The XCelliStem Wound Powder is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.

Device Description

The XCelliStem Wound Powder is an extracellular matrix composed of porcine collagen for the management of wounds. It is white to off-white particulate that is to be used as a topical application. The product is provided sterile, for single use.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the XCelliStem Wound Powder. It outlines the regulatory process, intended use, and a comparison to predicate devices, focusing on biocompatibility, non-clinical, and clinical testing to establish substantial equivalence.

However, the document does not contain any information regarding acceptance criteria or a study that proves a device meets specific performance criteria in the context of an AI/algorithm-driven device. There is no mention of accuracy metrics, sensitivity, specificity, or any statistical evaluation of performance that would typically be associated with such a study. The information provided heavily emphasizes physical, chemical, and biological characteristics to demonstrate equivalence to existing wound dressings.

Therefore, I cannot fulfill your request with the provided text. The document does not describe the kind of study you are asking about (e.g., related to AI performance, human reader improvement with AI assistance, MRMC studies, ground truth establishment for a diagnostic algorithm).

The response to your request would be:

The provided document, K172593 for the XCelliStem Wound Powder, does not contain information about acceptance criteria or a study proving the device meets performance criteria in the context of an AI/algorithm-driven device. The 510(k) submission focuses on demonstrating substantial equivalence to predicate wound dressings through biocompatibility, non-clinical, and limited clinical testing, not on algorithm performance metrics. Therefore, I cannot provide the requested table or details about an AI performance study.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 16, 2018

StemSys Clay Fette CEO 10871 NW 52nd St. Ste 4 Sunrise, Florida 33351

Re: K172593 Trade/Device Name: XCelliStem Wound Powder Regulatory Class: Unclassified Product Code: KGN Dated: February 13, 2018 Received: February 14, 2018

Dear Clay Fette:

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172593

Device Name XCELLISTEM WOUND POWDER

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

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K172593 page 1 of 3

K172593

Applicant: StemSys

XCelliStem Wound Powder Traditional 510(k) Premarket Notification

Section 5 510(k) Summary

XCelliStem Wound Powder 510(k) SUMMARY -

Company Name:	StemSys
Company Address:	10871 NW 52nd St, Ste 4Sunrise, FL 33351
Contact Person:	Clay FetteChief Executive Officer
Phone Number:	561-324-9507
Date Prepared:	August 17, 2016
Device Trade Name:	XCelliStem Wound Powder
Device Common Name:	Wound Dressing
Classification Number:	Unclassified
Classification Name:	Dressing, Wound, Collagen
Product Code:	KGN

Predicate Devices:

Company	Device	510(k) Number
Cook Biotech Inc.	Cook ECM Powder	K152033
ACell, Inc.	ACell Powder Wound Dressing	K060888
Device Description:	The XCelliStem Wound Powder is an extracellular matrix composedof porcine collagen for the management of wounds. It is white to off-white particulate that is to be used as a topical application. Theproduct is provided sterile, for single use.
Intended Use:	The XCelliStem Wound Powder is intended for the management ofwounds including: partial and full-thickness wounds, pressure ulcers,diabetic ulcers, venous ulcers, chronic vascular ulcers,tunneled/undermined wounds, surgical wounds (donor sites/grafts,post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),trauma wounds (abrasions, lacerations, second-degree burns, and skintears), and draining wounds. The device is intended for one-time use.
Substantial Equivalence:	XCelliStem Wound Powder has the same intended use, principles ofoperation, and similar technological characteristics as both predicatedevices. While the subject device differs from the predicate devicesin the source tissue (porcine spleen and lung vs. porcine smallintestine or porcine urinary bladder), all three devices share the samemode of action in regards to covering the wound and providing a

Section 5.0

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moist wound environment to maintain an appropriate environment for wound management. XCelliStem Wound Powder is as safe and effective and performs as well as the legally marketed predicate devices based on an evaluation of biocompatibility, bench, nonclinical, and clinical performance; any differences in technological characteristics do not raise new questions about the safety and efficacy of XCelliStem Wound Powder.

Summary of Biocompatibility, Non-clinical testing, and Clinical testing

The following testing was performed to demonstrate substantial equivalence:

Biocompatibility testing:

Cytotoxicity ●
Sensitization ●
Intracutaneous Reactivity
Acute Systemic Toxicity
Pyrogenicity
Toxicology Risk Assessment
Implantation
Genotoxicity

Clinical testing:

Repeat Insult Patch Test ●
Skin Prick Test

Other testing:

Sterilization Validation ●
Viral Inactivation ●
Device Characterization: Collagen type composition, Sulfated glycosaminoglycan composition, Hyaluronic acid composition, Lipid composition, Elastin composition, Fibronectin composition, and Laminin composition
Extractables & Leachables
Bacterial Endotoxin

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K172593

XCelliStem Wound Powder Traditional 510(k) Premarket Notification

Product Name	Proposed XCelliStem WoundPowder	Cook ECM Powder	ACell Powder WoundDressing
Product Code,Regulation #,Name	KGNUnclassifiedDressing, Wound, Collagen	KGNUnclassifiedDressing, Wound, Collagen	KGNUnclassifiedDressing, Wound, Collagen
Manufacturer	StemSys	Cook Biotech Inc.	ACell, Inc.
Intended Use	The XCelliStem™ WoundPowder is intended for themanagement of wounds thatinclude:• Partial and fullthickness wounds• Pressure ulcers,• venous ulcers, diabeticulcers, chronicvascular ulcers• Second degree burns• Surgical wounds –donor sites/grafts,post-Moh's surgery,post-laser surgery,podiatric, wounddehiscence• Trauma wounds –abrasions, lacerations,and skin tears• Tunneled/underminedwounds• Draining wounds	Cook ECM Powder is intendedfor the management of woundsthat include:• Partial and fullthickness wounds• Pressure ulcers,• venous ulcers, diabeticulcers, chronicvascular ulcers• Second degree burns• Surgical wounds –donor sites/grafts,post-Moh's surgery,post-laser surgery,podiatric, wounddehiscence• Trauma wounds –abrasions, lacerations,and skin tears• Tunneled/underminedwounds• Draining wounds	The ACell™ Powder WoundDressing is intended for themanagement of woundsincluding:• Partial and fullthickness wounds• Pressure ulcers,• venous ulcers, diabeticulcers, chronicvascular ulcers• Second degree burns• Surgical wounds –donor sites/grafts,post-Moh's surgery,post-laser surgery,podiatric, wounddehiscence• Trauma wounds –abrasions, lacerations,and skin tears• Tunneled/underminedwounds• Draining wounds
Composition	Collagen type I, III, IV	Collagen type I, III, IV, VI	Collagen types I, III, IV
CollagenSource	Porcine spleen and lung	Porcine small intestinesubmucosa	Porcine urinary bladder
Sterile	Yes, E Beam	Yes, Ethylene Oxide	Yes, E Beam
How supplied	particulate;for single use	particulate;for single use	particulate;for single use
How applied	Topical use	Topical use	Topical use
Biocompatible	Yes	Yes	Yes
510(k) Number	K172593	K152033	K060888

Comparison Table for Substantial Equivalence

Regulation Number and Section

N/A