(28 days)
No
The device description and performance studies focus on the biological and physical properties of the extracellular matrix powder, with no mention of AI or ML.
Yes
The device is intended for the management of various types of wounds, including chronic and surgical wounds, by providing a scaffold for cellular invasion and capillary growth, which aligns with the definition of a therapeutic device.
No
The device is described as a "powdered device prepared for management of wounds" that "provides a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management." This indicates a therapeutic or wound management function, not a diagnostic one.
No
The device description clearly states it is composed of porcine small intestinal submucosa (SIS) processed into a powder, indicating it is a physical material, not software.
Based on the provided information, the Cook® ECM Powder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of wounds." This involves applying the device directly to a wound on a patient's body to aid in the healing process.
- Device Description: The description explains that the device provides a "scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management." This is a therapeutic or regenerative function, not a diagnostic one.
- Lack of Diagnostic Activities: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose a condition, monitor a disease, or determine compatibility.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. The Cook® ECM Powder's function is to directly interact with and support the healing of a wound on the body.
N/A
Intended Use / Indications for Use
Indications For Use: Cook® ECM Powder is intended for the management of wounds including:
· partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- · diabetic 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)
- · draining wounds
The device is provided sterile and intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
KGN
Device Description
Cook " ECM Powder is composed of porcine small intestinal submucosa (SIS) that has been processed to isolate the extracellular matrix (ECM), or medical-grade SIS. Further treatment and final sterilization yields a powdered device prepared for management of wounds. The powder is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 mitigate new risks posed by the size change and to demonstrate substantial equivalence to the predicate device:
- Biocompatibility Testing: o
- o Cytotoxicity
- Acute systemic toxicity о
- Irritation/Intracutaneous reactivity O
- Other Product Testing: o
- o Deplovability
- Simulated shipping, handling, and storage followed by visual inspection and o testing of seal strength and integrity
- Heavy metal quantification o
- Particle size characterization O
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.
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the first profile having a beak-like extension. The profiles are stacked on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Cook Biotech Incorporated Dr. Katie Molland Regulatory Affairs 1425 Innovation Place West Lafayette, Indiana 47906
Re: K152033 Trade/Device Name: Cook® ECM Powder Regulatory Class: Unclassified Product Code: KGN Dated: July 21, 2015 Received: July 22, 2015
Dear Dr. Molland:
This letter corrects our letter of August 19, 2015.
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 (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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) K152033
Device Name Cook® ECM Powder
Indications for Use (Describe)
Indications For Use: Cook® ECM Powder is intended for the management of wounds including:
· partial and full-thickness wounds
- pressure ulcers
- venous ulcers
- · diabetic 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)
- · draining wounds
The device is provided sterile and intended for one-time use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Submitted by: Perry Guinn, Vice President, Quality Assurance and Regulatory Affairs Cook Biotech Incorporated 1425 Innovation Place West Lafayette, IN 47906 (765) 497-3355 21 July, 2015
Name of Device:
Trade Name: Common/Usual name: Proposed classification name: Product Code: Device Class:
Cook® ECM Powder Collagen Wound Dressing Dressing, Wound, Collagen KGN The product code KGN is considered by FDA to be unclassified.
Performance Standards:
No performance standards that have been established under Section 514 of the Food, Drug and Cosmetic act apply to this device.
Predicate Device:
The predicate device for Cook® ECM Powder is Oasis® Wound Matrix manufactured by Cook Biotech Incorporated (510(k) No. K061711) cleared on July 19, 2006.
Reference Device:
The reference device for this submission is ACell™ Powdered Wound Dressing (510(k) No. K060888) cleared on June 23, 2006.
Intended Use:
The intended use of Cook® ECM Powder is for the management of wounds including:
- partial and full-thickness wounds ●
- pressure ulcers ●
- venous ulcers
- diabetic ulcers ●
- o chronic vascular ulcers
- o tunneled/undermined wounds
- o surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
4
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) ●
- draining wounds ●
The device is supplied sterile and is intended for one-time use.
This intended use is identical to that previously cleared under K061711 for the predicate device.
Device Description:
Cook " ECM Powder is composed of porcine small intestinal submucosa (SIS) that has been processed to isolate the extracellular matrix (ECM), or medical-grade SIS. Further treatment and final sterilization yields a powdered device prepared for management of wounds. The powder is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.
Comparison to Predicate Device:
The modification made to Oasis® Wound Matrix to produce Cook® ECM Powder can be defined as a change in device size. Like Cook® ECM Powder, Oasis® Wound Matrix is composed of medical-grade SIS. Both devices have the same intended use, however, the predicate device is a flat sheet of SIS, while the subject device is a flat sheet that has been cryomilled into a powder.
Comparison to Reference Device:
ACell" Powdered Wound Dressing is another product indicated for wound healing that is manufactured from porcine tissue; in this case urinary bladder matrix (UBM). UBM is also a three-dimensional, acellular, collagen-rich extracellular membrane. It is included in this submission as a reference device in order to highlight a common technological characteristic both the subject and reference devices are powdered forms of extracellular matrix sheets (Oasis Wound Matrix and ACell" UBM Lyophilized Wound Dressing, respectively) that are intended to aid in wound management.
5
Summary of Non-Clinical Tests:
The following testing was performed to mitigate new risks posed by the size change and to demonstrate substantial equivalence to the predicate device:
- Biocompatibility Testing: o
- o Cytotoxicity
- Acute systemic toxicity о
- Irritation/Intracutaneous reactivity O
- Other Product Testing: o
- o Deplovability
- Simulated shipping, handling, and storage followed by visual inspection and o testing of seal strength and integrity
- Heavy metal quantification o
- Particle size characterization O
Substantial Equivalence:
Table 5-1 below provides a comparison of the subject device and its predicate.
Conclusion:
In summary, the subject device, Cook® ECM Powder, has been compared to the predicate device, Oasis® Wound Matrix, on the bases of fundamental scientific technology and intended use. Oasis® Wound Matrix is an FDA-cleared device of long standing (K973170/K061711). The intended uses of both subject and predicate devices are identical. Furthermore, the devices share a common basic material, SIS. The safety of SIS, both in Oasis® Wound Matrix and other Cook Biotech Inc. products, has been established via biocompatibility testing as well as a significant history of successful treatment throughout the body in a wide variety of applications on or in nearly one million human patients. Any potential new risks associated with the change in shape of the predicate device from sheet to powder form have been identified by appropriate risk analysis techniques. These potential new risks have been addressed with verification and validation activities in a manner satisfactory to the pre-determined acceptance criteria to ensure that no change to device safety has occurred. Based on comparison of fundamental scientific technology and intended use and following completion of verification and validation testing, it is the position of CBI that Cook® ECM Powder is substantially equivalent to Oasis® Wound Matrix and the technological differences between subject and predicate devices do not raise new questions of safety or effectiveness.
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| Device | Cook® ECM Powder
(Subject Device) | Oasis® Wound Matrix
(Predicate Device) |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Cook Biotech Inc. | Cook Biotech Inc. |
| 510(k) number | K152033 | K061711 |
| Intended Use | The intended use of Cook® ECM
Powder is for the management of
wounds including: partial and full-
thickness wounds, pressure ulcers,
venous ulcers, diabetic 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),
draining wounds. | The intended use of Oasis® Wound
Matrix is for the management of
wounds including: partial and full-
thickness wounds, pressure ulcers,
venous ulcers, diabetic 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),
draining wounds. |
| Product Code | KGN | KGN |
| Material | Porcine small intestinal submucosa;
primarily Types I, III, IV and VI
collagen (constituents of the
extracellular matrix) | Porcine small intestinal submucosa;
primarily Types I, III, IV and VI
collagen (constituents of the
extracellular matrix) |
| Dimensions | Particles of ≤1000 μm | Sheets of 2 cm x 2 cm to 20 cm x
40 cm |
| Supplied sterile? | Yes | Yes |
| Sterilization
method | Ethylene Oxide | Ethylene Oxide |
| Intended for single
use? | Yes | Yes |
Table 5-1. Substantial Equivalence Information