(380 days)
Not Found
No
The device description and performance studies focus on the material composition and physical properties of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is described as a "sterile silver moist wound dressing" used for the "management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness)," which indicates it is used for the treatment or mitigation of disease or injury.
No
Explanation: The device description clearly states "CELVER® is a sterile silver moist wound dressing." Its intended use is for the management of various wounds, not for identifying, monitoring, or predicting a medical condition. It's a therapeutic device, not a diagnostic one.
No
The device description clearly states that CELVER® is a sterile silver moist wound dressing composed of physical materials (sodium carboxymethylcellulose, sodium lactate, ionic silver, cotton substrate). It is a physical bandage, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that CELVER® is a wound dressing used for the management of various types of wounds (abrasions, cuts, burns, ulcers). This is a therapeutic application, not a diagnostic one.
- Device Description: The description details the composition and function of a wound dressing that absorbs exudate and maintains a moist wound environment. This is consistent with a wound care product, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) to provide information about a patient's health status or disease.
- Predicate Device: The predicate device (ConvaTec Absorbent Antimicrobial Wound Dressing) is also a wound dressing, further supporting that CELVER® is in the wound care category.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or other conditions. CELVER® does not perform this function.
N/A
Intended Use / Indications for Use
For prescription use, under the supervision of a health care professional, CELVER® may be used for the management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness).
For over-the-counter use, CELVER® may be used for minor abrasions, minor lacerations, minor cuts, minor scalds and 1st degree burns.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
CELVER® is a sterile silver moist wound dressing. CELVER® is composed of sodium carboxymethylcellulose, sodium lactate and ionic silver imbedded into a non-woven 100% cotton substrate.
In contact with wound exudate, the highly adsorbent dressing creates a soft cohesive gel that forms an intimate contact with the wound surface and maintains a moist wound-healing environment.
The construction of the bandage provides for easy removal with minimal residue left on the wound.
The bandage dimensions are 4" x 4" and is further perforated into 15 equal sections appropriately ¾" x 1 ½" for flexibility and ease of use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For prescription use, under the supervision of a health care professional, CELVER® may be used for the management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness).
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)
Non-clinical: Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the CELVER® with respect to the predicate device.
Third party testing was performed including biocompatibility testing per ISO 10993-10:2002 and ISO10993-5:2009
The device passed all of the tests based on pre-determined Pass/Fail criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Attachment 2
ﺔ ﺍﻟﻤﺮﺍﺟﻊ
MAY 3 1 2012
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is:___k111382
Submitter's Identification: 1.
Cellulose Concepts LLC 2867 Industrial Plaza Drive, Suite C Tallahassee, FL 32301
Phone: 850 391 9859
Date Summary Prepared: December 6, 2011
Name of the Device: 2.
Proprietary name: CELVER®
- Unclassified 3. Classification:
FRO Product Code:
Common or Usual Name: 4.
Common Name: Absorbent Antimicrobial Wound Dressing
Predicate Device Information: 5.
K013814 ConvaTec Absorbent Antimicrobial Wound Dressing
6. Description:
CELVER® is a sterile silver moist wound dressing. CELVER® is composed of sodium carboxymethylcellulose, sodium lactate and ionic silver imbedded into a non-woven 100% cotton substrate.
In contact with wound exudate, the highly adsorbent dressing creates a soft cohesive gel that forms an intimate contact with the wound surface and maintains a moist wound-healing environment.
The construction of the bandage provides for easy removal with minimal
Page \$\frac{1}{4}^2$
1
residue left on the wound.
The bandage dimensions are 4" x 4" and is further perforated into 15 equal sections appropriately ¾" x 1 ½" for flexibility and ease of use.
7. Intended Use:
For prescription use, under the supervision of a health care professional, CELVER® may be used for the management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness).
Comparison to Predicate: 8.
The predicate device and CELVER® are indicated for acute and chronic wounds. Both dressings are of a similar composition consisting of silver and absorbent padding to absorb wound exudate, and create a moist wound environment supportive of the healing process.
Performance Data: 9.
Non-clinical: Verification, validation, and testing activities were conducted to establish the performance, functionality, and reliability characteristics of the CELVER® with respect to the predicate device.
Third party testing was performed including biocompatibility testing per ISO 10993-10:2002 and ISO10993-5:2009
The device passed all of the tests based on pre-determined Pass/Fail criteria.
10. Conclusions:
The data from the biocompatibility and non clinical tests show that the CELVER®is as safe and effective as the legally marketed predicate device.
Therefore we conclude that the CELVER®is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cellulose Concepts, LLC % MDI Consultants, Incorporated Ms. Maria F. Griffin 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re: K111382
Trade/Device Name: CELVER Regulation Class: Unclassified Product Code: FRO Dated: May 17, 2012 Received: May 21, 2012
Dear Ms. Griffin:
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 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
MAY 3 1 2012
3
Page 2 - Ms. Griffin
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: CELVER®
Indications For Use:
For over-the-counter use, CELVER® may be used for minor abrasions, minor lacerations, minor cuts, minor scalds and 1st degree burns.
Prescription Use
Over-The Counter Use
(Per 21 CFR 801 Subpart D) OR (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)
Daniel Kiene for MM
(Division Sign Jil) Division of Surgical. Orthopedic. and Restorative Devices
510(k) Number K111382
5
INDICATIONS FOR USE
510(k) Number (if known): K111382
Device Name: CELVER®
Indications For Use:
For prescription use, under the supervision of a health care professional, CELVER® may be used for the management of partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcer and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness).
Prescription Use _ X
(Per 21 CFR 801 Subpart D) OR 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)
David Kaniebaum MM
(Division Sign-Off)
Division of Surgical. Orinopedic, and Restorative Devices
510(k) Number K11382
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