The Pacific™ Plus PTA catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The Pacific Plus is an Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal hub, a coaxial dual lumen shaft, and a distal dilatation balloon. 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 guide wire with a maximum outer diameter of 0.018 inches (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. Two radiopaque marker bands are placed under the balloon segment of the catherser shaft to provide visual reference points for balloon positioning within the vessel.

The Pacific Plus catheter is compatible with guidewires with a maximum diameter of 0.018" (0.46 mm) and with 4F or 5F introducer sheaths depending on balloon size. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 90, 130 and 180 cm.

Balloon sizes range from 2.0mm to 7.0mm in diameter, with balloon lengths from 20mm to l 50mm. All balloons reach nominal diameter at 8atm (Nominal Pressure) and have rated burst pressure (RBP) of 22atm, 16atm, 14atm and 12atm depending on the balloon diameter and balloon length.

AI/ML Overview

The manufacturer, Medtronic Vascular, studied the Pacific Plus PTA Catheter.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Pacific Plus PTA Catheter were met through extensive bench and biocompatibility testing. The submission states, "All of the pre-determined acceptance criteria were met and results passed" for both bench and biocompatibility testing. No specific numerical thresholds for acceptance were listed in the provided text, but the qualitative statement confirms that the device performed as required.

Test Category	Acceptance Criteria	Reported Device Performance
Bench Testing	The bench testing plan was developed with consideration of recommendations from applicable FDA guidance documents, ISO, and ASTM standards. Specific tests included: • Dimensional verification • Balloon preparation, deployment and retraction • Balloon rated burst pressure (RBP) • Balloon fatigue (repeated balloon inflations) • Balloon Compliance • Balloon Inflation/Deflation Time • Catheter Bond Strength • Flexibility and Kink test • Torque Strength • Radiopacity • Coating Integrity • Particulate evaluation • Guide wire compatibility • Introducer sheath compatibility • Coating lubricity	"All of the pre-determined acceptance criteria were met and results passed."
Biocompatibility Testing	Biocompatibility testing was conducted in accordance with ANSI/AAMI/ISO 10993-1:2009, FDA Blue Book Memorandum #G95-1, FDA 21 CFR Part 58, and FDA guidance for Class II Special Controls. Specific tests included: • ISO L929 MEM Elution Test • ISO Kligman Maximization Test • ISO Intracutaneous Injection Test • ISO Systemic Injection Test • ISO Material Mediated Rabbit Pyrogen Test • ISO Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay (AMES Test) • ASTM Direct and Indirect Contact Hemolysis Rabbit Blood • ISO Complement Activation Assay (Indirect Contact) • ISO In-vivo Dog Thromboresistance	"All of the pre-determined acceptance criteria were met and results passed."

2. Sample Size and Data Provenance

The document does not specify the exact sample sizes used for the bench or biocompatibility tests. The data provenance is described as "bench testing" and "biocompatibility testing," implying laboratory-based studies. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, though the nature of the tests suggests prospective laboratory studies.

3. Number, Qualifications, and Adjudication of Experts for Ground Truth

This information is not applicable. The device is a medical catheter, and the "ground truth" for its performance is established through objective engineering bench tests and standardized biological evaluations (biocompatibility). There is no mention of human expert evaluation in establishing ground truth for the device's technical specifications.

4. Adjudication Method

Not applicable for this type of device and testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed. This type of study focuses on the effectiveness of human readers, often with and without AI assistance, typically in image interpretation or diagnostic tasks. The Pacific Plus PTA Catheter is a physical medical device, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Pacific Plus PTA Catheter is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for the performance of the Pacific Plus PTA Catheter was established through:

Bench Testing: Objective measurements and observations against pre-defined engineering and performance specifications and industry standards (ISO, ASTM).
Biocompatibility Testing: Results from standardized biological assays and in-vivo tests to assess the device's interaction with biological systems, ensuring it meets safety criteria.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" typically applies to machine learning algorithms or AI models. The development of the catheter involved design, material selection, and manufacturing processes, but not a training set in the context of AI.

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

Not applicable, as there was no training set in the context of AI/machine learning. The "ground truth" for the device's design and manufacturing was established through engineering principles, material science, and adherence to regulatory standards.

Summary

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JAN 2 9 2013

3.0 510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).

Applicant/Submitter:

Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403

Tel: 707-525-0111 Fax: 707-566-1245

Contact person: Diana Johnson, Regulatory Affairs Director

Official Contact Person: Maddalena Pinsi, Regulatory Affairs Specialist INVATEC INNOVATIVE TECHNOLOGIES, S.p.A. 7, Via Martiri della Libertà Roncadelle, ITALY 25030.

Tel: 707-591-2656 Fax: 707-566-1245

Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403

Tel: 707-591-2656 Fax: 707-566-1245

Email: maddalena.pinsi@medtronic.com

Diana Johnson, Regulatory Affairs Director

Email: diana.j.johnson@medtronic.com

Alternate Contact:

Date Prepared:

October 26, 2012

Device Information:

Trade Name: Common Name: Regulation Name: Classification: Classification Panel: Regulation Number: Product Code:

Medtronic Vascular Pacific™ Plus K123358, Traditional 510(k)

Pacific™ Plus Percutaneous Transluminal Angioplasty Catheter Percutaneous Catheter Class II Peripheral 21 CFR 870.1250 LIT, DOY

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Predicate Devices

Pacific™ Xtreme PTA Balloon Dilatation Catheter (K103464 SE-12/22/2010) .
Amphirion™ DEEP 0.014" OTW PTA Balloon Catheter (K052791 SE-11/04/2005 and . K083919 SE-03/13/2009)
REEF HP™ 0.035" OTW PTA Balloon Dilatation Catheter (K092361 SE-10/29/2009) .

Reference Device

· Amphirion™ Plus PTA Catheter (K121265 SE-05/22/2012)

Device Description

Indications for Use

The Pacific Plus PTA Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The indications for use for the Pacific Plus are equivalent and covered by the currently cleared predicate devices, Pacific Xtreme PTA Balloon Dilatation Catheter (hereinafter referred to as "Pacific Xtreme"), Amphirion DEEP PTA Balloon catheter (hereinafter referred to as "Amphirion DEEP") and REEF HP PTA Balloon Catheter (hereinafter referred to as "REFF HP").

Technological Characteristics

The Pacific Plus (hereinafter referred to also as "subject device") is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter. The overall design and the fundamental scientific technology (operating principle or mechanism of action) of the Pacific Plus device are

Medtronic Vascular Pacific™ Plus K123358 Traditional 510(k)

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K123358
p. 3 of 5

equivalent to the currently cleared predicate devices, Pacific Xtreme, Amphirion DEEP and REEF HP. Description of the modified device, Pacific Plus, is provided in the table below:

Characteristic	Modified Pacific Plus
Balloon Lengths (mm)	The subject device balloon lengths are within the Amphirion DEEP predicatedevice balloon length range.
Balloon Diameter(mm)	The subject device balloon diameters are within the Amphirion DEEP and REEFHP predicate devices balloon diameter range.
Balloon Material	The subject device with balloon diameter from 2.0mm to 4.0mm uses a balloonmaterial type that is the same as the one used in the REEF HP predicate device.In addition the balloon material is supplied as compliant to USP Class VI.The Pacific Plus balloons with diameter from 5.0mm to 7.0mm use a materialidentical to the guidewire tube component of the Pacific Xtreme predicate device.Biocompatibility evaluation and comparative, design verification and shelf lifetesting have been performed on the subject device in order to support withobjective evidence its safety and effectiveness and the results met the requiredspecifications.
Catheter UseableLength (cm)	The Pacific Plus 90cm and 130cm usable lengths are within the Pacific Xtremepredicate device's range, while the longer catheter useable length of 180cm wasdesigned for the subject device increasing the shaft length by 30cm compared toAmphirion DEEP without changing the fundamental scientific technology. Thislonger catheter useable length was added to the subject catheter usable lengthsize matrix in order to expand the size offerings and it is driven by the need toprovide the physicians with a more comprehensive size mix. There are nochanges to the technical features of the usable length design and the 180cm shaftlength is made of identical materials and manufacturing processes as the othersizes.Proper design verification, shelf life and comparative testing has been performedon the subject device in order to support with objective evidence its safety andeffectiveness and all the results have met the requested specifications.
Catheter ShaftDiameter	The shaft diameter is within the range of the Pacific Xtreme shaft diameters.
Catheter ShaftMaterial	The Pacific Plus catheter shaft material is identical to the material used on theAmphirion DEEP predicate device.
Catheter Coating	The coating has the same base and function as the coating of the AmphirionDEEP and Pacific Xtreme predicate devices; three reagents have been changed inthe formula in comparison to the predicate devices with no new risks.Biological evaluation and comparative, design verification and shelf life testinghave been performed on the subject device in order to support with objectiveevidence its safety and effectiveness and the results met the requiredspecifications.
GuidewireCompatibility	The subject device guidewire compatibility is within the Amphirion DEEP andPacific Xtreme predicate devices guidewire compatibility range.
Guidewire TubeMaterial	The subject device guidewire tube material is the same as the Pacific Xtremepredicate device guidewire tube material.
Characteristic	Modified Pacific Plus
Introducer SheathCompatibility	The subject device introducer sheath compatibility is the same as the Pacific Xtreme predicate device introducer sheath compatibility.
Nominal Pressure(atm)	The nominal pressure (8atm) is within the range of the REEF HP and Pacific Xtreme predicate devices nominal pressure.
Rated Burst Pressure(atm)	The subject device has a Rated Burst Pressure (RBP) of 22,16,14 and 12 atm depending on balloon diameters. These RBPs are within the range of the REEF HP and Pacific Xtreme predicate devices RBP.

Medtronic Vascular .
Pacific™ Plus
K123358 Traditional 510(k)

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Summary of Bench Testing

The Pacific Plus was thoroughly tested on the bench to evaluate and verify that it meets the required performance specifications. The bench testing plan was developed with the consideration of the recommendations outlined in the applicable FDA guidance documents. ISO and ASTM standards. Testing performed on the Pacific Plus device included the following:

. Dimensional verification
. Balloon preparation, deployment and retraction
. Balloon rated burst pressure (RBP)
. Balloon fatigue (repeated balloon inflations)
. Balloon Compliance
Balloon Inflation/Deflation Time •
. Catheter Bond Strength
. Flexibility and Kink test
. Torque Strength
. Radiopacity
. Coating Integrity
. Particulate evaluation
. Guide wire compatibility
. Introducer sheath compatibility
. Coating lubricity

All of the pre-determined acceptance criteria were met and results passed.

Summary of Biocompatibility Testing

The Pacific Plus is an externally communicating device, which contacts circulating blood for the limited contact duration (<24hours).

Biocompatibility testing was conducted on the finished Pacific Plus in accordance with the principles of the ANSI/AAMI/ISO 10993-1:2009 Biological evaluation of medical Men'ces -

Medtronic Vascular Pacific™ Plus K123358 Traditional 510(k)

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Part 1: Evaluation and testing within a risk management process as specified in the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' and in accordance with FDA 21 CFR Part 58: Good Laboratory Practice for Non clinical Laboratory Studies, and FDA guidance: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (Sept 2010).

The biocompatibility testing performed for the Pacific Plus device included the following:

ISO L929 MEM Elution Test .
ISO Kligman Maximization Test .
ISO Intracutaneous Injection Test .
ISO Systemic Injection Test .
ISO Material Mediated Rabbit Pyrogen Test .
ISO Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay (AMES Test) .
ASTM Direct and Indirect Contact Hemolysis Rabbit Blood .
ISO Complement Activation Assay (Indirect Contact) .
ISO In-vivo Dog Thromboresistance .

All of the pre-determined acceptance criteria were met and results passed.

Assessment of non-clinical performance data for equivalence

Bench and biocompatibility testing of the Pacific Plus were performed in accordance with the relevant FDA guidance, ISO and ASTM standards. Results from these non-clinical testing demonstrates that the Pacific Plus met the pre-determined acceptance criteria and performs comparably to the predicate devices. No new type of safety or effectiveness issues were observed during the testing.

Conclusion

Based on the considerations above, Medtronic believes that the Pacific Plus is substantially equivalent to the predicate devices Pacific Xtreme, Amphirion DEEP and REEF HP in terms of indications for use, design, material, fundamental scientific technology (operating principle or mechanism of action) and performance characteristics, therefore it is suitable for the Traditional 510(k) process.

Results from the non-clinical performance testing demonstrate that the Pacific Plus is substantially equivalent to the predicate devices in terms of safety, effectiveness and performance.

Medtronic Vascular Pacific™ Plus K123358 Traditional 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 2 9 2013

Medtronic Vascular c/o Ms. Diana Johnson, Regulatory Affairs Director 3576 Unocal Place Santa Rosa, CA 95403

Re: K123358

Trade/Device Name: Pacific™ Plus PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: October 26, 2012 Received: October 31, 2012

Dear Ms. Johnson:

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

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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.

Matthew G. Hillebrenner

for

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 2.0

Indications for Use

510(k) Number (if known): K123358

Device Name: Pacific™ Plus

Indications For Use:

The Pacific™ Plus PTA catheter is intended to dilate stenoses in the iliac, femoral, The Factor - 1 fac + 1 . Copyliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Prescription Use × (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)

gs. Hillel

(Division Sign-Off) Division of Cardiovascular Devices

142358 510(k) Number

Page 1 of 1

MedIronic vascular Pacific™ Plus
K123358 Traditional 510(k)

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).