XCelliStem Wound Powder

K172593 · Stemsys · KGN · Mar 16, 2018 · SU

Device Facts

• Record ID: K172593
• Device Name: XCelliStem Wound Powder
• Applicant: Stemsys
• Product Code: KGN · SU
• Decision Date: Mar 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

XCelliStem Wound Powder is a sterile, porcine-derived extracellular matrix (ECM) particulate dressing. Composed of collagen types I, III, and IV sourced from porcine spleen and lung tissue. Applied topically to wounds to provide a moist environment for wound management. Intended for single-use in clinical or home settings. Functions as a physical wound covering; supports wound healing environment. No active electronic components or software.

Clinical Evidence

Clinical testing included Repeat Insult Patch Test and Skin Prick Test. Biocompatibility testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, implantation, and genotoxicity. Additional non-clinical testing included sterilization validation, viral inactivation, and characterization of collagen, glycosaminoglycan, hyaluronic acid, lipid, elastin, fibronectin, and laminin composition.

Technological Characteristics

Extracellular matrix (ECM) particulate dressing; porcine-derived collagen types I, III, IV. Sterile; E-beam sterilization. Topical application. No energy source or connectivity. No software.

Indications for Use

Indicated for management of partial/full-thickness wounds, pressure/diabetic/venous/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's/laser/podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.

Predicate Devices

• Cook ECM Powder (K152033)
• ACell Powder Wound Dressing (K060888)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------------|
| <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 4<br>Sunrise, FL 33351 |
| Contact Person: | Clay Fette<br>Chief 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 composed<br>of porcine collagen for the management of wounds. It is white to off-<br>white particulate that is to be used as a topical application. The<br>product is provided sterile, for single use. | | |
| Intended Use: | The XCelliStem Wound Powder is intended for the management of<br>wounds including: partial and full-thickness wounds, pressure ulcers,<br>diabetic ulcers, venous ulcers, chronic vascular ulcers,<br>tunneled/undermined wounds, surgical wounds (donor sites/grafts,<br>post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),<br>trauma wounds (abrasions, lacerations, second-degree burns, and skin<br>tears), and draining wounds. The device is intended for one-time use. | | |
| Substantial Equivalence: | XCelliStem Wound Powder has the same intended use, principles of<br>operation, and similar technological characteristics as both predicate<br>devices. While the subject device differs from the predicate devices<br>in the source tissue (porcine spleen and lung vs. porcine small<br>intestine or porcine urinary bladder), all three devices share the same<br>mode 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 Wound<br>Powder | Cook ECM Powder | ACell Powder Wound<br>Dressing |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,<br>Regulation #,<br>Name | KGN<br>Unclassified<br>Dressing, Wound, Collagen | KGN<br>Unclassified<br>Dressing, Wound, Collagen | KGN<br>Unclassified<br>Dressing, Wound, Collagen |
| Manufacturer | StemSys | Cook Biotech Inc. | ACell, Inc. |
| Intended Use | The XCelliStem™ Wound<br>Powder is intended for the<br>management of wounds that<br>include:<br>• Partial and full<br>thickness wounds<br>• Pressure ulcers,<br>• venous ulcers, diabetic<br>ulcers, chronic<br>vascular ulcers<br>• Second degree burns<br>• Surgical wounds –<br>donor sites/grafts,<br>post-Moh's surgery,<br>post-laser surgery,<br>podiatric, wound<br>dehiscence<br>• Trauma wounds –<br>abrasions, lacerations,<br>and skin tears<br>• Tunneled/undermined<br>wounds<br>• Draining wounds | Cook ECM Powder is intended<br>for the management of wounds<br>that include:<br>• Partial and full<br>thickness wounds<br>• Pressure ulcers,<br>• venous ulcers, diabetic<br>ulcers, chronic<br>vascular ulcers<br>• Second degree burns<br>• Surgical wounds –<br>donor sites/grafts,<br>post-Moh's surgery,<br>post-laser surgery,<br>podiatric, wound<br>dehiscence<br>• Trauma wounds –<br>abrasions, lacerations,<br>and skin tears<br>• Tunneled/undermined<br>wounds<br>• Draining wounds | The ACell™ Powder Wound<br>Dressing is intended for the<br>management of wounds<br>including:<br>• Partial and full<br>thickness wounds<br>• Pressure ulcers,<br>• venous ulcers, diabetic<br>ulcers, chronic<br>vascular ulcers<br>• Second degree burns<br>• Surgical wounds –<br>donor sites/grafts,<br>post-Moh's surgery,<br>post-laser surgery,<br>podiatric, wound<br>dehiscence<br>• Trauma wounds –<br>abrasions, lacerations,<br>and skin tears<br>• Tunneled/undermined<br>wounds<br>• Draining wounds |
| Composition | Collagen type I, III, IV | Collagen type I, III, IV, VI | Collagen types I, III, IV |
| Collagen<br>Source | Porcine spleen and lung | Porcine small intestine<br>submucosa | Porcine urinary bladder |
| Sterile | Yes, E Beam | Yes, Ethylene Oxide | Yes, E Beam |
| How supplied | particulate;<br>for single use | particulate;<br>for single use | particulate;<br>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