(84 days)
Not Found
No
The device description focuses on the physical and chemical properties of the microspheres and their mechanism of action (embolization). There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies are based on material properties and biocompatibility, not algorithmic performance.
Yes
The device is intended for the embolization of hypervascularized tumors and arteriovenous malformations, which is a therapeutic intervention designed to treat medical conditions.
No
The device, QuadraSphere Microspheres, is described as a permanent implantable device designed for controlled, targeted embolization to occlude blood vessels, which is a therapeutic rather than a diagnostic function.
No
The device is described as physical microspheres made of acrylic copolymer, provided in vials, and intended for injection into blood vessels. This clearly indicates a physical hardware component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- QuadraSphere Microspheres Function: QuadraSphere Microspheres are designed to be injected into the body (in vivo) to physically block blood vessels. They are a therapeutic device used for embolization, not a diagnostic tool that analyzes biological samples.
The description clearly states that the microspheres are "permanent implantable devices" and are "injected into the target vessel with an intravascular catheter(s) to selectively occlude blood vessels." This is the opposite of an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
QuadraSphere Microspheres are indication of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.
Product codes (comma separated list FDA assigned to the subject device)
KRD, HCG
Device Description
QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are in vials 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 (um)
V225QS | 30-60
V325QS | 50-100
V525QS | 100-150
V725QS | 150-200
QuadraSphere Microspheres have the following properties:
- 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 devices K052742 (50-100um, 100-150um and 150-200µm) and K113822 (30-60µm). 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
vessels, vasculature
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)
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. Non-clinical performance testing conducted on the predicate device includes: · Chemical analysis · Size range · Catheter compatibility · Density • Packaging performance • Shelf Life & · Sterility Safety · Biocompatibility Performance Tests Biocompatibility evaluation was performed in accordance with ISO 10993-1:2009 for permanent implants in contact with blood for the predicate devices K052742 (50-100μm, 100-150μm and150-200μm) and K113822 (30-60um), and is being adopted for this subject device based upon the fact that all devices are made from the same materials using the same manufacturing and sterilization processes. No new testing was performed since both predicate devices, K052742 (50-100μm, 100-150μm and150-200μm) and K113822 (30-60μm), and the QuadraSphere Microspheres have identical technological subject characteristics, manufacturing, processing and sterilization.
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.
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
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2015
BioSphere Medical S.A. Alix Fonlladosa Regulatory Affairs Manager Parc des Nations - Paris Nord 2 383 rue de la Belle Étoile 95700 Roissy-en-France France
Re: K151187
Trade/Device Name: QuadraSphere Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: II Product Code: KRD, HCG Dated: April 30, 2015 Received: May 4, 2015
Dear Alix Fonlladosa,
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
1
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); medical device reporting (reporting of medical device-related 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 at its toll-free number (800) 638-2041 or at (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 yours.
Benjamin R. Fisher -S
Benjamin R. Fisher, PhD Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/1 description: The image contains the logo for BioSphere Medical. The logo consists of a blue circle with white curved lines inside, followed by the text "BioSphere" in a bold, sans-serif font. Below "BioSphere" is the word "Medical" in a smaller, sans-serif font. A registered trademark symbol is present next to the word "BioSphere".
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name QuadraSphere Microspheres
Indications for Use (Describe)
QuadraSphere Microspheres are indication 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the logo for BioSphere Medical. The logo consists of a blue circle with white curved lines inside, followed by the words "BioSphere" in bold black letters and "Medical" in a smaller, lighter font below. A small registered trademark symbol is present next to the word "BioSphere".
Section 5
510(k) Summary
| General
| Provisions | Submitter Name: | BioSphere Medical S.A. |
|---|---|---|
| Address: | 383 Rue de la Belle Étoile | |
| 95700 Roissy-en-France | ||
| Telephone Number: | +33 (0)1 48 17 25 29 | |
| Fax Number: | +33 (0)1 49 38 02 68 | |
| Contact Person: | Alix Fonlladosa | |
| Registration Number: | 9615728 | |
| Correspondent Name: | BioSphere Medical S.A. | |
| Address: | 383 Rue de la Belle Étoile | |
| 95700 Roissy-en-France | ||
| Telephone Number: | +33 (0)1 48 17 25 30 | |
| Fax Number: | +33 (0)1 49 38 02 68 | |
| Contact Person: | Lionel Ekedi Ngando | |
| Registration Number: | 9615728 | |
| Subject | ||
| Device | Trade Name: | QuadraSphere Microspheres |
| Common/Usual Name: | Embolization Device | |
| Classification Name: | Vascular Embolization Device | |
| Predicate | ||
| Device | Premarket Notification Predicate Device # 1: | |
| Trade Name: QuadraSphere Microspheres (Size:50-100μm, 100- | ||
| 150μm, 150-200 μm) | ||
| Common/Usual Name: Embolization Device | ||
| Classification Name: Vascular Embolization Device | ||
| Manufacturer: BioSphere Medical S.A. | ||
| Premarket Notification: K052742, cleared Nov 7, 2006 | ||
| Premarket Notification Predicate Device # 2: | ||
| Trade Name: QuadraSphere Microspheres (Size: 30-60μm) | ||
| Common/Usual Name: Embolization Device | ||
| Classification Name: Neurovascular Embolization Device | ||
| Manufacturer: BioSphere Medical S.A. | ||
| Premarket Notification: K113822, cleared Feb 6, 2012 | ||
| Classification | Class II | |
| 21 CFR § 870.3300, 21 CFR § 882.5950 | ||
| Product code: KRD, HCG | ||
| Division of Cardiovascular Devices | ||
| Intended Use | QuadraSphere Microspheres are indicated for embolization of | |
| hypervascularized tumors including hepatoma, and peripheral arteriovenous | ||
| malformations. |
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Image /page/4/Picture/1 description: The image shows the logo for BioSphere Medical. The logo consists of a blue circle with three white curved lines inside, followed by the text "BioSphere" in a larger, bold font and "Medical" in a smaller font below it. There is a registered trademark symbol next to the word "BioSphere".
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Image /page/5/Picture/1 description: The image shows the logo for BioSphere Medical. The logo consists of a blue circle with three white curved lines inside, followed by the text "BioSphere" in a bold, sans-serif font on the top line and "Medical" in a smaller, sans-serif font on the bottom line. A registered trademark symbol is located to the right of the word "BioSphere".
QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are in vials 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 (um) |
|---|---|
| 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 devices K052742 (50-100um, 100-150um and 150-200μm) and K113822 (30-60μm). 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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Image /page/6/Picture/1 description: The image shows the logo for BioSphere Medical. The logo consists of a blue circular graphic on the left, followed by the text "BioSphere" in a larger, bolder font, and "Medical" in a smaller font below it. A registered trademark symbol is present next to the word "BioSphere".
The technological characteristics of the subject of this Traditional 510(k) are identical to the predicate QuadraSphere Microspheres, K052742 (50-100µm, 100-150µm and 150-200µm) cleared on November 7, 2006 and K113822 (30-60µm) cleared on February 6, 2012. Only the indications for use change between the subject device and the legally marketed QuadraSphere Microspheres, K052742 and K113822. The indications for use statement of the subject QuadraSphere Microspheres includes a specific indication by identifying "hepatoma" as being a subset of hypervascularized tumors treated with vascular embolization devices, as established by 21 CFR § 870.3300.
| Technological Characteristics Comparison Table | |||||
|---|---|---|---|---|---|
| Attribute | Predicate | ||||
| Device | |||||
| QuadraSphere | |||||
| Microspheres | |||||
| 50-100μm | |||||
| 100-150μm | |||||
| 150-200 μm | Predicate | ||||
| Device | |||||
| QuadraSphere | |||||
| Microspheres | |||||
| 30-60μm | Subject | ||||
| Device | |||||
| QuadraSphere | |||||
| Microspheres | |||||
| 30-60μm | |||||
| 50-100μm | |||||
| 100-150μm | |||||
| 150-200 μm | Comment | ||||
| Comparison | |||||
| to Predicate | Shelf Life | ||||
| (single use) | Three years | ||||
| (36 months) | Three years | ||||
| (36 months) | Three years | ||||
| (36 months) | Same | ||||
| Material | PVA Acrylic | ||||
| Copolymer | |||||
| (vinyl alcohol- | |||||
| sodium | |||||
| acrylate) | PVA Acrylic | ||||
| Copolymer | |||||
| (vinyl alcohol- | |||||
| sodium | |||||
| acrylate) | PVA Acrylic | ||||
| Copolymer | |||||
| (vinyl alcohol- | |||||
| sodium | |||||
| acrylate) | Same | ||||
| Physical | |||||
| Characteristics | Biocompatible, | ||||
| hydrophilic, | |||||
| non- | |||||
| resorbable, | |||||
| expandable, | |||||
| conformable | |||||
| and swell upon | |||||
| exposure to | |||||
| aqueous | |||||
| solutions | Biocompatible, | ||||
| hydrophilic, | |||||
| non- | |||||
| resorbable, | |||||
| expandable, | |||||
| conformable | |||||
| and swell upon | |||||
| exposure to | |||||
| aqueous | |||||
| solutions | Biocompatible, | ||||
| hydrophilic, | |||||
| non- | |||||
| resorbable, | |||||
| expandable, | |||||
| conformable | |||||
| and swell upon | |||||
| exposure to | |||||
| aqueous | |||||
| solutions | Same | ||||
| Sterilization | Radiation | ||||
| Sterilized | Radiation | ||||
| Sterilized | Radiation | ||||
| Sterilized | Same | ||||
| Performance | Designed for | ||||
| controlled, | |||||
| targeted | |||||
| embolization | |||||
| when vessel | |||||
| conformity is | |||||
| desired | Designed for | ||||
| controlled, | |||||
| targeted | |||||
| embolization | |||||
| when vessel | |||||
| conformity is | |||||
| desired | Designed for | ||||
| controlled, | |||||
| targeted | |||||
| embolization | |||||
| when vessel | |||||
| conformity is | |||||
| desired | Same | ||||
| Volume of | |||||
| Microspheres | |||||
| in Vial (dry) | 25 mgs per vial | 25 mgs per vial | 25 mgs per vial | Same |
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Image /page/7/Picture/1 description: The image shows the logo for BioSphere Medical. The logo consists of a blue circle with white curved lines inside, followed by the text "BioSphere" in a bold, sans-serif font. Below "BioSphere" is the word "Medical" in a smaller, sans-serif font.
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. Non-clinical performance testing conducted on the predicate device includes: · Chemical analysis · Size range · Catheter compatibility · Density • Packaging performance • Shelf Life & · Sterility Safety · Biocompatibility Performance Tests Biocompatibility evaluation was performed in accordance with ISO 10993-1:2009 for permanent implants in contact with blood for the predicate devices K052742 (50-100μm, 100-150μm and150-200μm) and K113822 (30-60um), and is being adopted for this subject device based upon the fact that all devices are made from the same materials using the same manufacturing and sterilization processes. No new testing was performed since both predicate devices, K052742 (50-100μm, 100-150μm and150-200μm) and K113822 (30-60μm), and the QuadraSphere Microspheres have identical technological subject characteristics, manufacturing, processing and sterilization. Based on the same intended use (other than the requested change that is the objective of this submission), design, fundamental scientific technological characteristics, fundamental operational characteristics and safety and Summary of performance testing, the BioSphere Medical subject QuadraSphere Substantial Microspheres device meets the requirements that are considered essential Equivalence for its intended use and is substantially equivalent to the predicate devices, QuadraSphere Microspheres K052742 (50-100µm, 100-150µm and 150-200um) and K113822 (30-60µm).