(29 days)
Not Found
No
The document describes a physical medical device (PICC catheter) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would suggest the incorporation of AI or ML. The changes described are purely related to the physical components and materials of the catheter.
No.
The device is for access and administration, not for treating a disease or condition.
No
The device is indicated for providing access to the central venous system for administration of fluids, medications, nutrients, sampling of blood, and power injection of contrast media. These are therapeutic or access-related functions, not diagnostic ones. While blood sampling and contrast media injection can be part of diagnostic procedures, the device itself is a tool for access and delivery, not for diagnosing a condition.
No
The device description clearly indicates it is a physical catheter (PICC) with specific dimensions, materials, and performance characteristics related to fluid flow, pressure, and physical integrity. The changes described are related to the print ink on the physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for accessing the central venous system for administering fluids, medications, nutrients, sampling blood, and power injecting contrast media. These are all procedures performed on the patient, not on a sample of bodily fluid or tissue outside the body for diagnostic purposes.
- Device Description: The device is described as an intravascular catheter, which is a tool used for accessing blood vessels within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide diagnostic information. The blood sampling mentioned is for collection, not for analysis by the device itself.
- Performance Studies: The performance studies focus on the physical and material properties of the catheter and its ability to perform its intended function (flow rate, strength, biocompatibility, etc.), not on the accuracy or reliability of any diagnostic results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The Xcela Power Injectable PICC, Xcela PICC with PASV Valve and Xcela Hybrid PICC with PASV Valve are peripherally inserted central catheters (PICC). They are available in single and multi-lumen configurations in a wide range of sizes from 3F to 6F outside catheter diameter. They are rated for maximum power injector settings up to 325 psi and a maximum power injection flow rate up to 6 ml/second based on the model. The devices are also available kitted with procedural accessories. The specific change cleared by this 510(k) is a change in the catheter shaft, luer, and suture wing print ink.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system (via peripheral access)
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)
The performance evaluation focused on the impact of the change in print ink. Study types included:
- Biocompatibility tests: 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
§ 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.”
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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)
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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