(341 days)
Not Found
No
The device description and performance studies focus on the physical and biological properties of an absorbable gelatin sponge for hemostasis, with no mention of AI or ML technologies.
Yes
The device is used to control bleeding during and after ENT surgeries, which indicates a therapeutic purpose.
No
The device is intended for controlling bleeding during and after ENT surgeries, not for diagnosing conditions.
No
The device description clearly states it is a sterile, absorbable gelatin sponge, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for controlling bleeding during and after ENT surgeries by physical means (tamponade, absorption, platelet aggregation). This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description details a physical sponge used to absorb blood and create a barrier. It doesn't mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, tissue, or other biological samples to provide information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on physical properties and biocompatibility, not on diagnostic accuracy or performance metrics like sensitivity, specificity, etc., which are typical for IVDs.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely focused on controlling bleeding during a surgical procedure.
N/A
Intended Use / 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 to moderate bleeding by tamponande effect, blood absorption and platelet aggregation.
Product codes (comma separated list FDA assigned to the subject device)
KHJ, LYA
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),
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Residue on Ignition
Formaldehyde Residual
Absorption
pH Testing
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
Systemic Injection Test
Kligman Skin Sensitization
Intracutaneous Injection Test
Rabbit Pyrogen Test
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 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),
1
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.
2
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.
3
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
4
Indications for Use Statement
510(k) Number:
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