(28 days)
Not Found
Not Found
No
The summary describes embolization microspheres, a physical medical device, and makes no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for the embolization of hypervascular tumors and arteriovenous malformations, which is a therapeutic intervention.
No
Explanation: The device is indicated for "embolization," which is a treatment procedure, not a diagnostic one.
No
The device description and intended use clearly indicate that the device is "Contour SET ™ Microspheres," which are physical particles used for embolization. There is no mention of software as the primary component or function of the 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 arteriovenous malformations. This is a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is described as "Microspheres," which are physical particles used for embolization.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) outside the body.
- Providing diagnostic information about a patient's condition.
- Using reagents or assays.
IVDs are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Contour SET ™ Microspheres are used for a therapeutic intervention in vivo.
N/A
Intended Use / Indications for Use
Contour SET ™ Microspheres are indicated for use for the embolization of hypervascular tumors and arteriovenous malformations.
Product codes
HCG
Device Description
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Contour ® Emboli PVA, Embosphere Microspheres, EmboGold Microspehers
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).
0
Special 510(k)
Contour SE™ Microspheres
July 24, 2002
Summary of Safety and Effectiveness
AUG 2 2 2 2002
| General
| Provisions | Trade Name: Contour SET ™ Microspheres |
|---|---|
| Classification Name: Artificial Embolization Device | |
| Name of | |
| Predicate | |
| Devices | Contour ® Emboli PVA |
| Embosphere Microspheres | |
| EmboGold Microspehers | |
| Classification | Class II |
| 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 are indicated for use for the embolization of |
| hypervascular tumors and arteriovenous malformations. | |
| Biocompatibility | The Contour SET ™ Microspheres 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. |
0048
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract shapes that resemble human profiles or stylized wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2002
Jodi Lynn Greenizen Regulatory Affairs Project Manager Boston Scientific Corporation 10 Glens Falls Technical Park Dix Avenue Glens Falls, New York 12801-3864
Re: K022427
Trade/Device Name: Contour SE™ Microspheres Regulation Number: 882.5950 Regulation Name: Artificial embolization devices Regulatory Class: Class III Product Code: HCG Dated: July 24, 2002 Received: July 25, 2002
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 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 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.
2
Page 2 – Ms. Jodi Lynn Greenizen
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,
for Mark N. Melkers
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
| 510(k)
Number
| (if known) | Unknown |
|---|---|
| Device Name: | Contour SET TM Microspheres |
| Indications | |
| for Use | Contour SET TM Microspheres are indicated for use for the embolization of |
| hypervascular tumors and arteriovenous malformations. |
(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)
Confidential
Boston Scientific Corporation
OR
Over-The Counter Use
(Optional Format 1-2-96)
for Mark N. Mekerson
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number. K022427