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.

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.

Device Description

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. 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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves device performance. It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria in the way one might for a novel AI device. Therefore, some of the requested categories (especially those related to AI algorithm performance) will not be applicable or directly found in this type of document.

Summary of Acceptance Criteria and Device Performance:

The document describes the Xcela Power Injectable PICC, Xcela PICC with PASV Valve Technology, and Xcela Hybrid PICC with PASV Valve Technology. The core premise for this 510(k) submission is that the only difference compared to previously cleared predicate devices (K093366, K111906, and K150527) is a change in the catheter shaft, luer, and suture wing print ink. Therefore, the "acceptance criteria" and "device performance" largely refer to the established performance characteristics of the predicate devices, which the modified device is expected to meet due to the minor nature of the change.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a minor modification and not a de novo device, explicit numerical acceptance criteria for each test are not listed in this summary. Instead, the document states that the modified device has "identical technological characteristics and performance as the predicate intravascular catheters." The performance aspects are implied by the types of tests performed.

Performance Characteristic (Implied Acceptance Criteria: Equivalent to Predicate Device)	Reported Device Performance (Achieved)
Material Performance (Specific to New Components)
Cytotoxicity	Performed, implied acceptable.
Sensitization	Performed, implied acceptable.
Intracutaneous Reactivity	Performed, implied acceptable.
Acute Systemic Toxicity	Performed, implied acceptable.
Materials Mediated Pyrogen	Performed, implied acceptable.
Subchronic Toxicity	Performed, implied acceptable.
Subacute Toxicity	Performed, implied acceptable.
Direct Contact Hemolysis	Performed, implied acceptable.
Extract Method Hemolysis	Performed, implied acceptable.
Coagulation - Partial Thromboplastin Time	Performed, implied acceptable.
In-Vitro Hemocompatibility	Performed, implied acceptable.
Complement Activation	Performed, implied acceptable.
Bacterial Mutagenicity - Ames Assay	Performed, implied acceptable.
In-Vitro Mouse Lymphoma Assay	Performed, implied acceptable.
In-Vivo Mouse Micronucleus Assay	Performed, implied acceptable.
4 Week Implantation	Performed, implied acceptable.
13 Week Implantation	Performed, implied acceptable.
USP Physicochemical Test for Plastics >661<	Performed, implied acceptable.
Catheter Shaft Print Integrity	Performed, implied acceptable.
Functional Performance (Inherited from Predicate; "Acceptable" is implied)
Power Injection Flow Rate	Max. power injection flow rate up to 6 ml/second (depending on model); specific rates for each model are listed in the 'Indications for Use' (e.g., 4F Single Lumen - 45cm length: 4 mL/sec; 6F Dual Lumen - 55cm length: 5 mL/sec). Note: The Hybrid PICC with PASV Valve explicitly states a max of 6mL/sec for non-valved lumens.
Static Burst Strength	Testing performed on predicate, results applicable.
Multiple Power Injections	Testing performed on predicate, results applicable.
Gravity Flow Rate	Testing performed on predicate, results applicable.
Catheter Length	Testing performed on predicate, results applicable.
Priming Volume	Testing performed on predicate, results applicable.
Dimensional Verification (ID, OD, Length)	Testing performed on predicate, results applicable.
Catheter Kink/Flex Resistance (Elongation, Stiffness, Flex Life Strength)	Testing performed on predicate, results applicable.
Alcohol Compatibility	Testing performed on predicate, results applicable.
Catheter Marking & Identification/Radiopacity Testing	Testing performed on predicate, results applicable. (Note: Specific print integrity test done for the modified device also, but overall marking/radiopacity is covered.)
Tensile Testing (Catheter and Assembly)	Testing performed on predicate, results applicable.
Valve Performance (for PASV and Hybrid models)	Testing performed on predicate, results applicable.
Leak Strength	Testing performed on predicate, results applicable.
Aspiration Strength	Testing performed on predicate, results applicable.
Vesicant Testing	Testing performed on predicate, results applicable.
Compatibility Testing	Testing performed on predicate, results applicable.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated in terms of number of units tested for each specific test in this summary. The tests performed are typical for medical device bench testing.
Data Provenance: The new tests (biocompatibility and print integrity) were conducted by Navilyst Medical, Inc. (the submitter). The performance data for all other characteristics relies on studies previously conducted on the predicate devices (K093366, K111906, K150527), which were also manufactured by Navilyst Medical. Thus, the data provenance is from the manufacturer's internal testing. Not applicable for country of origin in this context, as it's bench testing. The data is effectively retrospective for the predicate device performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts:

This question is not applicable to this type of device submission. The "ground truth" here is based on engineering specifications, standardized test methods (e.g., ISO, FDA guidance), and objective measurement. There are no "experts" establishing ground truth in the sense of clinical interpretation for a diagnostic AI.

4. Adjudication Method for the Test Set:

Not applicable. This is not a clinical study involving human judgment or interpretation. Performance is measured against physical and chemical standards.

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:

This question is not applicable. This device is a physical medical catheter, not an AI or diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. This device is a physical medical catheter, not an AI or diagnostic imaging device.

7. The Type of Ground Truth Used:

The ground truth used for validating the performance of the catheter is based on:

Established engineering specifications and design requirements.
International standards (e.g., EN ISO 10555-1, EN ISO 10555-3).
FDA guidance documents (e.g., "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters," G95-1 for biocompatibility).
Objective physical and chemical measurements obtained through laboratory testing (e.g., flow rate measurements, burst strength, toxicity assays).

8. The Sample Size for the Training Set:

This question is not applicable. This device is a physical medical catheter and does not involve AI or machine learning algorithms that require a "training set."

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable for the reasons stated above.

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 features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

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 (800) 638-2041 or (301) 796-7100 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 (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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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)

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

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)

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below

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510(K) SUMMARY FOR THE 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.

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.”