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.

AI/ML Overview

This document describes the acceptance criteria and supporting study for the Gel-Bead Embolization Spheres (600-800um - 1 ml and 2 ml sphere volumes) device.

The study presented focuses on demonstrating the substantial equivalence of the new 600-800 µm sphere size and new 1ml sphere volume, to previously cleared Gel-Bead embolization spheres (K133237 and K171946). This is primarily achieved through bench testing of key device characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Deliverability: The device must be able to be delivered through compatible catheters.	The verification tests demonstrated that the Gel-Bead embolization spheres (600-800 µm) met the specified acceptance criteria for deliverability. (Specific quantitative results are not provided in the document, but it states the criteria were met.)
Sphere Diameter: The spheres must fall within the specified size range of 600-800 µm.	The verification tests demonstrated that the Gel-Bead embolization spheres (600-800 µm) met the specified acceptance criteria for sphere diameter. (Specific quantitative results are not provided in the document, but it states the criteria were met, specifically for the 600-800 µm size.)
Sphericity: The spheres must exhibit an acceptable level of sphericity.	The verification tests demonstrated that the Gel-Bead embolization spheres (600-800 µm) met the specified acceptance criteria for sphericity. (Specific quantitative results are not provided in the document, but it states the criteria were met.)
No New Safety or Performance Issues: The introduction of the new sphere size and volume should not raise any new safety or performance concerns compared to the predicate device.	The verification test results demonstrated that the Gel-Bead embolization spheres (600-800 µm) did not raise new safety or performance issues.

Detailed Information on the Study:

The provided document describes a bench test study rather than a clinical study involving human or animal subjects for evaluating performance in a biological context. The primary goal of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics and performance in a controlled laboratory environment.

Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample sizes used for each of the bench tests (Deliverability, Sphere Diameter, Sphericity).
- Data Provenance: The study appears to be an in-vitro (bench) study conducted by the manufacturer, Vascular Solutions. There is no indication of country of origin for the data in the context of clinical trials, as this is a laboratory-based evaluation.
Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This information is not applicable to this type of study. Bench tests rely on objective measurement and predefined specifications (acceptance criteria) rather than expert interpretation of data points to establish a "ground truth." The "ground truth" for these tests is the physical measurement itself against the defined thresholds.
Adjudication Method for the Test Set:
- This information is not applicable to this type of study. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers independently assess data and discrepancies need to be resolved. Bench tests involve direct measurements against predefined criteria.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (embolization spheres), not an AI or imaging diagnostic tool that would typically involve human readers.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is not an algorithm or AI. The performance tested is the inherent physical and functional characteristics of the embolization spheres themselves.
Type of Ground Truth Used:
- The "ground truth" for this study is based on pre-defined engineering specifications and measurable physical properties of the device (e.g., specific diameter ranges, mechanical properties related to deliverability, and optical properties related to sphericity). These are verified through direct measurement and laboratory testing, rather than expert consensus, pathology, or outcomes data which are typical for clinical performance evaluation.
Sample Size for the Training Set:
- This concept is not applicable to this study. "Training set" refers to data used to train machine learning models. This study is a bench test verification of a physical device against engineering specifications.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this type of device and study.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: 763-656-4300 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	Gel-Bead embolization spheres, Vascular Solutions(K133237 cleared April 25, 2014; K171946 cleared October 25, 2017)

Device Description

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 embolizationspheres	Gel-Bead (2 ml fill)(K171946)	Gel- Bead (original)(K133237)
Indications for use	Gel-Bead embolizationspheres are intended for usein embolization ofhypervascular tumors.	Same	Same
Sphere volume	1ml and 2 ml sphere fillvolumes	Same - 2 ml spheres	Same -1 ml spheres

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Characteristic	Subject Device	Predicate Device
	600-800 µm embolizationspheres	Gel-Bead (2 ml fill)(K171946)	Gel- Bead (original)(K133237)
Sphere sizes	600-800 µm	Current sizes bracket thenew 600-800 µm size100 – 300 µm300 – 500 µm500 – 700 µm700 – 1000 µm	Current sizes bracket thenew 600-800 µm size100 – 300 µm300 – 500 µm500 – 700 µm700 – 1000 µm
Compatibledelivery catheters(inner diameter)	600-800 µm: 0.027"	Current compatibilitysizes bracket the new600-800 µm size100 – 300 µm: 0.020"300 – 500 µm: 0.020"500 – 700 µm: 0.023"700 – 1000 µm: 0.038"	Current compatibilitysizes bracket the new600-800 µm size100 – 300 µm: 0.020"300 – 500 µm: 0.020"500 – 700 µm: 0.023"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.

Regulation Number and Section

§ 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).