(274 days)
No
The 510(k) summary describes a foam dressing for negative pressure wound therapy and does not mention any AI or ML components or functionalities. The performance studies are bench tests comparing physical properties and fluid removal rates.
No
The device is a foam dressing used in conjunction with a wound vacuum system, which promotes wound healing, but the foam dressing itself is not directly therapeutic; it's a component of a therapeutic system.
No
The Genadyne A4-XLR8 Foam Dressing is a wound dressing used in conjunction with a wound vacuum system to promote wound healing by removing excess exudates, infectious material, and tissue debris. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a physical foam dressing made of reticulated flexible polyether and polyurethane hydrophobic foam material, housed in a physical pouch, and sterilized. It is a hardware component used in conjunction with a wound vacuum system.
Based on the provided information, the Genadyne A4-XLR8 Foam Dressing is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to be used in conjunction with a wound vacuum system to deliver negative pressure therapy to wounds. This is a therapeutic application, not a diagnostic one.
- Mechanism of Action: The device works by facilitating the removal of excess exudates, infectious material, and tissue debris from the wound. This is a physical process to aid healing, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the material and form of the dressing, which is consistent with a wound care product, not a diagnostic reagent or instrument.
- Performance Studies: The performance studies focus on the physical properties and function of the dressing in a simulated wound environment (dimensions, suction pressure, fluid removal rate). These are relevant to the performance of a wound dressing, not the accuracy of a diagnostic test.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Genadyne A4-XLR8 Foam Dressing does not perform this function.
N/A
Intended Use / Indications for Use
Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote would healing by the removal of excess exudates, infectious material and tissue debris.
A4-XLR8 Foam Dressing is appropriate for use on the following wounds:
- Pressure ulcers ●
- Diabetic/Neuropathic Ulcers .
- Venous insufficiency ulcers ●
- Traumatic wounds ●
- Post-operative and dehisced surgical wounds ●
- Skin flap and grafts .
Product codes
OMP
Device Description
Genadyne A4-XLR8 Foam Dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO.
Genadyne A4-XLR8 Foam Dressing is available in three sizes; 1) small, 2) medium and 3) large.
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)
Test: L929 MEM Elution Test - ISO
Standard: ISO 10993-5
Results: Reticulated PE/PU, is considered non-cytotoxic and meets the requirements of the Elution Test defined in ISO 10993-5 guidelines.
Test: L929 MEM Elution Test - ISO
Standard: ISO 10993-5
Results: Reticulated PE/PU, is considered non-cytotoxic and meets the requirements of the Elution Test defined in ISO 10993-5 guidelines.
Test: L929 MEM Elution Test - ISO
Standard: ISO 10993-10
Results: Reticulated PE/PU, is considered non-cytotoxic and meets the requirements of the Elution Test defined in ISO 10993-5 guidelines.
Test: Kligman Maximization Test - ISO
Standard: ISO 10993-10
Results: Based on the criteria of the protocol, a Grade I sensitization rate is not considered significant and the test article meets the requirements of the ISO 10993-10 guidelines.
Test: Intracutaneous Injection Test - ISO
Standard: ISO 10993-10
Results: Based on the criteria of the protocol, the test article is considered a negligible irritant and meets the requirements of the ISO 10993-10 guidelines.
Test: Kinetic Limulus Amebocyte Lysate Test (LAL)
Standard: USP 32, NF 27:2009
Results: The test article contains 0.00689 EU/mL. The correlation coefficient for the linear regression was calculated to be -0.999.
Test: Inhibition and Enhancement Testing, LAL Kinetic Method
Standard: USP 32, NF 27:2009
Results: The correlation coefficient for the linear regression was calculated to be -0.999 for standard curve, -0.996 for sample 1 and -0.997 for sample 2 and -0.998 for sample 3. There was no inhibition or enhancement present in the test article.
Test: Bacteriostasis & Fungistasis / Direct Transfer
Standard: USP 32, NF 27:2009
Results: The test article is considered non-bacteriostatic and non-fungistatic, according to the USP guidelines.
Test: Bioburden Validation – Exhaustive Recovery
Standard: ANSI/AAMI/ISO 11737-1: 2006
Results: The percent recovery was 100% and the recovery factor was 1 using the exhaustive recovery method.
Test: Accelerated Aging
Standard: ASTM F1980-07
Results: At the time of this filing 4-months of real-time testing has been completed
Test: Residual EtO, ECh, and EG
Standard: ISO 10993-10
Results: Ethylene Oxide – Not Detected Ethylene Chlorohydrin - Not Detected Ethylene Glycol - 1.18 mg, 1.71 mg, 1.43 mg, 1,65 mg, 1.34 mg, 1.31 mg
Test: Comparative Bench Testing of Subject Device Vs Predicate Device
Standard: In-house
Results: Based on the comparative bench test it was established that the A4-XLR8 Foam Dressing Kit is substantially equivalent to the Renasys F NPWT Dressing Kit
Overview of Comparative Bench Test:
Genadyne collected data on 3 different conditions during the bench test to demonstrate that under a vacuum environment and at different set levels of vacuum pressure, the foam performed exactly as expected and there were no unexpected outcomes during the tests.
Tests conducted:
- Dimensions were recorded before and after the 72 hours bench test. The results demonstrated after undergoing long periods of suction pressures both dressings appeared unchanged.
- Suction pressures were recorded to determine the variation in suction pressures between the Genadyne A4Foam Dressing and the Smith & Nephew Foam. It was determined that the difference in suction pressures between the two dressings is ± 5mmHg. It was also noted that pressure distribution appeared to be uniform across both dressings.
- Fluid removal rates were recorded to determine the wound exudate removal rate between the Genadyne A4 Foam Dressing and the Smith & Nephew Foam Dressing using plasma to simulate wound exudate. Suction was continuous for the entire 72 hour study. Fluid removal rate was found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
092992
pg. 1 of 4
510(k) Summary 807.92(c)
JUN 2 9 2010
SPONSOR
807.92(a)(1) Genadyne Biotechnologies, Inc.
Company Name:
Company Address
65 Watermill Lane Great Neck, NY 11021
Telephone: Fax:
800.208.2025 516.487.7878
Contact Person:
Chien-Ming Goh
Summary Preparation Date: June 17, 2010
DEVICE NAME
807.92(a)(2)
| Trade Name: | A4-XLR8 Foam Dressing |
|---|---|
| Common/Usual Name: | Foam Dressing |
| Classification Name: | Negative Pressure Wound Therapy Powered |
| Suction Pump and Accessories | |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Device Class: | Class II |
| Panel: | General & Plastic Surgery |
PREDICATE DEVICE
807.92(a)(3)
Legally Marketed Equivalent Device 510(k) # Company Product RenasysTM-F NPWT Foam Dressing K082211 Smith & Nephew, Inc.
DEVICE DESCRIPTION
807.92(a)(4)
Genadyne A4-XLR8 Foam Dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO.
Genadyne A4-XLR8 Foam Dressing is available in three sizes; 1) small, 2) medium and 3) large.
1
DEVICE INTENDED USE
807.92(a)(5)
Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
A4-XLR8 Foam Dressing is appropriate for use on the following wounds:
- Pressure ulcers .
- Diabetic/Neuropathic Ulcers .
- Venous insufficiency ulcers ●
- Traumatic wounds ●
- Post-operative and dehisced surgical wounds ●
- Comparative Bench ●
Caution: Federal law restricts this device to sale by or on the order of a physician.
NONCLINICAL AND CLINICAL TEST
807.92(b)
| Test | Standard | Results |
|---|---|---|
| L929 MEM Elution Test |
- ISO | ISO 10993-5 | Reticulated PE/PU, is
considered non-cytotoxic
and meets the requirements
of the Elution Test defined
in ISO 10993-5 guidelines. |
| L929 MEM Elution Test - ISO | ISO 10993-5 | Reticulated PE/PU, is
considered non-cytotoxic
and meets the requirements
of the Elution Test defined
in ISO 10993-5 guidelines. |
| L929 MEM Elution Test - ISO | ISO 10993-10 | Reticulated PE/PU, is
considered non-cytotoxic
and meets the requirements
of the Elution Test defined
in ISO 10993-5 guidelines. |
| Kligman Maximization
Test - ISO | ISO 10993-10 | Based on the criteria of the
protocol, a Grade I
sensitization rate is not
considered significant and
the test article meets the
requirements of the ISO
10993-10 guidelines. |
| Intracutaneous Injection
Test - ISO | ISO 10993-10 | Based on the criteria of the
protocol, the test article is
considered a negligible
irritant and meets the |
| Kinetic Limulus
Amebocyte Lysate Test
(LAL) | USP 32, NF 27:2009 | requirements of the ISO 10993-10 guidelines.
The test article contains 0.00689 EU/mL. The correlation coefficient for the linear regression was calculated to be -0.999. |
| Inhibition and
Enhancement Testing,
LAL Kinetic Method | USP 32, NF 27:2009 | The correlation coefficient for the linear regression was calculated to be -0.999 for standard curve, -0.996 for sample 1 and -0.997 for sample 2 and -0.998 for sample 3. There was no inhibition or enhancement present in the test article. |
| Bacteriostasis &
Fungistasis / Direct
Transfer | USP 32, NF 27:2009 | The test article is considered non-bacteriostatic and non-fungistatic, according to the USP guidelines. |
| Bioburden Validation –
Exhaustive Recovery | ANSI/AAMI/ISO 11737-1:
2006 | The percent recovery was 100% and the recovery factor was 1 using the exhaustive recovery method. |
| Accelerated Aging | ASTM F1980-07 | At the time of this filing 4-months of real-time testing has been completed |
| Residual EtO, ECh, and
EG | ISO 10993-10 | Ethylene Oxide – Not Detected Ethylene Chlorohydrin - Not Detected Ethylene Glycol - 1.18 mg, 1.71 mg, 1.43 mg, 1,65 mg, 1.34 mg, 1.31 mg |
| Comparative Bench
Testing of Subject Device
Vs Predicate Device | In-house | Based on the comparative bench test it was established that the A4-XLR8 Foam Dressing Kit is substantially equivalent to the Renasys F NPWT Dressing Kit * |
2
3
*OVERVIEW OF COMPARATIVE BENCH TEST
To ensure that the Genadyne A4-XLR8 Foam Dressing Kit is substantially equivalent to the Smith and Nephew Renasys F NPWT Foam Dressing Kit, Genadyne collected data on 3 different conditions during the bench test to demonstrate that under a vacuum environment and at different set levels of vacuum pressure, the foam performed exactly as expected and there were no unexpected outcomes during the tests.
The following tests were conducted:
-
- Dimensions were recorded before and after the 72 hours bench test. The results demonstrated after undergoing long periods of suction pressures both dressings appeared unchanged.
-
- Suction pressures were recorded to determine the variation in suction pressures between the Genadyne A4Foam Dressing and the Smith & Nephew Foam. It was determined that the difference in suction pressures between the two dressings is ± 5mmHg. It was also noted that pressure distribution appeared to be uniform across both dressings.
-
- Fluid removal rates were recorded to determine the wound exudate removal rate between the Genadyne A4 Foam Dressing and the Smith & Nephew Foam Dressing using plasma to simulate wound exudate. Suction was continuous for the entire 72 hour study. Fluid removal rate was found to be substantially equivalent.
SUBSTANTIAL EQUIVALENCE
807.92(b)(3)
In establishing substantial equivalence to the predicate device, Genadyne Biotechnologies evaluated the indications for use, material, technology, and product specifications of the product. Performance testing has been completed to demonstrate the substantial equivalence of the Genadyne A4-XLR8 Foam Dressing for its indications for use.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Genadyne Biotechnologies, Inc. % Smith Associates E.J. Smith 1468 Harwell Avenue Crofton, Maryland 21114
JUN 2 9 2010
Re: K092992
Trade/Device Name: A4-XLR8 Foam Dressing Regulation Number: 21 CFR 878.4780 Regulation Name: A4-XLR8 Foam Dressing Regulatory Class: II Product Code: OMP Dated: June 1, 2010 Received: June 1, 2010
Dear E.J. Smith:
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
5
Page 2 - E.J. Smith
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director
Enclosure
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use
510(k) Number (if known):
Device Name: A4-XLR8 Foam Dressing
Indications for Use:
Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote would healing by the removal of excess exudates, infectious material and tissue debris.
A4-XLR8 Foam Dressing is appropriate for use on the following wounds:
- Pressure ulcers ●
- Diabetic/Neuropathic Ulcers .
- Venous insufficiency ulcers ●
- Traumatic wounds ●
- Post-operative and dehisced surgical wounds ●
- Skin flap and grafts .
Caution: Federal law restricts this device to sale by or on the order of a physician.
(Check appropriate designation below)
Prescription Use X (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 OF NEEDED)
Consurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kraaffer MxM
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
Page of
510(k) Number KD92992