The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Device Description

The Pantera LEO PTCA catheter is a sterile, single-use, intravascular balloon catheter for the dilatation of stenotic segments in coronary arteries or bypass grafts. The dilatation balloon is designed to inflate to a known diameter and length at a specific inflation pressure consistent with the compliance chart, which is included in the Instructions for Use (IFU), Compliance Data Card (CDC), and on the labels. The dilatation catheter has a soft tip that is tapered at the distal end of the catheter to facilitate advancement of the catheter. The balloon is folded to achieve a low crossing profile and is connected to the tip. A radiopaque marker is located at each end of the balloon cylindrical section to facilitate fluoroscopic visualization and positioning of the balloon catheter to and across the lesion. The proximal section of the catheter is a single lumen stainless steel hypotube with a single Luer port for the inflation / deflation of the balloon. The Pantera LEO has two coatings; a hydrophobic silicone coating on the outer surface of the hypotube (proximal outer shaft) and balloon, and a hydrophilic polymeric-based coating on the outer surface of the distal outer shaft. The dilatation catheter is compatible with guide wire and guiding catheter sizes according to the recommendations on the label.

AI/ML Overview

Please note that the provided document is a 510(k) Summary for a medical device (Pantera LEO PTCA Catheter) seeking clearance as substantially equivalent to a predicate device. This type of regulatory submission primarily focuses on demonstrating equivalence through non-clinical (bench and biocompatibility) testing, rather than extensive clinical studies that would typically involve humans and advanced AI/algorithm performance.

Therefore, many of the questions related to AI performance, human reader studies, and large-scale clinical ground truth will not be applicable to this document. The focus here is on physical device performance and material safety.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from industry standards/guidance)	Reported Device Performance
Design Verification In-vitro Testing	The device must meet required performance specifications as per Class II Special Controls Guidance for PTCA Catheters (Sept 8, 2010).	Pantera LEO met all specified design and performance requirements. Performance specifically demonstrated equivalence or betterment compared to the predicate device.
Dimensional Verification	(Conformity to design specifications)	Met specifications.
Balloon Preparation, Deployment, and Retraction	(Smooth and intended function)	Met specifications.
Balloon Rated Burst Pressure	(Ability to withstand specified pressure without failure)	Met specifications.
Balloon Fatigue (Repeat Balloon Inflations)	(Durability over multiple inflations)	Met specifications.
Balloon Compliance (Diameter vs. Pressure)	(Balloon inflates to known diameter and length at specific pressure as per compliance chart)	Met specifications; compliance chart provided.
Tip Pull Test	(Adequate tip securement)	Met specifications.
Flexibility and Kink Test	(Resistance to kinking, adequate flexibility)	Met specifications.
Catheter Bond Strength	(Integrity of catheter components)	Met specifications.
Torque Strength	(Ability to transmit torque without failure)	Met specifications.
Radiopacity	(Visibility under fluoroscopy)	Met specifications.
Coating Integrity	(Coating remains intact and functional)	Met specifications.
Particulate Evaluation	(Minimal particulate shedding)	Met specifications.
Shelf Life Testing	Supports a 3-year shelf life.	Supported a 3-year shelf life.
Balloon Inflation and Deflation Time	(Within acceptable limits for clinical use)	Met specifications.
Additional Tests for In-Stent Restenosis/Stent Expansion
Balloon Rated Burst Pressure in Stent	(Ability to withstand specified pressure within a stent)	Met specifications.
Balloon Fatigue / Repeat Balloon Inflation in Stent	(Durability over multiple inflations within a stent)	Met specifications.
Biocompatibility Testing	No evidence of adverse biological effects as per ISO 10993-1 and 2016 FDA Guidance for ISO 10993.	No evidence of adverse biological effects; concluded biologically safe for intended use.

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

Sample Size for Test Set: The document does not specify exact sample sizes for each in-vitro bench test. However, these are generally performed on a sufficient number of device units (e.g., typically 3-10 or more, depending on the test) to statistically demonstrate compliance with engineering specifications.
Data Provenance: All data presented is from non-clinical (in-vitro bench) testing and biocompatibility testing conducted by BIOTRONIK, Inc. This is prospective internal testing, not data from human subjects or clinical trials. The country of origin of the data is implicitly where the testing was performed, which would be associated with the manufacturer (BIOTRONIK, Inc. – Lake Oswego, Oregon, USA, with potentially some testing at manufacturing sites in other countries, though not specified).

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

Not applicable. For this type of device (PTCA catheter), "ground truth" in the context of AI or diagnostic imaging is not relevant. The "ground truth" for the non-clinical tests is established by objective physical measurements against engineering specifications and accepted industry standards (e.g., ISO, ASTM, FDA guidance documents). These tests do not rely on expert consensus or interpretation of clinical images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically in clinical studies or image review. The non-clinical tests described are objective physical evaluations with pass/fail criteria based on measured performance against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance.

Not applicable. This document is for a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance were not conducted as they are irrelevant for this device.

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

Not applicable. This device is a physical medical instrument (PTCA catheter), not an algorithm or AI system. Standalone algorithm performance studies are not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical bench testing, the "ground truth" is defined by engineering specifications, industry standards, and regulatory guidance documents. For biocompatibility, the "ground truth" is adherence to ISO 10993-1 and FDA guidance, ensuring biological safety based on established scientific principles. There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical tests.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed through traditional engineering methods and validated through the referenced non-clinical tests.

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

Summary

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

January 26, 2017

Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs And Compliance 6024 Jean Road Lake Oswego, Oregon 97035

Re: K163660

Trade/Device Name: Pantera LEO Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: December 22, 2016 Received: December 27, 2016

Dear Jon Brumbaugh:

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 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.

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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/ResourcesforYou/Industry/default.htm. 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

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,

Fernando
Fernando Aguel-S
Aguel-S

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

510(k) Number (if known) K163660

Device Name Pantera LEO

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Research Use (Part 21 CFR 201.Subpart B)	☐ Over-The-Counter Use (21 CFR 201.66)
----------------------------------------------------------------------------------	----------------------------------------

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary per 21 CFR 807.92

Date Prepared:	January 25, 2017
Name and Address ofApplicant:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
510(k) Contact Personand Phone Number:	Jon BrumbaughVice President, Regulatory Affairs and CompliancePhone: (888) 345-0374Fax: (503) 635-9936jon.brumbaugh@biotronik.com
Proprietary Name:	Pantera LEO
Common Name:	Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter
Device Classification:	Class II (special controls)
Regulation Number:	870.5100
Classification Name:	Catheter, transluminal coronary angioplasty, percutaneous
Product Code:	LOX
Predicate Device(s):	BIOTRONIK Pantera Pro (K160985, cleared October 7, 2016)
Device Description:	The Pantera LEO PTCA catheter is a sterile, single-use, intravascular ballooncatheter for the dilatation of stenotic segments in coronary arteries or bypassgrafts. The dilatation balloon is designed to inflate to a known diameter andlength at a specific inflation pressure consistent with the compliance chart, whichis included in the Instructions for Use (IFU), Compliance Data Card (CDC), andon the labels.The dilatation catheter has a soft tip that is tapered at the distal end of thecatheter to facilitate advancement of the catheter. The balloon is folded toachieve a low crossing profile and is connected to the tip. A radiopaque markeris located at each end of the balloon cylindrical section to facilitate fluoroscopicvisualization and positioning of the balloon catheter to and across the lesion.The proximal section of the catheter is a single lumen stainless steel hypotubewith a single Luer port for the inflation / deflation of the balloon. ThePantera LEO has two coatings; a hydrophobic silicone coating on the outersurface of the hypotube (proximal outer shaft) and balloon, and a hydrophilicpolymeric-based coating on the outer surface of the distal outer shaft.The dilatation catheter is compatible with guide wire and guiding catheter sizesaccording to the recommendations on the label.

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Pantera LEO Available Sizes(Usable Catheter Length = 145 cm)
	Balloon length [mm]
Balloon Ø [mm]	8	12	15	20	30
2.0	X	X	X	X	X
2.25	X	X	X	X	X
2.5	X	X	X	X	X
2.75	X	X	X	X	X
3.0	X	X	X	X	X
3.25	X	X	X	X	X
3.5	X	X	X	X	X
3.75	X	X	X	X	X
4.0	X	X	X	X	X
4.5	X	X	X	X	X
5.0	X	X	X	X	X
X	Available sizes

Indications For Use: The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Purpose of Submission: BIOTRONIK submits this 510(k) for clearance of Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter. The predicate device is the Pantera Pro PTCA Dilatation Catheter (K160985, cleared October 7, 2016). The modifications described in this submission are limited to the balloon compliance and materials of construction, which are utilized in other BIOTRONIK devices.

Comparison of Pantera LEO has the same intended use as the predicate device. The Technological indications for use are similar, with only minor differences in the wording for post-Characteristics dilatation. The fundamental scientific technology and principles of operation of the Pantera LEO are identical to the predicate device Pantera Pro. There are only minor technological differences between the Pantera LEO and the Pantera Pro. which can be summarized as differences in materials of construction of a few device components. However, these differences in material do not affect the principles of operation or intended use. The safety and effectiveness of Pantera LEO are supported by product testing conducted according to the BIOTRONIK design controls.

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Summary of Non-Clinical Data

Testing according to BIOTRONIK design control and verification/validation processes demonstrates that the Pantera LEO is comparable to the predicate device. Modifications to technological characteristics do not raise new or different questions of safety and effectiveness.

Design Verification in-vitro testing:

The following in-vitro bench tests were completed on the Pantera LEO in accordance with the requirements of Guidance for Industry and FDA Staff -Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010, and verify that it meets the required performance specifications.

●

. Dimensional Verification
Balloon Preparation. Deployment . and Retraction
Balloon Rated Burst Pressure .
. Balloon Fatique (Repeat Balloon Inflations)
. Balloon Compliance (Diameter vs. Pressure)
. Tip Pull Test
Flexibility and Kink Test ●

Catheter Bond Strength

Torque Strength ●
Radiopacity ●
Coating Integrity ●
Particulate Evaluation .
- Shelf Life testing to support a 3-year shelf life
. Balloon Inflation and Deflation Time

Additional Tests for Catheters Intended for In-Stent Restenosis or for Stent Expansion following Stent Deployment:

Balloon Rated Burst Pressure in Stent .
Balloon Fatique / Repeat Balloon Inflation in Stent .

Biocompatibility Testing:

The Pantera LEO PTCA Catheter is intended for short-term use in direct contact with circulating blood. Therefore, it is classified in accordance with ISO 10993-1 "Biological evaluation of medical devices" as an external communicating device with limited (≤ 24 h) contact duration with circulating blood. Biocompatibility testing was conducted to demonstrate that the requirements of ISO 10993-1 and the 2016 FDA Guidance for ISO 10993 (#1811) have been met for the Pantera LEO PTCA balloon catheter. There was no evidence of adverse biological effects, indicating that there is no biological risk caused by the materials/device or possible leachable substances. Therefore, it can be concluded that the Pantera LEO balloon catheters are biologically safe for their intended use.

The Pantera LEO met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing. The bench validation testing and biocompatibility testing demonstrated that the Pantera LEO is substantially equivalent in terms of safety and effectiveness to the predicate device.

Summary of Clinical The determination of substantial equivalency on this subject device does not rely Data: upon the clinical data. There is no clinical data submitted in this application.

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Conclusion:

The intended use of the subject device, Pantera LEO, as described in the labeling, is identical to that of the predicate device, Pantera Pro (K160985). In addition, the indications for use are similar, with only minor differences in the wording for post-dilatation, and the fundamental scientific technology has not changed. BIOTRONIK believes that the minor differences proposed in this submission do not raise new or different questions regarding safety and effectiveness and that substantial equivalence for safety and effectiveness can be determined using existing design controls. Summaries of performance testing, showing Pantera LEO performs equivalently or better than the predicate, have been provided in this Special 510(k). The biocompatibility testing shows the materials of construction are biologically safe for the intended use. Therefore, Pantera LEO should be considered substantially equivalent to the predicate device, Pantera Pro.

Regulation Number and Section

§ 870.5100 Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter.

(a)
Standard PTCA Catheter —(1)Identification. A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. A PTCA balloon catheter has a single or double lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of radiographic marker to facilitate fluoroscopic visualization of the balloon during use. A PTCA catheter is intended for balloon dilatation of a hemodynamically significant coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. A PTCA catheter may also be intended for the treatment of acute myocardial infarction; treatment of in-stent restenosis (ISR) and/or post-deployment stent expansion.(2)
Classification. Class II (special controls). The special control for this device is “Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters.” See § 870.1(e) for the availability of this guidance document.(b)
Cutting/scoring PTCA Catheter —(1)Identification. A cutting/scoring PTCA catheter is a balloon-tipped catheter with cutting/scoring elements attached, which is used in those circumstances where a high pressure balloon resistant lesion is encountered. A cutting/scoring PTCA catheter is intended for the treatment of hemodynamically significant coronary artery stenosis for the purpose of improving myocardial perfusion. A cutting/scoring PTCA catheter may also be indicated for use in complex type C lesions or for the treatment of in-stent restenosis.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 870.3.