The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces.

Device Description

The SyntheMed Device ("the device") is a single use, synthetic, bioresorbable polymeric film composed of polymers used extensively in implantable, absorbable medical devices. The device comprises bis(hydroxyl)-terminated PLA-PEG-PLA triblocks, where PLA = poly(lactic acid) and PEG = poly(ethylenc glycol). These PLA-PEG-PLA triblocks are chain extended to yicld the device's final high molecular weight polymer. This device functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. The device leaves the site of placement by natural elimination within 4 weeks, or it may be aspirated from the cavity earlier at the discretion of the physician.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the SyntheMed Device, a nasal dressing. It does not describe a study involving the device's performance against specific acceptance criteria in a quantitative manner as one might find for an AI/ML medical device. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices.

Therefore, many of the requested elements for an AI/ML device study will not be applicable or available in this document. I will fill in the available information and explicitly state when information is not provided.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with quantitative performance metrics are provided in this document. The entire submission is built around demonstrating substantial equivalence to predicate devices, rather than meeting novel performance criteria.

Acceptance Criteria	Reported Device Performance
Not explicitly defined for novel performance metrics. The implicit "acceptance criteria" is substantial equivalence to predicate devices regarding indications for use, materials, and method of action.	The device is deemed substantially equivalent in indications, materials, and method of action to the listed predicate devices (Polyganics Nasospore, Genzyme Hylasine, Medtronic Xomed Meropack Nasal Dressing).

2. Sample size used for the test set and the data provenance

Not applicable. This is not a study measuring performance against a test set in the context of an AI/ML device. The "test" for this device is the comparison to predicate devices, which involves reviewing their characteristics and demonstrating similarity.

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 an AI/ML device performance study is not relevant here. The ground "truth" for substantial equivalence is based on regulatory definitions and comparisons to existing devices.

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

Not applicable. No test set requiring expert adjudication 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 applicable. This device is a physical nasal dressing, not an AI/ML diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant.

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

Not applicable. This device is a physical product and does not involve an algorithm.

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

Not applicable. The "truth" in this submission is the regulatory concept of substantial equivalence, established by comparing the device's characteristics (indications, materials, function) to legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set with established ground truth.

Summary of the Study that Proves the Device meets the Acceptance Criteria (Substantial Equivalence):

The "study" described in the provided document is a comparative analysis for substantial equivalence as required for a 510(k) pre-market notification. The core of this "study" is outlined in Section 6, "Substantial Equivalence Summary".

Objective: To demonstrate that the SyntheMed Device is substantially equivalent to legally marketed predicate devices, thereby establishing its safety and effectiveness.
Methodology: The manufacturer, SyntheMed, Inc., compared the SyntheMed Device to three predicate devices: Polyganics Nasospore (K052099), Genzyme Hylasine (K012532), and Medtronic Xomed Meropack Nasal Dressing (K041381).
Comparison Areas: The comparison focused on:
- Indications for Use: The SyntheMed Device's indication for use (fragmentable nasal dressing for patients undergoing nasal/sinus surgery as a space-occupying stent to separate and prevent adhesions between mucosal surfaces) was shown to be shared with all predicate devices.
- Material Composition: The SyntheMed Device (PLA, PEG) was compared to the materials of the predicate devices. While the exact chemical compositions differ, the document emphasizes that PLA and PEG are FDA-approved GRAS polymers widely used in resorbable medical devices, implying a similar safety profile. It also notes that the SyntheMed Device is a "resorbable, synthetic polymeric material similar to Nasospore, Meropack and Hylasine."
- Method of Action: The SyntheMed Device's method of action (hygroscopic, fragments in contact with fluids) was directly compared to the predicate devices. Nasopore shares the same method of action, while Hylasine and Meropack are hygroscopic and form a gelatinous mass. The document implicitly argues that these mechanisms achieve a similar clinical function.
- Biocompatibility: All devices, including the SyntheMed Device, adhere to ISO 10993 standards for biocompatibility. Animal studies were also performed on the SyntheMed Device under GLP and ISO 10993/USP guidelines to support safety and biocompatibility.
- Sterility: All devices are sterile.
Conclusion: SyntheMed, Inc. concluded that the SyntheMed Device is substantially equivalent to the predicates based on design, indications, and intended use, and shares similar indications for use language. The FDA's letter (K082276) confirms this substantial equivalence determination.

Summary

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NOV 1 8 2008

5 510(k) Summary

Contact:	Eli Pines, Ph D.
Device Trade Name:	SyntheMed Device
Manufacturer:	SyntheMed, Inc.200 Middlesex Essex TurnpikeSuite 210Iselin, NJ 08830
Common Name:	Nasal Dressing
Classification:	21 CFR §874.4780
Class:	I
Product Code:	LYA

Indications For Use:

The SyntheMed Device is a fragmentable nasal dressing and is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to scparate and prevent adhesions between mucosal surfaces.

Device Description:

Predicate Device(s):

The SyntheMed Device is substantially equivalent to the following previously cleared devices.

1. Polyganics Nasospore (K052099)
1. Genzyme Hylasine (K012532)
1. Medtronic Xomed Meropack Nasal Dressing (K041381)

Performance Standards:

FDA has not established performance standards for this class of device.

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6. Substantial Equivalence Summary

The SyntheMed Device is substantially equivalent in materials, indications, function and/or performance to the following predicate devices:

1. Polyganics Nasosporc (K052099)
1. Genzyme Hylasine (K012532)
1. Medtronic Xomed Meropack Nasal Dressing (K041381)

SyntheMcd, Inc believes the SyntheMed Dcvice is substantially equivalent to the above predicates based on design, indications and intended use. SyntheMed has provided a discussion comparing the indications, the materials, and the method of action demonstrating the substantial equivalence of the SyntheMed Device.

	SYNTHEMEDDEVICE	NasoSpore	Hylasine	MeroPack
Company	SyntheMed Inc	Polyganics	Genzyme	Medtronic/Xomed
510(k)Reference	This submission	K052099	K012532	K041381
Device name	IntraNasal Splint	IntraNasal Splint	IntraNasal Splint	IntraNasal Splint
Used In	Nasal/sinus surgery	Nasal/sinus surgery	Nasal/sinus surgery	Nasal/sinus surgery
Indications for Use	The SyntheMed Deviceis a fragmentable nasaldressing and isindicated for use in pa-tients undergoingnasal/sinus surgery as aspace occupying stentto separate and preventadhesions betweenmucosal surfaces.	Nasopore is afragmentable nasaldressing and is indicatedfor use in patientsundergoing nasal/sinussurgery as a spaceoccupying stent to separateand prevent adhesionsbetween mucosal surfaces;to help control minimalbleeding following surgeryor nasal trauma bytamponade effect andblood absorption.	HylaSine is indicated foruse in patientsundergoing nasal/sinussurgery as a spaceoccupying gel stent toseparate and preventadhesions betweenmucosal surfaces in thenasal cavity, to helpcontrol minimalbleeding followingsurgery or nasal trauma,and to preventlateralization of themiddle turbinate duringthe post operative period.	MeroPack Tm BioresorbableNasal Dressing and SinusStent is for use in patientsundergoing nasal/sinussurgery as a space occupyingstent to separate and preventadhesions between mucosalsurfaces during mesothelialcell regeneration in the nasalcavity; to help controlminimal bleeding followingsurgery or nasal trauma bytamponade effect, bloodabsorption and plateletaggregation; and to preventlateralization of the middleturbinate during thepostoperative period.
Material Composition	PLA, PEG	Fragmentable poly (DL-lactide/co caprolactone)urethane	Chemically modifiedhyaluronic acid andcarboxymethylcellulose	Esterified hyaluronic acid andcollagen
Method of action	Hygroscopic, fragmentsin contact with fluids	Hygroscopic, fragments incontact with fluids	Hygroscopic, formsgelatinous mass incontact with fluids	Hygroscopic, formsgelatinous mass in contactwith fluids
Biocompatibility	ISO 10993	ISO 10993	ISO 10993	ISO 10993 and FDAGuidance G95-1
Sterile	Yes	Yes	Yes	Yes

A table comparing the subject and predicate devices is presented below.

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General Substantial Equivalence

The SyntheMed Device shares indications for the intended use with all predicate devices referenced in the above Table. The SyntheMed Device is a resorbable, synthetic polymeric material similar to Nasospore, Meropack and Hylasine.

The SyntheMed Device is applicd with in a similar manner as the prodicates listed. It is placed at the surgical site at the conclusion of the procedure.

Material Substantial Equivalence

The SyntheMed Device is a synthetic, resorbable polymeric film comprised of polylactic acid (PLA) and polyethylene glycol (PEG) polymers.

Polyethylene glycol (PEG) is an FDA-approved Generally Recognized as Safe (GRAS) polymer that is widely used in foods, cosmetics and pharmaceuticals, including topical, ingestable and injectable drug formulations as well as hydrogels..

PLA is an FDA-approved Generally Recognized as Safe (GRAS) polymer that is used in numerous resorbable surgical devices such as sutures, ligatures and meshes.

The SyntheMed Device biodegrades (resorbs) within a similar timeframe as the prodicate devices.

Animal studies have been performed on the SyntheMed Device. These tests are described in detail in the Safety/Biocompatibility Section. The GLP studies were conducted to demonstrate and support the safety and biocompatibility of the SyntheMed Device. These studies were conducted by NaMSA under USP and ISO 10993 Guidelines.

Conclusion

The SyntheMed Device is substantially equivalent to the predicates in the nasal dressing product category. The indications, design principles and instructions for use are comparable to the referenced predicates and the SyntheMed Device shares similar indications for use language with these predicate devices. In summary, the SynthcMed Device is substantially cquivalent to valid predicate nasal dressings.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2008

SyntheMed, Inc. c/o Eli Pines, Ph.D. Vice President and Chief Scientific Officer 200 Middlesex Essex Turnpike: Suite 210 Iselin, NJ 08830

Re: K082276

Trade/Device Name: SyntheMed Device Regulation Number: 21 CFR 874.4780 Regulation Name: Intranasal Splint Regulatory Class: Class I Product Code: LYA Dated: October 27, 2008 Received: October 28, 2008

Dear Dr. Pines:

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 -Eli Pines, Ph.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pa (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Melvin B. Eggers, und

Malvina B. Eydelman, M.L 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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4 Indications for Use

510(k) Number (if known): Ko B22760

Device Name: SYNTHEMED DEVICE

Prescription Use ﺮ ﮨﮯ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Cce Be
(Division Sig. or Off.

(Division Sign-Off Division of Ophthalmic and Ear. Nose and Throat Devices

510(k) Number K082276

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.