Who is the manufacturer of UNO Negative Pressure Wound Therapy System?

Genadyne Biotechnologies, Inc. filed the 510(k) submission for UNO Negative Pressure Wound Therapy System (K221891).

What is the FDA product code for UNO Negative Pressure Wound Therapy System?

OMP. It is classified under 21 CFR 878.4780 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for UNO Negative Pressure Wound Therapy System?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like UNO Negative Pressure Wound Therapy System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

UNO Negative Pressure Wound Therapy System

K221891 · Genadyne Biotechnologies, Inc. · OMP · Dec 14, 2022 · General, Plastic Surgery

Device Facts

Record ID	K221891
Device Name	UNO Negative Pressure Wound Therapy System
Applicant	Genadyne Biotechnologies, Inc.
Product Code	OMP · General, Plastic Surgery
Decision Date	Dec 14, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Single-patient-use negative pressure wound therapy (NPWT) system; provides controlled negative pressure to wound sites to remove exudate and infectious material. System includes therapy unit, 200/300 mL canisters, and sterile dressing kits. Unit features interface panel for alerts, information, and therapy selection; provides continuous (80/125 mmHg) or variable (80/30 mmHg or 125/30 mmHg) pressure modes. Operated by clinicians or patients in clinical/home settings. Powered by rechargeable lithium-ion battery. Disposable components (foam dressing, drape) are sterile and latex-free. Output allows healthcare providers to monitor therapy; benefits patient by promoting wound healing.

Clinical Evidence

No clinical data. Bench testing only; compliance with IEC 60601-1 and IEC 60601-1-2 standards provided.

Technological Characteristics

Powered suction pump; rechargeable lithium-ion battery (3.6V, 1700mAh); input 100-240VAC. Max vacuum 125 mmHg. Dimensions 4 3/8" x 3" x 1 5/8". Sterile ethylene oxide-processed dressings (foam/drape). Hydrophobic shut-off filter in canisters. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing via removal of low to moderate exudates and infectious material. Applicable to chronic, acute, traumatic, subacute, dehisced wounds, ulcers (diabetic/pressure), flaps, grafts, and closed surgical incisions. Contraindicated for untreated osteomyelitis, malignancy, exposed arteries/veins/organs, non-enteric/unexplored fistulas, anastomotic sites, emergency airway aspiration, pleural/mediastinal/chest tube drainage, and surgical suction.

Regulatory Classification

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.

Predicate Devices

Genadyne UNO 30 (K190028)

Related Devices

K180840 — UNO Negative Pressure Wound Therapy System · Genadyne Biotechnologies, Inc. · Nov 30, 2018
K183543 — ACTIV.A.C. Therapy Unit · Kci USA, Inc. · Mar 20, 2019
K211318 — PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs · Smith Nephew Medical Limited · Jan 5, 2022
K161432 — MyNeWT Negative Pressure Wound Therapy System · Stortford Medical, LLC · Feb 8, 2017
K161599 — UNO Negative Pressure Wound Therapy System · Genadyne Biotechnologies, Inc. · Apr 6, 2017

Submission Summary (Full Text)

{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) | <label><input type="checkbox"/> Residential Use (Part 21 CFR 801 Subpart D)</label> | |-------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart G)</label> | |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.