(199 days)
Not Found
No
The device description and performance studies focus on the material composition and biological properties of the wound powder, with no mention of AI or ML algorithms for analysis, diagnosis, or treatment guidance.
Yes
The device is described as "intended for the management of wounds," which addresses a medical condition and implies a therapeutic purpose.
No
The device description and intended use indicate that the XCelliStem Wound Powder is a treatment for wounds, composed of porcine collagen for topical application. It is not described as being used to identify, diagnose, or monitor a medical condition.
No
The device description explicitly states it is an "extracellular matrix composed of porcine collagen" and a "white to off-white particulate," indicating it is a physical material, not software.
Based on the provided information, the XCelliStem Wound Powder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the management of wounds by topical application. This is a therapeutic or wound care application, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue samples to diagnose a condition.
- Device Description: The device is described as an extracellular matrix composed of porcine collagen for topical application to wounds. This aligns with a wound dressing or wound care product, not an IVD.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological specimens, detect markers, or provide diagnostic information about a patient's health status.
- Testing Performed: The testing performed (biocompatibility, clinical testing like patch tests, sterilization validation, etc.) is typical for a medical device intended for direct contact with the body for wound management, not for an IVD.
In summary, the XCelliStem Wound Powder is a medical device intended for the treatment and management of wounds, not for diagnostic purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
KGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wounds (partial and full-thickness, pressure ulcers, diabetic ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined, 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).
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)
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
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.
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
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.
1
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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K172593 page 1 of 3
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 |
| Sunrise, FL 33351 | |
| Contact Person: | Clay Fette |
| 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 | ||
| 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. | |||
| 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. | |||
| Substantial Equivalence: | XCelliStem Wound Powder has the same intended use, principles of | ||
| operation, and similar technological characteristics as both predicate | |||
| devices. While the subject device differs from the predicate devices | |||
| in the source tissue (porcine spleen and lung vs. porcine small | |||
| intestine or porcine urinary bladder), all three devices share the same | |||
| mode of action in regards to covering the wound and providing a |
Section 5.0
4
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
5
XCelliStem Wound Powder Traditional 510(k) Premarket Notification
| Product Name | Proposed XCelliStem Wound
Powder | Cook ECM Powder | ACell Powder Wound
Dressing |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code,
Regulation #,
Name | KGN
Unclassified
Dressing, Wound, Collagen | KGN
Unclassified
Dressing, Wound, Collagen | KGN
Unclassified
Dressing, Wound, Collagen |
| Manufacturer | StemSys | Cook Biotech Inc. | ACell, Inc. |
| Intended Use | The XCelliStem™ Wound
Powder is intended for the
management of wounds that
include:
• Partial and full
thickness wounds
• Pressure ulcers,
• venous ulcers, diabetic
ulcers, chronic
vascular ulcers
• Second degree burns
• Surgical wounds –
donor sites/grafts,
post-Moh's surgery,
post-laser surgery,
podiatric, wound
dehiscence
• Trauma wounds –
abrasions, lacerations,
and skin tears
• Tunneled/undermined
wounds
• Draining wounds | Cook ECM Powder is intended
for the management of wounds
that include:
• Partial and full
thickness wounds
• Pressure ulcers,
• venous ulcers, diabetic
ulcers, chronic
vascular ulcers
• Second degree burns
• Surgical wounds –
donor sites/grafts,
post-Moh's surgery,
post-laser surgery,
podiatric, wound
dehiscence
• Trauma wounds –
abrasions, lacerations,
and skin tears
• Tunneled/undermined
wounds
• Draining wounds | The ACell™ Powder Wound
Dressing is intended for the
management of wounds
including:
• Partial and full
thickness wounds
• Pressure ulcers,
• venous ulcers, diabetic
ulcers, chronic
vascular ulcers
• Second degree burns
• Surgical wounds –
donor sites/grafts,
post-Moh's surgery,
post-laser surgery,
podiatric, wound
dehiscence
• Trauma wounds –
abrasions, lacerations,
and skin tears
• Tunneled/undermined
wounds
• Draining wounds |
| Composition | Collagen type I, III, IV | Collagen type I, III, IV, VI | Collagen types I, III, IV |
| Collagen
Source | Porcine spleen and lung | Porcine small intestine
submucosa | 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 |