Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

K173891 · Vascular Solutions, Inc. · KRD · Jan 19, 2018 · Cardiovascular

Device Facts

• Record ID: K173891
• Device Name: Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume
• Applicant: Vascular Solutions, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.

Device Story

Gel-Bead embolization spheres consist of porcine-derived biodegradable gelatin spheres suspended in saline within a pre-filled 20 ml syringe. Intended for use in hypervascular tumor embolization, the spheres are delivered via a compatible catheter (not included) into the target vasculature. The device is used in a clinical setting by a physician. The spheres act as an embolic agent to occlude blood flow to the tumor, potentially reducing tumor vascularity. The device is single-use and sterilized via Gamma irradiation.

Clinical Evidence

Bench testing only. Verification testing included deliverability, sphere diameter, and sphericity. Results confirmed the 600-800 µm spheres met all specified acceptance criteria.

Technological Characteristics

Material: Porcine-derived gelatin. Form factor: Spheres in 1 ml or 2 ml volumes, 600-800 µm diameter. Delivery: Compatible with 0.027" inner diameter catheters. Sterilization: Gamma irradiation. Connectivity: None.

Indications for Use

Indicated for embolization of hypervascular tumors in patients requiring vascular embolization.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Gel-Bead embolization spheres (K133237)
• Gel-Bead (2 ml fill) (K171946)

Submission Summary (Full Text)

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January 19, 2018

Vascular Solutions, Inc. Lisa Gallatin Director of Regulatory 6464 Sycamore Court N Minneapolis, Minnesota 55369

Re: K173891

Trade/Device Name: Gel-Bead Embolization Spheres (600-800um - 1 ml and 2 ml sphere volumes) Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: December 20, 2017 Received: December 21, 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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)

K173891

Device Name Gel-Bead embolization spheres

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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#### 510(k) Summary

[As required by 21 CFR 807.92]

Date Prepared: January 16, 2018

510(k) Number: ___K173891

#### Submitter's Name / Contact Person

#### Manufacturer

Vascular Solutions 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Lisa Gallatin Director of Regulatory Tel: [phone] Fax: [phone]

#### General Information

| Trade Name | Gel-Bead |
|---------------------|-------------------------------------------------------------------------------------------------------------------------|
| Common / Usual Name | Embolization spheres |
| Classification Name | Class II – 21 CFR 870.3300;<br>KRD – Device, vascular, for promoting embolization |
| Predicate Device | Gel-Bead embolization spheres, Vascular Solutions<br>(K133237 cleared April 25, 2014; K171946 cleared October 25, 2017) |

#### Device Description

The Gel-Bead embolization spheres product consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains either 1 ml or 2 ml of spheres suspended in 5 ml or 4 ml of saline, respectively. Offered in five nominal size ranges (100-300 µm, 500-700 µm, 600-800 µm, 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 subject and predicate device.

| Characteristic | Subject Device | Predicate Device | |
|---------------------|------------------------------------------------------------------------------------------------------|-----------------------------------|-----------------------------------|
| | 600-800 μm embolization<br>spheres | Gel-Bead (2 ml fill)<br>(K171946) | Gel- Bead (original)<br>(K133237) |
| Indications for use | Gel-Bead embolization<br>spheres are intended for use<br>in embolization of<br>hypervascular tumors. | Same | Same |
| Sphere volume | 1ml and 2 ml sphere fill<br>volumes | Same - 2 ml spheres | Same -1 ml spheres |

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| Characteristic | Subject Device | Predicate Device | |
|------------------------------------------------------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 600-800 µm embolization<br>spheres | Gel-Bead (2 ml fill)<br>(K171946) | Gel- Bead (original)<br>(K133237) |
| Sphere sizes | 600-800 µm | Current sizes bracket the<br>new 600-800 µm size<br>100 – 300 µm<br>300 – 500 µm<br>500 – 700 µm<br>700 – 1000 µm | Current sizes bracket the<br>new 600-800 µm size<br>100 – 300 µm<br>300 – 500 µm<br>500 – 700 µm<br>700 – 1000 µm |
| Compatible<br>delivery catheters<br>(inner diameter) | 600-800 µm: 0.027" | Current compatibility<br>sizes bracket the new<br>600-800 µm size<br>100 – 300 µm: 0.020"<br>300 – 500 µm: 0.020"<br>500 – 700 µm: 0.023"<br>700 – 1000 µm: 0.038" | Current compatibility<br>sizes bracket the new<br>600-800 µm size<br>100 – 300 µm: 0.020"<br>300 – 500 µm: 0.020"<br>500 – 700 µm: 0.023"<br>700 – 1000 µm: 0.038" |
| Material | Porcine-derived gelatin | Same | Same |
| Sterility | Gamma irradiation | Same | Same |

### Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence supporting the substantial equivalence of the 600-800 um size embolization spheres. The 600-800 µm size 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:

- Deliverability
- Sphere Diameter
- Sphericity

The verification test results demonstrate that the Gel-Bead embolization spheres (600-800 um) met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the 600-800 um embolization spheres product is substantially equivalent to the predicate devices.