PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM

K052038 · Boston Scientific Corporation · LIT · Aug 16, 2005 · Cardiovascular

Device Facts

• Record ID: K052038
• Device Name: PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM
• Applicant: Boston Scientific Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Aug 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Device Story

Peripheral Cutting Balloon (PCB) catheter; Monorail (MR) and Over-the-Wire (OTW) delivery systems. Features balloon with 3-4 longitudinal atherotomes (microsurgical blades). Inflation scores plaque to initiate crack propagation; allows lesion dilatation at lower pressures; minimizes barotrauma. Radiopaque markers on guidewire tubing assist positioning. OTW version uses dual-lumen catheter; MR version uses proximal hypotube and distal Pebax shaft with 24 cm guidewire exit port for rapid exchange. Distal section coated with Bioslide BL. Used by physicians in clinical settings for dialysis fistula interventions.

Clinical Evidence

Bench testing and biocompatibility testing only. No clinical data provided.

Technological Characteristics

Balloon catheter with 3-4 longitudinal atherotomes. Materials: Pebax distal shaft, hypotube proximal shaft (MR), Bioslide BL coating. Rated Burst Pressure (RBP) 12 atm. Available diameters 2.0-4.0 mm, length 1.5 cm. Delivery: Monorail or Over-the-Wire. Radiopaque markers for positioning.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) for obstructive lesions in synthetic or native 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

• Boston Scientific small Peripheral Cutting Balloon (K051254)
• Boston Scientific 1 cm Peripheral Cutting Balloon (K051254, K040155)
• Boston Scientific 2 cm Peripheral Cutting Balloon (K051254, K041993)

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

May 31, 2016

Boston Scientific Corporation c/o Ms. Renuka S. Krishnan 3574 Ruffin Road San Diego, CA 92123

Re: K052038

Trade/Device Name: Peripheral Cutting Balloon Small Monorail Over-The-Wire Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: PNO Dated: July 27, 2005 Received: July 28, 2005

Dear Ms. Krishnan:

This letter corrects our substantially equivalent letter of August 16, 2005.

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 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

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Page 2 - Ms. Renuka S. Krishnan

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.

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" (21CFR 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,

# Misti L. Malone -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):

K052038

Device Name:

Peripheral Cutting Balloon™: small Monorail and Over-the-Wire Delivery systems

Indications For Use:

The Peripheral Cutting Balloon™ catheters are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: No (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blumermon
Myles Sign Off

(Division Sign-Off) Division of Cardiovascular Deviges 510(k) Number KO5dD

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K052038

AUG i 6 2005

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### 510(k) SUMMARY

Boston Scientific Corporation Submitter's Name and Address 3574 Ruffin Road San Diego, CA 92123 Renuka Krishnan Contact Person Principal Specialist, Regulatory Affairs [phone] PTA catheter Common or Usual Name LIT Product Code Classification Class II Peripheral Cutting Balloon: small Monorail Proprietary Names and Over-the-Wire Delivery Systems (PCB: small MR and OTW).

#### Predicate Devices

Boston Scientific small Peripheral Cutting Balloon; K051254 Boston Scientific 1 cm Peripheral Cutting Balloon; K051254 and K040155 Boston Scientific 2 cm Peripheral Cutting Balloon; K051254 and K041993

#### Device Description

The PCB: small MR and OTW features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the PCB device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Angioplasty (PTA) with the PCB device allows dilatation of the target lesion with less pressure, minimizing barotrauma.

Radiopaque markers are placed on the guidewire tubing at the ends of the atherotomes to provide visual reference points for balloon positioning within the vessel. The Rated Burst Pressure (RBP) is 12 atm. The devices are available in nominal balloon diameters from 2.0 mm to 4.0 mm and 1.5 cm length (Table 1, p. 2).

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| Nom. Diameter (mm) | Over-the-Wire | Monorail |
|--------------------|---------------|--------------|
| 2.00 | PCBO2015140F | PCBM2015140F |
| 2.50 | PCBO2515140F | PCBM2515140F |
| 3.00 | PCBO3015140F | PCBM3015140F |
| 3.50 | PCBO3515140F | PCBM3515140F |
| 4.00 | PCBO4015140F | PCBM4015140F |

Table 1. Model Numbers, PCB:small MR and OTW

* Catheter length: 140 cm.

The OTW devices are attached to a Y-connector at one end; the MR is attached to a female luer. The catheter body for the PCB: small OTW has two lumens. The outer lumen is the balloon inflation lumen. The inner lumen is used to pass the catheter over a guidewire.

The proximal shaft for the PCB:small MR is a hypotube. This hypotube contains the balloon inflation lumen. The distal shaft is made of Pebax material and has a lumen for balloon inflation as well as a guidewire lumen. The guidewire lumen is colored green for case of guidewire insertion. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchange of the catheter. The PCB:small MR and OTW are coated with Bioslide BL at the distal section.

#### Intended Use

The Peripheral Cutting Balloons are indicated for Percutaneous Transluminal Angioplasty of obstructive lesions of synthetic or native arteriovenous dialysis fistulae.

#### Substantial Equivalence

The PCB: small MR and OTW will incorporate a substantially equivalent design, fundamental technology and intended use as those featured in predicate devices.

#### Performance Testing

Bench testing and biocompatibility testing support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed devices have been designed and tested to assure conformance to the requirements for its intended use.

#### Conclusion

The PCB: small MR and OTW have been shown to be Substantially Equivalent to the predicate devices.

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