains a needlesafety shield which minimizes thepossibility of needlesticks if manuallyactivated following blood collection.The VACUTAINER® brand bloodcollection sets and Safety-Lok™ bloodcollection set is also recommended foruse in patients with small veins.The VACUTAINER® brand bloodcollection sets and Safety-Lok™ bloodcollection set is also indicated for theintravenous administration of fluidsand may be used for any patient | The Saf-T HOLDER® BloodCulture device is intended foruse as a culture bottle orvacuum tube holder that canbe attached to a female Luerconnector of the Saf-T Wing®blood collection set orequivalent. |
| population with consideration given topatient size, appropriateness for thesolution being infused and duration oftherapy. | |||
| DeviceDescription | The Kurin set is a sterile,single use blood culturecollection set. The Kurinincludes a winged needlewith flexible tubing and anattached vial adapterintended for venipuncture toobtain blood culturesamples. Kurin is identical inevery way to existing setsused to collect blood culturesample except for theinsertion into the tubing ofthe Kurin blood capturechamber. The Kurin bloodcapture device sequestersthe initial draw of bloodupon initial venipuncture.The set is provided with asafety shield for covering theused needle prior todisposal. The amount ofblood diverted is very small,estimated at a fraction of 1ml. | The Vacutainer Brand Blood Collectionsets and safety-Lok blood collection setis a sterile winged blood collectionneedles with flexible tuning and afemale luer adapter manufactured byBecton Dickinson Vacutainer Systems,Sumter, South Carolina. The Safety-LokBlood Collection set is provided with asafety shield for covering the usedneedle prior to disposal. A male lueradapter is provided on specific reordernumbers. A male luer adapter containsa non-patient needle end forpuncturing the stopper of anevacuated blood collection tube. Thosewithout a male luer adapter areprovided a protective cap on the end ofthe female luer adapter. | The Saf-T HOLDER® BloodCulture device is a sterilemulti-sample luer adapter forvenous blood sampling thatincludes a blood culture bottleholder with a fixed back endneedle, male luer threadedconnector and vacuum tubeadapter. |
| Product Code | JKA | JKA | JKA |
| Patient Interface | Used only by trainedprofessionals in a medicalsetting | Used only by trained professionals in amedical setting | Used only by trainedprofessionals in a medicalsetting |
| Materials and Chemical Composition | |||
| Kurin Materials | Makrolon Polycarbonate | unknown, medical grade plastic | unknown, medical gradeplastic |
| Tubing | Transparent Flexible tubing | Substantially equivalent | NA since this is just the adapter |
| Adapter | Male or Female Luer | Substantially equivalent | Substantially equivalent |
| Performance/Design Specifications | |||
| Sequestersinitial blood | Yes | No | No |
| Single UseDevice | Single Use | Single Use | Single Use |
| Indicated forInfusion | No | Yes | No |
| Needle Gauge | 21, 23, 25 Gauge | 21, 23, 25 Gauge | Standard vial adapter |
| LabeledPyrogen Free | No | Yes | No |
| Sterilization | Yes, EtO | Yes, EtO | Yes, EtO |
| Expiration/ShelfLife | 1 year (with protocols up to3 years) | 3 years | 5 years |
| Size (LxWxH) | 21G, 3/4 inch, 12 inchtubing,0.337 volume | 21G, 3/4 inch, 12 inch tubing,0.337volume | 2.5 in x 2 in |
| 23G, 3/4 inch, 12 inchtubing,0.332 volume | 23G, 3/4 inch, 12 inch tubing,0.332volume | ||
| 25G, 3/4 inch, 12 inchtubing,0.331 volume | 25G, 3/4 inch, 12 inch tubing,0.331volume | ||
| Principles ofOperation | The winged needle is used toaccess the patient's bloodstream, the safety shield isused cover the needle aftercollection, the kurincomponent sequesters theinitial sample of blood andthe vial adapter is used tointerface with a vacuum tubeor culture bottle. There is noenergy source, the subjectdevice fills with blood bydifferences in pressuregradient. | The winged needle is used to accessthe patient's blood stream, the safetyshield is used cover the needle aftercollection, the tubing and luerconnector are used to attach to a vialadapter or infusion set. There is noenergy source, the subject device fillswith blood by differences in pressuregradient. | Cylindrical holder for vacuumbottle or tube placement withthreads that are compatiblewith blood collection needlesand luers. |
| Biocompatibility | Conforms with ISO 10993 | Conforms with ISO 10993 | Conforms with ISO 10993 |
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N. Non-Clinical Testing
All testing met specifications for the subject device and demonstrates substantial equivalence to the predicates.
-
- Sterilization – The Kurin device is sterilized using a validated EO sterilization process which complies with ISO 11135-1:2006 Sterilization of health care products – Ethylene Oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- Aging/Shelf Life Test– The Kurin device was validated to achieve 1-year shelf life with protocols 2. for up to 3 years of shelf life for sterility and performance.
-
- Functional, Leakage and Tensile Test – The Kurin set confirmed the addition of the Kurin device shows no compromise to the function of the blood collection device in regards to functionality. With the addition of the device the product does not leak and passed tensile testing in accordance with sections 5.2 and 5.3 of ISO 1135-3 - Transfusion equipment for medical use --Part 3: Blood-taking set for single use.
- Packaging Integrity and Shipping Test This test was completed and the Kurin device passed all 4. tests in accordance with ISO 11607 and ASTM D4169-14.
-
- Biocompatibility Tests – The Kurin device passed two types of biocompatibility tests: the MEM Elution Test demonstrated that no leachables are present from the system and the IVH Blood Count Test which demonstrated that the blood path did not adversely affect the constituents of blood exposed to the systems fluid path.
-
- User Verification Test - Testing was conducted to evaluate if the instructions for use were easy to understand and the functionality of the device.
-
- Flow Rate Test – Testing verified that the addition of the Kurin Device into the tubing of the FDA cleared BD Vacutainer® brand blood collection set and Safety-Lok™ Blood Collection set did not change the flow rate of liquid passing through the device.
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O. Clinical Testing
No clinical test data is required of the Proposed Device.
P. Conclusion
The above information and tests conducted demonstrate that the Subject Device is substantially equivalent to the identified predicates.
§ 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.