(86 days)
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No
The description focuses on the material composition and physical properties of a wound dressing, with no mention of AI or ML capabilities.
Yes
The device is described as a wound dressing intended for the management of various wounds, which falls under the scope of therapeutic applications in medicine.
No
The device is described as a wound dressing for the management of burns, sores, blisters, scrapes, ulcers, and other wounds. Its function is to provide a physical covering and aid in wound management, not to diagnose a condition.
No
The device description clearly states it is a "sterile, disposable, single use wound dressing" composed of physical materials (hydrocolloid, hydrophillic, fibrous type I bovine collagen) and is available in different sizes. This indicates a physical medical device, not a software-only one. The performance studies also focus on physical characteristics like biocompatibility, sterilization, and physical requirements.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "management of burns, sores, blisters, scrapes, ulcers, and other wounds." This describes a therapeutic or wound care application, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a "sterile, disposable, single use wound dressing." This is a physical dressing applied to a wound, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for direct application to a wound for healing and protection, which falls under the category of wound care devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The management of burns, sores, blisters, scrapes, ulcers, and other wounds.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Skin Temp. H. Dressing is a sterile, disposable, single use wound dressing. It is a hydrocolloid and hydrophillic dressing composed of fibrous type I bovine collagen. The device is to be provided in hydrated as well as dry form. The device is to be used for the management of burns, blisters, sores, scrapes, ulcers and other wounds. The Skin.Temp. II. Dressing will be available in 2"X2", 3"X4" and 8"X12" sizes and additional sizes may introduced at a later time.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Multiple tests concerning product functionality, biocompatibility, packaging and sterilization have been performed on the SkinTemp device to ensure that it is as safe and as effective as the predicate device. Testing was performed to verify that the performance characteristics of SkinTemp II Dressing are analogous to the predicate device. Testing includes:
a) Biocompatibility: Testing has confirmed that SkinTemp II Dressing meets all biocompatibility testing requirements stated by FDA regulations and ISO 10993. Biocompatibility tests were performed by North American Science Association, Inc. (NAmSA) in accordance with proper regulations. Biocompatibility testing has shown that this device is safe for use as a medical device for wound management.
b) Sterilization: SkinTemp II Dressings are to be eBEAM Irradiation sterilized per the recommendations of AAMI TIR-27 document titled: Sterilization of healthcare products -Radiation Sterilization Substantiation of 25kGy as a Sterilization Dose Method VD Max. The product has been validated and routine control of the sterilization process has been created in accordance with the recommendations set forth in ISO 11137-1:2006; Sterilization of medical devices- Validation and routine control of sterilization by irradiation.
c) Design Verification: Design verification testing via functional testing of SkinTemp II Dressing is detailed in Section 20.2. This testing included General Physical Requirements, Dimensional Analysis, Visual Inspections, Moisture Content testing, Package and Labeling requirements and Operational Environment Requirements.
d) Process Validation: SkinTemp II dressings are to be manufactured in an ISO 13485:2003 certified cleanroom environment. The environment certifications are conducted annually and are available on plant site. Furthermore, complete process validation testing has also been performed and is detailed in Section 20.3.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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N/A
0
Image /page/0/Picture/0 description: The image shows the logo for Human BioSciences. The logo consists of a stylized DNA strand on the left and the words "Human BioSciences" on the right. The words are in a bold, sans-serif font, with "Human" stacked on top of "BioSciences."
OCT 2 6 202
7. 510(K) SUMMARY PER 807.92(A)(1)
Date Prepared: July 27, 2012
Submitter's Information
Owner/Operator:
Dr. Manoj K. Jain CEO Human BioSciences, Inc. Phone: (301) 740-1893 Fax: (301) 740-1899
Submission Contact Information
| Name: | Jack Slovick |
|---|---|
| Title: | Quality and Regulatory |
| Phone: | (763) 639-0238 |
| Email: | jack_slovick@yahoo.com |
Proposed Device
| Classification name: | Dressing, Wound, Collagen |
|---|---|
| Class: | Unclassified |
| Product Code: | KGN |
7.1 Indications for Use
The management of burns, sores, blisters, scrapes, ulcers, and other wounds.
7.2 Description of Device
Skin Temp. H. Dressing is a sterile, disposable, single use wound dressing. It is a hydrocolloid and hydrophillic dressing composed of fibrous type I bovine collagen. The device is to be provided in hydrated as well as dry form. The device is to be used for the management of burns, blisters, sores, scrapes, ulcers and other wounds. The Skin.Temp. II. Dressing will be available in 2"X2", 3"X4" and 8"X12" sizes and additional sizes may introduced at a later time.
Traditional 510(k) application for SkinTemp II Dressing
Human Biosciences, Inc. Page 1 of 6
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Image /page/1/Picture/0 description: The image shows the logo for Human BioSciences. The logo consists of a stylized image of DNA strands on the left and the words "Human BioSciences" on the right. The words are in a bold, sans-serif font, with "Human" stacked on top of "BioSciences."
Product List
SkinTemp dressings are available in the following sizes:
- 2" x 2" Sterile dressing (ST 1022) I
- . 3" x 4" Sterile dressing (ST 1002)
- 8" x 12" Sterile dressing (ST 1003) u
ST 1022
- Sterile Product .
- . Packaged for a shelf life of 5 years in US conditions
- Moisture Content: