(86 days)
No
The summary describes a physical embolization device (microspheres) and its intended use. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance study focuses on clinical outcomes of the physical device.
Yes
The device is used for the "embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs)", which is a therapeutic intervention.
No
The device is described as being used for "embolization," which is a therapeutic procedure to block blood vessels, not to diagnose a condition.
No
The device description clearly states "Contour SE™ Microspheres," indicating a physical product (microspheres) used for embolization, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of hypervascular tumors and AVMs. This is a therapeutic procedure performed in vivo (within the body) to block blood vessels.
- Device Description: The description reinforces the use of microspheres for embolization, which is an interventional procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are used for diagnostic purposes, not therapeutic intervention.
The device is clearly intended for a medical procedure performed directly on the patient, which is characteristic of a therapeutic or interventional device, not an IVD.
N/A
Intended Use / Indications for Use
Contour SET™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).
Product codes
74 KRD, 85 NAJ
Device Description
Contour SET™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).
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)
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
MAR 2 6 2004
Image /page/0/Picture/1 description: The image shows a sequence of handwritten alphanumeric characters. The sequence reads 'K034068' from left to right. The characters are written in a simple, slightly rough style, with some variations in line thickness.
Section 15
Summary of Safety and Effectiveness
| General Provisions | Trade Name: Contour SET™ Microspheres
Classification Name: Artificial Embolization Device |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of
Predicate
Devices | Contour SET™ Microspheres (K022427, K032707 & K032542)
Contour™ Emboli PVA (K030966) |
| Classification | Class III |
| 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 | Contour SET™ Microspheres may be used for the embolization of hypervascular
tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs). |
| Biocompatibility | No new materials have been introduced during this modification to the indications
for use statement as compared to the predicate devices. The predicate devices
have been tested for biocompatibility per ISO 10993. All data demonstrate this
device is biocompatible for its intended use. |
| Summary of
Substantial
Equivalence | The Contour SET™ Microspheres 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. |
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 26 2004
Ms. Jennifer Bolton, RAC Senior Regulatory Affairs Specialist Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537
Re: K034068
Trade/Device Name: UAE Contour SE™ Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Arterial embolization device Regulatory Class: III Product Code: 74 KRD and 85 NAJ Dated: December 30, 2003 Received: December 31, 2003
Dear Ms. Bolton:
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.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and it your be FDA finding of substantial equivalence of your device to a legally promaticated predicated. " ceresults 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 If you dosite specific at 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 Other or other 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. brogden.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K034068
Device Name: Contour® SE™ Microspheres
Indications For Use: Contour SE™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Choydon
(Division Sion Off) Division of Reproductive. And and Radiological Devices 510(k) Number
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