EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135

K062126 · Biosphere Medical, Inc. · DQO · Aug 9, 2006 · Cardiovascular

Device Facts

• Record ID: K062126
• Device Name: EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
• Applicant: Biosphere Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Aug 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

Device Story

EmboCath® Plus Infusion Microcatheter is a sterile, single-use, peripheral vascular catheter; features tapered reinforced shaft, inner lubricious lumen, hydrophilic outer coating, and radiopaque distal marker. Operated by physicians in clinical settings to access distal vasculature over a guidewire; facilitates delivery of diagnostic, embolic, or therapeutic agents and superselective angiography. Device provides improved torque transmission and navigation through tortuous anatomy. Output is the delivery of agents to target sites; assists clinicians in therapeutic/diagnostic procedures. Benefits include precise agent delivery and vascular access.

Clinical Evidence

Bench testing only. Verification and validation testing included visual/dimensional inspection, trackability, kink resistance, patency, coating lubricity, aspiration, stiffness, tensile failure load, column strength, and leak/burst pressure testing. Results demonstrate equivalence to predicate device.

Technological Characteristics

Tapered 3.0-2.8F single lumen catheter; materials include Pebax, Nylon12, stainless steel, polyvinylpyrrolidone (PVP), and polyacrylamide. Features reinforced shaft for torque transmission, lubricious inner lumen, hydrophilic outer coating, and radiopaque distal marker. Compatible with guidewires up to 0.025 inches. Standard luer adapter at proximal end.

Indications for Use

Indicated for infusion of diagnostic, embolic, and therapeutic agents into peripheral vascular systems, guidewire exchange/support, and superselective angiography of peripheral vasculatures in patients requiring peripheral vascular access.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• EmboCath Hydrophilic Catheter (K003105)

Submission Summary (Full Text)

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K062126

# 510(k) Summary EmboCath® Plus Infusion Microcatheter BioSphere Medical, Inc.

AUG - 9 2006

## 1. SUBMITTER/510(K) HOLDER

BioSphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 USA

Contact Person: Irina Kulinets Sr. Director Regulatory Affairs and Quality Assurance Telephone: [phone]

Fax: [phone]

Date Prepared: July 26, 2006

## 2. DEVICE NAME

EmboCath® Plus Infusion Microcatheter Proprietary Name: Common/Usual Name: Infusion Catheter Catheter Intravascular Diagnostic (21CFR 870.1200, Classification Name: DQO)

#### 3. PREDICATE DEVICES

- . EmboCath Hydrophilic Catheter (K003105)
#### 4. DEVICE DESCRIPTION

The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCath Hydrophilic Catheter (K003105) is sterile, biocompatible, single use, peripheral vascular catheter constructed of a tapered reinforced shaft, inner lubricious lined lumen, hydrophilic outer surface, radiopaque marker and a standard luer adapter at the proximal end.

The device will be provided in the following configurations:

- . Inner Diameter: 0.028 in.
- . Outer Diameters: 3 F proximally to 2.8 F distally
- Lengths: 100 cm and 135 cm as indicated on product label .

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## న. INTENDED USE

The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

BioSphere Medical, Inc. bases its claim of the substantial equivalence of the EmboCath® Plus Infusion Microcatheter with the cited predicate device based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics. The function of the EmboCath® Plus Infusion Microcatheter is to facilitate the access of distal vasculature over a guidewire and deliver various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems.

The EmboCath® Plus Infusion Microcatheter is a tapered 3.0-2.8F single lumen catheter designed to facilitate the access of distal vasculature over a guidewire. The catheter has a semi-rigid proximal shaft and becomes progressively more flexible toward the distal end. The shaft is reinforced, which provides improved torque transmission. The inner lumen is lined with a lubricious material to facilitate the movement of guidewires or other devices. The outer diameter of the catheter is coated with a hydrophilic surface to enhance the ability to navigate tortuous anatomy. The distal tip of the catheter has a single radiopaque marker to facilitate fluoroscopic visualization. The hub at the proximal end incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter lumen is 0.028 inches and guidewires measuring up to 0.025 inches (0.635 mm) in diameter are recommended.

#### 7. PERFORMANCE TESTING

In-vitro design verification and validation testing demonstrates that the EmboCath® Plus Infusion Microcatheter is equivalent to its predicate device and fulfills design and performance specifications.

The following design verification testing were performed:

- Visual Inspection ਼
- Dimensional Inspection o

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- Trackability Test (in simulated anatomy) 0
- Kink Resistance Test o
- Patency Test (for embolic patency) ಂ
- Coating Lubricity Test o
- Aspiration Test o
- Stiffness Test 0
- Tensile Failure Load Test 0
- Column Test o
- Leak/Burst Test (Static Pressure) o

## 8. PRODUCT FEATURE COMPARISON

| Feature | EmboCath® Plus<br>Infusion Microcatheter<br>Subject device | EmboCath Hydrophilic Infusion<br>Catheter (K003105)<br>Predicate device |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The EmboCath® Plus<br>Infusion Microcatheter is<br>intended for: infusion of<br>various diagnostic,<br>embolic and therapeutic<br>agents into the body's<br>vascular systems<br>(peripheral) guidewire<br>exchange/support; and<br>superselective<br>angiography of the<br>peripheral vasculatures. | The EmboCath® Plus Infusion<br>Microcatheter is intended for: infusion<br>of various diagnostic, embolic and<br>therapeutic agents into the body's<br>vascular systems (neuro, peripheral,<br>coronary) guidewire exchange/support;<br>and superselective angiography of the<br>peripheral and coronary vasculatures. |
| Design: Length | 100 cm and 135 cm | 100 cm and 135 cm |
| Design:<br>Internal<br>Diameter | 0.028 in. | 0.028 in. |
| Design Outer<br>Diameter: | 0.038 in. distal 30 cm<br>0.039 in. proximal (65 cm<br>and 70 cm) | 0.038 in. distal 30 cm<br>0.039 in. proximal (65 cm and 70 cm) |
| Materials | Predominantly Pebax,<br>Nylon12, Stainless Steel,<br>Polyvinylpyrrolidone<br>(PVP), Polyachrylamide | Predominantly Pebax, Nylon12,<br>Stainless Steel<br>Polyvinylpyrrolidone (PVP) |

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## 9. SUMMARY OF SUBSTANTIAL EQUIVALENCE

Biosphere Medical, Inc determination of substantial equivalence to EmboCath Hydrophilic Catheter (K003105) predicate device is based on the following. The subject catheter is substantially equivalent to EmboCath Hydrophilic Catheter (K003105) with respect to:

- o Size
- Construction O
- Intended use o
- Performance characteristics O
- Biocompatibility 0
- 0 Packaging
- Sterilization method 0

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2006

BioSphere Medical, Inc. c/o Ms. Irina Kulinets 1050 Hingham Street Rockland, MA 02370

Re: K062126

EmboCath Plus Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (Two) Product Code: DQO Dated: July 26, 2006 Received: July 26, 2006

Dear Ms. Kulinets:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Irina Kulinets

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

R.Z. M.D.

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): KO6 J 126

escription USA

EmboCath® Plus Infusion Microcatheter Device Name: Indications For Use:

The EmboCath® Plus Infusion Microcatheter is intended for:

infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
|-----------------------------|------------------------|
|-----------------------------|------------------------|

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division/Sign-Off) | Division of Cardiovascular Devices |
|---------------------|------------------------------------|
| 510(k) Number | K062126 |

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