Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical gel stent and does not mention any computational or data-driven components indicative of AI/ML.

Therapeutic

Yes
HylaSine is used to treat patients undergoing nasal/sinus surgery by preventing adhesions, controlling bleeding, and preventing turbinate lateralization, which are therapeutic interventions.

Diagnostic

No

Explanation: The device description and intended use indicate that HylaSine is a space-occupying gel stent used post-surgery to prevent adhesions and control bleeding, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states that HylaSine is a "sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan," which is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use of HylaSine is to be used in patients undergoing nasal/sinus surgery as a physical barrier and stent. It is applied directly to the surgical site to separate tissues, control bleeding, and prevent complications.
Device Description: The description details a physical gel that is placed within the body.
Lack of Diagnostic Function: There is no mention of this device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. HylaSine is used in vivo (within the body) as a therapeutic and supportive device during the healing process.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

Product codes (comma separated list FDA assigned to the subject device)

LYA

Device Description

HylaSine™, hylan B gel is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. This hyaluranon is a bioresorbable material that functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine sinus surgery. HylaSine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nasal/sinus cavities

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)

Not Found

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.

K982731, K972082, K002131

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

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.

Summary

0

genzyme

Section 7.0 510(k) Summary

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 Hylasine™.

7.1 Sponsor/Applicant Name and Address

Genzyme Corporation One Kendall Square Cambridge, MA. 02139

7.2 Sponsor Contact Name

Alexander E. Kuta, Vice President, Regulatory Affairs Phone: 617/374-7358, Fax: 617/374/7470, e-mail: alex.kuta@genzyme.com

7.3 Date that 510(k) Summary Was Prepared

June 26, 2001

7.4 Name of the Medical Device

Classification name: Intranasal Splint (Ear, Nose & Throat) Common/usual name: Intranasal Splint Proprietary name: Hylasine™

7.5 Legally Marketed Devices to Which Substantial Equivalence is Claimed

Xomed MeroGel™ Nasal Dressing and Sinus Stent (Xomed, K982731) Custom Nasal Splint (Boston Medical, K972082) LactoSorb Ethmoid Stent (Walter Lorenz Surgical, K002131)

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Description of the Device 7.6

HylaSine™, hylan B gel is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. This hyaluranon is a bioresorbable material that functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine sinus surgery. HylaSine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

Intended Use of the Device 7.7

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

Technological Comparison between Subject and Predicate Devices 7.8

Boston Medical Products' Custom Nasal Splint and Lorenz Surgical's LactoSorb Ethmoid Stent have similar indications as the proposed Hylasine. Boston Medical Products' Custom Nasal Splint prevents adhesions between mucosal tissues after surgery.

Xomed's MeroGel Nasal Dressing and Hylasine share a similar material composition in that they are both composed of derivatives of hyaluronic acid. Although Merogel has been cleared as an Epistaxis Balloon, it is used in the nasal/sinus cavity, as is an Intranasal Splint. Whether a hyaluronic acid product is classified as an Intranasal Splint or Epistaxis Balloon does not raise any new safety issues. Hylasine™ is also similar to Xomed's MeroGel Nasal Dressing and LactoSorb's LactoSorb Ethmoid Stent in that all three devices are bioresorbable.

Hylasine™, Boston Medical Products' Custom Nasal Splint and LactoSorb's LactoSorb Ethmoid Stent are all classified by the same product code of 77LYA with the generic name of Intranasal Solint

In conclusion, Hylasine™ has similar intended use, material composition, bioresorbability, and product code as other legally marketed devices.

2

genzyme

	Hylasine™	MeroGel Nasal Dressing	Custom Nasal Splint	LactoSorb Ethmoid Stent
	Genzyme
Corporation	Xomed	Boston Medical
Products	Walter Lorenz Surgical
Device Name	PROPOSED	(K982731)	(K972082)	(K002131)
Product Code	Intranasal Splint	Epistaxis balloon	Intranasal Splint	Intranasal Splint
	77LYA	77EMX	77LYA	77LYA
Indications/Intended
Use	For use in patients
undergoing nasal/sinus
surgery as a space-
occupying gel stent to
separate and prevent
adhesions between
mucosal surfaces in the
nasal cavity, to help
control minimal bleeding
following surgery or nasal
trauma, and to prevent
lateralization of the middle
turbinate during the
postoperative period.	For use in the nasal/sinus
cavities as a space-occupying
dressing and/or stent, to
separate mucosal surfaces and
to help control minimal
bleeding following surgery.	To provide septal
support and reduce or
prevent adhesions
between the septum and
lateral nasal wall
following surgery	For use during ethmoidectomy procedures.

igure 7- 1Comparison to Marketed Device

Proprietary and Confidentia

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal features a stylized image of an eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest the feathers and form of the bird. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 3 0 2001

Ms. Nancy A. Immel Senior Regulatory Associate Genzyme Corporation 1125 Pleasant View Terrace Ridgefield. New Jersey 07657

Re: K012532

Trade Name: Hylasine™ Hylan B Gel Regulation Number: 21 CFR 874.4780 Regulatory Class: Class I Product Code: LYA Dated: August 2, 2001 Received: August 6, 2001

Dear Ms. Immel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 promoted 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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K012532

Image /page/5/Picture/1 description: The image shows the word "genzyme" in a bold, sans-serif font. The letters are closely spaced, giving the word a compact appearance. The text is black against a white background.

Hylasine™ Hylan B Gel Premarket [510(k)] Notification

Section 2.0 Statement of Intended Use

HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K012532