The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

6F Triple Lumen / 55 cm - 6 mL/sec

BioFlo PICC with ENDEXO and PASV Valve Technology

The BioFlo PICC with ENDEXO and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

3F Single Lumen/55 cm - 1 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec
6F Triple Lumen/55 cm - 6 mL/sec

BioFlo PICC with ENDEXO Technology

The BioFlo PICC with ENDEXO Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

3F Single Lumen/55 cm - 1 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec
6F Triple Lumen/55 cm - 6 mL/sec

BioFlo Midline Catheter

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.

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

Xcela Power Injectable PICC

The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

4F Single Lumen/45 cm - 4 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/45 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec

Xcela PICC with PASV Valve Technology

The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. 6F catheter is indicated for patients weighing >10 kg.

Xcela Hybrid PICC with PASV Technology

The Xcela Hybrid PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. 6F catheter is indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

6F Triple Lumen/55 cm - 6 mL/sec

Device Description

The BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection that is available in a triple lumen configuration. The lumens are differentiated by colored Luer lock hubs that indicate lumen size, "No CT" for non-power injectable lumens are indicated on the luer lock hubs. For non-valved lumens, maximum power injection flow rates are indicated on the clamp(s).

The BioFlo PICCs with ENDEXO and PASV Valve Technology are radiopaque, polyurethane catheters with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection. The catheter is available in single and multi-lumen configurations. The lumens are differentiated by colored Luer lock hubs that indicate lumen size and maximum power injection flow rates or "No CT" for nonpower injectable lumens.

The BioFlo PICC with ENDEXO Technology is a radiopaque, polyurethane catheter with luer lock hub(s), polyurethane extension tube(s) and suture wing. The catheter is available in single, dual and triple lumen configurations. The lumens are differentiated by colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s).

The BioFlo Midline with ENDEXO Technology is a radiopaque, polyurethane catheter with luer lock hub(s), polyurethane extension tube(s) and suture wing. The catheter is available in single and dual lumen configurations. The BioFlo Midline is clearly labeled on all available catheter surfaces to identify as a MIDLINE versus a traditional PICC. Maximum power injection flow rates are indicated on the clamp(s). The catheter is offered in 3F, 4F, and 5F sizes.

The Xcela Hybrid PICC with PASV Valve Technology is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection. The lumens are differentiated by colored Luer lock hubs that indicate lumen size. "No CT" for non-power injectable lumens are indicated on the luer lock hubs. For non-valved lumens, maximum power injection flow rates are indicated on the clamp(s).

The Xcela PICC with PASV Valve Technology is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing capable of power injection. The catheter is available in single and multi-lumen configurations. The lumens are differentiated by colored Luer lock hubs that indicate lumen size and maximum power injection flow rates or "No CT" for non-power injectable lumens.

The Xcela Power Injectable PICC is a radiopaque, polyurethane catheter with Luer lock hub(s), polyurethane extension tube(s) and suture wing. The catheter is available in single and dual lumen configurations. The lumens are differentiated by colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s).

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - K252373

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.02

December 16, 2025

Spectrum Vascular
Sharon Klugewicz
Chief Operating Officer/SVP Regulatory Affairs
50 Main St.
Suite 1000
White Plains, New York 10606

Re: K252373

Trade/Device Name: BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology

Regulation Number: 21 CFR 880.5970
Regulation Name: Percutaneous, implanted, long-term intravascular catheter
Regulatory Class: Class II
Product Code: LJS, PND
Dated: November 13, 2025
Received: November 13, 2025

Dear Sharon Klugewicz:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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K252373 - Sharon Klugewicz Page 2

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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K252373 - Sharon Klugewicz Page 3

Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

DAVID WOLLOSCHECK -S

David Wolloscheck, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices, and
Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K252373

Device Name: BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo Midline Catheter; Xcela Hybrid PICC with PASV Valve Technology; Xcela PICC with PASV Valve Technology; Xcela Power Injectable PICC

Indications for Use (Describe)

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology

Maximum Power Injection Flow Rate:

6F Triple Lumen / 55 cm - 6 mL/sec

BioFlo PICC with ENDEXO and PASV Valve Technology

Maximum Power Injection Flow Rate:

3F Single Lumen/55 cm - 1 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec
6F Triple Lumen/55 cm - 6 mL/sec

BioFlo PICC with ENDEXO Technology

Maximum Power Injection Flow Rate:

3F Single Lumen/55 cm - 1 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec
6F Triple Lumen/55 cm - 6 mL/sec

BioFlo Midline Catheter

Maximum Power Injection Flow Rate:

3F Single Lumen/20 cm - 2 mL/sec

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4F Single Lumen/20 cm - 6 mL/sec
5F Single Lumen/20 cm - 6 mL/sec
5F Dual Lumen/20 cm - 6 mL/sec

Xcela Power Injectable PICC

Maximum Power Injection Flow Rate:

4F Single Lumen/45 cm - 4 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/45 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec

Xcela PICC with PASV Valve Technology

Xcela Hybrid PICC with PASV Technology

Maximum Power Injection Flow Rate:

6F Triple Lumen/55 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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) SUMMARY - K252373

1. SUBMITTER INFORMATION

Applicant: Spectrum Vascular
Contact: Sharon Klugewicz
Phone: 516-425-4446
Email: sklugewicz@spectrumvascular.com
Address: 50 Main Street, Suite 1000
White Plains, NY 10606

2. CORRESPONDENT INFORMATION

Contact: Sharon Klugewicz
Title: Sr. VP, Quality and Regulatory Affairs
Firm: Spectrum Vascular

3. DATE PREPARED: DECEMBER 8, 2025

4. DEVICE INFORMATION

Trade Name:

BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
BioFlo PICC with ENDEXO Technology
BioFlo PICC with ENDEXO Technology and PASV Valve Technology
BioFlo Midline Catheter
Xcela Hybrid PICC with PASV Valve Technology
Xcela PICC with PASV Valve Technology
Xcela Power Injectable PICC

Common Name: Peripherally Inserted Central Catheter (PICC)
Regulation Number: 21 CFR 880.5970
Regulation Name: Percutaneous, implanted, long-term intravascular catheter
Product Code: LJS, PND
Regulatory Class: Class II

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5. PREDICATE DEVICE INFORMATION

Device Name: PICC Maximal Barrier Nursing Kits
Common Name: Peripherally Inserted Central Catheter (PICC)
510(k) Number: K163452
Manufacturer: Navilyst Medical, Inc.

The predicate device has not been subject to a design related recall.

6. DEVICE DESCRIPTION

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7. INTENDED USE / INDICATIONS FOR USE

7.1. BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology

Maximum Power Injection Flow Rate:

6F Triple Lumen / 55 cm - 6 mL/sec

7.2. BioFlo PICC with ENDEXO and PASV Valve Technology

Maximum Power Injection Flow Rate:

3F Single Lumen/55 cm - 1 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec
6F Triple Lumen/55 cm - 6 mL/sec

7.3. BioFlo PICC with ENDEXO Technology

The BioFlo PICC with ENDEXO Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media. 6F is catheter indicated for patients weighing >10 kg.

Maximum Power Injection Flow Rate:

3F Single Lumen/55 cm - 1 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec

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5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec
6F Triple Lumen/55 cm - 6 mL/sec

7.4. BioFlo Midline Catheter

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

7.5. Xcela Power Injectable PICC

Maximum Power Injection Flow Rate:

4F Single Lumen/45 cm - 4 mL/sec
4F Single Lumen/55 cm - 3.5 mL/sec
5F Single Lumen/55 cm - 5 mL/sec
5F Dual Lumen/45 cm - 5 mL/sec
5F Dual Lumen/55 cm - 4 mL/sec
6F Dual Lumen/55 cm - 5 mL/sec

7.6. Xcela PICC with PASV Valve Technology

7.7. Xcela Hybrid PICC with PASV Technology

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Maximum Power Injection Flow Rate:

6F Triple Lumen/55 cm - 6 mL/sec

7.8. Conclusion

The Intended Use of the subject devices is the same as the intended use of the predicate devices, with the addition of the following: "6F catheter indicated for patients weighing >10 kg." The Indications for Use of the predicate devices (K163452) reference a specific kit configuration ("Maximal Barrier Nursing Kit") at the beginning of each Intended Use/Indications for Use statement in the Instructions For Use (IFU). The reference to this specific kit configuration has been removed from the Intended Use / Indications for Use statement, as the kit configurations are already included under the Device Description in the IFU. All other aspects of the Intended Use / Indications for Use statements remain unchanged. The PICC and Midline catheters remain the same, apart from the changes to the sterilization cycle parameters which are the subject of this 510(k) submission. The kit configurations are consistent with the device description in the IFU and include the exact same PICC or Midline catheters that were included in the predicate device. These changes do not have any impact on the final finished kit or its performance, and as such, do not raise any new concerns of safety or efficacy.

8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology, BioFlo PICC with ENDEXO Technology, BioFlo PICC with ENDEXO Technology and PASV Valve Technology, BioFlo Midline Catheter, Xcela Hybrid PICC with PASV Valve Technology, Xcela PICC with PASV Valve Technology, and Xcela Power Injectable PICC are identical to the PICC Maximal Barrier Nursing Kits. No changes have been made to the designs of the devices. This 510(k) is submitted to address changes to the sterilization process parameters and location.

Table 1: Device Comparison Table – BioFlo PICC Family

	Subject Device BioFlo PICC Family	Predicate Device PICC Family K163452
Product Code	LJS	LJS
Models	BioFlo Hybrid with ENDEXO & PASV ValveBioFlo with ENDEXO & PASV ValveBioFlo with ENDEXO	BioFlo Hybrid with ENDEXO & PASV ValveBioFlo with ENDEXO & PASV ValveBioFlo with ENDEXO
Outer Diameter (mm)	3F Single lumen – 1.05 mm4F Single lumen - 1.40 mm5F Single lumen - 1.70 mm5F Dual lumen - 1.75 mm6F Dual lumen – 1.95 mm6F Triple lumen – 2.20 mm	3F Single lumen – 1.05 mm4F Single lumen - 1.40 mm5F Single lumen - 1.70 mm5F Dual lumen - 1.75 mm6F Dual lumen – 1.95 mm6F Triple lumen – 2.20 mm

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	Subject Device BioFlo PICC Family	Predicate Device PICC Family K163452
# of Lumens	PICC with ENDEXO3F Single lumen4F Single lumen5F Single lumen5F Dual lumen6F Dual lumen6F Triple lumenPICC with ENDEXO and PASV Valve3F Single lumen4F Single lumen5F Single lumen5F Dual lumen6F Dual lumen6F Triple lumenBioFlo Hybrid PICC with ENDEXO and PASV Valve6F Triple lumen	PICC with ENDEXO3F Single lumen4F Single lumen5F Single lumen5F Dual lumen6F Dual lumen6F Triple lumenPICC with ENDEXO and PASV Valve3F Single lumen4F Single lumen5F Single lumen5F Dual lumen6F Dual lumen6F Triple lumenBioFlo Hybrid PICC with ENDEXO and PASV Valve6F Triple lumen
Lumen Gauge	3F single lumen: 204F single lumen: 17.05F single lumen: 15.55F dual lumen: 17.5 (both lumens)6F dual lumen: 16.5 (both lumens)6F triple lumen: 16.5 (1 large power injectable lumen) and 19.0 (2 small non-power injectable lumens)	3F single lumen: 204F single lumen: 17.05F single lumen: 15.55F dual lumen: 17.5 (both lumens)6F dual lumen: 16.5 (both lumens)6F triple lumen: 16.5 (1 large power injectable lumen) and 19.0 (2 small non-power injectable lumens)
Usable/Effective Length	All models: 55 cm	All models: 55 cm
Lumen Size (mm)	3F Single lumen – 0.6 mm4F Single lumen - 0.9 mm5F Single lumen - 1.1 mm5F Dual lumen -0.8 / 0.8 mm6F Dual lumen – 0.9 / 0.9 mm6F Triple lumen – 1.1 / 0.6 / 0.6 mm	3F Single lumen – 0.6 mm4F Single lumen - 0.9 mm5F Single lumen - 1.1 mm5F Dual lumen -0.8 / 0.8 mm6F Dual lumen – 0.9 / 0.9 mm6F Triple lumen – 1.1 / 0.6 / 0.6 mm
Priming Volume	3F single lumen: < 0.8 mL4F single lumen: <1.1 mL5F single lumen: < 1.2 mL5F dual lumen: < 1.0 mL6F dual lumen: <1.1 mL6F triple lumen: < 0.9 mL (1 large power injectable lumen) and < 0.6 mL (2 small non-power injectable lumens)	3F single lumen: < 0.8 mL4F single lumen: <1.1 mL5F single lumen: < 1.2 mL5F dual lumen: < 1.0 mL6F dual lumen: <1.1 mL6F triple lumen: < 0.9 mL (1 large power injectable lumen) and < 0.6 mL (2 small non-power injectable lumens)
Maximum Power Injection Flow Rate	3F Single Lumen - 1 mL/sec4F Single Lumen - 3.5 mL/sec5F Dual Lumen - 4 mL/sec5F Single Lumen - 5 mL/sec6F Dual Lumen - 5 mL/sec6F Triple Lumen - 6 mL/sec	3F Single Lumen - 1 mL/sec4F Single Lumen - 3.5 mL/sec5F Dual Lumen- 4 mL/sec5F Single Lumen - 5 mL/sec6F Dual Lumen - 5 mL/sec6F Triple Lumen - 6 mL/sec

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	Subject Device BioFlo PICC Family	Predicate Device PICC Family K163452
Packaging	Polystyrene tray/Poly pouch	Polystyrene tray/Poly pouch
Sterilization	EtO	EtO
SAL	10⁻⁶	10⁻⁶

Table 2: Device Comparison Table – BioFlo Midline Catheter

	Subject Device BioFlo Midline Catheter	Predicate Device BioFlo Midline Catheter K163452
Product Code	PND	PND
Models	BioFlo Midline with ENDEXO Technology	BioFlo Midline with ENDEXO Technology
Outer Diameter (mm)	3F Single lumen – 1.02 mm4F Single lumen - 1.40 mm5F Single lumen - 1.68 mm5F Dual lumen - 1.73 mm	3F Single lumen – 1.02 mm4F Single lumen - 1.40 mm5F Single lumen - 1.68 mm5F Dual lumen - 1.73 mm
# of Lumens	3F - Single lumen4F - Single lumen5F - Single lumen5F - Dual lumen	3F - Single lumen4F - Single lumen5F - Single lumen5F - Dual lumen
Lumen Gauge	3F single lumen: 20.04F single lumen: 17.05F single lumen: 15.55F dual lumen: 17.5 (both lumens)	3F single lumen: 20.04F single lumen: 17.05F single lumen: 15.55F dual lumen: 17.5 (both lumens)
Usable/Effective Length	20 cm	20 cm
Lumen Size (mm)	3F Single lumen - 0.6 mm4F Single lumen - 0.9 mm5F Single lumen - 1.1 mm5F Dual lumen - 0.8 / 0.8 mm	3F Single lumen - 0.6 mm4F Single lumen - 0.9 mm5F Single lumen - 1.1 mm5F Dual lumen -0.8 / 0.8 mm
Priming Volume	3F single lumen: 0.43 mL4F single lumen: 0.52 mL5F single lumen: 0.57 mL5F dual lumen: 0.60 mL	3F single lumen: 0.43 mL4F single lumen: 0.52 mL5F single lumen: 0.57 mL5F dual lumen: 0.60 mL
Maximum Power Injection Flow Rate	3F Single lumen - 2 mL/sec4F Single lumen - 6 mL/sec5F Single lumen - 6 mL/sec5F Dual lumen - 6 mL/sec	3F Single lumen - 2 mL/sec4F Single lumen - 6 mL/sec5F Single lumen - 6 mL/sec5F Dual lumen - 6 mL/sec
Minimum Gravity Flow Rate (water)	3F Single Lumen - 512 mL/hr4F Single Lumen – 1,928 mL/hr5F Single Lumen – 2, 280 mL/hr5F Dual Lumen – 1,524 mL/hr	3F Single Lumen - 512 mL/hr4F Single Lumen – 1,928 mL/hr5F Single Lumen – 2, 280 mL/hr5F Dual Lumen – 1,524 mL/hr
Packaging	Polystyrene tray/Poly pouch	Polystyrene tray/Poly pouch

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	Subject Device BioFlo Midline Catheter	Predicate Device BioFlo Midlline Catheter K163452
Sterilization	EtO	EtO
SAL	10⁻⁶	10⁻⁶

Table 3: Device Comparison Table – Xcela PICC Family

	Subject Device Xcela PICC Family	Predicate Device Xcela PICC Family K163452
Product Code	LJS	LJS
Models	Xcela Power Injectable PICCXcela PICC with PASV ValveXcela Hybrid PICC with PASV Valve	Xcela Power Injectable PICCXcela PICC with PASV ValveXcela Hybrid PICC with PASV Valve
Outer Diameter (mm)	Xcela Power Injectable PICC4F Single lumen (45 cm): 1.40 mm4F Single lumen (55 cm): 1.40 mm5F Single lumen (55 cm): 1.68 mm5F Dual lumen (45 cm): 1.73 mm5F Dual lumen (55 cm): 1.73 mm6F Dual lumen (55 cm): 1.94 mmXcela PICC with PASV Valve3F Single lumen (55 cm) – 1.05 mm4F Single lumen (55cm) – 1.40 mm5F Single lumen (55 cm) – 1.70 mm5F Dual lumen (55 cm) – 1.75 mm6F Dual lumen (55 cm) – 1.95 mm6F Triple lumen (55 cm) – 2.20 mmXcela Hybrid PICC with PASV Valve6F Triple lumen - 2.20 mm	Xcela Power Injectable PICC4F Single lumen (45 cm): 1.40 mm4F Single lumen (55 cm): 1.40 mm5F Single lumen (55 cm): 1.68 mm5F Dual lumen (45 cm): 1.73 mm5F Dual lumen (55 cm): 1.73 mm6F Dual lumen (55 cm): 1.94 mmXcela PICC with PASV Valve3F Single lumen (55 cm)– 1.05 mm4F Single lumen (55 cm) – 1.40 mm5F Single lumen (55 cm) – 1.70 mm5F Dual lumen (55 cm) – 1.75 mm6F Dual lumen (55 cm) – 1.95 mm6F Triple lumen (55 cm) – 2.20 mmXcela Hybrid PICC with PASV Valve6F Triple lumen - 2.20 mm

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	Subject Device Xcela PICC Family	Predicate Device Xcela PICC Family K163452
# of Lumens	Xcela Power Injectable PICC4F Single lumen (45 cm)4F Single lumen (55 cm)5F Single lumen (55 cm)5F Dual lumen (45 cm)5F Dual lumen (55 cm)6F Dual lumen (55 cm)Xcela PICC with PASV Valve3F Single lumen (55 cm)4F Single lumen (55 cm)5F Single lumen (55 cm)5F Dual lumen (55 cm)6F Dual lumen (55 cm)6F Triple lumen (55 cm)Xcela Hybrid PICC with PASV Valve6F Triple Lumen (55 cm)	Xcela Power Injectable PICC4F Single lumen (45 cm)4F Single lumen (55 cm)5F Single lumen (55 cm)5F Dual lumen (45 cm)5F Dual lumen (55 cm)6F Dual lumen (55 cm)Xcela PICC with PASV Valve3F Single lumen (55 cm)4F Single lumen (55 cm)5F Single lumen (55 cm)5F Dual lumen (55 cm)6F Dual lumen (55 cm)6F Triple lumen (55 cm)Xcela Hybrid PICC with PASV Valve6F Triple Lumen (55 cm)
Lumen Gauge	Xcela Power Injectable PICC4F Single lumen (45 cm): 17.04F Single lumen (55 cm): 17.05F Single lumen (55 cm): 15.55F Dual lumen (45 cm): 17.5 (both lumens)5F Dual lumen (55 cm): 17.5 (both lumens)6F Dual lumen (55 cm): 16.5 (both lumens)Xcela PICC with PASV Valve3F Single lumen (55 cm)– 20.04F Single lumen (55 cm) – 17.05F Single lumen (55 cm) – 15.55F Dual lumen (55 cm) – 17.5 (both lumens)6F Dual lumen (55 cm) – 16.5 (both lumens)6F Triple lumen (55 cm) – 16.5 / 19.0 (1 large power injectable lumen / 2 small non-power injectable lumens)Xcela Hybrid PICC with PASV Valve6F Triple lumen hybrid (55 cm) – 16.5 / 19.0(1 large power injectable lumen / 2 small non-power injectable lumens)	Xcela Power Injectable PICC4F Single lumen (45 cm): 17.04F Single lumen (55 cm): 17.05F Single lumen (55 cm): 15.55F Dual lumen (45 cm): 17.5 (both lumens)5F Dual lumen (55 cm): 17.5 (both lumens)6F Dual lumen (55 cm): 16.5 (both lumens)Xcela PICC with PASV Valve3F Single lumen (55 cm) – 20.04F Single lumen (55 cm) – 17.05F Single lumen (55 cm) – 15.55F Dual lumen (55 cm) – 17.5 (both lumens)6F Dual lumen (55 cm) – 16.5 (both lumens)6F Triple lumen – 16.5 / 19.0(1 large power injectable lumen / 2 small non-power injectable lumens)Xcela Hybrid PICC with PASV Valve6F Triple lumen hybrid (55 cm) – 16.5 / 19.0(1 large power injectable lumen / 2 small non-power injectable lumens)
Usable/Effective Length	Xcela Power Injectable PICC4F Single lumen: 45 cm4F Single lumen: 55 cm5F Single lumen: 55 cm5F Dual lumen: 45 cm5F Dual lumen: 55 cm6F Dual lumen: 55 cmXcela PICC with PASV Valve3F Single lumen: 55 cm4F Single lumen: 55 cm5F Single lumen: 55 cm5F Dual lumen: 55 cm	Xcela Power Injectable PICC4F Single lumen: 45 cm4F Single lumen: 55 cm5F Single lumen: 55 cm5F Dual lumen: 45 cm5F Dual lumen: 55 cm6F Dual lumen: 55 cmXcela PICC with PASV Valve3F Single lumen: 55 cm4F Single lumen: 55 cm5F Single lumen: 55 cm5F Dual lumen: 55 cm

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6F Dual lumen: 55 cm
6F Triple lumen: 55 cm
Xcela Hybrid PICC with PASV Valve
6F Triple lumen: 55 cm

6F Dual lumen: 55 cm
6F Triple lumen:55 cm
Xcela Hybrid PICC with PASV Valve
6F Triple lumen: 55 cm

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	Subject Device Xcela PICC Family	Predicate Device Xcela PICC Family K163452
Lumen Size (mm)	Xcela Power Injectable PICC4F Single lumen (45 cm): 0.9 mm4F Single lumen (55 cm): 0.9 mm5F Single lumen (55 cm): 1.1 mm5F Dual lumen (45 cm): 0.8 mm (both lumens)5F Dual lumen (55 cm): 0.8 mm (both lumens)6F Dual lumen (55 cm): 0.9 mm (both lumens)Xcela PICC with PASV Valve3F Single lumen (55 cm) – 0.6 mm4F Single lumen (55 cm) - 0.9 mm5F Single lumen (55 cm) – 1.1 mm5F Dual lumen (55 cm) – 0.8 / 0.8 mm6F Dual lumen (55 cm) – 0.9 / 0.9 mm6F Triple lumen (55 cm) – 1.1 / 0.6 / 0.6 mmXcela Hybrid PICC with PASV Valve6F Triple lumen : 1.1 / 0.6 / 0.6 mm	Xcela Power Injectable PICC4F Single lumen (45 cm): 0.9 mm4F Single lumen (55 cm): 0.9 mm5F Single lumen (55 cm): 1.1 mm5F Dual lumen (45 cm): 0.8 mm (both lumens)5F Dual lumen (55 cm): 0.8 mm (both lumens)6F Dual lumen (55 cm): 0.9 mm (both lumens)Xcela PICC with PASV Valve3F Single lumen (55 cm) – 0.6 mm4F Single lumen (55 cm) - 0.9 mm5F Single lumen (55 cm) – 1.1 mm5F Dual lumen (55 cm) – 0.8 / 0.8 mm6F Dual lumen (55 cm) – 0.9 / 0.9 mm6F Triple lumen (55 cm) – 1.1 / 0.6 / 0.6 mmXcela Hybrid PICC with PASV Valve6F Triple lumen : 1.1 / 0.6 / 0.6 mm
Priming Volume	Xcela Power Injectable PICC4F Single lumen (45 cm): < 0.9 mL4F Single lumen (55 cm): <1.0 mL5F Single lumen (55 cm): < 1.2 mL5F Dual lumen (45 cm): < 0.9 mL5F Dual lumen (55 cm): < 1.0 mL6F Dual lumen (55 cm): < 1.1 mLXcela PICC with PASV Valve3F Single lumen (55 cm) < 0.8 mL4F Single lumen (55 cm) <1.1 mL5F Single lumen (55 cm) < 1.2 mL5F Dual lumen (55 cm) < 1.0 mL6F Dual lumen (55 cm) < 1.1 mL6F Triple lumen (55 cm) < 0.9 mL / < 0.6 mL (1 large power injectable lumen / 2 small non-power injectable lumens)Xcela Hybrid PICC with PASV Valve6F Triple lumen (55 cm): < 0.7 mL / < 0.6 mL (1 large power injectable lumen / 2 small non-power injectable lumens)	Xcela Power Injectable PICC4F Single lumen (45 cm): < 0.9 mL4F Single lumen (55 cm): <1.0 mL5F Single lumen (55 cm): < 1.2 mL5F Dual lumen (45 cm): < 0.9 mL5F Dual lumen (55 cm): < 1.0 mL6F Dual lumen (55 cm): < 1.1 mLXcela PICC with PASV Valve3F Single lumen < 0.8 mL4F Single lumen <1.1 mL5F Single lumen < 1.2 mL5F Dual lumen < 1.0 mL6F Dual lumen < 1.1 mL6F Triple lumen < 0.9 mL / < 0.6 mL (1 large power injectable lumen / 2 small non-power injectable lumens)Xcela Hybrid PICC with PASV Valve6F Triple lumen (55 cm): < 0.7 mL / < 0.6 mL (1 large power injectable lumen / 2 small non-power injectable lumens)

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	Subject Device Xcela PICC Family	Predicate Device Xcela PICC Family K163452
Minimum Gravity Flow Rate (water)	Xcela Power Injectable PICC4F Single lumen (45 cm): 848 mL/hr4F Single lumen (55 cm): 848 mL/hr5F Single lumen (55 cm): 1856 mL/hr5F Dual lumen (45 cm): 428 mL/hr5F Dual lumen (55 cm): 428 mL/hr6F Dual lumen (55 cm): 690 mL/hrXcela PICC with PASV Valve3F Single lumen (55 cm): 30 mL/hr4F Single lumen (55 cm): 150 mL/hr5F Single lumen (55 cm): 240 mL/hr5F Dual lumen (55 cm): 60 mL/hr6F Dual lumen (55 cm): 132 mL/hr6F Triple lumen (55 cm): 132 mL/hr / 30 mL/hr (1 large power injectable lumen / 2 small non-power injectable lumens)Xcela Hybrid PICC with PASV Valve6F Triple lumen: 892 mL/hr / 30 mL/hr (1 large power injectable lumen / 2 small non-power injectable lumens)	Xcela Power Injectable PICC4F Single lumen (45 cm): 848 mL/hr4F Single lumen (55 cm): 848 mL/hr5F Single lumen (55 cm): 1856 mL/hr5F Dual lumen (45 cm): 428 mL/hr5F Dual lumen (55 cm): 428 mL/hr6F Dual lumen (55 cm): 690 mL/hrXcela PICC with PASV Valve3F Single lumen (55 cm): 30 mL/hr4F Single lumen (55 cm): 150 mL/hr5F Single lumen (55 cm): 240 mL/hr5F Dual lumen (55 cm): 60 mL/hr6F Dual lumen (55 cm): 132 mL/hr6F Triple lumen (55 cm): 132 mL/hr / 30 mL/hr (1 large power injectable lumen / 2 small non-power injectable lumens)Xcela Hybrid PICC with PASV Valve6F Triple lumen: 892 mL/hr / 30 mL/hr (1 large power injectable lumen / 2 small non-power injectable lumens)
Packaging	Polystyrene tray/Poly pouch	Polystyrene tray/Poly pouch
Sterilization	EtO	EtO
SAL	10⁻⁶	10⁻⁶

9. KIT CONFIGURATIONS

The subject devices are offered in a variety of kit configurations. Some kit configurations incorporate minor changes to the specific kit components. All changes were evaluated in accordance with the Quality System which assessed any potential impact to the final kit (e.g., packaging, sterilization). Based on this assessment, it was determined that the changes do not have any impact on the final finished kit or its performance, and as such, do not raise any new concerns of safety or efficacy.

10. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING

Biocompatibility Testing

The medical devices in their final finished form are identical to the predicate devices (K163452) in formulation, processing, sterilization method, and geometry. No other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). Therefore, no biocompatibility testing was conducted.

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Electrical Safety

Not applicable. The device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

Electromagnetic Compatibility (EMC)

Not applicable. The device contains no electric components, generates no electrical emissions, and uses no electrical energy of any type.

Software

Not applicable. The device contains no software.

Performance Testing

The following performance testing was conducted to validate changes to the sterilization cycle parameters:

Ethylene Oxide Sterilization Performance Qualification
Evaluation of ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals

11. CONCLUSION

The results of the performance testing described above demonstrate that the subject devices are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”