(403 days)
Not Found
No
The summary describes a physical medical device (microspheres) used for embolization and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for embolization of tumors and arteriovenous malformations, which are direct treatments for medical conditions.
No
The device is described as microspheres intended for embolization of tumors and arteriovenous malformations, which is a therapeutic rather than diagnostic function. It is used to block blood vessels, not to provide diagnostic information about a patient's condition.
No
The device description clearly states that the device is composed of physical microspheres, which are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of hypervascularized tumors and peripheral vascular 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 material (microspheres) used to physically block blood flow.
- Lack of Diagnostic Function: The device does not perform any tests on samples taken from the body (in vitro) to diagnose a condition. It is used to treat a condition that has already been diagnosed.
IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The BioSphere QuadraSphere™ Microspheres are intended for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).
QuadraSphere Microspheres are indicated for embolization of hypervascularized arteriovenous malformations.
Product codes
KRD, HCG
Device Description
BioSphere Medical, Inc., QuadraSphere™ Microspheres are sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres. They are provided in three (nominal) microsphere sizes: 50 to 100 um, 100 to 150 um, and 150 to 200 um in containers (vials) containing 50 mg of the dry spheres.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic imaging
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)
In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K042231, K022427, K032542, K944354, K991549
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
K05 2742
510(k) Summary for the BioSphere Medical, Inc. QuadraSphere™ Microspheres
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SUBMITTER/510(K) HOLDER 1.
BioSphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 USA
NGV - 7 2006
Contact Person: Irina Kulinets Telephone: 781-681-7900
Date Prepared: September 29, 2005
2. DEVICE NAME
Proprietary Name: QuadraSphere™ Microspheres Common/Usual Name: Embolization device Classification Name: Vascular embolization device
3. PREDICATE DEVICES
- Biocompatibles UK Ltd., GelSpheres, BeadBlock Compressible . Microspheres (K042231)
- Boston Scientific Corporation, Contour SE (K022427, K032542) .
- Interventional Therapeutics Corporation, Contour Emboli (K944354) .
- BioSphere Medical, Inc., Embospheres (K991549) .
DEVICE DESCRIPTION 4.
BioSphere Medical, Inc., QuadraSphere™ Microspheres are sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres. They are provided in three (nominal) microsphere sizes: 50 to 100 um, 100 to 150 um, and 150 to 200 um in containers (vials) containing 50 mg of the dry spheres.
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5. INTENDED USE
The BioSphere QuadraSphere™ Microspheres are intended for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
BioSphere Medical, Inc. bases its claim of the substantial equivalence of the QuadraSphere™ Microspheres with the cited predicate devices based on intended use, indications for use, fundamental 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. Like predicate devices the QuadraSphere™ Microspheres are available in a range of sizes to permit selection of the most appropriate size for target vessels. All cited embolization agents are intended for single use and are provided sterile.
7. PERFORMANCE TESTING
In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a stacked formation, resembling a bird-like shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biosphere Medical, Inc. % Medical Device Consultants, Inc. Rosina Robinson, RN, Med, RAC Principal Consultant 49 Plain Street North Attleboro, Massachusetts 02760
NOV - 7 2006
Re: K052742
Trade/Device Name: QuadraSphere™ Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II Product Code: KRD, HCG Dated: August 15, 2006 Received: August 16, 2006
Dear Ms. Robinson:
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
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Page 2 – Rosina Robinson, RN, Med, RAC
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.
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
Rumm
DEA
ARECTOR
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052742_____________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
QuadraSphere Microspheres are indicated for embolization of hypervascularized arteriovenous malformations.
| Prescription Use | X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 4052742 |
|---|---|
| --------------- | --------- |