(373 days)
Not Found
No
The description focuses on the mechanical function of a negative pressure wound therapy pump 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.
No
The device is a wound suction pump intended for negative pressure wound therapy, specifically for promoting wound healing by removing exudates and infectious material. It does not perform any diagnostic function.
No
The device description explicitly states it is a "portable, battery powered wound suction pump" and includes "dressing and canister," indicating it is a hardware device with physical components for delivering negative pressure wound therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for negative pressure wound therapy, which is a treatment applied directly to a wound on the body. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving testing of samples like blood or tissue).
- Device Description: The description details a "wound suction pump" and a "NPWT system" that includes a dressing and canister. These components are consistent with a device used for wound treatment on the body.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis.
Therefore, the UNO 30 is a therapeutic device for wound management, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The UNO 30 is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound. The unit provides negative pressure at either 80mmHg or 125mmHg in continuous mode and 80mmHg/30mmHg or 125mmHg/30mmHg in variable mode. The UNO 30 NPWT system includes dressing and canister.
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)
Bench tests including pressure precision, battery life, absorbance, and alert functionality were conducted to show that the device still functions as appropriately needed during the course of 30 days. It also showed that after 30 days, the unit does not turn on even with new sets of batteries.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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 and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2020
Genadyne Biotechnologies Swara Vashi Regulatory Affairs Engineer and Official Correspondent 16 Midland Ave Hicksville, New York 11801
Re: K190028
Trade/Device Name: UNO 30 Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: December 16, 2019 Received: December 17, 2019
Dear Swara Vashi:
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
1
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 (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 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,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) 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
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Indications for Use
510(k) Number (if known) K190028
Device Name UNO 30
Indications for Use (Describe)
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 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Traditional 510k Summary
Negative Pressure Wound Therapy
Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801
E-mail:SwaraV@genadyne.com; Andrew@genadyne.com (t) 516.487.8787 (f) 516.977.8974
Contact Person: Swara Vashi; Mr. Chien-Ming GOH (Andrew)
Date Prepared: January 10, 2020
Name of Device
UNO 30
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, K180840. The secondary predicate device is Avelle Negative Pressure Wound Therapy System K180205.
Device Description
The UNO 30 is portable, battery powered wound suction pump with the intention to deliver negative pressure wound therapy to the wound. The unit provides negative pressure at either 80mmHg or 125mmHg in continuous mode and 80mmHg/30mmHg or 125mmHg/30mmHg in variable mode. The UNO 30 NPWT system includes dressing and canister.
4
Intended Use / 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.
Technological Characteristics
Table of Comparison to Predicate Devices:
| | Primary Predicate
Device | Secondary Predicate
Device | Proposed Device |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Company | Genadyne
Biotechnologies | ConvaTec Limited | Genadyne
Biotechnologies |
| Device Name | Genadyne UNO
Negative Pressure
Wound Therapy System | Avelle Negative
Pressure Wound
Therapy | UNO 30 |
| 510 (K) Number | K180840 | K180205 | K190028 |
| Technical Data | | | |
| Max Vacuum | 125 mmHg | 144 mmHg | 125 mmHg |
| Battery Type | Alkaline-Manganese
Dioxide AA (QU1500) | Lithium Batteries | Alkaline-Manganese
Dioxide AA (QU1500) |
| Power (Battery) | 3V DC | 4.5V DC/Battery | 3V DC |
| Dimensions / Weight | 3" x 4.4" x 2.4" / 400g | 3" x 3" x 1" / 78g | 3" x 4.4" x 2.4" / 400g |
| Device Lifespan | 7 days | 30 days | 30 days |
| | | | |
| Accessories | | | |
| | Contains canisters:- 70
ml disposable canister
with a build-in
hydrophobic shut off
filter for overflow
protection | Contains absorbent
wound dressing which
is connected via tubing
and luer lock fittings
and adhesive fixation
strips.
Does not contain a
canister. | Contains canisters :- 70
ml disposable canister
with a build-in
hydrophobic shut off
filter for overflow
protection |
| Reusable | No | No | No |
| | | | |
| Sterile | Dressings are provided
sterile | Dressings are provided
sterile | Dressings provided are
sterile |
| | | | |
| | | | |
| Accessories | | | |
| Dressings | 10cm x 10cm | 12cm x 41cm | 10cm x 10cm |
| | 10cm x 20cm
10cm x 30cm | 12cm x 31cm
12cm x 21cm | 10cm x 20cm
10cm x 30cm |
| | 10cm x 40cm | 16cm x 21cm | 10cm x 40cm |
| | 15cm x 15cm | 16cm x 16cm | 15cm x 15cm |
| | 15cm x 20cm | | 15cm x 20cm |
| | 15cm x 30cm | | 15cm x 30cm |
| | 20cm x 20cm | | 20cm x 20cm |
| | 20cm x 25cm | | 20cm x 25cm |
| | 25cm x 25cm | | 25cm x 25cm |
| | 4 X Fixation Strips | Fixation strips | 4 x Fixation Strips |
| | Carrying Case | Carrying case | Carrying Case |
| | | 2 sets of 3 batteries | |
| | | | |
| Indications for Use | | | |
| | Genadyne UNO is
indicated for use in
patients who would | The Avelle NPWT
System is indicated for
use on patients that | UNO 30 is indicated for
use in patients who
would benefit from |
| | benefit from negative | would benefit from a | negative pressure |
| | pressure wound therapy | Negative Pressure | wound therapy |
| | particularly as the device | Wound Therapy | particularly as the |
| | may promote wound | (NPWT) device as it | device may promote |
| | healing by the removal | may promote wound | wound healing by the |
| | of low to moderate | healing via removal of | removal of low to |
| | exudates and infectious | exudate and infectious | moderate exudates and |
| | material. | materials from low to | infectious material. |
| | Appropriate wound | moderately exuding
wound such as: | Appropriate wound |
| | types include:
- Chronic | -Chronic wound e.g. | types include:
- Chronic |
| | - Acute | Leg ulcers | - Acute |
| | - Traumatic | -Acute wounds | - Traumatic |
| | - Subacute and | -subacute and | - Subacute and |
| | dehisced wounds | dehisced wounds | dehisced wounds |
| | - Partial-thickness burns | -traumatic wounds | - Ulcers (such as |
| | - Ulcers (such as | -flaps and grafts | diabetic or pressure) |
| | diabetic or pressure) | -surgically closed | - Flaps and grafts |
| | - Flaps and grafts | incision sites. | - Closed Surgical |
| | - Closed Surgical
Incision | Avelle NPWT System | Incision |
| | | is suitable for use in a | UNO 30 is a single |
| | Genadyne UNO is a | hospital, post-acute | patient use device. |
| | single patient use | and home health | |
| | device. | environment. | |
| | | | |
| Contraindications | | | |
| | The Genadyne UNO is
contraindicated in the | Avelle NPWT System
should NOT be used in | The UNO 30 is
contraindicated in the |
| | presence of: | the following situations: | presence of: |
| | Necrotic tissue with
Eschar present | Necrotic wounds or
wounds with eschar
present. | Necrotic tissue with
Eschar present |
| - | Untreated osteomyelitis | Wounds with
confirmed and
untreated osteomyelitis | Untreated osteomyelitis |
| - | Malignancy (with
exception to enhance
quality of life) | Malignant wounds
(wound bed and/or
wound margins)
(except in palliative
care to enhance
quality of life). | Malignancy (with
exception to enhance
quality of life) |
| - | Exposed arteries, veins,
or organs | Patients who are
sensitive to, or have
known allergies to,
silicone/acrylic
adhesives, sodium
carboxymethylcellulose
or nylon. | Exposed arteries, veins,
or organs |
| - | Non-enteric and
unexplored fistulas | Non-enteric and
unexplored fistulas | Non-enteric and
unexplored fistulas |
| - | Anastomotic sites | Anastomosis sites | Anastomotic sites |
| - | Emergency airway
aspiration | For emergency airway
aspiration | Emergency airway
aspiration |
| - | Pleural, mediastinal or
chest tube drainage | Pleural, mediastinal or
chest tube drainage. | Pleural, mediastinal or
chest tube drainage |
| - | Surgical suction | 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 / Transport | | | |
| | -18°C to +43°C (0°F to
110°F) | -25 to +70 °C (-13 -
158 °F) | -18°C to +43°C (0°F to
110°F) |
| Relative Humidity | 15% to 95 % | 90% | 15% to 95 % |
| Atmospheric pressure | 700 - 1060 mbar | 700-1060 mbar | 700 - 1060 mbar |
| Operation | | | |
| | 18°C to 34°C (65°F to
94°F) | 5-40°C (41- 104°F) | 18°C to 34°C (65°F to
94°F) |
| Relative Humidity | 10% to 95 % | 15-90% | Relative Humidity 10%
to 95 % |
| Atmospheric pressure | 700 - 1060 mbar | 700 to 1060mbar | 700 - 1060 mbar
Atmospheric pressure |
5
6
7
15. Discussion of nonclinical and clinical testing
The pump hardware, dressings, and accessories are unchanged from the predicate (K180840). The pump software was updated to enable a 30-day use-life. Additional bench tests were performed and the software documentation in this submission has been assembled according to the recommendations in the FDA document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005.
The software Level of Concern has been evaluated and determined to be Moderate, and appropriate documentation is included, as recommended by the cited FDA guidance.
Bench tests including pressure precision, battery life, absorbance, and alert functionality were conducted to show that the device still functions as appropriately needed during the course of 30 days. It also showed that after 30 days, the unit does not turn on even with new sets of batteries.
-
- Conclusion & Determination of Substantial Equivalence
Based on the information presented above, it is concluded that UNO 30 Negative Pressure Wound Therapy System is substantially equivalent to its predicate device.
- Conclusion & Determination of Substantial Equivalence