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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called Hylasine™ Hylan B Gel, an intranasal splint. However, it does not contain information about explicit acceptance criteria or a study proving the device meets those criteria, nor does it detail device performance metrics.

Instead, the document focuses on establishing substantial equivalence to legally marketed predicate devices. This is a common pathway for Class II and Class I medical devices in the US, where the focus is on showing that the new device is as safe and effective as a device already on the market, rather than requiring extensive clinical trials to prove efficacy against specific, predefined performance metrics.

Here's a breakdown of what is and is not present in the provided text, based on your requested categories:

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

Not present. The document does not specify quantitative acceptance criteria (e.g., "device must reduce adhesions by X%"). It also does not report specific performance metrics from a study (e.g., "adhesion rate was Y%"). The closest it comes to a "performance" comparison is highlighting shared indications for use and material composition with predicate devices, implying similar performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not present. There is no mention of a "test set" or any clinical study data involving human subjects to evaluate Hylasine™'s performance. The 510(k) submission is based on comparison to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not present. As no test set or clinical study is described, there's no mention of experts or ground truth establishment in this context.

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

Not present. No clinical study or adjudication method is described.

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 present. This device is a physical intranasal splint, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI-related effectiveness study is irrelevant and not mentioned.

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

Not present. This device is a physical product, not an algorithm.

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

Not present. No clinical studies are described where a ground truth would be established. The "ground truth" for this 510(k) submission is the regulatory acceptance of its predicate devices.

8. The sample size for the training set

Not present. There is no mention of a "training set" as this is not an AI/algorithm-based device.

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

Not present. No training set is mentioned.

Summary of the Document's Approach:

The provided 510(k) summary for Hylasine™ follows an approach of substantial equivalence to predicate devices. The "study" here is essentially a comparison of the new device's characteristics (intended use, material composition, bioresorbability, product code) to those of existing, legally marketed devices.

The acceptance criteria for a 510(k) submission like this are implicitly:

The device has the same intended use as a predicate device.
The device has the same technological characteristics as a predicate device, OR, if it has different technological characteristics, these differences do not raise new questions of safety and effectiveness.

The document demonstrates this by presenting a table comparing Hylasine™ to three predicate devices (Xomed MeroGel™, Boston Medical Custom Nasal Splint, LactoSorb Ethmoid Stent) across several attributes. The FDA's letter (K012532) confirms that based on this comparison, Hylasine™ was found to be substantially equivalent to the referenced predicate devices, allowing it to be marketed.

Summary

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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

Intended Use of the Device 7.7

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.

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genzyme

	Hylasine™	MeroGel Nasal Dressing	Custom Nasal Splint	LactoSorb Ethmoid Stent
	GenzymeCorporation	Xomed	Boston MedicalProducts	Walter Lorenz Surgical
Device Name	PROPOSED	(K982731)	(K972082)	(K002131)
Product Code	Intranasal Splint	Epistaxis balloon	Intranasal Splint	Intranasal Splint
	77LYA	77EMX	77LYA	77LYA
Indications/IntendedUse	For use in patientsundergoing nasal/sinussurgery as a space-occupying gel stent toseparate and preventadhesions betweenmucosal surfaces in thenasal cavity, to helpcontrol minimal bleedingfollowing surgery or nasaltrauma, and to preventlateralization of the middleturbinate during thepostoperative period.	For use in the nasal/sinuscavities as a space-occupyingdressing and/or stent, toseparate mucosal surfaces andto help control minimalbleeding following surgery.	To provide septalsupport and reduce orprevent adhesionsbetween the septum andlateral nasal wallfollowing surgery	For use during ethmoidectomy procedures.The LactoSorb Ethmoid Stent is intended tokeep the middle turbinate away from the lateralnasal wall during the healing process afternasal/sinus surgery. The stent provides enoughrigidity in the nasal cavity to keep the middleturbinate from adhering to the lateral nasalwall.
Material Composition	Derivative hyaluronic acid	Derivative hyaluronic acid	Plastic	LactoSorb 82%PLLA/18% PGA
Bioresorbable	YES	YES	NO	YES

igure 7- 1Comparison to Marketed Device

Proprietary and Confidentia

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

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

Section 2.0 Statement of Intended Use

Prescription Use
(Per 21 CFR 801.109)

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

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.