(63 days)
No
The 510(k) summary describes a physical medical device (a catheter) and its performance characteristics, with no mention of AI, ML, image processing, or data analysis that would typically indicate the presence of such technology.
No
The device is described as a catheter for venous access and administration of fluids/medications, which serves as a delivery system rather than a therapeutic agent itself.
No
Explanation: The device is described as a catheter for peripheral venous therapy, used for administering fluids, medications, and sampling blood. These are therapeutic and access functions, not diagnostic capabilities.
No
The device description clearly indicates it is a physical catheter, a hardware component, and the performance studies focus on bench testing of physical properties like flow rate, burst strength, and material compatibility.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "short term access to the peripheral venous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products." This describes a device used in vivo (within the body) for therapeutic and diagnostic sample collection purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter inserted into a vein for direct access to the bloodstream. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: The document does not mention any components or functions related to analyzing biological samples outside the body, which is the core function of an IVD.
Therefore, based on the provided information, the BioFlo Midline catheter is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The BioFlo Midline catheter is indicated for short term access to the peripheral venous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.
Maximum Power Injection Flow Rate
- 3F Single Lumen / 20 cm - 2 mL/sec
- 4F Single Lumen / 20 cm 6 mL/sec
- 5F Single Lumen / 20 cm 6 mL/sec
- 5F Dual Lumen / 20 cm 6 mL/sec
Product codes (comma separated list FDA assigned to the subject device)
PND
Device Description
The BioFlo Midline Catheter is a short term peripheral venous access device between 3 to 10 inches in length (8 to 25 cm). Midlines are usually placed in an arm vein such as the basilic, brachial or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous system
Indicated Patient Age Range
Not Found
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)
There was no performance testing required due to the DFU change. Performance testing of the predicate BioFlo Midline Catheter included non-clinical bench testing conducted in accordance to the following FDA Guidance Documents and international standards:
- FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters"
- EN ISO 10555-1:2013 - "Intravascular Catheters - Sterile and Single-Use Catheters - Part 1: General Requirements"
- EN ISO 10555-3:2013 "Intravascular Catheters Sterile and Single-Use Catheters - Part 3: Central Venous Catheters"
- ISO 594-2:1998 - "Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings"
- EN ISO 10993-1:2009 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"
Bench testing included:
- Power Injection Flow Rate
- Static Burst Strength
- Multiple Power Injections
- Gravity Flow Rate
- Catheter Length
- Priming Volume
- Midline Identification
- Dimensional Verification (including ID, OD, Length)
- Catheter Kink/Flex Resistance (including Elongation, Stiffness, Flex Life Strength)
- Alcohol Compatibility
- Catheter Marking & Identification/Radiopacity Testing
- Tensile Testing (of Catheter and Assembly)
- Compatibility Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
Navilyst Medical, Inc. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 07152
Re: K161866
Trade/Device Name: BioFlo Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: PND Dated: July 7, 2016 Received: July 7, 2016
Dear Robin Fuller:
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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 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,
Tina
Kiang -S
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) K161866
Device Name BioFlo Midline Catheter
Indications for Use (Describe)
The BioFlo Midline catheter is indicated for short term access to the peripheral venous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.
Maximum Power Injection Flow Rate
- 3F Single Lumen/20 cm - 2 mL/sec
-
- 4F Single Lumen/20 cm 6 mL/sec
-
- 5F Single Lumen/20 cm 6 mL/sec
-
- 5F Dual Lumen/20 cm 6 mL/sec
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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.
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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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary for the BioFlo Midline Catheter
Date prepared: 8-September-2016
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Robin Fuller Sr. Manager, Regulatory Affairs 508-658-7986
Or
Wanda Carpinella Director, Regulatory Affairs 508-658-7929
C. Subject Device
| Trade Name: | BioFlo Midline Catheter |
|---|---|
| Common name: | Intravascular Catheter |
| Regulation Number | 21CFR§880.5200 |
| Regulation Name: | Intravascular Catheter |
| Regulatory Class: | Class II |
| Product Code: | PND |
| Classification Panel: | General Hospital |
D. Predicate Device
Trade Name: 510(k) Reference: Common name: Regulation Number Regulation Name: Regulatory Class: Product Code: Classification Panel:
BioFlo Midline Catheter K150407 Intravascular Catheter 21CFR§880.5200 Intravascular Catheter Class II PND General Hospital
E. Device Description
The BioFlo Midline Catheter is a short term peripheral venous access device between 3 to 10 inches in length (8 to 25 cm). Midlines are usually placed in an arm vein such as the basilic, brachial or cephalic and the tip ends below the level of the axillary line. Midline catheters are longer than peripheral IV catheters which are generally 1 to 3 inches long and shorter than
4
peripherally inserted central catheters (PICC) which extend into the superior vena cava. This device provides an alternative to short peripheral IVs and PICCs for certain treatments.
F. Intended Use/Indications for Use
The BioFlo Midline Catheter is indicated for short term access to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products.
Maximum Power Injection Flow Rates:
- . 3F Single Lumen, 20cm: 2 mL/sec
- 4F Single Lumen, 20cm: 6 mL/sec ●
- 5F Single Lumen, 20cm: 6 mL/sec ●
- 5F Dual Lumen, 20cm: 6 mL/sec .
G.Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed device is identical in regards to materials, design and components and technological characteristics as the predicate device. The only difference between the proposed device and the predicate device is a change to the Directions For Use (DFU). These changes are noted in Table 1 below.
| DFU Section | Proposed Device:
BioFlo Midline
Catheter | Predicate Device:
BioFlo Midline
Catheter (K150407) |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications For
Use | The BioFlo Midline
is indicated for short
term access to the
peripheral venous
system for
intravenous therapy,
including but not
limited to, the
administration of
fluids, medications
and the sampling of
blood and blood
products. | The BioFlo Midline is
indicated for short
term access ( 9 * solutions > 600 mOsmL |
| | | |
Table 1: Comparison of DFU changes
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Consistent with the Infusion Nurses Society Standards Practice (INS) 2011, the BioFlo Midline Catheter DFU lists out the therapies not appropriate for Midline Catheters under the Indications for Use and Warnings sections. In the INS 2011 version under the section on Midline catheters it states:
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"Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with pH less than 5 or greater than 9, and infusates with an osmolality greater than 600 mOsm/L".
Since the original 510(k) submission was concurred (K150407) the INS Standards of Practice has been revised (2016). In the INS 2016 version they have removed reference to infusates with pH less than 5 or greater than 9 and increased the infusates with osmolality from greater than 600 mOsm/L to greater than 900 mOsm/L. In order to not have to update the DFU each time the INS standard changes, we are proposing to change this information in the DFU to refer to the standards of practice. This is similar to the DFU of another Midline Catheter, the Bard PowerGlide Midline catheter (K133856). The Bard PowerGlide Catheter does not refer to therapies not appropriate and the Warning section does not list out therapies not appropriate but rather, refers to those therapies requiring central venous access and refers to standards of practice. The change being made to the BioFlo Midline Catheter DFU would be the same as the Bard PowerGlide Midline DFU.
The change in the Directions for Use does not change the intended use of the device which is to be used for short term access (