(63 days)
No
The device description and performance studies focus on the physical and chemical properties of a gel for hemostasis, with no mention of AI or ML technologies.
Yes
The device is described as aiding in the natural healing process and acting as a nasal packing to treat anterior epistaxis, which are therapeutic actions.
No
This device is a treatment for anterior epistaxis, designed to control bleeding and aid healing. It does not perform any diagnostic functions.
No
The device description clearly states it is a physical gel made of crosslinked gelatin and hyaluronic acid, intended for injection into the nasal cavity. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Epi-Stop™ Nasal Gel/Epistaxis Pack is a physical device (a gel) that is applied directly to the anterior nasal cavity to control bleeding and aid in healing. It does not analyze a sample taken from the body to provide diagnostic information.
- Intended Use: The intended use is to "Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation" and "Act as an adjunct to aid in the natural healing process." These are therapeutic and supportive functions, not diagnostic ones.
- Mechanism of Action: The device works by creating a physical barrier, absorbing blood, and promoting platelet aggregation at the site of bleeding. This is a direct physical interaction with the tissue, not an analysis of a biological sample.
Therefore, the Epi-Stop™ Nasal Gel/Epistaxis Pack falls under the category of a medical device used for treatment and support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use in patients suffering from anterior epistaxis to:
- Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation;
- Act as an adjunct to aid in the natural healing process.
Epi-Stop™ Nasal Gel/Epistaxis Pack is indicated for use as a nasal packing to treat anterior epistaxis.
Epi-Stop™ Nasal Gel/Epistaxis Pack is intended for use under the direction of a licensed healthcare provider.
Product codes
LYA
Device Description
Epi-Stop™ Nasal Gel/Epistaxis Pack is a single use, hemostatic, and injectable gel, made of crosslinked gelatin and hyaluronic acid, indicated for the treatment of anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack creates a moist environment for healing and the ability of absorbing and stopping nose bleeding within minutes. Due to its viscoelasticity and low extrusion force, Epi-Stop™ Nasal Gel/Epistaxis Pack can be injected into the anterior nasal cavity and the gel must be left in the nose for at least 72 hours. Afterwards, the gel can be removed by using safe water for gentle irrigation (either sterile or boiled water) or using safe lukewarm water.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anterior nasal cavity, Kiesselbach's plexus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed healthcare provider, medical professional or trained personnel
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
Performance testing:
- Occlusion: Tested in comparison with Chitogel® Endoscopic Sinus Surgery Kit. Both devices succeeded in sealing the open surface of the glass flask for 60 minutes, preventing water leakage.
- Absorption: Tested in comparison with Chitogel® Endoscopic Sinus Surgery Kit. Both devices showed comparable absorption properties after three hours of being submerged in water, based on their initial weight.
- Dynamic Viscosity: Measured and compared to Chitogel® Endoscopic Sinus Surgery Kit. Both showed viscosities within the acceptable range for a hemostat. Epi-Stop™ Nasal Gel/Epistaxis Pack had a lower viscosity, which improves handling characteristics.
- Extrusion Force: Analyzed in both devices. Both scored within the acceptance range.
- pH: Measured at 0, 3.5, and 18 months real-time to establish shelf life stability. The pH remained stable for the proposed 18-month shelf-life.
In-vivo study:
- Study Type: In vivo animal study.
- Purpose: To verify that Epi-Stop™ Nasal Gel/Epistaxis Pack stays at the initial site of placement (bleeding site) for three days, and to test its hemostatic capabilities.
- Comparison: Chitogel® Endoscopic Sinus Surgery Kit (predicate device) was included.
- Key Results: Both Epi-Stop™ Nasal Gel/Epistaxis Pack and Chitogel® Endoscopic Sinus Surgery Kit were able to stop anterior mild bleeding within the indicated timeframe. The predicate was slightly faster, but both performed within the same acceptance criteria range. Both gels remained at the injection site with no dripping observed during 24, 48, and 72 hours of monitoring.
Key Metrics
Not Found
Predicate Device(s)
Chitogel® Endoscopic Sinus Surgery Kit (K172179)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 22, 2023
BioMed ENT, Inc. % Marcela Garcia Principal Investigator BioMed Elements B.V. Kerkenbos 1077-V Nijmegen, Gelderland 6546 BB Netherlands
Re: K230142
Trade/Device Name: Epi-Stop Nasal Gel/Epistaxis Pack Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: January 18, 2023 Received: January 18, 2023
Dear Marcela Garcia:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230142
Device Name Epi-Stop™ Nasal Gel/Epistaxis Pack
Indications for Use (Describe)
Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use in patients suffering from anterior epistaxis to:
-
Help control minimal bleeding following trauma by barrier function, blood absorption and platelet aggregation;
-
Act as an adjunct to aid in the natural healing process.
Epi-Stop™ Nasal Gel/Epistaxis Pack is indicated for use as a nasal packing to treat anterior epistaxis.
Epi-Stop™ Nasal Gel/Epistaxis Pack is intended for use under the direction of a licensed healthcare provider.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for BioMed ENT. The words "BioMed" are in orange, and the word "ENT" is in gray. To the right of the words is a graphic of seven hexagons arranged in a triangular shape. The hexagons are colored in shades of orange and blue.
510(K) SUMMARY
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of Epi-Stop™ Nasal Gel/Epistaxis Pack.
| Applicant: | BioMed ENT, Inc.
18911 Hardy Oak Blvd,
San Antonio, TX 78258,
United States,
210-846-0692 |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Trade name: | Epi-Stop™ Nasal Gel/Epistaxis Pack |
| Common name: | Nasal Packing |
| Classification name: | Intranasal Splint |
| Number: | 21 CFR 874.4780 |
| Device Classification: | Class I |
| Device Product Code: | LYA |
| Device Panel: | Ear, Nose and Throat |
| Predicate Device: | Chitogel® Endoscopic Sinus Surgery Kit (K172179) |
| Contact Person: | Tonny Voermans
President
T: +31(0) 24 711 4079
E: t.voermans@biomed-ent.com |
| Date: | 2023 March 21 |
Device Description
Epi-Stop™ Nasal Gel/Epistaxis Pack is a single use, hemostatic, and injectable gel, made of crosslinked gelatin and hyaluronic acid, indicated for the treatment of anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack creates a moist environment for healing and the ability of absorbing and stopping nose bleeding within minutes. Due to its viscoelasticity and low extrusion force, Epi-Stop™ Nasal Gel/Epistaxis Pack can be injected into the anterior nasal cavity and the gel must be left in the nose for at least 72 hours. Afterwards, the gel can be
4
Image /page/4/Picture/0 description: The image contains the logo for BioMed ENT. The words "BioMed" are in orange, and the word "ENT" is in gray. To the right of the words is a graphic of seven hexagons arranged in a triangular shape. The hexagons are colored in shades of orange and blue.
removed by using safe water for gentle irrigation (either sterile or boiled water) or using safe lukewarm water.
Principle of operation. In Figure 1 the commercial presentation of Epi-Stop™ Nasal Gel/Epistaxis Pack is shown and it consists of a cardboard box (secondary package) as an outer package (a). Inside the box, a leaflet with the instructions for use (IFU) can be found, together with a sterile sealed-pouch (primary package) containing a capped syringe and an applicator (b). The sterile pouch can be peeled-open, and the capped syringe and applicator can be taken out of the primary package (c). The gel is contained and sealed in this syringe and should only be injected through the applicator by a medical professional or trained personnel. To properly use Epi-Stop™ Nasal Gel/Epistaxis Pack, a medical professional or trained personnel should twist-and-remove the cap tip from the syringe (d) and attach the applicator instead (e). The applicator can then be introduced in the anterior nasal cavity against the injury site, and the gel can be injected in one smooth notion in compliance with the IFU.
Image /page/4/Figure/4 description: The image shows five different views of a medical product called Epi-Stop Nasal Gel. Image a) shows the product's packaging, which is a box with the product name and the manufacturer's logo. Images b) through e) show the product itself, which is a syringe filled with a gel-like substance. The syringe is shown in different stages of use, with the gel being dispensed from the syringe in images d) and e).
Figure 1. Visual representation of Epi-Stop™ Nasal Gel/Epistaxis Pack and its key components.
Mechanism of Action. Briefly, to successfully stop anterior mild bleeding, Epi-Stop™ Nasal Gel/Epistaxis Pack relies primarily on an optimal occlusion, followed by good absorption to retain blood, and lastly on an optimal viscosity designed to facilitate the subject device's ability to properly adapt to the implant area once it has been injected in the anterior nasal cavity.
Device components. A brief summary in Table 1 of the product components with the duration and type of contact.
| together with duration and type of contact for each of the items listed. | |||
|---|---|---|---|
| Device components | Type of contact | Duration | |
| 1 | Cardboard box | Not a patient-contacting material | N/A |
| 2 | IFU | Not a patient-contacting material | N/A |
| 3 | Pouch | Not a patient-contacting material | N/A |
| 4 | Cap tip | Not a patient-contacting material | N/A |
| 5 | Syringe | patient-contacting material. |