(100 days)
Not Found
No
The device description focuses on the material composition and physical properties of a wound dressing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for the dressing and management of various types of wounds, aiming to provide a moist healing environment to support wound healing, which aligns with the definition of a therapeutic device.
No
The device is described as a wound dressing (sponge) that provides a moist healing environment to support wound healing. It is used for the management and dressing of various types of wounds, not for diagnosis.
No
The device description clearly states it is a "sterile, porous, soft chitosan sponge dressing" and describes its physical form, material, and sterilization method, indicating it is a physical medical device, not software.
Based on the provided information, the Sentrex BioSponge MPD is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Sentrex BioSponge MPD Function: The Sentrex BioSponge MPD is a wound dressing applied directly to the wound surface. Its purpose is to manage and dress wounds by providing a moist healing environment and absorbing exudate. It does not analyze or test biological specimens to provide diagnostic information.
- Intended Use: The intended use clearly states it is for the "dressing and management of" various types of wounds. This is a therapeutic and wound care function, not a diagnostic one.
- Device Description: The description focuses on the material (chitosan sponge), its properties (porous, soft, absorbent), and how it functions as a dressing. There is no mention of analyzing biological samples.
Therefore, the Sentrex BioSponge MPD falls under the category of a wound care device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sentrex BioSponge MPD is indicated in the dressing and management of:
- Full thickness and partial thickness wounds
- Pressure ulcers
- Venous ulcers
- Ulcers caused by mixed vascular etiologies
- Diabetic ulcers
- First and second degree burns
- Donor sites and other bleeding surface wounds
- Abrasions
- Trauma wounds healing by secondary intention
- Dehisced wounds
- Surgical wounds
- Dehisced surgical wounds
- Grafts
The Sentrex BioSponge MPD may be cut to size.
The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).
Product codes (comma separated list FDA assigned to the subject device)
FRO
Device Description
The Sentrex BioSponge MPD is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The dressing is made of chitosan, a naturally occurring, biodegradable, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex BioSponge MPD may be moistened with saline in accordance with physician recommendation.
When moistened, the Sentrex BioSponge MPD is a highly conformable dressing that maintains contact with the wound surface. The Sentrex BioSponge MPD provides a moist wound environment, which may help minimize wound trauma at dressing changes. In vivo data has shown that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT).
The Sentrex BioSponge MPD is provided in the following sizes (I x w x h):
2.5cm x 10cm x 0.6cm
2.5cm x 20cm x 0.6cm
5cm x 5cm x 0.6cm
5cm x 10cm x 0.6cm
5cm x 15cm x 0.6cm
10cm x 10cm x 0.6cm
10cm x 15cm x 0.6cm
10cm x 20cm x 0.6cm
2.5cm x 10cm x 1cm
2.5cm x 20cm x 1cm
5cm x 5cm x 1cm
5cm x 10cm x 1cm
5cm x 15cm x 1cm
10cm x 10cm x 1cm
10cm x 15cm x 1cm
10cm x 20cm x 1cm
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)
New in vivo testing has been performed since K112191 was cleared to demonstrate that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT).
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.
K112191, K071552, K984371, K083113, K033869, K081635
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
K123466
p 1/3
510k Premarket Application
Section 5: 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Applicant: Bionova Medical, Inc. 3011 Centre Oak Way, Suite 102 Germantown. TN 38138 Ph: (901) 748-2581 Fax: (901) 748-2583
Official Correspondent: Alex Greene Director Clinical and Regulatory Bionova Medical, Inc. Phone: (901) 748-2581 Email: alex@bionovamedical.com
18 December 2012 Date of Submission:
Proprietary Name: Sentrex BioSponge MPD
Common Name: Dressing, Wound, Drug
Regulatory Class: Unclassified
FRO Product Codes:
Predicate Device(s):
- K112191, Sentrex BioSponge Wound Dressing .
- K071552, Puracol Plus AG Collagen Microscaffold BioSponge ◆
- . K984371, Mepitel Non-Adherent Silicone Dressing
- . K083113, ACTICOAT Flex 7 Dressing
- . K033869, Contreet Foam Cavity Dressing with Silver
- K081635, INTEGRA Meshed Bilayer Wound Matrix ●
Device Description:
The Sentrex BioSponge MPD is a sterile, porous, soft chitosan sponge dressing that provides a moist healing environment to support wound healing. The dressing is made of chitosan, a naturally occurring, biodegradable, biocompatible polysaccharide derived from shellfish. The shells are processed and chemically treated. Once in bandage form, they are sterilized by gamma irradiation and packed in a heat-sealed foil laminate pouch. The Sentrex BioSponge MPD may be moistened with saline in accordance with physician recommendation.
APR 5 2013
ﺗﺎ ﮨ
1
When moistened, the Sentrex BioSponge MPD is a highly conformable dressing that maintains contact with the wound surface. The Sentrex BioSponge MPD provides a moist wound environment, which may help minimize wound trauma at dressing changes. In vivo data has shown that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT).
The Sentrex BioSponge MPD is provided in the following sizes (I x w x h):
2.5cm x 10cm x 0.6cm 2.5cm x 20cm x 0.6cm 5cm x 5cm x 0.6cm 5cm x 10cm x 0.6cm 5cm x 15cm x 0.6cm 10cm x 10cm x 0.6cm 10cm x 15cm x 0.6cm 10cm x 20cm x 0.6cm
2.5cm x 10cm x 1cm 2.5cm x 20cm x 1cm 5cm x 5cm x 1cm 5cm x 10cm x 1cm 5cm x 15cm x 1cm 10cm x 10cm x 1cm 10cm x 15cm x 1cm 10cm x 20cm x 1cm
Intended Use:
The Sentrex BioSponge MPD is indicated in the dressing and management of:
- Full thickness and partial thickness wounds .
- . Pressure ulcers
- Venous ulcers .
- . Ulcers caused by mixed vascular etiologies
- Diabetic ulcers �
- First and second degree burns .
- . Donor sites and other bleeding surface wounds
- . Abrasions
- . Trauma wounds healing by secondary intention
- Dehisced wounds .
- . Surgical wounds
- Dehisced surgical wounds �
- � Grafts
The Sentrex BioSponge MPD may be cut to size.
The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).
2
Summary of Technological Characteristics
The Sentrex BioSponge MPD requested for clearance in this submission has the same technological characteristics as the previously cleared Sentrex BioSponge Wound Dressing (K112191). It is a sterile, porous, soft sponge dressing manufactured by a proprietary process from chitosan, a non-toxic, biodegradable, biocompatible, natural-based biopolymer. Chitosan has extensive safety data associated with its use in biomedical applications. Like collagen, chitosan induces a minimal foreign body reaction and retains more moisture than standard gauze, providing a moist environment to support wound healing.
Summary of Nonclinical Testing
New in vivo testing has been performed since K112191 was cleared to demonstrate that the Sentrex BioSponge MPD may be used in conjunction with negative pressure wound therapy (NPWT).
Determination of Substantial Equivalence
The claim of substantial equivalence of the Sentrex BioSponge MPD to the predicate devices is based on the comparison of the intended use, device description, product technical/material characteristics, and performance characteristics. Bionova Medical, Inc. considers the Sentrex BioSponge MPD to be as safe and as effective, with substantially equivalent performance to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter dated: April 5, 2013
Bionova Medical, Inc. % Mr. Alex Greene Director, Clinical and Regulatory 3011 Centre Oak Way, Suite 102 Germantown, Tennessee 38138
Re: K123961
Trade/Device Name: Sentrex BioSponge MPD Regulatory Class: Unclassified Product Code: FRO Dated: March 05, 2013 Received: March 07, 2013
Dear Mr. Greene:
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. 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
4
Page 2 - Mr. Alex Greene
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.
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nimelkerson -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4: Indications for Use Statement
510(k) Number: To be assigned
Device Name:
Sentrex BioSponge MPD
Indications for Use:
The Sentrex BioSponge MPD is indicated in the dressing and management of:
- . Full thickness and partial thickness wounds
- . Pressure ulcers
- . Venous ulcers
- . Ulcers caused by mixed vascular etiologies
- . Diabetic ulcers
- . First and second degree burns
- Donor sites and other bleeding surface wounds .
- . Abrasions
- . Trauma wounds healing by secondary intention
- . Dehisced wounds
- . Surgical wounds
- . Dehisced surgical wounds
- t Grafts
The Sentrex BioSponge MPD may be cut to size.
The Sentrex BioSponge MPD is indicated for wounds with moderate to high amounts of exudate, and may be used in conjunction with negative pressure wound therapy (NPWT).
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Kraūse
Page 1 of _ 1
(Division Sign-Off) . Division of Surgical Devices 510(k) Number: K123961
Bionova Medical, Inc. 5 March 2013
3