(168 days)
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.
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.
This document is a 510(k) Summary for the Genadyne UNO Negative Pressure Wound Therapy System, seeking FDA clearance for a modified version of an existing device (K190028). The submission focuses on demonstrating substantial equivalence to the predicate device, primarily through non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria with detailed performance metrics. Instead, it relies on demonstrating compliance with recognized electrical safety and electromagnetic compatibility standards, and on a comparison of technical specifications with a legally marketed predicate device.
However, based on the non-clinical testing mentioned and the comparison table, we can infer the acceptance criteria are met by demonstrating conformity to relevant standards and maintaining equivalent performance to the predicate device for critical specifications.
| Feature/Specification | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Passed IEC 60601-1 reports submitted |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Passed IEC 60601-1-2 reports submitted |
| Max Vacuum | 125 mmHg (matching predicate) | 125 mmHg (matches predicate) |
| Battery Type | Rechargeable Lithium Ion Battery (modified from predicate) | Lithium Ion Battery (new, tested for safety) |
| Charger | Presence of charger (new feature) | Yes, Input: 100VAC-240VAC, 50-60Hz; Output: 5V DC, 2A, 10W |
| Power Battery | 3.6V, 1700mAh (modified from predicate) | 3.6V, 1700mAh (new) |
| Dimensions | Physically compatible with intended use (modified from predicate) | 4 3/8" x 3" x 1 5/8" (modified) |
| Accessories (Canisters/Dressings) | Identical to predicate | Identical to predicate (70ml, 10cm x 10cm, etc.) |
| Reusability | Non-reusable (identical to predicate) | No (matches predicate) |
| Sterility | Dressings provided sterile (identical to predicate) | Dressings are provided Sterile (matches predicate) |
| Indications for Use | Identical to predicate | Identical to predicate |
| Contraindications | Identical to predicate | Identical to predicate |
| Storage/Transport Temperature | -18°C to +43°C (0°F to 109.4°F) (identical to predicate) | -18°C to +43°C (0°F to 109.4°F) (matches predicate) |
| Storage/Transport Relative Humidity | 15% to 95 % (identical to predicate) | 15% to 95 % (matches predicate) |
| Storage/Transport Atmospheric Pressure | 700 - 1060 mbar (identical to predicate) | 700 - 1060 mbar (matches predicate) |
| Operation Temperature | 18°C to 34°C (65°F to 93.2°F) (identical to predicate) | 18°C to 34°C (65°F to 93.2°F) (matches predicate) |
| Operation Relative Humidity | 10% to 95 % (identical to predicate) | 10% to 95 % (matches predicate) |
| Operation Atmospheric Pressure | 700 - 1060 mbar (identical to predicate) | 700 - 1060 mbar (matches predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or a specific number of devices tested for performance. The testing involved compliance with IEC standards for electrical safety and EMC. These standards typically involve a defined set of tests on representative units of the device rather than a "sample size" in the statistical sense for clinical studies. The number of devices used for these engineering tests is not disclosed.
- Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are described as "non-clinical" and implicitly prospective as they were performed on the new device model to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the submission relies solely on non-clinical testing (electrical safety, EMC) and comparison to a predicate device's specifications. There was no "ground truth" derived from expert consensus on medical images or clinical outcomes for this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as there was no clinical study with a test set requiring adjudication of findings. The assessment was based on engineering test results against established compliance standards.
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:
This information is not applicable. No MRMC comparative effectiveness study was performed as this is a Negative Pressure Wound Therapy System, not an AI-powered diagnostic imaging device. The changes relate to the pump's power source and housing, not its interaction with clinical interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This device is a Negative Pressure Wound Therapy System, which is a physical medical device, not an algorithm or software. No standalone algorithm performance was evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The concept of "ground truth" as typically understood in the context of diagnostic AI or clinical studies (e.g., pathology, expert consensus) is not applicable to this submission. The "ground truth" for the non-clinical tests would be the established requirements and limits defined by the IEC 60601-1 and IEC 60601-1-2 standards. The device's performance (e.g., maintaining 125 mmHg vacuum) is directly measured and compared against its own specifications and the predicate device's specifications.
8. The sample size for the training set:
This information is not applicable. This device is a physical medical device. It does not use machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
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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.
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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
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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)
| Residential Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart G) |
|X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K221891
510k Summary
Date Prepared: April 29, 2022
| 1. | Applicant | Genadyne Biotechnologies, Inc.16 Midland Ave,Hicksville, NY 11801T: (516) 487-87878F: (516) 487-7878www.genadyne.com |
|---|---|---|
| 2. | Registration number | 2435947 |
| 3. | Contact Person | Mr. Chien-Ming GohVice presidentandrew@genadyne.com |
| 4. | Trade/Proprietary NameIncluding Model Number ofDevice | Genadyne UNO Negative Pressure Wound TherapySystem , U-S0004, U-S0005, U-S0006 |
| 5. | Common Name or classificationof device | Powered Suction Pump (21 CFR 878.4780, ProductCode OMP) Class II |
| 6. | Address of Manufacturing Facility | 519 Johnson AveBohemia, NY 11716 |
| 7. | a. Class in which device hasbeen placed | II |
| 8. | b. Panel | General Plastic Surgery |
| 9. | c. Reason for 510(k) special | Modified plastic housing and change from batterypowered to rechargeable lithium ion batteries ofcurrent legally device |
| 10. | d. Identification of legallymarketed device whichwe claim substantialequivalence | Genadyne UNO 30 , K190028 |
| 11. | Brief Description of thedevice | The Genadyne UNO Negative Pressure WoundTherapy System is a single patient use NegativePressure Wound Therapy (NPWT) Unit designed formoderate to low severity wounds. The Genadyne UNONegative Pressure Wound Therapy System has apre-determined lifespan. The unit has an interfacepanel which provides alert and information signals andselectable therapy options. This unit provides negativepressure at either 80 mmHg or 125 mmHg, and hasselections of Continuous Mode at 80mmHg/ 30mmHgor 125mmHg / 30mmHg in Variable Mode. TheGenadyne UNO Negative Pressure Wound TherapySystem 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 useThe 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. |
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13. Comparison of subject and predicate device
| Predicate Device | Subject Device | |
|---|---|---|
| Company | GenadyneBiotechnologies, Inc. | Genadyne Biotechnologies, Inc. |
| Device Name | UNO 30 | Genadyne UNO Negative Pressure WoundTherapy System |
| 510k number | K190028 | K221891 |
| Technical data | ||
| Max Vacuum | 125 mmHg | 125 mmHg |
| Battery Type | Alkaline-ManganeseDioxide AA (QU1500) | Lithium Ion Battery |
| Charger | No | YesInput: 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 :- 70ml disposable canisterwith a built-inhydrophobic shut offfilter for overflowprotection | Contains canisters :- 70ml disposable canisterwith a built-inhydrophobic shut offfilter for overflowprotection |
| Reusable | No | No |
| Sterile | Dressings are providedSterile | Dressings are provided Sterile |
| Accessories | ||
| Dressings | 10cm x 10cm10cm x 20cm10cm x 30cm10cm x 40cm15cm x 15cm15cm x 20cm15cm x 30cm20cm x 20cm20cm x 25cm25cm x 25cm | 10cm x 10cm10cm x 20cm10cm x 30cm10cm x 40cm15cm x 15cm15cm x 20cm15cm x 30cm20cm x 20cm20cm x 25cm25cm x 25cm |
| 4 X Fixation Strips | 4 X Fixation Strips | |
| Carrying case | Carrying case | |
| Indications for Use | UNO 30 is indicated foruse in patients whowould benefit fromnegative pressurewound therapyparticularly as thedevice may promotewound healing by theremoval of low tomoderate exudates andinfectious material.Appropriate woundtypes include:- Chronic- Acute- Traumatic- Subacute anddehisced wounds- Ulcers (such asdiabetic or pressure)- Flaps and grafts- Closed SurgicalIncisionUNO 30 is a singlepatient use device. | Genadyne UNO Negative PressureWound Therapy System is indicated foruse in patients whowould benefit fromnegative pressurewound therapyparticularly as thedevice may promotewound healing by theremoval of low tomoderate exudates andinfectious material.Appropriate woundtypes include:- Chronic- Acute- Traumatic- Subacute anddehisced wounds- Ulcers (such asdiabetic or pressure)- Flaps and grafts- Closed SurgicalIncisionGenadyne UNO Negative PressureWound Therapy System is a singlepatient use device. |
| Contraindications | ||
| The UNO 30 iscontraindicated in thepresence of: | The UNO rev B iscontraindicated in thepresence of: | |
| Untreated osteomyelitis | Untreated osteomyelitis | |
| Malignancy (withexception to enhancequality of life) | Malignancy (withexception to enhancequality of life) | |
| Exposed arteries, veins,or organs | Exposed arteries, veins,or organs | |
| Non-enteric andunexplored fistulas | Non-enteric andunexplored fistulas | |
| Anastomotic sites | Anastomotic sites | |
| Emergency airwayAspiration | Emergency airwayAspiration | |
| Pleural, mediastinal orchest tube drainage | Pleural, mediastinal orchest 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 |
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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.
§ 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.