Passeo-35 PTA Catheter

K142379 · Biotronik, Inc. · LIT · Dec 5, 2014 · Cardiovascular

Device Facts

• Record ID: K142379
• Device Name: Passeo-35 PTA Catheter
• Applicant: Biotronik, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Dec 5, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Passeo-35 Peripheral Dilatation Catheter is intended for dilatation of stenotic segments in peripheral vessels and arteriovenous dialysis fistulae.

Device Story

The Passeo-35 is an over-the-wire, dual-lumen percutaneous transluminal angioplasty (PTA) catheter used by physicians to dilate stenotic peripheral vessels and arteriovenous dialysis fistulae. The device features a balloon with radiopaque markers at each end for fluoroscopic positioning and a tapered soft tip for lesion advancement. It is compatible with 0.035" guide wires. The operator connects an inflation device to a proximal Luer port to inflate the balloon to a specific diameter and pressure, as defined by the compliance chart. The catheter shaft is coated with a hydrophobic silicone to improve trackability. The device is delivered via standard percutaneous access over a guide wire. By inflating the balloon within a stenotic lesion, the device mechanically dilates the vessel, potentially improving blood flow and resolving obstructive lesions. The device is provided sterile and is intended for single use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing only, including biocompatibility (ISO 10993), mechanical performance (tensile strength, torque, kink resistance, fatigue, burst pressure), and simulated use testing in anatomical models.

Technological Characteristics

Over-the-wire 2-lumen balloon catheter. Materials: Pebax (shaft/tip), Poly-Amide (balloon), Polycarbonate (manifold), Pt/Ir (markers). Hydrophobic silicone coating. Sterilization: EO gas. Compatible with 0.035" guide wires. Dimensions: 5F shaft, 3-10mm balloon diameters, lengths up to 200mm. Standards: ISO 10993, ISO 25539-2, ASTM F2081, ISO 10555.

Indications for Use

Indicated for dilation of stenosis in renal, iliac, femoral, popliteal, and infrapopliteal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Regulatory Classification

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.

Predicate Devices

• Passeo-35 (K082933)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is simple and recognizable, representing the department's role in promoting health and well-being.

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

December 5, 2014

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

Re: K142379

> Trade/Device Name: Passeo-35 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 4, 2014 Received: November 5, 2014

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

{1}------------------------------------------------

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

K142379 510(k) Number (if known):

Device Name: Passeo-35 Peripheral Dilatation Catheter

Indications for Use:

The Passeo-35 Peripheral Dilatation Catheter is indicated to dilate stenosis in the renal, iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

# Prescription Use _____________________________________________________________________________________________________________________________________________________________

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the letters "BIO" inside of a circle on the left, followed by the word "BIOTRONIK" in large, bold, dark blue letters. Below the word "BIOTRONIK" is the phrase "excellence for life" in a smaller, lighter blue font.

# Passeo-35 Peripheral Dilatation Catheter Special 510(k) Premarket Notification 510(k) Summary

| Name and Address of Sponsor: | BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person and Phone Number: | Jon Brumbaugh<br>Vice President, Regulatory Affairs and Compliance<br>BIOTRONIK, Inc.<br>6024 Jean Road<br>Lake Oswego, OR 97035<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | December 5, 2014 |
| Device Name: | |
| Proprietary Name: | Passeo-35 Peripheral Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Angioplasty (PTA)<br>Catheter |
| Classification: | Class II (21 CFR 870.1250) |
| Classification Name: | Catheter, angioplasty, peripheral, transluminal |
| Product Code: | LIT |

#### Predicate Device:

| | 510(k) # | Device Name | Manufacturer | Date of Clearance |
|------------|----------|-------------|--------------|-------------------|
| Predicate: | K082933 | Passeo-35 | BIOTRONIK | 3-Nov-2008 |

#### General Description:

The Passec-35 Peripheral Dilatation Catheter (Passeo-35) is intended for dilatation of stenotic segments in peripheral vessels. One radiopaque marker is located at either end of the balloon to facilitate fluoroscopic visualization and positioning of the balloon catheter towards and across the lesion. The dilatation balloon is designed to inflate to a known diameter at a specific inflation pressure consistent with the compliance chart on the label. The balloon catheter includes a tapered soft tip to facilitate advancement of the catheter.

The balloon catheter shaft has two Luer ports at the proximal end. One port) serves for connecting an inflation device to inflate/deflate the balloon. The other port) enables insertion of the guide wire. The balloon catheter is a dual lumens contained within one tube. The smaller lumen is the balloon inflation/deflation lumen permits the use of guide wires with a maximum diameter of 0.035" to facilitate advancement of the Passeo-35 catheter towards and through the lesion(s) to be dilated. The balloon catheter is compatible with introducer) sizes according to the recommendations on the label. The balloon catheter has a silicone coating (hydrophobic) to improve the trackability characteristics.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for BIOTRONIK. The logo consists of the BIOTRONIK name in bold, dark blue letters, with a light blue circle containing the letters "BIO" to the left. Below the name is the phrase "excellence for life" in a smaller, light blue font.

#### Indication for Use:

The Passeo-35 Peripheral Dilatation Catheter is indicated to dilate stenosis in the renal, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

#### Purpose of Submission:

BIOTRONIK submits this 510(k) for clearance of additional device size configurations for the Passeo-35 including additional balloon lengths up to 200mm. In addition, device and packaging materials changes are documented and labeling is updated for clarity as well as to reflect the new sizes and RBPs.

| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | | | |
|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameters | Passeo-35<br>K082933 | Passeo-35<br>Subject Device | Rationale for Substantial<br>Equivalence |
| Proprietary name | Passeo-35 Peripheral<br>Dilatation Catheter | Passeo-35 Peripheral<br>Dilatation Catheter | Same |
| Common name | PTA catheter | PTA catheter | Same |
| Classification | Class II (21 CFR 870.1250) | Class II (21 CFR 870.1250) | Same |
| Classification<br>name | Catheter, angioplasty,<br>peripheral, transluminal | Catheter, angioplasty,<br>peripheral, transluminal | Same |
| Product code | LIT | LIT | Same |
| Intended use / Indications for Use | | | |
| Intended use | The Passeo-35 Peripheral<br>Dilatation Catheter is intended<br>for dilatation of stenotic<br>segments in peripheral<br>vessels and arteriovenous<br>dialysis fistulae. | The Passeo-35 Peripheral<br>Dilatation Catheter is intended<br>for dilatation of stenotic<br>segments in peripheral<br>vessels and arteriovenous<br>dialysis fistulae. | Same |
| Indications for<br>Use | The Passeo-35 Peripheral<br>Dilatation Catheter is<br>indicated to dilate stenosis in<br>the renal, iliac, femoral,<br>popliteal and infrapopliteal<br>arteries and for the treatment<br>of obstructive lesions of native<br>or synthetic arteriovenous<br>dialysis fistulae. | The Passeo-35 Peripheral<br>Dilatation Catheter is<br>indicated to dilate stenosis in<br>the renal, iliac, femoral,<br>popliteal and infrapopliteal<br>arteries and for the treatment<br>of obstructive lesions of native<br>or synthetic arteriovenous<br>dialysis fistulae. | Same |
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | | | |
| Parameters | Passeo-35<br>K082933 | Passeo-35<br>Subject Device | Rationale for Substantial<br>Equivalence |
| Contraindications | All general contraindications<br>for percutaneous transluminal<br>angioplasty (PTA) are<br>contraindications for this<br>device. Contraindications for<br>this device and peripheral<br>dilatation catheters in general<br>are:<br>• Lesions that cannot be<br>reached or treated with the<br>system<br>• Large amounts of acute or<br>subacute thrombus at the<br>target lesion<br>• Perforated vessels<br>• Lesion that lies within or<br>adjacent to an aneurysm<br>• Uncorrected bleeding<br>disorders<br>• Renal insufficiency or an<br>allergy to contrast media<br>Furthermore, all procedure-<br>related contraindications as<br>described in the national and<br>international guidelines of the<br>respective medical<br>associations apply. | All general contraindications<br>for percutaneous transluminal<br>angioplasty (PTA) are<br>contraindications for this<br>device. Contraindications for<br>this device and peripheral<br>dilatation catheters in general<br>are:<br>• Lesions that cannot be<br>reached or treated with the<br>system<br>• Large amounts of acute or<br>subacute thrombus at the<br>target lesion<br>• Perforated vessels<br>• Lesion that lies within or<br>adjacent to an aneurysm<br>• Uncorrected bleeding<br>disorders<br> | Same |
| Intended user | Physicians competent in PTA<br>procedures | Physicians competent in PTA<br>procedures | Same |
| Method of<br>placement | Standard percutaneous<br>access to site over a guide<br>wire, with fluoroscopic<br>visualization | Standard percutaneous<br>access to site over a guide<br>wire, with fluoroscopic<br>visualization | Same |
| Sterilization / Shelf life / Packaging | | | |
| Sterilization | EO gas | EO gas | Same |
| Sterilization<br>System | Sauter EO Sterilizer | Sauter EO Sterilizer<br>or<br>Sterichem EO Sterilizer | Does not alter intended use.<br>Validation testing according to<br>design controls support<br>equivalence. BIOTRONIK<br>uses either sterilizer in<br>production. |
| SAL | 10-6 | 10-6 | Same |
| Shelf life | 3 years | 3 years | Same |
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | | | |
| Parameters | Passeo-35<br>K082933 | Passeo-35<br>Subject Device | Rationale for Substantial<br>Equivalence |
| Protective sheath | Balloon has a protective<br>sheath. Spiral dispenser<br>sealed in a Tyvek® and<br>PET/PE pouch.<br>Product is packed in an outer<br>cardboard carton. | Balloon has a protective<br>sheath. Spiral dispenser<br>sealed in a Tyvek® and<br>PET/PE pouch.<br>Product is packaged in an<br>outer cardboard carton. | Same |
| Shelf life | 3 years | 3 years | Same |
| Instructions for<br>Use and labeling | As provided in K082933. | Minor wording & symbol<br>changes | Changes do not alter intended<br>use, technological<br>characteristics, or raise<br>different questions of safety<br>and effectiveness. |
| Device Design | | | |
| Device<br>description | Over the wire 2-lumen balloon<br>catheter | Over the wire 2-lumen balloon<br>catheter | Same |
| Radiopaque<br>markers | 2 – one at each end of the<br>balloon<br>Material: 90% Pt / 10% Ir<br>Length: 1.5 mm | 2 – one at each end of the<br>balloon<br>Material: 90% Pt / 10% Ir<br>Length: 1.5 mm | Same |
| Usable length<br>[cm] | 80 and 130 | 80, 90 and 130 | Does not alter intended use.<br>Performance testing<br>according to design controls<br>support equivalence. |
| Introducer<br>sheath<br>compatibility | 5F (Balloon Ø: 3 – 7 mm)<br>6F (Balloon Ø: 8 – 10 mm) | 5F (Balloon Ø: 3 – 7 mm)<br>6F (Balloon Ø: 8 – 10 mm) | Same |
| Crossing profile | Ø: 3-7mm: max. 0.074 inches<br>Ø: 8-10mm: max. 0.083<br>inches | Ø: 3-7mm: max. 0.074 inches<br>Ø: 8-10mm: max. 0.083<br>inches | Same |
| Guide wire<br>compatibility | 0.035" | 0.035" | Same |
| Shaft outer<br>diameter [F] | 5 | 5 | Same |
| Shaft inner<br>diameter [mm] | 0.96 | 0.98 | The larger inner diameter of<br>Passeo-35 LE does not alter<br>the intended use or raise<br>different safety and<br>effectiveness questions.<br>Performance testing data<br>showed substantial<br>equivalence to the predicate. |
| Balloon diameter<br>[mm] | 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0,<br>10.0 | 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0,<br>10.0 | Same |
| Substantial Equivalence of Passeo-35 to existing (predicate) Passeo-35 product line | | | |
| | Passeo-35 | Passeo-35 | Rationale for Substantial |
| Parameters | K082933 | Subject Device | Equivalence |
| Balloon length<br>[mm] | 20, 40, 60, 80, 100 | 20, 40, 60*, 80*, 100*, 120,<br>150, 170, 200<br>(* new balloon lengths for<br>some balloon diameter sizes,) | Same intended use and does<br>not raise different safety and<br>effectiveness questions.<br>Performance testing data<br>demonstrate substantial<br>equivalence. |
| Balloon wrapping | 5 folds | 5 folds | Same |
| Balloon Nominal<br>pressure [atm] | 7 | 7 | Same |
| Balloon RBP<br>[atm] | 20 (Balloon Ø: 3 - 4 mm)<br>16 (Balloon Ø: 5 - 6 mm)<br>14 (Balloon Ø: 7 - 8 mm)<br>12 (Balloon Ø: 9 - 10 mm) | 20 (Balloon Ø: 3mm)<br>18 (Balloon Ø: 4mm)<br>16 (Balloon Ø: 5 - 6 mm)<br>14 (Balloon Ø: 7 - 8 mm)<br>12 (Balloon Ø: 9mm)<br>11 (Balloon Ø: 10 mm) | Same intended use and does<br>not raise different safety and<br>effectiveness questions.<br>Performance testing data<br>demonstrate substantial<br>equivalence. |
| Materials of Construction (Direct and indirect patient contact) | | | |
| Tip | Pebax 5533 SA01 | Pebax 5533 SA01 | Same |
| Balloon…