Kurin Blood Culture Collection Set

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | <span style="font-size: 20px;">☑</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 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 Consultant<br>Pathway LLC<br>8779 Cottonwood Ave<br>Suite 105<br>Santee CA 92071<br>Ph: 949.636.4621<br>Email: erbakersd@gmail.com | | F. Trade Name: | Kurin Blood Culture Collection Set | | G. Predicate Device(s): | (1) BD Vacutainer Blood collection set and Safety-Lok blood<br>collection set (K980414)<br>(2) Smith Medical Saf-T Holder Adapter (K923090) | | H. Common Name: | Venous Blood Collection Device | | I. Classification: | Class II | | Regulation<br>Number | Product<br>Code | Classification Name | Device<br>Class | |----------------------|-----------------|----------------------------------|-----------------| | 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 {4}------------------------------------------------ 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 Set<br>Model Multiple | | Manufacturer: | Becton Dickinson | | Common/Usual Name: | Accessory to: Tubes, Vials, Systems, Serum<br>Separators, 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, Blood<br>Collection | | Regulation Number: | 862.1675 | | Product Codes: | JKA | | Classification: | II | ## M. Substantial Equivalence | Feature | Proposed Device<br>The "Kurin" | VACUTAINER BRAND SAFETY-LOK<br>BLOOD COLLECTION SET MODEL<br>MULTIPLE<br>K980414 | SAF-T HOLDER MULTI<br>SAMPLE LUER ADAPTER W/<br>BLOOD<br>K923090 | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The Kurin Blood Culture<br>Collection Set is a winged<br>blood collection needle with<br>flexible tubing intended for<br>venipuncture to obtain blood<br>samples. It is provided with a<br>safety shield for covering the<br>used venipuncture needle<br>prior to disposal to aid in the<br>prevention of needlestick<br>injury if manually activated<br>after the blood draw. For<br>blood collection, the set also<br>includes a safety shield and<br>apparatus for connection to<br>vacuum based collection<br>vials. | The VACUTAINER® brand blood<br>collection sets and Safety-Lok™ blood<br>collection set is a winged blood<br>collection needle and flexible tubing<br>for venipuncture to collect blood<br>specimens from patients or monitoring<br>blood pressure. The Safety-Lok™ blood<br>collection set also contains a needle<br>safety shield which minimizes the<br>possibility of needlesticks if manually<br>activated following blood collection.<br>The VACUTAINER® brand blood<br>collection sets and Safety-Lok™ blood<br>collection set is also recommended for<br>use in patients with small veins.<br>The VACUTAINER® brand blood<br>collection sets and Safety-Lok™ blood<br>collection set is also indicated for the<br>intravenous administration of fluids<br>and may be used for any patient | The Saf-T HOLDER® Blood<br>Culture device is intended for<br>use as a culture bottle or<br>vacuum tube holder that can<br>be attached to a female Luer<br>connector of the Saf-T Wing®<br>blood collection set or<br>equivalent. | | | | population with consideration given to<br>patient size, appropriateness for the<br>solution being infused and duration of<br>therapy. | | | Device<br>Description | The Kurin set is a sterile,<br>single use blood culture<br>collection set. The Kurin<br>includes a winged needle<br>with flexible tubing and an<br>attached vial adapter<br>intended for venipuncture to<br>obtain blood culture<br>samples. Kurin is identical in<br>every way to existing sets<br>used to collect blood culture<br>sample except for the<br>insertion into the tubing of<br>the Kurin blood capture<br>chamber. The Kurin blood<br>capture device sequesters<br>the initial draw of blood<br>upon initial venipuncture.<br>The set is provided with a<br>safety shield for covering the<br>used needle prior to<br>disposal. The amount of<br>blood diverted is very small,<br>estimated at a fraction of 1<br>ml. | The Vacutainer Brand Blood Collection<br>sets and safety-Lok blood collection set<br>is a sterile winged blood collection<br>needles with flexible tuning and a<br>female luer adapter manufactured by<br>Becton Dickinson Vacutainer Systems,<br>Sumter, South Carolina. The Safety-Lok<br>Blood Collection set is provided with a<br>safety shield for covering the used<br>needle prior to disposal. A male luer<br>adapter is provided on specific reorder<br>numbers. A male luer adapter contains<br>a non-patient needle end for<br>puncturing the stopper of an<br>evacuated blood collection tube. Those<br>without a male luer adapter are<br>provided a protective cap on the end of<br>the female luer adapter. | The Saf-T HOLDER® Blood<br>Culture device is a sterile<br>multi-sample luer adapter for<br>venous blood sampling that<br>includes a blood culture bottle<br>holder with a fixed back end<br>needle, male luer threaded<br>connector and vacuum tube<br>adapter. | | Product Code | JKA | JKA | JKA | | Patient Interface | Used only by trained<br>professionals in a medical<br>setting | Used only by trained professionals in a<br>medical setting | Used only by trained<br>professionals in a medical<br>setting | | Materials and Chemical Composition | | | | | Kurin Materials | Makrolon Polycarbonate | unknown, medical grade plastic | unknown, medical grade<br>plastic | | 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 | | | | | Sequesters<br>initial blood | Yes | No | No | | Single Use<br>Device | Single Use | Single Use | Single Use | | Indicated for<br>Infusion | No | Yes | No | | Needle Gauge | 21, 23, 25 Gauge | 21, 23, 25 Gauge | Standard vial adapter | | Labeled<br>Pyrogen Free | No | Yes | No | | Sterilization | Yes, EtO | Yes, EtO | Yes, EtO | | Expiration/Shelf<br>Life | 1 year (with protocols up to<br>3 years) | 3 years | 5 years | | Size (LxWxH) | 21G, 3/4 inch, 12 inch<br>tubing,0.337 volume | 21G, 3/4 inch, 12 inch tubing,0.337<br>volume | 2.5 in x 2 in | | | 23G, 3/4 inch, 12 inch<br>tubing,0.332 volume | 23G, 3/4 inch, 12 inch tubing,0.332<br>volume | | | | 25G, 3/4 inch, 12 inch<br>tubing,0.331 volume | 25G, 3/4 inch, 12 inch tubing,0.331<br>volume | | | Principles of<br>Operation | The winged needle is used to<br>access the patient's blood<br>stream, the safety shield is<br>used cover the needle after<br>collection, the kurin<br>component sequesters the<br>initial sample of blood and<br>the vial adapter is used to<br>interface with a vacuum tube<br>or culture bottle. There is no<br>energy source, the subject<br>device fills with blood by<br>differences in pressure<br>gradient. | The winged needle is used to access<br>the patient's blood stream, the safety<br>shield is used cover the needle after<br>collection, the tubing and luer<br>connector are used to attach to a vial<br>adapter or infusion set. There is no<br>energy source, the subject device fills<br>with blood by differences in pressure<br>gradient. | Cylindrical holder for vacuum<br>bottle or tube placement with<br>threads that are compatible<br>with blood collection needles<br>and luers. | | Biocompatibility | Conforms with ISO 10993 | Conforms with ISO 10993 | Conforms with ISO 10993 | {5}------------------------------------------------ {6}------------------------------------------------ ## N. Non-Clinical Testing All testing met specifications for the subject device and demonstrates substantial equivalence to the predicates. - 1. 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. - 3. 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. - 5. 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. - 6. User Verification Test - Testing was conducted to evaluate if the instructions for use were easy to understand and the functionality of the device. - 7. 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. {7}------------------------------------------------ ## 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.