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.

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.

AI/ML Overview

This document is a 510(k) summary for the BioFlo Midline Catheter, which concerns a change in the Directions For Use (DFU) of an already cleared device. Therefore, the information typically found in acceptance criteria and detailed study reports for a device's initial clearance is not fully present or directly applicable.

Based on the provided text, the device itself (BioFlo Midline Catheter) was previously cleared, and this submission (K161866) focuses specifically on a change to its labeling (DFU). The core claim is that since only the DFU changed, and the physical device is identical to the predicate (K150407), no new performance testing was required.

Here's an attempt to answer your questions based on the available information, noting where data is implicitly accepted from the predicate or explicitly stated as not applicable for this particular submission:

1. A table of acceptance criteria and the reported device performance

For this specific 510(k) (K161866), no new acceptance criteria or reported performance data for the device itself are provided because the change is limited to the DFU. The performance of the device is considered substantially equivalent to the predicate device (K150407) based on its identical materials, design, and components.

However, the document lists the types of bench testing performed for the predicate BioFlo Midline Catheter (K150407), which would have had associated acceptance criteria at the time of its clearance.

Acceptance Criteria (Inferred from Predicate's Testing Areas)	Reported Device Performance (For K161866 - assumed equivalent to predicate K150407)
Power Injection Flow Rate (specific mL/sec values per size)	* 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
Static Burst Strength	Assumed to meet standard requirements (Detail not provided in this document)
Multiple Power Injections	Assumed to meet standard requirements (Detail not provided in this document)
Gravity Flow Rate	Assumed to meet standard requirements (Detail not provided in this document)
Catheter Length (conforming to specified range)	"between 3 to 10 inches in length (8 to 25 cm)"
Priming Volume	Assumed to meet standard requirements (Detail not provided in this document)
Midline Identification	Assumed to meet standard requirements (Detail not provided in this document)
Dimensional Verification (ID, OD, Length)	Assumed to meet standard requirements (Detail not provided in this document)
Catheter Kink/Flex Resistance (Elongation, Stiffness, Flex Life Strength)	Assumed to meet standard requirements (Detail not provided in this document)
Alcohol Compatibility	Assumed to meet standard requirements (Detail not provided in this document)
Catheter Marking & Identification/Radiopacity Testing	Assumed to meet standard requirements (Detail not provided in this document)
Tensile Testing (Catheter and Assembly)	Assumed to meet standard requirements (Detail not provided in this document)
Compatibility Testing	Assumed to meet standard requirements (Detail not provided in this document)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

For K161866, no new performance testing was conducted, hence no test set sample size is applicable.

For the predicate device (K150407), which underwent the listed bench testing, the document does not specify the sample sizes used for each test or the data provenance. It only states that the tests were non-clinical bench testing conducted according to FDA guidance and international standards. This implies lab-based testing rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to an update based solely on a change to the Directions For Use (DFU), as no clinical ground truth assessment or expert review of performance data was conducted for this specific submission. The DFU change was aligned with updated Infusion Nurses Society (INS) Standards of Practice and compared to another cleared midline catheter's DFU.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this submission as no new testing was performed and no expert adjudication of performance data was required regarding the DFU change.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an intravascular catheter, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For K161866, the "ground truth" for the DFU change was the Infusion Nurses Society (INS) Standards of Practice, specifically noting changes made between the 2011 and 2016 versions, and comparison to the DFU of a similar predicate device (Bard PowerGlide Midline catheter K133856) to ensure consistent clinical interpretation and safety.

For the predicate device (K150407)'s original bench testing, the ground truth would have been established by the performance characteristics defined in the relevant international standards (e.g., EN ISO 10555-1, EN ISO 10555-3, ISO 594-2, EN ISO 10993-1) and FDA guidance documents.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an algorithm that requires a training set.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K161866

Device Name BioFlo Midline Catheter

Indications for Use (Describe)

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)

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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

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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 MidlineCatheter	Predicate Device:BioFlo MidlineCatheter (K150407)
IntendedUse/Indications ForUse	The BioFlo Midlineis indicated for shortterm access to theperipheral venoussystem forintravenous therapy,including but notlimited to, theadministration offluids, medicationsand the sampling ofblood and bloodproducts.	The BioFlo Midline isindicated for shortterm access (< 30days) to the peripheralvenous system forintravenous therapy,including but notlimited to, theadministration offluids, medicationsand the sampling ofblood and bloodproducts.
	Maximum PowerInjection Flow Rate● 3F SingleLumen/20 cm –	Therapies notappropriate for BioFloMidline cathetersinclude continuousvesicant therapy,parenteral nutrition
	2mL/sec 4F Single Lumen/20 cm – 6 mL/sec 5F Single Lumen/20 cm – 6mL/sec 5F Dual Lumen/20 cm – 6mL/sec	infusates with pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600 mOsm/LMaximum Power Injection Flow Rate 3F Single Lumen/20 cm – 2mL/sec 4F Single Lumen/20 cm – 6 mL/sec 5F Single Lumen/20 cm – 6mL/sec 5F Dual Lumen/20 cm – 6mL/sec
Warnings	Therapies not appropriate for BioFlo Midline Catheters include those therapies requiring central venous access.	Therapies not appropriate for BioFlo Midline Catheters include: Continuous vesicants * parenteral nutrition * solutions with pH < 5 and > 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 (< 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. The change to the DFU is within an approved set of indications and does not affect the safety or effectiveness of the device.

H.Performance Data

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

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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 .

F. Conclusion

Based on the proposed device having identical materials, design and components and technological characteristics as the predicate device and the same or similar Intended Use as the predicate device the proposed device is determined to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).