ComboCath OTW PTA Dilatation Catheter

K150452 · Summa Therapeutics, LLC · LIT · Aug 13, 2015 · Cardiovascular

Device Facts

• Record ID: K150452
• Device Name: ComboCath OTW PTA Dilatation Catheter
• Applicant: Summa Therapeutics, LLC
• Product Code: LIT · Cardiovascular
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

ComboCath OTW PTA Dilatation Catheter is an over-the-wire balloon catheter used for peripheral angioplasty. Device features two independent lumens: one for balloon inflation/deflation and one for guidewire placement and fluid injection via proximal exit holes. Includes three radiopaque markers for angiographic visualization. Operated by physicians in clinical settings. Inflation occurs via a proximal hub with an inflation port and a Touhy-Borst valve with a stopcock. Device is inserted over a 0.014" guidewire to the target lesion; balloon is inflated to dilate obstructive lesions in arteries or dialysis fistulae. Benefits include restoration of blood flow in peripheral vasculature and maintenance of dialysis access patency.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Functional testing conducted to demonstrate performance and substantial equivalence to the predicate device.

Technological Characteristics

Over-the-wire (OTW) balloon catheter; 150cm working length; 0.014" guidewire compatible; two-lumen shaft (inflation/guidewire); thermoplastic polymer balloon; three radiopaque markers; proximal hub with inflation port and Touhy-Borst valve with stopcock; 5F sheath compatibility. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty (PTA) in peripheral vasculature (iliac, femoral, popliteal, infra-popliteal, renal arteries) or treatment of obstructive lesions in native/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

• Boston Scientific (Coyote™ ES) PTA Balloon Dilatation Catheter (K111295)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other.

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

August 13, 2015

Summa Therapeutics, LLC Richard Rush Regulatory Affairs Consultant 257 Castro Street, #216 Mountain View, California 94041

Re: K150452

Trade/Device Name: ComboCath OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: July 17, 2015 Received: July 21, 2015

Dear Mr. Rush:

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 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.

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

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

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

510(k) Number (if known) K150452

Device Name

Summa Therapeutics ComboCath(TM) OTW PTA Dilatation Catheter

Indications for Use (Describe)

The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(K) SUMMARY

Image /page/3/Picture/3 description: The image contains the logo for Summa Therapeutics. The word "SUMMA" is in a bold, sans-serif font and is colored in blue. Below the word "SUMMA" is the word "THERAPEUTICS" in a smaller, sans-serif font and is colored in gray. The logo is simple and modern.

February 19, 2015

To Whom It May Concern:

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.

510(k) number:

Date Prepared: February 19, 2015

Applicant Information: Summa Therapeutics, LLC 257 Castro Street, #216 Mountain View, CA 94041

Contact Person: Richard Rush, Regulatory Affairs Consultant Phone Number: [phone] Fax Number: [phone]

Device Information:

| Trade Name: | ComboCath™ OTW PTA Dilatation Catheter |
|----------------------|----------------------------------------|
| Common Name: | Balloon Catheter |
| Classification: | Class II per 21 CFR 870.1250 |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | LIT |

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

# Physical Description:

The ComboCath™ OTW PTA Dilatation Catheter is an 0.014" (0.36mm) guidewire compatible balloon angioplasty catheter with an effective working length of 150cm. The angioplasty catheter includes a semi-compliant distal Balloon of known diameter and length when inflated to recommended pressures.

The device construction consists of a catheter shaft with two independent lumens extending along its length. One lumen is for inflation and deflation of the angioplasty balloon. The other lumen is for placement of the quidewire and injection of fluids via the catheter's Exit Holes that are positioned proximal to the Balloon.

The proximal Hub includes an Inflation Port used for inflation of the Balloon and a standard Touhy-Borst valve with a side port terminated by a Stopcock that permits injection of fluids.

The catheter includes three radiopaque markers to aid angiographic placement of the device.

#### Indications for Use:

The ComboCath™ OTW PTA Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) in the peripheral vasculature, including iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

#### Predicate Device:

Boston Scientific (Coyote™ ES) PTA Balloon Dilatation Catheter (K111295)

The devices share similar intended use, technological characteristics, construction, and materials, as are commonly found in intravascular balloon catheters.

#### Substantial equivalence:

The ComboCath™ OTW PTA Dilatation Catheter's design, materials, operating principles and intended use are substantially equivalent to predicate device Boston Scientific (Coyote™ ES) PTA Balloon Dilatation Catheter (K111295).

#### Performance

Functional testing was conducted to support the claim of substantial equivalence and to demonstrate performance of the ComboCath™ OTW PTA Dilatation Catheter for its intended use.

{5}------------------------------------------------

Both devices were evaluated and found similar in design and materials as summarized in Table 4-1 below:

| Characteristic | Summa Therapeutics'<br>ComboCath™ OTW PTA Dilatation<br>Catheter | Boston Scientific<br>(Coyote ™ ES) PTA Balloon Dilatation<br>Catheter (K111295) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use<br>statement | The ComboCath OTW PTA Dilatation<br>Catheter is indicated for Percutaneous<br>Transluminal Angioplasty (PTA) in the<br>peripheral vasculature, including iliac,<br>femoral, popliteal, infra-popliteal and renal<br>arteries, and for the treatment of<br>obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. | The Coyote ES OTW PTA Balloon<br>Dilatation Catheter is indicated for<br>Percutaneous Transluminal Angioplasty<br>(PTA) in the peripheral vasculature,<br>including iliac, femoral, infrapopliteal,<br>popliteal, renal arteries, and for the<br>treatment of obstructive lesions of native or<br>synthetic arteriovenous dialysis fistulae. |
| Design | Over-the-wire (OTW)<br>Two lumen catheter shaft : (1) Lumen for<br>balloon inflation and (1) Lumen for<br>guidewire<br>Thermoplastic polymer balloon<br>Radiopaque marker | Over-the-wire (OTW)<br>Two lumen catheter shaft : (1) Lumen for<br>balloon inflation and (1) Lumen for<br>guidewire<br>Thermoplastic polymer balloon<br>Radiopaque marker |
| Shaft and Balloon<br>Material | Thermoplastic | Thermoplastic |
| Guidewire<br>Compatibility | 0.014" (0.36 mm) | 0.014" (0.36 mm) |
| Compatible Sheath<br>Size | 5F | 4F |
| Balloon Diameter | 2.5, 3.0, 3.5, 4.0 mm | 1.5, 2.0, 2.5, 3.0, 3.5, 4.0 mm |
| Balloon Length | 40 mm | 20, 30, 40 mm |
| Catheter Working<br>Length | 150 cm | 90, 150 cm |

| | | | | | | Table 4-1: Design and Materials Comparison |
|--|--|--|--|--|--|--------------------------------------------|
|--|--|--|--|--|--|--------------------------------------------|

## Biocompatibility

The ComboCath™ OTW PTA Dilatation Catheter is constructed using commonly used materials in other medical devices. The ComboCath™ OTW PTA Dilatation Catheter passed all testing required to demonstrate biocompatibility per ISO 10993-1, Biological Evaluation of Medical Devices.

## Summary:

Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to function for its intended use and be substantially equivalent to the predicate device.