(50 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on the mechanical function of negative pressure wound therapy.
Yes
The “Intended Use / Indications for Use” section states the device "may promote wound healing," which is a therapeutic effect.
No
The device description indicates it is a "portable suction device" used for wound debridement and fluid removal, which are therapeutic actions, not diagnostic ones. Its "Intended Use" also describes therapeutic benefits ("promote wound healing by the removal of excess exudates, infectious material and tissue debris") rather than providing information for diagnosis.
No
The device description explicitly states it is a "portable suction device," indicating it is a hardware device that provides negative pressure wound therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device that applies negative pressure to a wound to promote healing by removing exudate and debris. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The description confirms it's a portable suction device used with wound sealing kits, again indicating a direct therapeutic application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used to analyze samples to gain information about a patient's health status, not to directly treat a condition on the body.
N/A
Intended Use / Indications for Use
The Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
Product codes
OMP
Device Description
The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.
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)
Performance testing has been completed to demonstrate the safe and effective use of the Genadyne A4-XLR8 Wound Vacuum System for the intended use.
Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K090636 page 1/2
Special 510k Summary
General Information
-
- Applicant:
Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 (t) 516.487.8787 (f) 516.487.7878 www.genadyne.com
- Applicant:
APR 2 9 2009
-
- Contact Person: Mr. Chien-Ming GOH (Andrew) Vice President Genadyne Biotechnologies Inc. 65 Watermill Lane, Great Neck, NY 11021 Tel: 516-487-8787 Fax: 516-487-7878 Andrew@genadyne.com
3. Trade/Proprietary Name Including Model Number of Device:
Genadyne A4-XLR8 Wound Vacuum System
4. Common Name or Classification Name (21 CFR Part 807.87) of Device:
Powered Suction Pump (21 CFR 878.4780, Product Code
OMP)
5. Class in which Device has been placed:
- Class II
6. Reason for Premarket Notification:
Introduction of a new device that is a modification of a legally marketed device.
7. Identification of Legally Marketed Device Which We Claim Substantial Equivalence (Predicate Device):
Genadyne A4 Wound Vacuum System (K082676)
1
K090638 page 2/2
8. Compliance with Requirements of the Federal FD&C Act:
The General and Restorative Device Panel (DGRD) has classified this device as Class II, 21 CFR 878.4780
OMP Product Code:
9. Kit Certification and Information:
This device kit is exactly the same as its predicate device (K082676)
10. Description of the Device
The product is a portable suction device that may promote wound healing when used with accessory wound sealing kits.
11. Intended use of the Device
Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
12. Substantial Equivalence
In establishing substantial equivalence to the predicate device. Genadyne Biotechnologies evaluated the indications for use, material, technology, product specifications, and energy requirements of the system. Performance testing has been completed to demonstrate the safe and effective use of the Genadyne A4-XLR8 Wound Vacuum System for the intended use.
13. Summary of Safety and Effectiveness
Performance testing and device comparison demonstrates that the subject device is substantially equivalent to the predicate device, and is safe and effective for the intended use.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing left. 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 9200 Corporate Boulevard Rockville MD 20850
APR 9 9 2009
Genadyne Biotechnologies, Inc. % Mr. Chien-Ming Goh Vice President 65 Watermill Lane Great Neck, New York 11021
Re: K090638
Trade/Device Name: Genadyne A4-XLR8 Wound Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: April 20, 2009 Received: April 23, 2009
Dear Mr. Goh:
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 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 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at
3
Page 2 - Mr. Chien-Ming Goh
(240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
For Nelo V
O.K.
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Genadyne A4-XLR8 Wound Vacuum System
Indications For Use:
The Genadyne A4-XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
Prescription Use (Per 21 CFR 801 Subpart D)
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 CDRH, Office of Device Evaluation (ODE)
Daniel Krane fee MXM
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K990638