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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gel-Bead device, based on the requested information:

This device is a medical device (embolization spheres), not an AI/ML device. Therefore, many of the requested fields pertinent to AI/ML device studies (like those related to AI effectiveness, ground truth for training sets, etc.) are not applicable in this context and will be marked as such.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Characteristic	Reported Device Performance (Met/Not Met)
Sphere suspension in contrast	Met acceptance criteria
Pepsin digestion	Met acceptance criteria
Supplied volume	Met acceptance criteria
Deliverability	Met acceptance criteria
Glutaraldehyde residuals	Met acceptance criteria

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each of the bench tests (sphere suspension, pepsin digestion, supplied volume, deliverability, glutaraldehyde residuals). It also does not explicitly mention the data provenance in terms of country of origin or whether it was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. These are bench tests measuring physical and chemical properties of the device, not diagnostic interpretations requiring expert ground truth in the context of AI/ML.

4. Adjudication Method for the Test Set

Not applicable, as ground truth establishment by experts is not relevant for these bench tests. The acceptance criteria were likely objective measurements defined by the manufacturer based on regulatory guidelines and validated methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/ML device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for these bench tests would be the established scientific and engineering principles, regulatory standards, and internal specifications for the physical and chemical properties of the embolization spheres. For example, for "supplied volume," the ground truth would be the expected nominal volume (2 ml) and acceptable deviation from that volume. For "glutaraldehyde residuals," the ground truth would be the acceptable safe limit for residuals.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device, "Gel-Bead" embolization spheres (2 ml fill), underwent a series of bench tests to demonstrate substantial equivalence to its predicate device (Gel-Bead, K133237). The studies focused on evaluating the device's functionality and technological characteristics.

The specific tests conducted were:

Sphere suspension in contrast: This likely assesses how well the spheres remain suspended in a contrast agent, which is crucial for their navigability and visualization during clinical use.
Pepsin digestion: This test evaluates the biodegradability of the gelatin spheres, confirming they break down as intended over time after embolization.
Supplied volume: This verifies that the actual volume of spheres provided in the syringe meets the specified amount (2 ml).
Deliverability: This assesses the ability of the spheres to be successfully delivered through compatible catheters without clumping or clogging, which is critical for clinical efficacy.
Glutaraldehyde residuals: This measures any residual glutaraldehyde (a cross-linking agent sometimes used in gelatin products), ensuring it is below safe limits.

The document states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." This indicates that for each of these measured characteristics, the device performed within the predefined acceptable ranges or thresholds. The exact numerical acceptance criteria are not provided in this document, but the overall conclusion is that they were successfully met.

Summary

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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

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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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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

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 embolizationspheres are intended for use inembolization of hypervasculartumors.	Same	Similar
Sphere volume	2 ml spheres	1 ml spheres	2 ml spheres

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Characteristic	Subject DeviceGel-Bead (2 ml fill)	Predicate DeviceGel- Bead (K133237)	Reference DeviceHydroPearl (K150870)
Sphere sizes	100-300 μm; 300-500 μm;500-700 μm; 700-1000 μm	Same	Similar75-1000 μm
Compatibledelivery catheters(inner diameter)	100 – 300 μm: 0.020"300 – 500 μm: 0.020"500 – 700 μm: 0.023"700 – 1000 μm: 0.038"	Same	SimilarMicrospheres can bedelivered through acatheter of 0.017" –0.041' ID
Material	Porcine-derived gelatin	Same	Polyethylene glycoldiacrylamide
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.

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).