(14 days)
Not Found
No
The summary describes a mechanical catheter for delivering fluids and mentions fluoroscopic visibility for positioning, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the Peregrine System is "intended for the infusion of diagnostic and therapeutic agents". The 'Device Description' further clarifies that it is "designed to deliver diagnostic and therapeutic agents".
Yes
The 'Intended Use / Indications for Use' explicitly states that "The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area." The mention of "diagnostic agents" indicates its role in diagnosis.
No
The device description clearly outlines a physical catheter with needles, a control handle, and lumens for fluid delivery, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This testing is performed outside of the living body (in vitro).
- Peregrine System Function: The Peregrine System is a catheter designed to infuse substances into the perivascular area of a living patient. This is an in vivo procedure, meaning it takes place within the living body.
- Intended Use: The intended use clearly states "infusion of diagnostic and therapeutic agents into the perivascular area." This is a delivery mechanism, not a diagnostic test performed on a specimen.
The device is a medical device used for delivering substances within the body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Peregrine System Infusion Catheter is intended for the Indications for Use: infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.
The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The Peregrine System Infusion Catheter is a percutaneous catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 5-7 mm in diameter and is compatible with guide catheters of at least 7F.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
perivascular area of the peripheral vasculature
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)
Non-clinical testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1 with Amendments 1 and 2, and customized testing for performance. Testing performed on the proposed device included:
- Visual/Dimensional Inspection .
- Air Ingress/Negative Collapse .
- Tensile Strength .
- . Liquid Leakage under Pressure/Leakage at Hub
- Flexibility and Kink .
- . Tip Stiffness
- Guide Tube Deployment Force ●
- . Catheter Torque
- . Guidewire Torque
- Corrosion Resistance .
- Chemical Compatibility .
- Simulated Use Testing ●
- Biocompatibility: ●
- Cytotoxicity o
- o Sensitization
- Irritation/Intracutaneous O
- Acute systemic toxicity O
- Materials mediated pyrogenicity o
- Hemocompatibility hemolysis by direct contact O
- Hemocompatibility hemolysis by extract o
- O Complement activation of C3a and SC5b-9
- O Thrombogenicity in Sheep
- Packaging/Simulated Shipping Testing .
- Sterilization validation .
- In-vivo testing .
The non-clinical bench testing, simulated-use testing and in-vivo testing demonstrate that the Peregrine System Infusion Catheter functions as intended, meets the requirements of ISO 10555-1, and performs equivalent or better than the predicate device. The testing supports a determination of substantial equivalence to products previously cleared by FDA.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Mercator MicroSyringe II Infusion Catheter K062752, Rex Medical Quadra-Fuse Multi-pronged Injection Needle (exempt)
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Ablative Solutions. The words "ABLATIVE" and "SOLUTIONS" are stacked on top of each other in a bold, sans-serif font. Above the "I" in "ABLATIVE" is a small, dark, teardrop-shaped graphic. The logo is simple and modern, and the use of bold font makes it easily readable.
510(K) SUMMARY (21 CFR 807.92)
ABLATIVE SOLUTIONS, INC. PEREGRINE SYSTEM™ INFUSION CATHETER
- Ablative Solutions, Inc. 510(k) Owner: 801 Hermosa Way Menlo Park, CA 94025 Tel: (650) 867-2957 Fax: (650) 648-0700
- Contact Person: Sharon Rockwell Tel: (714) 695-9269 Fax: (714) 779-0406 E-mail: srockwell@writeme.com
- February 2014 Date Prepared:
Trade Name: Peregrine System™ Infusion Catheter
- Common Name: Continuous flush catheter
- Classification Name: Continuous flush catheter per 21 CFR 870.1210, KRA
- Predicate Devices: Mercator MicroSyringe II Infusion Catheter K062752 Rex Medical Quadra-Fuse Multi-pronged Injection Needle (exempt)
- Device Description: The Peregrine System Infusion Catheter is a percutaneous catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 5-7 mm in diameter and is compatible with guide catheters of at least 7F.
- The Peregrine System Infusion Catheter is intended for the Indications for Use: infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.
1
The indications are substantially equivalent to the indications for the Mercator MedSystems MicroSyringe II Infusion Catheter. The MicroSyringe II is additionally indicated for use in the coronary vessels and for injection of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall. Technological
Characteristics: The Peregrine System Infusion Catheter has three equally circumferentially spaced needles which deliver a diagnostic or therapeutic agent to a pre-specified depth by actuating the handle. A fluid can therefore be delivered to the perivascular area with complete circumferential coverage using a single injection. The needles are advanced mechanically from the handle.
The technological characteristics are comparable to the predicate device, which delivers drugs through a single micro-needle to a pre-specified depth. The micro-needle in the predicate device punctures the vessel wall using the force of a balloon at the distal Multiple, circumferential micro-needle end of the catheter. technology also exists in commercially available injection needles, which are 510(k) exempt.
The technological characteristics of the Peregrine System Infusion Catheter are comparable to the predicate device, and can be validated with bench testing. There are no technological differences which could raise new questions of safety or efficacy.
Non-Clinical
Performance Data:
Non-clinical testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1 with Amendments 1 and 2, and customized testing for performance. Testing performed on the proposed device included:
- Visual/Dimensional Inspection .
- Air Ingress/Negative Collapse .
- Tensile Strength .
- . Liquid Leakage under Pressure/Leakage at Hub
- Flexibility and Kink .
- . Tip Stiffness
- Guide Tube Deployment Force ●
- . Catheter Torque
- . Guidewire Torque
- Corrosion Resistance .
- Chemical Compatibility .
- Simulated Use Testing ●
- Biocompatibility: ●
2
- Cytotoxicity o
- o Sensitization
- Irritation/Intracutaneous O
- Acute systemic toxicity O
- Materials mediated pyrogenicity o
- Hemocompatibility hemolysis by direct contact O
- Hemocompatibility hemolysis by extract o
- O Complement activation of C3a and SC5b-9
- O Thrombogenicity in Sheep
- Packaging/Simulated Shipping Testing .
- Sterilization validation .
- In-vivo testing .
Conclusions:
The non-clinical bench testing, simulated-use testing and in-vivo testing demonstrate that the Peregrine System Infusion Catheter functions as intended, meets the requirements of ISO 10555-1, and performs equivalent or better than the predicate device. The testing supports a determination of substantial equivalence to products previously cleared by FDA.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2014
Ablative Solutions, Inc. c/o Sharon Rockwell Regulatory Affairs Consultant 801 Hermosa Way Menlo Park, CA 94025
Re: K140637
Trade/Device Name: Peregrine System™ Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: February 26, 2014 Received: March 12, 2014
Dear Ms. Rockwell:
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.
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
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Page 2 - Ms. Sharon Rockwell
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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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/ReportalProblem/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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K140637 ....
Device Name: Peregrine System™ Infusion Catheter
Indications for Use: The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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