(194 days)
Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.
Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.
The document describes the Prontosan® Wound Gel X, a wound dressing, and its substantial equivalence to predicate devices. It mentions that performance testing was conducted to support this claim.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1 | Test results met the acceptance criteria. |
| USP <51> | Not explicitly stated, implied to be passed | Test results met the acceptance criteria. |
| Strike Through Barrier Test | Not explicitly stated, implied to be passed | Test results met the acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details on the sample sizes used for the biocompatibility, USP <51>, or Strike Through Barrier tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. The testing described appears to be laboratory-based performance and biocompatibility testing, not studies requiring expert interpretation of results to establish ground truth in the context of medical imaging or diagnostic devices.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The testing described does not involve adjudication as it's not a study where human readers or algorithms interpret data against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through biocompatibility and performance testing, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable as Prontosan® Wound Gel X is a wound dressing, not an algorithm or AI device. The studies mentioned are traditional medical device performance tests.
7. Type of Ground Truth Used
The ground truth for the performance tests (Biocompatibility, USP <51>, Strike Through Barrier Test) would be established by the defined standards and protocols of these specific tests. For example, for biocompatibility, the ground truth is adherence to the requirements of ISO 10993-1. For USP <51>, it likely refers to antimicrobial effectiveness testing against predefined microorganisms and reduction criteria.
8. Sample Size for the Training Set
This is not applicable and not provided. Prontosan® Wound Gel X is a medical device (wound dressing), not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above; there is no training set for this type of medical device.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public I lealth Service
October 8, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Commi Center - WO66-G608 Silver Spring, MD 20993-0002
B. Braun Medical, Incorporated Ms. Nancy Skocypec Senior Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K130857
Trade/Device Name: Prontosan" Wound Gel X Regulatory Class: Unclassified Product Code: FRO Dated: August 14, 2013 Received: August 19, 2013
Dear Ms. Skocypec:
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 10 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 complics 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-rclated adverse cvents) (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.
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Page 2 - Ms. Nancy Skocypec
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 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 -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Page __________ of ______ l
510(k) Number (if known): K130857
Device Name:
Prontosan® Wound Gel X
Indications For Use:
Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use ___
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
3
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4. INDICATIONS FOR USE STATEMENT
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
Device Name: Prontosan® Wound Gel X
Indications For Use:
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
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5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| DATE: | August 14, 2013 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341610-266-0500 |
| Contact: Nancy Skocypec, Regulatory Affairs ManagerPhone: (610) 596-2796Fax: (610) 266-4962E-mail: nancy.skocypec@bbraun.com | |
| TRADE NAME: | Prontosan® Wound Gel X |
| COMMON NAME: | Wound dressing |
| Device Classification: | Unclassified, Product Code FRO |
| PREDICATE DEVICE: | Silver Shield™ Antimicrobial Skin and Wound Gel (K062212) |
| PolyFIT™+ Absorbing Antimicrobial Dressings, PolyFIT™+ HighAbsorbing Antimicrobial Dressings (K121522) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.
INDICATIONS FOR USE
Rx - Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 15 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
SUBSTANTIAL EQUIVALENCE
B. Braun Medical Inc's. Prontosan Wound Gel X is substantially equivalent to the predicate devices having similar indications for use, technological properties and performance.
TECHNICAL CHARACTERISTICS
Prontosan Wound Gel X has similar physical and technical characteristics to the predicate devices.
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PERFORMANCE DATA
Biocompatibility and performance testing was performed with Prontosan Wound Gel X to support substantial equivalence to the predicate devices. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing completed included USP<51> and a Strike Through Barrier Test. Test results met the acceptance criteria.
CONCLUSION
Based on the results of biocompatibility and performance testing, the proposed Wound Gel X is considered substantially equivalent to the predicate devices and effective for its' intended use.
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5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DATE:
l i
August 14, 2013
SUBMITTER:
B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500
Prontosan® Wound Gel X
OCT 08 2013
Contact: Nancy Skocypec, Regulatory Affairs Manager Phone: (610) 596-2796 Fax: (610) 266-4962 E-mail: nancy.skocypec@bbraun.com
| TRADE NAME: |
|---|
| ------------- |
COMMON NAME: Wound dressing
. Device Classification: Unclassified, Product Code FRO
PREDICATE DEVICE:
Silver Shield " Antimicrobial Skin and Wound Gel (K062212)
PolyFIT + Absorbing Antimicrobial Dressings, PolyFIT" + High Absorbing Antimicrobial Dressings (K121522)
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.
INDICATIONS FOR USE
OTC - Prontosan Wound Gel X is indicated for the management minor cuts. minor lacerations, minor burns (13) degree burns), and abrasions.
SUBSTANTIAL EQUIVALENCE
B. Braun Medical Inc's. Prontosan Wound Gel X is substantially equivalent to the predicate devices having similar indications for use, technological properties and performance.
TECHNICAL CHARACTERISTICS T
Prontosan Wound Gel X has similar physical and technical characteristics to the predicate devices.
PERFORMANCE DATA
Biocompatibility and performance testing was performed with Prontosan Wound Gel X to support substantial equivalence to the predicate devices. Biocompatibility testing was performed in
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accordance with ISO 10993-1. Performance testing completed included USP<51> and a Strike Through Barrier Test. Test results met the acceptance criteria. .
CONCLUSION
ﺰ
に
Based on the results of biocompatibility and performance testing, the proposed Wound Gel X is considered substantially equivalent to the predicate devices and effective for its' intended use.
2
N/A