(359 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical performance of the microspheres, with no mention of AI or ML technologies.
Yes
The device is used for embolization of tumors and malformations, which is a therapeutic intervention.
No
The device description indicates that EMBOSPHERE® Microspheres are used for arterial embolization to treat conditions, not to diagnose them.
No
The device description clearly states that the device is composed of physical microbeads made of acrylic polymer and gelatin, which are delivered via a microcatheter. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "embolization of hypervascular tumors and arteriovenous malformations." This is a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is described as "spherical microbeads for arterial embolization" delivered via a microcatheter. This is a physical device used for a medical intervention.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
The information clearly indicates a device used for a therapeutic intervention within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
EMBOSPHERE® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.
Product codes
HCG
Device Description
EMBOSPHERE® Microspheres are spherical microbeads for arterial embolization, made of acrylic polymer impregnated with gelatin. They are delivered with the help of a microcatheter in an amount appropriate to the area to be embolized. Six ranges of EMBOSPHERE® Microspheres are available in order to allow the physician to choose the calibration necessary for the vessel being embolized:
- 40-120 microns
- 100-300 microns
- 300-500 microns
- 500-700 microns
- 700-900 microns
- 900-1200 microns
The EMBOSPHERE Microspheres, like the predicate devices, are available in a range of sizes to permit selection of the most appropriate size for target vessels. EMBOSPHERE Microspheres and all of the substantially equivalent embolization devices are intended for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic imaging
Anatomical Site
vascular target
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / 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
The substantial equivalence of EMBOSPHERE® Microspheres was supported by both in-vitro and in-vivo performance testing, which included the following:
- biocompatibility testing conducted in accordance with ISO 10993
- bench testing conducted during the development of the product
- animal testing to examine ease of injection, depth of penetration, and tissue reaction"
- clinical data describing the European experience with using EMBOSPHERE® Microspheres to treat a variety of hypervascular tumors and arteriovenous malformations'
- the results of a clinical study comparing EMBOSPHERE® Microspheres to PVA for preoperative embolization of meningiomas.
Key Metrics
Not Found
Predicate Device(s)
K944354, K871047, K961923, K964112
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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Image /page/0/Picture/1 description: The image shows a series of numbers and letters written in a stylized, calligraphic font. The characters appear to be 'K961549'. The font is bold and the characters are closely spaced, giving the impression of a continuous, flowing design. The image is in black and white, with the characters standing out against a white background.
510(k) Summary for Biosphere Medical, Inc. EMBOSPHERE® Microspheres
1. SPONSOR
Biosphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 (781) 681-7900 Telephone: (781) 681-5093 Fax:
Contact Individual: Jon McGrath
2. DEVICE NAME ·
EMBOSPHERE® Microspheres Proprietary Name: Artificial embolization device Common/Usual Name: Artificial embolization device Classification Name:
3. PREDICATE DEVICES
- ITC Contour Emboli (K944354) .
- ITC Radiopaque Spherical Emboli (RSE) (K871047) �
- Target Therapeutics Berenstein Coil (K961923, K964112) .
DEVICE DESCRIPTION 4.
EMBOSPHERE® Microspheres are spherical microbeads for arterial embolization, made of acrylic polymer impregnated with gelatin. They are delivered with the help of a microcatheter in an amount appropriate to the area to be embolized. Six ranges of EMBOSPHERE® Microspheres are available in order to allow the physician to choose the calibration necessary for the vessel being embolized:
- 40-120 microns
- 100-300 microns
- 300-500 microns
- 500-700 microns
- 700-900 microns · 1
- 900-1200 microns -
Biosphere Medical, Inc.
EMBOSPHERE® Microspheres
April 24, 2000
1
ಳು INTENDED USE
EMBOSPHERE® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE હ.
The method of application for EMBOSPHERE® Microspheres and all of the predicate devices is the same. All are intended to be delivered to selected sites through catheters with a diameter appropriate for the vascular target and the size of the emboli. Accurate placement of all of the embolization devices is assured through visualization of the embolization process using radiographic imaging. The RSE silicone elastomer microspheres and the Berenstein Coils are both radiopaque, while the PVA particles and EMBOSPHERE® Microspheres are mixed with a radiopacity agent prior to injection to permit visualization. The EMBOSPHERE® Microspheres, like the predicate devices, are available in a range of sizes to permit selection of the most appropriate size for target vessels. EMBOSPHERE Microspheres and all of the substantially equivalent embolization devices are intended for single use. The ITC RSE silicone microspheres are supplied non-sterile, while the EMBOSPHERE® Microspheres, and all of the other predicate devices, are supplied sterile.
7. PERFORMANCE TESTING
The substantial equivalence of EMBOSPHERE® Microspheres was supported by both in-vitro and in-vivo performance testing, which included the following:
- biocompatibility testing conducted in accordance with ISO 10993 .
- bench testing conducted during the development of the product ●
- animal testing to examine ease of injection, depth of penetration, and 0 tissue reaction"
- . clinical data describing the European experience with using EMBOSPHERE® Microspheres to treat a variety of hypervascular tumors and arteriovenous malformations'
- the results of a clinical study comparing EMBOSPHERE® Microspheres . to PVA for preoperative embolization of meningiomas.4
Biosphere Medical, Inc. EMBOSPHERE® Microspheres
:5 :00 :00 :00 :00 :
AMERICA (1) 2017-1917 (1978) 1997-1999
April 24, 2000
1 Laurent A, Beaujeux R, Wassef M, et al.: Trisacryl gelatin microspheres for the therapeutic embolization, I: Development and in vitro evaluation. AJNR, 17:533-40, Mar 1996.
2 Derdeya CP, Graves VB, Salamat MS, et al .: Collagen-coated acrylic microspheres for embolotherapy: In vivo and in vitro characteristics. AINR, 18:647-53, Apr 1997.
3 Beaujeux R, Laurent A, Wassef M, et al.: Trisacryl gelain microspheres for therapeutic embolization, II: Preliminary clinical evaluation in tumors and arteriovenous malformations. AJNR, 17:541-48, Mar 1998
4 Bendszus M, Klein R, Burger R, et al .: Efficacy of trisacryl gelatin microspheres versus polyvinyl alcohol particles in the prooperative embolization of meningiomas. AJNR, 21(2):255-61, Feb 2000.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biosphere Medical, Inc. c/o Ms. Sheila Hemeon-Hever, J.D., R.A.C. Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
APR 26 2000
K991549 Re: Trade Name: EMBOSPHERE® Microspheres Regulatory Class: III Product Code: HCG
Dated: January 26, 2000 Received: January 27, 2000
Dear Ms.Hemeon-Heyer:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Sheila Hemeon-Heyer, J.D., R.A.C.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
s R lehner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K991G45
Device Name: _BioSepra EMBOSPHERE® Microspheres
Indications For Use:
EMBOSPHERE® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dulles R. lochner.
(Divi
Devices
K991549
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use