Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC

K152409 · Navilyst Medical, Inc. · LJS · Sep 24, 2015 · General Hospital

Device Facts

• Record ID: K152409
• Device Name: Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
• Applicant: Navilyst Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. The Xcela PICC with PASV Valve technology is indicated for short- or long-term 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. The Xcela Hybrid PICC with PASV Valve technology is indicated for short- or long-term 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.

Device Story

Peripherally inserted central catheter (PICC) provides access to central venous system; enables administration of fluids, medications, nutrients, blood sampling, and power injection of contrast media. Device inserted peripherally by clinician; remains in situ for short or long-term therapy. Features include single or multi-lumen configurations, PASV valve technology (in specific models), and radiopaque markings. Power injection capability supports flow rates up to 6 mL/sec and pressures up to 325 psi. Non-valved lumens in hybrid models support central venous pressure monitoring. Device facilitates clinical management of patients requiring frequent or prolonged venous access; reduces need for repeated venipuncture.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, hemocompatibility, mutagenicity, implantation studies) and performance verification (power injection flow rate, static burst strength, kink/flex resistance, tensile testing, valve performance, leak/aspiration strength, and radiopacity).

Technological Characteristics

Intravascular catheter; single/multi-lumen; 3F to 6F diameters. Materials include radiopaque components. Rated for power injection up to 325 psi and 6 mL/sec. Standards: EN ISO 10555-1, EN ISO 10555-3, ISO 10993-1. Sterilization: Sterile, single-use. Connectivity: None.

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Xcela Power Injectable PICC (K150527)
• Xcela PICC w/PASV Valve (K093366)
• Xcela Hybrid PICC w/PASV Valve (K111906)

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

September 24, 2015

Navilyst Medical, INC. Ms. Robin Fuller Sr. Manager, Regulatory Affairs 26 Forest Street Marlborough, MA 01752

Re: K152409

Trade/Device Name: Xcela Power Injectable PICC, Xcela PICC with PASV Valve Technology, and Xcela Hybrid PICC with PASV Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long- term intravascular catheter Regulatory Class: II Product Code: LJS Dated: August 25, 2015 Received: August 26, 2015

Dear Ms. 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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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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510(k) Number (if known) K152409

Device Name Xcela Power Injectable PICC Xcela PICC with PASV Valve technology Xcela Hybrid PICC with PASV Valve technology

#### Indications for Use (Describe)

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 administrations and nutrients, the sampling of blood, and for power injection of contrast media.

Maximum Power Injection Flow Rate

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

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 administrations and nutrients, the sampling of blood, and for power injection of contrast media.

The Xcela Hybrid PICC with PASY Valve technology is indicated for short or long-term 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. The maximum power injection flow rate is 6 mL/sec.

Type of Use (*Select one or both, as applicable*)

| <div> <b> <span></span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-----------------------------------------------------------------------------------------|
| <div> <b> <span></span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(K) SUMMARY FOR THE XCELA POWER INJECTABLE PICC, XCELA PICC WITH PASV VALVE AND XCELA HYBRID PICC WITH PASV VALVE

Date prepared: September 24, 2015

- A. Sponsor
Navilyst Medical. Inc 26 Forest Street Marlborough, MA 01752

### B. Contact

Robin Fuller Sr. Manager, Regulatory Affairs 508-658-7986

C. Device Name Trade Name:

> Common/Usual name: Classification Name:

Classification Panel: ProCode

# D. Predicate Device Common/Usual name:

Classification Name:

Classification Panel: Premarket Notification OR

Wanda Carpinella Director, Regulatory Affairs 508-658-7929

Xcela Power Injectable PICC; Xcela PICC w/PASV Valve technology; Xcela Hybrid PICC w/PASV Valve technology Peripherally Inserted Central Catheter (PICC) Percutaneous, implanted, long-term intravascular catheter 21CFR§880.5970, Class II General Hospital LIS

Peripherally Inserted Central Catheter (PICC) Percutaneous, implanted, long-term intravascular catheter 21CFR8880.5970, Class II General Hospital K150527 (Xcela Power Injectable PICC), K093366 (Xcela PICC w/PASV Valve), K111906 (Xcela Hybrid PICC w/PASV Valve)

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# E. Device Description

# Intended Use

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.

| Maximum Power Injection Flow Rate | |
|-----------------------------------|------------|
| Description | Flow Rate |
| 4F Single Lumen - 45cm length | 4 mL/sec |
| 4F Single Lumen - 55cm length | 3.5 mL/sec |
| 5F Single Lumen - 55cm length | 5 mL/sec |
| 5F Dual Lumen - 45 cm length | 5 mL/sec |
| 5F Dual Lumen - 55cm length | 4 mL/sec |
| 6F Dual Lumen - 55cm length | 5 mL/sec |

The Xcela PICC with PASV Valye is technology indicated for short- or long-term 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.

The Xcela Hybrid PICC with PASV Valve technology is indicated for short- or long-term 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 iniection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate is 6 mL/sec.

# E. Summary of Similarities and Differences in Technological Characteristics and Performance

The only difference compared to the current Xcela Power Injectable PICC, Xcela PICC with PASV Valve and Xcela Hybrid PICC with PASV Valve catheters cleared via K093366, K111906 and K150527 is a change of the catheter shaft, luer and suture wing print ink. The proposed device has identical technological characteristics and performance as the predicate intravascular catheters. Both the proposed and predicate devices are, in brief,

- · intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media.
- · available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter;
- · rated for maximum power injector settings up to 325 psi
- · rated for maximum power injection flow rate up to 6 ml/second based on model; and
- · available kitted with a range of procedural accessories for user convenience

# F. Performance Data

The impact that the modification has on any associated device risks were evaluated as part of the Risk Analysis (FMEA) activity. There were no modifications of the risk analysis documentation relating to this modification studies performed focused primarily on the features associated with the change (new catheter shaft, luer and suture wing print ink).

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Therefore, product features/specifications affected by this change were tested (catheter shaft print integrity and biocompatibility testing). The following biocompatibility tests were performed:

Cytotoxicity Sensitization Intracutaneous Reactivity Acute Systemic Toxicity Materials Mediated Pyrogen Subchronic Toxicity Subacute Toxicity Hemolysis - Direct Contact Hemolysis Extract Method Coagulation - Partial Thromboplastin Time In-Vitro Hemocompatibility Complement Activation Bacterial Mutagenicity - Ames Assay In-Vitro Mouse Lymphoma Assay In-Vivo Mouse Micronucleus Assay 4 Week Implantation 13 Week Implantation USP Physicochemical Test for Plastics >661<

Since the only change was the ink all other tests that have been performed on the predicate devices are applicable to this device. The testing completed on the predicate devices were as follows:

- · Power Injection Flow Rate
- · Static Burst Strength
- · Multiple Power Injections
- · Gravity Flow Rate
- · Catheter Length
- · Priming Volume
- · 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)
- · Valve Performance
- · Leak Strength
- · Aspiration Strength
- · Vesicant Testing
- ·Compatibility Testing

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The Xcela Power Injectable PICC, Xcela PICC with PASV Valye and Xcela Hybrid PICC with PASV Valve are substantially equivalent to Navilyst predicate devices based on comparison of technological characteristics and the results of non-clinical tests which included the performance evaluation and biocompatibility testing conducted in accordance with the following FDA guidance documents, international standards, and testing which included:

- EN ISO 10555-1:2009, Sterile, Single use intravascular catheters Part 1: General � Requirements
- . EN ISO 10555-3:1997 Corrigendum 1:2002. Sterile. Single-Use Intravascular Catheters – Part 3: Central Venous Catheters
- FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term . and Long-Term Intravascular Catheters dated March 16, 1995"
- � FDA Blue Book Guidance G95-1 "Use of International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"

# G. Conclusion

The results of the non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.