The Pacific Plus PTA Catheter is intended to dilate stenoses in the illiofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent postdilatation in the peripheral arteries.

Device Description

The Pacific Plus PTA catheter is an Over the Wire (OTW) peripheral balloon catheter, specifically designed for percutaneous transluminal angioplasty (PTA) in stenosed vessel segments. The OTW catheter is used to guide the balloon to the stenosed vessel segment. The balloon is then inflated to dilate the vessel.

The catheter is a coaxial dual lumen device. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.018 in (0.46 mm). The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution.

The Pacific Plus PTA catheter is available in balloon diameters 4.0 mm - 7.0 mm, and balloon lengths from 20 mm to 300 mm, with 90 cm, 150 cm, and 200 cm catheter lengths. The distal section of the catheter includes a lubricious hydrophilic coating.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Pacific Plus PTA Catheter. This document is a regulatory submission for a medical device and, therefore, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific clinical performance acceptance criteria in the manner one might find for a novel diagnostic or AI-driven decision support tool.

The "acceptance criteria" in this context refer to the benchmark performance of the predicate device and relevant industry standards for similar devices. The "study" proving the device meets these criteria is the bench testing and biocompatibility evaluation performed.

Here's an analysis of the provided information based on your request, keeping in mind the nature of a 510(k) submission for a catheter:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a device like a PTA catheter, "acceptance criteria" are typically defined by engineering specifications, safety standards, and performance characteristics demonstrated by equivalent predicate devices, rather than clinical metrics like sensitivity/specificity for diagnostic AI. The "reported device performance" are the results of bench tests confirming these specifications are met or are comparable to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate & Standards)	Reported Device Performance (Summary from Bench Testing)
Dimensional & Physical Properties	Conformance to specified balloon diameters, lengths, catheter lengths, and dimensional accuracy.	Dimensional Verification: Confirmed by testing.
Functional Performance	- Effective balloon preparation, deployment, and retraction. - Ability to withstand rated burst pressure. - Resistance to fatigue under repeated inflation/deflation. - Specific balloon compliance (expansion profile). - Acceptable inflation/deflation times.	- Balloon Preparation, Deployment and Retraction: Demonstrated to function as intended. - Balloon Rated Burst Pressure: Met specified pressure limits, comparable to predicate. - Balloon Fatigue: Demonstrated acceptable durability. - Balloon Compliance: Within expected range, comparable to predicate. - Balloon Inflation/Deflation Time: Within acceptable limits.
Mechanical Integrity	- Sufficient bond strength between components. - Acceptable catheter flexibility and kink resistance. - Adequate torque strength for navigation. - Integrity of hydrophilic coating.	- Catheter Bond Strength and tip pull test: Met specified strength requirements. - Catheter Flexibility and Kink Test: Demonstrated acceptable flexibility and kink resistance. - Catheter Torque Strength: Met specified torque limits. - Catheter coating Integrity: Confirmed to be intact and functional.
Safety	- Absence of unacceptable particulate matter. - Biocompatibility (cytotoxicity, pyrogenicity, systemic toxicity, sensitization, intracutaneous reactivity, hemocompatibility).	- Particulate Evaluation: Met acceptable limits. - Biocompatibility Testing: All tests (Cytotoxicity, Pyrogenicity, Systemic Toxicity, Sensitization, Intracutaneous Reactivity, Haemocompatibility - Hemolysis, Complement Activation, Partial Thromboplastin Time (PTT), Thromboresistance) were passed, concluding the device is biocompatible for its intended use.
Sterility	Sterility assurance level and method.	Same sterility assurance level and method of sterilization as predicate.
Packaging	Suitable packaging materials.	Similar packaging materials to predicate.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the bench tests. It refers to "internal risk analysis procedures" that determined the extent of testing. For medical device bench testing, the sample size is typically determined by statistical methods or established industry standards to ensure sufficient confidence in the results for each specific test (e.g., a certain number of catheters are tested for burst pressure, fatigue, etc.).
Data Provenance: The data is "internal" research and development data, generated by Medtronic Vascular, Inc. through their bench testing and biocompatibility assessments. This is not clinical data, but rather engineering and laboratory testing data. The country of origin of the data is implicitly the USA, where Medtronic is headquartered and the submission was made to the FDA. The data is prospective in the sense that the tests were conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable in the traditional sense. For a PTA catheter, "ground truth" for bench testing is established by engineering specifications, validated test methods (e.g., ASTM, ISO standards), and the performance characteristics of the legally marketed predicate device. This is not a situation where human experts are adjudicating clinical images or patient outcomes to establish ground truth for an AI algorithm. The "experts" involved would be Medtronic's R&D engineers, quality assurance personnel, and regulatory affairs specialists who designed the tests, conducted them, and interpreted the results against established standards and predicate performance. Their qualifications would be in engineering, materials science, and medical device regulations.

4. Adjudication Method for the Test Set

Not Applicable. As explained above, this is not a study requiring adjudication by experts to establish ground truth. The results of the bench tests are objectively measured against predefined acceptance criteria (e.g., a specific burst pressure, a certain bond strength, pH levels for biocompatibility assays).

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

No. This type of study is specifically relevant for diagnostic AI or decision support systems where human interpretation of data is a key component. The Pacific Plus PTA Catheter is an interventional medical device, not a diagnostic AI tool, so an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

No. This question is relevant to AI algorithms. The Pacific Plus PTA Catheter is a physical medical device. The "performance" being evaluated is its physical and mechanical characteristics in a standalone bench testing environment, but this is distinct from an AI algorithm's standalone performance.

7. The Type of Ground Truth Used

For bench testing, the "ground truth" consisted of engineering specifications, international standards (e.g., ISO 10993-1), and the established performance characteristics of the legally marketed predicate device (K123358) and reference devices. These benchmarks define what constitutes acceptable performance for each test. For biocompatibility, the ground truth is established by conformity to the biological safety limits specified in ISO 10993-1.

8. The Sample Size for the Training Set

Not Applicable. This question is relevant to machine learning/AI models. The Pacific Plus PTA Catheter does not involve a "training set" in the context of AI. The development of the catheter relies on engineering design principles, material science, and prior knowledge from predicate devices, not on training an algorithm with a dataset.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no AI training set, this question is not relevant.

In summary, the provided document details a 510(k) submission for a physical medical device. The "study" demonstrating performance involved extensive bench testing and biocompatibility evaluation against engineering specifications, international standards, and the characteristics of predicate devices. This is fundamentally different from the evaluation of an AI-driven diagnostic or decision support system, which would involve clinical studies, ground truth established by expert consensus or pathology, and various performance metrics like sensitivity, specificity, or AUC.

Summary

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November 18, 2020

Medtronic Vascular, Inc (formerly d.b.a ev3 Inc., Covidien Ilc) Rupali Gupta Principal Regulatory Specialist 3033 Campus Drive Maple Grove, Minnesota 55441

Re: K202800

Trade/Device Name: Pacific Plus PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: September 21, 2020 Received: September 23, 2020

Dear Rupali Gupta:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202800

Device Name Pacific Plus PTA Catheter

Indications for Use (Describe)

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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Pacific Plus PTA Catheter 510(k) K202800 - Summary

510(k) Summary

Pacific™ Plus PTA Catheter

This 510(k) Summary is being submitted in accordance with the requirements of 21 C.F.R § 807.92.

1. Submitter Information

Applicant	Medtronic, Inc710 Medtronic ParkwayMinneapolis, MN 55432Tel: 763-514-4000
Contact Person	Rupali GuptaPrincipal Regulatory Affairs SpecialistTel: 763-398-7000
Date Prepared	September 21, 2020

2. Subject Device

Device Trade Name	Pacific Plus PTA Catheter
Device Common Name	Catheter, Angioplasty, Peripheral, Transluminal
Classification Name	Percutaneous Catheter
Product Code	LIT
Classification	Class II
Classification Panel &	Cardiovascular
Regulation Number	21 CFR§870.1250

3. Predicate Device

Device Trade Name	Pacific Plus PTA Catheter (Primary Predicate)
510(k) Number	K123358
510(k) Clearance Date	January 29, 2013

4. Reference Devices

Device Trade Name	PowerCross .018" OTW PTA Dilatation Catheter
510(k) Number	K093286
510(k) Clearance Date	November 13, 2009

Device Trade Name	Pacific Xtreme PTA Balloon Dilatation Catheter
510(k) Number	K103464

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acific Plus PTA Catheter 510(k) K202800 - Summary

510(k) Clearance Date	December 22, 2010

Device Trade Name	Ultraverse 018 PTA Balloon Dilatation Catheter
510(k) Number	K192318
510(k) Clearance Date	October 3, 2019

5. Device Description

6. Indications for Use

The Pacific Plus PTA catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for stent postdilatation in the peripheral arteries.

7. Comparison of Technological Characteristics with Predicate Device

The Pacific Plus PTA Catheter uses similar design and materials as the predicate device. Modifications have been made to the Pacific Plus PTA Catheter design and materials to accommodate expanded product size offerings. The overall design and fundamental scientific technology (operating principle or mechanism of action) of the subject device are the same as the predicate device. All devices are used by the physician in a similar manner typical of a PTA balloon catheter.

The proposed and predicate devices share the following technological characteristics:

Same intended use
Similar indications for use ●
Same fundamental scientific technology

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Pacific Plus PTA Catheter 510(k) K202800 - Summary

Same principles of operation
Similar balloon diameters
Similar balloon lengths ●
Similar rated burst pressure ●
Same lubricious coating
Similar packaging materials ●
Same sterility assurance level and method of sterilization .

8. Performance Data

To demonstrate substantial equivalence of the Pacific Plus PTA Catheter to the predicate and reference devices, bench testing and biocompatibility evaluation was performed. Results from these testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.

Performance Bench Testing

Using internal risk analysis procedures, the following performance tests were performed:

Dimensional Verification ●
Balloon Preparation, Deployment and Retraction
Balloon Rated Burst Pressure ●
Balloon Fatigue
Balloon Compliance
Balloon Inflation/Deflation Time
Catheter Bond Strength and tip pull test
Catheter Flexibility and Kink Test ●
Catheter Torque Strength
Catheter coating Integrity
Particulate Evaluation .

The results from these tests demonstrate that the technological characteristics and performance criteria of the Pacific Plus PTA Catheter devices are comparable to the predicate and reference devices and that the Pacific Plus PTA Catheter performs in a manner equivalent to the predicate and reference devices currently on the market with the same intended use.

Biocompatibility Testing

The biocompatibility evaluation for the Pacific Plus PTA Catheter was conducted in accordance with the principles of the ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process and FDA guidance: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters. Sept 2010 and CDRH's 2016 Biocompatibility Guidance, Use of International Standard ISO 10993-1, Biological

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Pacific Plus PTA Catheter 510(k) K202800 - Summary

evaluation of medical devices-Part 1: Evaluation and testing within a risk management process as recognized by FDA.

The biocompatibility testing included the following tests:

Cytotoxicity .
Pyrogenicity ●
Systemic Toxicity ●
Sensitization ●
Intracutaneous Reactivity (irritation) ●
Haemocompatibility -Hemolysis ●
Haemocompatibility -Complement Activation
Haemocompatibility -Partial Thromboplastin Time (PTT) ●
Haemocompatibility Thromboresistance .

The Pacific Plus PTA Catheter is considered biocompatible for its intended use under ISO 10993-1 category: externally communicating device, circulating blood contact with limited (<24 hour) exposure.

9. Conclusions

Based on the same intended use, similar indications for use, similar technological characteristics, and safety and performance data, Medtronic Vascular, Inc considers the Pacific Plus PTA Balloon Catheter substantially equivalent to the legally marketed predicate device (Pacific Plus, K123358) and reference devices (PowerCross, K093286, Pacific Xtreme, K103464 and Ultraverse, K192318).

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).