(88 days)
The XCell® Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCell® Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the supervision of a health care professional, the XCell® Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions.
The device is intended for one-time use.
Not Found
This 510(k) summary for the XYLOS™ XCell® Antimicrobial Dressing focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from the provided text.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary aims to demonstrate substantial equivalence to predicate devices based on similar intended use, technological characteristics, and performance, rather than providing specific performance metrics against pre-defined acceptance criteria for a new clinical study.
2. Sample Size Used for the Test Set and the Data Provenance
This information is not applicable to this 510(k) summary as no specific test set data from a study proving device performance is presented. The submission relies on comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable for the same reason as above.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as above.
5. 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
This information is not applicable. The device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This information is not applicable as the device is a wound dressing, not an algorithm.
7. The Type of Ground Truth Used
This information is not applicable as no specific study data or ground truth establishment is detailed for this 510(k) beyond demonstrating equivalence to existing legally marketed devices. The "ground truth" here is effectively that the predicate devices are safe and effective.
8. The Sample Size for the Training Set
This information is not applicable as the device is a wound dressing, not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
Summary based on the provided 510(k) information:
The provided document is a 510(k) summary for a medical device (wound dressing) aiming for market clearance based on substantial equivalence to predicate devices. It does not contain details of a specific study designed to meet pre-defined acceptance criteria with quantifiable performance metrics, as would be expected for a novel device requiring such a study. The "proof" is the demonstration of similarity to already cleared devices.
The key points from the document pertinent to its clearance are:
- Intended Use: Similar to predicate devices (partial and full-thickness wounds, absorb exudates, moist wound environment, barrier to microbial colonization/penetration, protection against abrasion, desiccation, external contamination, etc.).
- Technological Characteristics: Implied to be similar to predicate devices.
- Performance: Implied to be similar to predicate devices, but no specific performance data from a new study is provided to establish new acceptance criteria.
The 510(k) process primarily confirms that a new device is as safe and effective as (substantially equivalent to) an already legally marketed device, rather than requiring exhaustive de novo clinical trials to prove performance against specific new criteria.
{0}------------------------------------------------
XYLOS™ XCell® Antimicrobial Dressing 510(k) Summary
DATE PREPARED: 13FEB03
SUBMITTED BY:
MAR 0 7 2003
XYLOS Corporation 838 Town Center Drive Langhorne, PA 19407
CONTACT PERSON:
Patsy J. Trisler, J.D., RAC Senior Director, Medical Device Consulting PharmaNet, Inc. 815 Connecticut Avenue, NW, Suite 800 Washington, D.C. 20006 202-835-1346 (direct dial) 609-520-8107 (fax)
DEVICE:
Classification Name: Common/Usual Name: Proprietary Name:
Dressing Wound Dressing XYLOS™ XCell® Antimicrobial Wound Dressing
DEVICE CLASSIFICATION:
Product Code/Classification Number: FRO Regulatory Class: Unclassified
PREDICATE DEVICES:
Kendall Kerlix Antimicrobial Gauze K990530 NAD ConvaTec Aquacel Ag Absorbent Antimicrobial Wound Dressing K013814 FRO Maersk Medical Arglaes AB Antimicrobial Barrier Film Dressing K990810 MGP XYLOS™ XCell® Wound Dressing K974251 MGQ XYLOS™ XCell® Wound Dressing K011379 Exempt NAE
STATEMENT OF SUBSTANTIAL EQUIVALENCE:
XYLOS™ XCell® Antimicrobial Wound Dressing is substantially equivalent to the predicate devices, having similar intended use, technological characteristics, and performance.
INTENDED USE:
Indications (From Labeling): The XCell® Antimicrobial Wound Dressing is intended for use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCell® Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain. Under the supervision of a health care professional, the XCell® Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions. The device is intended for one-time use.
Replacement Page 000039
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a bird or eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 7 2003
Xylos Corporation c/o Patsy Trisler PharmaNet, Inc. 815 Connecticut Avenue, N.W. Suite 800 Washington, D.C. 20006
Re: K024054
Trade/Device Name: Xylos™ Xcell® Antimicrobial Wound Dressing Regulation Name: Hydrogel wound dressing with a drug Regulatory Class: Unclassified Product Code: MGQ Dated: December 5, 2002 Received: December 9, 2002
Dear Ms. Trisler:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
{2}------------------------------------------------
Page 2 -- Ms. Patsy Trisler
(21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use FORM
Page 1 of 1
510(k) Number (if known) _
Device Name:
XYLOS™ XCell® Antimicrobial Wound Dressing
The XCell® Antimicrobial Wound Dressing is intended for Indications for Use: use on partial and full-thickness wounds as an effective barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The XCell® Antimicrobial Wound Dressing is intended to cover a wound or burn on a patient's skin to absorb areas of wound exudates and to provide a moist wound environment that supports the autolytic debridement of areas of the wound that are necrotic. The dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the Instructions-for-use. The wound dressing also protects against abrasion, desiccation, and external contamination. The moist environment has a cooling effect that may reduce pain.
Under the supervision of a health care professional, the XCell® Antimicrobial Wound Dressing is intended for the local management of exuding wounds, including infected and non-infected pressure ulcers, venous ulcers, diabetic ulcers, arterial ulcers, donor sites and other bleeding surface wounds, dermal lesions, trauma injuries or incisions, superficial cuts, minor scalds and burns, minor skin irritations, lacerations and abrasions.
The device is intended for one-time use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21CFR 801.109)
OR
Over-the-Counter-Use Optional Format 1-2-96 Replacement Page 000019
iriam C Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K024054
N/A