(301 days)
Not Found
No
The summary describes a standard negative pressure wound therapy device and does not mention any AI or ML capabilities.
Yes
The device is indicated for use in patients who would benefit from negative pressure wound therapy, specifically to promote wound healing by removing exudates and infectious material, which are therapeutic actions.
No
Explanation: The device is a wound therapy system designed to promote healing by applying negative pressure and removing exudates, not to diagnose a medical condition.
No
The device description explicitly states it is a "portable, battery powered wound suction pump," indicating it is a hardware device with a physical pump component.
Based on the provided information, the Genadyne UNO is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device that applies negative pressure to a wound to promote healing by removing exudates and infectious material. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The description confirms it's a portable, battery-powered wound suction pump. This is a physical device used for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used for diagnostic purposes by analyzing samples, not for direct therapeutic application to a wound.
N/A
Intended Use / Indications for Use
Genadyne UNO 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 low to moderate exudates and infectious material.
Appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
Genadyne UNO is a single patient use device.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
It appears that the non-clinical results are all showing that it is safe for patient use. The dressing kit, which contains a silicone foam dressing, 4 PU film strips, met the acceptance criteria for biocompatibility testing, and the pump has met the acceptance criteria for all applicable IEC testing. Bench testing was done with in house protocol to establish ensure the performance and outcome of is expected when using together with the device as a system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2017
Genadyne Biotechnologies, Inc. Chien Ming Goh (Andrew) Vice President, Regulatory Affairs 16 Midland Ave Hicksville, New York 11801
Re: K161599
Trade/Device Name: Uno Negative Pressure Wound Therapy System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: January 18, 2017 Received: February 28, 2017
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 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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Genadyne UNO Negative Pressure Wound Therapy
Indications for Use (Describe)
Genadyne UNO 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 low to moderate exudates and infectious material.
Appropriate wound types include:
- Chronic
- Acute
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
Genadyne UNO is a single patient use device.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510k Summary
Negative Pressure Wound Therapy
Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801
E-mail: Andrew@genadyne.com (t) 516.217.0100 (f) 516.977.8974
Contact Person: Mr. Chien-Ming GOH (Andrew)
Date Prepared: April 4, 2017
Name of Device
Genadyne UNO Negative Pressure Wound Therapy System
Common or Usual Name
Powered Suction Pump
Classification Name
OMP, Negative Pressure Wound Therapy Powered Suction Pump
21 C.F.R. § 878.4780
Predicate Device
Pico Single Use Negative Pressure Wound Therapy System, K151436
Device Description
The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.
Intended Use / Indications for Use
Genadyne UNO 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 low to moderate exudates and infectious material.
Appropriate wound types include:
-
Chronic
-
Acute
4
- Traumatic
- Subacute and dehisced wounds
- Partial-thickness burns
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
It is a single patient use device.
Technological Characteristics
Table of Comparison to Predicate Devices:
| Comparative Information | ||
|---|---|---|
| Predicate Device | New Device | |
| Company | Smith and Nephew | Genadyne Biotechnologies |
| Device Name | Pico Single Use Negative Pressure | |
| Wound Therapy System | UNO Single Patient Use Negative | |
| Pressure Wound Therapy System | ||
| 510 (K) Number | K151436 | |
| Technical Data | ||
| Max Vacuum | 100 mmHg | 125 mmHg |
| Battery Type | Lithium AA (L91) | Alkaline-Manganese Dioxide AA |
| (QU1500) | ||
| Power (Battery) | 3V DC | 3V DC |
| Dimensions / Weight | 3.5" x 3.5" x 1.0" / |