Crosstella OTW

K160004 · KANEKA Corporation · LIT · Apr 29, 2016 · Cardiovascular

Device Facts

• Record ID: K160004
• Device Name: Crosstella OTW
• Applicant: KANEKA Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Crosstella OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapoplited 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.

Device Story

Over-the-wire (OTW) balloon dilatation catheter; consists of outer/inner tubes, balloon, radiopaque markers, manifold, reinforcement tube, strain relief. Operates by inflating/deflating balloon via inflation device connected to proximal manifold; guidewire lumen allows insertion of 0.018-inch guidewire. Used by physicians in clinical settings for percutaneous transluminal angioplasty (PTA) procedures. Provides mechanical dilation of stenotic peripheral arteries and dialysis fistulae; facilitates stent post-dilatation. Benefits patient by restoring vessel patency and improving blood flow.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via in vitro testing: dimensional verification, balloon preparation/deployment/retraction, rated burst pressure, fatigue, compliance, inflation/deflation time, bond strength, flexibility, kink test, torque strength, radiopacity, coating integrity, and particulate evaluation. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemocompatibility, and genotoxicity.

Technological Characteristics

OTW balloon catheter; 2.0-6.0 mm balloon diameters; 20-200 mm balloon lengths; 900/1500 mm catheter lengths. Compatible with 0.018" guidewires and 4F/5F sheaths. Features radiopaque markers. Materials evaluated for biocompatibility per ISO 10993. Sterilization method consistent with predicate.

Indications for Use

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

• PowerCross™ .018" OTW PTA Dilatation Catheter (K093286)

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

April 29, 2016

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

Re: K160004

Trade/Device Name: Crosstella OTW PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: March 29, 2016 Received: March 31, 2016

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K160004

#### Device Name

Crosstella OTW PTA Balloon Dilatation Catheter

#### Indications for Use (Describe)

The Crosstella OTW PTA Balloon Dilatation Catheter is intended to dilate stenoral, ilio-femoral, popliteal, infrapoplited 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(K) SUMMARY

## Crosstella 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:

## Official Correspondent

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

Date Prepared: March 22, 2016

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### Subject Device Name:

| Trade Name | Crosstella OTW |
|----------------------|----------------------------------------------------------------|
| 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:

- PowerCross™ .018" OTW PTA Dilatation Catheter or "PowerCross" [K093286 (ev3 ● Inc.)]
### Device Description:

Crosstella OTW PTA Balloon Dilatation Catheter (Crosstella OTW) is an over-the-wire type of balloon dilation catheter, which consists of an outer tube, inner tube, balloon, radiopaque markers, manifold, outer reinforcement tube 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. Crosstella 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 inner tube to the guidewire port of the manifold for the introduction of a guidewire.

The maximum compatible diameter of a guidewire used together with Crosstella OTW in a PTA procedure is 0.018 inches. Additionally, the compatible size of a sheath introducer is 4 The nominal inflated balloon diameters range from 2.0 mm to 6.0 mm with balloon or 5 Fr. working lengths of 20 mm to 200 mm. Two different catheter working lengths will be provided: 900 and 1500 mm.

#### Indications for Use

The Crosstella OTW 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.

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

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

#### Comparison of Technological Characteristics to Predicate Device

#### Technological Comparison to Predicate Device

The Crosstella OTW has the following similarities to the predicate PowerCross device:

- Same intended use
- Similar 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 Crosstella 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:

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, Coating Integrity, 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 Crosstella 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.

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#### Biocompatibility:

To demonstrate the biological safety of the body-contacting materials and substantial equivalence of the Crosstella OTW to the predicate device, the following biocompatibility testing was performed 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 Crosstella OTW is biocompatible for its intended use similar to the predicate device.

#### Conclusions:

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