(221 days)
X-Cell™, a hydrogel wound dressing is a device intended to cover a wound or burn on a patient's skin to absorb wound exudate, and protect against abrasion, friction, dessication, or external contamination. The moist environment has a cooling effect that may reduce pain.
X-Cell™ wound dressing may be used for the management of:
- Partlal to Full thickness wounds (arterial, venous, pressure and diabetic ulcers); .
- First and Second degree burns (severe sunbum, etc.); .
- Post-operative surgical wounds; .
- Donor sites; .
- Dermal Lesions (cuts, abrasions, exc.) .
X-Cell™, a hydrogel wound dressing
This document is a 510(k) summary for the X-Cell™ Hydrogel Wound Dressing, asserting its substantial equivalence to predicate devices rather than providing a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these provided excerpts.
However, based on the information provided, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device must be safe for its intended purpose. | The results of biocompatibility tests show the device to be safe for its intended purpose. |
| Substantial Equivalence: Device must be substantially equivalent to legally marketed predicate devices. | The X-Cell™ hydrogel wound dressing is substantially equivalent to the NU-GEL hydrogel wound dressing (Johnson & Johnson) and the Aquacel wound dressing (ConvaTec) predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence through biocompatibility testing and comparison to predicates, not a clinical trial with a specific test set.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not available. Ground truth establishment by experts is typically relevant for clinical studies, which are not detailed here.
4. Adjudication Method for the Test Set
This information is not available. Adjudication methods are relevant for clinical studies with expert review, which are not outlined.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not available. An MRMC study is a type of clinical study focused on reader performance, which is not described.
6. Standalone (Algorithm Only) Performance Study
This information is not available. This type of study would be relevant for AI/algorithm-based devices, but the X-Cell™ Wound Dressing is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" here is the regulatory assessment of biocompatibility and substantial equivalence to predicate devices. This is established through:
- Biocompatibility testing results: The document states the results of these tests show the device to be safe.
- Comparison to predicate devices: The X-Cell™ is compared to NU-GEL and Aquacel wound dressings, implying their established safety and efficacy serve as a benchmark for equivalence.
8. Sample Size for the Training Set
This information is not available. A "training set" is relevant for machine learning algorithms, which are not applicable to this physical wound dressing.
9. How the Ground Truth for the Training Set Was Established
This information is not available as there is no training set for a physical wound dressing; this concept applies to AI/ML models.
Summary of what can be inferred from the document:
The 510(k) submission for the X-Cell™ Wound Dressing uses two primary methods to demonstrate its safety and effectiveness for substantial equivalence:
- Biocompatibility Testing: The results indicated the device is safe for its intended purpose. No specific study details (e.g., sample size, type of tests) are provided in this summary.
- Comparison to Predicate Devices: The device is presented as substantially equivalent to the NU-GEL hydrogel wound dressing and the Aquacel wound dressing. This implies that the safety and performance profile of these existing, legally marketed devices serve as the "ground truth" for demonstrating equivalence.
The document does not describe a clinical study with a test set of patients or experts, as it is a 510(k) summary focusing on substantial equivalence rather than a full clinical trial report.
{0}------------------------------------------------
JUN 22 1998
The same of the stage of the same of the same and and and and the
L974251
X-Celli™ Wound Dressing : Revised EXHIBIT III-1 : Summary of safety and effectiveness information
EXHIBIT III-1 : X-CELL HYDROGEL WOUND DRESSING
510 (K) SUMMARY
Submitted By : Eric Flam, Ph.D. NTL Associates, Inc. East Brunswick, NJ 08816 (408) 390-5656 May 29, 1998
Device Name :XYLOS : X-CELL WOUND DRESSING
-
(a) Intended Use
X-Cell™, a hydrogel wound dressing is a device intended to cover a wound or burn on a patient's skin to absorb wound exudate, and protect against abrasion, friction, dessication, or external contamination. The moist environment has a cooling effect that may reduce pain. -
(b) Biocompatibility
The results of the biocompatibility tests show the device to be safe for its intended purpose. -
(c) Substantial Equivalence
The X-Cell™ hydrogel wound dressing is substantially equivalent to the NU-GEL hydrogel wound dressing (from Johnson & Johnson) and the Aquacel wound dressing (from ConvaTec) predicate devices.
P 22
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 22 1998
XYLOS Corporation ·c/o Eric Flam, Ph.D. NTL Associates, Inc. 29 Ainsworth Avenue East Burnswick, New Jersey 08816
K974251 Re: Trade Name: X-Cell™ Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: March 30, 1998 Received: April 1, 1998
Dear Dr. Flam:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the following limitations:
- l. This device may not be labeled for use on third degree burns.
-
- This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for 4. any type of wound.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). 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.
{2}------------------------------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Celia M. Witten, Ph.D., M.D. DIRECTOR Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
X-CcllTM Wound Dressing : Revised APPENDAX IV-A
Page_1 l of
510{k} Number {lf known):_ K974251
Device Name: Xylos X-Cell™ wound dressing
Indiaalions For Use:
Prescription
X-Cell™ wound dressing may be used for the management of:
- Partlal to Full thickness wounds (arterial, venous, pressure and diabetic ulcers); .
- First and Second degree burns (severe sunbum, etc.); .
- Post-operative surgical wounds; .
- Donor sites; .
- Dermal Lesions (cuts, abrasions, exc.) .
(PLEASE OO NOT WRITE BELOW THIS UNE-CONTINUE ON ANOTHER PAGE IF NEEDED!
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K974251 |
Prescription Use (Per 21 CFR 801.109)
ેત્ત્વ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
N/A