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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the UNO 30 device:

The provided text is a 510(k) Premarket Notification for the UNO 30, a Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to predicate devices, rather than a novel claim requiring extensive clinical trials or an AI's performance evaluation. Therefore, the information you're asking for, particularly concerning AI performance metrics, clinical study design, and expert adjudication, is not present in this document. The device is a physical medical device (pump, dressings, canister), not an AI-powered diagnostic or assistive tool.

However, I can extract the relevant information available for the device as described.

Acceptance Criteria and Device Performance (Based on "Technological Characteristics" and "Discussion of nonclinical and clinical testing" sections)

This document doesn't present "acceptance criteria" in the typical sense of performance thresholds for an AI or diagnostic device. Instead, it focuses on demonstrating that the UNO 30 maintains similar technical characteristics and safety/effectiveness as its predicate devices, primarily the Genadyne UNO (K180840) with an extended use-life.

The key "performance" aspect evaluated here is the extended device lifespan to 30 days while maintaining the functionality of the predicate.

1. A table of acceptance criteria and the reported device performance

Characteristic	Acceptance Criteria (Implied by Predicate & Device Purpose)	Reported Device Performance (UNO 30)
Max Vacuum	Comparable to predicate (125 mmHg or 144 mmHg)	125 mmHg
Battery Type	Alkaline-Manganese Dioxide AA (QU1500)	Alkaline-Manganese Dioxide AA (QU1500)
Power (Battery)	3V DC	3V DC
Dimensions / Weight	3" x 4.4" x 2.4" / 400g	3" x 4.4" x 2.4" / 400g
Device Lifespan	Extended from 7 days (primary predicate) to 30 days (secondary predicate)	30 days (Bench tests confirmed functionality for 30 days and unit shutdown after 30 days)
Software Level of Concern	Moderate (per FDA guidance)	Moderate (appropriate documentation included)
Pressure Precision	Functional during 30-day use-life	Bench tested and verified as functioning appropriately during the course of 30 days.
Battery Life	Functional during 30-day use-life	Bench tested and verified as functioning appropriately during the course of 30 days. Unit does not turn on even with new batteries after 30 days.
Absorbance	Functional during 30-day use-life	Bench tested and verified as functioning appropriately during the course of 30 days.
Alert Functionality	Functional during 30-day use-life	Bench tested and verified as functioning appropriately during the course of 30 days.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes bench testing, not a clinical study involving patients or data sets. Therefore, there's no "sample size for the test set" in the context of patient data, nor a country of origin for such data. The tests were performed on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical pump, not an AI or diagnostic tool requiring ground truth established by experts for performance evaluation. The "ground truth" here is the expected physical performance of the device (e.g., maintaining pressure, battery life, proper shutdown).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As this is bench testing of a physical device, there's no expert adjudication involved in the sense of reviewing outputs or diagnoses.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is about a physical NPWT device, not an AI or diagnostic tool. No MRMC study was performed, and thus no effect size related to AI assistance is provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI. The software component mentioned is for device control and functionality, not for standalone diagnostic or assistive performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the bench tests was the engineering specifications and expected functional performance of the device (e.g., a pressure reading close to 125 mmHg, battery lasting for a certain duration, a specific alert triggering correctly). This is based on established engineering principles and the device's design requirements.

8. The sample size for the training set

Not applicable. There is no AI or machine learning model that requires a "training set" described in this document.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI model.

Summary

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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

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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/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)

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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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

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Intended Use / Indications for Use

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 PredicateDevice	Secondary PredicateDevice	Proposed Device
Company	GenadyneBiotechnologies	ConvaTec Limited	GenadyneBiotechnologies
Device Name	Genadyne UNONegative PressureWound Therapy System	Avelle NegativePressure WoundTherapy	UNO 30
510 (K) Number	K180840	K180205	K190028
Technical Data
Max Vacuum	125 mmHg	144 mmHg	125 mmHg
Battery Type	Alkaline-ManganeseDioxide AA (QU1500)	Lithium Batteries	Alkaline-ManganeseDioxide 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:- 70ml disposable canisterwith a build-inhydrophobic shut offfilter for overflowprotection	Contains absorbentwound dressing whichis connected via tubingand luer lock fittingsand adhesive fixationstrips.Does not contain acanister.	Contains canisters :- 70ml disposable canisterwith a build-inhydrophobic shut offfilter for overflowprotection
Reusable	No	No	No

Sterile	Dressings are providedsterile	Dressings are providedsterile	Dressings provided aresterile


Accessories
Dressings	10cm x 10cm	12cm x 41cm	10cm x 10cm
	10cm x 20cm10cm x 30cm	12cm x 31cm12cm x 21cm	10cm x 20cm10cm 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 isindicated for use inpatients who would	The Avelle NPWTSystem is indicated foruse on patients that	UNO 30 is indicated foruse in patients whowould 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 exudingwound 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 SurgicalIncision	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 iscontraindicated in the	Avelle NPWT Systemshould NOT be used in	The UNO 30 iscontraindicated in the
	presence of:	the following situations:	presence of:
	Necrotic tissue withEschar present	Necrotic wounds orwounds with escharpresent.	Necrotic tissue withEschar present
-	Untreated osteomyelitis	Wounds withconfirmed anduntreated osteomyelitis	Untreated osteomyelitis
-	Malignancy (withexception to enhancequality of life)	Malignant wounds(wound bed and/orwound margins)(except in palliativecare to enhancequality of life).	Malignancy (withexception to enhancequality of life)
-	Exposed arteries, veins,or organs	Patients who aresensitive to, or haveknown allergies to,silicone/acrylicadhesives, sodiumcarboxymethylcelluloseor nylon.	Exposed arteries, veins,or organs
-	Non-enteric andunexplored fistulas	Non-enteric andunexplored fistulas	Non-enteric andunexplored fistulas
-	Anastomotic sites	Anastomosis sites	Anastomotic sites
-	Emergency airwayaspiration	For emergency airwayaspiration	Emergency airwayaspiration
-	Pleural, mediastinal orchest tube drainage	Pleural, mediastinal orchest tube drainage.	Pleural, mediastinal orchest 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 to110°F)	-25 to +70 °C (-13 -158 °F)	-18°C to +43°C (0°F to110°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 to94°F)	5-40°C (41- 104°F)	18°C to 34°C (65°F to94°F)
Relative Humidity	10% to 95 %	15-90%	Relative Humidity 10%to 95 %
Atmospheric pressure	700 - 1060 mbar	700 to 1060mbar	700 - 1060 mbarAtmospheric pressure

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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.

1. 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.

Regulation Number and Section

§ 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.