The Gel-Block Embolization Pledgets are an embolic device consisting of two radially-compressed gelatin pledgets that can be delivered through a catheter system. The pledgets are stored individually within a transparent delivery assembly that has a luer lock on the proximal end and a vented cap on the distal end. The luer lock allows for attachment to syringes for flushing, while the vented cap allows the flushing to occur without pledget evacuation from the delivery assembly. After flushing, the vented cap is removed to expose a threaded luer that connects to the hub of an in-place delivery catheter. The Gel-Block Embolization Pledgets consist of the following components: Two gelatin pledgets, in individual delivery assemblies; One syringe for pledget delivery.

AI/ML Overview

This document describes the acceptance criteria and the study conducted for the Gel-Block Embolization Pledgets (K113266). However, it's important to note that this 510(k) summary does not present acceptance criteria and performance data in a typical, quantitative format often seen for diagnostic or AI-driven medical devices. Instead, it describes a series of studies designed to demonstrate substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, which are common for AI/diagnostic devices. Instead, the acceptance criteria are implicitly defined by the successful completion of various tests and the demonstration of substantial equivalence to predicate devices. The "reported device performance" refers to the qualitative successful outcome of these tests.

Acceptance Criteria Category	Specific Test/Evaluation	Reported Device Performance
Functional Equivalence	Swelling capability	Demonstrated similar swelling to predicate.
	Pepsin digestibility	Successfully evaluated (details not provided, but implies satisfactory outcome).
	Flushing capability	Successfully evaluated (details not provided, but implies satisfactory outcome).
	Deliverability	Successfully evaluated (details not provided, but implies satisfactory outcome).
	Formaldehyde residuals	Successfully evaluated (details not provided, but implies satisfactory outcome).
Biocompatibility	Cytotoxicity	Demonstrated compliant with ISO 10993-1.
	Sensitization	Demonstrated compliant with ISO 10993-1.
	Irritation/intracutaneous reactivity	Demonstrated compliant with ISO 10993-1.
	Acute systemic toxicity	Demonstrated compliant with ISO 10993-1.
	Subchronic toxicity	Demonstrated compliant with ISO 10993-1.
	Genotoxicity	Demonstrated compliant with ISO 10993-1.
	Hemocompatibility	Demonstrated compliant with ISO 10993-1; in vitro testing did not produce evidence of significant hemolysis, mitigating concern from minor anemia in animal study.
	Implantation	Demonstrated compliant with ISO 10993-1.
Embolic Efficacy & Safety	GLP Animal Study (Renal arteries in sheep)	Angiography and/or histopathology confirmed embolic effect for at least four weeks. All test animals had renal infarct indicative of successful embolization for a duration similar to control animals. No observed incidents of non-targeted embolization. No signs of systemic toxicity.
Overall	Substantial Equivalence to Predicates	All tests (design verification, animal study, biomaterial) did not raise new safety or performance questions and support substantial equivalence.

Note: The acceptance criteria here are largely qualitative – evidence of functional performance, biocompatibility, and embolic efficacy and safety equivalent to predicate devices, without introducing new safety or performance concerns.

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

Sample Size for Test Set:
- GLP Animal Study: 9 test animals (adult female sheep) and 4 control animals (adult female sheep).
- In vitro/Bench Testing: Sample sizes for swelling capability, pepsin digestibility, flushing capability, deliverability, formaldehyde residuals, and biocompatibility tests are not specified in this summary.
Data Provenance: The animal study was conducted as a "GLP animal study," indicating it was a prospective study following Good Laboratory Practice (GLP) guidelines. The country of origin is not specified but implicitly within the regulatory framework for FDA submission.

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

Animal Study Ground Truth: The ground truth for embolic effect in the animal study was established through angiography and/or histopathology. The number of experts interpreting these results and their specific qualifications (e.g., veterinary pathologists, radiologists) are not specified in this summary.

4. Adjudication Method for the Test Set

Animal Study Adjudication: The document does not specify a formal adjudication method (e.g., 2+1, 3+1 consensus) for the angiography or histopathology results in the animal study. The statement "Angiography and/or histopathology confirmed..." implies an assessment by qualified personnel, but details on consensus or adjudication are absent.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was NOT done. This type of study is typically for evaluating the impact of a diagnostic aid (like AI) on human performance. The Gel-Block Embolization Pledgets is a therapeutic device, not a diagnostic one. The study focused on demonstrating the device's inherent safety and effectiveness, and substantial equivalence to existing devices.

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

Yes, a standalone study was done. The animal study and the various bench and biocompatibility tests represent "standalone" evaluations of the device itself, independent of human interpretation or assistance in the way an AI algorithm would be evaluated. The device's performance was directly measured or observed.

7. The Type of Ground Truth Used

Animal Study: The primary ground truth for the animal study was histopathology and angiography. This represents direct observation of the physiological effect of the embolization (e.g., renal infarct) and the presence/absence of blood flow.
Bench/Biocompatibility Tests: The ground truth for these tests would be defined by the specific measurement standards and protocols of each test (e.g., standardized methods for measuring swelling, digestibility, or cell viability).

8. The Sample Size for the Training Set

Not Applicable. This device is a physical medical implant, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and development of the device would involve engineering, material science, and preclinical testing, but not machine learning training.

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

Not Applicable. As there is no training set for an AI algorithm, this question is not relevant to the Gel-Block Embolization Pledgets device.

Summary

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510(k) Summary

Date Prepared: May 9, 2012

510(k) Number: K113266

Submitter's Name / Contact Person

Manufacturer

Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: 763-656-4300; Fax: 763-656-4250 Establishment Registration # 2134812

Contact Person Jennifer Ruether Sr. Regulatory Product Specialist

General Information

Trade Name Common / Usual Name Classification Name Predicate Devices

Gel-Block Embolization Pledgets . Device, vascular, for promoting embolization 870.3300; KRD; vascular embolization device; Class II K991549: Embosphere Microspheres (BioSphere Medical, Inc.) K052742: QuadraSphere Microspheres (BioSphere Medical, Inc.)

Device Description

The Gel-Block Embolization Pledgets consist of the following components:

Two gelatin pledgets, in individual delivery assemblies
One syringe for pledget delivery .

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Intended Use / Indications

The Gel-Block Embolization Pledgets are intended for use in embolization of hypervascularized tumors and arteriovenous malformations (A VMs).

Technological Characteristics

The Gel-Block Embolization Pledgets are similar in design to the predicate devices, as all of them provide a mechanical barrier to blood flow in the vasculature and are delivered using catheters. The ability of the Gel-Block to swell is similar to that of the QuadraSpheres. The subject device is available in three consistent sizes, while the predicates are available in defined size ranges. The subject and predicate devices also differ in shape; because the Gel-Block Pledgets are larger than the predicate microspheres, they are cylindrical in shape for easy delivery through a catheter. The Gel-Block Embolization Pledgets also differ from both predicate devices in terms of materials, and therefore degradation; the Embospheres consist of a non-resorbable acrylic polymer impregnated with porcine gelatin, while the Gel-Block is made wholly from resorbable porcine gelatin. The QuadraSpheres consist of a sodium acrylate-vinyl alcohol co-polymer.

The technological differences between the subject and predicate devices have been evaluated through biocompatibility, bench, and animal testing to provide evidence of safe and effective use of the Gel-Block Embolization Pledgets, thereby establishing substantial equivalence to the predicate devices.

Substantial Equivalence and Summary of Studies

The Gel-Block Embolization Pledgets are substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been verified through the following tests:

. Swelling capability
Pepsin digestibility .
Flushing capability .
◆ Deliverability
. Formaldehyde residuals

Biocompatibility was verified through the following test strategy compliant with ISO 10993-1:

Cytotoxicity
. Sensitization
. Irritation/intracutaneous reactivity
Acute systemic toxicity ●
. Subchronic toxicity
. Genotoxicity
Hemocompatibility .
. Implantation

A GLP animal study was conducted on nine test and four control (Embosphere Microspheres) adult female sheep over a period of 12 weeks. Angiography and/or histopathology confirmed that the Gel-Block Embolization Pledgets provided an embolic effect in renal arteries for at least four weeks. All test animals had renal infarct indicative of successful embolization for a duration similar to that of the control animals. There were no observed incidents of non-targeted embolization in nearby vessels. No signs of systemic toxicity were observed. Anemia was observed in four test animals. However, in vitro

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hemocompatibility testing did not produce evidence of significant hemolysis, thus mitigating this concern.

Results of the design verification, animal study, and biomaterial tests did not raise new safety or performance questions and support the substantial equivalence of the Gel-Block Embolization Pledgets to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

WAY. 1 4 2012

Vascular Solutions, Inc. c/o Jennifer Ruether Senior Regulatory Product Specialist 6464 Sycamore Court Minneapolis. MN 55369

Re: K113266

Trade/Device Name: Gel-Block Embolization Pledgets Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular embolization device Regulatory Class: Class II Product Code: KRD Dated: March 19, 2012 Received: March 20, 2012

Dear Ms. Ruether:

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.

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Page 2 - Ms. Jennifer Ruether

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.S. Killilea

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

K113266 510(k) Number (if known):

Device Name: Gel-Block Embolization Pledgets

Indications for Use:

The Gel-Block Embolization Pledgets are intended for use in embolization of hypervascularized tumors and arteriovenous malformations (AVMs).

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. A. Hillel

Page 1 of 1 (Posted November 13, 2003)

(Division Sign-Off)
Division of Cardiovascular Devices

长川多266 510(k) Number

Gel-Block Embolization Pledgets Traditional 510(k) - Page 4 of 2070

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).