CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER

K030966 · Boston Scientific Corp · NAJ · Sep 23, 2003 · Cardiovascular

Device Facts

• Record ID: K030966
• Device Name: CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
• Applicant: Boston Scientific Corp
• Product Code: NAJ · Cardiovascular
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations. The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.

Device Story

Contour Emboli PVA particles and FasTracker-325 infusion catheter used for embolization procedures. Catheter delivers diagnostic contrast or therapeutic PVA particles to peripheral/coronary vasculature; specifically uterine arteries for leiomyoma uteri occlusion. Used by physicians in clinical settings. Catheter assists in precise delivery of embolic agents to occlude blood flow to target lesions. Benefits include minimally invasive treatment of hypervascular tumors and uterine fibroids.

Clinical Evidence

Prospective clinical study conducted to support safety and effectiveness for treatment of uterine fibroids.

Technological Characteristics

Biocompatible materials tested per ISO 10993. System consists of PVA embolic particles and infusion catheter for vascular delivery.

Indications for Use

Indicated for patients requiring embolization of hypervascular tumors, leiomyoma uteri, or arteriovenous malformations. Includes delivery of diagnostic/therapeutic agents to peripheral and coronary vasculature, specifically delivery of Contour Emboli PVA to uterine arteries for leiomyoma uteri occlusion.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Contour® Emboli PVA (K871047, K914866, K944354)
• Fas-Tracker®-325 Infusion Catheter (K926243)
• Embosphere Microspheres (K991549, K021397)
• EmboGold Microspheres (K010026)

Submission Summary (Full Text)

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K030966

# Section 8

# Summary of Safety and Effectiveness

| General<br>Provisions | Trade Name: Contour® Emboli PVA and FasTracker®-325 Infusion Catheter |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Classification Name: Artificial Embolization Device and Intravascular Infusion Catheter |
| Name of<br>Predicate<br>Devices | Contour® Emboli PVA (K871047, K914866, K944354)<br>Fas-Tracker®-325 Infusion Catheter (K926243)<br>Embosphere Microspheres(K991549, K021397)<br>EmboGold Microspheres (K010026) |
| Classification | Class III, Contour® Emboli PVA<br>Class II, FasTracker®-325 Infusion Catheter |
| Performance<br>Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Use<br>and Device<br>Description | The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations. |
| | The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri. |
| Biocompatibility | The Contour® Emboli PVA and FasTracker®-325 Infusion Catheter have been tested for biocompatibility per ISO 10993. All data demonstrate this device is biocompatible for its intended use. |
| | Continued on next page |

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### Summary of Safety and Effectiveness, Continued

Summary of Substantial Equivalence

The Contour® Emboli PVA and FasTracker®-325 Infusion Catheter have been tested and compared to the predicate device. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. Clinical data were collected in a prospective clinical study to support the safety and effectiveness of these devices for treatment of uterine fibroids.

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SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation Oncology Division 10 Glen Falls Technical Park Dix Avenue GLEN FALLS NY 12801

Re: K030966

Trade/Device Name: Contour® Emboli PVA and FasTracker®-325 Infusion Catheter Regulation Number: 21 CFR §882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: 85 NAJ Dated: June 20, 2003 Received: June 23, 2003

Dear Ms. Greenizen:

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 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); 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.

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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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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#### Indications For Use

510(k) Number (if known)

++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Device Name: Contour® Emboli PVA Fas-Tracker®-325 Infusion Catheters

The Contour Emboli PVA are used for the embolization of hypervascular Indications for Use tumors, leiomyoma uteri, and arteriovenous malformations.

> The FasTracker-3250 Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.

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

| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prescription Use (Per 21 CFR 801.109) | <div> (Division Sign-Off) </div> <div> Division of Reproductive, Abdominal, Over-The Counter Use </div> <div> and Radiological Devices </div> |
| 510(k) Number | K030966 |
| | Optional Format 1-2-96 |