The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

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.

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 Passeo 35 Xeo Catheter is an over-the-wire (OTW) balloon dilatation catheter, indicated for dilatation of stenotic segments in peripheral vessels. The Passeo 35 Xeo Catheter is a dual lumen design with both lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen. The larger lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo 35 Xeo Catheter towards and through the lesion(s) to be dilated.

The Passeo-18 peripheral dilatation catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon.

The Passeo-14 peripheral dilatation catheter is intended for the dilatation of stenotic segments in lower limb arteries. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. One radiopaque marker is located at each end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen.

The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm. The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers. The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires. The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.

Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

AI/ML Overview

The provided FDA 510(k) clearance letter (K250706) is for BIOTRONIK's peripheral and coronary dilatation catheters. This document describes several devices: Passeo-35 Xeo, Passeo-18, Passeo-14, Oscar Peripheral Multifunctional Catheter System, Pantera LEO PTCA Catheter, and Pantera Pro PTCA Catheter.

It's important to note that this 510(k) Summary does not describe an AI/ML powered device. Instead, it focuses on the physical and performance characteristics of medical devices (catheters). Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," and details about training data, are not applicable to this type of submission.

The "performance testing" mentioned throughout the document refers to bench testing and engineering assessments to ensure the physical device meets its design specifications and performs safely and effectively. It does not involve AI model performance evaluation with clinical data.

Here's an attempt to answer the applicable parts of your request based on the provided text, with clear indications where the information is not present or not relevant to an AI/ML device:

Acceptance Criteria and Study to Prove Device Meets Criteria

The acceptance criteria for these devices are implicitly derived from the design specifications and are demonstrated through performance (bench) testing. The study proving these devices meet the acceptance criteria is a series of performance (bench) tests.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes technological characteristics and states that "All necessary performance testing was conducted... to ensure that the devices conform to the design specification." The "Subject Devices" column in the tables explicitly states "Identical" for most characteristics, meaning they meet the same specifications as the predicate devices. The only explicit change mentioned is that "Components will be brought into compliance with ISO 80369-7:2021" for Luer connectors and manifolds. The full set of specific performance acceptance criteria values (e.g., specific burst pressure thresholds, flexibility requirements, etc.) are not explicitly detailed in this summary but are indirectly stated as being met for "consistent performance during its intended use."

Here's a summary derived from the comparison tables, focusing on the acceptance of "identical" characteristics:

Acceptance Criteria Category	Specific Criteria (from Predicate Device)	Reported Device Performance (Subject Device)
Intended User	Physicians competent in PTA procedures	Identical
Method of Placement	Standard percutaneous access to site over a guide wire, with fluoroscopic visualization	Identical
Sterilization	EO gas, SAL 10⁻⁶	Identical
Shelf Life	3 years	Identical
Radiopaque Markers	Presence, material, number, length, and spacing as specified for each device type	Identical
Usable Length	Specified lengths (e.g., 90, 130, 170 cm for Passeo-35 Xeo)	Identical
Introducer Sheath Compatibility	Specified F sizes and balloon diameter/length compatibility	Identical
Crossing Profile	Maximum inches/mm as specified	Identical
Guide Wire Compatibility	Specified guide wire diameter (e.g., 0.035" for Passeo-35 Xeo)	Identical
Shaft Outer Diameter	Specified F size	Identical
Balloon Diameter	Specified range of diameters (e.g., 3.0-12.0 mm for Passeo-35 Xeo)	Identical
Balloon Length	Specified range of lengths (e.g., 20-250 mm for Passeo-35 Xeo)	Identical
Balloon Wrapping	Specified folds (e.g., 3-5 folds for Passeo-35 Xeo)	Identical
Balloon Nominal Pressure	Specified atm	Identical
Balloon RBP (Rated Burst Pressure)	Specified atm, often varying by balloon diameter/length	Identical
Guiding Catheter Compatibility (PTCA catheters)	Minimum F size/ID	Identical
Distal Outer Shaft/Balloon Coating (PTCA catheters)	Hydrophilic/Hydrophobic coating as specified	Identical
Luer Connectors and Manifolds	Previously Luer lock connectors (L2)	Will be brought into compliance with ISO 80369-7:2021 (This is the only explicitly noted difference/update)

Overall Performance Conclusion: "The collective results of the performed testing demonstrated that the materials chosen, the manufacturing processes, and design of the components meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not introduce new issues of safety or effectiveness when compared to the predicate device."

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

The document specifies "performance testing" or "bench testing," which refers to laboratory-based evaluations of the physical device. It does not mention a test set with patient data or any sample size related to clinical data. The provenance is not applicable as this concerns physical device characteristics, not data.

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

This information is not applicable as the evaluation is not based on expert-labeled ground truth for an AI/ML algorithm but on physical measurements and engineering tests of the device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the evaluation is not based on expert consensus or adjudication of clinical cases for an AI/ML algorithm.

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

This information is not applicable as the device is a physical medical instrument (catheter), not an AI/ML diagnostic or assistive tool.

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

This information is not applicable as the device is a physical medical instrument (catheter), not an AI/ML algorithm.

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

The "ground truth" for these devices is the established engineering specifications, material properties, and performance benchmarks that the predicate devices have successfully met. These are verified through various physical and mechanical bench tests (e.g., burst pressure, flexibility, lubricity, dimensional accuracy, etc.). The document indicates these tests confirm the new devices' conformity to these specifications.

8. The sample size for the training set

This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training.

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

This information is not applicable as the device is a physical medical instrument (catheter) and does not involve AI/ML training or a training set with ground truth.

Summary

FDA 510(k) Clearance Letter - K250706

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 4, 2025

BIOTRONIK, Inc.
Jon Brumbaugh
Vice President, Regulatory Affairs and New Product Development
6024 Jean Road
Lake Oswego, Oregon 97035

Re: K250706

Trade/Device Name: Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Regulation Number: 21 CFR 870.1250, 21 CFR 870.5100

Regulation Name: Percutaneous Catheter, Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Regulatory Class: Class II

Product Code: LIT, LOX

Dated: March 7, 2025

Received: March 10, 2025

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 (the 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 available 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

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K250706 - Jon Brumbaugh Page 2

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

Page 3

K250706 - Jon Brumbaugh Page 3

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-devices/device-advice-comprehensive-regulatory-assistance/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,

ARIEL G. ASH-SHAKOOR -S
Digitally signed by ARIEL G. ASH-SHAKOOR -S
Date: 2025.04.03 15:13:43 -04'00'

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

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K250706

Device Name
Passeo-35 Xeo Peripheral 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K250706

Device Name
Passeo-18 peripheral dilatation catheters

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 6

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K250706

Device Name
Passeo-14 Peripheral Dilatation Catheter

Indications for Use (Describe)

Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 7

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K250706

Device Name
Oscar Peripheral Multifunctional Catheter System

Indications for Use (Describe)

The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 8

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K250706

Device Name
Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 9

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K250706

Device Name
Pantera Pro Percutaneous Transluminal Coronary Angioplasty 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 10

Passeo®-35 Xeo Peripheral Dilatation Catheter (K250706)

510(K) Summary

Date Prepared: April 2, 2025

Contact: Jon Brumbaugh
Vice President, Regulatory Affairs & New Product Development
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035 USA
Phone (888) 345-0374
Email: jon.brumbaugh@biotronik.com

Trade Names: Passeo-35 Xeo Peripheral Dilatation Catheter

Regulation Description: Percutaneous catheter

Device Type: Catheter, angioplasty, peripheral, transluminal

Product Code: LIT

Regulation Number: 870.1250

Predicate Device: Passeo-35 Xeo (K222065)

Device Description

Indications for Use

Passeo-35 Xeo is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.

Comparison of Technological Characteristics with the Predicate Devices

The modified devices are substantially equivalent to the predicate devices and have comparable safety and technological features as mentioned below.

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the performance testing.

Page 11

Passeo-35 Xeo Peripheral Dilatation Catheter K250706

Comparison of Technological Characteristics with Predicate Devices

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-35 Xeo Predicate Device (K222065)	Subject Devices
Proprietary name	Passeo-35 Xeo	Identical
Common name	PTA catheter	Identical
Classification	Class II (21 CFR 870.1250)	Identical
Classification name	Catheter, angioplasty, peripheral, transluminal	Identical
Product code	LIT	Identical
Indications for Use	The Passeo-35 Xeo peripheral dilatation catheter is indicated to dilate stenosis in the iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Passeo-35 is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.	Identical
Contraindications	Passeo-35 Xeo is contraindicated for use in patients with: •A lesion that cannot be reached or treated with the dilatation catheter. • Large amounts of acute or sub-acute thrombus at the target lesion. •Perforated vessels. •A lesion that lies within or adjacent to an aneurysm. •Uncorrected bleeding disorders. •A renal insufficiency or an allergy to contrast media. Furthermore, all general PTA and procedure-related contraindications as described in the national and international guidelines of the respective medical associations apply.	Identical

Page 2 of 5

Page 12

Passeo-35 Xeo Peripheral Dilatation Catheter K250706

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-35 Xeo Predicate Device (K222065)	Subject Devices
Intended user	Physicians competent in PTA procedures	Identical
Method of placement	Standard percutaneous access to site over a guide wire, with fluoroscopic visualization	Identical
Sterilization / Shelf Life / Packaging	3 years	Identical
Sterilization	EO gas	Identical
Sterilization System	SteriMed EO Sterilizer or Sterichem EO Sterilizer	Identical
SAL	10⁻⁶	Identical
Shelf life	3 years	Identical
Device description	Over the wire 2-lumen balloon catheter	Identical
Radiopaque markers	2 markers– one at each end of the balloon Material: 90% Pt / 10% Ir	Identical
Usable length [cm]	90, 130, and 170	Identical
Introducer sheath compatibility	5F (Balloon Ø: 3 – 7 mm) 6F (Balloon Ø: 8 – 10 mm) 7F (Balloon Ø: 12 mm) * *Size only available for Xeo with Catheter length 90, and 130 cm	Identical
Crossing profile	Ø: 3–7mm: max. 0.074 inches Ø: 8–10mm: max. 0.083 inches	Identical
Guide wire compatibility	0.035"	Identical
Shaft outer diameter [F]	5	Identical

Page 3 of 5

Page 13

Passeo-35 Xeo Peripheral Dilatation Catheter K250706

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-35 Xeo Predicate Device (K222065)	Subject Devices
Balloon diameter [mm]	3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 and 12.0	Identical
Balloon length [mm]	20, 40, 60, 80, 100, 120, 150, 170, 200 and 250	Identical
Balloon wrapping	3-5 folds	Identical
Balloon Nominal pressure [atm]	7	Identical
Balloon RBP [atm]	21 (Balloon Ø: 3mm) 18 (Balloon Ø: 4mm) 16 (Balloon Ø: 5 – 6 mm) 14 (Balloon Ø: 7 – 8 mm) 12 (Balloon Ø: 9mm) 11 (Balloon Ø: 10 mm) 10 (Balloon Ø: 12 mm)	Identical
Luer connectors and manifolds	Manifold (sub-component 1) with 1x female Luer lock connector with lugs (L2) – variant A Manifold (sub-component 2) with 1x female Luer lock connector with lugs (L2) – variant A	Components will be brought into compliance with ISO 80369-7:2021

Page 4 of 5

Page 14

Passeo-35 Xeo Peripheral Dilatation Catheter K250706

Performance Data

All necessary performance testing was conducted on the Passeo-35 Xeo Catheters to ensure that the devices conform to the design specification and to support a determination of substantial equivalence to the predicate devices.

The collective results of the performed testing demonstrated that the materials chosen, the manufacturing processes, and design of the components meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not introduce new issues of safety or effectiveness when compared to the predicate device.

Conclusions

Based on the performance testing and the technological characteristics, it can be concluded that the Passeo-35 Xeo catheters meet their established performance for their intended use and are substantially equivalent to the predicate devices.

Page 5 of 5

Page 15

Passeo-18 Peripheral Dilatation Catheters (K250706)

510(K) Summary

Date Prepared: April 2, 2025

Trade Names: Passeo-18 peripheral dilatation catheters

Regulation Description: Percutaneous catheter

Device Type: Catheter, angioplasty, peripheral, transluminal

Product Code: LIT

Regulation Number: 870.1250

Predicate Device: Passeo-18 (K151744)

Device Description

The dilatation catheter includes a soft tapered tip to facilitate advancement of the catheter. The dilatation catheter has two Luer-ports at the proximal end. One port (inflation port) serves for connecting an inflation device to inflate/deflate the balloon. The other port enables flushing of the guide wire lumen. The dilatation catheter has a hydrophobic silicone coating on the shaft outer surface and a hydrophobic patchwork coating on the balloon.

Indications for Use

Comparison of Technological Characteristics with the Predicate Devices

The modified devices are substantially equivalent to the predicate devices and have comparable safety and technological features as mentioned below.

Page 16

Passeo-18 Peripheral Dilatation Catheters K250706

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the performance testing.

Page 2 of 6

Page 17

Passeo-18 Peripheral Dilatation Catheters K250706

Comparison of Technological Characteristics with Predicate Devices

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-18 Predicate Device (K151744)	Subject Devices
Proprietary name	Passeo-18	Identical
Common name	PTA catheter	Identical
Classification	Class II (21 CFR 870.1250)	Identical
Classification name	Catheter, angioplasty, peripheral, transluminal	Identical
Product code	LIT	Identical
Indications for Use	The Passeo-18 peripheral dilatation catheter is indicated to dilate stenosis in the femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.	Identical
Contraindications	Contraindications for this device and peripheral dilation catheters in general are: Inability to cross the target lesion with a guide wire Bleeding diathesis	Identical

Page 3 of 6

Page 18

Passeo-18 Peripheral Dilatation Catheters K250706

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-18 Predicate Device (K151744)	Subject Devices
Intended user	Physicians competent in PTA procedures	Identical
Method of placement	Standard percutaneous access to site over a guide wire, with fluoroscopic visualization	Identical
Sterilization / Shelf Life / Packaging	3 years	Identical
Sterilization	EO gas	Identical
Sterilization System	Sauter EO Sterilizer or Sterichem EO Sterilizer	Identical
SAL	10⁻⁶	Identical
Shelf life	3 years	Identical
Device description	Over the wire balloon catheter	Identical
Radiopaque markers	2 markers – one at each end of the balloon Material: 90% Pt / 10% Ir Length: 1.5 mm	Identical
Usable length [cm]	90, 130, 150 (for balloon diameter 2.0 mm only)	Identical
Introducer sheath compatibility	4F: Balloon Ø: 2.0–5.0 mm; nominal length: all balloon lengths; Ø: 6 mm, nominal length: 20 to 80 mm; Ø: 7 mm, nominal length: 20 to 60 mm 5F: Balloon Ø: 6 mm, nominal length: 120 to 220 mm Balloon Ø: 7 mm, nominal length: 80 to 220 mm	Identical

Page 4 of 6

Page 19

Passeo-18 Peripheral Dilatation Catheters K250706

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-18 Predicate Device (K151744)	Subject Devices
Crossing profile	Ø: 2.0–5.0 mm: max. 0.057 inches Ø: 6.0 mm: max. 0.061 inches Ø: 7.0 mm: max. 0.071 inches	Identical
Guide wire compatibility	0.018"	Identical
Shaft outer diameter [F]	4 and 5	Identical
Balloon diameter [mm]	2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0	Identical
Balloon length [mm]	20, 40, 60, 80, 120, 150, 170, 200, 220	Identical
Balloon wrapping	5 folds	Identical
Balloon Nominal pressure [atm]	6	Identical
Balloon RBP [atm]	12 (Balloon Ø: 7-6 mm, 5x150 mm) 13 (Ø4-5 x 170-220 mm) 14 (Ø2-3.5 x 200-220 mm) 15 (Ø 2-3.4 x 20-170 mm, Ø 4 x 20-150 mm, Ø 5 x 20-120 mm)	Identical
Luer connectors and manifolds	Manifold with 2x female Luer lock connectors (L2)	Components will be brought into compliance with ISO 80369-7:2021

Page 5 of 6

Page 20

Passeo-18 Peripheral Dilatation Catheters K250706

Performance Data

All necessary performance testing was conducted on the Passeo-18 Catheters to ensure that the devices conform to the design specification and to support a determination of substantial equivalence to the predicate devices.

Conclusions

Based on the performance testing and the technological characteristics, it can be concluded that the Passeo-18 catheters meet their established performance for their intended use and are substantially equivalent to the predicate devices.

Page 6 of 6

Page 21

Passeo-14 Peripheral Dilatation Catheter (K250706)

510(K) Summary

Date Prepared: April 2, 2025

Trade Names: Passeo-14 Peripheral Dilatation Catheter

Regulation Description: Percutaneous catheter

Device Type: Catheter, angioplasty, peripheral, transluminal

Product Code: LIT

Regulation Numbers: 870.1250

Predicate Device: Passeo-14 (K152240)

Device Description

Indications for Use

Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.

Comparison of Technological Characteristics with the Predicate Devices

The modified devices are substantially equivalent to the predicate devices and have comparable safety and technological features as mentioned below.

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the performance testing.

Page 22

Passeo-14 Peripheral Dilatation Catheter K250706

Comparison of Technological Characteristics with Predicate Devices

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-14 Predicate Device (K152240)	Subject Devices
Proprietary name	Passeo-14	Identical
Common name	PTA catheter	Identical
Classification	Class II (21 CFR 870.1250)	Identical
Classification name	Catheter, angioplasty, peripheral, transluminal	Identical
Product code	LIT	Identical
Indications for Use	The Passeo-14 is indicated for balloon dilatation of the stenotic portion of a lower limb artery for the purpose of improving perfusion.	Identical
Contraindications	All general contraindications for percutaneous transluminal angioplasty (PTA) are contraindications for this device. Contraindications for this device and peripheral dilatation catheters in general are: • Lesions that cannot be reached or treated with the system • Large amounts of acute or subacute thrombus at the target lesion • Perforated vessels • Lesion that lies within or adjacent to an aneurysm • Uncorrected bleeding disorders • Renal insufficiency or an allergy to contrast media Furthermore, all procedure-related contraindications as described in the national and international guidelines of the respective medical associations apply.	Identical

Page 2 of 5

Page 23

Passeo-14 Peripheral Dilatation Catheter K250706

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-14 Predicate Device (K152240)	Subject Devices
Intended user	Physicians competent in PTA procedures	Identical
Method of placement	Standard percutaneous access to site over a guide wire, with fluoroscopic visualization	Identical
Sterilization / Shelf Life / Packaging	3 years	Identical
Sterilization	EO	Identical
Sterilization System	Sauter EO Sterilizer or Sterichem EO Sterilizer	Identical
SAL	10⁻⁶	Identical
Shelf life	3 years	Identical
Device description	Over the wire 2-lumen balloon catheter	Identical
Radiopaque markers	2 markers – one at each end of the balloon Material: 90% Pt / 10% Ir Length: 1.0 mm	Identical
Usable length [cm]	90, 120, 150	Identical
Introducer sheath compatibility	4F for all balloon diameters	Identical
Crossing profile	Ø: 1.5mm: max. 1.12mm (0.044 in) Ø: 2.0mm: max. 1.14mm ().045 in) Ø: 2.5mm: max. 1.19mm (0.047 in) Ø: 3.0mm: max. 1.24mm (0.049 in) Ø: 3.5 4 mm: max 1.32mm (0.052 in)	Identical
Guide wire compatibility	0.014"	Identical

Page 3 of 5

Page 24

Passeo-14 Peripheral Dilatation Catheter K250706

Table 1: Comparison of Passeo Subject Devices to Predicate Devices

Characteristic	Passeo-14 Predicate Device (K152240)	Subject Devices
Shaft outer diameter [F]	Max. 3.9 (proximal) Max. 3.1 F (distal)	Identical
Balloon diameter [mm]	1.5, 2.0, 2.5, 3.0, 3.5, 4.0	Identical
Balloon length [mm]	20, 40, 70, 100, 140, 180, 220	Identical
Balloon wrapping	3 folds	Identical
Balloon Nominal pressure [atm]	7	Identical
Balloon RBP [atm]	14 for all diameters	Identical
Luer connectors and manifolds	Manifold with 2x female Luer lock connectors (L2)	Components will be brought into compliance with ISO 80369-7:2021

Page 4 of 5

Page 25

Passeo-14 Peripheral Dilatation Catheter K250706

Performance Data

All necessary performance testing was conducted on the Passeo-14 Catheters to ensure that the devices conform to the design specification and to support a determination of substantial equivalence to the predicate devices.

Conclusions

Based on the performance testing and the technological characteristics, it can be concluded that the Passeo-14 catheters meet their established performance for their intended use and are substantially equivalent to the predicate devices.

Page 5 of 5

Page 26

OSCAR® PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM (K250706)

510(K) Summary

Date Prepared: April 2, 2025

Trade Names: Oscar Peripheral Multifunctional Catheter system

Regulation Description: Percutaneous catheter

Device Type: Catheter, angioplasty, peripheral, transluminal

Product Code: LIT (Primary), KRA (Secondary)

Regulation Number: 870.1250, 870.1210

Predicate Device: Oscar (K241711)

Device Description

The over the wire (OTW) catheter has a retractable sheath allowing the balloon to be inflated at various lengths as determined by the physician. The balloon lengths are graduated with evenly spaced radiopaque markers.

The Oscar Peripheral Multifunctional Catheter system is a 4F and 6F catheter system with a shaft working length of 60 cm or 120 cm, compatible with 0.014" (Oscar 4F) and 0.018" (Oscar 6F) guide wires.

The device uses a semi-compliant balloon with a size dependent rated burst pressure and an indicated clinical use range of 6 atm to 16 atm. The balloon expands to a set nominal diameter (2.0, 2.5, 3.0, 4.0, 5.0, 6.0 and 7.0 mm). If required, separate PTA balloon catheters in same size range are also available separately.

Indications for Use

Page 27

OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM K250706

The product is also intended for injection of radiopaque contrast media for the purpose of angiography.

Comparison of Technological Characteristics with the Predicate Devices

The modified devices are substantially equivalent to the predicate devices and have comparable safety and technological features as mentioned below.

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the performance testing.

Page 2 of 5

Page 28

OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM K250706

Comparison of Technological Characteristics with Predicate Devices

Table 1: Comparison Oscar Peripheral Multifunctional Catheter System Subject Devices to Predicate Devices

Characteristic	Oscar Peripheral Multifunctional Catheter system Predicate Device (K241711)	Subject Devices
Proprietary Name	Oscar Peripheral Multifunctional Catheter system	Identical
Classification	Class II (21 CFR 870.1250)	Identical
Product Code	LIT/KRA	Identical
Device Description	The Oscar Peripheral Multifunctional Catheter system is an intravascular balloon catheter system, supplied with a retractable sheath (Oscar Support Catheter), a flexible catheter (Oscar Dilator) and a PTA balloon (Oscar PTA balloon), allowing a variable guide wire support and injection of fluids, and adjustable length inflatable balloon up to 180 mm.	Identical
Indications for Use	The Oscar Peripheral Multifunctional Catheter system is indicated for percutaneous transluminal interventions in the peripheral vasculature to provide support during access into and to dilate stenoses in femoral, popliteal and infrapopliteal arteries. The product is also intended for injection of radiopaque contrast media for the purpose of angiography.	Identical
Catheter Type	Over the wire	Identical
Coating	Hydrophobic	Identical
Recommended Guide Wire	0.014''/0.018"	Identical
Balloon Material	Semi- compliant	Identical
Balloon Diameter (mm)	2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0 and 7.0 mm	Identical
Balloon Adjustable Length (mm) (BL)	Length: 20-180 mm (Ø2.0-6.0) Length: 20-100 mm (Ø7.0)	Identical
Balloon Marker	Distal radiopaque balloon marker (1) and subsequently two radiopaque markers (2) at 60 mm distance each for the dimensions 2-6 mm, or two radiopaque markers at 50 mm distance for the 7 mm dimension of the Oscar PTA balloon.	Identical

Page 3 of 5

Page 29

OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM K250706

Table 1: Comparison Oscar Peripheral Multifunctional Catheter System Subject Devices to Predicate Devices

Characteristic	Oscar Peripheral Multifunctional Catheter system Predicate Device (K241711)	Subject Devices
Balloon Length Variability	Yes	Identical
Outer Sheath	Yes	Identical
Number of Radiopaque Marker Bands	3 for diameters 2-6mm 2 for 7mm diameter	Identical
Location Markers	PTA Balloon radiopaque markers: • Ø2.0-6.0: three markers starting distally, each 60 mm apart • Ø7.0: two markers starting distally, 50 mm apart	Identical
Support Catheter Usable Length (SCUL)	4F / 6F: 108 cm (long) 6F: 60 cm (short)	Identical
Total Length (TL)	4F / 6F: 141 cm / 142 cm (long) 6F: 93 cm / 86 cm (short)	Identical
Maximum Usable Catheter Length (UL)	4F / 6F: 127 cm / 128 cm (long) 6F: 80 cm / 72 cm (short)	Identical
Sterilization Method	EO	Identical
SAL	10⁻⁶	Identical
Shelf Life	3 years	Identical
Luer connectors and manifolds	4F: Manifold (Balloon) with 2x female Luer lock connectors (L2), Connector (Dilator) with 1x female Luer lock connector (L2) 6F: Manifold (Balloon) with 2x female Luer lock connectors (L2), Connector (Dilator) with 1x female Luer lock connectors (L2)	Components will be brought into compliance with ISO 80369-7:2021

Page 4 of 5

Page 30

OSCAR PERIPHERAL MULTIFUNCTIONAL CATHETER SYSTEM K250706

Performance Data

All necessary performance testing was conducted on the Oscar Catheters to ensure that the devices conform to the design specification and to support a determination of substantial equivalence to the predicate devices.

Conclusions

Based on the performance testing and the technological characteristics, it can be concluded that the Oscar catheters meet their established performance for their intended use and are substantially equivalent to the predicate devices.

Page 5 of 5

Page 31

Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (K250706)

510(K) Summary

Date Prepared: April 2, 2025

Trade Names: Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Regulation Description: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Device Type: Catheter, transluminal coronary angioplasty, percutaneous

Product Code: LOX

Regulation Number: 870.5100

Predicate Device: Pantera LEO (K242969)

Device Description

Indications for Use

Comparison of Technological Characteristics with the Predicate Devices

The modified devices are substantially equivalent to the predicate devices and have comparable safety and technological features as mentioned below.

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the performance testing.

Page 32

Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter K250706

Comparison of Technological Characteristics with Predicate Devices

Table 1: Comparison of Pantera LEO Subject Device to Predicate Device

Characteristic	Pantera LEO Predicate Device (K242969)	Subject Devices
Proprietary name	Panera LEO Fast-Exchange PTCA Catheter	Identical
Common name	PTCA Catheter	Identical
Classification	PTCA Catheter, LOX, Class II (21 CFR 870.5100)	Identical
Product code	LOX	Identical
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.	Identical
Contraindications	All general contraindications for percutaneous transluminal coronary angioplasty (PTCA) are contraindications for this device. Contraindications for this device and for PTCA in general are: - Lesions that cannot be reached or treated with the system. - Target vessel unprotected left main coronary artery. - Coronary artery spasm in the absence of a significant stenosis. Furthermore, all procedure-related contraindications as described in the national and international guidelines of the respective medical associations apply.	Identical
Intended user	Physicians competent in PTCA procedures	Identical
Method of placement / principles of operation	Device operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end	Identical
Sterilization	EO gas	Identical
SAL	10⁻⁶	Identical
Shelf life	3 years	Identical
Device description	Device is a PTCA rapid exchange system with a balloon at the distal end of the catheter.	Identical
Balloon diameter [mm]	2.0, 2.25, 2.5, 2.75, 3.0, 3.25, 3.5, 3.75, 4.0, 4.5, 5.0	Identical
Balloon length [mm]	8, 12, 15, 20, 30	Identical

Page 2 of 4

Page 33

Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter K250706

Table 1: Comparison of Pantera LEO Subject Device to Predicate Device

Characteristic	Pantera LEO Predicate Device (K242969)	Subject Devices
Radiopaque markers	Ø all sizes: Two marker bands	Identical
Usable length [cm]	145	Identical
Guiding catheter compatibility (Min. guiding catheter I.D)	Single Device: 5F (0.056 inch/1.42 mm)	Identical
Guide wire compatibility	0.014 inch (0.36 mm)	Identical
Balloon Nominal pressure [atm]	all sizes: 14 atm	Identical
Balloon RBP [atm]	Ø: 2.0-4.0 mm: 20 atm Ø: 4.5–5.0 mm: 18 atm	Identical
Distal outer shaft coating	Hydrophilic coating	Identical
Balloon coating	all sizes: Hydrophobic coating	Identical
Balloon folding	Ø 2.0 – 5.0 mm: Tri-fold	Identical
Luer connectors and manifolds	Hub with one female Luer lock connector (L2)	Components will be brought into compliance with ISO 80369-7:2021

Page 3 of 4

Page 34

Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter K250706

Performance Data

All necessary performance testing was conducted on the Pantera LEO Catheters to ensure that the devices conform to the design specification and to support a determination of substantial equivalence to the predicate devices.

Conclusions

Based on the performance testing and the technological characteristics, it can be concluded that the Pantera LEO catheters meet their established performance for their intended use and are substantially equivalent to the predicate devices.

Page 4 of 4

Page 35

Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter (K250706)

510(K) Summary

Date Prepared: April 2, 2025

Trade Names: Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter

Regulation Description: Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Device Type: Catheter, transluminal coronary angioplasty, percutaneous

Product Code: LOX

Regulation Number: 870.5100

Predicate Device: Pantera Pro (K242969)

Device Description

Indications for Use

Comparison of Technological Characteristics with the Predicate Devices

The modified devices are substantially equivalent to the predicate devices and have comparable safety and technological features as mentioned below.

The minor device differences do not introduce new issues of safety or effectiveness as demonstrated by the performance testing.

Page 36

Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter K250706

Comparison of Technological Characteristics with Predicate Devices

Table 1: Comparison of Pantera Pro Subject Devices to Predicate Devices

Characteristic	Pantera Pro Predicate Device (K242969)	Subject Devices
Proprietary name	Pantera Pro Coronary Dilatation Catheter	Identical
Common name	PTCA Catheter	Identical
Classification	PTCA Catheter, LOX, Class II (21 CFR 870.5100)	Identical
Product code	LOX	Identical
Indications for Use	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.	Identical
Contraindications	All general contraindications for percutaneous transluminal coronary angioplasty (PTCA) are contraindications for this device. Contraindications for this device and for PTCA in general are: - Lesions that cannot be reached or treated with the system. - Target vessel unprotected left main coronary artery. - Coronary artery spasm in the absence of a significant stenosis. Furthermore, all procedure-related contraindications as described in the national and international guidelines of the respective medical associations apply.	Identical
Intended user	Physicians competent in PTCA procedures	Identical
Method of placement / principles of operation	Device operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end	Identical
Sterilization	EO gas	Identical
SAL	10⁻⁶	Identical
Shelf life	3 years	Identical
Device description	Device is a PTCA rapid exchange system with a balloon at the distal end of the catheter.	Identical

Page 2 of 4

Page 37

Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter K250706

Table 1: Comparison of Pantera Pro Subject Devices to Predicate Devices

Characteristic	Pantera Pro Predicate Device (K242969)	Subject Devices
Balloon diameter [mm]	1.25, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0	Identical
Balloon length [mm]	6, 10, 15, 20, 25, 30	Identical
Radiopaque markers	Ø1.25 - 1.5 mm: One marker band Ø >1.5 mm: Two marker bands	Identical
Usable length [cm]	140	Identical
Guiding catheter compatibility (Min. guiding catheter I.D)	Single Device: 5F (0.056 inch/1.42 mm)	Identical
Guide wire compatibility	0.014 inch (0.36 mm)	Identical
Balloon Nominal pressure [atm]	all sizes: 7 atm	Identical
Balloon RBP [atm]	all sizes: 14 atm	Identical
Distal outer shaft coating	Hydrophilic coating	Identical
Balloon coating	Ø 1.25 – 2.0 mm: Hydrophilic coating Ø 2.5 - 4.0 mm: Hydrophobic coating	Identical
Balloon folding	Ø 1.25 – 1.5 mm: Two-fold Ø 2.0 – 4.0 mm: Tri-fold	Identical
Luer connectors and manifolds	Hub with one female Luer lock connector (L2)	Components will be brought into compliance with ISO 80369-7:2021

Page 3 of 4

Page 38

Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter K250706

Performance Data

All necessary performance testing was conducted on the Pantera Pro Catheters to ensure that the devices conform to the design specification and to support a determination of substantial equivalence to the predicate devices.

Conclusions

Based on the performance testing and the technological characteristics, it can be concluded that the Pantera Pro catheters meet their established performance for their intended use and are substantially equivalent to the predicate devices.

Page 4 of 4

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).