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 (K161599).

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: Traditional).

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

K161599 · Genadyne Biotechnologies, Inc. · OMP · Apr 6, 2017 · General, Plastic Surgery

Device Facts

Record ID	K161599
Device Name	UNO Negative Pressure Wound Therapy System
Applicant	Genadyne Biotechnologies, Inc.
Product Code	OMP · General, Plastic Surgery
Decision Date	Apr 6, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4780
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Portable, battery-powered suction pump; applies negative pressure to wound sites to remove low-to-moderate exudates and infectious material; promotes wound healing. Single-patient use; operated by clinician or patient. System includes pump, disposable 70ml canisters with hydrophobic shut-off filters, and sterile dressings. Healthcare providers monitor wound progress; device output (negative pressure) facilitates exudate management. Benefits include accelerated healing and infection control in chronic, acute, and traumatic wounds.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on dressing kits (silicone foam, PU film strips). Pump performance verified via in-house protocols and compliance with IEC 60601-1 and IEC 60601-1-2 standards.

Technological Characteristics

Powered suction pump; 3V DC power via Alkaline-Manganese Dioxide AA batteries. Max vacuum 125 mmHg. Includes 70ml disposable canisters with hydrophobic shut-off filters. Sterile dressings (silicone foam, PU film). Dimensions 3" x 4.4" x 2.4"; weight 400g. Compliance: IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for patients requiring negative pressure wound therapy to promote healing of chronic, acute, traumatic, subacute, dehisced wounds, partial-thickness burns, ulcers (diabetic/pressure), flaps, and grafts. Contraindicated for necrotic tissue with eschar, 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

Pico Single Use Negative Pressure Wound Therapy System (K151436)

Related Devices

K180840 — UNO Negative Pressure Wound Therapy System · Genadyne Biotechnologies, Inc. · Nov 30, 2018
K090638 — GENADYNE A4-XLR8 WOUND VACUUM SYSTEM · Genadyne Biotechnologies, Inc. · Apr 29, 2009
K143726 — XLR8 PLUS (XLR8+) · Genadyne Biotechnologies, Inc. · Jun 19, 2015
K180614 — PICO Single Use Negative Pressure Wound Therapy System · Smith & Nephew Medical Limited · Apr 6, 2018
K110078 — EXTRICARE · Devon Medical Products, Inc. · Feb 10, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the caduceus symbol. 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) K161599 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) #### 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}------------------------------------------------ # 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" / <120g | 3" x 4.4" x 2.4" / 400g | | Accessories | | | | Canisters | N/A | Two 70 ml disposable canister with a build-in hydrophobic shut off filter for overflow protection | | Reusable | No | No | | Sterile | Pump, dressing, and secondary fixation strips are sterile | Dressings provided are sterile | | Accessories | | | | | | 70ml Canisters | | Dressings | 10cm x 20cm 10cm x 30cm 15cm x 15cm 15cm x 20cm | 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 | | | Fixation Strips | Fixation Strips | | | Carrying Case | Carrying Case | | | | | | Indications for Use | | | | | PICO is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: - Chronic - Acute - Traumatic - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions PICO Single Use Negative Pressure Wound Therapy System is suitable for use in both hospital and homecare setting | 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. | | | | | | Contraindications | | | | - | The Pico is contraindicated in the presence of : | The Genadyne UNO is contraindicated in the presence of: | | - | Necrotic tissue with Eschar present | Necrotic tissue with Eschar present | | - | Previously confirmed and untreated osteomyelitis. | Untreated osteomyelitis | | - | malignancy in the wound bed or margins of the wound (except in palliative care 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 | JEC 60601-1-2 | | UL 60601-1 | | | | Can/CSA C22.2 | | | | Storage / Transport | 5°C to +25°C (41°F to 77°F) | -18°C to +43°C (0°F to 110°F) | | | Relative Humidity 10% to 75 % | Relative Humidity 10% to 95 % | | | 700 - 1060 mbar Atmospheric pressure | 700 – 1060 mbar Atmospheric pressure | | Operation | 5°C to 35°C (41°F to 95°F) | 18°C to 34°C (65°F to 94°F) | | | Relative Humidity 10% to 95 % | Relative Humidity 10% to 95 % | | | 700 - 1060 mbar Atmospheric pressure | 700 - 1060 mbar Atmospheric pressure | {5}------------------------------------------------ {6}------------------------------------------------ - 15. Discussion of nonclinical and clinical testing 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. The Genadyne UNO has similar design characteristics and provides similar functions to the PICO system. The intended use, indications and instructions for use for the subject and predicate devices are similar. The dressing materials and features are all similar as well. The Genadyne UNO does not raise any new issues of safety and effectiveness. Therefore, it is in our conclusion that the Genadyne UNO is substantially equivalent to the predicate device. - 16. Conclusion & Determination of Substantial Equivalence Based on the information presented above, it is concluded that the UNO is substantially equivalent to the predicate device.