Sepragel ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

Device Description

Sepragel ENT is a sterile, non-pyrogenic, transparent, viscoelastic, bioresorbable gel composed of cross-linked molecules of hyaluronan. It is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or gel stent intended to separate and prevent adhesions between mucosal surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.

SeprageI™ ENT hylan B gel, is a sterile, non-pyrogenic, transparent, viscoelastic gel composed of cross-linked molecules of hyaluronan. This hyaluronan is a bioresorbable material that functions to fill the sinus cavity, middle ear and external ear canal following surgery and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine Otologic surgery. Sepragel ENT leaves the site of placement by natural elimination. In nasal/sinus applications it may be aspirated from the cavity earlier at the discretion of the physician.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Sepragel™ ENT Bioresorbable Packing/Stent. A 510(k) submission is primarily for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily for proving that a device meets specific clinical performance acceptance criteria through the types of studies typically associated with clinical trials of AI/ML devices or novel therapies.

Based on the provided text, there is no information about:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set or data provenance for a performance study.
Number of experts used to establish ground truth or their qualifications.
Adjudication methods.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance studies.
Type of ground truth used (e.g., pathology, outcomes data).
Sample size for a training set.
How ground truth for a training set was established.

The document demonstrates regulatory approval based on substantial equivalence to predicate devices. The key aspects of the submission are:

1. Acceptance Criteria and Device Performance:
No specific quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are mentioned. The approval is based on demonstrating that the Sepragel™ ENT is substantially equivalent in terms of intended use, technological characteristics, and safety to already marketed devices.

2. Study/Evidence for Substantial Equivalence:
The "study" or evidence provided is a comparison of technological characteristics to predicate devices, as detailed in Table 4. This table highlights similarities and some differences in:

Manufacturer
Product Classifications/Codes
Intended Use/Indications
Material Composition (Derivative hyaluronic acid for all)
Bioresorbability (YES for all)
Product matrix (Gel in a syringe for Sepragel ENT and Hylasine™, Non-woven pad for MeroGel™)

The document asserts that Sepragel™ ENT is "substantially equivalent" to these predicates because it shares material composition (hyaluronan), bioresorbability, similar intended uses (with Sepragel ENT having an expanded indication to middle and external ear applications not explicitly listed for Sepragel Sinus, but listed for MeroGel Otologic Pack), and a similar product matrix to Sepragel Sinus.

3. Other Requested Information (Not Applicable/Not Provided):
All other requested points (sample sizes, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth, training set size, training ground truth establishment) are not relevant or not provided in this type of 510(k) submission. These details are typically found in clinical trials or performance studies designed to evaluate the efficacy or accuracy of a device, especially for AI/ML or diagnostic tools, which is not the nature of this submission. The submission is focused on demonstrating that the device is as safe and effective as devices already on the market through comparison.

Summary

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043035

JUL 1 1 2005

genzyme

Sepragel™ ENT Bioresorbable Packing/Stent Premarket |510(k)| Notification

510(K) SUMMARY (AS REQUIRED BY 21 CFR 807.92)

Pursuant to Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, Genzyme Corporation is providing a summary of the safety and effectiveness information available for SeprageI™ ENT Bioresorbable packing/stent (SeprageI™ ENT).

Sponsor/Applicant Name and Address: 7.1

Genzyme Corporation 500 Kendall Street Cambridge, MA 02142

Sponsor Contact Information: 7.2

Barbara Pizza Manager, Regulatory Affairs Phone: 617.252.7953 FAX: 617.761.8414 email: barbara.pizza@genzyme.com

Date of Preparation of 510(k) Summary: 7.3

Date

Device Trade or Proprietary Name: 7.4

SeprageI™ ENT Bioresorbable Packing/Stent

Device Common/Usual or Classification Name: 7.5

Ear, nose and throat synthetic polymer material

Identification of the Legally Marketed Devices to which Equivalence 7.6 is Being Claimed:

510(k) Number	Name of Predicate Device	Name of Manufacturer(Town, State)
K012532(K993362)	SepragelTM Sinus	Genzyme CorporationCambridge, MA
K001148(K002972)	MeroGelTM Nasal Otologic Pack(MeroGelTM Control Gel ENTSurgical Dressing)	Medtronic XomedJacksonville, FL

Device Description: 7.7

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genzyme

surfaces, to help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process.

Intended Use: 7.8

Seprage! ENT packing/stent is indicated for use in patients undergoing nasal/sinus, middle ear and external ear canal surgery as a space-occupying dressing and/or stent intended to prevent adhesions in the nasal cavity, separate mucosal surfaces, help control minimal bleeding following surgery or trauma, and act as an adjunct to aid in the natural healing process. The device is indicated for use in the middle ear following canalplasty, myringoplasty, tympanoplasty, stapes and mastoid surgery. The device is indicated following nasal/sinus surgery or trauma to prevent lateralization of the middle turbinate during the post operative period.

Comparison of Technological Characteristics of SeprageI™ ENT with 7.9 Legally Marketed Devices:

Table 4 is the Table of Similarities and Differences between Genzyme's Seprage1™ ENT Bioresorbable Packaing/Stent and the legally marketed devices identified in Section 7.6.

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genzyme

able 4: Comparison to Marketed Device

Device Name	Sepragel™ ENT	Hylasine™ (Sepragel Sinus)	MeroGel™Nasal Dressing/Sinus Stentand Otologic Packing
	Genzyme Corporation	Genzyme Corporation	Medtronic Xomed
	PROPOSED	(K993362, K012532)	(K001148)
	ENT synthetic polymer material	Epistaxis balloon/Intranasal Splint	Epistaxis balloon/ ENT synthetic polymermaterial
Product Code	77KHJ	77EMX/LYA	77KHJ
IntendedUse/Indication	For use in patients undergoingnasal/sinus surgery as a space-occupying gel stent to separate andprevent adhesions between mucosalsurfaces in the nasal cavity, to helpcontrol minimal bleeding followingsurgery or nasal trauma, and toprevent lateralization of the middleturbinate during the postoperativeperiod. The device is also indicatedfor use in the middle ear and externalear canal following canalplasty,myringoplasty, tympanoplasty and,and stapes and mastoid surgery.	For use in patients undergoingnasal/sinus surgery as a space-occupying gel stent to separate andprevent adhesions between mucosalsurfaces in the nasal cavity, to helpcontrol minimal bleeding followingsurgery or nasal trauma, and toprevent lateralization of the middleturbinate during the postoperativeperiod.	MeroGel Otologic Pack is a spaceoccupying dressing and/or stent intended toseparate mucosal surfaces, help controlminimal bleeding and act as an adjunct toaid in the natural healing process. Thedevice is indicated for use in the middleear and external ear canal followingcanalplasty, myringoplasty, tympanoplastyand, and stapes and mastoid surgery.
MaterialComposition	Derivative hyaluronic acid	Derivative hyaluronic acid	Derivative hyaluronic acid
Bioresorbable	YES	YES	YES
Product matrix	Gel in a syringe	Gel in a syringe	Non-woven pad in a protective foldedsheet

roprietary and Confidentis

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JUL 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Genzyme Corporation c/o Barbara Pizza Manager Regulatory Affairs 55 Cambridge Parkway Cambridge, MA 02142

Re: K043035

Trade/Device Name: Seprage1™ ENT Nasal/Sinus and Otologic Dressing Regulation Number: 21 CFR 874.3620 Regulation Name: ENT synthetic polymer material Regulatory Class: Class II Product Code: KHJ Dated: June 17, 2005 Received: June 20, 2005

Dear Ms. Pizza:

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.

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 or any Federal 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Barbara Pizza

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 Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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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genzyme

510(k) Number (if known): New Application

Sepragel™ ENT Bioresorbable Packing/Stent Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CRF 801.109)

sion Sign-Off ivision of Ophthalmic Ear Nose and Throat I

510(k) Number Proprietary and Confidential OR

Over-The-Counter Use (Optional Format 1-2-96)

Regulation Number and Section

§ 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.