(454 days)
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.
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.
The provided text is a 510(k) summary for the M-BOLUS™ Embolic Microspheres. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance studies in the way one would for a novel device or AI algorithm.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or not present in this type of regulatory submission. This document is a premarket notification for a medical device that claims substantial equivalence to an already approved device.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present specific quantitative acceptance criteria or detailed performance results in the format of a table as typically seen for AI/software-based devices. The basis for acceptance is stated as "substantial equivalence" to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Boston Scientific Contour SE™ Microspheres) | "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." "M-Bolus™ successfully completed biocompatibility testing per ISO 10993-1." |
| Design and Material Characteristics | "The technological characteristics of the M-Bolus™ Embolic Microspheres are the same as the predicate devices, including design and material." |
| Biocompatibility | "The M-Bolus™ successfully completed biocompatibility testing per ISO 10993-1." |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a physical embolic microsphere, not an AI algorithm. There is no "test set" of data in the typical sense for an AI model. Biocompatibility testing was mentioned, but no sample sizes or data provenance for that testing are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" to be established by experts for a physical device like embolic microspheres in this context. The evaluation is based on material properties, design, and intended use as compared to a predicate device.
4. Adjudication method for the test set
Not applicable. There is no "test set" and thus no adjudication method needed for expert consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical device (embolic microspheres), not an AI algorithm intended for use by human readers. Therefore, an MRMC study and AI assistance effect size are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used
Not applicable. As this is a physical device, the "ground truth" concept in the context of expert consensus or pathology for diagnostic AI is not relevant. The substantial equivalence claim is based on comparing the device's technical characteristics, materials, and intended use to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm that requires a training set or ground truth for its development.
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| Submitted by: | Scion Cardio-Vascular, Inc.14256 SW 119th AvenueMiami, FL 33186Phone: (305) 259-8880Fax: (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 abiocompatible, non-degradable and non-absorbable syntheticpolymer called Polyvinyl Alcohol (PVA).The M-BOLUSTM Embolic Microspheres are preciselymanufactured spheres, with a smooth and lightly poroussurface with hydrophilic characteristics.The M-BOLUSTM Embolic Microspheres, which are supplied ina hydrated state (0.9% Sodium Chloride), are soft and flexibleallowing them to be compressed/deformed as they travelthrough the lumen of a delivery catheter or the vasculature.The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheresare substantially equivalent to the predicate devices. |
| Intended Use: | The M-BolusTM Embolic Microspheres are intended for theembolization of arteriovenous malformations (AVMs) andhypervascular tumors. They may be used for vascularocclusion of vessels within the neurovascular system whenpresurgical 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
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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
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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
§ 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).