(245 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a standard wound suction pump.
Yes
The device is described as a "Negative Pressure Wound Therapy System" and its "Intended Use" is to "promote wound healing." These phrases directly indicate a therapeutic purpose.
No
The provided text describes the device as promoting wound healing by removing exudates and infectious material, and delivering negative pressure wound therapy. There is no information suggesting it diagnoses conditions or processes medical imaging for diagnostic purposes.
No
The device description explicitly states it is a "portable, battery powered wound suction pump," indicating it is a hardware device with a physical pump component.
Based on the provided information, the Genadyne UNO device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for negative pressure wound therapy to promote wound healing by removing exudates and infectious material. This is a therapeutic application, not a diagnostic one.
- Device Description: The description confirms it's a wound suction pump for delivering negative pressure therapy.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide information about a patient's health status or disease.
- Anatomical Site: The device is applied to the wound bed or margins, which is consistent with a therapeutic device for wound care.
- Performance Studies: The performance studies focus on the device's mechanical function (pressure precision, absorbance, alerts) and biocompatibility, not on diagnostic accuracy.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Genadyne UNO does not perform any such function.
N/A
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, 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.
Product codes
OMP
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.
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 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Build Correspondence
Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the agency's full name on the right. The seal features an eagle design, while the text part displays "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The logo is commonly used to represent the FDA and its role in regulating food and drugs in the United States.
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 | |||
|---|---|---|---|
| Secondary | |||
| Predicate Device | Primary | ||
| Predicate Device | New Device | ||
| Company | Smith and | ||
| Nephew | Genadyne | ||
| Biotechnologies | Genadyne | ||
| Biotechnologies | |||
| Device Name | Pico Single Use | ||
| Negative | |||
| Pressure Wound | |||
| Therapy System | Genadyne UNO | ||
| Negative Pressure | |||
| Wound Therapy | Genadyne UNO | ||
| Negative Pressure | |||
| Wound Therapy | |||
| System | |||
| 510 (K) Number | K151436 | K161599 | K180840 |
| Technical Data | |||
| Max Vacuum | 100 mmHg | 125 mmHg | 125 mmHg |
| Battery Type | Lithium AA (L91) | Alkaline- | |
| Manganese | |||
| Dioxide AA | |||
| (QU1500) | Alkaline- | ||
| Manganese | |||
| Dioxide AA | |||
| (QU1500) | |||
| Power (Battery) | 3V DC | 3V DC | 3V DC |
| Dimensions / | |||
| Weight | 3.5" x 3.5" x 1.0" / |