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 Description

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. 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.

AI/ML Overview

The provided text is a 510(k) summary for the Genadyne XLR8 Plus (XLR8+) Wound Vacuum System, seeking substantial equivalence to a predicate device. This type of document focuses on demonstrating that a new device is as safe and effective as a legally marketed device, rather than rigorously proving performance against pre-defined acceptance criteria through extensive studies in the way an AI/ML device submission might.

Therefore, the information required for acceptance criteria and the study proving it typically found in AI/ML device descriptions is not present in this document. This document details a special 510(k), which implies minor modifications to an existing device, and thus relies heavily on the equivalence of the modified device to the predicate device, rather than new performance studies.

Here's a breakdown of why each requested point cannot be fully addressed by this document:

A table of acceptance criteria and the reported device performance: This document doesn't define quantitative acceptance criteria for performance in the way an AI/ML device would (e.g., sensitivity, specificity, AUC). Instead, it compares technical characteristics and intended use to a predicate device. The "performance" reported is essentially that it matches the predicate.

Table based on available comparative information (technical characteristics):

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (XLR8 Plus)
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	5.9" x 4" x 2.4"	5.9" x 4" x 3.4" (larger depth)
Weight	1.5 lbs	1.65 lbs
Canister Sizes	200, 400, 600, 800 ml	200, 400, 600, 800 ml
Reusable	No	No
Sterile	Non Sterile	Non Sterile
Indications for Use	Matches predicate	Matches predicate
Contraindications	Matches predicate	Matches predicate
Precautions	Matches predicate	Matches predicate
Compliance (Standards)	IEC 60601-1, IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2
Storage/Transport Temp	-18°C to +43°C	-18°C to +43°C
Storage/Transport RH	10% to 95%	10% to 95%
Storage/Transport Atm	700 - 1060 mbar	700 - 1060 mbar
Operation Temp	18°C to 34°C	18°C to 34°C
Operation RH	10% to 95%	10% to 95%
Operation Atm	700 - 1060 mbar	700 - 1060 mbar

Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No test set sample size or data provenance is mentioned. The device's substantial equivalence is primarily based on comparisons of its technical specifications to the predicate device, not on new clinical performance data from a test set. This is a common approach for "Special 510(k)" submissions for minor modifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set requiring expert-established ground truth for the performance claims.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As there's no mention of a test set requiring ground truth, no adjudication method is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a wound vacuum system, not an AI/ML imaging or diagnostic device. There is no concept of "human readers" or "AI assistance" in its function.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the context of clinical validation for AI/ML devices is not relevant here. The "truth" for this submission is that its physical and functional characteristics are substantially equivalent to the predicate.
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML.
How the ground truth for the training set was established: Not applicable.

Summary of the Study (as described in the document):

The "study" or justification for substantial equivalence is a comparison of technological characteristics and indications for use between the new device (XLR8 Plus) and its predicate device (A4-XLR8). The document emphasizes that "Everything in the XLR8 Plus (XLR8+) Wound Vacuum System is exactly the same as the predicate device... with the exception of an increment in depth of 1" to the back cover housing." This suggests that the "study" was primarily an engineering and design comparison, demonstrating that the minor physical change does not alter the fundamental safety and effectiveness or performance parameters of the device. The compliance with electrical safety standards (IEC 60601-1, IEC 60601-1-2) for both devices further supports this claim of equivalence.

Summary

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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:

Prescription Use × (Per 21 CFR 801 Subpart D)

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 PresidentGenadyne 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 PoweredSuction Pump
6.	Regulation Number	21 CFR 878.4780
7.	Product Code	OMP
8.	Class in which Device hasbeen placed	Class II
9.	Panel	General & Plastic Surgery
10.	Reason for PremarketNotification	New Device
11.	Identification of LegallyMarketed Device Which WeCan Claim SubstantialEquivalence (PredicateDevice)	A4-XLR8 Wound Vacuum SystemK090638
12.	Brief Description of Device	The XLR8 Plus (XLR8+) Wound Vacuum System isportable, rechargeable battery powered woundsuction pump with the intention to deliver negativepressure to the wound. The XLR8 Plus (XLR8 +) isa modification to the existing A4-XLR8 woundvacuum system with exactly the same internalcomponents 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 mldisposable canister with a build-in hydrophobic shut off filter foroverflow protection	200, 400, 600, 800 ml disposablecanister with a build-in hydrophobicshut 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 WoundVacuum System is indicated foruse in patients who wouldbenefit from negative pressurewound therapy particularly asthe device may promote woundhealing by the removal of excessexudates, infectious material andtissue debris.	Genadyne XLR8 Plus WoundVacuum System is indicated for usein patients who would benefit fromnegative pressure wound therapyparticularly as the device maypromote wound healing by theremoval of excess exudates,infectious material and tissuedebris.

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 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 taken forpatients who are or may be:	Precautions should be taken forpatients who are or may be:
-	Receiving anticoagulant therapy	Receiving anticoagulant 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, 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 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
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.

Regulation Number and Section

§ 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.