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 Description

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

AI/ML Overview

The provided text details the submission of the Contour® Emboli PVA and FasTracker®-325 Infusion Catheter for 510(k) clearance, asserting substantial equivalence to predicate devices. However, the document does not explicitly describe acceptance criteria, nor does it provide a study report detailing specific performance metrics against such criteria. It mentions a prospective clinical study, but no performance data from that study is included within the provided sections.

Therefore, the following information is not available in the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

What is present in the document is the following:

Clinical Data Source: Clinical data were collected in a prospective clinical study to support the safety and effectiveness of these devices for treatment of uterine fibroids. This indicates that a clinical study was performed, but the results and details of this study are not within the provided text.
Biocompatibility Testing: The devices were tested for biocompatibility per ISO 10993, and all data demonstrated biocompatibility for their intended use. This is a form of acceptance criteria (biocompatibility) with a positive outcome, but it's not related to diagnostic or therapeutic efficacy performance.
Substantial Equivalence: The submission asserts that the devices have been tested and compared to predicate devices, and "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This is the primary "proof" for 510(k) clearance, but it refers to a comparison with existing devices rather than a detailed performance study against specific, pre-defined acceptance criteria for the new device.

Summary

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K030966

Section 8 Summary of Safety and Effectiveness

GeneralProvisions	Trade Name: Contour® Emboli PVA and FasTracker®-325 Infusion Catheter
	Classification Name: Artificial Embolization Device and Intravascular Infusion Catheter
Name ofPredicateDevices	Contour® Emboli PVA (K871047, K914866, K944354)Fas-Tracker®-325 Infusion Catheter (K926243)Embosphere Microspheres(K991549, K021397)EmboGold Microspheres (K010026)
Classification	Class III, Contour® Emboli PVAClass II, FasTracker®-325 Infusion Catheter
PerformanceStandards	Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act
Intended Useand DeviceDescription	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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Image /page/2/Picture/1 description: The image shows a black and white logo. The logo is circular and contains an emblem of three stylized lines resembling a bird in flight. The emblem is positioned in the center of the circle. The text around the circle is not clear enough to read.

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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I lerine Artery Embelization mtadi PV A & Fas Tracker & 33 lotu

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)	(Division Sign-Off) Division of Reproductive, Abdominal, Over-The Counter Use and Radiological Devices
510(k) Number	K030966
	Optional Format 1-2-96

Regulation Number and Section

§ 870.3300 Vascular embolization device.

(a)
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.(b)
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).