Metacross OTW PTA Balloon Dilatation Catheter

K152080 · KANEKA Corporation · LIT · Sep 24, 2015 · Cardiovascular

Device Facts

• Record ID: K152080
• Device Name: Metacross OTW PTA Balloon Dilatation Catheter
• Applicant: KANEKA Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal 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

Over-the-wire (OTW) balloon dilatation catheter; consists of distal, center, and proximal tubes, balloon, guidewire transition tube, radiopaque markers, manifold, and strain relief. Used in peripheral vasculature procedures; operated by physicians. Balloon inflated/deflated via inflation device connected to proximal manifold. Guidewire (up to 0.035 inch) inserted through distal lumen. Facilitates vessel dilation and stent post-dilatation. Benefits include restoration of blood flow in stenotic arteries and dialysis fistulae.

Clinical Evidence

Bench testing only. Performance evaluated per FDA guidance for PTCA catheters. Tests included dimensional verification, balloon burst pressure, fatigue, compliance, inflation/deflation time, bond strength, flexibility, kink, torque, radiopacity, and particulate evaluation. Biocompatibility testing (ISO 10993) leveraged from reference device, covering cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, and genotoxicity. All predetermined acceptance criteria met.

Technological Characteristics

OTW balloon catheter; 0.035" guidewire compatibility; 5-7 Fr sheath compatibility. Nominal balloon diameters 3.0 mm; working lengths 20-200 mm; catheter lengths 650, 900, 1350 mm. Radiopaque markers for visualization. Sterilized device. Materials biocompatibility verified per ISO 10993.

Indications for Use

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

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)

Reference Devices

• Metacross RX PTA Balloon Dilatation Catheter (K150865)

Submission Summary (Full Text)

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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

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

September 24, 2015

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

Re: K152080

Trade/Device Name: Metacross OTW PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 24, 2015 Received: July 27, 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 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

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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

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## Indications for Use

510(k) Number (if known) K152080

#### Device Name

Metacross OTW PTA Balloon Dilatation Catheter

Indications for Use (Describe)

The Metacross OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapopliteal 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 style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(K) SUMMARY

## Metacross OTW PTA Balloon Dilatation Catheter

## 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: July 24, 2015

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#### Subject Device Name:

| Trade Name | Metacross OTW PTA Balloon Dilatation Catheter |
|----------------------|----------------------------------------------------------------|
| Common or usual name | Percutaneous (peripheral) transluminal<br>angioplasty catheter |
| Classification name | Percutaneous catheter [21 CFR 870.1250;<br>Product code LIT |
| Class | II |
| Classification Panel | Cardiovascular (74) |

#### Predicate Device:

- EverCross™ .035" OTW PTA Dilatation Catheter or "EverCross" [K082579 (ev3, ● Inc.)]
#### Reference Device:

- Metacross RX PTA Balloon Dilatation Catheter [K150865 (Kaneka Corporation)]
#### Device Description:

Metacross OTW PTA Balloon Dilatation Catheter (Metacross OTW) is an over the wire type of balloon dilation catheter, which consists of a distal tube, center tube, proximal tube, balloon, guidewire transition tube, radiopaque markers, manifold, 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 manifold at the proximal end. Metacross OTW has a guidewire lumen at the distal end of the catheter through which a guidewire can be inserted, and also an opening along the guidewire transition tube, center tube and proximal tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Metacross OTW in a PTA procedure is 0.035 inches; hence, sheathless guiding catheters and sheaths with a diameter of 5, 6 or 7 Fr have been deemed to be compatible with Metacross OTW. The nominal inflated balloon diameters range from 3.0 mm with balloon working lengths of 20 mm to 200 mm. Three different catheter working lengths will be provided: 650, 900 and 1350 mm.

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### Indications for Use

The Metacross OTW PTA Balloon Dilatation Catheter 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 Device

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

#### Comparison of Technological Characteristics to Predicate Device

#### Technological Comparison to Predicate Device

The Metacross OTW has the following similarities to the predicate EverCross device:

- Same intended use ●
- . Same indications for use
- Same target population ●
- . Same operating principle
- Similar materials
- Same fundamental scientific technology
- Same sterility assurance level and method of sterilization

### Performance Testing

To demonstrate substantial equivalence of Metacross OTW to the predicate device, the technological characteristics and performance criteria were evaluated 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:

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

The results from these tests demonstrate that the technological characteristics and performance criteria of the Metacross OTW 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 OTW to the predicate device, the following biocompatibility testing was leveraged from the Metacross RX reference device in accordance with "Draft Guidance for Industry and Food and Drug Administration Staff; Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'" (dated April 23, 2013):

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 OTW is biocompatible for its intended use similar to the predicate device.

#### Conclusions:

The Metacross OTW 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 OTW PTA Balloon Dilatation Catheter is substantially equivalent to legally marketed predicate device.