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.

AI/ML Overview

The provided text describes the 510(k) summary for the ABLATIVE SOLUTIONS, INC. PEREGRINE SYSTEM™ INFUSION CATHETER. It focuses on the device's technological characteristics and non-clinical performance data to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting performance in a way that aligns with typical AI/algorithm-related studies.

Therefore, many of the requested elements for an AI device study are not present in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way one would for an AI algorithm. Instead, it lists various non-clinical tests conducted to demonstrate the device's functional integrity and safety.

Acceptance Criteria Category	Specific Tests Conducted	Outcome/Reported Performance
Biocompatibility	Cytotoxicity	Met ISO 10993 standards
	Sensitization	Met ISO 10993 standards
	Irritation/Intracutaneous	Met ISO 10993 standards
	Acute systemic toxicity	Met ISO 10993 standards
	Materials mediated pyrogenicity	Met ISO 10993 standards
	Hemocompatibility hemolysis (direct contact)	Met ISO 10993 standards
	Hemocompatibility hemolysis (extract)	Met ISO 10993 standards
	Complement activation of C3a and SC5b-9	Met ISO 10993 standards
	Thrombogenicity in Sheep	Met ISO 10993 standards
Functional Performance	Visual/Dimensional Inspection	Functions as intended
	Air Ingress/Negative Collapse	Functions as intended
	Tensile Strength	Functions as intended
	Liquid Leakage under Pressure/Leakage at Hub	Functions as intended
	Flexibility and Kink	Functions as intended
	Tip Stiffness	Functions as intended
	Guide Tube Deployment Force	Functions as intended
	Catheter Torque	Functions as intended
	Guidewire Torque	Functions as intended
	Corrosion Resistance	Functions as intended
	Chemical Compatibility	Functions as intended
	Simulated Use Testing	Functions as intended
Device Integrity	Packaging/Simulated Shipping Testing	Functions as intended
	Sterilization validation	Functions as intended
Clinical Performance	In-vivo testing	Functions as intended

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a comprehensive non-clinical testing program as outlined in the "Non-Clinical Performance Data" section.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in terms of individual units tested for each specific test. The document mentions "testing performed on the proposed device," implying an adequate number of devices were tested per standard practice for each test type, but specific quantities are not provided.
Data Provenance: The tests are described as "non-clinical bench testing, simulated-use testing and in-vivo testing." This indicates the data is generated through laboratory experiments and animal (sheep) studies, not human clinical data. The country of origin for these labs is not specified. It is prospective in the sense that the tests were designed and executed to evaluate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as the document describes the testing of a medical device (catheter), not an AI algorithm requiring expert-established ground truths on medical images or patient data. The "ground truth" here is adherence to engineering standards (ISO 10993, ISO 10555-1) and functional performance criteria. The experts involved would be engineers, scientists, and technicians conducting the tests and interpreting results against established standards. Their qualifications are not detailed.

4. Adjudication method for the test set

Not applicable for a device testing report of this nature. Adjudication methods like 2+1 or 3+1 typically refer to conflicts in expert labelers for AI ground truth, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a physical medical device (infusion catheter), not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm; it's a medical device.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is established by:

Adherence to International Standards: ISO 10993 (Biocompatibility) and ISO 10555-1 (Catheter standards).
Functional Performance Specifications: Predefined engineering specifications for mechanical, chemical, and fluid delivery characteristics.
In-vivo observations: Performance in animal models (e.g., thrombogenicity in sheep) against expected physiological responses.

8. The sample size for the training set

Not applicable. This is not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for this device.

Summary

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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.

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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: ●

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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.

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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

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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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Regulation Number and Section

§ 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).