(172 days)
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.
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.
This document describes a 510(k) premarket notification for the Genadyne XLR8 Plus (XLR8+) Negative Pressure Wound Therapy device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a novel device or a PMA.
Therefore, the typical metrics and study designs associated with proving a device meets specific acceptance criteria via a study (especially for AI/ML-driven devices with performance metrics like sensitivity, specificity, or AUC) are not present in this document. The "acceptance criteria" here are primarily met by demonstrating comparable performance and characteristics to the predicate device.
Here's an analysis based on the provided text, addressing your points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are implicitly defined by the characteristics of the predicate device (A4-XLR8 Wound Vacuum System, K090638). The new device, XLR8 Plus, aims to be substantially equivalent. The table provided is a comparative table, not a pure acceptance criteria table with a "pass/fail" for an independent study.
Acceptance Criteria (Implied by Predicate Performance) and Reported Device Performance:
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (New Device) |
|---|---|---|
| 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 |
| Canister Sizes | 200, 400, 600, 800 ml | 200, 400, 600, 800 & 1100 ml |
| Reusable | No | No |
| Sterile | Non Sterile | Non Sterile |
| Indications for Use | Substantially similar | Substantially similar |
| Contraindications | Identical list | Identical list |
| Precautions | Identical list | Identical list |
| Compliance | IEC 60601-1, 3rd Edition | IEC 60601-1, IEC 60601-1-2 |
| Storage/Transport | -18°C to +43°C, 10-95% RH, 700-1060 mbar | Identical |
| Operation | 18°C to 34°C, 10-95% RH, 700-1060 mbar | Identical |
Note: For the 510(k) process, the new device can be better than the predicate in some aspects (like suction capacity or additional canister size) as long as it doesn't raise new questions of safety or effectiveness.
2. Sample Size for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the context of an AI/ML device validating performance on a dataset of patient cases. The testing conducted for this device is focused on engineering verification and validation (e.g., measuring suction, power, verifying dimensions, and confirming compliance with electrical safety standards). These tests are typically performed on a small number of production or pre-production units.
- Sample Size: Not specified in terms of patient data or clinical cases, as this is not an AI/ML driven device requiring such clinical validation. Laboratory (bench) testing of the device itself would likely involve a small number of units (e.g., 3-10).
- Data Provenance: Not applicable in the context of patient data. The provenance for the device's technical specifications would be from internal engineering and manufacturing. This is a physical medical device, not a software device processing patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a negative pressure wound therapy system, not an imaging analysis or diagnostic AI/ML device requiring expert interpretation for ground truth establishment.
4. Adjudication Method
Not applicable. There is no expert review or adjudication process outlined for this type of device submission. Performance is based on engineering specifications and bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML diagnostic or assistive device that would participate in an MRMC study to compare human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance
Not applicable. This is a physical medical device, not a standalone algorithm.
7. Type of Ground Truth Used
Not applicable. Ground truth for an AI/ML context doesn't apply here. The "truth" for this device lies in its adherence to engineering specifications, safety standards, and functional performance metrics (like creating negative pressure). Bench testing and electrical safety compliance form the basis of "truth."
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, no training set for an AI/ML model is involved.
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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
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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.
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Technological Characteristics
| Comparative Information | ||
|---|---|---|
| Predicate Device | New Device | |
| Company | Genadyne Biotechnologies | Genadyne Biotechnologies |
| Device Name | A4-XLR8 Wound VacuumSystem | XLR8 Plus (XLR8+) Wound VacuumSystem |
| 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 mldisposable canister with abuild-in hydrophobic shut offfilter for overflow protection | 200, 400, 600, 800 & 1100 mldisposable canister with a build-inhydrophobic shut off filter for overflowprotection |
| Reusable | No | No |
| Non Sterile | ||
| Sterile | Non Sterile | |
| Accessory Kit | ||
| A4-XLR8 Foam Dressing(K092992) | A4-XLR8 Foam Dressing (K092992)XLR8 Bridge DressingXLR8 Port PadXLR8 Transparent FilmGauze Dressing with Silicone DrainGauze Dressing with XLR8 Port Pad | |
| Indications for Use | ||
| Genadyne A4-XLR8 WoundVacuum System is indicatedfor use in patients who wouldbenefit from negative pressurewound therapy particularly asthe device may promote wound | Genadyne XLR8 Plus WoundVacuum System is indicated for usein patients who would benefit fromnegative pressure wound therapyparticularly as the device maypromote wound healing by the | |
| healing by the removal ofexcess exudates, infectiousmaterial and tissue debris. | removal of excess exudates.infectious material and tissue debris. | |
| Contraindications | ||
| The Genadyne A4-XLR8 iscontraindicated in the presenceof : | The Genadyne XLR8 Plus iscontraindicated in the presence of: | |
| - | Necrotic tissue | Necrotic tissue |
| - | Untreated osteomyelitis | Untreated osteomyelitis |
| - | Malignancy (with exception toenhance quality of life) | Malignancy (with exception toenhance quality of life) |
| - | Untreated malnutrition | Untreated malnutrition |
| - | Exposed arteries, veins, ororgans | Exposed arteries, veins, or organs |
| Precautions | ||
| Precautions should be takenfor patients who are or may be: | Precautions should be taken forpatients who are or may be: | |
| - | Receiving anticoaqulanttherapy | Receiving anticoaqulant therapy |
| - | Suffering from difficulthemostasis | 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 Atmosphericpressure | 700 - 1060 mbar Atmosphericpressure | |
| 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 Atmosphericpressure | 700 - 1060 mbar Atmosphericpressure |
Table of Comparison to Predicate Devices:
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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.
§ 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.