(139 days)
OxyBand ™ Wound Dressings are intended to provide a moist environment to facilitate the normal wound healing process. OxyBand TM Wound Dressings can be used to cover and protect wounds and catheter sites, or used as a secondary dressing for other would products such as gauze, alginates, hydrogels, debridement facilitators, or a protective cover at risk skin. The OxyBand TM Wound Dressings are indicated for: clean closed surgical incisions, skin graft donor sites, Stage For II 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.
The Over-The-Counter OxyBand ™ Wound Dressings are intended to protect light to moderate wounds, including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, minor burns, to protect chafed or irritated skin or skin continuously exposed to moisture, and to create a moist environment for wound healing.
OxyBand™ is a multilayer wound dressing that keeps out water, dirt and germs, and supplies oxygen to the wound. It is designed to be applied directly over clean skin or wounds for up to 5 days. A study has shown that upon attaching the dressing over a test plate, oxygen levels rise steadily over the device area for the first few hours and then maintain at elevated levels through 5 days as long as the dressing remains intact and secure around the perimeter.
The provided text is a 510(k) Summary of Safety and Effectiveness for the OxyBand™ Wound Dressing. It describes the device, its indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
The statement "A study has shown that upon attaching the dressing over a test plate, oxygen levels rise steadily over the device area for the first few hours and then maintain at elevated levels through 5 days as long as the dressing remains intact and secure around the perimeter" is the only mention of a "study." However, this is a general statement about the device's function, not a detailed description of an efficacy study with acceptance criteria and results.
Therefore, I cannot provide the requested information from the given text.
Here's a breakdown of why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory equivalence with predicate devices rather than specific performance benchmarks met through testing.
- Sample size used for the test set and the data provenance: Not present. The "study" mentioned is a general observation about oxygen levels, not a clinical trial with a defined test set.
- 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 applicable, as there's no diagnostic study or expert-adjudicated test set described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 wound dressing, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable, as there is no training set for a wound dressing device.
- How the ground truth for the training set was established: Not applicable.
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043063 lot 4
510(k) Summary of Safety and Effectiveness for the OxyBand III. Technologies OxyBand TM Wound Dressing
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with This STO(K) Bammary of the SMDA 1990 and 21 CFR 807.92.
1. General Information
MAR 2 4 2005 OxyBand Technologies Submitter: 33 Bayview Terrace Mill Valley, CA 94941 Maureen O'Connell Contact Person: 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-207-1246 March 16, 2005 Summary Preparation Date: 2. Names OxyBand TM Wound Dressing Device Name: Dressing, wound and burn, occlusive Classification Name: Product Code: MGP Panel: Plastic and Reconstructive Surgery Devices
3. Predicate Devices
The OxyBand TM Wound Dressing is substantially equivalent to the 3M Medical Products Tegaderm ™ Transparent Dressing (K973036), the Innovative Troudots Togaderin
Film and Intelligent Film and Intelligent Film Dressings (K973312) and the Kinetic Concepts, Inc. KCI Wound Cell Transparent Wound Dressing (K020781).
4. Device Description
OxyBand™ is a multilayer wound dressing that keeps out water, dirt and germs, and supplies oxygen to the wound. It is designed to be applied directly over clean skin or wounds for up to 5 days. A study has shown that upon attaching the dressing over a test plate, oxygen levels rise steadily over the device area for the first few hours and then maintain at elevated levels through 5 days as long as the dressing remains intact and secure around the perimeter.
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K043063 2 of 4
5. Indications for Use
Indications for USE
OxyBand ™ Wound Dressings are available as both Prescription and Over-The-Counter products.
The Prescription OxyBand ™ Wound Dressings are intended to provide a moist The Prescription OxyBand --- Wound Dressings process. OxyBand T" Wound environment to facilitate the normal wounds and catheter sites, or used as a Diessings can be used to over and products such as gauze, alginates, hydrogels, secondary dressing for other would products sam as gisk skin. The OxyBaft TM
debridement facilitators, or a protective cover at risk skin. The OxyBaff Wound Dressings are indicated for: clean closed surgical incisions, skin graft Wound Dressings are indicated ron orders, pressure sores, superficial wounds such donor sites, Stage For it pressure re, p.
as abrasions, skin tears, and blisters, lacerations, first and second degree burns, as abrastons, skin tearing and to moisture, secondary dressing over gauze, alginates or hydrogels.
The Over-The-Counter OxyBand ™ Wound Dressings are intended to protect File Over-The Counter OnyBana
light to moderate wounds, including skin tears, scrapes, minor pressure sores, ifgit to moderate wounds, merading shirts, to protect chafed or irritated skin or abrasions, birsters, faceratems, and to create a moist environment for wound healing.
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KOY 3063
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K043063
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
OxyBand ™ Wound Dressings are intended to provide a moist environment to OxyBand '" Wound Dressings are intention to provide a more of the sunselves can
facilitate the normal wound healing process. OxyBand The secondary facilitate the normal wound nearing process. Or used as a secondary
be used to cover and protect wounds and catheres sites, budrogels be used to cover and protect wounds and as gauze, alginates, hydrogels, dressing for other would products such as sauze, arguitator, in a logo Co.
debridement facilitators, or a protective cover at risk skin. The OxyBand TM
assurent facilitators debridement facilitators, or a proceen to see surgical incisions, skin graft
Wound Dressings are indicated for: clean closed surprisions, superficial wounds su Wound Dressings are indicated for. Crean oressure sores, superficial wounds such donor sites, Stage For If pressure areers, proens, first and second degree burns,
as abrasions, skin tears, and blisters, lacerations, assessdage dressing over as abrasions, skin tears, and bilsters, nascraneses, in
chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ メ (Part 21 CFR 801 Subpart D)
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)
Signature
MATZALAN
Land No. 12611
N(K) Nu... K04 3063
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K043063 4 of 4
Indications for Use
K043063_______________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
OxyBand™ Wound Dressings Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
OxyBand ™ Wound Dressings are intended to protect light to moderations, OxyBand "" Wound Dressings are intence to pressure sores, blisters, lacerations,
including skin tears, scrapes, minor pressure soressions, blisters, lacerations, including skin tears, scrapes, inthor prossure sores, as a more online ously exposed to
minor burns, to protect chafed or irritated skin or skin continuously exposed to
r mi millor burns, to protect enarous or wironment for wound healing.
Prescription Use __ (Part 21 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
.043063
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a logo with the words 'SERVICES USA' in a circular arrangement at the top left. Below the text is a symbol consisting of three stylized human profiles facing right. To the right of the symbol is a large, bold letter 'D', which is the only visible part of a word or phrase.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2005
Oxyband Technologies, Inc. c/o Ms. Maureen O'Connell 5 Timber Lane North Reading, Massachusetts 01864
Re: K043063
Trade/Device Name: OxyBand™ Wound Dressings Regulatory Class: Unclassified Product Code: FRO Dated: March 10, 2005 Received: March 10, 2005
Dear Ms. O'Connell:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premained in substantially equivalent (for the indications
referenced above and have determined the device is substance in interestate referenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule) to regary manced provice Medical Device Amendments, or to commerce prior to May 28, 1776, the enactions with the provisions of the Federal Food. Drug. devices that have been recuired in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the devices, baojest to annual registration, listing of general controls provisions of the rict mercial sequences against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ( If your device is classified (sec above) into exist on major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlis. Entrologically in the 898. In addition, FDA may be found in the Code of Peacharies.
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 Please be advised that FDA s issuates of a bassaint... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . that FIFA has made a decemmation administered by other Federal agencies. You must or any Federal statutes and regulations administered of the registration and listing (21 Comply with an the Act 31equirements, meteans. In and actual and and and as a set CFR Part 807), fallemig (21 CFR Part 820); good if applicable, the electronic form in the quality systems (QU) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1
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Page 2 - Ms. Maureen O'Connell
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin mancemly your antial equivalence of your device to a legally premarket notification. The FDA inding of substantial before 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
s and the may of 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 If you desire specific advice for your de not of the Also, please not the regulation entitled, white in contact the Office of Comphanee at (210) 276 - 17 - 17 807.97). You may obtain "Misbranding by reference to prematics nothead.org the Act from the Division of Small other general information on your responsionnes and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance to too corph/industry/support/index.html.
Sincerely yours,
for
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KOY 3063
Indications for Use
K043063 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
OxyBand ™ Wound Dressings are intended to provide a moist environment to OxyBand - Wound Dressings are intended to process. OxyBand TM Wound Dressings can
facilitate the normal wound healing process. OxyBand TM Wound Dressings can facilitate the normal wound noaling personal catheter sites, or used as a secondary be used to cover and process much as gauze, alginates, hydrogels, dressing for other would products such as sames as angeriasks skin. The OxyBand TM
debridement facilitators, or a protective cover at risks skin. The OxyBand TM debrident facilitators, or a provice clean closed surgical incisions, skin graft Wound Dressings are marcated ronleers, pressure sores, superficial wounds such donor sites, Stage For II prossars rs, lacerations, first and second degree burns, as abrasions, skin tears, and onsters, nations, and to moisture, secondary dressing over gauze, alginates or hydrogels.
AND/OR Prescription Use __ X (Part 21 CFR 801 Subpart D)
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)
Signature
RESERVE
BANK OF
NEW ZEALAND
04 3063
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4 of 4 K043063
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
OxyBand ™ Wound Dressings are intended to protect light to moderate wounds, OxyBalld -- Would Dressings are messure sores, abrasions, blisters, lacerations, including skiff icals, scrapes, innits pressure sees), in continuously exposed to moisture, and to create a moist environment for wound healing.
1
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
R Over-T
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)
.
... .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ICO 43063
N/A