(121 days)
No
The device description and performance studies focus on the physical properties and biocompatibility of a wound dressing, with no mention of AI or ML capabilities.
Yes
The device is described as a 'wound dressing' used for the 'management of pressure ulcers, 1st and 2nd degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites', indicating its use in treating and supporting healing processes for various injuries.
No
Explanation: This device is a wound dressing designed for healing and monitoring of wounds, not for diagnosing medical conditions. While it allows "monitoring wound healing stages," this is a visual observation of a treatment's progress, not a diagnostic assessment that identifies the nature or cause of a disease or condition.
No
The device description clearly states it is a physical wound dressing made of absorbent acrylic polymers, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dressing for managing various types of wounds. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical properties and function of the dressing (absorbent, transparent, maintains moist environment) for wound healing. It does not mention any diagnostic capabilities or analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples from the body (like blood, urine, tissue), detecting specific markers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on the physical and biological properties of the dressing (absorption, sterility, shelf-life, biocompatibility) and its ability to function as a wound dressing. They do not involve diagnostic accuracy metrics.
In vitro diagnostics are devices used to examine specimens taken from the body to provide information for diagnosis, monitoring, or screening. This device is applied to the body to aid in healing, which is a different category of medical device.
N/A
Intended Use / Indications for Use
Sterile, single-use dressings for management of pressure ulcers, 1st and 2nd degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.
Product codes
FRO
Device Description
The AbsoClear product family is a series of single-use, sterile transparent synthetic wound dressings made of absorbent acrylic polymers. The dressings maintain a moist wound environment, which has been shown to be conducive to wound healing, but that also can also absorb wound exudate. Full transparency allows monitoring wound healing stages without removal of the dressing. The sterile dressings are supplied singly in sealed trilaminate pouches and are sterilized by gamma irradiation.
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
Healthcare professionals and consumers
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)
Bench Testing: All acceptance criteria for the following were met in GLP testing of each lot of . AbsoClear product: absorption capacity, sterility, package seal strength and seal integrity. For products that include adhesive borders, routine acceptance testing includes coat weight, peel adhesion, and MVTR.
Sterilization: The gamma sterilization process was validated per ISO 11137 to a Sterility Assurance Level of 10e-6. Bioburden and pyrogenicity testing were done as part of this process and all acceptance criteria were met.
Shelf-life: Testing was done per multiple standards on the following to ensure that the product and packaging met all specifications after storage at 40°C for twelve months plus real time stability at 25°C for three years: peel adhesion; moisture vapor transmission rate; absorption capacity; sterility; packaging seal strength; packaging seal integrity. Shelf-life of the product is validated to three years.
Biocompatibility: Per ISO 10993-1:2009, AbsoClear is categorized as surface-contacting device that comes in contact with breached or compromised surfaces and has a possible exposure time of >24 hr. but not to exceed 30 days. According to this categorization the following biocompatibility tests were performed with the finished packaged, sterilized product: cytotoxicity [ISO 10993-5]; sensitization [ISO 10993-10]; and intracutaneous reactivity [ISO 10993-10]. Tests were done by an accredited testing laboratory and the product met all acceptance criteria.
Clinical Studies: All materials used in these products have been in use for these indications for many years. Therefore, non-clinical data on the pharmacodynamics, pharmacokinetics as well as on the toxicity of the substance are available. Additional clinical testing was not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K811291, K812678, K852750, K901845, K932422, K973036
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
K|30553
Image /page/0/Picture/1 description: The image shows the logo for "Pharmaplast". The logo consists of a stylized letter "P" inside of a circle, followed by the word "Pharmaplast" in a bold, sans-serif font. Below the text is a thick, black line that tapers to a point on the right side.
3 2013 JUL
510(k) Summary
This summary of information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
510(k) owner's name: Pharmaplast S.A.E. Address: Amria Free Zone, 23512, Alexandria, Egypt Phone and fax numbers: +203-450-0264, Fax +203-450-0263 Contact person: Mamdouh Atteia Summary Date: 27 September 2012
Pharmaplast S.A.E. 510[k]
AbsoClear®
1
Trade or proprietary name of the device: AbsoClear®
Classification Name: Dressings, Wound and Burn, Occlusive (no drug or biologic)
Product Code: FRO
Classification: Unclassified; 510[k] required
Legally marketed device to which equivalence is claimed: 3M Tegaderm™ Transparent Film Dressing; K973063
Device Description
The AbsoClear product family is a series of single-use, sterile transparent synthetic wound dressings made of absorbent acrylic polymers. The dressings maintain a moist wound environment, which has been shown to be conducive to wound healing, but that also can also absorb wound exudate. Full transparency allows monitoring wound healing stages without removal of the dressing. The sterile dressings are supplied singly in sealed trilaminate pouches and are sterilized by gamma irradiation.
Intended Use
Sterile, single-use dressings for management of pressure ulcers, 155 and 200 degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.
Comparison to predicate device
Summary Comparison Table of New Device to Predicate Device
| Parameter | Device | Predicate Device |
|---|---|---|
| Device Name | AbsoClear Gel | |
| AbsoClear Gel Comfort | Tegaderm Transparent Film | |
| Dressing | ||
| Manufacturer | Pharmaplast S.A.E. | 3M |
| 510[k] # | K130553 | K811291, K812678, K852750, |
| K901845, K932422, and K973036 | ||
| Class | Unclassified | Same |
| 21 CFR | ||
| number/category | NA | Same |
| Code | FRO; unclassified | Same |
| Product Type | Dressings, Wound and | |
| Burn, Occlusive | Same | |
| Description | Transparent, | |
| nonresorbable, sterile | ||
| dressing | Same | |
| Parameter | Device | Predicate Device |
| Intended Use | For management of | |
| pressure ulcers, 1st and | ||
| 2nd degree bums, skin | ||
| tears, abrasions, or | ||
| irritated skin and surgical | ||
| incisions and graft donor | ||
| sites. | To cover and protect catheter | |
| sites and wounds, to maintain a | ||
| moist environment for wound | ||
| healing or to facilitate autolytic | ||
| Style | Flat; adhesive edge on | |
| some models | Flat; adhesive edge | |
| Components | Polyurethane film | |
| backing laminated with a | ||
| synthetic acrylate | ||
| dressing | Same | |
| Additive | No drug or biologic agent | Same |
| End User | Healthcare professionals | |
| and consumers | Same | |
| Frequency of | ||
| Use | Single-use only | Same |
| Mode of Action | Provides a barrier to | |
| liquids and | ||
| contaminants, supports a | ||
| moist wound | ||
| environment, and allows | ||
| the exchange of gases | ||
| such as oxygen and | ||
| water vapor | Same | |
| Sterility | SAL 10e-6; gamma | |
| irradiation: ISO 11137 | Same |
2
Bench Testing
All acceptance criteria for the following were met in GLP testing of each lot of . AbsoClear product: absorption capacity, sterility, package seal strength and seal integrity. For products that include adhesive borders, routine acceptance testing includes coat weight, peel adhesion, and MVTR.
AbsoClear®
3
Sterilization
The gamma sterilization process was validated per ISO 11137 to a Sterility Assurance Level of 10°. Bioburden and pyrogenicity testing were done as part of this process and all acceptance criteria were met.
Shelf-life
Testing was done per multiple standards on the following to ensure that the product and packaging met all specifications after storage at 40°C for twelve months plus real time stability at 25°C for three years: peel adhesion; moisture vapor transmission rate; absorption capacity; sterility; packaging seal strength; packaging seal integrity. Shelf-life of the product is validated to three years.
Biocompatibility
Per ISO 10993-1:2009, AbsoClear is categorized as surface-contacting device that comes in contact with breached or compromised surfaces and has a possible exposure time of >24 hr. but not to exceed 30 days. According to this categorization the following biocompatibility tests were performed with the finished packaged, sterilized product: cytotoxicity [ISO 10993-5]; sensitization [ISO 10993-10]; and intracutaneous reactivity [ISO 10993-10]. Tests were done by an accredited testing laboratory and the product met all acceptance criteria.
Clinical Studies
All materials used in these products have been in use for these indications for many years. Therefore, non-clinical data on the pharmacodynamics, pharmacokinetics as well as on the toxicity of the substance are available. Additional clinical testing was not required.
Device Comparison Statement
The Pharmaplast S.A.E. AbsoClear product line is biocompatible and has similar technological characteristics and materials as a previously cleared device and therefore raises no new no new issues of safety or effectiveness.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Pharmaplast S.A.E. % Biotechnology Transfer, LLC Ms. Cynthia Pritchard 1016 Tobiano Lane Raleigh, North Carolina 27614
Re: K130553
Trade/Device Name: AbsoClear Regulatory Class: Unclassified Product Code: FRO Dated: April 27, 2013 Received: May 22, 2013
Dear Ms. Pritchard:
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
July 3, 2013
5
Page 2 - Ms. Cynthia Pritchard
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/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Document Mail Center WO66-G609 Center for Devices and Radiological Health U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Indications for Use
510(k) Number (if known): K130553
Device Name: AbsoClear Gel and AbsoClear Gel Comfort
Indications for Use:
Sterile, single-use dressings for management of pressure ulcers, 131 and 200 degree bums, skin tears, abrasions, or irritated skin and surgical incisions and graft donor sites.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-the-Counter Use (Part 21 CFR 807 Subpart C)
Jiyoung Dang -S
and
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130553
Pharmaplast S.A.E. 510[k]
AbsoClear®
Section 4: Page 1 of 1