(194 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a wound gel, with no mention of AI or ML.
Yes
The device is indicated for the management of various wounds and burns, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The provided text describes Prontosan® Wound Gel X as a wound dressing for managing various types of wounds and burns. Its function is to maintain a clean, moist wound environment and act as a barrier to microbial colonization, not to diagnose medical conditions.
No
The device description clearly states it is a hydrogel wound dressing supplied in tubes, indicating it is a physical product, not software.
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 Prontosan® Wound Gel X is for the management of various types of wounds (ulcers, burns, cuts, etc.). This is a topical application for treating the wound itself, not for diagnosing a condition or analyzing a sample taken from the body.
- Device Description: The description details a hydrogel wound dressing with a preservative and surfactant. This aligns with a wound care product, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility and barrier properties, which are relevant to a wound dressing, not a diagnostic device.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. Prontosan® Wound Gel X does not fit this definition.
N/A
Intended Use / 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.
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
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.
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)
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 and a Strike Through Barrier Test. Test results met the acceptance 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.
Silver Shield™ Antimicrobial Skin and Wound Gel (K062212), PolyFIT™+ Absorbing Antimicrobial Dressings, PolyFIT™+ High Absorbing Antimicrobial Dressings (K121522)
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/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.
1
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
2
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
3
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
4
5. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| DATE: | August 14, 2013 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| 610-266-0500 | |
| Contact: Nancy Skocypec, Regulatory Affairs Manager | |
| Phone: (610) 596-2796 | |
| Fax: (610) 266-4962 | |
| E-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™+ 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 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.
5
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 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.
6
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
7
accordance with ISO 10993-1. Performance testing completed included USP 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