(137 days)
No
The device description and performance studies focus on the physical components and functionality of a blood collection set, with no mention of AI or ML.
No.
The device is described as a blood culture collection set intended for venipuncture to obtain blood samples, and its function is to collect blood samples, not to treat a disease or condition.
No
Explanation: The device is intended for collecting blood samples and sequesters initial blood draw; it does not perform any diagnostic function itself.
No
The device description clearly states it is a sterile, single-use blood culture collection set including a winged needle, tubing, and a blood capture chamber. This is a physical medical device, not software.
Based on the provided information, the Kurin Blood Culture Collection Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for venipuncture to obtain blood samples." This describes a device used for collecting a biological sample, not for performing a diagnostic test on that sample.
- Device Description: The description focuses on the physical components of the blood collection set, including the needle, tubing, safety features, and a "blood capture chamber" that sequesters a small amount of blood. It does not describe any components or processes for analyzing the blood or providing diagnostic information.
- Lack of Diagnostic Function: The device's function is to collect blood. While the collected blood may be used for subsequent in vitro diagnostic testing (like blood cultures), the Kurin device itself does not perform the diagnostic test.
- Performance Studies: The performance studies listed focus on the physical and functional aspects of the collection set (sterilization, shelf life, leakage, flow rate, biocompatibility, etc.). There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVD devices.
- Predicate Devices: The predicate devices listed are also blood collection sets and adapters, which are not IVD devices.
In summary, the Kurin Blood Culture Collection Set is a device used to collect a sample that can then be used for in vitro diagnostic testing, but it does not perform the diagnostic test itself. Therefore, it is not an IVD device.
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 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.
Product codes
JKA
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.
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
Used only by trained professionals in a medical setting
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)
Non-Clinical Testing:
- Sterilization: The Kurin device is sterilized using a validated EO sterilization process which complies with ISO 11135-1:2006.
- Aging/Shelf Life Test: 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: 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: This test was completed and the Kurin device passed all 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.
Clinical Testing:
No clinical test data is required of the Proposed Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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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
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) | ☑ |
|---|---|
| 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 Consultant |
| Pathway LLC | |
| 8779 Cottonwood Ave | |
| Suite 105 | |
| Santee CA 92071 | |
| Ph: 949.636.4621 | |
| 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 |
| collection set (K980414) | |
| (2) Smith Medical Saf-T Holder Adapter (K923090) | |
| H. Common Name: | Venous Blood Collection Device |
| I. Classification: | Class II |
| Regulation
Number | Product
Code | Classification Name | Device
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 |
| Model Multiple | |
| Manufacturer: | Becton Dickinson |
| Common/Usual Name: | Accessory to: Tubes, Vials, Systems, Serum |
| 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 |
| Collection | |
| Regulation Number: | 862.1675 |
| Product Codes: | JKA |
| Classification: | II |
M. Substantial Equivalence
| Feature | Proposed Device
The "Kurin" | VACUTAINER BRAND SAFETY-LOK
BLOOD COLLECTION SET MODEL
MULTIPLE
K980414 | SAF-T HOLDER MULTI
SAMPLE LUER ADAPTER W/
BLOOD
K923090 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 safety shield and
apparatus for connection to
vacuum based collection
vials. | The VACUTAINER® brand blood
collection sets and Safety-Lok™ blood
collection set is a winged blood
collection needle and flexible tubing
for venipuncture to collect blood
specimens from patients or monitoring
blood pressure. The Safety-Lok™ blood
collection set also contains a needle
safety shield which minimizes the
possibility of needlesticks if manually
activated following blood collection.
The VACUTAINER® brand blood
collection sets and Safety-Lok™ blood
collection set is also recommended for
use in patients with small veins.
The VACUTAINER® brand blood
collection sets and Safety-Lok™ blood
collection set is also indicated for the
intravenous administration of fluids
and may be used for any patient | The Saf-T HOLDER® Blood
Culture device is intended for
use as a culture bottle or
vacuum tube holder that can
be attached to a female Luer
connector of the Saf-T Wing®
blood collection set or
equivalent. |
| | | population with consideration given to
patient size, appropriateness for the
solution being infused and duration of
therapy. | |
| Device
Description | The Kurin set 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
sample 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 Vacutainer Brand Blood Collection
sets and safety-Lok blood collection set
is a sterile winged blood collection
needles with flexible tuning and a
female luer adapter manufactured by
Becton Dickinson Vacutainer Systems,
Sumter, South Carolina. The Safety-Lok
Blood Collection set is provided with a
safety shield for covering the used
needle prior to disposal. A male luer
adapter is provided on specific reorder
numbers. A male luer adapter contains
a non-patient needle end for
puncturing the stopper of an
evacuated blood collection tube. Those
without a male luer adapter are
provided a protective cap on the end of
the female luer adapter. | The Saf-T HOLDER® Blood
Culture device is a sterile
multi-sample luer adapter for
venous blood sampling that
includes a blood culture bottle
holder with a fixed back end
needle, male luer threaded
connector and vacuum tube
adapter. |
| Product Code | JKA | JKA | JKA |
| Patient Interface | Used only by trained
professionals in a medical
setting | Used only by trained professionals in a
medical setting | Used only by trained
professionals in a medical
setting |
| Materials and Chemical Composition | | | |
| Kurin Materials | Makrolon Polycarbonate | unknown, medical grade plastic | unknown, medical grade
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
initial blood | Yes | No | No |
| Single Use
Device | Single Use | Single Use | Single Use |
| Indicated for
Infusion | No | Yes | No |
| Needle Gauge | 21, 23, 25 Gauge | 21, 23, 25 Gauge | Standard vial adapter |
| Labeled
Pyrogen Free | No | Yes | No |
| Sterilization | Yes, EtO | Yes, EtO | Yes, EtO |
| Expiration/Shelf
Life | 1 year (with protocols up to
3 years) | 3 years | 5 years |
| Size (LxWxH) | 21G, 3/4 inch, 12 inch
tubing,0.337 volume | 21G, 3/4 inch, 12 inch tubing,0.337
volume | 2.5 in x 2 in |
| | 23G, 3/4 inch, 12 inch
tubing,0.332 volume | 23G, 3/4 inch, 12 inch tubing,0.332
volume | |
| | 25G, 3/4 inch, 12 inch
tubing,0.331 volume | 25G, 3/4 inch, 12 inch tubing,0.331
volume | |
| Principles of
Operation | The winged needle is used to
access the patient's blood
stream, the safety shield is
used cover the needle after
collection, the kurin
component sequesters the
initial sample of blood and
the vial adapter is used to
interface with a vacuum tube
or culture bottle. There is no
energy source, the subject
device fills with blood by
differences in pressure
gradient. | The winged needle is used to access
the patient's blood stream, the safety
shield is used cover the needle after
collection, the tubing and luer
connector are used to attach to a vial
adapter or infusion set. There is no
energy source, the subject device fills
with blood by differences in pressure
gradient. | Cylindrical holder for vacuum
bottle or tube placement with
threads that are compatible
with blood collection needles
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.
-
- 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.
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.