(71 days)
Not Found
No
The summary describes a hydrogel wound dressing and does not mention any AI or ML capabilities.
Yes
The device, a "Hydrophilic Wound Dressing," is intended for the "dressing and management of minor burns, superficial cuts, lacerations, and abrasions; minor irritations of the skin," and "wounds such as partial thickness dermal ulcers...surgical wounds...and second-degree burns" to "support wound healing." These uses indicate a therapeutic purpose.
No
The device is a wound dressing designed for management and healing, not for diagnosing conditions. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a hydrogel, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a "Hydrophilic Wound Dressing" and a "hydrogel" applied directly to wounds on the body. Its purpose is to provide a moist environment for wound healing.
- Lack of In Vitro Testing: There is no mention of this device being used to test samples taken from the body. It is applied to the body.
Therefore, this device falls under the category of a wound dressing, which is a medical device but not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MGQ, FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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).
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.
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
N/A
0
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
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.
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
1
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 Wound
Dressing | Bionect Clear Hydrogel |
| 510(k) Number | not assigned | K984264 |
| Intended use | Same | Same |
| Material
Characteristics | chitosan based hydrogel | Hyaluronic acid sodium salt
hydrogel |
| Forms | clear hydrogel | clear hydrogel |
| How supplied | Sterile | Sterile |
| Sterilization
Method | 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.
2
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
3
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
page 1 of 1
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