(24 days)
Not Found
No
The document describes a physical medical device (PICC catheter) and its performance characteristics, with no mention of AI or ML technology.
No
The device is a catheter used for intravenous therapy and blood sampling, which are procedures rather than direct therapeutic actions from the device itself.
No
The device description indicates it is a catheter used for administering fluids, medications, nutrients, blood sampling, and contrast media for imaging, and for monitoring central venous pressure. These are all therapeutic or supportive functions, not diagnostic ones.
No
The device description clearly describes a physical catheter with various hardware components (flexible radiopaque catheters, suture wings, extension tubes, luer lock adapters, valves, etc.). It is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a catheter for accessing the central venous system for intravenous therapy, blood sampling, and power injection of contrast media. These are all procedures performed in vivo (within the body).
- Device Description: The description details a physical catheter designed for insertion into a blood vessel.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are typically used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions. This device is used directly on the patient for therapeutic and diagnostic imaging purposes.
N/A
Intended Use / Indications for Use
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. The maximum power injection flow rate for the Xcela™ Hybrid PICC with PASV™ Valve Technology is 6 mL/sec.
Product codes
LJS
Device Description
The Xcela™ Hybrid PICC with PASV™ Valve Technology are flexible radiopaque catheters with suture wings for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with two pressure activated safety valves (PASV™), available in a triple lumen configuration; a reverse tapered shaft to aid in staunching bleeding at the insertion site and a non-valved lumen for central venous pressure monitoring.
The lumens are differentiated by proximally located colored extension tube clamps and/or colored luer adaptors, with gauge descriptor, if the lumen is rated for power injection the maximum power injection flow rates, and "NO CT" for non-power injectable lumens.
The Xcela™ Hybrid PICC with PASV™ Valve Technology is designed with the option of being used with power injectors for the administration of contrast media for imaging studies such as Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs).
The catheters are available as single, sterile packages with a variety of procedural accessories in standard kit configurations and as a convenience to suite specific clinical needs.
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
The performance evaluation of the Xcela™ Hybrid PICC with PASV™ included testing conducting in accordance with the following FDA guidance document and international standards with successful results:
- EN ISO 10555-1:2009, Sterile, Single use intravascular catheters Part 1: General . Requirements
- EN ISO 10555-3:1997 COR 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"
The testing performed is summarized below:
Performance Testing – Proposed 6F Triple Lumen Hybrid PICC with PASV™
| Test | Test Objective | Test Result |
|---|---|---|
| 1. | Product Labeling: Verify catheter is labeled correctly. | PASS |
| 2. | Central Venous Pressure Monitoring: Verify that catheter can monitor central venous pressure (Non-Valved Lumen Only) | PASS |
| 3. | Luer Connection: Verify luer to EN 1707 | PASS |
| 4. | Assembly Leak Strength: Verify the catheter assembly does not leak simulating the method in ISO 10555-1 clause 4.6.1. | PASS |
| 5. | Assembly Aspiration Strength (Closed Ended): Verify catheter assembly does not leak simulating the method in ISO 10555-1 clause 4.6.2. | PASS |
| 6. | Assembly Aspiration Strength (Open Ended): Verify the catheter assembly does not leak simulating the method in ISO 10555-1 clause 4.6.2. | PASS |
| 7. | Priming Volume: Verify the priming volume of the catheter | PASS |
| 8. | Power Injection Flow Rate: Verify the catheter can meet its labeled flow rate. | PASS |
| 9. | Power Injection Multiple Injections: Verify catheter can withstand multiple simulated use injections at the maximum target flow rate. | PASS |
| 10. | Static Burst: Verify catheter does not leak/burst when taken to failure below the minimum requirement. | PASS |
| 11. | Oversleeve to PASV™ Valve Housing and Hybrid Luer Tensile Strength: Verify force at break of the valve housing to oversleeve and hybrid luer to oversleeve simulating the method in ISO 10555-1 clause 4.5 and ISO 10555-3 clause 4.7. | PASS |
| 12. | Gravity Flow Rate: Verify gravity flow rate of the catheter simulating the method in ISO 10555-3 clause 4.6. | PASS |
| 13. | Long term Extension Tube Life (Non-valved lumen): Verify effectiveness of extension tube to undergo repeat clamping without cracking or leaking | PASS |
| 14. | Long Term Clamp Life (Non-Valved lumen): Verify effectiveness of clamp to undergo repeat clamping without cracking. | PASS |
| 15. | Long Term Clamp Life Compatibility with Extension Tube (non-Valved lumen): Verify effectiveness of clamp and extension tube to not leak after repeat clamping. | PASS |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K 111906
510(k) Summary for the XCELA™ HYBRID PICC WITH PASV™ VALVE TECHNOLOGY
Date prepared: 11-May-2011
A. Sponsor
Navilyst Medical, Inc 26 Forest Street Marlborough, MA 01752
B. Contact
Lorraine M. Hanley VP Global Regulatory Affairs 508-658-7945
and
Wanda Carpinella Sr. Mgr. Global Regulatory Affairs 508-658-7929
C. Device Name
Trade Name: Common/Usual name: Classification Name:
Classification Panel:
D. Predicate Device(s)
Common/Usual name: Classification Name:
Premarket Notification(s):
XCELA™ HYBRID PICC WITH PASVTM VALVE TECHNOLOGY
Peripherally Inserted Central Catheter (PICC) Short and Long-Term Intravascular Catheter 21CFR8880.5970. Class II General Hospital
Peripherally Inserted Central Catheter (PICC) Short and Long-Term Intravascular Catheter 21CFR§880.5970, Class II K101326, K091261, K093366
E. Device Description
The Xcela™ Hybrid PICC with PASVTM Valve Technology are flexible radiopaque catheters with suture wings for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with two pressure activated safety valves (PASV™), available in a triple lumen configuration; a reverse tapered shaft to aid in staunching bleeding at the insertion site and a non-valved lumen for central venous pressure monitoring.
1
The lumens are differentiated by proximally located colored extension tube clamps and/or colored luer adaptors, with gauge descriptor, if the lumen is rated for power injection the maximum power injection flow rates, and "NO CT" for non-power injectable lumens.
The Xcela™ Hybrid PICC with PASV™ Valve Technology is designed with the option of being used with power injectors for the administration of contrast media for imaging studies such as Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs).
The catheters are available as single, sterile packages with a variety of procedural accessories in standard kit configurations and as a convenience to suite specific clinical needs.
F. Intended Use
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. The maximum power injection flow rate for the Xcela™ Hybrid PICC with PASV™ Valve Technology is 6 mL/sec.
G. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed device has similar materials, design, components and technological characteristics as the predicate intravascular catheters.
The predicate devices are offered in sizes 3 F to 6 F outside diameter, single and multilumen (dual and triple) models, whereas the proposed device is offered in 6 F outside diameter. multi-lumen (triple); both predicate and proposed devices offer PASV valved and non-valved models, and are for optional use to power inject contrast media.
H. Substantial Equivalence
Based on responses to questions posed in FDA's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicate devices.
2
I. Performance Data
The performance evaluation of the Xcela™ Hybrid PICC with PASV™ included testing conducting in accordance with the following FDA guidance document and international standards with successful results:
- EN ISO 10555-1:2009, Sterile, Single use intravascular catheters Part 1: General . Requirements
- EN ISO 10555-3:1997 COR 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"
The testing performed is summarized below:
Performance Testing – Proposed 6F Triple Lumen Hybrid PICC with PASV™
| Test | Test Objective | Test Result |
|---|---|---|
| 1. | Product Labeling: Verify catheter is labeled correctly. | PASS |
| 2. | Central Venous Pressure Monitoring: Verify that catheter can monitor central venous pressure (Non- | |
| Valved Lumen Only) | PASS | |
| 3. | Luer Connection: | |
| Verify luer to EN 1707 | PASS | |
| 4. | Assembly Leak Strength: Verify the catheter assembly does not leak simulating the method in ISO | |
| 10555-1 clause 4.6.1. | PASS | |
| 5. | Assembly Aspiration Strength (Closed Ended): Verify catheter assembly does not leak simulating the | |
| method in ISO 10555-1 clause 4.6.2. | PASS | |
| 6. | Assembly Aspiration Strength (Open Ended): | |
| Verify the catheter assembly does not leak simulating the method in ISO 10555-1 clause 4.6.2. | PASS | |
| 7. | Priming Volume: | |
| Verify the priming volume of the catheter | PASS | |
| 8. | Power Injection Flow Rate: Verify the catheter can meet its labeled flow rate. | PASS |
| 9. | Power Injection Multiple Injections: Verify catheter can withstand multiple simulated use injections at | |
| the maximum target flow rate. | PASS | |
| 10. | Static Burst: Verify catheter does not leak/burst when taken to failure below the minimum requirement. | PASS |
| 11. | Oversleeve to PASVTM Valve Housing and Hybrid Luer Tensile Strength: | |
| Verify force at break of the valve housing to oversleeve and hybrid luer to oversleeve simulating the | ||
| method in ISO 10555-1 clause 4.5 and ISO 10555-3 clause 4.7. | PASS | |
| 12. | Gravity Flow Rate: | |
| Verify gravity flow rate of the catheter simulating the method in ISO 10555-3 clause 4.6. | ||
| 13. | Long term Extension Tube Life (Non-valved lumen): | |
| Verify effectiveness of extension tube to undergo repeat clamping without cracking or leaking | PASS | |
| 14. | Long Term Clamp Life (Non-Valved lumen): | |
| Verify effectiveness of clamp to undergo repeat clamping without cracking. | ||
| 15. | Long Term Clamp Life Compatibility with Extension Tube (non-Valved lumen): | |
| Verify effectiveness of clamp and extension tube to not leak after repeat clamping. | PASS |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. To the left of the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Lorraine M. Hanley Vice President, Global Regulatory Affairs Navilyst Medical, Incorporated 26 Forest Street Marlborough, Massachusetts 01752
JUL 29 2011
Re: K111906
Trade/Device Name: Xcela™ Hybrid PICC with PASV™ Valve Technology Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous Implanted Long-term Intravascular Catherter Regulatory Class: II Product Code: LJS Dated: June 30, 2011 Received: July 5, 2011
Dear Ms. Hanley:
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.
4
Page 2 - Ms. Hanley
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,
Anthony D. Wang
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
510(k) Number (if Known):
Device Name:
Xcela™ Hybrid PICC with PASV™ Valve Technology
Indications for Use:
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. The maximum power injection flow rate for the Xcela™ Hybrid PICC with PASV™ Valve Technology is 6 mL/sec.
Prescription Use (21 CFR 801 Subpart D) 2 And/Or
AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. St
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: