Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product to determine whether these conditions exist. Kytogenics' Hydrophilic Wound Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (post operative incisions and donor sites, and second degree burns.

Device Description

NOCC™ (N,O-Carboxymethylchitosan) Hydrophilic Wound Dressing is a hydrogel that provides a moist wound environment to support wound healing. The gel is clear which aids in visualization of the wound.

AI/ML Overview

This document is a 510(k) summary for the NOCC™ Hydrophilic Wound Dressing. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details are not available in the provided text.

Based on the provided text, here's what can be extracted:

A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance metrics from a study for the NOCC™ Hydrophilic Wound Dressing. Instead, it relies on demonstrating substantial equivalence to a predicate device (Bionect Clear Hydrogel). The "performance" is implicitly tied to the predicate's established safety and effectiveness.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Similar intended use	Same as predicate (dressing and management of various wounds, burns, abrasions).
Similar technical characteristics	Chitosan-based hydrogel, clear hydrogel form, sterile, moist heat sterilization.
Bioresorbable	"demonstrated that NOCC is bioresorbable"
Biocompatible	"demonstrated that NOCC is biocompatible"
Bioadhesion	"excellent bioadhesion to both soft tissue (mucosal) and hard tissue (bone)"
Safe and Effective	Substantially equivalent to predicate, which is considered safe and effective.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission references "Numerous studies, as well as over 10 years of evaluation" for NOCC's bioresorbability, biocompatibility, and bioadhesion, but does not detail these studies' design, sample sizes, or provenance.
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)
This information is not provided. As no specific test set study with a ground truth is described, there's no mention of experts for this purpose.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not applicable as the device is a wound dressing, not an AI-assisted diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a wound dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the claims of bioresorbability, biocompatibility, and bioadhesion, the ground truth would likely refer to laboratory test results and possibly preclinical (animal) and/or limited clinical outcomes data from the "numerous studies" and "10 years of evaluation" mentioned. Specific details are not provided.
The sample size for the training set
This information is not provided. If an algorithm were involved, this question would be relevant. For a wound dressing, this concept doesn't typically apply in the same way.
How the ground truth for the training set was established
This information is not provided and is not applicable in the context of this device and submission type.

Summary

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080010

MAR 1 4 2008

Section 5: 510(k) Summary

The following information is provided as required by 21 CFR & 807.87 for the NOCC™ Hydrophilic Wound Dressing 510(k) premarket notification.

The safety and effectiveness of the NOCC™ Hydrophilic Wound Dressing is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices.

Sponsor: Kytogenics Pharmaceuticals, Inc. Adams Building, 1st Floor 466 Southern Boulevard Chatham, NJ 07928 Ph. 973-410-0200 Fax. 973-410-0220

Contact: Marina Zazanis, President & CEO

Date of Submission:	December 28, 2007
Proprietary Name:	NOCC™ Hydrophilic Wound Dressing
Common Name:	dressing, wound and burn, hydrogel w/drug and/or biologic,hydrophilic wound dressing
Regulatory Class:	Unclassified
Product Codes:	MGQ, dressing, wound and burn, hydrogel w/drug and/or biologic
Predicate Devices:	Biorest Clear Hydrogel Fidia Pharmaceutical (K034264)

redicate Devices: Bionect Clear Hydrogel, Fidia Pharmaceutical (K984264)

Device Description

Intended Use

NOCC™ Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product

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Kytogenics' Hydrophilic Wound to determine whether these conditions exist. Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers) surgical wounds (post operative incisions and donor sites, and second degree burns.

Comparison to predicate device

Company	Kytogenics Pharmaceuticals,Inc.	Fidia Pharmaceutical
Proprietary Name	NOCCTM Hydrophilic WoundDressing	Bionect Clear Hydrogel
510(k) Number	not assigned	K984264
Intended use	Same	Same
MaterialCharacteristics	chitosan based hydrogel	Hyaluronic acid sodium salthydrogel
Forms	clear hydrogel	clear hydrogel
How supplied	Sterile	Sterile
SterilizationMethod	Moist heat	Gamma Irradiation
Packaging	polyethylene bottles	tube

Summary of Technological Characteristics

NOCC is similar in structure to Hyaluronic Acid (HA) and shares many of the same properties. Both materials are highly hydrated, lubricious, viscoelastic, biocompatible and bioresorbable.

Summary of Nonclinical Tests

Numerous studies, as well as over 10 years of evaluation, have demonstrated that NOCC is bioresorbable and biocompatible. The technology has been shown to have excellent bioadhesion to both soft tissue (mucosal) and hard tissue (bone).

Technological Characteristics and Substantial Equivalence

The claim of substantial equivalence of NOCC™ Hydrophilic Wound Dressing to the predicate device is based on the comparison of the intended use, product technical characteristics, and performance characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2008

Kytogenics Pharmaceuticals, Inc. % Ms. Marina Zazanis President & CEO 466 Southern Boulevard Adams Building, 18t Floor Chatham, New Jersey 07928

Re: K080010

Trade/Device Name: NOCC™ Hydrophilic Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: February 29, 2008 Received: March 03, 2008

Dear Ms. Zazanis:

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. 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

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Page 2 - Ms. Marina Zazanis

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 Compliance at (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 Postmarket Surveillance at (240) 276-3474. For questions regarding 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,

Mark N Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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080010
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Section 4: Indications for Use Statement

510(k) Number: To be assigned

NOCCTM Hydrophilic Wound Dressing Device Name:

Indications for Use: Hydrophilic Wound Dressing is indicated in the dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin. A health care professional may be consulted prior to the first use of the product to determine whether these conditions exist. Kytogenics' Hydrophilic Wound Dressing may also be used under the care of a health care professional for wounds such as partial thickness dermal ulcers (pressure sores, venous stasis ulcers, diabetic ulcers), surgical wounds (post operative incisions and donor sites, and second degree burns.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle for mx

Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number K080010

Regulation Number and Section

N/A