(186 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological effects of the embolization spheres, with no mention of AI or ML technologies.
Yes
The device is intended for the embolization of hypervascular tumors, which is a therapeutic intervention aimed at treating the condition.
No
Explanation: The device is intended for embolization of hypervascular tumors, which is a therapeutic intervention, not a diagnostic one. It does not identify or characterize a disease, but rather treats it.
No
The device description clearly states it consists of physical components (biodegradable gelatin spheres, syringe, saline) and is sterilized by Gamma irradiation, indicating a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "embolization of hypervascular tumors." This is a therapeutic procedure performed in vivo (within the body) to block blood vessels.
- Device Description: The device is a physical material (gelatin spheres) intended to be implanted into the body via a catheter.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health information. This device is a therapeutic implant used directly within the body.
N/A
Intended Use / Indications for Use
Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.
Product codes (comma separated list FDA assigned to the subject device)
KRD
Device Description
The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains 1 ml of spheres suspended in 5 ml of saline. Gel-Bead is offered in four size ranges: 100-300 µm, 300-500 µm, 500-700 µm and 700-1000 µm. The spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Angiography
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)
The subject device design was evaluated through biocompatibility and animal tests to provide evidence of safe and effective use of Gel-Bead. A GLP animal study was conducted on twelve mature miniature swine, with animals survived up to 12 weeks following implantation. Eight animals were implanted with Gel-Bead and four animals implanted with a control (Embosphere). Gel-Bead spheres were consistently and reliably implanted in the selected target arteries of appropriate size and not in additional non-target tissues or regions. All instances of Gel-Bead delivery resulted in successful arterial occlusion at the time of implant, as confirmed by angiography. There were similar well-demarcated foci of infarction, indicative of successful embolization, observed in the target organs of both test article animals. There were no clinically significant abnormalities identified in the clinical pathology blood results that negatively reflected on either the test or control devices. Examination of the tissues distant to the implantation sites did not identify any systemic abnormalities. Verification, animal study, and biocompatibility test results met the specified acceptance criteria and did not raise new safety or performance issues.
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 [As required by 21 CFR 807.92] Date Prepared: April 25, 2014 510(k) Number: K133237
Submitter's Name / Contact Person
Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Ellie Gillespie Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253
General Information
| Trade Name | Gel-Bead embolization spheres |
|---|---|
| Common / Usual Name | embolization spheres |
| Classification Name | 870.3300, KRD - Device, vascular, for promoting embolization, Class I |
| Predicate Device(s) | K021397 – Embosphere Microspheres (Biosphere Medical, Inc./Merit |
| Medical Systems, Inc.) | |
| K113266 - Gel-Block Embolization Pledgets (Vascular Solutions, Inc.) |
Device Description
The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains 1 ml of spheres suspended in 5 ml of saline. Gel-Bead is offered in four size ranges: 100-300 µm, 300-500 µm, 500-700 µm and 700-1000 µm. The spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.
Intended Use / Indications
Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.
1
Technological Characteristics
11
Gel-Bead has the same intended use as both predicate devices but Embosphere and Gel-Block are also intended for use in arteriovenous malformations and Embosphere is also intended for use in symptomatic uterine fibroids. Gel-Bead is similar in design to the predicate devices as they are gelatincontaining embolization devices delivered through a catheter with the same principle of operation (create a mechanical obstruction to blood flow in the target vessel, as evidenced by disruption in the contrast flow rate). Gel-Bead size ranges are within the range of Embosphere Microspheres (Embosphere). Gel-Bead is biodegradable like Gel-Block embolization pledgets (Gel-Block). The only technological difference between the subject device and the predicate devices is the materials of construction.
Substantial Equivalence and Summary of Studies
The subject device design was evaluated through biocompatibility and animal tests to provide evidence of safe and effective use of Gel-Bead. Gel-Bead is substantially equivalent to the specified predicate devices based on comparisons of device functionality, technological characteristics, and indications for use. The subject device design has been verified through an animal study and the following biocompatibility tests performed as recommended by ISO 10993-1:
- · Cytotoxicity
- o L929 MEM Elution
- Agar Diffusion o
- · Sensitization
- Kligman Maximization Sensitization Test (Direct) o
- · Irritation/Intracutaneous Reactivity
- o Intracutaneous Injection (Direct)
- · Acute Systemic Toxicity
- o Acute Systemic Injection Test
- 0 Material Mediated Rabbit Pyrogen (Direct Exposure)
- · Hematology
- o Hemolysis (Direct)
- Hemolysis (Indirect) 0
- Complement Activation (Direct) O
- · Genotoxicity
- Bacterial Mutagenicity Test Ames Assay O
- o Mouse Lymphoma Forward Mutation Assay
- Rodent Bone Marrow Micronucleus Assay O
2
A GLP animal study was conducted on twelve mature miniature swine, with animals survived up to 12 weeks following implantation. Eight animals were implanted with Gel-Bead and four animals implanted with a control (Embosphere). Gel-Bead spheres were consistently and reliably implanted in the selected target arteries of appropriate size and not in additional non-target tissues or regions. All instances of Gel-Bead delivery resulted in successful arterial occlusion at the time of implant, as confirmed by angiography. There were similar well-demarcated foci of infarction, indicative of successful embolization, observed in the target organs of both test article animals. There were no clinically significant abnormalities identified in the clinical pathology blood results that negatively reflected on either the test or control devices. Examination of the tissues distant to the implantation sites did not identify any systemic abnormalities.
Verification, animal study, and biocompatibility test results met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, Gel-Bead is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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April 25, 2014
Vascular Solutions, Inc. Ellie Gillespie Senior Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369
K133237 Re:
Trade/Device Name: Gel-Bead™ Embolization Spheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: March 18, 2014 Received: March 20, 2014
Dear Ms. Gillespie:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rove 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 conimered prices 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 I ou may, morely manso 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), II your device is blassified (oos aothols. 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 ulal FDA has made a determination that your istered by other Federal agencies. You must comply of of all the Act's requirements, including, but not limited to: registration and listing (21 CFR
4
Page 2 - Ellie Gillespie
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K133237 510(k) Number (if known): _
Device Name: Gel-Bead embolization spheres
Indications for Use:
Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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