(371 days)
Not Found
No
The document describes a physical medical device (PICC catheter) with a surface modification technology. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device facilitates the administration of therapies (infusion, intravenous therapy) and diagnostic procedures (blood sampling, central venous pressure monitoring), but it does not directly treat a medical condition.
No
The device is a peripherally inserted central catheter (PICC) used for infusion, therapy, blood sampling, pressure monitoring, and contrast media injection, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter made of polyurethane with specific dimensions and features, indicating it is a hardware device.
Based on the provided information, the Nylus™ PICC is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of the Nylus™ PICC is to provide peripheral access to the central venous system for various medical procedures like infusion, therapy, blood sampling, and monitoring. This is a direct interaction with the patient's circulatory system.
- Device Description: The description details a physical catheter designed to be inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. The Nylus™ PICC does not perform this function. It is a device used within the body for therapeutic and diagnostic access purposes.
Therefore, the Nylus™ PICC is a medical device, but it falls under the category of an implantable or invasive device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Platelet Adherence:
99% reduction in platelet adherence compared to unmodified catheter control in an in vitro 2-hour bovine blood flow loop
Following 45 days of exposure to serum, 97% reduction in platelet adherence compared to predicate uncoated PICC in an in vitro 2-hour bovine blood flow loop
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:
Greater than 99% decrease in thrombus weight accumulation compared to the unmodified control catheter in an in vitro 2-hour blood flow loop
99% decrease in surface area of thrombus coverage compared to the predicate uncoated PICC in an in vivo 4-hr canine model
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
510(k) Premarket Notification Submission K113225: Nylus™ PICC
SECTION 5
NOV
510(k) SUMMARY
In Compliance with 21 CFR 807.92
Submitter Information
N
| 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 |
1
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:
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.
2
510(k) Premarket Notification Submission K113225: Nylus™ PICC
Indications for Use
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.
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
3
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 |
|---|---|
| Platelet | |
| Adherence | 99% reduction in platelet adherence compared to unmodified catheter |
| control in an in vitro 2-hour bovine blood flow loop | |
| Following 45 days of exposure to serum, 97% reduction in platelet | |
| adherence compared to predicate uncoated PICC in an in vitro 2-hour | |
| bovine blood flow loop | |
| 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 | Greater than 99% decrease in thrombus weight accumulation compared |
| to the unmodified control catheter in an in vitro 2-hour blood flow loop | |
| 99% decrease in surface area of thrombus coverage compared to the | |
| predicate 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.
4
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.
5
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
6
510(k) Premarket Notification Submission: Nylus™ PICC
Indications for Use
510(k) Number (if known): K113225
Device Name: Nylus™ PICC
Indications for Use:
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.
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