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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the BioFlo Midline Catheter. It outlines the device's characteristics, intended use, and a comparison with predicate and reference devices, along with performance data from non-clinical bench testing. However, the document does not describe a clinical study in the format requested, nor does it provide the detailed acceptance criteria and study results for a device that relies on AI or machine learning.

The acceptance criteria mentioned are general performance aspects for a medical device (intravascular catheter), and the "study" referred to is a series of non-clinical bench tests. The concept of "AI performance," "human reader improvement with AI," "standalone algorithm performance," "ground truth," and "training set" are not applicable to this particular device and its regulatory submission as described.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an attempt to extract relevant information from the document, acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance:

The document lists various non-clinical bench tests performed. These tests implicitly define "acceptance criteria" through their successful completion, demonstrating that the device meets relevant standards for its intended use. Exact quantitative acceptance criteria are not explicitly stated in numerical form within this summary, but the successful completion of the tests implies meeting the required thresholds.

Acceptance Criteria (Implied by successful test)	Reported Device Performance (Implied by successful test)
Power Injection Flow Rate requirements	Met
Static Burst Strength requirements	Met
Multiple Power Injections requirements	Met
Gravity Flow Rate requirements	Met
Catheter Length specifications	Met
Priming Volume specifications	Met
Midline Identification	Met
Dimensional Verification (ID, OD, Length)	Met
Catheter Kink/Flex Resistance	Met
Alcohol Compatibility	Met
Catheter Marking & Identification/Radiopacity	Met
Tensile Testing (Catheter and Assembly)	Met
Compatibility Testing (with insertion accessories)	Met

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The document only mentions "non-clinical bench testing." For bench tests, sample sizes can vary significantly depending on the specific test and standard requirements, but these are typically physical units, not patient data sets.
Data provenance: Not applicable in the context of clinical or image-based data. The tests are non-clinical bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical medical device (catheter) undergoing bench testing, not a diagnostic or AI-driven device requiring expert-established ground truth from patient data.

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

Not applicable. This concept is relevant for clinical studies or AI evaluations involving human readers and ground truth, not for the described bench tests.

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:

No. This is not an AI-based device, and no MRMC study was performed or mentioned.

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

No. This is not an AI-based device.

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

Not applicable in the context of patient data ground truth. The "ground truth" for bench testing is defined by the technical specifications and performance requirements outlined in the referenced standards (e.g., ISO 10555-1, ISO 594-2).

8. The sample size for the training set:

Not applicable. This device does not involve an AI algorithm that requires a training set.

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

Not applicable. This device does not involve an AI algorithm.

Summary of the Study (Bench Testing) that Proves the Device Meets Acceptance Criteria:

The study proving the BioFlo Midline Catheter meets acceptance criteria consists of a series of non-clinical bench tests. These tests were conducted in accordance with several FDA Guidance Documents and international standards, including:

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"

The specific tests performed included: Power Injection Flow Rate, Static Burst Strength, Multiple Power Injections, Gravity Flow Rate, Catheter Length, Priming Volume, Midline Identification, Dimensional Verification, Catheter Kink/Flex Resistance, Alcohol Compatibility, Catheter Marking & Identification/Radiopacity Testing, Tensile Testing, and Compatibility Testing with insertion accessories.

The submission concludes that "successful results of non-clinical bench testing" demonstrate that the proposed device is substantially equivalent to the predicate device. This implies that the device met all the required performance specifications and safety criteria as defined by the referenced standards and guidance documents.

Summary

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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 two main elements: a circular text element and a stylized symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of a human figure, with three profiles facing right, stacked on top of each other.

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.

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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 (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

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	Food and Drug Administration	Expiration Date: January 31, 2017
	Indications for Use	See PRA Statement below.
510(k) Number (if known)
Unknown	K150407
Device NameBioFlo 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 withpH 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)
	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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:
	Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov
	"An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number."

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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

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

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F. Intended Use/Indications for Use

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 Navilyst Medical, Inc. BioFlo Midline Catheter is substantially equivalent to the Bard PowerGlide Midline Catheter (K133856); and furthermore, contains the identical materials as the referenced Navilyst Medical, Inc. NMI PICC III devices (K131942).

Table 1 below compares the key characteristics and components of the proposed and predicate/reference devices, and demonstrates that the proposed BioFlo Midline Catheter and the predicate Bard PowerGlide Midline Catheter are substantially equivalent in regards to Intended Use, key device characteristics, catheter shaft material, range of sizes and lengths, power injectability as well as ProCode and Regulation Number. The proposed device and predicate PowerGlide Midline Catheter differ in that the proposed device is provided with individual catheter placement accessories, whereas the predicate PowerGlide Midline Catheter uses an "Integrated All-In-One". Compatibility testing of the proposed device with insertion accessories demonstrated that the performance was not affected by this minor difference.

Further, the proposed BioFlo Midline Catheter is the same as the referenced NMI PICC III devices, with the exception of catheter indwell time and catheter length. Successful results of bench testing conducted on the proposed device (as described in more detail in Section H below) confirmed that these differences did not raise any new questions of safety and/or effectiveness.

Table 2 contains a side-by-side comparison of the materials of the proposed BioFlo Midline Catheter and referenced NMI PICC III's - both of which are manufactured by Navilyst Medical, Inc. - demonstrating that they are identical. Thus, no new issues of biocompatibility have been identified.

Characteristic	Proposed Device:BioFlo Midline Catheter(K150407)	Predicate Device:Bard PowerGlide MidlineCatheter (K133856)	Reference Device:NMI PICC III's (K131942)
Intended Use	Short term peripheral venous access device.	Short term peripheral venous access device.	Long term peripheral venous access device.
Catheter Shaft Material	Polyurethane	Polyurethane	Polyurethane
Key DeviceComponents	Catheter Shaft, Suture Wing,Extension Tube, Luer Hub,Oversleeve, Clamp	Catheter Shaft, Suture Wing,Luer Hub	Catheter Shaft, Suture Wing,Extension Tube, Luer Hub, Oversleeve
Maximum PowerInjection	325 psi	325 psi	325 psi
Catheter OutsideDiameter	3F – 5F	2F – 4F	3F – 6F
Catheter UsableLength	10 cm – 20 cm	8 cm – 10 cm	55 cm
Number of Lumens	Single and Dual Lumen	Single Lumen	Single, Dual, and Triple Lumen
X-Ray ConfirmationRequired	No	No	Yes

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Identified as “Midline”	Midline	Midline	PICC
Catheter Shaft Design	Reverse Taper	Reverse Taper	Reverse Taper
ProCode	FOZ	FOZ	LJS
Regulation Number	880.5200	880.5200	880.5970
Placement Technique	Modified Seldinger Technique	Integrated All-In-OneModified Seldinger Technique	Seldinger Technique; ModifiedSeldinger Technique

Table 2: Comparison of Materials of Proposed BioFlo Midline Catheter and Reference NMI PICC III's (K131942)
Device Component	Proposed Device:BioFlo Midline Catheter (K150407)	Reference Device:NMI PICC III's (K131942)
Catheter Tubing	Polyurethane w/ 30% Barium Sulfate, 2%Endexo, and 0.2% Teal Colorant	Identical
Suture Wing	Polyurethane w/ 20% Barium Sulfate	Identical
Extension Tubing	Polyurethane	Identical
Oversleeve	Polycarbonate Polyurethane w/ 20% Barium Sulfate	Identical
Purple Luer	Purple Polyetherimide	Identical
White Luer	White Polyetherimide	Identical
Ink	MD-1001 No-Tox Medical Device Ink, NT 16 Black w/ MD-1210 Reducer	Identical
Clamp	Natural Acetal and Polyurethane	Identical

H. Performance Data

The performance evaluation of the proposed 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 to support substantial equivalence 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 ●

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I. Conclusion

Based upon the above comparisons and successful results of non-clinical bench testing conducted in accordance to the FDA Guidance Documents and international standards listed, as well as responses to questions posed within FDA's 510(k) Decision-Making Tree, 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).