(364 days)
Not Found
No
The summary describes a negative pressure wound therapy dressing kit and pump, with no mention of AI or ML capabilities.
Yes.
The device is described as a "negative pressure wound therapy device" intended to provide negative pressure to the wound bed and transport exudates, used for open abdominal wounds to facilitate healing, which falls under the definition of a therapeutic device.
No.
The device is a wound dressing kit for negative pressure wound therapy, indicated for managing open abdominal wounds and transporting exudates. Its function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components like foam, contact layers, transparent dressings, and port pads, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage open abdominal wounds with negative pressure, transport exudates, and temporarily bridge abdominal wall openings. This is a therapeutic and wound management function, not a diagnostic one.
- Device Description: The device is a negative pressure wound therapy system component (dressing kit) designed to apply negative pressure and remove fluid from a wound. This is a physical intervention, not a test performed on a sample from the body to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
- Performance Studies: The performance studies focus on physical properties and function (pressure precision, absorbance, alerts, dimensions, biocompatibility), not diagnostic accuracy metrics like sensitivity, specificity, etc.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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 setting(trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
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.
Product codes
OMP, FTL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wounds / open abdomens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
acute hospital setting(trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
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)
Bench tests were conducted on the subject device to determine its performance. Performance tests include pressure precision, absorbance, alert and dimension test. The results were within the acceptable limit of the criteria that were set prior the experiment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/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
1
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 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.
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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 for | ||
| Use | The Avance Foam Abdominal | |
| Dressing Kit is indicated for | ||
| temporary bridging of abdominal | ||
| wall openings where primary | ||
| closure is not possible and/or | ||
| repeat abdominal entries may be | ||
| required. Its intended use is with | ||
| patients who have open | ||
| abdominal wounds with exposed | ||
| viscera and organs, and including | ||
| but not limited to patients with | ||
| abdominal compartment | ||
| syndrome. It is intended for use in | ||
| acute hospital settings (trauma, | ||
| general and plastic surgery wards) | ||
| and should ideally be applied in | ||
| the operating theatre. The | ||
| dressing kit is intended for use | ||
| together with the Avance Max | ||
| NPWT pump and its accessories. | 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. | ||
| Foam Material | Hydrophobic reticulated | |
| polyurethane green color foam. | Fully reticulated hydrophobic polyurethane | |
| foam. | ||
| Kit Components | Avance View Pad | |
| Avance Abdominal Foam | ||
| Avance Organ Contact Layer | ||
| Avance Transparent Film | XLR8 Port Pad | |
| Oval Green Abdominal Foam | ||
| Organ Contact Layer | ||
| Transparent Dressing | ||
| Kit Component | ||
| Material | Avance View Pad: PVC (polyvinyl | |
| chloride) port | ||
| Avance Abdominal Foam: | ||
| Hydrophobic reticulated | ||
| polyurethane foam | ||
| Avance Organ Contact Layer: Oval | ||
| polyurethane foam with | ||
| fenestrations | XLR8 Port Pad: Silicone foam with PVC | |
| (polyvinyl chloride) port | ||
| Oval Green Abdominal Foam: fully | ||
| reticulated hydrophobic polyurethane foam | ||
| Organ Contact Layer: Polyurethane Foam | ||
| Transparent Dressing: polyurethane film | ||
| with silicone adhesive | ||
| Avance Transparent Film: thin | ||
| polyurethane film coated with soft | ||
| silicone adhesive | ||
| Contraindications | ||
| – | Direct positioning of NPWT over | |
| exposed organs, large veins and | ||
| arteries, tendons or nerves. Malignant | ||
| wounds * Untreated osteomyelitis " | ||
| Non-enteric or unexplored fistulas * | ||
| Undebrided wounds with necrotic | ||
| tissue and eschar present1 | Untreated osteomyelitis | |
| • Direct positioning of NPWT foam over | ||
| exposed organs, large veins and arteries, | ||
| anastomotic sites, tendons or nerves. | ||
| • Necrotic tissue with eschar present | ||
| • Malignancy in wound (with exception of | ||
| palliative care to enhance quality of life) | ||
| • Non-enteric and unexplored fistulas | ||
| Packaging | Each component is placed in low | |
| density polyethylene pouch with a | ||
| coated Tyvek header. | 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.) | ||
| Shelf Life | 2 years | 2 years |
Table of Comparison to Predicate Devices:
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| Discussion of non-clinical and
clinical testing | K182722
Biocompatibility tests were performed to support limited contact
exposure on breached or compromised surface. The dressing is
intended to be used for maximum 24 hours. |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Bench tests were conducted on the subject device to determine
its performance. Performance tests include pressure precision,
absorbance, alert and dimension test. The results were within the
acceptable limit of the criteria that were set prior the experiment. |
| Conclusion & Determination of
Substantial Equivalence | Based on the information presented above, it is concluded that
the XLR8 Abdominal Wound Dressing Kit is substantially
equivalent to its predicate device Avance Foam Abdominal
Dressing Kit (K161939) with respect to intended use, material and
technological characteristics. |