XLR8 Abdominal Wound Dressing Kit is indicated for use in conjunction with Genadyne NPWT System's XLR8+ for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome. XLR8 Abdominal Wound dressing Foam is used for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. It is intended for use in acute hospital setting(trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

Device Description

XLR8 Abdominal Wound dressing is a negative pressure wound therapy device intended to provide negative pressure to the wound bed and transport exudates from the wound. Abdominal Foam is a fully reticulated hydrophobic polyurethane foam made with polyether resin.

XLR8 Abdominal Wound dressing Kit along with Genadyne XLR8+ Negative Pressure Wound therapy Pump and its accessories is a complete negative pressure system for managing open abdomens. This dressing kit is intended for use in acute hospital settings and should ideally be applied in the operating theatre.

The dressing kit consists of one Oval Green Abdominal Foam, one Organ Contact Layer, four transparent dressing, two XLR8 port pad. Each foam is individually packaged in a medical grade Tyvek pouch (1073B Tyvek and a polyester/polyethylene laminate with a 0.375″ side and chevron seals.)

XLR8 Abdominal Wound Dressing Foam is for prescription use only.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device to a legally marketed predicate device. This type of submission focuses on comparing the new device's features to an existing one, rather than presenting a clinical study proving its performance against specific acceptance criteria for a diagnostic AI.

Therefore, the document does not contain the information requested about acceptance criteria, a study proving device performance against those criteria, or details related to AI/MRMC studies, ground truth establishment, or training set specifics.

Specifically, the document includes:

Device Name: XLR8 Abdominal Wound Dressing Kit
Predicate Device: Avance Abdominal Dressing Kit (K161939)
Regulation Number: 21 CFR 878.4780 (Powered suction pump)
Device Description: It's a negative pressure wound therapy device, an abdominal dressing kit used with a negative pressure wound therapy pump. The foam material is fully reticulated hydrophobic polyurethane.
Indications for Use: Temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required, for patients with open abdominal wounds with exposed viscera and organs, including abdominal compartment syndrome. Intended for use in acute hospital settings and ideally applied in the operating theatre.
Technological Characteristics Comparison Table: This table compares various attributes of the XLR8 Abdominal Wound Dressing Kit to its predicate, such as company, device name, 510(k) number, single use/reusable, sterile, indications for use, foam material, kit components, kit component material, contraindications, packaging, and shelf life.
Discussion of Non-Clinical and Clinical Testing: This section briefly mentions that biocompatibility tests were performed to support limited contact exposure and bench tests were conducted on performance (pressure precision, absorbance, alert, and dimension). It states that "The results were within the acceptable limit of the criteria that were set prior the experiment." However, it does not list these specific criteria or their measured values.

Missing Information (critical for addressing the prompt):

The document does not provide any of the following:

A table of acceptance criteria and reported device performance linked to a specific study.
Sample size used for a "test set" (as it's a non-AI device, there isn't a "test set" in the context of AI model evaluation). The testing mentioned is bench testing for physical properties, not a clinical trial to prove efficacy or safety against quantitative metrics in human patients with a specific sample size.
Data provenance, expert numbers, qualifications, or adjudication methods. These are relevant for AI/diagnostic studies, not for this type of device's 510(k) submission.
MRMC comparative effectiveness study details.
Standalone (algorithm only) performance.
Type of ground truth used.
Sample size or ground truth establishment for a "training set."

In conclusion, the provided FDA 510(k) document is for a physical medical device (wound dressing kit) and does not describe the kind of performance study, acceptance criteria, or AI model evaluation metrics relevant to the prompt. The "acceptance criteria" mentioned are for internal bench tests confirming physical properties, not clinical performance or diagnostic accuracy.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 27, 2019

Genadyne Biotechnologies Swara Vashi Regulatory Affairs Engineer 16 Midland Ave Hicksville, New York 11801

Re: K182722

Trade/Device Name: XLR8 Abdominal Wound Dressing Kit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: OMP, FTL Dated: August 28, 2019 Received: August 30, 2019

Dear Swara Vashi:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Cynthia J. Chang, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182722

Device Name XLR8 Abdominal Wound Dressing Kit

Indications for Use (Describe)

XLR8 Abdominal Wound Dressing Kit is indicated for use in conjunction with Genadyne NPWT System's XLR8+ for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome. XLR8 Abdominal Wound dressing foam is used for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. It is intended for use in acute hospital setting(trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

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

Genadyne Biotechnologies, Inc. 16 Midland Ave, Hicksville, NY 11801

E-mail: Swara Vashi (t) 516.487.8787 (f) 516.977.8974

Contact Person: Swara Vashi, Mr. Chien-Ming GOH (Andrew).

Date Prepared: 27 September 2019

Name of Device: XLR8 Abdominal Wound Dressing Kit

Common or Usual Name: NPWT Dressing Kit

Regulation Name: Powered Suction Pump

Device Class: Class II

Regulation Number: 21 CFR 878.4780

Classification Product Code: OMP

Subsequent Product Code: FTL

Predicate Device: Avance Abdominal Dressing Kit, K161939

Device Description

XLR8 Abdominal Wound Dressing Foam is for prescription use only.

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Indications for Use

XLR8 Abdominal Wound Dressing kit is indicated for use in conjunction with Genadyne NPWT System's XLR8+ for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome. XLR8 Abdominal Wound Dressing Foam is used for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.

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Technological Characteristics

Table of Comparison to Predicate Devices:
	Predicate Device	Subject Device
Company	Molnlycke Health Care Us, LLC	Genadyne Biotechnologies
Device Name	Avance Abdominal Dressing Kit	XLR8 Abdominal Wound Dressing Kit
510 (K) Number	K161939	K182722
Single Use/Reusable	Single Use	Single Use
Sterile	Sterile (EtO)	Sterile(EtO)
Indications forUse	The Avance Foam AbdominalDressing Kit is indicated fortemporary bridging of abdominalwall openings where primaryclosure is not possible and/orrepeat abdominal entries may berequired. Its intended use is withpatients who have openabdominal wounds with exposedviscera and organs, and includingbut not limited to patients withabdominal compartmentsyndrome. It is intended for use inacute hospital settings (trauma,general and plastic surgery wards)and should ideally be applied inthe operating theatre. Thedressing kit is intended for usetogether with the Avance MaxNPWT pump and its accessories.	XLR8 Abdominal Wound Dressing Kit isindicated for use in conjunction withGenadyne NPWT System's XLR8+ forpatients who have open abdominal woundswith exposed viscera and organs, includingbut not limited to patients with abdominalcompartment syndrome. XLR8 AbdominalWound dressing Foam is used fortemporary bridging of abdominal wallopenings where primary closure is notpossible and/or repeat abdominal entriesmay be required.It is intended for use in acute hospitalsetting (trauma, general and plastic surgerywards) and should ideally be applied in theoperating theatre.
Foam Material	Hydrophobic reticulatedpolyurethane green color foam.	Fully reticulated hydrophobic polyurethanefoam.
Kit Components	Avance View PadAvance Abdominal FoamAvance Organ Contact LayerAvance Transparent Film	XLR8 Port PadOval Green Abdominal FoamOrgan Contact LayerTransparent Dressing
Kit ComponentMaterial	Avance View Pad: PVC (polyvinylchloride) portAvance Abdominal Foam:Hydrophobic reticulatedpolyurethane foamAvance Organ Contact Layer: Ovalpolyurethane foam withfenestrations	XLR8 Port Pad: Silicone foam with PVC(polyvinyl chloride) portOval Green Abdominal Foam: fullyreticulated hydrophobic polyurethane foamOrgan Contact Layer: Polyurethane FoamTransparent Dressing: polyurethane filmwith silicone adhesive
	Avance Transparent Film: thinpolyurethane film coated with softsilicone adhesive
Contraindications
–	Direct positioning of NPWT overexposed organs, large veins andarteries, tendons or nerves. Malignantwounds * Untreated osteomyelitis "Non-enteric or unexplored fistulas *Undebrided wounds with necrotictissue and eschar present1	Untreated osteomyelitis• Direct positioning of NPWT foam overexposed organs, large veins and arteries,anastomotic sites, tendons or nerves.• Necrotic tissue with eschar present• Malignancy in wound (with exception ofpalliative care to enhance quality of life)• Non-enteric and unexplored fistulas
Packaging	Each component is placed in lowdensity polyethylene pouch with acoated Tyvek header.	Each foam is individually packaged in a medicalgrade tyvek pouch (1073B Tyvek and apolyester/polyethylene laminate with a 0.375"side and chevron seals.)
Shelf Life	2 years	2 years

Table of Comparison to Predicate Devices:

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Discussion of non-clinical andclinical testing	K182722Biocompatibility tests were performed to support limited contactexposure on breached or compromised surface. The dressing isintended to be used for maximum 24 hours.
	Bench tests were conducted on the subject device to determineits performance. Performance tests include pressure precision,absorbance, alert and dimension test. The results were within theacceptable limit of the criteria that were set prior the experiment.
Conclusion & Determination ofSubstantial Equivalence	Based on the information presented above, it is concluded thatthe XLR8 Abdominal Wound Dressing Kit is substantiallyequivalent to its predicate device Avance Foam AbdominalDressing Kit (K161939) with respect to intended use, material andtechnological characteristics.

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.