(119 days)
K1964240
I964240
No
The 510(k) summary describes a topical emulsion for wound management and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
No
PruTect™ is described as a topical emulsion for wound management, creating an optimum moist environment for healing and isolating the wound. While it aids healing, it is not described as directly treating or curing a disease or condition in the way a therapeutic device typically would (e.g., pain relief, disease progression modification, organ function support). It acts as a dressing to support the natural healing process.
No
PruTect™ is described as a water-based emulsion for the dressing and management of superficial wounds, burns, and other skin conditions. Its intended use focuses on providing a moist environment for healing and isolating wounds, not on diagnosing medical conditions.
No
The device description clearly states it is a "Topical Emulsion," which is a physical substance applied to the skin, not a software program.
Based on the provided information, PruTect™ is NOT an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that PruTect™ is a topical emulsion for the dressing and management of various types of wounds. This is a direct application to the body for therapeutic purposes.
- Device Description: It is described as a "non-sterile, semi-viscous emulsion intended for topical application." This further reinforces its use on the body surface.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. There is no mention of specimen collection, analysis, or diagnostic information being generated by PruTect™.
- Predicate Device: The predicate device, Biafine® Topical Emulsion, is also a topical wound dressing, not an IVD.
Therefore, PruTect™ falls under the category of a topical wound care product, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
PruTect™ is a water-based emulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, Ist and 2nd degree burns, including sunburns, and radiation dermatis. When applied properly to a wound, PruTect™ provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
PruTectTM is indicated for use in:
- Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
- Superficial Wounds
- 1st and 2nd Degree Burns, including Sunburns
- Dermal Donor and Graft Site Management
- Radiation Dermatitis
- Minor Abrasio»
Product codes
MGQ, FRO
Device Description
PruTect™ Topical Emulsion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in both 45 gm and 90 gm tube formats.
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)
Functional and performance testing has been conducted to assess the safety and efficacy of PruTect™ Topical Emulsion and the results are satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Biafine® Topical Emulsion cleared under 1964240
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo for PRUGEN IP HOLDINGS, INC. with the text "510(k) Summary" underneath. To the right of the logo is the number 109287 written in cursive. The image appears to be a document or report cover page.
Date Prepared: September 9, 200
1. Owner's Name:
. PruGen, IP Holdings Inc. 8711 East Pinnacle Peak Road Suite C-201 PMB 225 Scottsdale, AZ 85255 Robert L. Knechtel, M.D., J.D. (T): 480-563-2406 (F): 815-261-5953 -(E): rknechtel@prugen.com
JAN 1 5 2010
-
- Proprietary Name: PruTect™ Topical Emulsion Common Name: Dressing, Wound & Burn, Hydrogel w/ Drug or Biologic Classification Name: Dressing, Wound & Burn, Hydrogel w/ Drug or Biologic
- (Product Code MGQ)
Contact Person:
Substantially Equivalent Device: 3.
PruGen IP Holdings, Inc. believes that PruTect™ Topical Emulsion is substantially equivalent to the following currently marketed device: Biafine® Topical Emulsion cleared under 1964240,
- Device Description:
PruTect™ Topical Emulsion is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requiring a physician diagnosis disease state) use in both 45 gm and 90 gm tube formats.
ડ. Intended Use of the Device:
PruTect™ is a water-based emulated for the dressing and management of superficial wounds, minor abrasions, dermal ulcers, donor sites, Ist and 2nd degree burns, including sunburns, and radiation dermatis. When applied properly to a wound, PruTect™ provides an optimum moist environment for the healing process and isolates the wound from harmful germs and other external contamination.
Summary of Technical Characteristics of Device compared to Predicate Devices 6.
The referenced predicate device is a non-sterile emulsion that is applied to relieve the symptoms of superficial wounds, minor abrassions, dermal ulcers, donor sites, I st and 2nd degree burns, including sunburns, and radiation dermatitis.
- Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of PruTect™ Topical Emulsion and the results are satisfactory.
8711 East Pinnacle Peak Road · Suite C-201, PMB 225 Scottsdale, AZ 85255 · 480.585.0122 ﺎ -
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN 1 5 2010
PruGen IP Holdings, Inc. % Robert L. Knechtel, M.D., J.D. EVP and General Counsel 8711 E. Pinnacle Peak Road, Suite C-201, PMB 225 Scottsdale, Arizona 85255
Re: K092878
Trade/Device Name: PruTect™ Topical Emulsion Regulatory Class: Unclassified Product Code: FRO Dated: January 7, 2009 Received: January 8, 2009
Dear Dr. Knechtel:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 (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.
2
Page 2 - Robert L. Knechtel, M.D., J.D.
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
ely yours,
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE
Device Trade Name: PruTect™ Topical Emulsion
510(k) number: K092878
FOR TOPICAL DERMATOLOGICAL USE ONLY
PruTectTM is indicated for use in:
- · Full Thickness Wounds, Pressure Sores, Dermal Ulcers including Lower Leg Ulcers
- · Superficial Wounds
- · 1st and 2nd Degree Burns, including Sunburns
- · Dermal Donor and Graft Site Management
- · Radiation Dermatitis
- · Minor Abrasio»
| Prescription Use | X |
|---|---|
| Over the counter use |
(Part 21 CFR 801 Subpart D)
Daniel Krane
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092578