K Number
K150407
Device Name
BioFlo Midline Catheter
Date Cleared
2015-05-15

(86 days)

Product Code
Regulation Number
880.5200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BioFlo Midline Catheter is indicated for short term access (< 30 days) 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. 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 osmolarity greater than 600 mOsm/L. 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 .
Device Description
The BioFlo Midline Catheter is a short term (< 30 days) non-valved peripheral venous access devices 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.
More Information

No
The 510(k) summary describes a physical medical device (a catheter) and its intended use and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are entirely bench testing of physical properties.

No.

The device is a midline catheter used for administering fluids, medications, and sampling blood, rather than directly providing therapy itself.

No

Explanation: The device is a BioFlo Midline Catheter, which is indicated for "short term access (

No

The device description and performance studies clearly indicate this is a physical medical device (catheter) and not a software-only device.

Based on the provided information, 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 (

N/A

Intended Use / Indications for Use

The BioFlo Midline Catheter is indicated for short term access (

§ 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).

0

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 15, 2015

Navilyst Medical, Inc. Mr. Brandon Brackett Specialist II, Global Regulatory Affairs 26 Forest Street Marlborough, Massachusetts 01752

Re: K150407

Trade/Device Name: Bioflo Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 12, 2015 Received: February 18, 2015

Dear Mr. Brackett:

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 (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/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 yours,

Tina
Kiang-S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Food and Drug AdministrationExpiration Date: January 31, 2017
Indications for UseSee PRA Statement below.
510(k) Number (if known)
UnknownK150407
Device Name
BioFlo Midline Catheter
Indications for Use (Describe)
including but not limited to, the administration of fluids, medications, and the sampling of blood products.
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 osmolarity greater than 600 mOsm/L.
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)

Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - BioFlo Midline Catheter

Date Prepared: May 12, 2015 Submission Number: K150407

A. Sponsor

Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752

B. Contact

Brandon M. Brackett Specialist II, Global Regulatory Affairs 508-658-7984

C. Device Name

Trade Name:BioFlo Midline Catheter
Common/Usual Name:Midline Catheter
Device Classification Name:Intravascular Catheter
Classification Panel:General Hospital
ProCode / Regulation Number:FOZ / 880.5200

OR

D. Predicate & Reference Devices

Predicate 510(k):

Trade Name: Common/Usual Name: Device Classification Name: Classification Panel: ProCode / Regulation Number:

Reference 510(k):

Trade Name: Common/Usual Name: Device Classification Name:

Classification Panel: ProCode / Regulation Number:

Wanda Carpinella Director, Global Regulatory Affairs 508-658-7929

Bard PowerGlide Midline Catheter (K133856) Midline Catheter Intravascular Catheter General Hospital FOZ / 880.5200

NMI PICC III and NMI HPICC III (K131942) PICC Percutaneous, Implanted, Long-Term Intravascular Catheter General Hospital LIS / 880.5970

E. Device Description

The BioFlo Midline Catheter is a short term (