(118 days)
No
The summary describes a physical medical device (embolization spheres) and its performance through bench testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the embolization of hypervascular tumors, which is a therapeutic intervention.
No
The device is intended for the embolization of hypervascular tumors, which is a therapeutic intervention, not a diagnostic one.
No
The device is a physical product consisting of biodegradable gelatin spheres prefilled in a syringe, intended for embolization procedures. It is a hardware 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 within the body to block blood vessels.
- Device Description: The device is a physical object (gelatin spheres) intended for delivery via a catheter into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. This device does not perform any such diagnostic testing on specimens.
Therefore, the Gel-Bead embolization spheres are a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Gel-Bead embolization spheres are 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 prefilled in a 20 ml syringe. The syringe contains 2 ml of spheres suspended in 4 ml of saline. Gel-Bead is offered in four nominal size ranges: 100-300 um, 300-500 um, 500-700 um and 700-1000 um. 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence supporting Gel-Bead embolization spheres (2 ml fill) substantial equivalence. The Gel-Bead embolization spheres (2 ml fill) product is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- Sphere suspension in contrast
- Pepsin digestion
- Supplied volume
- Deliverability
- Glutaraldehyde residuals
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Gel-Bead embolization spheres (2 ml fill) product is substantially equivalent to the predicate device.
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.
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
October 25, 2017
Vascular Solutions, Inc. Lisa Gallatin Director of Regulatory 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K171946
Trade/Device Name: Gel-Bead Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 2, 2017 Received: October 3, 2017
Dear Lisa Gallatin:
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 of medical device-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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171946
Device Name Gel-Bead
Indications for Use (Describe)
Gel-bead embolization spheres are intended for use in embolization of hypervascular tumors.
| 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)
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3
510(k) Summary
[As required by 21 CFR 807.92] Date Prepared: June 27, 2017 K171946 510(k) Number:
Submitter's Name / Contact Person
| Manufacturer | Contact Person |
|---|---|
| Vascular Solutions, Inc. | Lisa Gallatin |
| 6464 Sycamore Court North | Director of Regulatory |
| Minneapolis, MN 55369 USA | Tel: 763-656-4300 |
| Establishment Registration # 2134812 | Fax: 763-656-4253 |
General Information
| Trade Name | Gel-Bead |
|---|---|
| Common / Usual Name | Embolization spheres |
| Classification Name | Class II – 21 CFR 870.3300; |
| KRD – Device, vascular, for promoting embolization | |
| Predicate Device | K133237 – Gel-Bead embolization spheres, Vascular Solutions, Inc. |
| Reference Device | K150870 - HydroPearl microspheres, MicroVention, Inc. |
Device Description
The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres prefilled in a 20 ml syringe. The syringe contains 2 ml of spheres suspended in 4 ml of saline. Gel-Bead is offered in four nominal size ranges: 100-300 um, 300-500 um, 500-700 um and 700-1000 um. 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
Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.
Technological Characteristics Comparison
The table below compares the technological characteristics of the Gel-Bead embolization spheres.
| Characteristic | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Gel-Bead (2 ml fill) | Gel- Bead (K133237) | HydroPearl (K150870) | |
| Indications for use | Gel-Bead embolization | ||
| spheres are intended for use in | |||
| embolization of hypervascular | |||
| tumors. | Same | Similar | |
| Sphere volume | 2 ml spheres | 1 ml spheres | 2 ml spheres |
4
| Characteristic | Subject Device
Gel-Bead (2 ml fill) | Predicate Device
Gel- Bead (K133237) | Reference Device
HydroPearl (K150870) |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------|
| Sphere sizes | 100-300 μm; 300-500 μm;
500-700 μm; 700-1000 μm | Same | Similar
75-1000 μm |
| Compatible
delivery catheters
(inner diameter) | 100 – 300 μm: 0.020"
300 – 500 μm: 0.020"
500 – 700 μm: 0.023"
700 – 1000 μm: 0.038" | Same | Similar
Microspheres can be
delivered through a
catheter of 0.017" –
0.041' ID |
| Material | Porcine-derived gelatin | Same | Polyethylene glycol
diacrylamide |
| Sterility | Gamma irradiation | Same | Steam |
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence supporting Gel-Bead embolization spheres (2 ml fill) substantial equivalence. The Gel-Bead embolization spheres (2 ml fill) product is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- Sphere suspension in contrast ●
- Pepsin digestion ●
- Supplied volume ●
- Deliverability ●
- Glutaraldehyde residuals ●
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Gel-Bead embolization spheres (2 ml fill) product is substantially equivalent to the predicate device.