(168 days)
No
The description focuses on the mechanical aspects of negative pressure wound therapy, selectable pressure settings, and disposable components. There is no mention of AI, ML, or any features that would suggest adaptive or learning capabilities based on wound characteristics or patient data.
Yes
The intended use explicitly states the device "may promote wound healing by the removal of low to moderate exudates and infectious material," which is a therapeutic effect.
No
The device is a Negative Pressure Wound Therapy (NPWT) system designed to treat wounds by promoting healing through the removal of exudates and infectious material. It provides therapy rather than diagnosing a condition.
No
The device description explicitly details hardware components such as a "Negative Pressure Wound Therapy (NPWT) Unit," an "interface panel," "canisters," and "sterile dressing kits." It also mentions physical parameters like "negative pressure at either 80 mmHg or 125 mmHg." This indicates it is a physical medical device with integrated software, not a software-only device.
Based on the provided text, the Genadyne UNO Negative Pressure Wound Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Genadyne UNO Negative Pressure Wound Therapy System is a therapeutic device that applies negative pressure directly to a wound to promote healing. It does not analyze biological samples.
- Intended Use: The intended use clearly describes treating wounds by removing exudates and infectious material, not diagnosing or monitoring a condition through laboratory analysis.
Therefore, the Genadyne UNO Negative Pressure Wound Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Genadyne UNO Negative Pressure Wound Therapy System is 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
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed Surgical Incision
Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.
Product codes
OMP
Device Description
The Genadyne UNO Negative Pressure Wound Therapy System is a single patient use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO Negative Pressure Wound Therapy System has a pre-determined lifespan. The unit has an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and has selections of Continuous Mode at 80mmHg/ 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Negative Pressure Wound Therapy System Therapy Kits include a therapy unit. 200 ml and 300 mL canisters, and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO Negative Pressure Wound Therapy System can be provided separately. The dressing is intended to be used for a maximum of 3 days. Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes. Disposable components of the Genadyne UNO Negative Pressure Wound Therapy System, including the foam dressing and drape, are packaged sterile (Ethylene Oxide) and not made with natural rubber latex. All disposable components of the Genadyne UNO Negative Pressure Wound Therapy System are for single use only. The Genadyne UNO Negative Pressure Wound Therapy System dressings are to be used only with the Genadyne UNO Negative Pressure Wound Therapy System.
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)
Clinical testing was not performed because as the changes are on the pump itself, which does not have any contact with the patient's wound. For non-clinical tests, we have submitted in this submission the IEC 60601-1 and IEC 60601-1-2 reports to ensure that the Genadyne UNO Negative Pressure Wound Therapy System has passed and are in compliance with the standard.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 14, 2022
Genadyne Biotechnologies, Inc Andrew Goh Vice President 16 Midland Ave Hicksville, New York 11801
Re: K221891
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: May 19, 2022 Received: June 29, 2022
Dear Andrew 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Julie A. Morabito -S
Julie Morabito Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221891
Device Name
Genadyne UNO Negative Pressure Wound Therapy (NPWT) System
Indications for Use (Describe)
Genadyne UNO Negative Pressure Wound Therapy System is 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
- Ulcers (such as diabetic or pressure)
- Flaps and grafts
- Closed Surgical Incision
Genadyne UNO Negative Pressure Wound Therapy System is a single patient use device.
Type of Use (Select one or both, as applicable)
| Residential Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart G) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K221891
510k Summary
Date Prepared: April 29, 2022
| 1. | Applicant | Genadyne Biotechnologies, Inc.
16 Midland Ave,
Hicksville, NY 11801
T: (516) 487-87878
F: (516) 487-7878
www.genadyne.com |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Registration number | 2435947 |
| 3. | Contact Person | Mr. Chien-Ming Goh
Vice president
andrew@genadyne.com |
| 4. | Trade/Proprietary Name
Including Model Number of
Device | Genadyne UNO Negative Pressure Wound Therapy
System , U-S0004, U-S0005, U-S0006 |
| 5. | Common Name or classification
of device | Powered Suction Pump (21 CFR 878.4780, Product
Code OMP) Class II |
| 6. | Address of Manufacturing Facility | 519 Johnson Ave
Bohemia, NY 11716 |
| 7. | a. Class in which device has
been placed | II |
| 8. | b. Panel | General Plastic Surgery |
| 9. | c. Reason for 510(k) special | Modified plastic housing and change from battery
powered to rechargeable lithium ion batteries of
current legally device |
| 10. | d. Identification of legally
marketed device which
we claim substantial
equivalence | Genadyne UNO 30 , K190028 |
| 11. | Brief Description of the
device | The Genadyne UNO Negative Pressure Wound
Therapy System is a single patient use Negative
Pressure Wound Therapy (NPWT) Unit designed for
moderate to low severity wounds. The Genadyne UNO
Negative Pressure Wound Therapy System has a
pre-determined lifespan. The unit has an interface
panel which provides alert and information signals and
selectable therapy options. This unit provides negative
pressure at either 80 mmHg or 125 mmHg, and has
selections of Continuous Mode at 80mmHg/ 30mmHg
or 125mmHg / 30mmHg in Variable Mode. The
Genadyne UNO Negative Pressure Wound Therapy
System Therapy Kits include a therapy unit. 200 ml |
| | and 300 mL canisters, and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO Negative Pressure Wound Therapy System can be provided separately. The dressing is intended to be used for a maximum of 3 days. Therapy duration of the dressing may be less than indicated if clinical practice or other factors such as wound type, wound size, rate or volume of exudate, orientation of the dressing or environmental conditions, result in more frequent dressing changes. Disposable components of the Genadyne UNO Negative Pressure Wound Therapy System, including the foam dressing and drape, are packaged sterile (Ethylene Oxide) and not made with natural rubber latex. All disposable components of the Genadyne UNO Negative Pressure Wound Therapy System are for single use only. The Genadyne UNO Negative Pressure Wound Therapy System dressings are to be used only with the Genadyne UNO Negative Pressure Wound Therapy System. | |
| 12. | Indications for use
The Genadyne Uno NPWT 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 low to moderate exudates and infectious material. | |
4
13. Comparison of subject and predicate device
| Predicate Device | Subject Device | |
|---|---|---|
| Company | Genadyne | |
| Biotechnologies, Inc. | Genadyne Biotechnologies, Inc. | |
| Device Name | UNO 30 | Genadyne UNO Negative Pressure Wound |
| Therapy System | ||
| 510k number | K190028 | K221891 |
| Technical data | ||
| Max Vacuum | 125 mmHg | 125 mmHg |
| Battery Type | Alkaline-Manganese | |
| Dioxide AA (QU1500) | Lithium Ion Battery | |
| Charger | No | Yes |
| Input: 100VAC-240VAC, 50-60Hz. | ||
| Output: 5V DC, 2A, 10W. | ||
| Power Battery | 3V DC | 3.6V, 1700mAh |
| Dimensions | 3" x 4 3/8" x 2 1/4" | 4 3/8" x 3" x 1 5/8" |
| Accessories | Contains canisters :- 70 | |
| ml disposable canister | ||
| with a built-in | ||
| hydrophobic shut off | ||
| filter for overflow | ||
| protection | Contains canisters :- 70 | |
| ml disposable canister | ||
| with a built-in | ||
| hydrophobic shut off | ||
| filter for overflow | ||
| protection | ||
| Reusable | No | No |
| Sterile | Dressings are provided | |
| Sterile | Dressings are provided Sterile | |
| Accessories | ||
| Dressings | 10cm x 10cm | |
| 10cm x 20cm | ||
| 10cm x 30cm | ||
| 10cm x 40cm | ||
| 15cm x 15cm | ||
| 15cm x 20cm | ||
| 15cm x 30cm | ||
| 20cm x 20cm | ||
| 20cm x 25cm | ||
| 25cm x 25cm | 10cm x 10cm | |
| 10cm x 20cm | ||
| 10cm x 30cm | ||
| 10cm x 40cm | ||
| 15cm x 15cm | ||
| 15cm x 20cm | ||
| 15cm x 30cm | ||
| 20cm x 20cm | ||
| 20cm x 25cm | ||
| 25cm x 25cm | ||
| 4 X Fixation Strips | 4 X Fixation Strips | |
| Carrying case | Carrying case | |
| Indications for Use | UNO 30 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 - Ulcers (such as
diabetic or pressure) - Flaps and grafts
- Closed Surgical
Incision
UNO 30 is a single
patient use device. | Genadyne UNO Negative Pressure
Wound Therapy 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 low to
moderate exudates and
infectious material.
Appropriate wound
types include: - Chronic
- Acute
- Traumatic
- Subacute and
dehisced wounds - Ulcers (such as
diabetic or pressure) - Flaps and grafts
- Closed Surgical
Incision
Genadyne UNO Negative Pressure
Wound Therapy System is a single
patient use device. |
| Contraindications | | |
| | The UNO 30 is
contraindicated in the
presence of: | The UNO rev B is
contraindicated in the
presence of: |
| | Untreated osteomyelitis | Untreated osteomyelitis |
| | Malignancy (with
exception to enhance
quality of life) | Malignancy (with
exception to enhance
quality of life) |
| | Exposed arteries, veins,
or organs | Exposed arteries, veins,
or organs |
| | Non-enteric and
unexplored fistulas | Non-enteric and
unexplored fistulas |
| | Anastomotic sites | Anastomotic sites |
| | Emergency airway
Aspiration | Emergency airway
Aspiration |
| | Pleural, mediastinal or
chest tube drainage | Pleural, mediastinal or
chest tube drainage |
| | Surgical suction | Surgical suction |
| Compliance | | |
| | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-1-2 | IEC 60601-1-2 |
| Storage/Transport | | |
| | -18°C to +43°C (0°F to 109.4°F) | -18°C to +43°C (0°F to 109.4°F) |
| Relative Humidity | 15% to 95 % | 15% to 95 % |
| Atmospheric Pressure | 700 - 1060 mbar | 700 - 1060 mbar |
| Operation | | |
| | 18°C to 34°C (65°F to 93.2°F) | 18°C to 34°C (65°F to 93.2°F) |
| Relative Humidity | 10% to 95 % | 10% to 95 % |
| Atmospheric pressure | 700 - 1060 mbar | 700 - 1060 mbar |
5
6
14. Discussion of Non-Clinical and Clinical Testing
Clinical testing was not performed because as the changes are on the pump itself, which does not have any contact with the patient's wound.
For non-clinical tests, we have submitted in this submission the IEC 60601-1 and IEC 60601-1-2 reports to ensure that the Genadyne UNO Negative Pressure Wound Therapy System has passed and are in compliance with the standard.
15. Conclusion & Determination of Substantial Equivalence
Based on the information presented in the submission, it is concluded that the Genadyne UNO Negative Pressure Wound Therapy System is substantially equivalent to predicate device.