(252 days)
The Flowable Wound Matrix 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, 2nd degree burns, skin tears) and draining wounds.
The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix 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.
I am sorry, but the provided text only contains a 510(k) summary for the "Flowable Wound Matrix" device. It outlines the device description, its intended use, comparison to predicate/reference devices, and a summary of non-clinical tests conducted for substantial equivalence.
However, the document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets them. Specifically, it lacks:
- A table of acceptance criteria and reported device performance. It only lists performed tests (biocompatibility, rehydration and deployment, package integrity, shelf life, collagen characterization).
- Sample sizes used for a test set, data provenance, or details about ground truth establishment.
- Information on the number of experts or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Sample size for a training set or how ground truth for a training set was established.
This document is focused on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and comparison of features, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2016
Cook Biotech Incorporated Nick Wang, Ph.D. Regulatory Affairs Scientist 1425 Innovation Place West Lafayette, Indiana 47906
Re: K160136
Trade/Device Name: Flowable Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: September 2, 2016 Received: September 6, 2016
Dear Dr. Wang:
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 devicerelated 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.
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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/ResourcesforYou/Industry/default.htm. 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.
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
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K160136
Device Name Flowable Wound Matrix
Indications for Use (Describe) The Flowable Wound Matrix is intended for the management of wounds including:
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partial and full-thickness wounds,
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pressure ulcers,
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venous ulcers,
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diabetic ulcers,
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chronic vascular ulcers,
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tunneled/undermined wounds.
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surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
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trauma wounds (abrasions, lacerations, 2nd degree burns, skin tears),
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draining wounds.
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 W. GuinnVice President of Quality Assurance & Regulatory AffairsCook Biotech Incorporated1425 Innovation PlaceWest Lafayette, IN 47906(765) 497-335523 September 2016 |
|---|---|
| --------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Name of Device:
| Trade/Proprietary Name: | Flowable Wound Matrix |
|---|---|
| 510(k) Number: | K160136 |
| Common/Usual Name: | Dressing, Wound, Collagen |
| Classification Name: | Dressing, Wound, Collagen |
| Product Code: | KGN |
| Device Class: | The product code KGN is considered by FDA to be unclassified. |
Predicate Device:
Oasis Wound Matrix (K061711)
Reference Devices:
Integra Flowable Wound Matrix (K072113) Cook ECM Powder (K152033) MicroMatrix (K153754)
Intended Use:
The Flowable Wound Matrix 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, 2nd degree burns, skin tears) and draining wounds.
Device Description:
The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech
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Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix 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 subject and predicate devices share the same fundamental technology; the main components of both devices are porcine SIS. The main difference between the subject and predicate is the device configuration and method of application. The Oasis Wound Matrix is supplied as a dry sheet of SIS and is applied topically by rehydrating and placing the sheet directly onto a wound. The Flowable Wound Matrix, in contrast, is particulate SIS supplied dry in a cylindrical shape. Upon rehydration with saline, the device acquires a gel-like consistency and can be applied directly to the wound site using the supplied syringe.
Summary of Non-Clinical Tests:
The following testing was performed to demonstrate substantial equivalence:
- Biocompatibility Testing:
- o Cytotoxicity
- o Sensitization
- Irritation/Intracutaneous Reactivity O
- O Acute Systemic Toxicity
- Other Testing: ●
- Rehydration and Deployment o
- o Package Integrity
- Shelf Life o
- Collagen Characterization (Western Blot and Digital Scanning o Calorimetry)
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Substantial Equivalence:
Table 5-1 provides a comparison of the subject and predicate devices.
To provide further evidence of substantial equivalence, CBI used the 510(k) Decision-Making Flowchart from the FDA guidance document Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (July 28, 2014) to compare and assess the intended use and the technological characteristics of the subject and predicate devices. Specifically, the intended uses of both devices are identical. In terms of technological characteristics, while the subject device differs from the predicate device in form (sheet vs. flowable), both devices share the same underlying technology, namely topical application of porcine SIS for wound management. In this 510(k), CBI submits biocompatibility, deployment, package and shelf-life testing as evidence to demonstrate the device can function as intended and performs comparably to the predicate device that is currently marketed for the same intended use. In conclusion, CBI believes the Flowable Wound Matrix is substantially equivalent to the Oasis Wound Matrix based on success in non-clinical testing and the identical nature of the fundamental technology and intended use.
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| Flowable WoundMatrix (SubjectDevice) | Oasis® Wound Matrix(Predicate Device) | Integra™ FlowableWound Matrix(Reference Device) | Cook ECM Powder(Reference Device) | MicroMatrix®(Reference Device) | Flowable WoundMatrix (SubjectDevice) | Oasis® Wound Matrix(Predicate Device) | Integra™ FlowableWound Matrix(Reference Device) | Cook ECM Powder(Reference Device) | MicroMatrix(Reference Device) | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 510(k)number | K160136 | K061711 | K072113 | K152033 | K153754 | Dimensions | Particles of ≤1000 µmin diameterVolume of device is1.25cc | 2 cm x 2 cm to 20 cmby 40 cm | Collagen Particles of200 – 2000 um indiameter*Volume of device is3cc | Particles of ≤1000 µmin diameter | Two particledistributions, particlesof <500 um and <1000um |
| Indicationfor Use | The Flowable WoundMatrix is intended forthe management ofwounds including:partial and full-thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/underminedwounds, surgicalwounds (donorsites/grafts, post-Moh'ssurgery, post-lasersurgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,second-degree burns,and skin tears),draining wounds. | Oasis® Wound Matrixis intended for themanagement of woundsincluding: partial andfull-thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/underminedwounds, surgicalwounds (donorsites/grafts, post-Moh'ssurgery, post-lasersurgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,second-degree burns,and skin tears),draining wounds. | Integra™ FlowableWound Matrix isintended for themanagement of woundsincluding: partial andfull-thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/underminedwounds, surgicalwounds (donorsites/grafts, post-Moh'ssurgery, post-lasersurgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,second-degree burns,and skin tears),draining wounds. | Cook® ECM Powder isintended for themanagement of woundsincluding: partial andfull-thickness wounds,pressure ulcers, venousulcers, diabetic ulcers,chronic vascular ulcers,tunneled/underminedwounds, surgicalwounds (donorsites/grafts, post-Moh'ssurgery, post-lasersurgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,second-degree burns,and skin tears),draining wounds. | MicroMatrix® isintended for themanagement of topicalwounds including:partial and full-thickness wounds,pressureulcers, venous ulcers,diabetic ulcers, chronicvascular ulcers,tunneled/underminedwounds, surgicalwounds (donor sites/grafts, post-Mohssurgery, post-lasersurgery, podiatric,wound dehiscence),trauma wounds(abrasions, lacerations,second-degree burns,and skin tears), anddraining wounds. | Technological Features | Device is rehydrated toa gel-like consistencyusing saline in a dualsyringe/luer connectorsystem, and thenapplied topically. | Sheet is rehydrated andapplied topically | Device is rehydrated toa gel-like consistencyusing saline in a dualsyringe/luer connectorsystem, and thenapplied topically. | Powder, applieddirectly topically | Particle, applieddirectly topically |
| CollagenSource | Porcine small intestinalsubmucosa | Porcine small intestinalsubmucosa | Bovine tendon collagen | Porcine small intestinalsubmucosa | Porcine urinary bladdermatrix | Suppliedsterile? | Yes | Yes | Yes | Yes | Yes |
| Sterilizationmethod | E-beam | Ethylene Oxide | Unknown | Ethylene Oxide | E-beam | ||||||
| Intended forsingle use? | Yes | Yes | Yes | Yes | Yes |
Table 5-1. Substantial Equivalence Information
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N/A