(380 days)
For over-the-counter use, CELVER® may be used for minor abrasions, minor lacerations, minor cuts, minor scalds and 1st degree burns.
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).
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.
This document describes the 510(k) submission for the medical device CELVER®, an absorbent antimicrobial wound dressing, and its substantial equivalence to a predicate device. The information provided focuses on the regulatory submission process and not on a clinical trial with specific acceptance criteria and performance metrics typically associated with AI/software devices. Therefore, much of the requested information, such as sample size, expert ground truth, adjudication methods, and MRMC studies, is not applicable or available in this document.
Here's an attempt to address the points based on the provided text, highlighting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass/Fail per ISO 10993-10:2002 and ISO10993-5:2009 | The device passed all of the tests based on pre-determined Pass/Fail criteria. |
| Performance/Functionality | (Not explicitly detailed, but implied suitability for wound care) | Verification, validation, and testing activities were conducted to establish performance, functionality, and reliability characteristics with respect to the predicate device. |
| Reliability | (Not explicitly detailed) | Verification, validation, and testing activities were conducted to establish reliability characteristics with respect to the predicate device. |
| Substantial Equivalence | As safe and effective as the legally marketed predicate device. | The data from the biocompatibility and non-clinical tests show that the CELVER® is as safe and effective as the legally marketed predicate device, thus demonstrating substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any testing. The document refers to "testing activities" and "third-party testing" but does not quantify the number of units or samples tested for biocompatibility or other performance aspects.
- Data Provenance: Not specified. The testing activities are described as "third-party testing," but the country of origin of the data or whether it was retrospective or prospective is not mentioned. Given the nature of a 510(k) for a physical device, this would likely involve laboratory testing rather than clinical data from human subjects in the way AI/software studies do.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided in the document. The "ground truth" for a physical device's characteristics (like biocompatibility) is typically established by laboratory standards and protocols, not by expert consensus on clinical findings.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving human readers and interpretations, which is not the type of study described here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, and therefore, no effect size of human readers improving with or without AI assistance is mentioned. This type of study is relevant for AI/software devices that assist human interpretation, not for a physical wound dressing in a 510(k) submission focused on substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone (algorithm only) performance study was not done. This is not an AI/software device. The performance evaluation was for the physical properties and safety of the wound dressing itself.
7. The Type of Ground Truth Used
- For biocompatibility, the ground truth was established by pre-determined Pass/Fail criteria based on international standards (ISO 10993-10:2002 and ISO10993-5:2009).
- For other performance and functionality aspects, the ground truth was implicitly related to the characteristics of the predicate device which CELVER® aimed to be substantially equivalent to.
8. The Sample Size for the Training Set
- Not applicable/Not provided. There is no concept of a "training set" for this type of device and submission. This is relevant for machine learning models, not for a physical wound dressing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided, as there is no training set for this device.
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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
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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
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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
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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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