(30 days)
QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are packaged in a vial containing 25 mg of dry microspheres. The expansion rate is dependent on ionic concentration. When in contact with blood, non-ionic contrast media, or normal saline (NaCl 0.9%), QuadraSphere Microspheres expand to approximately 4 times their dry state diameter; equal to 64x volume. They are available in a range of sizes.
This document describes the QuadraSphere Microspheres, a vascular embolization device. The main change in this submission is the extension of the product line to include a 20-40 µm size, in addition to existing sizes.
Here's the information regarding the acceptance criteria and study as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a precise "acceptance criteria" table with numerical targets, but it lists performance parameters tested and states that the device met the pre-determined acceptance criteria for each.
| Parameter Tested | Reported Device Performance |
|---|---|
| Macroscopic appearance of the powder | Met pre-determined acceptance criteria |
| Microscopic examination of the microspheres | Met pre-determined acceptance criteria |
| Swelling in Hexabrix of the microspheres | Met pre-determined acceptance criteria |
| Humidity of the microspheres | Met pre-determined acceptance criteria |
| Bacterial endotoxins | Met pre-determined acceptance criteria |
| Catheter compatibility | Met pre-determined acceptance criteria |
| Animal testing | Met pre-determined acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., number of microsphere batches for appearance, number of animals for in-vivo testing).
- Provenance: The studies were conducted by Biosphere Medical, S.A. No specific country of origin for the data is mentioned beyond the company's location in France. The document describes "design verification and validation testing," implying this was prospective testing directly supporting the device's clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or diagnosis. The tests are focused on physical and biological properties of the microspheres themselves.
4. Adjudication Method for the Test Set:
Not applicable. This is a technical performance study, not one requiring adjudication of diagnostic interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. This document does not describe an MRMC study. The device is a physical product (microspheres), not an AI algorithm for diagnostic assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This device is not an AI algorithm.
7. The Type of Ground Truth Used:
The ground truth for the performance tests was based on established engineering and biological specifications for medical device manufacturing and safety. For example:
- Physical properties (appearance, microscopic features, swelling) are typically compared against pre-defined specifications for the material and design.
- Biocompatibility is assessed against ISO 10993-1 standards.
- Bacterial endotoxin levels are measured against established safety limits.
- Catheter compatibility is tested against functional requirements for delivery.
- Animal testing would have pre-defined endpoints to evaluate safety and function in a biological system.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable. This device is not an AI algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2017
Biosphere Medical, S.A. Lionel Ngando Regulatory Affairs Specialist Parc des nations - Paris Nord 2 383 Rue de la Belle Etoile 95700 Roissy en France, France
Re: K172372
Trade/Device Name: QuadraSphere Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD, HCG Dated: August 2, 2017 Received: August 7, 2017
Dear Lionel Ngando:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Joyce M. Whang -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017 |
|---|---|
| Indications for Use | See PRA Statement below. |
| 510(k) Number ( if known ) | K172372 |
|---|---|
| Device Name | QuadraSphere Microspheres |
| Indications for Use ( Describe ) | QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations. |
| Type of Use ( Select one or both, as applicable ) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| August 02, 2017 | ||
|---|---|---|
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number: | Biosphere Medical, S.A.Parc des Nations – Paris Nord 2383, rue de la Belle Etoile95700 Roissy-en-France, France+33 (0)1 48 17 25 29+33 (0)1 49 38 02 68Alix Fonlladosa9615728 |
| Correspondent Name:Address:Telephone Number:Fax Number:Contact Person:Registration Number: | Biosphere Medical, S.A.Parc des Nations – Paris Nord 2383, rue de la Belle Etoile95700 Roissy-en-France, France+33 (0)1 48 17 25 21+33 (0)1 49 38 02 68Lionel Ekedi Ngando9615728 | |
| SubjectDevice | Trade Name:Common/Usual Name:Classification Name: | QuadraSphere® MicrospheresEmbolization Device21 CFR 870.3300 Vascular Embolization Device21 CFR 882.5950 Neurovascular Embolization Device |
| Predicate Device | Trade Name:Common/Usual Name:Classification Name:Manufacturer:Premarket Notification: | QuadraSphere® MicrospheresEmbolization Device21 CFR 870.3300 Vascular Embolization Device21 CFR 882.5950 Neurovascular Embolization DeviceBiosphere Medical, S.A.K153102, cleared November 23, 2015 |
| Classification | Class II21 CFR 870.330021 CFR 882.5950FDA Product Code: | KRD and HCGReview Panel: Division of Cardiovascular Devices |
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QuadraSphere Microspheres are indicated for embolization of Intended Use hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are packaged in a vial containing 25 mg of dry microspheres. The expansion rate is dependent on ionic concentration. When in contact with blood, non-ionic contrast media, or normal saline (NaCl 0.9%), QuadraSphere Microspheres expand to approximately 4 times their dry state diameter; equal to 64x volume.
They are available in a range of sizes.
| Reference | Size range (µm) |
|---|---|
| V125QS | 20-40 |
| V225QS | 30-60 |
| V325QS | 50-100 |
| V525QS | 100-150 |
| V725QS | 150-200 |
QuadraSphere Microspheres have the following properties:
Device Description
- Spherical shape with consistent cross sectional diameter after ● reconstitution with aqueous-based solutions such as contrast media and 0.9% saline solution for predictable flow directed level of occlusion in the vasculature.
- Rapidly absorb contrast media and 0.9% saline solution.
- . Conform to vessel lumen, providing more surface contact with vessel intima.
- Expand up to four times the stated dry diameter when hydrated with . non-ionic aqueous solutions, resulting in an increase in surface area contact for a more complete vessel occlusion.
The principles of operation for the QuadraSphere Microspheres are the same as the predicate device K153102. QuadraSphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolization. The device is provided dry (in a vial) and must be rehydrated before use. The microspheres are injected into the target vessel with an intravascular catheter(s) to selectively occlude blood vessels. Contrast enhancement using commercially available ionic or non-ionic contrast media allows the embolization procedure to be monitored using fluoroscopy. The embolization agents are intended for single use and are provided sterile.
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The technological characteristics of the subject of this Special 510(k) are substantially equivalent to the predicate QuadraSphere Microspheres, K153102 cleared on November 23, 2015. Both devices use the same components and materials. The device indications remain unchanged.
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Bold type indicates differences between subject and predicate device, K1513102. | |||
| Attribute | PredicateDeviceQuadraSphereMicrospheresK153102 | Subject DeviceQuadraSphereMicrospheres20-40μm | Comment |
| Microspheres Size | 30 to 60μm,50 to 100μm,100 to 150μm,150 to 200μm | 20 to 40 μm30 to 60μm,50 to 100μm,100 to 150μm,150 to 200μm | Will be extendedto 20-40μm |
| CathetercompatibilityComparison toPredicate | 20 to 40µm - ≥ 0.020"30 to 60µm - ≥ 0.021"50 to 100µm - ≥0.021"100 to 150µm - ≥ 0.024"150 to 200µm - ≥ 0.027" | Injectable in0.020" and widerID microcatheters. | |
| Shelf Life(Single use) | Three years(36 months) | Three years(36months) | Same |
| Material (spheres) | PVA AcrylicCopolymer (vinylalcohol-sodiumacrylate) | PVA AcrylicCopolymer (vinylalcohol-sodiumacrylate) | Sa me |
| PhysicalCharacteristics | Biocompatible,hydrophilic, non-resorbable,expandable,conformable andswell uponexposure toaqueoussolutions | Biocompatible,hydrophilic, non-resorbable,expandable,conformable andswell uponexposure toaqueoussolutions | Same |
| Principle ofOperation | The microspheresare administeredwith radiopaquecontrast mediuminto the patient'sartery via amicrocatheter. | The microspheresare administeredwith radiopaquecontrast mediuminto the patient'sartery via amicrocatheter. | Same principle ofoperation |
| Sterilization | RadiationSterilized | RadiationSterilized | Same |
| Performance | Designed forcontrolled,targetedembolizationwhen vesselconformity isdesired | Designed forcontrolled,targetedembolizationwhen vesselconformity isdesired | Same |
| Volume ofMicrospheres inVial (dry) | 25 mg per vial | 25 mg per vial | Same |
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BioSphere Medical, S.A. bases its claim of the substantial equivalence of the QuadraSphere Microspheres with the cited predicate device based on intended use, indic ntal scientific technological characteristics, and fundamental operational characteristics. In all cases, the embolization agent is delivered to selected sites through catheters with a diameter that is appropriate for the vascular target and the size of the embolization agent. Accurate placement is assured through visualization of the injection process using fluoroscopic imaging. Embolization agents are mixed with the contrast media before injection to optimize visualization of the embolization procedure. The subject device, QuadraSphere® Microspheres, is available in a 20 to 40 um size microspheres to permit selection of the appropriate size for target vessels. All cited embolization agents are intended for single use and are provided sterile.
Safety & Performance Tests
No performance standards applicable to this device have been adopted under Section 514 of the Act. However, vascular embolization devices are subject to the special controls specified in "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices," issued on December 29, 2004.
Biocompatibility assessment was performed in accordance with ISO 10993-1 for permanent implants in contact with blood for the predicate device and are being adopted for this subject device based upon the fact that both devices are made from the same materials using the same processes with now the inclusion of an additional size offering.
In-vitro and in-vivo (animal study) design verification and validation testing demonstrates that the BioSphere Medical QuadraSphere Microspheres 20 to 40µm fulfill design and performance specifications. Performance testing of the subject device was conducted based on the requirements of design input and output requirements as below:
- Macroscopic appearance of the powder .
- Microscopic examination of the microspheres ●
- Swelling in Hexabrix of the microspheres .
- Humidity of the microspheres
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| Bacterial endotoxins Catheter compatibility Animal testing | |
|---|---|
| The results of the testing demonstrated that the subject BioSphere MedicalQuadraSphere Microspheres 20 to 40 µm met the pre-determinedacceptance criteria applicable to the size requirements and performance ofthe device. | |
| Summary ofSubstantialEquivalence | Based on the same intended use, design, fundamental scientifictechnological characteristics, fundamental operational characteristics andsafety and performance testing, the BioSphere Medical subjectQuadraSphere Microspheres 20 to 40 µm device meets the requirementsthat are considered essential for its intended use and is substantiallyequivalent to the predicate device, QuadraSphere Microspheres K153102. |
§ 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).