(245 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, Closed surgical incision. Genadyne UNO is a single patient use device.
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.
This looks like a 510(k) premarket notification for a medical device. Based on the provided text, here's a breakdown of the acceptance criteria and study information for the Genadyne UNO Negative Pressure Wound Therapy System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly list "acceptance criteria" for performance tests in a tabular format with corresponding reported values. Instead, it states that "The results were within the acceptable limit of the criteria that were set prior the experiment." However, based on the non-clinical testing discussion, we can infer the types of performance aspects tested.
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Pressure Precision | "Results were within the acceptable limit" |
| Absorbance | "Results were within the acceptable limit" |
| Alert Functionality | "Results were within the acceptable limit" |
| Biocompatibility | "The data and results show that the device is biocompatible." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "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."
- Sample Size for Test Set: 15 patients
- Data Provenance: Not explicitly stated, but clinical case series generally imply prospective or retrospective data from a clinical setting.
- Retrospective/Prospective: Not specified, but "case series" can be either.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The document refers to a "clinical case series" as "supplementary performance data," but it does not describe how the outcomes for these 15 patients were adjudicated or evaluated by experts to establish a 'ground truth' for device performance in the context of an AI/algorithm. This device is a physical pump, not an AI diagnostic tool, therefore, the concept of "ground truth" as typically applied to image analysis or diagnostic algorithms doesn't directly apply in the same way. The "ground truth" here would relate to the patient's actual wound healing and safety outcomes, which would likely have been determined by the treating clinicians.
4. Adjudication Method for the Test Set
Not applicable/Not provided. As noted above, this isn't an AI diagnostic device where expert adjudication of outputs would typically be required. The "clinical case series" would involve patient follow-up and clinical assessment by healthcare professionals.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving image interpretation where multiple readers evaluate cases with and without AI assistance). The Genadyne UNO is a Negative Pressure Wound Therapy System, which is a therapeutic device, not a diagnostic one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The Genadyne UNO is a physical medical device (a powered suction pump for wound therapy), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The Type of Ground Truth Used
For the clinical case series, the "ground truth" would be the clinical outcomes observed in the 15 patients regarding wound healing, removal of exudates/infectious material, and absence of adverse events associated with the device's use. This would be based on clinical assessment and patient follow-up by healthcare professionals. For the bench tests, the ground truth would be based on objective measurements of physical parameters (pressure, absorbance, alert function) against predefined engineering specifications.
8. The Sample Size for the Training Set
Not applicable. As the Genadyne UNO is a physical medical device and not an AI/Machine Learning algorithm, there is no "training set." The device's performance is established through bench testing and clinical observations, not through a learning process from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: Andrew@genadyne.com; SwaraV@genadyne.com (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 | |||
|---|---|---|---|
| SecondaryPredicate Device | PrimaryPredicate Device | New Device | |
| Company | Smith andNephew | GenadyneBiotechnologies | GenadyneBiotechnologies |
| Device Name | Pico Single UseNegativePressure WoundTherapy System | Genadyne UNONegative PressureWound Therapy | Genadyne UNONegative PressureWound TherapySystem |
| 510 (K) Number | K151436 | K161599 | K180840 |
| Technical Data | |||
| Max Vacuum | 100 mmHg | 125 mmHg | 125 mmHg |
| Battery Type | Lithium AA (L91) | Alkaline-ManganeseDioxide AA(QU1500) | Alkaline-ManganeseDioxide AA(QU1500) |
| Power (Battery) | 3V DC | 3V DC | 3V DC |
| Dimensions /Weight | 3.5" x 3.5" x 1.0" /<120g | 3" x 4.4" x 2.4" /400g | 3" x 4.4" x 2.4" /400g |
| Device Lifespan | 7 days | 24 hours | 7 days |
| Accessories | |||
| Canisters | N/A | Two 70 mldisposablecanister with abuild-in | Two 70 mldisposablecanister with abuild-in |
| hydrophobic shutoff filter foroverflow protection | hydrophobic shutoff filter foroverflow protection | ||
| Reusable | No | No | No |
| Sterile | Dressings areprovided sterile | Dressingsprovided aresterile | Dressingsprovided aresterile |
| Accessories | |||
| Dressings | 10cm x 20cm10cm x 30cm15cm x 15cm15cm x 20cm | 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 |
| Fixation StripsCarrying Case | 4 x Fixation StripsCarrying Case | 4 x Fixation StripsCarrying Case | |
| Indications forUse | |||
| PICO is indicatedfor patients whowould benefitfrom a suctiondevice (negativepressure woundtherapy) as it maypromote woundhealing viaremoval of low tomoderate levelsof exudate andinfectiousmaterials.Appropriatewound typesinclude:- Chronic- Acute- Traumatic- Subacute anddehisced wounds- Partial-thicknessburns | Genadyne UNO isindicated for use inpatients whowould benefit fromnegative pressurewound therapyparticularly as thedevice maypromote woundhealing by theremoval of low tomoderateexudates andinfectious material.Appropriate woundtypes include:- Chronic- Acute- Traumatic- Subacute anddehisced wounds- Partial-thicknessburns - Ulcers(such as diabeticor pressure)- Flaps and grafts | Genadyne UNO isindicated for use inpatients whowould benefit fromnegative pressurewound therapyparticularly as thedevice maypromote woundhealing by theremoval of low tomoderateexudates andinfectious material.Appropriate woundtypes include:- Chronic- Acute- Traumatic- Subacute anddehisced wounds- Partial-thicknessburns- Ulcers (such asdiabetic orpressure) | |
| - Ulcers (such asdiabetic orpressure)- Flaps and grafts- Closed surgicalincisionsPICO Single UseNegativePressure WoundTherapy Systemis suitable for usein both hospitaland homecaresetting | Genadyne UNO isa single patientuse device. | - Flaps and grafts- Closed SurgicalIncisions.Genadyne UNO isa single patientuse device. | |
| Contraindications | |||
| The Pico iscontraindicated inthe presence of : | The GenadyneUNO iscontraindicated inthe presence of: | The GenadyneUNO iscontraindicated inthe presence of: | |
| Necrotic tissuewith Escharpresent | Necrotic tissuewith Escharpresent | Necrotic tissuewith Escharpresent | |
| Previouslyconfirmed anduntreatedosteomyelitis. | Untreatedosteomyelitis | Untreatedosteomyelitis | |
| malignancy in thewound bed ormargins of thewound (except inpalliative care toenhance qualityof life) | Malignancy (withexception toenhance quality oflife) | Malignancy (withexception toenhance quality oflife) | |
| Exposed arteries,veins, or organs | Exposed arteries,veins, or organs | Exposed arteries,veins, or organs | |
| Non-enteric andunexploredfistulas | Non-enteric andunexplored fistulas | Non-enteric andunexplored fistulas | |
| - | Anastomotic sites | Anastomotic sites | Anastomotic sites |
| - | Emergencyairway aspiration | Emergency airwayaspiration | Emergency airwayaspiration |
| - | Pleural,mediastinal orchest tubedrainage | Pleural,mediastinal orchest tubedrainage | Pleural,mediastinal orchest tubedrainage |
| - | 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) | 5°C to +25°C(41°F to 77°F) | -18°C to +43°C(0°F to 110°F) |
| Relative Humidity10% to 95 % | Relative Humidity10% to 75 % | Relative Humidity10% to 95 % | |
| 700 – 1060 mbarAtmosphericpressure | 700 - 1060 mbarAtmosphericpressure | 700 – 1060 mbarAtmosphericpressure | |
| Operation | 18°C to 34°C(65°F to 94°F) | 5°C to 35°C (41°Fto 95°F) | 18°C to 34°C(65°F to 94°F) |
| Relative Humidity10% to 95 % | Relative Humidity10% to 95 % | Relative Humidity10% to 95 % | |
| 700 - 1060 mbarAtmosphericpressure | 700 - 1060 mbarAtmosphericpressure | 700 - 1060 mbarAtmosphericpressure |
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.
-
- Conclusion & Based on the information presented above, it is Determination of concluded that the UNO is substantially equivalent to Substantial Equivalence the 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.