(60 days)
K04063
Not Found
No
The provided text describes a wound dressing and its intended use, focusing on material composition and function. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is described as assisting in managing wound healing and facilitating the normal wound healing process by providing a moist, oxygen-rich environment, indicating a therapeutic function for wounds, burns, and other skin conditions.
No
The provided text explicitly states the intended use of the device is for managing wound healing and providing a moist, oxygen-rich environment for the healing process. It describes the device as a wound dressing for protection and covering, not for diagnosing medical conditions.
No
The device description clearly describes a physical wound dressing made of polyurethane film and adhesive, which are hardware components. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a wound dressing that is applied externally to the body to manage wound healing by providing a moist, oxygen-rich environment and protection. This is a therapeutic and protective function, not a diagnostic one.
- Device Description: The description details the physical components of a wound dressing (polyurethane film, adhesive, oxygen barrier film). There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any kind of diagnostic result.
- Anatomical Site: The anatomical sites listed are external wounds and skin, consistent with a topical wound care product.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
OxyBand™ Wound Dressings are intended to provide a moist, oxygen rich environment to facilitate the normal wound healing process. OxyBand™ Wound Dressings can be used to cover and protect wounds and cather sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debritement facilitators, or a protective cover over at risk skin. Common applications include: clean dosed surgical incisions, sin graft donor sites, Slage I or II pressure ulcers, pressure sores, superficial wounds such as abrasigns, skirtes, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
O2S OxyBand™ Wound Dressings assist in managing wound healing. O2S OxyBand™ Wound Dressings can be used to protect light to moderate wounds including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, and minor burns, chafed or irritated skin.
O2S OxyBand™ Wound Dressings assist in managing wound healing. O2S OxyBand™ Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover over at risk skin. Common applications include: clean closed surgical incisions, skin graft donor sites, Stage I or II pressure ulcers, pressure sores, superficial wounds such as abrasions, skin tears, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The OxyBand™ Wound Dressing is made up of a thin polyurethane film commonly used in other wound dressings, with adhesive that seals around the wound at the perimeter of the dressing. An occlusive oxygen barrier film is sealed over the polyurethane film to hold a layer of oxygen over the high oxygen permeability polyurethan
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)
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.
K04063
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
K121407. Page 1/2
9 2012 ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
)(k) Information
III. 510(k) Summary of Safety and Effectiveness for the O2S, LLC OxyBand™ Wound Dressing
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Submitter: O2S, LLC 1500 Spring Garden Street Philadelphia, PA 19130 Contact Person: David E. Petko, P.E. 1500 Spring Garden Street Philadelphia, PA 19130 Telephone: 215-299-8742 Fax: 215-299-2273 david.petko@o2soxygensystems.com Summary Preparation Date: May 8, 2012
2. Names
Device Name:
OxyBand™ Wound Dressing
Classification Name:
Dressing, wound and burn, occlusive
3. Predicate Devices
This device is the exact same device previously approved for our partner OxyBand Technologies, Inc. This device has previously been cleared for marketing under the OxyBand Technologies, Inc. 510(k), number K04063. O2S is filing its own 510(k) application, because O2S plans to produce and sell the same wound dressing to Governmental customers, and will assume the responsibilities of "product owner" under a new O2S 510(k). OxyBand Technologies, Inc. has retained the exclusive right to produce and sell these wound dressing products to non-Governmental customers, and will need to retain the OxyBand Technologies, Inc. original 510(k) for that purpose. See Appendix 2.
The O2S - OxyBand™ Wound Dressing is substantially equivalent to the predicate device and introduces no new indications for use. In addition, the requested inclications meet the requirements listed in the "FDA Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing" dated March 31, 1995.
4. Device Description
The OxyBand™ Wound Dressing is made up of a thin polyurethane film commonly used in other wound dressings, with adhesive that seals around the wound at the perimeter of the dressing. An occlusive oxygen barrier film is sealed over the polyurethane film to hold a layer of oxygen over the high oxygen permeability polyurethan
PAGE 8 OF 209
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1
K121407 page 2/2
·¯10(k) Information
5. Indications for Use
OxyBand™ Wound Dressings are intended to provide a moist, oxygen rich environment to facilitate the normal wound healing process. OxyBand™ Wound Dressings can be used to cover and protect wounds and cather sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debritement facilitators, or a protective cover over at risk skin. Common applications include: clean dosed surgical incisions, sin graft donor sites, Slage I or II pressure ulcers, pressure sores, superficial wounds such as abrasigns, skirtes, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. The logo is simple, using only black and white, and is designed to be easily recognizable.
JUL
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
g 2012
O2S, LLC % Mr. David Petko, P.E. 1 500 Spring Garden Street Philadelphia, Pennsylvania 19130
Re: K121407
Trade/Device Name: 02S OxyBand™ Wound Dressing Regulation Class: Unclassified Product Code: FRO Dated: June 21, 2012 Received: June 25, 2012
Dear Mr. Petko:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Mr. David Petko, P.E.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 1 2 1 4 0 7
Device Name: O2S OxyBand™M Wound Dressing
Indications for Use:
O2S OxyBand™ Wound Dressings assist in managing wound healing. O2S OxyBand™ Wound Dressings can be used to protect light to moderate wounds including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, and minor burns, chafed or irritated skin.
Prescription Use (Part21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) and and the same of the second security would would with and
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kane for UXM
(Division Sign-Off)
Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K121407
Page 1 of 1
PAGE 5 OF 28
AEP
01 JUNE 12
5
Indications for Use
510(k) Number (if known): K 1 2 1 4 0 7
Device Name: O2S OxyBand™ Wound Dressing
Indications for Use:
O2S OxyBand™ Wound Dressings assist in managing wound healing. O2S OxyBand™ Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover over at risk skin. Common applications include: clean closed surgical incisions, skin graft donor sites, Stage I or II pressure ulcers, pressure sores, superficial wounds such as abrasions, skin tears, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
X Prescription Use (Part21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Daniel Knaefler pMM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K/21407
PAGE 4 OF 28
ΔEP
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