(454 days)
Not Found
No
The device description focuses on the material and physical properties of the microspheres, and there is no mention of AI, ML, image processing, or any software-driven analysis or decision-making.
Yes
The device is described as "M-BolusTM Embolic Microspheres" intended for "embolization of arteriovenous malformations (AVMs) and hypervascular tumors" and "vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable." These actions are therapeutic interventions aimed at treating medical conditions.
No
The device is described as embolic microspheres intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, and for vascular occlusion. This is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device is made of a physical material (Polyvinyl Alcohol) and is supplied in a hydrated state, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "embolization of arteriovenous malformations (AVMs) and hypervascular tumors" and "vascular occlusion of vessels within the neurovascular system." This describes a therapeutic procedure performed within the patient's body, not a diagnostic test performed outside the body on biological samples.
- Device Description: The description details a physical object (microspheres) made of a synthetic polymer, designed to be delivered into the vasculature. This is consistent with an implantable or interventional device, not a reagent or instrument used for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The M-Bolus Embolic Microspheres do not fit this description. They are a therapeutic device used to physically block blood vessels.
N/A
Intended Use / Indications for Use
The M-BolusTM Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable.
Product codes
HCG
Device Description
M-BOLUSTM Embolic Microspheres are made out of a biocompatible, non-degradable and non-absorbable synthetic polymer called Polyvinyl Alcohol (PVA). The M-BOLUSTM Embolic Microspheres are precisely manufactured spheres, with a smooth and lightly porous surface with hydrophilic characteristics. The M-BOLUSTM Embolic Microspheres, which are supplied in a hydrated state (0.9% Sodium Chloride), are soft and flexible allowing them to be compressed/deformed as they travel through the lumen of a delivery catheter or the vasculature. The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheres are substantially equivalent to the predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular system
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
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| Submitted by: | Scion Cardio-Vascular, Inc.
14256 SW 119th Avenue
Miami, FL 33186
Phone: (305) 259-8880
Fax: (305) 259-8878 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Suzana Otaño-Lata |
| Date Prepared: | October 26, 2005 |
| Proprietary Name: | M-BolusTM Embolic Microspheres |
| Common Name: | Embolic Microspheres |
| Classification Name: | Neurovascular Embolization Device (21 CFR § 882.5950)
ProCode: HCG |
| Predicate Device: | Boston Scientific Corporation K032707 Contour SETM Microspheres |
| Device Description: | M-BOLUSTM Embolic Microspheres are made out of a
biocompatible, non-degradable and non-absorbable synthetic
polymer called Polyvinyl Alcohol (PVA).
The M-BOLUSTM Embolic Microspheres are precisely
manufactured spheres, with a smooth and lightly porous
surface with hydrophilic characteristics.
The M-BOLUSTM Embolic Microspheres, which are supplied in
a hydrated state (0.9% Sodium Chloride), are soft and flexible
allowing them to be compressed/deformed as they travel
through the lumen of a delivery catheter or the vasculature.
The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheres
are substantially equivalent to the predicate devices. |
| Intended Use: | The M-BolusTM Embolic Microspheres are intended for the
embolization of arteriovenous malformations (AVMs) and
hypervascular tumors. They may be used for vascular
occlusion of vessels within the neurovascular system when
presurgical devascularization is desirable. |
| Technological | The technological characteristics of the M-BolusTM Embolic |
Section 5 — 510(k) Summary
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Characteristics: Microspheres are the same as the predicate devices, including design and material. The M-Bolus™ successfully completed biocompatibility testing per ISO 10993-1.
Summary of Substantial Equivalence: The Scion Cardio-Vascular M-BOLUS™ is substantially equivalent to the currently marketed Contour SE™ Microspheres. No new issues of safety or efficacy have been raised. Scion Cardio-Vascular has provided information
and Neurovascular Embolization Devices.
supporting acceptability for use and substantial equivalence per Class II Special Controls Guidance Document: Vascular
KIT 2009
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEC 1 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Scion Cardio-Vascular % Ms. Suzana Otaño-Lata Consultant 14256 S.W. 119th Aenue Miami, Florida 33186
Re: K052509
Trade/Device Name: M-BOLUS™ Embolic Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Neurovascular embolization device Regulatory Class: II Product Code: HCG Dated: October 12, 2006 Received: October 13, 2006
Dear Ms. Otaño-Lata:
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. Suzana Otaño-Lata
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.
Sincercly vours
for
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Korosos
SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number: K052509
M-BロLUs™ Embolic Microspheres Device Name:
Indications For Use: The M-BOLUS™ Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical .............................................................................................................................................................................. devascularization is desirable.
× Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter (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)
ర్ల
ign-Off) (Division Page 1 of 1 Division of General, Restorative, and Neurological Devices
510(k) Number K052505