(63 days)
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.
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.
The provided document is a 510(k) summary for a medical device (Epi-Stop™ Nasal Gel/Epistaxis Pack), not a clinical study report for an AI/ML device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving an AI/ML device meets them.
The document discusses the substantial equivalence of the Epi-Stop™ Nasal Gel/Epistaxis Pack to a predicate device (Chitogel® Endoscopic Sinus Surgery Kit) based on biocompatibility testing and performance testing of the physical properties of the gel. It also mentions an in-vivo animal study to verify the device's ability to stay at the placement site and its hemostatic capabilities.
Here's why the document cannot answer your specific questions about AI/ML device acceptance criteria and study:
- Device Type: The Epi-Stop™ Nasal Gel/Epistaxis Pack is a physical medical device (nasal gel/packing) designed to treat anterior epistaxis (nosebleeds). It is not an AI/ML software or algorithm.
- Study Design: The studies described (biocompatibility, physical performance tests like absorption, occlusion, viscosity, extrusion force, pH, and an in-vivo animal study) are all related to the physical and biological characteristics of the gel itself, not to the performance of an AI/ML model.
- Ground Truth/Experts: The concept of "ground truth" established by experts, multi-reader multi-case (MRMC) studies, or training/test sets is specific to the validation of AI/ML algorithms, particularly in image analysis or diagnostic applications. These concepts are not applicable to the evaluation of a physical product like a nasal gel.
Therefore, it is not possible to extract the requested information regarding AI/ML device acceptance criteria and study design from this document.
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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
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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 VoermansPresidentT: +31(0) 24 711 4079E: 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
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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. | < 1 minute |
| 6 | Applicator1 | patient-contacting material. | < 1 minute |
| 7 | Epi-Stop™ Nasal Gel | patient-contacting material. | 72 hours |
Table 1. This table contains a list of all product components of Epi-Stop™ Nasal Gel/Epistaxis Pack,
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Image /page/5/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 design made up of seven hexagons in three different colors. The top hexagon is orange, the two hexagons below it are light orange, the two hexagons below that are light blue, and the two hexagons at the bottom are dark blue.
Indications for use
Epi-Stop™ Nasal Gel/Epistaxis Pack is a sterile, single use device indicated for 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.
Contraindications:
This product is contraindicated for use in patients with a known hypersensitivity/allergy to porcine-derived gelatin or its derivatives.
Possible Adverse Reactions:
Possible adverse effects associated with product use can include Allergic reactions, Scarring/synechia and Toxic syndrome (rare). For more information, please read Warnings and Precautions section in the Instructions For Use.
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Image /page/6/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 design made up of seven hexagons. Three of the hexagons are orange, two are light blue, and two are dark blue.
Comparison of Technological Characteristics with the Predicate Device.
Table 2. Comparison of predicate device with subject device Epi-Stop™ Nasal Gel/Epistaxis Pack
| Subject device | Predicate device | ||
|---|---|---|---|
| K230142 | K172179 | ||
| Epi-StopTM Nasal Gel/EpistaxisPack | Chitogel® Endoscopic SinusSurgery Kit | ||
| BioMed ENT, Inc. | Chitogel Ltd | ||
| Product Codes | LYA | LYA, | |
| Regulations | 874.4780 | 874.4780, | |
| DeviceClassification | Class I | Class I | |
| Indications for use: | Indications for use: | ||
| Indications foruse | Epi-StopTM Nasal Gel/EpistaxisPack is a sterile, single usedevice indicated for use inpatients suffering from anteriorepistaxis to:- Help control minimal bleedingfollowing trauma by barrierfunction, blood absorption andplatelet aggregation;- Act as an adjunct to aid in thenatural healing process. | Chitogel® Endoscopic SinusSurgery Kit is indicated for use inpatients undergoing nasal/sinussurgery as a space occupyingpacking to:- Separate tissue or structurescompromised by surgical trauma.- Separate and prevent adhesionsbetween mucosal surfaces in thenasal cavity.- Control minimal bleeding | |
| Epi-StopTM Nasal Gel/EpistaxisPack is indicated for use as anasal packing to treat anteriorepistaxis. | following surgery or trauma bytamponade effect, bloodabsorption and plateletaggregation.- Act as an adjunct to aid in the | ||
| Epi-StopTM Nasal Gel/EpistaxisPack is intended for use underthe direction of a licensedhealthcare provider. | natural healing process.The Chitogel® Endoscopic SinusSurgery Kit is indicated for use asa nasal packing to treat epistaxis. | ||
| TechnologicalCharacteristics | Injectable Nasal Gel | Injectable Nasal Gel | |
| Subject device | Predicate device | ||
| Epi-Stop™ Nasal Gel/EpistaxisPack is a single use, injectablegel, supplied sterile.Epi-Stop™ Nasal Gel/Epistaxis | Chitogel® Endoscopic SinusSurgery Kit is a single use,injectable gel, supplied sterile.In Chitogel® Endoscopic Sinus | ||
| How supplied | Pack consists of a pre-filledsyringe containing the gel, and anattachment/applicator to helpdeliver the gel in theKiesselbach's plexus. | Surgery Kit all components of thegel need to be mixed on-site bythe physician, using the syringeand the attachment provided. Thepre-measured components mix toform the biodegradable gel. | |
| Materials | -Porcine-derived gelatin (derivedfrom collagen) and-Hyaluronic acid and | - Chitosan and- Dextran Aldehyde Powder and- Phosphate Buffer Solution | |
| -Phosphate Buffer solution | |||
| Method of Action. | Method of Action. | ||
| Gel injected in the anterior nasalcavity. | Gel injected in the sinus cavity | ||
| Removal. | Removal. | ||
| Method of | Epi-Stop™ Nasal | Chitogel® Endoscopic Sinus | |
| Action/Removal | Gel/Epistaxis Pack can be | Surgery Kit is eliminated viagentle irrigation using saline or | |
| removed by using safe waterfor gentle irrigation (either | water. | ||
| sterile or boiled water) or using | |||
| safe lukewarm water. | |||
| Sterilization | Supplied sterile - Steamsterilization | Supplied sterile - ETO & Gamma | |
| Sterilization10-6 SALAssuranceLevel | 10-6 SAL | ||
| Single Use | Yes | Yes | |
| Shelf life | 18 months | 3 months | |
| Biocompatibility | Complies with ISO 10993-1 | Complies with ISO 10993-1 |
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Image /page/7/Picture/0 description: The image contains the logo for BioMed ENT. The words "BioMed" are in orange, and the letters "ENT" are in gray. To the right of the text is a pyramid shape made of six hexagons in shades of orange and blue.
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Image /page/8/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 design made up of seven hexagons in different shades of orange and blue.
Biocompatibility testing
The Epi-Stop™ Nasal Gel/Epistaxis Pack consists of well-known and commonly used materials. All materials are purchased from reputable vendors, and Epi-Stop™ Nasal Gel/Epistaxis Pack has been evaluated under biocompatibility studies, and have successfully passed all of the following:
Cytotoxicity. A Cytotoxicity study was conducted to analyze if Epi-Stop™ Nasal Gel/Epistaxis Pack could cause cell damage or cell death. Thus, the cytotoxic effect of Epi-Stop™ Nasal Gel/Epistaxis Pack was investigated through a Cytotoxic-Direct Contact test in compliance with ISO 10993-5:2009 and the standards of Good Laboratory Practice. According to the results and acceptance criteria stated in ISO 10993-5:2009, the test item Epi-Stop™ Nasal Gel/Epistaxis Pack must be considered NOT CYTOTOXIC.
Sensitization. A sensitization study was conducted to investigate if Epi-Stop™ Nasal Gel/Epistaxis Pack could induce an abnormally sensitive reaction on skin. Thus, Epi-Stop™ Nasal Gel/Epistaxis Pack was submitted to a biological evaluation in order to identify its potential sensitizing effects; this was done through a Delayed Hypersensitivity test (GPMT test) in compliance with ISO 10993-10:2010 and the standards of Good Laboratory Practice. To summarize, on the basis of the results, interpreted according to ISO 10993-10:2010, the test item Epi-Stop™ Nasal Gel/Epistaxis Pack must be considered NOT SENSITIZING.
In Vivo Acute Skin Irritation. An in vivo acute skin irritation test was conducted to investigate if Epi-Stop™ Nasal Gel/Epistaxis Pack could cause an irritant effect on skin. Thus, a biological evaluation was performed on Epi-Stop™ Nasal Gel/Epistaxis Pack via the following test: Skin Irritation in compliance with ISO 10993-23:2021 and the standards of Good Laboratory Practice. To summarize, on the basis of the results, interpreted according to ISO 10993-23:2021, the test item Epi-Stop™ Nasal Gel/Epistaxis Pack must be considered Negligibly irritant for the skin.
Acute Systemic Toxicity. An acute systemic toxicity test was conducted to investigate if Epi-Stop™ Nasal Gel/Epistaxis Pack could induce any adverse or toxic effect following it's placement. Thus, a biological evaluation was conducted on Epi-Stop™ Nasal Gel/Epistaxis Pack via a Systemic Toxicity test in compliance with ISO 10993-11:2017 and the standards of Good Laboratory Practice. In summary, and based on the results, which were interpreted in accordance with ISO 10993-11:2017, the test sample Epi-Stop™ Nasal Gel/Epistaxis Pack does not cause toxic symptoms and satisfies with the requirements of the test.
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Image /page/9/Picture/0 description: The image shows 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 design made up of six hexagons in different shades of orange and blue.
| Test | Applicable standards | Status |
|---|---|---|
| Cytotoxic-Direct Contacttest | ISO 10993-5:2009Good LaboratoryPractice | Not cytotoxic |
| Sensitization | ISO 10993-10:2010Good LaboratoryPractice | Not sensitizing |
| In Vivo Acute SkinIrritation | ISO 10993-23:2021Good LaboratoryPractice | Not irritant |
| Acute Systemic Toxicity | ISO 10993-11:2017Good LaboratoryPractice | Not toxic |
All Biocompatibility studies mentioned above were conducted in compliance with the following standards of Good Laboratory Practice:
- OECD Series on Principles of Good Laboratory Practice and ● Compliance Monitoring - OECD principles of Good Laboratory Practice (as revised in 1997) - Environment Directorate - Organization for Economic Co- Operation and Development, Paris 1998.
- Legislative decree n. 50 of March the 2ª, 2007. Enforcement of ● Community Directives 2004/9/CE and 2004/10/CE, concerning the inspection and verification of Good Laboratory Practice and the drawing of the legislative, regulatory and administrative dispositions relative to the application of Good Laboratory Practice rules, to the control of their application on the assays performed on the chemical substances (GU n.86 of April the 13th, 2007).
United States Food and Drug Administration, Title 21 Code of . Federal Regulations Part 58, Federal Register 22 December 1978, and subsequent amendments.
GLP Certification n. 2019/25 released by the Italian Ministry of Health . on September 12th 2019 authorizing Eurofins Biolab S.r.l. to perform analyses in compliance with the principles of good laboratory practices.
Performance testing
Performance of Epi-Stop™ Nasal Gel/Epistaxis Pack was analyzed and evaluated together with the predicate device Chitogel® Endoscopic Sinus Surgery Kit. In summary, absorption, occlusion, dynamic viscosity, extrusion force, and pH were the five tests conducted.
Occlusion.
Occlusion of the injury site is an important property responsible for the sealing between the wound's edges and the gel surface. A good occlusion will allow the hemostat to stop any leakage or outflow of blood outside the perimeter of the wound. The occlusion property of Epi-Stop™ Nasal Gel/Epistaxis Pack's was
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Image /page/10/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 design made up of seven hexagons in a honeycomb pattern. The hexagons are in shades of orange and blue.
tested in comparison with Chitogel® Endoscopic Sinus Surgery Kit. Briefly, in summary to the occlusion results, there was no leakage of water seen in any of the devices tested for a period of 60 minutes. Both, the predicate and subject device succeeded in sealing the open surface of the glass flask, preventing the water from leaking outside the flask containers.
Absorption.
The absorption property of an hemostat is relevant in allowing the retention of blood while the body carries on, independently, with its coagulation process. To test the retention that the Gelatin-HA meshwork can provide to Epi-Stop™ Nasal Gel/Epistaxis Pack an absorption test was conducted in comparison with Chitogel® Endoscopic Sinus Surgery Kit. In summary to the absorption results, it was concluded that both, the predicate device and subject device performed highly similar regarding the absorption property. After three hours of being submerged in water, both devices showed a comparable absorbance of water, based on their initial weight.
Dynamic Viscosity.
The internal resistance of Epi-Stop™ Nasal Gel/Epistaxis Pack is an important characteristic as it reflects upon the force or pressure required to spread the gel. Once adhered to the edges of the wound, Epi-Stop™ Nasal Gel/Epistaxis Pack will adapt to the surrounding areas to render the device more comfortable upon placement. For this, the internal resistance of Epi-Stop™ Nasal Gel/Epistaxis Pack was measured and compared to Chitogel® Endoscopic Sinus Surgery Kit. In summary, both Epi-Stop™ Nasal Gel/Epistaxis Pack and Chitogel® Endoscopic Sinus Surgery Kit showed viscosities within the acceptable range for a hemostat. However, although the viscosity of Epi-Stop™ Nasal Gel/Epistaxis Pack is lower than that of Chitogel® Endoscopic Sinus Surgery Kit, it will not compromise its intended use, but rather only improves the handling characteristics with respect to injectability and adaptability to the surrounding implant area. The different viscosity levels seen in the subject device (when compared to the predicate) are primarily intended to support the handling properties of the device. This in mind, to successfully stop anterior minimal 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.
Extrusion Force.
The applied force needed in order to eject the gel from the syringe was also analyzed in both devices. It was expected that both gels should be extruded from its own syringe by using similar extrusion force. Both devices scored within the acceptance range.
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Image /page/11/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 design made up of seven hexagons in a triangular shape. The hexagons are in shades of orange and blue.
To help establish the stability of Epi-Stop™ Nasal Gel/Epistaxis Pack over the entirety of its shelf life, the pH has been measured so far at 0, 3.5, and 18 months real-time. In summary, the pH of Epi-Stop™ Nasal Gel/Epistaxis Pack remained stable for the entirety of the proposed shelf-life, 18 months.
In-vivo study.
To verify that Epi-Stop™ Nasal Gel/Epistaxis Pack stays at the initial site of placement (bleeding site) for a period of three (3) days, and to test the hemostatic capabilities of the device, an in vivo animal study was conducted. Chitogel® Endoscopic Sinus Surgery Kit was included in this study as it is the predicate device that Epi-Stop™ is claiming substantial equivalence to.
In conclusion, both Epi-Stop™ Nasal Gel/Epistaxis Pack and Chitogel® Endoscopic Sinus Surgery Kit were able to stop anterior mild bleeding within the timeframe indicated. Although the predicate was slightly faster, both devices performed within the same acceptance criteria range. Together with this, according to the observations from the study, both gels also remained at the injection site and no dripping was observed during 24, 48, and 72 hours of monitoring.
Conclusion
In conclusion, Chitogel® Endoscopic Sinus Surgery Kit and Epi-Stop™ Nasal Gel/Epistaxis Pack are considered substantially equivalent since both devices are single use, and injectable gels that are provided sterile for the treatment of anterior epistaxis. These devices are also made of biopolymers recognized for their mucoadhesive properties (i.e. chitosan or gelatin). Both devices are indicated for use as a nasal packing to treat anterior epistaxis, and supplied sterile with a SAL of 10-6. Both, the predicate and subject device were tested through biocompatibility analyses and both, Chitogel® Endoscopic Sinus Surgery Kit and Epi-Stop™ Nasal Gel/Epistaxis Pack, passed Cytotoxicity, Sensitization, and Acute Systemic Toxicity. In addition to this, Epi-Stop™ Nasal Gel/Epistaxis Pack also passed in vivo skin irritation test.
The differences between the predicate and subject device are not significant enough to compromise the safety and effective performance of Epi-Stop™ Nasal Gel/Epistaxis Pack since it shares the same characteristics as Chitogel® Endoscopic Sinus Surgery Kit in order to effectively treat anterior epistaxis. Epi-Stop™ Nasal Gel/Epistaxis Pack also shares almost identical indications for use, highly similar technology (e.g., both are single use gels delivered in syringes), and mode of removal with regards to the predicate device discussed above.
To finalize, performance between devices was compared by testing properties such as absorption, occlusion, dynamic viscosity, extrusion force, and pH. Hence, Chitogel® Endoscopic Sinus Surgery Kit and Epi-Stop™ Nasal
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Image /page/12/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 design made up of seven hexagons in different shades of orange and blue.
Gel/Epistaxis Pack were analyzed and both devices exhibited values within acceptable ranges. Moreover, the in vivo study performed in both, the subject and predicate also showed that both devices remain at the injection site and are capable of stopping anterior bleeding in less than a minute. Based on these data, it was concluded that Epi-Stop™ Nasal Gel/Epistaxis Pack is as safe and effective as Chitogel® Endoscopic Sinus Surgery Kit when it comes to the treatment of anterior epistaxis.
§ 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.