(27 days)
Not Found
Not Found
No
The device description and summary of performance studies focus on the physical properties and delivery of the microspheres for embolization, with no mention of AI or ML technology.
Yes
The device is indicated for the embolization of hypervascular tumors and AVMs, which is a treatment for a medical condition.
No.
The device is used for embolization (treatment) of hypervascular tumors and AVMs, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical product (microspheres) packaged in syringes, not a software application.
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, including leiomyoma uteri and arteriovenous malformations (AVMs). This is a therapeutic procedure performed in vivo (within the body) to block blood vessels.
- Device Description: The device is a physical embolic material (microspheres) delivered through a catheter to achieve vascular occlusion. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to physically block blood vessels for therapeutic purposes.
N/A
Intended Use / Indications for Use
Contour SE Microspheres (Syringe) is intended to be used for the embolization of hypervascular tumors, including leiomyoma uteri and arteriovenous malformations (AVMs).
Product codes (comma separated list FDA assigned to the subject device)
HCG, KRD
Device Description
Contour SE Microspheres are spherical-shaped polyvinyl alcohol embolic devices to provide targeted vascular occlusion or reduction of blood flow within targeted vessels. The product is packaged sterile syringe containing a 1 mL of or 2 mL of Contour SE Microsphere and 5 mL of saline. Each syringe is packaged in a sterile, peel-away barrier.
Contour SE Microspheres are designated for smooth delivery through a variety of infusion catheters.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Contour SE Microspheres (Syringe) have been tested and compared to the predicate devices. All data gathered demonstrate this device as substantially equivalent. No new issues of safety and efficacy have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Contour SET™ Microspheres
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Page 1 of 1
Special 510(k)
Boston Scientisco Modified CSENA
| Summary of Safety and Effectiveness | K071634 | |
|---|---|---|
| General Information | Submitter: Boston Scientific Corporation | |
| 100 Boston Scientific Way | ||
| Marlborough, MA 01752 | ||
| 508-683-4234 | JUL 12 2007 | |
| Contact Person: Shilpa Prem | ||
| General Provisions | Trade Name: Contour SET™ Microspheres (Syringe) | |
| Classification Name: Vascular Embolization Device | ||
| Name of Predicate Devices | Contour SET™ Microspheres | |
| 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 Device Description | Contour SE Microspheres (Syringe) is intended to be used for the embolization of | |
| hypervascular tumors, including leiomyoma uteri and arteriovenous malformations | ||
| (AVMs). | ||
| Device Description | Contour SE Microspheres are spherical-shaped polyvinyl alcohol embolic devices to | |
| provide targeted vascular occlusion or reduction of blood flow within targeted | ||
| vessels. The product is packaged sterile syringe containing a 1 mL of or 2 mL of | ||
| Contour SE Microsphere and 5 mL of saline. Each syringe is packaged in a sterile, | ||
| peel-away barrier. |
Contour SE Microspheres are designated for smooth delivery through a variety of
infusion catheters. | |
| Summary of Substantial Equivalence | The Contour SE Microspheres (Syringe) have been tested and compared to the
predicate devices. All data gathered demonstrate this device as substantially
equivalent. No new issues of safety and efficacy have been raised. | |
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1
Public Health Service
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation, Inc % Ms. Shilpa Prem Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752-1234
JUL 1 2 2007
Re: K071634
Trade/Device Name: Contour SE " Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG, KRD Dated: June 14, 2007 Received: June 15, 2007
Dear Ms. Prem:
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.
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Page 2 - Ms. Shilpa Prem
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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1
Indications for Use
510(k) Number: K071634
Device Name: Contour SE™ Microspheres
Indications For Use: Contour SE Microspheres are indicated 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation)(ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number /K071634