The Nylus™ PICC is intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus PICC is indicated for dwell times shorter or greater than 30 days. The device has a maximum recommended infusion rating of 5mL/sec.

Device Description

The Nylus™ PICC is a 5Fr, dual-lumen Peripherally Inserted Central Catheter. The Nylus PICC is a device intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus PICC is indicated for dwell times shorter or greater than 30 days.

The Nylus PICC is made from polyurethane and is approximately 60cm long. It has a reversetapered catheter design, with an injection-molded hub and extension lines with Luer Lock fittings for access attachment. Further, the Nylus PICC has been tested to withstand pressure injection at 5ml/sec with a maximum power injector pressure of 300psi. The catheter's interior and exterior surfaces have been modified by Semprus Sustain™ Technology.

The Semprus Sustain Technology is a proprietary biomimetic polymer surface modification intended to reduce platelet adhesion and thrombus accumulation. The Semprus Sustain Technology does not contain or release any active agents. In vitro and short term, i.e. 4-hour in vivo acute animal studies have demonstrated a reduction in adhered platelets and thrombus accumulation on the surface of the Nylus PICC when compared to an unmodified catheter. Preclinical in vitro and animal models do not necessarily predict clinical performance with respect to thrombus accumulation.

AI/ML Overview

Here's an analysis of the provided 510(k) submission for the Nylus™ PICC, focusing on acceptance criteria and the supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a tabular format as would be typical for a formal performance study against predefined thresholds. Instead, it presents "results" that serve as evidence of the device's performance, particularly regarding the Semprus Sustain™ Technology. The implied acceptance criteria are a significant reduction in platelet adherence and thrombus accumulation compared to unmodified or predicate devices.

Characteristic	Implied Acceptance Criteria (Based on reported results)	Reported Device Performance (Nylus™ PICC)
Platelet Adherence (In vitro)	Significant reduction compared to unmodified/uncoated catheters	99% reduction in platelet adherence compared to unmodified catheter control in an in vitro 2-hour bovine blood flow loop. 97% reduction in platelet adherence compared to predicate uncoated PICC in an in vitro 2-hour bovine blood flow loop (after 45 days of serum exposure). Greater than 98% decrease in the attachment of platelets, lymphocytes, monocytes, and polymorphs compared to the predicate uncoated PICC in an in vitro human blood flow model.
Thrombus Accumulation (In vitro)	Significant reduction in thrombus weight/coverage compared to unmodified/uncoated catheters	Greater than 99% decrease in thrombus weight accumulation compared to the unmodified control catheter in an in vitro 2-hour blood flow loop.
Thrombus Accumulation (In vivo)	Significant reduction in thrombus coverage compared to predicate uncoated PICC in animal model	99% decrease in surface area of thrombus coverage compared to the predicate uncoated PICC in an in vivo 4-hr canine model.
Mechanical/Physical Properties	Meet expected performance requirements for a PICC device (e.g., infusion rate, pressure)	"Meets the expected performance requirements for a PICC device." Maximum recommended infusion rating of 5mL/sec. Maximum recommended pressure setting for power injection is 300 psi. (Tested to withstand 5ml/sec with max power injector pressure of 300psi).

2. Sample Sizes and Data Provenance

The submission provides limited detail on specific sample sizes for each test mentioned, particularly for the in vitro studies.

Test Set Sample Sizes:
- In vitro bovine blood flow loop: Not explicitly stated how many catheters were tested or the number of replicates.
- In vitro human blood flow model: Not explicitly stated how many catheters were tested or the number of replicates.
- In vivo 4-hr canine model: Not explicitly stated how many animals or catheters were used in this "short term" acute animal study.
Data Provenance:
- Country of origin: Not specified, but given the submitter's address (Cambridge, MA, U.S.A.) and FDA submission, it's highly likely the studies were conducted in the U.S. or at institutions adhering to international standards.
- Retrospective or Prospective: These studies are inherently prospective as they involve directed experiments designed to evaluate the device's performance.

3. Number of Experts and Qualifications for Ground Truth

Ground Truth Establishment for Test Set: Not applicable in the context of this submission. The ground truth for these studies is the direct measurement of platelet adherence and thrombus accumulation using laboratory techniques and visual assessment (e.g., surface area coverage) in controlled in vitro and in vivo settings. There is no mention of expert consensus being used to establish ground truth for the performance metrics described.

4. Adjudication Method for Test Set

Adjudication Method: Not applicable. These were laboratory and animal studies with quantifiable measurements (e.g., percentage reduction, weight, surface area) rather than subjective assessments requiring adjudication among human readers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The Nylus™ PICC is an implantable medical device, and its performance evaluation focused on its material properties and biological interactions rather than diagnostic accuracy involving human interpretation.

6. Standalone (Algorithm Only) Performance Study

Standalone Performance Study: Not applicable. This device does not involve an algorithm or AI. Its performance is evaluated through direct physical and biological testing.

7. Type of Ground Truth Used

The ground truth used for these performance studies was based on:

Direct Measurement: Quantifiable metrics like platelet count, thrombus weight, and surface area coverage.
Laboratory Assays: Specifically designed in vitro blood flow loops.
Animal Models: An in vivo 4-hour canine model for acute assessment of thrombus accumulation.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of this submission. The device's surface modification (Semprus Sustain™ Technology) is a designed physical property, not an algorithm that learns from data.

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: Not applicable, as there is no training set.

Summary

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510(k) Premarket Notification Submission K113225: Nylus™ PICC

SECTION 5

NOV

510(k) SUMMARY

In Compliance with 21 CFR 807.92

Submitter Information

Name:	Semprus BioSciences Corporation
Address:	One Kendall Square
	Building 1400 West
	Cambridge, MA 02139-1673 U.S.A.
Telephone Number:	617.577.7755

Contact Person: Telephone Number: Fax Number: Email:

Gregory Haas 610.698.581 ! 617.577.7756 Gregory.Haas@semprusbio.com

Date Prepared:

November 2, 2012

Device Name

Device Trade Name:	Nylus™ PICC
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification:	Sec 880.5970 Percutaneous, implanted, long-term intravascular catheter
Product Code:	LJS
Classification Panel:	80, General Hospital and Personal Use Device Panel

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510(k) Premarket Notification Submission K113225: Nylus™ PICC

MSD

Predicate Devices

Device Trade Name:	Synergy™ CT PICC
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification:	Sec 880.5970 Percutaneous, implanted, long-term intravascular catheter
510(k) Number:	K101329
Product Code:	LJS
Device Trade Name:	Zeus™ CT PICC
Common Name:	Peripherally Inserted Central Catheter (PICC)
Classification:	Sec 880.5970 Percutaneous, implanted, long-term intravascular catheter
510(k) Number:	K083763
Product Code:	LJS
Device Trade Name:	Duraspan™ Long-term Hemodialysis Catheter
Common Name:	Long Term Hemodialysis Catheter
Classification:	Sec 876.5540 Blood access device and accessories
510(k) Number:	K091506

Device Description

Product Code:

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510(k) Premarket Notification Submission K113225: Nylus™ PICC

Indications for Use

Rationale for Substantial Equivalence

As a PICC, the intended use of the Nylus PICC is equivalent to the predicate devices, Synergy™ CT PICC (K101329) and Zeus™ CT PICC (K083763). The Nylus PICC is equivalent to the predicate Zeus CT PICC and the Duraspan™ Long-term Hemodialysis Catheter in that each device has a biomimetic surface modification or coating.

The Nylus PICC is substantially equivalent to the predicate PICCs by intended use and design.

The Nylus PICC is identical to the predicates in dimension, 5Fr, 60cm .
. The Nylus PICC is identical to the predicates in configuration, dual lumen
The Nylus PICC has the same underlying materials as the predicate, except for some . colorants (color change is for brand identification)
· The Nylus PICC is sterilized via EO sterilization like the predicate Synergy CT PICC
. The Nylus PICC is identical to the predicates in labeling and physical properties. The maximum recommended infusion rating for power injection is 5mL/second. The maximum recommended pressure setting for power injection is labeled for a maximum of 300 psi.
. The Intended Use is identical to the predicates. They are all intended for use as PICCs. There is no change in the fundamental clinical intended use.

Summary of Safety and Effectiveness Data

Testing demonstrates that the Nylus PICC is as safe and effective as the predicate devices and meets all relevant consensus and FDA recognized standards. The test results in this submission demonstrate that the Nylus PICC meets the expected performance requirements for a PICC device, and is therefore substantially equivalent to the predicates relative to safety and

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510(k) Premarket Notification Submission K113225: Nylus™ PICC

mechanical properties as a PICC. The ability of the Semprus Sustain Technology to reduce platelet adhesion and thrombus accumulation on the device surface was demonstrated in both in vitro and animal tests.

Characteristic	Results
PlateletAdherence	99% reduction in platelet adherence compared to unmodified cathetercontrol in an in vitro 2-hour bovine blood flow loop
	Following 45 days of exposure to serum, 97% reduction in plateletadherence compared to predicate uncoated PICC in an in vitro 2-hourbovine blood flow loop
	Greater than 98% decrease in the attachment of platelets, lymphocytes,monocytes and polymorphs compared to the predicate uncoated PICC inan in vitro human blood flow model
ThrombusAccumulation	Greater than 99% decrease in thrombus weight accumulation comparedto the unmodified control catheter in an in vitro 2-hour blood flow loop
	99% decrease in surface area of thrombus coverage compared to thepredicate uncoated PICC in an in vivo 4-hr canine model

Conclusion

The Nylus PICC is substantially equivalent to predicate PICCs in terms of design and intended use. There is no difference in functionality as it relates to the PICC application. The Semprus Sustain surface modification, which is intended to reduce platelet adhesion and thrombus accumulation on the catheter surface, does not raise new questions of safety or effectiveness, as compared to the predicates. Therefore, the Nylus PICC is substantially equivalent to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 6, 2012

Semprus BioSciences Corporation Mr. Gregory Haas Vice President, Product Innovation and Strategy One Kendall Square Building 1400 West Cambridge, Massachusetts 02139

Re: K113225

Trade/Device Name: Nylus™ PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: September 13, 2012 Received: September 14, 2012

Dear Mr. Haas:

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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Page 2 - Mr. Haas

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Digitally signed by Anthony D. Watson

DN: c=US, o=U.S. Government, ou=HHHS, ou=FDA, ou=People, cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300092402 Date: 2012.11.05 16:40:32 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A. 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) Premarket Notification Submission: Nylus™ PICC

Indications for Use

510(k) Number (if known): K113225

Device Name: Nylus™ PICC

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

· Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

Lijd Hi- For RZC Nov 5, 2012.

thesiology, General Hospital

CONFIDENTIAL

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.”