The Gel-Block 10x embolization pledgets is an embolic device consisting of 10 radially compressed porcine derived gelatin pledgets packaged in one transparent glass vial. A delivery syringe is provided for introduction of the pledgets into the delivery catheter (not included). The pledgets are available in three sizes compatible with a delivery catheter having a minimum inner diameter of ≥ 0.038", ≥ 0.027", or ≥ 0.021". When unconstrained in a blood vessel, each pledget will occlude blood flow by swelling to a specified swell size. The finished product is sterilized by electron-beam irradiation and is intended for single use only.

AI/ML Overview

This document is a 510(k) premarket notification for the "Gel-Block 10x embolization pledgets." The FDA found the device to be substantially equivalent to a predicate device (K113266 - Gel-Block embolization pledgets). The information provided focuses on demonstrating this substantial equivalence, primarily by showing that the new device has similar technological characteristics and performance to the predicate device, especially considering changes in packaging.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that a series of tests were performed and that the "results... met the specified acceptance criteria." However, the exact numerical acceptance criteria and the detailed reported device performance values are not explicitly provided in the text. The document only confirms that the criteria were met.

Test Category	Acceptance Criteria (Not explicitly detailed)	Reported Device Performance (Summary)
Functional / Design	Not explicitly detailed	Deliverability: Met specified acceptance criteria
Biocompatibility	Not explicitly detailed	Cytotoxicity: Met specified acceptance criteria
		Sensitization: Met specified acceptance criteria
		Irritation/Intracutaneous Reactivity: Met specified acceptance criteria
		Acute Systemic Toxicity: Met specified acceptance criteria
		Hematology: Met specified acceptance criteria
Packaging Validation	Not explicitly detailed	Met specified acceptance criteria
Sterilization Validation	Not explicitly detailed	Met specified acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the tests (deliverability, biocompatibility, package validation, or sterilization validation). It also does not mention the country of origin of the data or whether the studies were retrospective or prospective. These details are typically found in the full study reports, which are not included in this summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of device and studies described. The studies conducted are primarily bench, biocompatibility, and sterilization tests, not clinical studies requiring expert interpretation of patient data or ground truth establishment in a medical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the studies are not clinical trials involving human interpretation or adjudication of medical findings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. The device is a vascular embolization pledget, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance was not conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. The device is a physical medical device, not an algorithm or software. "Standalone performance" in the context of AI does not apply here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the types of tests described (deliverability, biocompatibility, package, and sterilization), the "ground truth" would be established by:

Deliverability: Engineering specifications and performance metrics (e.g., successful passage through a catheter of a specified size, consistent deployment).
Biocompatibility: Established ISO 10993 standards and guidelines for biological evaluation of medical devices, which define acceptable thresholds for cytotoxicity, sensitization, etc.
Package and Sterilization Validation: Industry standards (e.g., ISO, ASTM) and internal quality control specifications for maintaining sterility and package integrity.

These are not "expert consensus, pathology, or outcomes data" in the typical clinical sense, but rather objective measurements against predefined technical standards.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above; there is no training set for this type of medical device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 20, 2014

Vascular Solutions, Inc. Adam Ettl Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369

Re: K143038

Trade/Device Name: Gel-block 10x Embolization Pledgets Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 21, 2014 Received: October 23, 2014

Dear Adam Ettl,

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -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) K143038

Device Name Gel-Block 10x embolization pledgets

Indications for Use (Describe)

The Gel-Block 10x embolization pledgets is intended for use in the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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2 510(k) Summary

[As required by 21 CFR 807.92] Date Prepared: October 21, 2014 510(k) Number: ____K143038

Submitter's Name / Contact Person

Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Adam Ettl Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253

General Information

Trade Name	Gel-Block 10x embolization pledgets
Common / Usual Name	Device, vascular, for promoting embolization
Classification Name	870.3300, KRD - vascular embolization device; Class II
Predicate Device	K113266 - Gel-Block embolization pledgets (Vascular Solutions, Inc.)

Device Description

Intended Use / Indications

The Gel-Block 10x embolization pledgets is intended for use in embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Technological Characteristics

The porcine derived gelatin pledgets in the Gel-Block 10x embolization pledgets and the Gel-Block embolization pledgets are identical. The only differences between the subject and predicate device are the package materials and configuration. The subject device contains 10 pledgets in a glass vial with a screw cap. while the predicate device contains two delivery assemblies each containing one pledget. The subject device does not include or require the use of the delivery assemblies as the pledgets are removed from the glass vial and placed directly in the tip of the delivery syringe. The subject and predicate devices each contain one delivery syringe, either 1cc or 3cc depending on the model. The

Vascular Solutions, Inc. 6464 Sycamore Court North ◆ Minneapolis, MN ◆ 55369 Phone: 763-656-4300 ♦ Fax: 763-656-4253

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subject device components (glass vial with screw cap, 10 pledgets, and one delivery syringe) are provided on a packing card and placed in a Tyvek pouch. The predicate device components (two individual pledgets packaged in separate delivery assemblies and one delivery syringe) are provided in a thermoformed tray with Tyvek lid that is placed in a Tyvek pouch. The subject and predicate devices are packaged in a retail box each containing five Tyvek pouches.

Substantial Equivalence and Summary of Studies

The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of substantial equivalence. The Gel-Block 10x embolization pledgets is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. Therefore the only new design verification test necessary was deliverability. Package validation tests and sterilization validation tests were completed to support the new package configuration. Biocompatibility tests were required to assess the Gel-Block 10x embolization pledgets package materials.

The following biocompatibility tests were performed as recommended by ISO 10993-1:

. Cytotoxicity
Sensitization ●
Irritation/Intracutaneous Reactivity ●
Acute Systemic Toxicity o
Hematology

The results of the deliverability, package, sterilization and biocompatibility tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Gel-Block 10x embolization pledgets 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).