(24 days)
Not Found
Not Found
No
The summary describes a wound dressing with oxygen enrichment and absorbent properties. There is no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is intended for the management of acute and chronic wounds, including various types of ulcers and burns, which are conditions that require therapeutic intervention.
No
The device is described as a wound dressing intended for management of acute and chronic wounds and wound exudates. It is not described as detecting, monitoring, or diagnosing any medical condition.
No
The device description clearly states it is a "single use, sterile, hydrophilic absorbent closed cell foam enriched with gaseous and dissolved oxygen," indicating it is a physical wound dressing, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of acute and chronic wounds" and is a "primary topical wound contact dressing." This describes a device that interacts directly with the wound externally for therapeutic purposes.
- Device Description: The description reinforces this by calling it a "topical moisture management wound dressing."
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, tissue) outside of the body to diagnose or monitor a medical condition. The testing mentioned relates to safety, biocompatibility, and sterility, which are standard for medical devices, but not specific to IVDs.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to manage wounds topically, which falls under the category of a therapeutic or wound care device, not an IVD.
N/A
Intended Use / Indications for Use
The new oxygen enriched topical hydrophilic closed cell foam wound dressings are indicated for use in the management of acute and chronic wounds. The products are intended as a primary topical wound contact dressings for use in the management of wound exudates for wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, puncture wounds, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
Over the Counter Use: AcryDerm Absorbent Oxygen Dressings are intended to be used on minor wounds including lacerations scrapes, skin tears, abrasions, blister wounds, and minor burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
AcryDerm Absorbent Oxygen Dressing is a single use, sterile, hydrophilic absorbent closed cell foam enriched with gaseous and dissolved oxygen intended for The oxygen enriched product is intended to be used as a topical moisture management wound dressing.
The AcryDerm Absorbent Oxygen Dressings are topical enriched oxygen containing hydrophilic moisture absorbent dressings capable of absorbing between 5 to 10 times their weight in moisture as defined by in vitro absorbency studies.
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)
Testing: the new products meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ISO standard (Biological Evaluation of Medical Devices) and the NIH Publication 99-4494. The product sterility assurance conforms to AAMI/ANSI/ISO 11137-1994.
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.
AcryDerm Advanced Wound Dressing-Noodles, OxyBand Wound Dressing, OxyBox System
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
SEP 1 9 2008
K082459
page 1 of 2
510(k) Summary
Sponsor:
AcrvMed, Inc. 9560 SW Nimbus Avenue Beaverton, OR 97008
Dr. Bruce L. Gibbins; (503)-624-9830 ext 301
AcryDerm Absorbent Oxygen Dressing
Device Name
Common Name:
Contact Person:
Hydrophilic wound dressing
FRO Classification Product Code:
General and Plastic Surgery Classification Advisory Panel:
Legally marketed device(s) for substantial equivalence comparison:
AcryDerm Advanced Wound Dressing-Noodles (AcryMed, Inc., OR) OxyBand Wound Dressing (Oxyband Technologies, MA) Oxybox System (Oxyfast Corporation, OH)
Description of Device: AcryDerm Absorbent Oxygen Dressing is a single use, sterile, hydrophilic absorbent closed cell foam enriched with gaseous and dissolved oxygen intended for The oxygen enriched product is intended to be used as a use in the management of wounds. topical moisture management wound dressing.
Intended use of the Device: The new oxygen enriched topical hydrophilic closed cell foam wound dressings are indicated for use in the management of acute and chronic wounds. The would dressings are interestional wound contact dressings for use in the management of wound exidates for wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, puncture wounds, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
Technological Characteristics: The AcryDerm Absorbent Oxygen Dressings are topical enriched oxygen containing hydrophilic moisture absorbent dressings capable of absorbing between 5 to 10 times their weight in moisture as defined by in vitro absorbency studies.
Testing: the new products meets or exceeds safety and biocompatibility assurance guidelines as provided in the guidance of Part-1 of the ISO standard (Biological Evaluation of Medical Devices) and the NIH Publication 99-4494. The product sterility assurance conforms to AAMI/ANSI/ISO 11137-1994.
Мавиfacturing: AcryDerm Absorbent Oxygen Dressings will be manufactured according to the Manufacturing. " Norgenine with good manufacturing practices to ensure the device is safe and effective for their intended uses.
Performance Standards: No performance standards are prescribed for the new product.
1
K082459
page 2 of 2
Introductory Information
AcryMed, Incorporated APPLICANT'S NAME: A. 9650 SW Nimbus Avenue APPLICANT'S ADDRESS B. Beaverton, OR 97008 CONTACT PERSON Dr. Bruce Gibbins ். (503) 624-9830 (ext. 301) phone (503) 639-0846 fax July 2008 DATE OF PREPARATION: D. The AcryDerm Absorbent Oxygen DEVICE NAME: E. Dressing PROPRIETARY NAME: F. NA Hydrophilic wound dressing COMMON NAME: G. ESTABLISHMENT NUMBER: 9010208 H. FRO I. CLASSIFICATION: General and Plastic Surgery CLASSIFICATION PANEL: J. Clearance to enter a new product into the REASON FOR NOTIFICATION: I. market AcryDerm Advanced Wound Dressing-J. PREDICATE DEVICE(s): Noodles-Noodles OxyBand Wound Dressing OxyBox System No special controls (section 513) or K. SPECIAL CONTROLS OR
performance standards (section 514) applicable to this device have been established by the Food and Drug Administration.
PERFORMANCE STANDARDS:
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
SEP 1 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AcryMed, Inc. % Bruce Gibbins, PhD Chief Technical Officer 9560 SW Nimbus Avenue Beaverton, Oregon 97008
Re: K082459
Trade/Device Name: AcryDerm Absorbent Oxygen Dressing AcryDerm Absorbent Oxygen Dressing OTC Regulatory Class: Unclassified Product Code: FRO Dated: August 22, 2008 Received: August 26, 2008
Dear Dr. Gibbins:
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.
3
Page 2 - Bruce Gibbins, PhD
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 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 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,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 42
Indications for Use
510(k) Number (if known): K082459
Device Name: AcryDerm Absorbent Oxygen Dressing
Indications For Use: The new oxygen enriched topical hydrophilic closed cell foam wound dressings are indicated for use in the management of acute and chronic wounds. The products are intended as a primary topical wound contact dressings for use in the management of wound exudates for wounds such as pressure ulcers, stasis ulcers, diabetic ulcers, first and second degree burns, lacerations, puncture wounds, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites.
Prescription Use (Part 21 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 (Division Sign-Off) | Device Evaluation (ODE) |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices |
| AcryDerm Silver Pre-market Notification 510(k) | 510(k) Number |
|---|---|
| ------------------------------------------------ | --------------- |
5
Page
Indications for Use
510(k) Number (if known): K082459
AcryDerm Absorbent Oxygen Dressing OTC Device Name:
Over the Counter Use: AcryDerm Absorbent Oxygen Dressings are intended to be used on minor wounds including lacerations scrapes, skin tears, abrasions, blister wounds, and minor burns.
Prescription Use (Part 21 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)
Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation (ODE)
General, Restorative,
and Neurological Devices
AcryDerm Silver Pre-market Notification 510(k)
Number 16082459
Page No. 6