The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing. The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: Separate tissue or structures compromised by surgical trauma; Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; Help control minimal bleeding following surgery or trauma; Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; Act as an adjunct to aid in the natural healing process. The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.

Device Description

The Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. Upon placement, the Nasal/Epistaxis Pack absorbs fluids in the field and swells and conforms to the mucosal tissue/treatment site surfaces to separate tissues and prevent adhesions, control minimal bleeding following surgery or trauma, to treat epistaxis, and to act as an adjunct to aid in the natural healing process.

AI/ML Overview

The provided document is a 510(k) summary for the Nasal/Epistaxis Pack, a medical device. This type of document is filed with the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a clinical study with specific acceptance criteria that an AI/device performance would need to meet.

Therefore, the information requested in your prompt (e.g., acceptance criteria, test set sample size, expert ground truth, MRMC study, training set size) is not applicable to this type of regulatory submission or the device it describes.

A 510(k) submission primarily focuses on comparing the new device's characteristics and performance to existing predicate devices. The "safety and effectiveness information" section in this document refers to comparative performance data demonstrating adequate device performance by showing substantial equivalence, not results from a study designed to meet specific performance metrics against a defined standard or ground truth as would be found in an AI/algorithm-focused study.

Here's an overview of what the document does provide, and why your specific questions are not directly answerable from this text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures for an AI/diagnostic device. The "acceptance criteria" for a 510(k) submission are typically demonstrating substantial equivalence to a predicate device across various characteristics (e.g., indications for use, design, materials, method of action, sterility, biocompatibility).
Reported Device Performance: The document states, "In addition, comparative performance test data demonstrated adequate device performance," and "The review of the indications for use and technical characteristics provided demonstrates that the Nasal/Epistaxis Pack is substantially equivalent to the predicate devices." This is a qualitative statement of meeting the equivalence criteria rather than specific numerical performance against a pre-defined metric. The table provided is a comparison of characteristics between the new device and predicate devices.

2. Sample sized used for the test set and the data provenance:

Not Applicable. This device is a physical sterile pack, not an AI or diagnostic tool that uses a "test set" of data in the typical sense. The "comparative performance test data" mentioned likely refers to bench testing (e.g., absorption capacity, degradation rates) or biocompatibility tests, not a clinical trial with a "test set" for performance evaluation against a diagnostic ground truth.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth, in the context of AI/diagnostic device evaluation, refers to the definitive determination of a condition (e.g., confirmed disease or pathology) used to assess the device's accuracy. This concept does not apply to a physical medical device like the Nasal/Epistaxis Pack.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. An MRMC study is designed for evaluating diagnostic devices, especially those involving human interpretation, and often the impact of AI assistance. This device is not a diagnostic tool or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. See point 3.

8. The sample size for the training set:

Not Applicable. This is not an AI/machine learning device that requires a "training set."

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary of what is provided in the K113585 document:

Device Name: Nasal/Epistaxis Pack
Product Description: Sterile, single-use co-polymer of polyethylene glycol (PEG) and chitosan, provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. It absorbs fluids, swells, conforms to tissue, separates tissues to prevent adhesions, controls minimal bleeding, and aids in healing.
Indications for Use:
- As a space-occupying packing in nasal/sinus surgery to:
  - Separate tissue/structures compromised by surgical trauma.
  - Separate and prevent adhesions between mucosal surfaces.
  - Help control minimal bleeding following surgery or trauma (by tamponade effect, blood absorption, platelet aggregation).
  - Act as an adjunct to aid in the natural healing process.
- As a nasal packing to treat epistaxis.
Predicate Devices:
- Nasopore® manufactured by Polyganics BV (K052099)
- Sepragel ENT Bioresorbable Packing/Stent manufactured by Genzyme Corporation (K043035)
- Rhinocell® Nasal Packings manufactured by Boston Medical Products, Inc. (K972459)
- MeroPack Bioresorbable Nasal Packing and Sinus Stent manufactured by Medtronic Xomed Inc. (K041381)
- MeroGel™ Control Gel ENT Surgical Dressing manufactured by Medtronic Xomed Inc. (K002972)
Basis for Substantial Equivalence: The Nasal/Epistaxis Pack shares the same indications for use, device operation, overall technical and functional capabilities with the predicate devices. Comparative performance test data demonstrated adequate device performance in supporting this claim of substantial equivalence. The provided table details the comparison of characteristics, including product codes, regulations, ingredients, method of action/removal, sterility, biocompatibility, and how supplied, across the new device and its predicates.

Summary

{0}------------------------------------------------

K113585

Section 5 - 510(k) Summary or 510(k) Statement

General Information I.

Submitter:

ﺮ ﺍﻟ

CogENT Therapeutics, LLC 703 Sandoval Way Hayward, CA 94544 Telephone: 650-450-4956

Contact Person:

Glen Gong Principal Telephone: 650-450-4956 x 102

Summary Preparation Date:

April 3, 2012

II. Names
Device Names:

Nasal/Epistaxis Pack

Intranasal splint, ENT polymer material, and Epistaxis Primary Classification Names: (packing)

III. Predicate Devices

Nasopore® manufactured by Polyganics BV (K052099) .
Sepragel ENT Bioresorbable Packing/Stent manufactured by Genzyme Corporation . (K043035)
Rhinocell® Nasal Packings manufactured by Boston Medical Products, Inc. . (K972459)
MeroPack Bioresorbable Nasal Packing and Sinus Stent manufactured by Medtronic . Xomed Inc. (K041381)
MeroGel" Control Gel ENT Surgical Dressing manufactured by Medtronic Xomed . Inc. (K002972)

IV. Product Description

V. Indications for Use

The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing.

{1}------------------------------------------------

The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:

Separate tissue or structures compromised by surgical trauma; ●
Separate and prevent adhesions between mucosal surfaces during mesothelial cell . regeneration in the nasal cavity;
Help control minimal bleeding following surgery or trauma; .
Help control minimal bleeding following surgery or nasal trauma by tamponade ● effect, blood absorption and platelet aggregation; and
Act as an adjunct to aid in the natural healing process. .

The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.

VI. Rationale for Substantial Equivalence

The Nasal/Epistaxis Pack shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices for use as a space-occupying stent/packing for nasal/sinus use.

In addition, comparative performance test data demonstrated adequate device performance.

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Nasal/Epistaxis Pack is substantially equivalent to the predicate devices (see Table on following page).

VIII. Conclusion

The Nasal/Epistaxis Pack was found to be substantially equivalent to the predicate devices.

The Nasal/Epistaxis Pack shares identical indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

יר

{2}------------------------------------------------

Characteristic	K052099Nasopore®Polyganics BV	K043035Sepragel ENTBioresorbablePacking/StentGenzyme Corp.	K972459Rhinocell® NasalPackingsBoston MedicalProducts, Inc.	K041381MeroPack BioresorbableNasal Packing and SinusStentMedtronic Xomed Inc.	K002972MeroGel™ Control GelENT Surgical DressingMedtronic Xomed Inc.
ProductCodes	LYA = Intranasal splint	KHJ = ENT SyntheticPolymer Material	EMX = Epistaxis balloon	LYA = Intranasal Splint	KHJ = ENT SyntheticPolymer Material
Regulations	21 CFR 874.4780	21 CFR 874.3620	21 CFR 874.4100	21 CFR.874.4780	21 CFR 874.3620
IndicationsFor Use		See Section V above
Ingredients	Crosslinked PolyethyleneGlycol (PEG) and Chitosan	Fragmentablepoly(DL-lactide-co-ε-caprolactone) urethane	Derivative ofhyaluronic acid	Polyvinyl alcohol (PVA)sponge using a patentedformula.	Esterfied hyaluronic acid(HYAFF®) and Collagen	Esterfied hyaluronic acid(HYAFF®)
Method ofaction/removal	• Hygroscopic, formsgelatinous mass in contactw/ fluids• Natural elimination,aspiration or gentleirrigation of residues• Upon application deviceswells and conforms tomucosal surfaces.	• Hygroscopic,fragments in contactwith fluids• Fragments withinseveral days afterinsertion in the nasalcavity• Drained from the nasalcavity via the naturalmucus flow.	• Fills nasal/sinuscavities• Leaves placementsite by naturalelimination, or maybe aspirated fromthe cavity earlier atphysician'sdiscretion	• The packings willexpand as fluid isintroduced, giving thesurgeon time foraccurate positioning.	• Hygroscopic, formsgelatinous mass incontact with fluids.• Absorbent >10 timesweight of device• The stent graduallydegrades over time andis slowly absorbedwithin 14 days, or itmay be aspirated fromthe cavity earlier at thediscretion of thephysician.	• Hygroscopic, formsgelatinous mass incontact with fluids.• Absorbent >6 timesweight of device• Dressing may becompressed/ shaped bysurgeon as needed• Gel eventuallydissolves, or it may beaspirated from thecavity earlier at thediscretion of thephysician.
Sterility	Sterile by E-BeamIrradiation	Sterile by EO gas	Sterile	Sterile by GammaIrradiation	Sterile by GammaIrradiation	Sterile by GammaIrradiation
Biocompat	Complies with ISO 10993-1	Complies withISO 10993-1	Unknown - notspecified	Unknown - not specified	Complies withISO 10993-1	Complies withISO 10993-1
HowSupplied	• 4.0 cm x 2.4 cm x 0.3 cmpack• Single use• Single barrier Foil pouch• Sterile, ready to use	• Single use• Single barrier Tyvekpouch	• Single use• Transparentviscoelastic gel	• Variety of shapes andsizes to choose from,both with and withoutintegral airways• Sterile, ready to use	• Single use• Lyophilized (freezedried) and compresseddressing	• Single use

Section 5: 510(k) Summary - Page 5-3

CogENT Therapeutics, LLC 510(k) Submission for:
Nasal/Epistaxis Pack

. "*

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

CogENT Therapeutics, LLC % Ms. Anne Worden Regulatory Consultant 703 Sandoval Way Hayward, CA 94544

APR 2 5 2012

Re: K113585

Trade Name: Nasal/Epistaxis Pack Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal splint Regulatory Class: I Product Code: LYA, EMX Dated: April 3 2012 Received: April 4, 2012

Dear Ms. Worden:

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 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 that I Dr mas intact and regulations administered by other Federal agencies. You must or any I 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2-Ms. Anne Worden

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your a vite soffices/CDRHOffices/ucm115809.html for go to mightwww.ida.gov/About Bril Sellers's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radionagiou. Heath of (con" (2) Children (2) (CFR Patt note the regulation entitied, "Misolanding of reference events under the MDR regulation (21 CFR Part 803), please go to

CFK Part 803), prease go to nttp://www.raa.governers/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general informations on your Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

(800) 030-2041 01 (50%) ical Devices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

{5}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K11

Nasal/Epistaxis Pack Device Name:

Indications for Use:

The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing.

The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to:

Separate tissue or structures compromised by surgical trauma; .
Separate and prevent adhesions between mucosal surfaces during mesothelial cell . regeneration in the nasal cavity;
Help control minimal bleeding following surgery or trauma; .
Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood . absorption and platelet aggregation;
Act as an adjunct to aid in the natural healing process. .

The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.

イ Prescription Use (Part 21 CFR 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)
--------------------------------------------------------

Signature
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k 113585

Page: 1 of 1

CogENT Therapeutics, LLC 510(k) Submission for: Nasal/Epistaxis Pack

Section 4: Indications for Use - Page 4-2

Regulation Number and Section

§ 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.