(282 days)
Not Found
No
The summary describes a physical wound dressing and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an incision dressing with antimicrobial gauze packing strips, used for wound care following surgery. Its function is to cover and absorb, which is supportive care rather than directly therapeutic. It does not actively treat a disease or condition beyond wound management.
No
The device is described as an incision dressing for use following surgery with sutured or stapled wounds, focusing on wound care rather than diagnosing a condition.
No
The device description clearly describes a physical wound dressing made of materials like silver alginate foam, gel foam, and antimicrobial gauze. It is a tangible, sterile, single-use device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dressing sutured or stapled wounds following surgery. This is a topical application for wound care, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a wound dressing with attached gauze strips. It is applied externally to the wound.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls under the category of a wound care product used in vivo (on the body).
N/A
Intended Use / Indications for Use
For use following surgery in sutured or stapled wounds, to be used incisional wound dressing with attached packing gauze strips.
Product codes (comma separated list FDA assigned to the subject device)
FRO
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.
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
Not Found
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)
Clinical Testing was not performed for this device as it is not a high risk, class III device for which clinical evaluations are needed.
Pull testing was performed on the PROTOCOL™ Incision Dressing and can be found in section 018 Performance Validation - Bench.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image.
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.
1
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
2
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)
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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, 2014
Revised May 8, 2015 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Owner: | DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849
Owner/Operator #1044833 |
| 510(k) Contact: | Elizabeth Wheeler
Senior Regulatory Affairs Specialist
865-362-2333
ewheeler@deroyal.com |
| Manufacturer: | DeRoyal Industries, Inc.
164 Giles Hollow Road
Rose Hill, VA 24281
FDA 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 and
Gel Foam Dressings with or without
Maltodextrin - K011618
Covidien
Kendall 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.
4
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 Device
DeRoyal- Calgitrol
AG Silver Alginate
Foam and Gel
Foam Dressings
with or without
Maltodextrin
K011618 | Predicate Device
Covidien- Kendall
Kerlix
Antimicrobial
Gauze K990530 | Proposed Device
PROTOCOL™
Incision Dressing |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------------------------------|
| Absorbency | Highly absorbent | Highly absorbent | Same as predicate |
| Materials | Gauze with silver
alginate | Gauze with
polyhexamethylene
biguanide
hydrochloride | Combination of
predicate device
materials |
| Design | Primary dressing | Packing gauze | Primary dressing
with 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.