BioFlo Midline Catheter

K150407 · Navilyst Medical, Inc. · FOZ · May 15, 2015 · General Hospital

Device Facts

• Record ID: K150407
• Device Name: BioFlo Midline Catheter
• Applicant: Navilyst Medical, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: May 15, 2015
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

BioFlo Midline Catheter is a non-valved, peripheral venous access device (3-10 inches long). Placed in arm veins (basilic, brachial, or cephalic) with tip ending below axillary line. Used for short-term (< 30 days) intravenous therapy, fluid administration, and blood sampling. Provides alternative to short peripheral IVs and PICCs. Operated by clinicians. Device features reverse-taper shaft design; supports power injection up to 325 psi. Output is venous access for therapy delivery. Benefits include reduced need for frequent peripheral IV restarts and alternative to central venous access for appropriate therapies.

Clinical Evidence

Bench testing only. No clinical data. Testing performed per FDA guidance and international standards (EN ISO 10555-1/3, ISO 594-2, EN ISO 10993-1). Evaluations included power injection flow rates, static burst strength, gravity flow, priming volume, kink/flex resistance, tensile testing, and biocompatibility.

Technological Characteristics

Polyurethane catheter shaft with 30% Barium Sulfate, 2% Endexo, and 0.2% Teal Colorant. Components include suture wing, extension tube, luer hub, oversleeve, and clamp. Dimensions: 3F-5F diameter, 10-20 cm length. Single and dual lumen configurations. Reverse-taper design. Power injectable up to 325 psi. Sterilization method not specified. Complies with ISO 594-2 (Luer taper) and EN ISO 10555 series.

Indications for Use

Indicated for patients requiring short-term (< 30 days) peripheral venous access for fluid/medication administration and blood sampling. Contraindicated for continuous vesicant therapy, parenteral nutrition, infusates with pH < 5 or > 9, and infusates with osmolarity > 600 mOsm/L.

Regulatory Classification

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.

Predicate Devices

• Bard PowerGlide Midline Catheter (K133856)

Reference Devices

• NMI PICC III (K131942)
• NMI HPICC III (K131942)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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 Name<br>BioFlo Midline Catheter | | |
| | Indications for Use (Describe) | |
| | including but not limited to, the administration of fluids, medications, and the sampling of blood products.<br>Therapies not appropriate for midline catheters include continuous vesicant therapy, parenteral nutrition, infusates with<br>pH less than 5 or greater than 9, and infusates with an osmolarity greater than 600 mOsm/L.<br>Maximum Power Injection Flow Rate:<br>-3F Single Lumen, 20 cm: 2 mL/sec<br>-4F Single Lumen, 20 cm: 6 mL/sec<br>-5F Single Lumen, 20 cm: 6 mL/sec<br>-5F Dual Lumen, 20 cm: 6 mL/sec | |
| | Type of Use (Select one or both, as applicable)<br>> 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<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | |
| | Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>PRAStaff(@fda.hhs.gov | |
| | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of<br>information 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 |

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 (< 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.

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#### F. Intended Use/Indications for 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 .

#### 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:<br>BioFlo Midline Catheter<br>(K150407) | Predicate Device:<br>Bard PowerGlide Midline<br>Catheter (K133856) | Reference Device:<br>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 Device<br>Components | Catheter Shaft, Suture Wing,<br>Extension Tube, Luer Hub,<br>Oversleeve, Clamp | Catheter Shaft, Suture Wing,<br>Luer Hub | Catheter Shaft, Suture Wing,<br>Extension Tube, Luer Hub, Oversleeve |
| Maximum Power<br>Injection | 325 psi | 325 psi | 325 psi |
| Catheter Outside<br>Diameter | 3F – 5F | 2F – 4F | 3F – 6F |
| Catheter Usable<br>Length | 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 Confirmation<br>Required | 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-One<br>Modified Seldinger Technique | Seldinger Technique; Modified<br>Seldinger Technique |

| Table 2: Comparison of Materials of Proposed BioFlo Midline Catheter and Reference NMI PICC III's (K131942) | | |
|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------|
| Device Component | Proposed Device:<br>BioFlo Midline Catheter (K150407) | Reference Device:<br>NMI PICC III's (K131942) |
| Catheter Tubing | Polyurethane w/ 30% Barium Sulfate, 2%<br>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.