(147 days)
Not Found
Not Found
No
The description focuses on the material composition and physical properties of a hydrogel wound dressing. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
Yes
The device is intended for the management of wounds and provides various therapeutic effects such as supporting autolytic debridement, resisting microbial colonization, reducing microbial penetration, protecting against abrasion, desiccation, and external contamination, and potentially reducing pain. It is also indicated for specific chronic wounds and burns under the direction of a healthcare professional.
No
The device description and intended use clearly state that BioAquaCare™ is a wound dressing designed to manage wounds and provide a moist environment for healing. It acts as a barrier and is for treatment and protection, not for identifying or diagnosing a condition.
No
The device description clearly states it is a hydrogel wound dressing composed of physical ingredients and supplied in various sizes and packaging, indicating it is a physical medical device, 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 that BioAquaCare™ is a wound dressing for the management of various types of wounds. This is a topical application for treating a physical condition.
- Device Description: The description details the composition of the hydrogel and its physical properties as a wound dressing. It does not mention any components or functions related to testing samples of human origin in vitro to provide diagnostic information.
- Lack of Diagnostic Function: The device's function is to provide a moist environment, debride necrotic tissue, act as a microbial barrier, and protect the wound. These are all therapeutic or protective functions, not diagnostic ones.
- No Mention of Testing or Analysis: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample to diagnose a condition or provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. BioAquaCare™ does not fit this description.
N/A
Intended Use / Indications for Use
BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and fullthickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and, diabetic ulcers; and (2) 2nd degree burns and donor
BioXquaCare™ is intended for single use only.
BioAquaCare™ is not intended for treatment of third degree burns.
Product codes
FRO
Device Description
BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG-Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. BioAquaCare™ contains up to 95% water which enables the dressing to provide a moist environment even if the wound bed is dry. BioAquaCare™ will not breakdown during use, so all the BioAquaCare™ components are removed from the wound when the dressings are lifted away. BioAquaCare™ does not include any medicinal substance, animal/human tissue or biologics. BioAquaCare™ is supplied either with or without medical grade gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.
BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 10 cm x 10 cm, 8 cm x 20 cm, 10 cm x 20 cm, or 10 cm x 27 cm). BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 clean room environment.
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
Under the direction of a health care professional
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)
Various in vitro and animal studies were conducted to characterize BioAquaCare's biocompatibility, preservative system's effectiveness and, effectiveness in the management of different types of wounds including partial thickness wounds , full thickness wounds, incision wounds, thermal burns, chemical burns and scarification.
In all instances, BioAquaCare™ functioned as intended and the performance observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Xylos Corporation's XCell® Antimicrobial Wound Dressing, AcryMed Inc.'s AcryDerm Gel Wound Dressing
Reference Device(s)
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
510(k) SUMMARY BAGTech's BioAquaCare™
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Hogan & Hartson L.L.P.
555 Thirteen Street Washington D.C.
Phone: (202) 637 5794 Facsimile: (202) 637 5910
DEC 2 1 2007
Contact Person: Jonathan S. Kahan, Partner
Date Prepared: July 26, 2007
Name of Device and Name/Address of Sponsor
Name of Device : BioAquaCare™
- BioArtificial Gel Technologies (BAGTech) Inc Sponsor : 400 de Maisonneuve West, Suite 1156 Montreal (Quebec) H3A 1L4 Canada
Common or Usual Name Hydrogel Wound Dressing
Classification Name Dressing, wound, drug
Classification: Unclassified
Product Code: FRO
Predicate Devices
Xylos Corporation's XCell® Antimicrobial Wound Dressing
AcryMed Inc.'s AcryDerm Gel Wound Dressing
1
Intended Use / Indications for Use
BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and fullthickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: {1} chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and, diabetic ulcers; and (2) 2nd degree burns and donor
BioXquaCare™ is intended for single use only.
BioAquaCare™ is not intended for treatment of third degree burns.
Technological Characteristics
BioAquaCare™ wound dressing is composed of the following ingredients: 1) PEG-Soy protein; 2) EDTA; 3) sodium phosphate; 4) sodium chloride; 5) water; and 6) Liquid Germall Plus® as a preservative. The preservative contained in BioAquaCare™ aids in providing an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. BioAquaCare™ contains up to 95% water which enables the dressing to provide a moist environment even if the wound bed is dry. BioAquaCare™ will not breakdown during use, so all the BioAquaCare™ components are removed from the wound when the dressings are lifted away. BioAquaCare™ does not include any medicinal substance, animal/human tissue or biologics. BioAquaCare™ is supplied either with or without medical grade gauze for mechanical support, and with a backing which serves to control the rate of water evaporation from the wound dressing upon application to the wounds.
2
BioAquaCare™ is packaged in either a single use blister packages or in plastic bag. BioAquaCare™ is supplied in a variety of sizes (i.e., 5 cm x 5 cm, 10 cm x 10 cm, 8 cm x 20 cm, 10 cm x 20 cm, or 10 cm x 27 cm). BioAquaCare™ is manufactured under aseptic conditions in a controlled class 100 clean room environment.
Performance Data
Various in vitro and animal studies were conducted to characterize BioAquaCare's biocompatibility, preservative system's effectiveness and, effectiveness in the management of different types of wounds including partial thickness wounds , full thickness wounds, incision wounds, thermal burns, chemical burns and scarification.
In all instances, BioAquaCare™ functioned as intended and the performance observed was as expected.
Substantial Equivalence
BioAquaCare™ is as safe and effective as the predicate devices. BioAquaCare™ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between BioAquaCare™ and its predicate devices raise no new issues of safety or effectiveness. Thus, BioAquaCare™ is substantially equivalent.
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEC 2 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BioArtificial Gel Technology % Hogan & Hartson, LLP Mr. Johnathan S. Kahan Columbia Square 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K072068 Trade/Device Name: BioAquaCare™ Regulatory Class: Unclassified Product Code: FRO Dated: December 13, 2007 Received: December 13, 2007
Dear Mr. Kahan:
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.
4
Page 2 – Mr. Johnathan S. Kahan
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 vours.
Mark N. Wilkinson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
pg 1 of 1
Indications for Use Statement
510(k) Number (if known): K072068
Device Name: BioAquaCare™
Indications for Use:
BioAquaCare™ is an hydrogel wound dressing intended for the management of wounds and provides a moist environment that supports the autolytic debridement of areas of the wound that are necrotic. BioAquaCare™ wound dressing provides an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. It is intended for use with dry, light and moderately exuding partial and full-thickness wounds such as minor burns, superficial injuries, lacerations, cuts, abrasions, incisions and surgical wounds, and skin tears. The dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the direction of a health care professional, BioAquaCare™ is indicated for the local management of: (1) chronic wounds such as pressure ulcers, lower extremity ulcers, venous ulcers, arterial ulcers, and diabetic ulcers; and (2) 2nd degree burns and donor sites.
BioAquaCare™ is intended for single use only.
BioAquaCare™ is not intended for treatment of third degree burns.
Prescription Use _ X AND/OR Over-The-Counter Use (Part 21 C.F.R. 801 Subpart D) (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark M. Millerson
Page __ of __
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
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