(204 days)
Not Found
No
The device description focuses on the physical properties and delivery method of microspheres, with no mention of AI or ML technologies.
Yes
The microspheres are intended for embolization of certain conditions (Arteriovenous malformations, hypervascular tumors, and uterine fibroids), indicating they are used to treat or manage a medical condition.
No
This device is intended for embolization, which is a therapeutic procedure to block blood vessels, not to diagnose a condition.
No
The device description clearly states that the device is comprised of physical microspheres made of acrylic polymer and porcine-derived gelatin, which are delivered via a catheter. This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Device Function: Embosphere and EmboGold Microspheres are implantable devices used for embolization. They are delivered directly into blood vessels within the body to block blood flow to specific areas.
- Intended Use: The intended use is for the embolization of arteriovenous malformations, hypervascular tumors, and uterine fibroids. This is a therapeutic intervention performed directly on the patient's anatomy, not an analysis of a specimen outside the body.
- Device Description: The description details the physical characteristics of the microspheres and their delivery method via catheter, which is consistent with an implantable or interventional device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, Embosphere and EmboGold Microspheres fall under the category of a medical device used for treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Embosphere® and EmboGold™ Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including and uterine fibroids.
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular turnors, and symptomatic uterine fibroids.
Product codes (comma separated list FDA assigned to the subject device)
85 NAJ
Device Description
Embosphere® and EmboGold™ Microspheres are small, flexible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and nonpyrogenic. They are delivered to the target site by a catheter under fluoroscopic control.
Both products are provided in six size ranges in order to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are:
- 40-120 microns 100-300 microns 300-500 microns 500-700 microns 700-900 microns 900-1200 microns
Only microspheres of 500 microns or greater should be used for the embolization of uterine fibroids.
The only difference between Embosphere® and EmboGold™ Microspheres is the colorization of the EmboGold™ Microspheres. Embosphere® Microspheres are translucent, although they are visible to the naked eye when in suspension. EmboGold™ Microspheres are purple/red in color for improved visibility during preparation and handling by the physician.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Uterine Fibroids
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical data was collected in a prospective clinical study to support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization.
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).
0
510(k) Summary
for
Embosphere® Microspheres and EmboGold™ Microspheres for use in Uterine Fibroid Embolization
-
- SPONSOR
Biosphere Medial, Inc. 1050 Hingham Street Rockland, MA 02370
- SPONSOR
Contact Person: Jon McGrath, Vice President of Research Telephone: 781-681-7950
Date Prepared: April 30, 2002
2. DEVICE NAME
| Proprietary Name: | Embosphere® Microspheres and EmboGold™
Microspheres for use in Uterine Fibroid Embolization |
|----------------------|------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Artificial emboli |
| Classification Name: | Artificial Embolization Device (21 CFR 882.5950 and
21 CFR 870 3300) |
3. PREDICATE DEVICES
Embosphere® Microspheres as reviewed under K991549 and EmboGold™ Microspheres as reviewed under K010026.
4. INTENDED USE
Embosphere® and EmboGold™ Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including and uterine fibroids.
1
5. DEVICE DESCRIPTION
Embosphere® and EmboGold™ Microspheres are small, flexible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and nonpyrogenic. They are delivered to the target site by a catheter under fluoroscopic control.
Both products are provided in six size ranges in order to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are:
- 40-120 microns 100-300 microns 300-500 microns 500-700 microns 700-900 microns 900-1200 microns
Only microspheres of 500 microns or greater should be used for the embolization of uterine fibroids.
The only difference between Embosphere® and EmboGold™ Microspheres is the colorization of the EmboGold™ Microspheres. Embosphere® Microspheres are translucent, although they are visible to the naked eye when in suspension. EmboGold™ Microspheres are purple/red in color for improved visibility during preparation and handling by the physician.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
Embosphere® and EmboGold™ Microspheres for uterine fibroid embolization are substantially equivalent to the same products when indicated for the more general intended use of embolization of hypervascular tumors. Clinical data was collected in a prospective clinical study to support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization. EmboGold™ Microspheres are the same product as Embosphere® Microspheres, except for the colorization. Data to support the substantial equivalence of EmboGold™ Microspheres to Embosphere® Microspheres was previously provided in K010026.
2
od and Drug Administration 00 Corporate Boulevard Rockville MD 20850
NOV 22 2002
BioSphere Medical, Inc. % Sheila Hemeon-Heyer, J.D., R.A.C. Senior Staff Consultant Medical Device Consultants 49 Plain Street NORTH ATTLEBORO MA 02760
Re: K021397 Trade/Device Name: Embosphere® Microspheres for UFE. Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization device Regulatory Class: III Product Code: 85 NAJ Dated: August 27, 2002 Received: August 28, 2002
Dear Ms. Hemeon-Heyer:
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 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.
3
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 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 one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Henry C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Embosphere® Microspheres for use in Device Name: Uterine Fibroid Embolization
Indications for Use:
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular turnors, and symptomatic uterine fibroids.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Beardon
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use __________
(Optional Format 1-2-96
Embosphere Microspheres & EmboGold Additional Information - K021397
August 27, 2002 CONFIDENTIAL Appendix E · Page 1