(143 days)
Not Found
No.
The device description and performance studies do not mention any AI, machine learning, or deep learning components. It describes a mechanical device for blood collection.
No.
The device is designed for blood collection, not for treating a disease or condition. While it interacts with the patient's body to obtain a sample, its primary function is diagnostic facilitation rather than therapeutic intervention.
No
Explanation: The device is used to collect blood specimens, which are then used for diagnosis, but the device itself does not perform any diagnostic function. It is a blood collection device.
No
The device is described as a physical product comprised of an inner flow tube, plunger, slider, male cannula, and flexible tube. It is sterile, single-use, and available in different gauges, all indicating a hardware medical device, not a software-only one. The performance studies and device description focus on physical attributes and mechanical testing.
No.
The device is for collecting blood specimens, not for performing tests on them.
N/A
Intended Use / Indications for Use
The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
Product codes
JKA
Device Description
The Navi™ Needle-free Blood Collection Device is a sterile packaged single use product designed to be attached to an already placed peripheral intravascular catheter (PIVC) system. The device is comprised of an inner flow tube with an atraumatic tip attached to a plunger that is advanced and retracted with the use of a slider. The slider extends through the proximal end of the housing and is connected to the plunger. A male cannula is positioned at the distal end of the housing with Luer clips configured to connect to a PIVC system. The inner flow tube is intended to be advanced distally through the PIVC into a patient blood vessel establishing fluid communication between the blood vessel and the collection assembly. The inner flow tube is designed to extend beyond the distal end of the PIVC. A lateral flexible tube with a female Luer connected to the housing provides a connection point for an evacuated tube holder or syringe to obtain a blood sample. Once complete, the inner flow tube is fully retracted back into the housing, and the device is removed from the PIVC system. The device is available in three sizes (20 GA, 22 GA and 24 GA) that are compatible with the corresponding PIVC.
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
adult and pediatric patients
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 Navi™ Needle-free Blood Collection Device was tested to demonstrate all product requirements and user needs were met. Based on the identified risks, the following tests were performed:
- Pressure Leak
- Vacuum Leak
- Pinch Clamp Leak
- Dimensional
- Kink Resistance
- Tensile Strength
- Catheter Gauge Compatibility
- Catheter Perforation
- Flow Rate
- Hemolysis
- Particulate
- Cannula Advancement Force
- Human Factors Testing
- Design Validation Testing
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.
FDA 510(k) Clearance Letter - Navi™ Needle-free Blood Collection Device
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 23, 2025
Venocare, Inc.
℅ Mark Smutka
Regulatory Consultant
Daniel & Daniel, LLC.
PO Box 129
Minden, Nevada 89423
Re: K244047
Trade/Device Name: Navi™ Needle-free Blood Collection Device
Regulation Number: 21 CFR 862.1675
Regulation Name: Blood Specimen Collection Device
Regulatory Class: Class II
Product Code: JKA
Dated: April 28, 2025
Received: April 28, 2025
Dear Mark Smutka:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K244047 - Mark Smutka Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K244047 - Mark Smutka Page 3
Sincerely,
Porsche Bennett
For David Wolloscheck, Ph.D.
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K244047
Device Name
Navi™ Needle-free Blood Collection Device
Indications for Use (Describe)
The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins.
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)
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."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
K244047 - 510(K) SUMMARY
Page 1 of 7
| Device Name | Navi™ Needle-free Blood Collection Device |
|---|---|
| Indications for Use | The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. |
Submitter Information
| Submitter Name | Venocare Inc. |
|---|---|
| Contact Person | Raul Leyte-Vidal |
| Telephone Number | 786.870.4020 |
| Address | 3750 NW 87th Avenue, Suite 260 Doral, FL 33178 |
| Date of Preparation | May 23rd, 2025 |
Subject Device
| Trade Name | Navi™ Needle-free Blood Collection Device |
|---|---|
| Common Name | Blood specimen collection device |
| Classification Name | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Class | Class II |
| Regulation Number | 21 CFR § 862.1675 |
| Product Code | JKA |
| Classification Panel | General Hospital |
Predicate Device
| Trade Name | PIVO™ Pro Needle-free Blood Collection Device |
|---|---|
| Common Name | Blood specimen collection device |
| Classification Name | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Class | Class II |
| Regulation Number | 21 CFR § 862.1675 |
| Product Code | JKA |
| 510(k) Number | K230865 |
Page 6
Page 2 of 7
Device Description
The Navi™ Needle-free Blood Collection Device is a sterile packaged single use product designed to be attached to an already placed peripheral intravascular catheter (PIVC) system. The device is comprised of an inner flow tube with an atraumatic tip attached to a plunger that is advanced and retracted with the use of a slider. The slider extends through the proximal end of the housing and is connected to the plunger. A male cannula is positioned at the distal end of the housing with Luer clips configured to connect to a PIVC system. The inner flow tube is intended to be advanced distally through the PIVC into a patient blood vessel establishing fluid communication between the blood vessel and the collection assembly. The inner flow tube is designed to extend beyond the distal end of the PIVC. A lateral flexible tube with a female Luer connected to the housing provides a connection point for an evacuated tube holder or syringe to obtain a blood sample. Once complete, the inner flow tube is fully retracted back into the housing, and the device is removed from the PIVC system. The device is available in three sizes (20 GA, 22 GA and 24 GA) that are compatible with the corresponding PIVC.
Technological Characteristics
The Navi™ Needle-free Blood Collection Device is substantially equivalent in indications for use, intended use, design, materials, and function to the PIVO device, cleared via 510(k) #K230865.
The following table includes a comparison of the Navi™ device to the PIVO blood collection device:
| Attribute | Predicate Device (K230865) PIVO™ Pro Needle-free Blood Collection Device | Subject Device (K244047) Navi™ Needle-free Blood Collection Device | Comparison |
|---|---|---|---|
| Owner | Becton Dickinson Infusion Therapy Systems, Inc. | Venocare Inc. | N/A |
| Classification | 21 CFR 862.1675 Class II JKA – Blood Specimen Collection Device | 21 CFR 862.1675 Class II JKA – Blood Specimen Collection Device | Same |
| Indications for Use | The PIVO™ Pro Needle-free Blood Collection Device attaches to a peripheral IV catheter system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, | The Navi™ Needle-free Blood Collection Device attaches to a peripheral intravascular catheter (PIVC) system for use to obtain venous blood specimens into a vacuum tube or syringe from adult and pediatric patients, | Same |
Page 7
Page 3 of 7
| Attribute | Predicate Device (K230865) | Subject Device (K244047) | Comparison |
|---|---|---|---|
| Indications for Use (continued) | including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. | including those with difficult intravenous access who may have small, fragile, and/or non-palpable veins. | Same |
| Intended Use | Venous blood draw | Venous blood draw | Same |
| Patient Interface | Separately placed commercially available peripheral IV catheter | Separately placed commercially available peripheral IV catheter | Same |
| PIV Attachment | Clip-to-connect | Push-connect | Different. Simulated use testing was done on the device to show that this difference does not raise new questions of safety or effectiveness. |
| Blood Collection Attachment | Female Luer to Blood Transfer Device or Syringe | Female Luer to Blood Transfer Device or Syringe | Same |
| Blood Control Mechanism | Cap on female luer and clamp on flexible tubing | User activated discontinuous lumen, clamp on extension tubing | Different. Performance and Simulated use testing were done on the device to show that this difference does not raise new questions of safety or effectiveness. |
| Tubing | Transparent Flexible | Transparent Flexible | Same |
Primary Components Dimensions and Material Composition
| ISO 10993-1 Biocompatibility Contact Type Duration | Body Contact: Externally communicating device Contact: Circulating blood Contact Duration: Limited (A) (