(64 days)
Not Found
No
The device description focuses on the physical properties and composition of the microspheres, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for embolization of hypervascular tumors and arteriovenous malformations, which is a therapeutic intervention.
No
The device is intended for embolization, which is a therapeutic procedure to block blood flow, not to diagnose a condition.
No
The device description clearly outlines a physical product consisting of microspheres made from polyvinyl alcohol, supplied in vials or syringes, and intended for physical embolization. There is no mention of software as a component or the primary function of the 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 the embolization of hypervascular tumors and arteriovenous malformations. This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The device is a physical microsphere designed to be delivered into arteries to occlude them. This is a medical device used for treatment, not for analyzing samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests on samples taken from the body to provide information about a person's health status. This device is used to directly treat a medical condition by physically blocking blood vessels.
N/A
Intended Use / Indications for Use
"GelSpheres™/BeadBlock™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).
GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
Product codes
HCG
Device Description
GelSpheres™ and BeadBlock™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). GelSpheres™ and BeadBlock Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ and BeadBlock Compressible Microspheres is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
GelSpheres™ Compressible Microspheres is supplied sterile and packaged in sealed glass vials. BeadBlock ™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /BeadBlock™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL., and (2) 2.0mL GelSpheres™/BeadBlock™ Compressible Microspheres in sterile PBS to a volume of 8 mL.
GelSpheres™ and BeadBlock Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200μm diameter. At the time of use, GelSpheres™/BeadBlock™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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).
0
Biocompatibles UK Ltd..
510(k) Pre-Market Notification
GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres
510(k) Summary
FEB - 4 2004
K033761
014
page 1 of
Submitter: Biocompatibles UK Ltd. Weydon Lane Chapman House Weydon Lane, Farnham, Surrey +44 1252732732
Contact: Dr. Alistair Taylor
510/k) Numbers and Product Codes of equivalent devices.
Biocure, Inc, GelSpheres™ Microspheres 510K Number: #023089 Product Code: HCG CFR Section: 882.5950
Indications for Use and Intended Population
"GelSpheres™/BeadBlock™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).
Device Description
GelSpheres™ and BeadBlock™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). GelSpheres™ and BeadBlock Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ and BeadBlock Compressible Microspheres is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
GelSpheres™ Compressible Microspheres is supplied sterile and packaged in sealed glass vials. BeadBlock ™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /BeadBlock™ Compressible
1
Biocompatibles UK Ltd.. 510(k) Pre-Market Notifica GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres
Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL., and (2) 2.0mL GelSpheres™/BeadBlock™ Compressible Microspheres in sterile PBS to a volume of 8 mL.
GelSpheres™ and BeadBlock Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200μm diameter. At the time of use, GelSpheres™/BeadBlock™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
Similarities and Differences to Predicates
The Intended Use of GelSpheres™ /BeadBlock™ Compressible Microspheres and the predicate device are the same and unchanged other than product names. This pre-market notification addresses the change of the final packager from Biocure, inc to Biocompatibles UK LTD.
There are more similarities than differences when comparing Biocompatibles, GelSpheres ™/BeadBlock™ to the predicate devices.
Performance Standards
GelSpheres™/BeadBlock Compressible Microspheres meet the following Performance Standards:
- Guidance For Industry; 2000: FDA Guidance for Neurological . Embolization Products
- ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, . Part I: Evaluation and Testing
- ISO/EN 10993-3; 1993 Biological Evaluation of Medical Devices, . Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
- ISO/EN 10993-4; 1993 Biological Evaluation of Medical Devices. . Part 4: Selection of tests for interaction with blood.
- ISO/EN 10993-6; 1995 Biological Evaluation of Medical Devices, . Part 6: Test for local effects after implantation.
- ISO/EN 10993-10; 1995 Biological Evaluation of Medical Devices, . Part 10: Tests for Irritation and Sensitization.
- ISO/EN 10993-11; 1993 Biological Evaluation of Medical Devices, . Part 11: Tests for Systemic Toxicity.
ge 2 of 3
2
Biocompatibles UK Ltd..
510(k) Pre-Market Notit
GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres
Ka33 761
- ISO/EN 10993-13; 1995 Biological Evaluation of Medical Devices, t Part 13: Identification and Quantification of potential degradation products from polymers.
- ISO/EN 11607; 1997 Packaging for terminally sterilized products. .
- AAMI TIR 22;1998 Guidance for application of EN 11607, . Packaging for terminally sterilized products
- AAMI 11134; 1993 Sterilization of Health Care Products -� Requirements for validation and routine control - Industrial moist heat sterilization 200 edition.
- ANSI/AAMI/ISO 14937; 2000 Sterilization of Health Care . Products - Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
- EN 554: Sterilization of Medical Devices validation and Routine . Control of Sterilization by Moist Heat
Conclusion
There are more similarities than differences between the predicate device and the Biocompatibles GelSpheres™/BeadBlock™ Compressible Microspheres. The product and primary packaging are identical and unchanged from K023089. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres have the same intended use, warnings and contraindications. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres are identical in design, and unchanged from K023089. When used in accordance with the instructions for use, by qualified personnel, the Biocompatibles GelSpheres™/BeadBlock™ Compressible Microspheres are safe and effective, as indicated, for the intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by three horizontal lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 4 2004
Biocompatibles U.K. Ltd c/o Mr. John Greenbaum Generic Devices Consulting 20310 SW 4811 Street Ft. Lauderdale, Florida 33332
Re: K033761
Trade/Devicc Name: Gelspheres™ Embolic Agent/Beadlock™ Embolic Agent Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: November 28, 2003 Received: December 8, 2003
Dear Mr. Greenbaum:
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 10 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 I'DA 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 sct forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. John Greenbaum
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 (301) 594-4659. Also, please note the regulation cntitled. "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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
(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
5
Indications for Use
Kossztel
510(k) Number (if known): K033761
Device Name: Gelspheres™ Embolic Agent/Beadlock™ Embolic Agent
Indications For Use: GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGF IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
lvision Sign-Ofl) f vision of General, Restorative ୍ୟ Neurological Devices
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