(282 days)
For use following surgery in sutured or stapled wounds, to be used incisional wound dressing with attached packing gauze strips.
PROTOCOL™ Incision Dressing is a sterile, single use device. It is manufactured by using the already cleared Calgitrol AG Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin (K011618) and sewing the Kendall Kerlix Antimicrobial Gauze (K990530) to the middle of the silver dressing as an additional absorption feature. The antimicrobial gauze packing strips will be inserted in to the wound, while the silver dressing will be the primary dressing on top of the wound. Adhesive tape will be applied to hold PROTOCOL™ Incision Dressing in place.
The provided FDA 510(k) premarket notification for the PROTOCOL™ Incision Dressing does not contain information typically associated with studies proving device performance against acceptance criteria in the context of an AI/algorithm-based medical device.
This document describes a traditional medical device (an incision dressing) and its substantial equivalence to predicate devices, rather than an AI or algorithm-driven device. Therefore, much of the requested information (like AI performance metrics, sample sizes for test and training sets, expert consensus for ground truth, MRMC studies, etc.) is not applicable or cannot be extracted from this document.
However, I can extract the relevant information regarding the device itself and the type of testing performed.
Device Description and Purpose:
The PROTOCOL™ Incision Dressing is a sterile, single-use incision dressing for use following surgery in sutured or stapled wounds. It combines features of existing cleared devices: a silver alginate foam primary dressing and antimicrobial gauze packing strips. The packing strips are inserted into the wound, and the silver dressing covers the wound, held in place by adhesive tape.
Acceptance Criteria and Reported Device Performance (as inferred from the document):
Given this is a physical medical device and not an AI, the "acceptance criteria" here refers to demonstrating safety and effectiveness by being substantially equivalent to existing predicate devices.
| Acceptance Criteria (Inferred) | Reported Device Performance (from "Summary of Technological Characteristics" and "Basis for Substantial Equivalence") |
|---|---|
| Absorbency: Device should be highly absorbent. | Highly absorbent: "Same as predicate" which were "Highly absorbent". |
| Materials: Device materials should be safe and effective for wound care. | Combination of predicate device materials: Uses materials from "Gauze with silver alginate" and "Gauze with polyhexamethylene biguanide hydrochloride." |
| Design: Device design should function as a primary dressing with packing gauze. | Primary dressing with packing gauze: Combines the "Primary dressing" design with "Packing gauze" design of the predicates. |
| Overall Safety and Effectiveness: Device should not raise new issues of safety and effectiveness. | Substantially Equivalent: "The proposed device does not raise any new issues of safety and effectiveness, and performs as well as the predicate devices." |
| Physical Integrity/Strength: The connection between components should be stable. | "Pull testing was performed" (Result implicitly satisfactory, as it achieved substantial equivalence). |
Study That Proves the Device Meets Acceptance Criteria:
The document refers to a "Summary of Testing Performed" which included:
- Bench Testing - Pull Testing: "Pull testing was performed on the PROTOCOL™ Incision Dressing and can be found in section 018 Performance Validation - Bench." This test likely evaluated the securement of the antimicrobial gauze to the silver dressing.
Information Not Applicable or Not Provided for this Device (due to it not being an AI/algorithm device):
- Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated via substantial equivalence and physical bench testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the AI sense was established.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Clinical Studies:
The document explicitly states: "Clinical Testing was not performed for this device as it is not a high risk, class III device for which clinical evaluations are needed." This further confirms that the assessment relies on substantial equivalence to predicate devices and bench testing, rather than clinical trials for novel performance claims.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DeRoyal Industries Incorporated Ms. Elizabeth Wheeler Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849
July 23, 2015
Re: K142962
Trade/Device Name: PROTOCOL™ Incision Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 8, 2015 Received: June 16, 2015
Dear Ms. Wheeler:
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142962
Device Name PROTOCOL(TM) Incision Dressing
Indications for Use (Describe)
For use following surgery in sutured or stapled wounds, to be used incisional wound dressing with attached packing gauze strips.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/1 description: The image shows the logo for DeRoyal. The logo is blue and features a stylized swoosh above the company name. The company name is written in a cursive font, with a registered trademark symbol next to the word "Royal".
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroval.com
DeRoyal Industries, Inc. Traditional 510(K) Submission - PROTOCOL™ Incision Dressing October 10, 2014
510(k) Summary
| Date prepared: | October 10, 2014Revised May 8, 2015 |
|---|---|
| 510(k) Owner: | DeRoyal Industries, Inc.200 DeBusk LanePowell, TN 37849Owner/Operator #1044833 |
| 510(k) Contact: | Elizabeth WheelerSenior Regulatory Affairs Specialist865-362-2333ewheeler@deroyal.com |
| Manufacturer: | DeRoyal Industries, Inc.164 Giles Hollow RoadRose Hill, VA 24281FDA Registration Number: 1123071 |
| Trade Name: | PROTOCOL™ Incision Dressing |
| Common Name: | Incision Dressing |
| Classification: | Dressing, Wound, Drug |
| Device Product Code: | FRO |
| Substantial Equivalency: | DeRoyal Industries, Inc.Calgitrol AG Silver Alginate Foam andGel Foam Dressings with or withoutMaltodextrin - K011618CovidienKendall Kerlix Antimicrobial Gauze -K990530 |
Indications for Use:
For use following surgery in sutured or stapled wounds, to be used as a closed incisional wound dressing with attached packing gauze strips.
Device Description:
PROTOCOL™ Incision Dressing is a sterile, single use device. It is manufactured by using the already cleared Calgitrol AG Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin (K011618) and sewing the Kendall Kerlix Antimicrobial Gauze (K990530) to the middle of the silver dressing as an additional absorption feature. The antimicrobial gauze packing strips will be inserted in to the wound, while the silver dressing will be the primary dressing on top of the wound. Adhesive tape will be applied to hold PROTOCOL™ Incision Dressing in place.
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Image /page/4/Picture/1 description: The image features the logo for DeRoyal, a company in the medical industry. The logo consists of a stylized, curved blue line that resembles a checkmark or a swoosh, positioned to the left of the company name. The text "DeRoyal" is written in a blue, sans-serif font, with the "R" having a registered trademark symbol next to it.
Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroval.com
Summary of Technological Characteristics:
| Feature | Predicate DeviceDeRoyal- CalgitrolAG Silver AlginateFoam and GelFoam Dressingswith or withoutMaltodextrinK011618 | Predicate DeviceCovidien- KendallKerlixAntimicrobialGauze K990530 | Proposed DevicePROTOCOL™Incision Dressing |
|---|---|---|---|
| Absorbency | Highly absorbent | Highly absorbent | Same as predicate |
| Materials | Gauze with silveralginate | Gauze withpolyhexamethylenebiguanidehydrochloride | Combination ofpredicate devicematerials |
| Design | Primary dressing | Packing gauze | Primary dressingwith packing gauze |
Basis for Substantial Equivalence:
In order to demonstrate substantial equivalence, DeRoyal evaluated the indications for use, materials, and product specifications. Testing has been successfully completed and documented to demonstrate that the proposed device is substantially equivalent to the previously cleared Calgitrol AG Silver Alginate Foam and Gel Foam Dressings with or without Maltodextrin (K011618) and Kendall Kerlix Antimicrobial Gauze (K990530). The proposed device does not raise any new issues of safety and effectiveness, and performs as well as the predicate devices.
Clinical Studies:
Clinical Testing was not performed for this device as it is not a high risk, class III device for which clinical evaluations are needed.
Summary of Testing Performed:
Pull testing was performed on the PROTOCOL™ Incision Dressing and can be found in section 018 Performance Validation - Bench.
N/A