(180 days)
No
The provided text describes medical devices (emboli and catheters) and their intended use and performance studies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality.
Yes
The device is described as being used for the "embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations," which are therapeutic interventions. Additionally, the FasTracker-325® Infusion Catheters are designed to deliver "therapeutic agents." Furthermore, the "Summary of Performance Studies" section mentions a clinical study to support the "safety and effectiveness of these devices for treatment of uterine fibroids," which is a therapeutic purpose.
No
The devices described, Contour® Emboli PVA and FasTracker-325® Infusion Catheters, are intended for embolization (therapeutic) and delivery of agents (therapeutic or diagnostic), but neither device itself is described as performing a diagnostic function. While the FasTracker-325® can deliver "diagnostic agents," it is the agent, not the catheter, that performs the diagnosis.
No
The device description clearly describes physical medical devices (embolization particles and infusion catheters) and their intended use in physical procedures. There is no mention of software as the primary or sole component.
Based on the provided text, neither the Contour® Emboli PVA nor the FasTracker-325® Infusion Catheters are IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The descriptions of these devices clearly state their intended use is for embolization (blocking blood vessels) and delivering agents directly into the body's vasculature. This is an in vivo (within the living body) procedure, not an in vitro (in glass, outside the body) diagnostic test.
The text describes medical devices used for therapeutic and diagnostic delivery within the body, not for analyzing samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes
85 NAJ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical data were collected in a prospective clinical study to support the safety and effectiveness of these devices for treatment of uterine fibroids.
Key Metrics
Not Found
Predicate Device(s)
K871047, K914866, K944354, K926243
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Section 8
Summary of Safety and Effectiveness
| General
| Provisions | Trade Name: Contour® Emboli PVA and FasTracker®-325 Infusion Catheter |
|---|---|
| Classification Name: Artificial Embolization Device and Intravascular Infusion Catheter | |
| Name of | |
| Predicate | |
| Devices | Contour® Emboli PVA (K871047, K914866, K944354) |
| Fas-Tracker®-325 Infusion Catheter (K926243) | |
| Embosphere Microspheres(K991549, K021397) | |
| EmboGold Microspheres (K010026) | |
| Classification | Class III, Contour® Emboli PVA |
| Class II, FasTracker®-325 Infusion Catheter | |
| Performance | |
| Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Use | |
| and Device | |
| 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 |
1
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.
2
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.
3
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
4
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 |