The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

Device Description

BIOTRONIK's Pantera Pro 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. Pantera Pro has balloon diameters ranging from ∅ 1.25 mm – 4.0 mm and balloon lengths ranging from ∅ 6 mm – 30 mm. All product sizes of Pantera Pro have a usable catheter length of 140 cm. The Pantera Pro has a soft tapered tip 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. The Pantera Pro has two coatings; a hydrophobic coating on the outer surface of the hypotube and a hydrophilic polymeric based coating on the outer surface of the distal outer shaft. In addition, a hydrophobic coating is applied on the balloons of sizes ∅ 2.5 – 4.0 mm whereas a hydrophilic coating is applied on the balloons of sizes ∅ 1.25 – 2.0 mm. The coating is activated by immersing the catheter in sterile saline prior to use. The Pantera Pro is compatible with guide wires of 0.014" (0.36 mm) diameter and guiding catheters with an inner diameter of ≥0.056" (1.42 mm; 5F). For all Pantera Pro product sizes, the nominal pressure (NP) required to achieve the nominal diameter is 7 atm and the rated burst pressure (RBP) is 14 atm.

AI/ML Overview

The provided text describes a medical device, the Pantera Pro Coronary Dilatation Catheter, and its acceptance for market. However, it does not detail a study involving AI or human readers, so I will answer based on the information available regarding the device's performance through non-clinical testing.

The acceptance criteria for the Pantera Pro Coronary Dilatation Catheter are based on various in-vitro bench tests and biocompatibility testing, ensuring it meets performance specifications and is biologically safe for its intended use. The study proving the device meets these criteria is a non-clinical design verification in-vitro testing and biocompatibility assessment.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria (Implied/Derived from context)	Reported Device Performance (Summary from text)
Design Verification	Dimensional Verification (including visual inspection)	Meets design specifications	Completed with satisfactory results.
	Balloon Preparation, Deployment and Retraction	Functionality within specification	Completed with satisfactory results.
	Balloon Rated Burst Pressure	≥ 14 atm	Nominal pressure (NP) is 7 atm, Rated Burst Pressure (RBP) is 14 atm, consistent across sizes. Testing confirmed performance.
	Balloon Fatigue	Withstands repeated inflation cycles	Completed with satisfactory results.
	Balloon Compliance	Meets specified diameter at pressure	Completed with satisfactory results.
	Balloon Inflation and Deflation Time	Within clinically acceptable times	Completed with satisfactory results.
	Catheter Bond Strength	Sufficient to maintain integrity	Completed with satisfactory results.
	Tip Pull Test	Sufficient to prevent detachment	Completed with satisfactory results.
	Flexibility and Kink Test	Maintains patency and navigability	Completed with satisfactory results.
	Torque Strength	Sufficient for precise navigation	Completed with satisfactory results.
	Radiopacity	Sufficient for visualization during procedure	Completed with satisfactory results.
	Coating Integrity	Coatings remain intact and functional	Completed with satisfactory results.
	Particulate Evaluation	Meets cleanliness requirements	Completed with satisfactory results.
	Shelf Life testing	Supports claimed shelf life	Provided to support a 3-year shelf life.
	For Stent Expansion - Balloon Rated Burst Pressure in Stent	≥ 14 atm (same as stand-alone but within stent)	Completed with satisfactory results.
	For Stent Expansion - Balloon Fatigue / Repeat Balloon Inflation in Stent	Withstands repeated inflation cycles within stent	Completed with satisfactory results.
Biocompatibility	Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Hemolysis, Complement activation, In Vivo Thrombogenicity, Hemocompatibility - Chandler Test, Bacterial Reverse Mutation Assay - AMES test, Mouse Lymphoma Assay, Mammalian Micronucleus Test	Meets ISO 10993-1:2009 standards and
FDA recommendations for limited exposure	All tests completed and the device "met all specified design and performance requirements. No new safety or effectiveness issues were raised during the testing." Biologically safe for intended use.
Sterilization	Sterility Assurance Level (SAL)	1 x 10-6	Sterilized with EO gas to achieve a SAL of 1 x 10-6.
	Endotoxin Limit	< 20 EU / device	Meets the endotoxin limit of 20 EU / device.

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

The document does not specify a distinct "test set" in terms of patient data or clinical samples for the non-clinical studies. Instead, the tests were performed on device samples (Pantera Pro Coronary Dilatation Catheter units). The sample size for each specific bench test (e.g., number of balloons tested for burst pressure, number of catheters for bond strength) is not explicitly stated in this summary but would be detailed in the full design verification report.

Data Provenance: The data provenance for these non-clinical tests is from in-vitro bench testing conducted by the manufacturer (BIOTRONIK, Inc.). There is no mention of country of origin for the data beyond the manufacturer's location in Lake Oswego, Oregon, USA. These are retrospective data in the sense that they are derived from controlled laboratory experiments and quality assessments during the device's development and validation, rather than prospective clinical trials.

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

This question is not applicable to the provided document. The "ground truth" for non-clinical performance and biocompatibility testing is established by engineering specifications, regulatory standards (e.g., FDA guidance documents, ISO standards), and pre-defined pass/fail criteria for each test. These are objective measurements and do not rely on expert consensus or interpretation of complex medical images or patient outcomes. The performance is compared against these objective, quantitative targets.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or subjective assessments to resolve discrepancies, often in imaging studies. Since the studies described are non-clinical, objective bench tests and biocompatibility assays, no adjudication method was employed. The results are quantitative and directly measured against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical investigation has been performed for this device." Therefore, there is no information on the effect size of how much human readers improve with AI vs. without AI assistance, as AI is not a component of this device, and no human-reader studies were conducted.

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

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (a catheter), not an artificial intelligence algorithm or software. Therefore, the concept of algorithm-only performance is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical studies relies on:

Engineering Specifications: Defined parameters for device dimensions, material properties, mechanical performance (e.g., burst pressure, flexibility, bond strength).
Regulatory Standards: Compliance with industry standards (e.g., ISO 10993 for biocompatibility) and FDA guidance documents setting performance expectations.
Established Test Methodologies: Standardized methods to objectively measure performance against the above specifications and standards.

8. The Sample Size for the Training Set

This question is not applicable. The device described, the Pantera Pro Coronary Dilatation Catheter, is a physical medical device; it is not an AI/ML algorithm that requires a "training set" of data. Its design and performance are validated through engineering and biocompatibility testing as opposed to machine learning techniques.

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

This question is not applicable, as there is no "training set" for this physical medical device.

Summary

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

October 7, 2016

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

Re: K160985

Trade/Device Name: Pantera Pro Coronary Dilatation Catheter Regulation Number: 21 CFR 870.5100 Regulation Name: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter Regulatory Class: Class II Product Code: LOX Dated: September 1, 2016 Received: September 6, 2016

Dear Mr. 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 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.

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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 yours,

Brian D. Pullin -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) K160985

Device Name

Pantera Pro Coronary Dilatation 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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510(k) Summary per 21 CFR 807.92

Date Prepared:	March 9, 2016
Applicant:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
Contact Person:	Jon BrumbaughVice President, Regulatory Affairs and CompliancePhone: (888) 345-0374Fax: (503) 635-9936jon.brumbaugh@biotronik.com
Proprietary Name:	Pantera Pro Coronary Dilatation Catheter
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
Device Description:	BIOTRONIK's Pantera Pro is a sterile, single-use, intravascular balloon catheter for thedilatation of stenotic segments in coronary arteries or bypass grafts. The dilatationballoon is designed to inflate to a known diameter and length at a specific inflationpressure. Pantera Pro has balloon diameters ranging from ∅ 1.25 mm – 4.0 mm andballoon lengths ranging from ∅ 6 mm – 30 mm. All product sizes of Pantera Pro have ausable catheter length of 140 cm. The Pantera Pro has a soft tapered tip at the distal endof the catheter to facilitate advancement of the catheter. The balloon is folded to achievea low crossing profile and is connected to the tip. The Pantera Pro has two coatings; ahydrophobic coating on the outer surface of the hypotube and a hydrophilic polymericbased coating on the outer surface of the distal outer shaft. In addition, a hydrophobiccoating is applied on the balloons of sizes ∅ 2.5 – 4.0 mm whereas a hydrophiliccoating is applied on the balloons of sizes ∅ 1.25 mm – 2.0 mm. The coating isactivated by immersing the catheter in sterile saline prior to use.The Pantera Pro is compatible with guide wires of 0.014" (0.36 mm) diameter andguiding catheters with an inner diameter of ≥0.056" (1.42 mm; 5F). For all Pantera Proproduct sizes, the nominal pressure (NP) required to achieve the nominal diameter is7 atm and the rated burst pressure (RBP) is 14 atm.
Indications For Use:	The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronaryartery or bypass graft stenosis for the purpose of improving myocardial perfusion. ThePantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-deliveryexpansion of balloon expandable stents.
Predicate Device(s):	Medtronic Sprinter Legend (P790017 /S096 & K103095)

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Comparison ofTechnologicalCharacteristics	Pantera Pro has the same intended use as the predicate devices. The materials, design, and performance characteristics are similar. Balloon lengths and diameters are within the same range as the Medtronic Sprinter Legend. Pantera Pro has a consistent nominal pressure (7 atm) and rated burst pressure (14 atm) across the entire size range whereas the predicates vary. As described in the device description, Pantera Pro has hydrophilic or hydrophobic balloon coating depending on balloon diameter. Sprinter Legend balloons have hydrophilic coating and Maverick² have hydrophobic. All devices are sterilized by EO gas sterilization.
Summary of Non-Clinical Data	Design Verification in-vitro testing:The following in-vitro bench tests were completed on the Pantera Pro 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 (including visual inspection) Balloon Preparation, Deployment and Retraction Balloon Rated Burst Pressure Balloon Fatigue Balloon Compliance Balloon Inflation and Deflation Time Catheter Bond Strength Tip Pull Test Flexibility and Kink Test Torque Strength Radiopacity Coating Integrity Particulate Evaluation Shelf Life testing was provided to support a 3 year shelf life. Additional Tests for Catheters Intended for Post-Delivery Expansion of Balloon Expandable Stents: Balloon Rated Burst Pressure in Stent Balloon Fatigue / Repeat Balloon Inflation in Stent

Comparison ofTechnologicalCharacteristics

Pantera Pro has the same intended use as the predicate devices. The materials, design, and performance characteristics are similar. Balloon lengths and diameters are within the same range as the Medtronic Sprinter Legend. Pantera Pro has a consistent nominal pressure (7 atm) and rated burst pressure (14 atm) across the entire size range whereas the predicates vary. As described in the device description, Pantera Pro has hydrophilic or hydrophobic balloon coating depending on balloon diameter. Sprinter Legend balloons have hydrophilic coating and Maverick² have hydrophobic. All devices are sterilized by EO gas sterilization.

Summary of Non-Clinical Data

Design Verification in-vitro testing:The following in-vitro bench tests were completed on the Pantera Pro 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 (including visual inspection) Balloon Preparation, Deployment and Retraction Balloon Rated Burst Pressure Balloon Fatigue Balloon Compliance Balloon Inflation and Deflation Time Catheter Bond Strength Tip Pull Test Flexibility and Kink Test Torque Strength Radiopacity Coating Integrity Particulate Evaluation Shelf Life testing was provided to support a 3 year shelf life. Additional Tests for Catheters Intended for Post-Delivery Expansion of Balloon Expandable Stents: Balloon Rated Burst Pressure in Stent Balloon Fatigue / Repeat Balloon Inflation in Stent

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Biocompatibility Testing:

Biocompatibility testing for the Pantera Pro has been completed in accordance with the recommendations 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 International Standard ISO10993- 1:2009, Biological Evaluation of Medical devices- Part 1: Evaluation and Testing for an external communicating device with limited exposure (i.e. whose contact with circulating blood is ≤ 24 hours). The following tests were conducted:

Cytotoxicity ●
Sensitization
Irritation/Intracutaneous Reactivity ●
Acute Systemic Toxicity ●
Pyrogenicity
Hemolysis ●
. Complement activation
In Vivo Thrombogenicity
Hemocompatibility - Chandler Test
Bacterial Reverse Mutation Assay - AMES test
Mouse Lymphoma Assay
. Mammalian Micronucleus Test

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

Summary of ClinicalData:	No clinical investigation has been performed for this device.
Sterilization:	The Pantera Pro catheter is provided sterile to the user. Pantera Pro is sterilized with EOgas to achieve a sterility assurance level (SAL) of 1 x 10-6. The device meets theendotoxin limit of 20 EU / device.
Conclusion:	The intended use of the subject Pantera Pro, as described in the labeling, is the same asthe predicate devices Sprinter Legend RX (P790017 / S096 & K103095) and Maverick2(P860019 / S179). In addition, the indications for use are similar and the fundamentaltechnology has not changed. Minor differences have been evaluated throughperformance testing that shows the Pantera Pro meets performance specifications. Thebiocompatibility testing shows the materials of construction are biologically safe for theintended use. Therefore, Pantera Pro is considered substantially equivalent to thepredicate device

Summary of ClinicalData:

No clinical investigation has been performed for this device.

Sterilization:

The Pantera Pro catheter is provided sterile to the user. Pantera Pro is sterilized with EOgas to achieve a sterility assurance level (SAL) of 1 x 10-6. The device meets theendotoxin limit of 20 EU / device.

Conclusion:

The intended use of the subject Pantera Pro, as described in the labeling, is the same asthe predicate devices Sprinter Legend RX (P790017 / S096 & K103095) and Maverick2(P860019 / S179). In addition, the indications for use are similar and the fundamentaltechnology has not changed. Minor differences have been evaluated throughperformance testing that shows the Pantera Pro meets performance specifications. Thebiocompatibility testing shows the materials of construction are biologically safe for theintended use. Therefore, Pantera Pro is considered substantially equivalent to thepredicate device

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.