(172 days)
No
The summary describes a standard wound vacuum system and does not mention any AI or ML capabilities.
Yes
The device is indicated for promoting wound healing by removing excess exudates, infectious material, and tissue debris, which are therapeutic actions.
No
The device description states its intention is "to generate negative pressure to remove exudate from the wound," indicating a therapeutic function (wound healing by removal of material) rather than a diagnostic one (identifying disease or condition).
No
The device description explicitly states it is a "portable, rechargeable battery powered wound suction pump," indicating it is a hardware device with a physical pump component.
Based on the provided information, the XLR8 Plus (XLR8+) Wound Vacuum System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- XLR8 Plus Function: The description clearly states the XLR8 Plus is a "wound suction pump" that generates negative pressure to "remove exudate from the wound." This is a therapeutic device that acts directly on the wound, not a device that analyzes specimens taken from the body.
- Intended Use: The intended use is to "promote wound healing by the removal of excess exudates, infectious material and tissue debris," which is a therapeutic action, not a diagnostic one.
Therefore, the XLR8 Plus falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The XLR8 Plus (XLR8+) Wound Vacuum 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 excess exudates, infectious material and tissue debris.
Product codes
OMP
Device Description
The XLR8 Plus (XLR8+) Wound Vacuum System is a portable, rechargeable battery powered wound suction pump with the intention to generate negative pressure to remove exudate from 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Genadyne Biotechnologies Incorporated Chien-Ming Goh Vice President, Regulatory Affairs 16 Midland Avenue Hicksville, New York 11801
Re: K143726
Trade/Device Name: Genadyne XLR8 Plus (XLR8+) Negative Pressure Wound Therapy Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: May 14, 2015 Received: May 18, 2015
Dear Chien-Ming 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
1
device-related 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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K143726
Device Name
Genadyne XLR8 Plus (XLR8+) Negative Pressure Wound Therapy
Indications for Use (Describe)
The XLR8 Plus (XLR8+) Wound Vacuum 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 excess exudates, infectious material and tissue debris.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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) 516.217.0101 (f) 516.977.8974
Contact Person: Mr. Chien-Ming GOH (Andrew)
Date Prepared: December 23, 2014
Name of Device
XLR8 Plus (XLR8+) Neqative Pressure Wound Therapy
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
A4-XLR8 Wound Vacuum System, K090638
Device Description
The XLR8 Plus (XLR8+) Wound Vacuum System is a portable, rechargeable battery powered wound suction pump with the intention to generate negative pressure to remove exudate from the wound.
Intended Use / Indications for Use
The XLR8 Plus (XLR8 +) Wound Vacuum 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 excess exudates, infectious material and tissue debris.
4
Technological Characteristics
| Comparative Information | ||
|---|---|---|
| Predicate Device | New Device | |
| Company | Genadyne Biotechnologies | Genadyne Biotechnologies |
| Device Name | A4-XLR8 Wound Vacuum | |
| System | XLR8 Plus (XLR8+) Wound Vacuum | |
| System | ||
| 510 (K) Number | K090638 | |
| Technical Data | ||
| Suction Capacity | 3.5 liters per minute | > 5 liters per minute |
| Max Vacuum | 230 mmHg | 230 mmHg |
| Power Requirements | 30W | 30W |
| Battery Type | Rechargeable Li-Ion | Rechargeable Li-Ion |
| Dimensions / Weight | 5.9" x 4" x 2.4" / 1.5 lbs | 5.9" x 4" x 3.4" / 1.65 lbs |
| Accessories | ||
| Canisters | 200, 400, 600, 800 ml | |
| disposable canister with a | ||
| build-in hydrophobic shut off | ||
| filter for overflow protection | 200, 400, 600, 800 & 1100 ml | |
| disposable canister with a build-in | ||
| hydrophobic shut off filter for overflow | ||
| protection | ||
| Reusable | No | No |
| Non Sterile | ||
| Sterile | Non Sterile | |
| Accessory Kit | ||
| A4-XLR8 Foam Dressing | ||
| (K092992) | A4-XLR8 Foam Dressing (K092992) | |
| XLR8 Bridge Dressing | ||
| XLR8 Port Pad | ||
| XLR8 Transparent Film | ||
| Gauze Dressing with Silicone Drain | ||
| Gauze Dressing with XLR8 Port Pad | ||
| Indications for Use | ||
| Genadyne A4-XLR8 Wound | ||
| Vacuum System is indicated | ||
| for use in patients who would | ||
| benefit from negative pressure | ||
| wound therapy particularly as | ||
| the device may promote wound | Genadyne XLR8 Plus Wound | |
| Vacuum 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 | ||
| healing by the removal of | ||
| excess exudates, infectious | ||
| material and tissue debris. | removal of excess exudates. | |
| infectious material and tissue debris. | ||
| Contraindications | ||
| The Genadyne A4-XLR8 is | ||
| contraindicated in the presence | ||
| of : | The Genadyne XLR8 Plus is | |
| contraindicated in the presence of: | ||
| - | Necrotic tissue | Necrotic tissue |
| - | Untreated osteomyelitis | Untreated osteomyelitis |
| - | Malignancy (with exception to | |
| enhance quality of life) | Malignancy (with exception to | |
| enhance quality of life) | ||
| - | Untreated malnutrition | Untreated malnutrition |
| - | Exposed arteries, veins, or | |
| organs | Exposed arteries, veins, or organs | |
| Precautions | ||
| Precautions should be taken | ||
| for patients who are or may be: | Precautions should be taken for | |
| patients who are or may be: | ||
| - | Receiving anticoaqulant | |
| therapy | Receiving anticoaqulant therapy | |
| - | Suffering from difficult | |
| hemostasis | Suffering from difficult hemostasis | |
| - | Untreated for malnutrition | Untreated for malnutrition |
| - | Non-complaint or combative | Non-complaint or combative |
| Compliance | ||
| IEC 60601-1, 3rd Edition | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| Storage / Transport | ||
| -18°C to +43°C (0°F to 110°F) | -18°C to +43°C (0°F to 110°F) | |
| Relative Humidity 10% to 95 % | Relative Humidity 10% to 95 % | |
| 700 - 1060 mbar Atmospheric | ||
| pressure | 700 - 1060 mbar Atmospheric | |
| pressure | ||
| Operation | 18°C to 34°C (65°F to 94°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 |
Table of Comparison to Predicate Devices:
5
Conclusion & 15. Determination of Substantial Equivalence Based on the information presented above, it is concluded that the XLR8 Plus (XLR8+) is substantially equivalent to the predicate device.