UNO Negative Pressure Wound Therapy System

K180840 · Genadyne Biotechnologies, Inc. · OMP · Nov 30, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180840
• Device Name: UNO Negative Pressure Wound Therapy System
• Applicant: Genadyne Biotechnologies, Inc.
• Product Code: OMP · General, Plastic Surgery
• Decision Date: Nov 30, 2018
• 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 - Closed surgical incision Genadyne UNO is a single patient use device.

Device Story

Portable, battery-powered negative pressure wound therapy (NPWT) system; delivers controlled suction to wound site to remove exudates and infectious material; promotes healing. Device comprises suction pump, disposable 70ml canisters with hydrophobic shut-off filters, and sterile dressings. Single-patient use; intended for clinical or home settings. Healthcare provider applies dressing and initiates therapy; device operates autonomously to maintain vacuum. Output is physical removal of wound fluids; clinical benefit is accelerated wound healing. System includes alerts for monitoring functionality.

Clinical Evidence

Clinical case series of 15 patients with closed surgical incisions provided as supplementary performance data. Bench testing conducted for pressure precision, absorbance, and alert functionality; results met pre-defined acceptance criteria. Biocompatibility testing performed for prolonged exposure on breached/compromised surfaces.

Technological Characteristics

Powered suction pump; 125 mmHg max vacuum; 3V DC power via Alkaline-Manganese Dioxide AA batteries. Dimensions 3" x 4.4" x 2.4"; weight 400g. Includes disposable 70ml canisters with hydrophobic shut-off filters. Sterile dressings provided. Compliance with IEC 60601-1 and IEC 60601-1-2. Operating range 18°C to 34°C, 10-95% RH.

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, partial-thickness burns, ulcers (diabetic/pressure), flaps, grafts, and closed surgical incisions. 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

• UNO Negative Pressure Wound Therapy System (K161599)
• Pico Single Use Negative Pressure Wound Therapy System (K151436)

Submission Summary (Full Text)

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November 30, 2018

Genadyne Biotechnologies, Inc. Andrew Goh Vice President 16 Midland Ave Hicksville, New York 11801

Re: K180840

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 22, 2018 Received: May 24, 2018

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known) K180840

#### Device Name

Genadyne UNO Negative Pressure Wound Therapy System

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
- Closed surgical incision

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 K180840

Genadyne UNO Negative Pressure Wound Therapy System

Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801

E-mail: [e-mail]; [e-mail] (t) 516.487.8787 (f) 516.977.8974

Contact Person: Mr. Chien-Ming GOH (Andrew); Swara Vashi

Date Prepared: November 29, 2018

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

The primary predicate device is UNO Negative Pressure Wound Therapy System, K161599. The proposed device and the primary predicate device are similar in terms of their technological characteristics.

The secondary predicate device is Pico Single Use Negative Pressure Wound Therapy System, K151436.The proposed device and the secondary predicate device are similar in terms of their indications for use.

## Device Description

The UNO Negative Pressure Wound Therapy System is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound.

#### Intended Use / Indications for Use

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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
- Closed surgical incisions

Genadyne UNO is a single patient use device.

## Technological Characteristics

| Comparative Information | | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Secondary<br>Predicate Device | Primary<br>Predicate Device | New Device |
| Company | Smith and<br>Nephew | Genadyne<br>Biotechnologies | Genadyne<br>Biotechnologies |
| Device Name | Pico Single Use<br>Negative<br>Pressure Wound<br>Therapy System | Genadyne UNO<br>Negative Pressure<br>Wound Therapy | Genadyne UNO<br>Negative Pressure<br>Wound Therapy<br>System |
| 510 (K) Number | K151436 | K161599 | K180840 |
| Technical Data | | | |
| Max Vacuum | 100 mmHg | 125 mmHg | 125 mmHg |
| Battery Type | Lithium AA (L91) | Alkaline-<br>Manganese<br>Dioxide AA<br>(QU1500) | Alkaline-<br>Manganese<br>Dioxide AA<br>(QU1500) |
| Power (Battery) | 3V DC | 3V DC | 3V DC |
| Dimensions /<br>Weight | 3.5" x 3.5" x 1.0" /<br><120g | 3" x 4.4" x 2.4" /<br>400g | 3" x 4.4" x 2.4" /<br>400g |
| Device Lifespan | 7 days | 24 hours | 7 days |
| Accessories | | | |
| Canisters | N/A | Two 70 ml<br>disposable<br>canister with a<br>build-in | Two 70 ml<br>disposable<br>canister with a<br>build-in |
| | | hydrophobic shut<br>off filter for<br>overflow protection | hydrophobic shut<br>off filter for<br>overflow protection |
| Reusable | No | No | No |
| Sterile | Dressings are<br>provided sterile | Dressings<br>provided are<br>sterile | Dressings<br>provided are<br>sterile |
| Accessories | | | |
| Dressings | 10cm x 20cm<br>10cm x 30cm<br>15cm x 15cm<br>15cm x 20cm | 10cm x 10cm<br>10cm x 20cm<br>10cm x 30cm<br>10cm x 40cm<br>15cm x 15cm<br>15cm x 20cm<br>15cm x 30cm<br>20cm x 20cm<br>20cm x 25cm<br>25cm x 25cm | 10cm x 10cm<br>10cm x 20cm<br>10cm x 30cm<br>10cm x 40cm<br>15cm x 15cm<br>15cm x 20cm<br>15cm x 30cm<br>20cm x 20cm<br>20cm x 25cm<br>25cm x 25cm |
| | Fixation Strips<br>Carrying Case | 4 x Fixation Strips<br>Carrying Case | 4 x Fixation Strips<br>Carrying Case |
| Indications for<br>Use | | | |
| | PICO is indicated<br>for patients who<br>would benefit<br>from a suction<br>device (negative<br>pressure wound<br>therapy) as it may<br>promote wound<br>healing via<br>removal of low to<br>moderate levels<br>of exudate and<br>infectious<br>materials.<br>Appropriate<br>wound types<br>include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and<br>dehisced wounds<br>- Partial-thickness<br>burns | Genadyne UNO is<br>indicated for use in<br>patients who<br>would benefit from<br>negative pressure<br>wound therapy<br>particularly as the<br>device may<br>promote wound<br>healing by the<br>removal of low to<br>moderate<br>exudates and<br>infectious material.<br>Appropriate wound<br>types include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and<br>dehisced wounds<br>- Partial-thickness<br>burns - Ulcers<br>(such as diabetic<br>or pressure)<br>- Flaps and grafts | Genadyne UNO is<br>indicated for use in<br>patients who<br>would benefit from<br>negative pressure<br>wound therapy<br>particularly as the<br>device may<br>promote wound<br>healing by the<br>removal of low to<br>moderate<br>exudates and<br>infectious material.<br>Appropriate wound<br>types include:<br>- Chronic<br>- Acute<br>- Traumatic<br>- Subacute and<br>dehisced wounds<br>- Partial-thickness<br>burns<br>- Ulcers (such as<br>diabetic or<br>pressure) |
| | - Ulcers (such as<br>diabetic or<br>pressure)<br>- Flaps and grafts<br>- Closed surgical<br>incisions<br>PICO Single Use<br>Negative<br>Pressure Wound<br>Therapy System<br>is suitable for use<br>in both hospital<br>and homecare<br>setting | Genadyne UNO is<br>a single patient<br>use device. | - Flaps and grafts<br>- Closed Surgical<br>Incisions.<br>Genadyne UNO is<br>a single patient<br>use device. |
| Contraindications | | | |
| | The Pico is<br>contraindicated in<br>the presence of : | The Genadyne<br>UNO is<br>contraindicated in<br>the presence of: | The Genadyne<br>UNO is<br>contraindicated in<br>the presence of: |
| | Necrotic tissue<br>with Eschar<br>present | Necrotic tissue<br>with Eschar<br>present | Necrotic tissue<br>with Eschar<br>present |
| | Previously<br>confirmed and<br>untreated<br>osteomyelitis. | Untreated<br>osteomyelitis | Untreated<br>osteomyelitis |
| | malignancy in the<br>wound bed or<br>margins of the<br>wound (except in<br>palliative care to<br>enhance quality<br>of life) | Malignancy (with<br>exception to<br>enhance quality of<br>life) | Malignancy (with<br>exception to<br>enhance quality of<br>life) |
| | Exposed arteries,<br>veins, or organs | Exposed arteries,<br>veins, or organs | Exposed arteries,<br>veins, or organs |
| | Non-enteric and<br>unexplored<br>fistulas | Non-enteric and<br>unexplored fistulas | Non-enteric and<br>unexplored fistulas |
| - | Anastomotic sites | Anastomotic sites | Anastomotic sites |
| - | Emergency<br>airway aspiration | Emergency airway<br>aspiration | Emergency airway<br>aspiration |
| - | Pleural,<br>mediastinal or<br>chest tube<br>drainage | Pleural,<br>mediastinal or<br>chest tube<br>drainage | Pleural,<br>mediastinal or<br>chest tube<br>drainage |
| - | Surgical suction | | Surgical suction |
| Compliance | | | |
| | IEC 60601-1 | IEC 60601-1 | IEC 60601-1 |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 |
| Storage /<br>Transport | -18°C to +43°C<br>(0°F to 110°F) | 5°C to +25°C<br>(41°F to 77°F) | -18°C to +43°C<br>(0°F to 110°F) |
| | Relative Humidity<br>10% to 95 % | Relative Humidity<br>10% to 75 % | Relative Humidity<br>10% to 95 % |
| | 700 – 1060 mbar<br>Atmospheric<br>pressure | 700 - 1060 mbar<br>Atmospheric<br>pressure | 700 – 1060 mbar<br>Atmospheric<br>pressure |
| Operation | 18°C to 34°C<br>(65°F to 94°F) | 5°C to 35°C (41°F<br>to 95°F) | 18°C to 34°C<br>(65°F to 94°F) |
| | Relative Humidity<br>10% to 95 % | Relative Humidity<br>10% to 95 % | Relative Humidity<br>10% to 95 % |
| | 700 - 1060 mbar<br>Atmospheric<br>pressure | 700 - 1060 mbar<br>Atmospheric<br>pressure | 700 - 1060 mbar<br>Atmospheric<br>pressure |

Table of Comparison to Predicate Devices:

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#### 15. Discussion of nonclinical and clinical testing

None of the dressing and device characteristics and technical specs were changed from the last clearance (K161599). Additional biocompatibility testing was performed to support prolonged exposure on breached or compromised surfaces. The dressing is intended to be used for a maximum of 3 days with multiple changes within 7-day device lifespan. A clinical case series from 15 patients with closed surgical incisions were provided as supplementary performance data in support of the safety of the device. The data and results show that the device is biocompatible.

Bench tests were conducted on the subject device to determine its performance. Performance tests include pressure precision, absorbance, and alert functionality. The results were within the acceptable limit of the criteria that were set prior the experiment.

- 16. Conclusion & Based on the information presented above, it is Determination of concluded that the UNO is substantially equivalent to Substantial Equivalence the predicate device.