Pantera Pro

K160985 · Biotronik, Inc. · LOX · Oct 7, 2016 · Cardiovascular

Device Facts

• Record ID: K160985
• Device Name: Pantera Pro
• Applicant: Biotronik, Inc.
• Product Code: LOX · Cardiovascular
• Decision Date: Oct 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5100
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Pantera Pro is a sterile, single-use, intravascular balloon dilatation catheter used by physicians in clinical settings (e.g., cath lab) to treat coronary artery or bypass graft stenosis. The device features a soft tapered distal tip, a foldable balloon, and a hypotube shaft. It is compatible with 0.014" guidewires and 5F guiding catheters. The operator advances the catheter to the target site; the balloon is inflated to a specific diameter and pressure (nominal 7 atm, rated burst 14 atm) using sterile saline to dilate the stenosis or expand a stent. Hydrophilic or hydrophobic coatings are applied to the shaft and balloon to facilitate navigation and performance. The device improves myocardial perfusion by restoring vessel patency. No software or electronic components are involved.

Clinical Evidence

No clinical investigation has been performed for this device. Substantial equivalence is supported by non-clinical bench testing and biocompatibility testing.

Technological Characteristics

Intravascular balloon dilatation catheter; 1.25–4.0 mm diameter; 6–30 mm length; 140 cm usable length. Features hydrophilic/hydrophobic coatings. Compatible with 0.014" guidewires and 5F guiding catheters. Nominal pressure 7 atm; rated burst pressure 14 atm. Sterilized via EO gas (SAL 10^-6). Complies with ISO 10993-1:2009 for biocompatibility.

Indications for Use

Indicated for patients requiring balloon dilatation of stenotic coronary arteries or bypass grafts to improve myocardial perfusion. Sizes 2.0–4.0 mm are also indicated for post-delivery expansion of balloon-expandable stents.

Regulatory Classification

Identification

Standard PTCA Catheter: 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. Cutting/scoring PTCA Catheter: 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.

Special Controls

*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.

Predicate Devices

• Medtronic Sprinter Legend (P790017 /S096 & K103095)

Reference Devices

• Maverick2 (P860019 / S179)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span style="font-size: 20px;">☑</span> </div> |
|----------------------------------------------|------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span style="font-size: 20px;">☐</span> </div> |

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### 510(k) Summary per 21 CFR 807.92

| Date Prepared: | March 9, 2016 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 |
| Contact Person: | Jon Brumbaugh<br>Vice President, Regulatory Affairs and Compliance<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| 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 the<br>dilatation of stenotic segments in coronary arteries or bypass grafts. The dilatation<br>balloon is designed to inflate to a known diameter and length at a specific inflation<br>pressure. Pantera Pro has balloon diameters ranging from ∅ 1.25 mm – 4.0 mm and<br>balloon lengths ranging from ∅ 6 mm – 30 mm. All product sizes of Pantera Pro have a<br>usable catheter length of 140 cm. The Pantera Pro has a soft tapered tip at the distal end<br>of the catheter to facilitate advancement of the catheter. The balloon is folded to achieve<br>a low crossing profile and is connected to the tip. The Pantera Pro has two coatings; a<br>hydrophobic coating on the outer surface of the hypotube and a hydrophilic polymeric<br>based coating on the outer surface of the distal outer shaft. In addition, a hydrophobic<br>coating is applied on the balloons of sizes ∅ 2.5 – 4.0 mm whereas a hydrophilic<br>coating is applied on the balloons of sizes ∅ 1.25 mm – 2.0 mm. The coating is<br>activated by immersing the catheter in sterile saline prior to use.<br>The Pantera Pro is compatible with guide wires of 0.014" (0.36 mm) diameter and<br>guiding catheters with an inner diameter of ≥0.056" (1.42 mm; 5F). For all Pantera Pro<br>product sizes, the nominal pressure (NP) required to achieve the nominal diameter is<br>7 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 coronary<br>artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The<br>Pantera Pro (balloon diameter 2.0 – 4.0 mm) is also indicated for post-delivery<br>expansion of balloon expandable stents. |
| Predicate Device(s): | Medtronic Sprinter Legend (P790017 /S096 & K103095) |

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| Comparison of<br>Technological<br>Characteristics | 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-<br>Clinical Data | Design Verification in-vitro testing:<br>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.<br>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 Clinical<br>Data: | 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 EO<br>gas to achieve a sterility assurance level (SAL) of 1 x 10-6. The device meets the<br>endotoxin limit of 20 EU / device. |
| Conclusion: | The intended use of the subject Pantera Pro, as described in the labeling, is the same as<br>the predicate devices Sprinter Legend RX (P790017 / S096 & K103095) and Maverick2<br>(P860019 / S179). In addition, the indications for use are similar and the fundamental<br>technology has not changed. Minor differences have been evaluated through<br>performance testing that shows the Pantera Pro meets performance specifications. The<br>biocompatibility testing shows the materials of construction are biologically safe for the<br>intended use. Therefore, Pantera Pro is considered substantially equivalent to the<br>predicate device |