GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP

K080022 · Vascular Solutions, Inc. · KHJ · Dec 9, 2008 · Ear, Nose, Throat

Device Facts

• Record ID: K080022
• Device Name: GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
• Applicant: Vascular Solutions, Inc.
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Dec 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Sterile, absorbable gelatin sponge; used during/after ENT surgeries. Applied directly to bleeding site; functions via physical tamponade, blood absorption, and promotion of platelet aggregation. Available in various sizes (1.5 cm disk to 100 cm rectangle). Applied dry or wetted with sterile water/saline. Used by surgeons to achieve hemostasis; provides physical barrier to blood flow. Benefits patient by controlling minimal to moderate bleeding.

Clinical Evidence

No clinical data. Bench testing performed to assess physical properties (pepsin digestion, absorption, residue on ignition, pH, formaldehyde residual) and biocompatibility (MEM elution, intracutaneous injection, systemic injection, rabbit pyrogen, skin sensitization, Ames assay, subcutaneous implantation).

Technological Characteristics

Absorbable gelatin sponge, USP. Sterile. Dimensions range from 1.5 cm disk to 100 cm rectangle. Functions via physical tamponade and physiological coagulation-inducing properties. Biocompatible material.

Indications for Use

Indicated for patients undergoing ENT surgeries requiring control of minimal to moderate bleeding via tamponade, blood absorption, and platelet aggregation.

Regulatory Classification

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.

Predicate Devices

• Gelita-Spon Absorbable Gelatin Sponge, USP (K060878)
• ThrombiGel® thrombin/gelatin foam hemostat (K063860)

Submission Summary (Full Text)

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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: [phone] ext. 399 |
| | Fax: [phone] |

#### 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 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),

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#### Intended Use/Indications for Use

l

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.

### 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

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.

#### 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 [phone]. 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 [phone] or [phone] 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