Metacross RX PTA Balloon Dilitation Catheter

K150865 · KANEKA Corporation · DQY · Aug 3, 2015 · Cardiovascular

Device Facts

• Record ID: K150865
• Device Name: Metacross RX PTA Balloon Dilitation Catheter
• Applicant: KANEKA Corporation
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 3, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Metacross RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Device Story

Metacross RX is a rapid exchange PTA balloon dilatation catheter used by physicians in clinical settings to treat peripheral arterial stenosis and arteriovenous dialysis fistulae. The device consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. The physician inserts a guidewire (up to 0.035 inches) through the distal lumen; the balloon is then positioned at the target lesion. An external inflation device connected to the proximal hub inflates the balloon to dilate the vessel or post-dilate a stent. The device facilitates blood flow restoration by mechanically expanding the narrowed vessel lumen. It is compatible with 6F or 7F sheaths/guiding catheters.

Clinical Evidence

Bench testing only. Performance evaluated per FDA guidance for PTCA catheters. Testing included dimensional verification, balloon burst pressure, fatigue, compliance, inflation/deflation time, bond strength, flexibility, kink, torque, radiopacity, and particulate evaluation. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, and genotoxicity. All predetermined acceptance criteria were met.

Technological Characteristics

Rapid exchange PTA balloon catheter. Nominal balloon diameters: 3.0-12.0 mm; working lengths: 20-200 mm; catheter lengths: 900, 1350, 2000 mm. Compatible with 0.035" guidewires and 6F/7F sheaths. Materials are biocompatible per ISO 10993-1. Sterilization method not specified.

Indications for Use

Indicated for patients requiring dilation of stenosis in iliac, femoral, popliteal, infra-popliteal, and renal arteries, or treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, and stent post-dilatation in peripheral vasculature.

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

• EverCross™ .035" OTW PTA Dilatation Catheter (K082579)
• Ultraverse® RX PTA Dilatation Catheter (K131199)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

August 3, 2015

Kaneka Corporation % Mr. Christopher Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852

Re: K150865

Trade/Device Name: Metacross RX PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 25, 2015 Received: June 26, 2015

Dear Mr. Sloan:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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,

# 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) K150865

#### Device Name

Metacross RX PTA Balloon Dilatation Catheter

Indications for Use (Describe)

The Metacross RX PTA Balloon Dilatation Catheter is intended to dilate stenosis in the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="padding-right: 5px;"> <b> </b> </span> <span style="padding-right: 20px;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> <span> <span style="padding-right: 5px;"> </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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# 510(K) SUMMARY FOR K150865

# Metacross RX PTA Balloon Dilatation Catheter

## Traditional 510(k) Submitter

Kaneka Corporation Medical Device Division 1-12-32, Akasaka, Minato-ku Tokyo, Japan Contact Person: Toshihiko Motomine Telephone: [phone] Email: [e-mail]

## Official Correspondent

Christopher M. Sloan Principal Consultant Quintiles Consulting 1801 Rockville Pike, Suite 300 Rockville, MD 20852 Phone: [phone] Facsimile: [phone] Email: [e-mail]

Date Prepared: August 2, 2015

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### Subject Device Name:

| Trade Name | Metacross RX |
|----------------------|----------------------------------------------------------------------|
| Common or usual name | Percutaneous (peripheral) transluminal<br>angioplasty catheter |
| Classification name | Percutaneous catheter [21 CFR 870.1250<br>product code DQY (or LIT)] |
| Class | II |
| Classification Panel | Cardiovascular (74) |

#### Predicate Devices:

- EverCross™ .035" OTW PTA Dilatation Catheter or "EverCross" [K082579 (ev3, ● Inc.)]
- Ultraverse® RX PTA Dilatation Catheter or "Ultraverse" [K131199 (Bard Peripheral . Vascular Inc.)]

#### Device Description:

Metacross RX PTA Balloon Dilatation Catheter (Metacross RX) is a rapid exchange balloon dilation catheter, which consists of a distal tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, hub, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the hub at the proximal end. Metacross RX has a lumen (guidewire transition tube) at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the balloon and distal tube to the guidewire port for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Metacross RX in PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 6 or 7 Fr have been deemed to be compatible with Metacross RX. The nominal inflated balloon diameters range from 3.0 mm to 12.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 900, 1350 and 2000 mm.

The Metacross RX is provided with the following accessory device:

- . Flushing Needle: provided per one catheter device for the purpose of flushing and filling of the guidewire lumen with heparinized saline before use.

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## Indications for Use

The Metacross RX is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

#### Comparison of Indications for Use to Predicate Devices

The indications for use of the Metacross RX is identical to that of the EverCross. The Metacross RX has the same intended use (percutaneous transluminal angioplasty) and similar indications for use as the Utraverse. Therefore, the subject device, Metacross RX, may be considered substantially equivalent to predicate devices.

#### Comparison of Technological Characteristics to Predicate Devices

#### Technological Comparison to Predicate Devices

The Metacross RX has the following similarities to the predicate devices:

- Same intended use (same as EverCross and Ultraverse) ●
- Same indications for use (same EverCross and similar to Ultraverse)
- . Same target population (same as EverCross and Ultraverse)
- . Same operating principle (same as EverCross and Ultraverse)
- Similar materials (similar to EverCross and Ultraverse)
- Same fundamental scientific technology (same as EverCross and Ultraverse) ●
- . Same sterility assurance level and method of sterilization (same as EverCross and Ultraverse)

## Performance Testing

To demonstrate substantial equivalence of Metacross RX to the predicate devices, the technological characteristics and performance criteria were evaluated the using the bench testing recommendations outlined in the FDA Guidance Document "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters'' dated September 8, 2010. The following in vitro tests were performed on the subject device:

Dimensional Verification, Balloon Preparation, Deployment and Retraction, Balloon Rated Burst Pressure, Balloon Fatigue (Repeat Balloon Inflations), Balloon Compliance, Balloon Inflation and Deflation Time, Catheter Bond Strength,

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Flexibility and Kink Test, Torque Strength, Radiopacity, Particulate Evaluation, Balloon Rated Burst Pressure (in Stent), and Balloon Fatigue (Repeat Balloon Inflations; in Stent), Transportation, and Shelf Life Testing.

The results from these tests demonstrate that the technological characteristics and performance criteria of the Metacross RX are adequate for the intended use of the device and that the device can perform in a manner equivalent to devices currently on the market with the same intended use.

#### Biocompatibility:

To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the Metacross RX to the predicate devices, the following biocompatibility testing was performed in accordance with ISO 10993-1.

Cytotoxicity, Sensitization, Intracutaneous reactivity (irritation), Systemic toxicity (acute), Pyrogenicity, Hemocompatibility (thrombogenicity, hemolysis, and immunology), and Genotoxicity (bacterial gene mutation assay, in vitro mammalian genotoxicity assay, and in vivo cytogenetics assay)

The results from these tests demonstrate that the Metacross RX is biocompatible for its intended use similar to the predicate devices.

#### Conclusions:

The Metacross RX met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Metacross RX PTA Balloon Dilatation Catheter is substantially equivalent to legally marketed predicate devices.