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.

AI/ML Overview

This submission details the SkinTemp II Dressing, a collagen-based wound dressing, as substantially equivalent to the predicate device, BioCore SkinTemp sheet. The core of the submission revolves around demonstrating this substantial equivalence through a comparison of technological characteristics and non-clinical testing.

Here's an analysis of the provided information concerning acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal table of "acceptance criteria" with quantitative performance metrics for the SkinTemp II Dressing. Instead, it relies on demonstrating substantial equivalence to a predicate device. The acceptance is implied by meeting or being analogous to the predicate device's characteristics and performance.

However, based on the non-clinical testing and comparison to the predicate, we can infer some "performance criteria" that the SkinTemp II Dressing met:

Accepted Performance Criteria Category	Target (Analogous to Predicate)	SkinTemp II Dressing Performance
Intended Use/Indications	Management of burns, sores, blisters, scrapes, ulcers, and other wounds.	Identical: "The HBS SkinTemp II Dressing is indicated for the management of burns, sores, blisters, scrapes, ulcers, and other wounds." (Page 2, Table 7.1)
Principles of Use	Cleanse wound, apply medication if needed, apply dressing, cover with non-adherent dressing, change as required.	Identical: "Cleanse the wound. Apply medication if needed. Apply dressing and cover with non-adherent dressing. Change as required." (Page 2, Table 7.1)
Scientific Technology	100% type I bovine collagen as primary constituent.	Identical: "The SkinTemp II Dressing uses 100% type I bovine collagen as its primary constituent." (Page 2, Table 7.1)
Configuration / System Components	Sterile, disposable, single use, collagen-based wound dressing with non-adherent backing. Hydrocolloid, absorbent, gel formation.	Identical: "Sterile, disposable, single use, collagen based wound dressing with non adherent backing. Further properties include: a) Hydrocolloid b) Absorbent Dressing c) Gel formation" (Page 2, Table 7.1)
Sterility Method	Electron Beam Sterilization.	Identical: "Each dressing is sterilized using Electron Beam Sterilization." (Page 2, Table 7.1) Validated per AAMI TIR-27 and ISO 11137-1:2006. (Page 4-5)
Materials	Type I Bovine Collagen, Distilled Water, Buffering Agent (Chemical Z).	Identical: "Type I Bovine Collagen, Distilled Water, Buffering agent / Chemical Z (proprietary name)" (Page 2, Table 7.1). The inclusion of Chemical Z was the specific reason for this new 510(k) submission to formally document an ingredient that was previously used but not formally documented in the predicate's 510(k). (Page 5)
Biocompatibility	Meet all biocompatibility testing requirements.	Confirmed: "Testing has confirmed that SkinTemp II Dressing meets all biocompatibility testing requirements stated by FDA regulations and ISO 10993." (Page 4) Performed by North American Science Association, Inc. (NAmSA).
Sterilization Assurance	Validated sterilization process.	Confirmed: Sterilized per AAMI TIR-27, validated, and routine control created in accordance with ISO 11137-1:2006. (Page 4-5)
Physical Requirements	General Physical Requirements, Dimensional Analysis, Visual Inspections, Moisture Content testing, Package and Labeling requirements, Operational Environment Requirements.	Confirmed: Design verification testing via functional testing detailed in Section 20.2 (not provided in the excerpt). This included General Physical Requirements, Dimensional Analysis (e.g., 2" ± 0.25" x 2" ± 0.25", < 17% Moisture Content, < 10 ppm Heavy Metals, Page 1), Visual Inspections, Moisture Content testing, Package and Labeling requirements and Operational Environment Requirements. (Page 5)
Manufacturing Process	Manufactured in a controlled environment with validated processes.	Confirmed: Manufactured in an ISO 13485:2003 certified cleanroom environment with complete process validation testing. (Page 5)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical or performance data from human subjects. The study presented here is a non-clinical substantial equivalence comparison.

Sample Size: Not applicable in the traditional sense of a clinical trial. The testing involves samples of the SkinTemp II Dressing undergoing physical, chemical, and biological evaluations. Specific sample sizes for each non-clinical test (e.g., biocompatibility samples, sterilization validation samples, dimensional analysis samples) are not provided in this summary.
Data Provenance: The testing was performed internally by Human BioSciences, Inc. and by a third-party laboratory, North American Science Association, Inc. (NAmSA), for biocompatibility. The summary does not provide country of origin or whether it's retrospective or prospective, but given it's non-clinical testing for a 510(k) submission, it would be prospective testing on the manufactured device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a non-clinical submission demonstrating substantial equivalence to a predicate device, not a study requiring expert readers or interpretation of clinical data. The "ground truth" for the non-clinical tests would be the established scientific and regulatory standards (e.g., FDA regulations, ISO standards, AAMI guidelines) and the documented characteristics of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication or clinical assessment involved in this type of substantial equivalence submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. There is no mention of an MRMC study. This submission focuses on the device itself and its equivalence to a predicate, not on the improvement of human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (wound dressing), not an algorithm or AI-based device.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is primarily:

Predicate Device Characteristics: The detailed specifications and approved 510(k) information of the BioCore SkinTemp sheet (K913023 & K925545). The new device's characteristics were compared point-by-point to this established device.
Regulatory Standards: ISO 10993 (Biocompatibility), AAMI TIR-27 (Sterilization), ISO 11137-1:2006 (Sterilization), and FDA regulations (e.g., 21 CFR Part 807.92). Performance parameters such as sterility, biocompatibility, and manufacturing quality are measured against these established standards.
Internal Specifications: For physical characteristics like size, moisture content, and heavy metals, the "ground truth" is the internal design specifications of the SkinTemp II Dressing, which are designed to be consistent with or superior to the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no machine learning "training set" involved as this is not an AI/algorithm-driven device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/algorithm.

Summary

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K122325

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

Traditional 510(k) application for SkinTemp II Dressing

Human Biosciences, Inc. Page 1 of 6

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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: < 17%
Size: 2" ± 0.25" x 2" ± 0.25 " E
. Heavy Metals: < 10 ppm

ST 1002

Sterile Product .
Packaged for a shelf life of 5 years in US conditions
. Moisture Content: < 17%
. Size: 3" ± 0.25" x 4" ± 0.25 "
. Heavy Metals: < 10 ppm

ST1003

Sterile Product .
I Packaged for a shelf life of 5 years in US conditions
. Moisture Content: < 17%
. Size: 8" ± 0.25" x 12" ± 0.25 "
. Heavy Metals: < 10 ppm

Figure 7.1 - Skintemp II Dressing, 2" x 2" configuration

Image /page/1/Picture/25 description: The image shows a square object with the dimensions labeled as 2" ± 0.3". The object is oriented diagonally in the frame, with the top point facing upwards. The object appears to be made of a textured material, and there is a dark shadow or marking across the middle of the square.

Traditional 510(k) application for SkinTemp II Dressing

Human Biosciences, Inc. Page 2 of 6

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7.3 Product Materials

Collagen o
Distilled water o
Buffering agent (HBS proprietary name 'Chemical Z') o

7.4 Predicate Device

Biocore Inc. SkinTemp sheet (K913023 & K925545)

7.5 Summary of Technical Characteristics

SkinTemp II Dressing is packaged as a low moisture hydrocolloid collagen wound dressing which gives SkinTemp II Dressing the advantage of being able to absorb liquid exudates and the flexibility to conform to most wound sites. Collagen protects the wound bed and newly formed granulation tissue by formation of a protective covering that is conducive to wound healing.

The HBS SkinTemp II Dressing is comparable in design and function to the predicate device: Biocore Inc. Skintemp sheet. Per 21 CFR Part 807.92(a)(5), the following table shows where the Human Biosciences, Inc. SkinTemp II Dressing is similar to and different from the Biocore SkinTemp sheet in terms of technological characteristics:

Table 7.1: Human Biosciences, Inc. SkinTemp II Dressing and Biocore Inc. SkinTemp
Sheet (predicate device) Comparison:

Feature/Characteristic	HBS SkinTemp IIDressing	Biocore Skintemp Sheet	Comparison
510(k) #	TBD	K913023 & K925545	N/A
Intended Use/Indications	The HBS SkinTemp IIDressing is indicated forthe management of burns,sores, blisters, scrapes,ulcers, and other wounds.	The BioCore SkinTempsheet is indicated for themanagement of burns,sores, blisters, scrapes,ulcers, and other wounds.	Identical
Feature/Characteristic	HBS SkinTemp IIDressing	Biocore Skintemp Sheet	Comparison
Principles ofUse	Brief Instructions for Use:Cleanse the wound. Applymedication if needed.Apply.dressing.and.coverwith.non-adherentdressing. Change asrequired.	Brief Instructions forUse:Cleanse the wound.Apply.medication.ifneeded. Apply dressingand cover with non-adherent dressing.	Identical
ScientificTechnology	The SkinTemp II Dressinguses 100% type I bovinecollagen as its primaryconstituent.	The SkinTemp Sheetuses 100% type I bovinecollagen as its primaryconstituent.	Identical
Configuration /SystemComponents	Sterile, disposable, singleuse, collagen based wounddressing with nonadherent backing. Furtherproperties include:a) Hydrocolloidb) AbsorbentDressingc) Gel formation	Sterile, disposable, singleuse, collagen basedwound dressing with nonadherent backing. Furtherproperties include:a) Hydrocolloidb) AbsorbentDressingc) Gel formation	Identical
Shippingconfiguration	SkinTemp.II.Dressing.ispacked in primarypackaging in the form of aTyvek pouch (1059B) andis then packed insecondary packing foradditional protection	SkinTemp.Sheet.ispacked in primarypackaging in the form of aTyvek pouch (1059B)and is then packed insecondary packing foradditional protection	Identical
Reusable orSingle PatientUse	Single Patient use	Single patient use	Identical
Biocompatible	Yes	Yes	Identical
Image: Human BioSciences logo
Feature/Characteristic	HBS SkinTemp IIDressing	Biocore Skintemp Sheet	Comparison
Sterility	Each dressing is sterilizedusing Electron BeamSterilization	Each sheet is sterilizedusing Electron BeamSterilization
Materials	Type I Bovine CollagenDistilled WaterBuffering agent /Chemical Z (proprietaryname)	Type I CollagenDistilled WaterBuffering Agent /Chemical Z (proprietaryname)	Identical
Size	SkinTemp II Dressingsare to be available in2"x2", 3"x4" & 8"x12"sizes	SkinTemp sheets areavailable in 2"x3", 3"x4"& 8"x12" sizes	Similar barring oneconfiguration.

Traditional 510(k) application for SkinTemp II Dressing

Human Biosciences, Inc. Page 3 of 6

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・

Traditional 510(k) application for SkinTemp II Dressing

Human Biosciences, Inc. Page 4 of 6

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Human

7.6 Summary of Non-Clinical Testing/Statement of Equivalence

The Human Biosciences, Inc. device is analogous to the predicate device (BioCore Skintemp sheet). Both are considered surface devices that come in contact with breached or compromised surfaces. They both have identical indications and instructions for use. Both have identical technological characteristics and have the same general shape, size and principles of use. Both devices consist of bovine collagen as the principle component. Finally, both have identical patient contact per ISO10993-1.

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. The results of the testing are detailed in Section 17 and full NAmSa studies are attached in Appendix B.
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

Traditional 510(k) application for SkinTemp II Dressing

Human Biosciences, Inc. Page 5 of 6

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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. The complete details about sterilization and dose audits are detailed in Section 16.

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.

7.7 Conclusion

SkinTemp II Dressing is equivalent in design, function, materials and intended use and is therefore substantially equivalent to the predicate device: BioCore SkinTemp sheet. Although both devices identical in all respects, HBS has been directed by the FDA through a warning letter dated May 10, 2012 to specifically document the use of the proprietary buffering agent 'Chemical Z' in a new 510k for SkinTemp. Biocore Inc. did not include this agent in its SkinTemp sheet 510k approvals (K913023 & K925545; filed in 1991 & 1993 respectively) due to confidentiality reasons. However, BioCore maintained full disclosure of the use of this agent from the beginning, both in its internal documents and with the FDA. FDA inspectors were made aware of the use of this buffering agent as back as 1994 during routine inspections. However, this 'Chemical Z' was never formally documented in a 510k approval. This buffering agent acts a preservative that protects the collagen in the device and helps extend the shelf life of the product prior to use. The agent is completely inert and has no active properties whatsoever. It is HBS' intention to file a new 510k for SkinTemp II Dressing and thereby formally document an ingredient that has always been part of the product.

Traditional 510(k) application for SkinTemp II Dressing

Human Biosciences, Inc. Page 6 of 6

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 26 2012

Human Biosciences, Incorporated % Methodize, Incorporated Mr. Jack Slovick President, Quality and Regulatory Affairs 2913 209th Lane Northwest Oak Grove, Minnesota 55011

Re: K122325

Trade/Device Name: Skin Temp II Dressing Regulatory Class: Unclassified Product Code: KGN Dated: October 10, 2012 Received: October 15, 2012

Dear Mr. Slovick:

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, listing 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 such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Jack Slovick

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sincerely, yours,

Mark M. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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6. INDICATIONS FOR USE STATEMENT

510(k) Number (if known): Pending

K 122325

Device Name: SkinTemp II Dressing

Indications for Use: The device is intended for the management of burns, sores, blisters, scrapes, ulcers, and other wounds.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Surgical, Orthopedic,
and Restorative Devices

Traditional 510(k) application for SkinTemp II Dressing	510(k) Number K122325
---------------------------------------------------------	-----------------------

CONFIDENTIAL
Human Biosciences, Inc.
Page 1 of 1

Regulation Number and Section

N/A