(301 days)
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.
The UNO Wound Vacuum System is portable, battery powered wound suction pump with the intention to apply negative pressure to the wound.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the Genadyne UNO Negative Pressure Wound Therapy System:
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a full clinical trial. As such, detailed human clinical study data proving the device meets acceptance criteria in the same way a new drug or novel device might is not typically included in these summaries. The "acceptance criteria" here largely refer to comparison against the predicate device's characteristics and meeting relevant safety standards.
Acceptance Criteria and Reported Device Performance
The core of the "acceptance criteria" for this 510(k) submission is demonstrating that the Genadyne UNO is substantially equivalent to the predicate device, the Pico Single Use Negative Pressure Wound Therapy System (K151436), and that it meets applicable safety and performance standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Criterion | Acceptance Criteria (based on predicate or standards) | Reported Device Performance (Genadyne UNO) |
|---|---|---|
| Intended Use/Indications | Indications for negative pressure wound therapy, promoting healing via removal of low to moderate exudates and infectious material for specified wound types (chronic, acute, traumatic, subacute/dehisced, partial-thickness burns, ulcers, flaps/grafts). | "Similar" to predicate: Indicated for negative pressure wound therapy, promoting healing via removal of low to moderate exudates and infectious material for same specified wound types. Single patient use. |
| Max Vacuum | 100 mmHg (Predicate: Pico) | 125 mmHg (Higher than predicate, but within expected therapeutic range for NPWT, no new safety/effectiveness concerns indicated). |
| Battery Type | Lithium AA (L91) (Predicate: Pico) | Alkaline-Manganese Dioxide AA (QU1500) (Different type, but likely deemed equivalent in function/safety for the application). |
| Power (Battery) | 3V DC (Predicate: Pico) | 3V DC (Matches predicate) |
| Canisters | N/A (Predicate: Pico did not use separate canisters, assumed to be integrated into dressing) | Two 70 ml disposable canisters with built-in hydrophobic shut-off filter for overflow protection (A functional difference from predicate but addresses exudate management effectively). |
| Reusable | No (Predicate: Pico) | No (Matches predicate) |
| Sterility | Pump, dressing, secondary fixation strips are sterile (Predicate: Pico) | Dressings provided are sterile (Implies the pump itself might not be sterile, but the critical patient-contact components are. This is a common arrangement). |
| Dressings | Various sizes (10x20, 10x30, 15x15, 15x20) (Predicate: Pico) | A wider range of sizes (10x20, 10x30, 10x40, 15x15, 15x20, 15x30, 20x20, 20x25, 25x25) (More options, but fundamentally similar in type/function). |
| Contraindications | Same as predicate: Necrotic tissue with Eschar, untreated osteomyelitis, malignancy (except palliation), exposed arteries/veins/organs, non-enteric/unexplored fistulas, anastomotic sites, emergency airway aspiration, pleural/mediastinal/chest tube drainage, surgical suction. | "Similar" to predicate, with minor phrasing differences but substantively the same list. |
| Biocompatibility | Meet biocompatibility standards for patient-contact materials. | Dressings (silicone foam, PU film strips) met acceptance criteria for biocompatibility testing. |
| Electrical Safety/EMC | IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), UL 60601-1, Can/CSA C22.2. | Pump met acceptance criteria for all applicable IEC testing (specific clauses not detailed beyond general standards). |
| Bench Testing (Performance) | Ensure expected performance and outcome when used as a system. | Bench testing was done with in-house protocol to ensure performance and outcome. |
| Storage/Transport Temps | 5°C to +25°C (Predicate: Pico) | -18°C to +43°C (Broader range than predicate, indicating robust design for storage/transport). |
| Operation Temps | 5°C to 35°C (Predicate: Pico) | 18°C to 34°C (Slightly narrower range than predicate, but within typical clinical environment). |
Study Details:
The document primarily describes non-clinical testing to support substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for individual tests. For the non-clinical testing, sample sizes would typically refer to the number of units tested per bench test (e.g., n=3, n=5, n=10 devices). The document states "Bench testing was done with in house protocol to establish ensure the performance and outcome."
- Data Provenance: The testing appears to be prospective bench testing conducted in-house by Genadyne Biotechnologies, Inc., and potentially by third-party labs for standards compliance (e.g., biocompatibility, IEC). The country of origin for the data generation would likely be the USA, as this is a US-based company submitting to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For bench/non-clinical testing, "ground truth" is typically established by engineering specifications, recognized standards (e.g., ISO, IEC), and scientific principles, not by expert medical consensus on individual cases.
4. Adjudication method for the test set:
- This is not applicable to the type of non-clinical, bench testing described. Adjudication methods like 2+1 or 3+1 are used for reviewing patient cases, often in diagnostic studies to establish a consensus ground truth.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, where human readers (e.g., radiologists) interpret images with and without AI assistance. The Genadyne UNO is a therapeutic negative pressure wound therapy system, not a diagnostic imaging device with AI interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The Genadyne UNO is a medical device (a powered suction pump) used directly on patients for wound therapy, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is its functional operation (e.g., maintaining negative pressure, managing exudate).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing described, the "ground truth" or reference standards used would be:
- Engineering specifications for device function (e.g., vacuum pressure, battery life).
- International standards (e.g., ISO 10993 for biocompatibility, IEC 60601 series for electrical safety and electromagnetic compatibility).
- Predicate device characteristics as a benchmark for comparison.
8. The sample size for the training set:
- Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm.
Summary of Device Meeting Acceptance Criteria:
The document concludes that the Genadyne UNO meets its acceptance criteria by demonstrating substantial equivalence to the predicate device and by passing relevant safety and performance non-clinical tests.
- Biocompatibility Testing: The dressing kit (silicone foam dressing, PU film strips) met accepted criteria.
- Electrical Safety & EMC Testing: The pump successfully met acceptance criteria for all applicable IEC testing.
- Bench Testing: In-house protocols were used to ensure the device's performance and outcome were as expected.
- Design & Function Comparison: While some technical specifications differ (e.g., max vacuum, battery type, canister use), these differences are highlighted and determined not to raise new issues of safety or effectiveness. The fundamental intended use, indications, and contraindications are presented as similar to the predicate.
The basis for acceptance is that the device is as safe and effective as a legally marketed predicate device, as evidenced by these non-clinical comparisons and standard compliance.
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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.
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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
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Indications for Use
510(k) Number (if known)
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)
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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
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- 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 PressureWound Therapy System | UNO Single Patient Use NegativePressure 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 abuild-in hydrophobic shut off filter foroverflow protection |
| Reusable | No | No |
| Sterile | Pump, dressing, and secondaryfixation strips are sterile | Dressings provided are sterile |
| Accessories | ||
| 70ml Canisters | ||
| Dressings | 10cm x 20cm10cm x 30cm15cm x 15cm15cm x 20cm | 10cm x 20cm10cm x 30cm10cm x 40cm15cm x 15cm15cm x 20cm15cm 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 whowould benefit from a suction device(negative pressure wound therapy)as it may promote wound healingvia removal of low to moderatelevels of exudate and infectiousmaterials. Appropriate wound typesinclude:- Chronic- Acute- Traumatic- Subacute and dehisced wounds- Partial-thickness burns- Ulcers (such as diabetic orpressure)- Flaps and grafts- Closed surgical incisionsPICO Single Use NegativePressure Wound Therapy Systemis suitable for use in both hospitaland homecare setting | UNO is indicated for use in patientswho would benefit from negativepressure wound therapy particularly asthe device may promote wound healingby the removal of low to moderateexudates 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 graftsGenadyne UNO is a single patientuse device. | |
| Contraindications | ||
| - | The Pico is contraindicated in thepresence of : | The Genadyne UNO iscontraindicated in the presence of: |
| - | Necrotic tissue with Eschar present | Necrotic tissue with Eschar present |
| - | Previously confirmed and untreatedosteomyelitis. | Untreated osteomyelitis |
| - | malignancy in the wound bed ormargins of the wound (except inpalliative care to enhance quality oflife) | Malignancy (with exception toenhance 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 tubedrainage | Pleural, mediastinal or chest tubedrainage |
| - | 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 |
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-
- 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.
- Discussion of nonclinical and clinical testing
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.
-
- Conclusion & Determination of Substantial Equivalence
Based on the information presented above, it is concluded that the UNO is substantially equivalent to the predicate device.
- Conclusion & Determination of Substantial Equivalence
§ 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.