← Product Code [OMP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP) · K141437
# XLR8 PLUS (XLR8+) (K141437)
_Genadyne Biotechnologies, Inc. · OMP · Sep 19, 2014 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K141437
## Device Facts
- **Applicant:** Genadyne Biotechnologies, Inc.
- **Product Code:** [OMP](/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP.md)
- **Decision Date:** Sep 19, 2014
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 878.4780
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
- **Attributes:** Therapeutic
## 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.
## Device Story
Portable, rechargeable battery-powered wound suction pump; delivers negative pressure to wound site. Modification of A4-XLR8 system; identical internal components. Features LCD screen, membrane control buttons, continuous and variable intermittent therapy modes. Alerts for leakage, blockage, full canister, low battery. Used in clinical or home settings; operated by healthcare providers or patients. Removes exudates, infectious material, and tissue debris to promote wound healing. Healthcare providers monitor wound status and device performance via alerts and visual interface.
## Clinical Evidence
Bench testing only. No clinical data presented. Substantial equivalence established through comparative technical specifications and performance testing against the predicate device.
## Technological Characteristics
Powered suction pump; rechargeable Li-Ion battery; 3.5 L/min suction capacity; 230 mmHg max vacuum. Dimensions: 5.9" x 4" x 3.4"; Weight: 1.65 lbs. Connectivity: None. Sterilization: Non-sterile. Standards: IEC 60601-1 (3rd Ed), IEC 60601-1-2. User interface: LCD screen and membrane overlay buttons.
## Regulatory 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.
## Predicate Devices
- A4-XLR8 Wound Vacuum System ([K090638](/device/K090638.md))
## Reference Devices
- A4-XLR8 Foam Dressing ([K092992](/device/K092992.md))
## Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a stylized image of three faces in profile. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the central emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
Genadyne Biotechnologies Incorporated Mr. Chien-Ming Goh Vice Presdient 16 Midland Avenue Hicksville, New York 11801
Re: K141437
Trade/Device Name: Genadyne XLR8 Plus (XLR8+) Wound Vacuum System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP Dated: August 19, 2014 Received: August 21, 2014
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
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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): K141437
Device Name: Genadyne XLR8 Plus (XLR8+) Wound Vacuum System
#### 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.
Prescription Use × (Per 21 CFR 801 Subpart D)
OR
Over-The Counter Use (21 CFR 807 Subpart C)
### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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### Special 510k Summary
# General Information
# Date: May 28, 2014
| 1. | Applicant | Genadyne Biotechnologies, Inc.
16 Midland Ave,
Hicksville, NY 11801
(t) 516.487.8787
(f) 516.977-8974 |
|-----|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact Person | Mr. Chien-Ming GOH (Andrew)
Vice President
Genadyne Biotechnologies Inc.
16 Midland Ave,
Hicksville, NY 11801
(t) 516.217.0101
(f) 516.977.8974 |
| 3. | Trade Name | XLR8 Plus (XLR8+) Wound Vacuum System
(Ref: A4-S0003) |
| 4. | Common Name | Powered Suction Pump |
| 5. | Classification Name | Negative Pressure Wound Therapy Powered
Suction Pump |
| 6. | Regulation Number | 21 CFR 878.4780 |
| 7. | Product Code | OMP |
| 8. | Class in which Device has
been placed | Class II |
| 9. | Panel | General & Plastic Surgery |
| 10. | Reason for Premarket
Notification | New Device |
| 11. | Identification of Legally
Marketed Device Which We
Can Claim Substantial
Equivalence (Predicate
Device) | A4-XLR8 Wound Vacuum System
K090638 |
| 12. | Brief Description of Device | The XLR8 Plus (XLR8+) Wound Vacuum System is
portable, rechargeable battery powered wound
suction pump with the intention to deliver negative
pressure to the wound. The XLR8 Plus (XLR8 +) is
a modification to the existing A4-XLR8 wound
vacuum system with exactly the same internal
components and accessories. |
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#### 13. Indications for use [21 CFR 807.92(a)(5)]
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.
#### 14. Technological Characteristics
Everything in the XLR8 Plus (XLR8+) Wound Vacuum System is exactly the same as the predicate device, the A4-XLR8 Wound Vacuum System, with the exception of an increment in depth of 1" to the back cover housing. The XLR8+ is a lightweight, portable wound suction device. It has a rechargeable battery, LCD screen for clear viewing, membrane overlay with buttons to control the device. It has 2 therapy options, continuous therapy and variable intermittent therapy. It consists of 5 alerts to notify the users of unwanted events, i.e. leakage in the dressing, blockage in the tubing, canister is full, low battery status.
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| Comparative Information | | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Predicate Device | New Device |
| Company | Genadyne Biotechnologies | Genadyne Biotechnologies |
| | A4-XLR8 Wound Vacuum | XLR8 Plus (XLR8+) Wound |
| Device Name | System | Vacuum System |
| 510 (K) Number | K090638 | |
| | | |
| Technical Data | | |
| Suction Capacity | 3.5 liters per minute | 3.5 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 ml disposable
canister with a build-in hydrophobic
shut off filter for overflow protection |
| Reusable | No | No |
| | | |
| Sterile | Non Sterile | Non Sterile |
| | | |
| Accessory Kit | | |
| | A4-XLR8 Foam Dressing
(K092992) | A4-XLR8 Foam Dressing
(K092992) |
| | | |
| 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
healing by the removal of excess
exudates, infectious material and
tissue debris. | 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
removal of excess exudates,
infectious material and tissue
debris. |
| | | |
| Contraindications | | |
| | The Genadyne A4-XLR8 is | The Genadyne XLR8 Plus is |
| | contraindicated in the presence of : | 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 anticoagulant therapy | Receiving anticoagulant 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, 3rd Edition |
| 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 |
| Additional Testing | | |
| | IEC 60601-1-2 | IEC 60601-1-2 |
Table of Comparison to Predicate Devices:
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#### 15. Conclusion & 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.
---
**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K141437](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/OMP/K141437)
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