(341 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological effects of the microspheres, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
Yes
The device is intended for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs), by blocking blood flow to target tissues. This application directly treats medical conditions, qualifying it as a therapeutic device.
No
Explanation: The device is an embolization agent designed to block blood flow to target tissues, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that Bead Block™ is made up of physical microspheres composed of a macromer derived from polyvinyl alcohol (PVA). This is a physical, implantable device, not software.
No, 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, treatment, or prevention of disease.
- Bead Block™ Function: Bead Block™ microspheres are designed to be implanted into the body to physically block blood flow to target tissues. They are a therapeutic device used for embolization, not for analyzing samples taken from the body.
The description clearly states its intended use is for embolization within the body, and the device description details its physical properties and how it's delivered internally. This aligns with the definition of a therapeutic medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Bead Block™ microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).
Product codes (comma separated list FDA assigned to the subject device)
NAJ
Device Description
Bead Block™ is made up of preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a fibroid or a cancerous tumor. Bead Block™ compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block™ microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.5-5Fr range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic imaging
Anatomical Site
arteries (to block blood flow to target tissue such as fibroid or cancerous tumor), uterine fibroids, arteriovenous malformations, uterine artery
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)
- Non-clinical testing: Confirmed safety and effectiveness through residual starting material specifications, residual solvent material, visual inspection (visual defects, color, solution clarity), catheter delivery (including catheter clogging, aggregates, ease of injection, particle shape after injection), particle size range confirmation, particle fiber shedding, pH, packaging integrity, shelf life, sterilization validation, endotoxin (
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2016
Biocompatibles UK Ltd % Simon Leppard Director of Regulatory Affairs BTG International, Inc. Lakeview, Riverside Way, Watchmoor Park Camberley, Surrey, GU15 3YL, GB
Re: K150876
Trade/Device Name: Bead Block™ Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: NAJ Dated: February 2, 2016 Received: February 4, 2016
Dear Simon Leppard,
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 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
1
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Image /page/1/Picture/8 description: The image shows the text "Herbert P. Lerner -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible and well-spaced. The overall impression is clean and professional.
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150876
Device Name Bead Block™
Indications for Use (Describe)
Bead Block™ microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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."
3
510(k) Summary for the Biocompatibles UK Ltd. Bead Block™ (per 21CFR 807.92)
1. SUBMITTER/510(K) HOLDER
Biocompatibles UK Ltd. Weydon Lane Chapman House Weydon Lane, Farnham, Surrey, GU9 8QL, UK
Contact Person: Simon Leppard Telephone: +44 (0) 1276 902 020 Fax: +44 (0) 1276 537 162 Email: simon.leppard@btgplc.com
March 4, 2016 Date Prepared:
2. DEVICE NAME
Proprietary Name: Bead Block™ Common/Usual Name: Embolic Agents Regulation: 870.3300, vascular embolization device Regulatory Class: II Product Code: NAJ, uterine artery embolization
3. PREDICATE DEVICES
The primary predicate device has been identified as listed below:
- . Predicate Device: Embosphere Microspheres, Biosphere Medical, Inc. (K021397)
4. DEVICE DESCRIPTION
Bead Block™ is made up of preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a fibroid or a cancerous tumor. Bead Block™ compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block™ microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.5-5Fr range.
4
| Bead Block™ Product Configurations | ||||
|---|---|---|---|---|
| Product Code | Size Range | Quantity | ||
| Bead Block | Quantity | |||
| Saline | Intended for | |||
| *UFE | ||||
| EB1S103 | 100-300μm | 1 ml | 6 ml | No |
| EB1S305 | 300-500μm | 1 ml | 6 ml | No |
| EB1S507 | 500-700μm | 1 ml | 6 ml | No |
| EB1S709 | 700-900μm | 1 ml | 6 ml | Yes |
| EB1S912 | 900-1200μm | 1 ml | 6 ml | Yes |
| EB2S103 | 100-300μm | 2 ml | 5 ml | No |
| EB2S305 | 300-500μm | 2 ml | 5 ml | No |
| EB2S507 | 500-700μm | 2 ml | 5 ml | No |
| EB2S709 | 700-900μm | 2 ml | 5 ml | Yes |
| EB2S912 | 900-1200μm | 2 ml | 5 ml | Yes |
Bead Block™ is available in the configurations shown in the table below.
*Uterine Fibroid Embolization
5. INDICATION FOR USE/INTENDED USE
Bead BlockTM microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).
6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S
Bead BlockTM and the proposed predicate device are size calibrated spherical particles delivered by microcatheters to occlude a target blood vessel. Bead Block™ and the predicate device (K021397) have the same intended use and similar technological characteristics including the following:
- Intended for the embolization of hypervascular tumors and arteriovenous ● malformations
- Size calibrated microspheres for embolization
- Delivery via microcatheter to the site of desired embolization ●
- Visualization of the embolization process using radiographic imaging ●
- A range of sizes permits selection of the most appropriate size for target vessels ●
The indications for use of Bead Block™ are comparable to the predicate device. However, Bead Block™ and the predicate device have different technological characteristics, as the subject device is made of polyvinyl alcohol and the predicate device is made of acrylic polymer and porcine derived gelatin. However, the difference in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
The device is subject to Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices issued on 29 December 2004.
5
The safety and effectiveness of Bead Block™ has been confirmed by non-clinical testing including:
- Residual starting material specifications
- Residual solvent material
- Visual inspection (visual defects, color, solution clarity) ●
- Catheter delivery, including catheter clogging, formation of ● aggregates, ease of injection, and shape of embolization particle after injection
- Confirmation of particle size range
- Particle fiber shedding
- pH
- Packaging integrity ●
- Shelf life
- Sterilization validation
- Endotoxin (