The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is intended for use during and after ENT surgeries for the control of minimal to moderate bleeding by tamponande effect, blood absorption and platelet aggregation.

Device Description

The Gel-Sponge ENT is a sterile, absorbable gelatin sponge, USP available in sizes ranging from a 1.5 cm disk to a 100 cm rectangular size. It is able to absorb and hold within its interstices, many times its weight of blood and other fluids. The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. Hemostasis is achieved by the physiological coagulation-inducing properties of the absorbable gelatin sponge. USP, The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied dry or is wetted before use with sterile water for injection or saline (not provided),

AI/ML Overview

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP, as described in the provided 510(k) summary, did not involve specific acceptance criteria in the typical sense of quantitative performance thresholds for a clinical study. Instead, the device's suitability for its intended use was established through a demonstration of substantial equivalence to existing predicate devices (Gelita-Spon Absorbable Gelatin Sponge, USP and ThrombiGel® thrombin/gelatin foam hemostat). This means the device was shown to be as safe and effective as a legally marketed device for which a PMA was not required.

The study that "proves" the device meets the acceptance criteria is implicitly the demonstration of substantial equivalence through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a substantially equivalent device, the "acceptance criteria" are primarily implied by the predicate device's performance and the successful completion of specific non-clinical tests to demonstrate that the new device shares similar characteristics and performs as expected. No specific quantitative performance metrics like sensitivity, specificity, or reduction in bleeding time were reported with acceptance thresholds.

Test Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Physical Properties	Pepsin Digestion	Suitable digestion properties (comparable to predicate)	Confirmed suitability for intended use
	Absorption	Ability to absorb and hold blood/fluids (comparable to predicate)	Confirmed suitability for intended use
	Residue on Ignition	Acceptable residue levels (comparable to predicate)	Confirmed suitability for intended use
	pH Testing	Acceptable pH range (comparable to predicate)	Confirmed suitability for intended use
	Formaldehyde Residual	Acceptable formaldehyde levels (comparable to predicate)	Confirmed suitability for intended use
Biocompatibility	MEM Elution	Non-cytotoxic	Biocompatible
	Systemic Injection Test	Non-systemically toxic	Biocompatible
	Kligman Skin Sensitization	Non-sensitizing	Biocompatible
	Intracutaneous Injection Test	Non-irritating	Biocompatible
	Rabbit Pyrogen Test	Non-pyrogenic	Biocompatible
	Ames Reverse Mutation Assay	Non-mutagenic	Biocompatible
	Short Term Subcutaneous Implantation Testing	Acceptable tissue reaction for short-term implantation	Biocompatible
Clinical Equivalence	N/A (Clinical Testing Not Required)	Substantially equivalent to predicate in terms of indications for use and technological characteristics	Demonstrated substantial equivalence to K060878 and K063860

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

Sample Size for Test Set: Not applicable. No clinical test set involving human subjects was used. The "test set" for non-clinical testing refers to samples of the device itself. The specific quantities of samples used for each bench and biocompatibility test are not provided in this summary.
Data Provenance: Not applicable, as no human data was collected. The testing was laboratory-based.

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

Not applicable. As no human clinical data was collected, there was no need for experts to establish ground truth for a test set of patient cases. The "ground truth" for the non-clinical tests would be established by standard laboratory methods and validated testing protocols.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring expert adjudication.

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

No. A MRMC comparative effectiveness study was not performed. The 510(k) summary explicitly states: "No human clinical testing was required for this device."

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

Not applicable. This device is a physical medical device (absorbable gelatin sponge), not an AI algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The Type of Ground Truth Used

Bench Testing: Ground truth established by validated laboratory standards and measurements for physical properties (e.g., pH, absorption capacity, formaldehyde residual).
Biocompatibility Testing: Ground truth established by in-vitro and in-vivo (animal model, for some tests like pyrogen and sensitization) toxicology and biocompatibility standards (e.g., ISO 10993 series).
For the overall product, the "ground truth" for its safety and effectiveness was assessed against the predicate devices through substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no "training set" in the machine learning sense. The manufacturing process of the device itself can be seen as a form of "training" to achieve consistent product characteristics, but this is not reported as a data set for an algorithm.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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Gel-Sponge ENT, Absorbable Gelatin Sponge, USP 510(k) Summary Page 1 of 2

510(k) Summary (As required by 21 CFR 807.92(c))

510(k) Number: K080022

DEC 0 9 2008

Date of Original Submission: December 28, 2007

Submitter Information

Submitter's Name:	Vascular Solutions, Inc.
Address:	6464 Sycamore Court Minneapolis, MN 55369

Establishment Registration 2134812

Contact Person:	Lisa Gallatin, RAC
	Senior Regulatory Affairs Associate
	Phone: (763) 656-4300 ext. 399
	Fax: (763) 656-4250

Device Information

Trade Name:	Gel-Sponge ENT, Absorbable Gelatin Sponge, USP
Common Name:	Gelatin Sponge
Classification Name:	Ear, Nose and Throat Synthetic Polymer Material
Product Code:	KHJ, LYA
Regulation:	21 CFR 874.3620

Predicate Device(s)

The predicate device is the currently marketed Gelita-Spon Absorbable Gelatin Sponge, USP (K060878) and ThrombiGel® thrombin/gelatin foam hemostat (K063860),

Device Description

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied directly over the source of bleeding, creating a physical barrier to blood flow through the application of adjunctive manual compression. Hemostasis is achieved by the physiological coagulation-inducing properties of the absorbable gelatin sponge. USP,

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is applied dry or is wetted before use with sterile water for injection or saline (not provided),

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Intended Use/Indications for Use

Summary of Non-Clinical Testing

Testing included assessment of the physical properties of the Gel-Sponge ENT. Absorbable Gelatin Sponge, USP and its ability to achieve its intended use. Bench testing of the physical properties of the Gel-Sponge ENT, Absorbable gelatin sponge, USP confirmed the suitability of the device for its intended use. The following physical tests were performed;

Pepsin Digestion	Absorption
Residue on Ignition	pH Testing
Formaldehyde Residual

A biocompatibility assessment was also performed. The purpose of the biocompatibility assessment was to demonstrate that samples of the Gel-Sponge ENT, Absorbable Gelatin Sponge, USP were biocompatible on the basis of the following testing;

MEM Elution	Intracutaneous Injection Test
Systemic Injection Test	Rabbit Pyrogen Test
Kligman Skin Sensitization	Ames Reverse Mutation Assay
Short Term Subcutaneous Implantation Testing

The results of the tests confirmed the suitability of the device for its intended use.

Summary of Clinical Testing

No human clinical testing was required for this device.

Statement of Equivalence

Conclusion

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is substantially equivalent to the currently marketed Gelita-Spon Absorbable Gelatin Sponge, USP based on a comparison of the indications for use and the technological characteristics of the devices based on the technological characteristics, and sterilization methods. Bench tests confirmed the suitability of the device for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 9 2008

Vascular Solutions, Inc. c/o Ms. Lisa A. Gallatin, RAC Senior Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, Minnesota 55369

Re: K080022

Trade/Device Name: Gel-Sponge ENT, Absorbable Gelatin Sponge, USP Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: December 2, 2008 Received: December 3, 2008

Dear Ms. 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 I ou mayy aters or visions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 that I Drederal statutes and regulations administered by other Federal agencies. You must of any I odelar buttates and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 101.11 in the quant) by received (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egolins, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number:

K080022

Gel-Sponge ENT, Absorbable Gelatin Sponge, USP Device Name:

Indications for Use:

The Gel-Sponge ENT, Absorbable Gelatin Sponge, USP is intended for use during and after ENT surgeries for the control of minimal bleeding by tamponade effect, blood absorption and platelet aggregation.

Prescription Use X (Part 21 CER 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Cern

of Ophthalmic Ear

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.