(136 days)
No
The device description and intended use focus on the material properties and physical form of an acellular wound dressing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as an acellular wound dressing intended for the management of wounds, not a device that provides therapy or treatment itself.
No
Explanation: The device is described as an "acellular wound dressing" intended for the "management of wounds." Its function is to facilitate healing, not to diagnose a condition.
No
The device description clearly states it is an "animal-sourced, acellular wound dressing" which is a physical product, not software.
Based on the provided information, the Geistlich Wound Matrix is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the management of wounds. This involves direct application to the wound to aid in healing, not for testing or analyzing samples taken from the body.
- Device Description: The description details a physical wound dressing made from animal tissue, designed to be applied to the wound surface. It doesn't describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers
The Geistlich Wound Matrix is a medical device intended for therapeutic use in wound care.
N/A
Intended Use / Indications for Use
The Geistlich Wound Matrix is intended for the management of wounds including:
- partial and full thickness wounds
- pressure ulcers
- venous ulcers
- diabetic ulcers
- chronic vascular ulcers
- surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence)
- trauma skin wounds (abrasions, laceration, second degree burns, skin tears)
Product codes
KGN
Device Description
The device is an animal-sourced, acellular wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. The Geistlich Wound Matrix is terminally sterilized in its packaging.
The device has a thickness of 2.5-5mm and is offered in 3 sizes: 15 mm x 20 mm; 20 mm x 30 mm; and 30 mm x 40 mm. The device can be trimmed as needed.
The device is intended to be used by licensed surgeons and will be supplied sterile for single one time use.
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
licensed surgeons
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)
Because the material of the subject device is identical to the reference device (K102531), the existing biocompatibility, sterilization, and shelf life information fully applies. Bench, animal, and clinical data are not necessary to support the substantial equivalence of a wound dressing.
The Geistlich Wound Matrix is identical in design and material to the reference device, the Geistlich MUCOGRAFT Collage Matrix (K102531).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the name written out in blue letters next to it. The Department of Health and Human Services seal is a circular emblem with a stylized image of a caduceus.
November 3, 2017
Geistlich Pharma AG % Stephen Rhodes Senior Consultant, Devices Biologics Consulting Group, Inc. 400 N. Washington St. Suite 100 Alexandria, Virginia 22314
Re: K171842
Trade/Device Name: Geistlich Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: June 9, 2017 Received: June 20, 2017
Dear Stephen Rhodes:
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
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
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) K171842
Device Name Geistlich Wound Matrix
Indications for Use (Describe)
The Geistlich Wound Matrix is intended for the management of wounds including:
· partial and full thickness wounds
- · pressure ulcers
- venous ulcers
- · diabetic ulcers
- · chronic vascular ulcers
- · surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, wound dehiscence)
- · trauma skin wounds (abrasions, laceration, second degree burns, skin tears)
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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary is provided below.
SUBMITTER 1.
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
Contact Person: Jan van der Ploeg Phone: +41 41 492 69 28 Email: jan.vanderploeg@geistlich.ch
Prepared By: Stephen P. Rhodes, Biologics Consulting Group, rhodes@biologicsconsulting.com Date Prepared: November 1, 2017
2. DEVICE
Name of Device: Geistlich Wound Matrix Common Name: Collagen Wound Dressing Classification Regulation/Class: unclassified Product Code: KGN Panel: General and Plastic Surgery
PREDICATE DEVICE 3.
Predicate Device: Miromatrix Wound Matrix (K140510)
Reference Device: Geistlich MUCOGRAFT® Collagen Matrix (K102531)
DEVICE DESCRIPTION 4.
The device is an animal-sourced, acellular wound dressing that is derived from porcine tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is intended for use in the management of wounds. The Geistlich Wound Matrix is terminally sterilized in its packaging.
The device has a thickness of 2.5-5mm and is offered in 3 sizes: 15 mm x 20 mm; 20 mm x 30 mm; and 30 mm x 40 mm. The device can be trimmed as needed.
The device is intended to be used by licensed surgeons and will be supplied sterile for single one time use.
4
ട. INDICATION FOR USE
The Geistlich Wound Matrix is intended for the management of wounds including:
- partial and full thickness wounds
- pressure ulcers
- venous ulcers ●
- diabetic ulcers ●
- chronic vascular ulcers
- surgical wounds (donor sites/grafts, post Moh's surgery, post laser surgery, podiatric, ● wound dehiscence)
- trauma skin wounds (abrasions, laceration, second degree burns, skin tears)
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.
The Geistlich Wound Matrix is an acellular wound dressing derived from non-crosslinked porcine (skin and connective) tissue. The porcine tissue undergoes processing to remove proteins and inactivate viruses. The device is mostly collagen Type 1, and is intended for use in the management of wounds. The Geistlich Wound Matrix is terminally sterilized in its packaging. The device is offered in sizes ranging from 15 mm x 20 mm x 40 mm and can be trimmed as needed.
The predicate Miromatrix Wound Matrix is also a non-crosslinked porcine-derived wound dressing that undergoes processing and sterilization to produce an acellular, virally-inactivated dressing that is mostly collagen Type 1 and that covers and protects the wound. Like the Geistlich Wound Matrix, the Miromatrix Wound Matrix is available in a range of sizes and may be cut to shape during surgery.
As is the case with collagen wound dressings on the market, there are differences in the design of the Geistlich Wound Matrix and the predicate dressing. For example, the subject device is derived from porcine connective tissue, whereas the predicate is derived from porcine liver tissue. The subject dressing is a bilayer with a thickness ranging from 2.5 - 5 mm. The predicate is provided in a single layer with a thickness of 0.3 - 1.5 mm. The predicate device is available in a wider range of sizes than the subject device. The difference between the single layer and bilayer design, sizes and thickness of the Geistlich Wound Matrix does not impact the safety and effectiveness of the dressing when compared to the Miromatrix Wound Matrix.
Overall, the technological characteristics of the Geistlich Wound Matrix and the Miromatrix Wound Matrix are similar. Both matrices are porcine-derived and are intended for wound management. While the intended uses of the subject and predicate dressing are the same, the technologies, are not the same.
The Geistlich Wound Matrix is the same product as the MUCOGRAFT reference device. The biocompatibility testing and product characterization studies performed on the MUCOGRAFT reference device apply to the Geistlich Wound Dressing.
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The table provides a summary comparison between the subject device, the proposed predicate, and the reference device.
| Subject Device | Predicate Device | Reference Device | |
|---|---|---|---|
| 510(k) Number | TBD | K140510 | K102531 |
| Applicant | Geistlich Pharma AG | Miromatrix Medical, Inc. | Geistlich Pharma AG |
| Device Name | Geistlich Wound Matrix | Miromatrix Wound Matrix | MUCOGRAFT® Collagen Matrix |
| Classification | |||
| Regulation, | |||
| Class | Unclassified | Unclassified | 21 CFR 872.3930, class II |
| Product Code | KGN | KGN | NPL |
| Indications for | |||
| Use | Geistlich Wound Matrix is intended | ||
| for the management of wounds | |||
| including: | |||
| • partial and full thickness wounds | |||
| • pressure ulcers | |||
| • venous ulcers | |||
| • diabetic ulcers | |||
| • chronic vascular ulcers | |||
| • surgical wounds (donor sites/grafts, | |||
| post Moh's surgery, post laser | |||
| surgery, podiatric, wound | |||
| dehiscence) | |||
| • trauma skin wounds (abrasions, | |||
| laceration, second degree burns, | |||
| skin tears) | Same as subject device, except | ||
| that indications also include | |||
| tunnel/undermined wounds and | |||
| draining wounds. | MUCOGRAFT® Collagen Matrix | ||
| is indicated for: | |||
| • Covering of implants placed in | |||
| immediate or delayed extraction | |||
| sockets | |||
| • Localized gingival | |||
| augmentation to increase | |||
| keratinized tissue (KT) around | |||
| teeth and implants | |||
| • Alveolar ridge reconstruction | |||
| for prosthetic treatment | |||
| • guided tissue regeneration | |||
| procedures in recession defects | |||
| for root coverage | |||
| Device | |||
| Description | Geistlich Wound Matrix is a collagen | ||
| matrix obtained by a standardized | |||
| controlled manufacturing process. The | |||
| matrix is made of collagen without | |||
| further crosslinking. The collagen is | |||
| extracted from veterinary certified pigs | |||
| and is carefully purified to avoid | |||
| antigenic reactions. | |||
| The device is composed of two | |||
| structures: one smooth structure and | |||
| one porous structure. The 'outer" side | |||
| with a smooth surface consists of | |||
| compact collagen and has a smooth | |||
| texture. The "inner" porous structure | |||
| consists of collagen fibers in a loose, | |||
| porous arrangement. | The Miromatrix Wound Matrix is | ||
| an animal-sourced, acellular | |||
| wound dressing that is derived | |||
| from porcine liver tissue. The | |||
| liver tissue undergoes perfusion | |||
| decellularization and the resulting | |||
| wound dressing is comprised | |||
| primarily of collagen type 1. The | |||
| Miromatrix Wound Matrix is | |||
| terminally sterilized in its | |||
| packaging and is hydrated, moist | |||
| and flexible when its packaging is | |||
| opened. | Same as subject device. | ||
| Material | Porcine | Porcine | Porcine |
| Thickness, mm | 2.5 - 5 mm | 0.3 - 1.5 mm | 2.5 - 5 mm |
| Range of sizes | 15 mm x 20 mm | ||
| 20 mm x 30 mm | |||
| 30 mm x 40 mm | 1 cm x 2 cm to 10 cm x 25 cm, | ||
| and may be trimmed or cut as | |||
| required | 15 mm x 20 mm | ||
| 20 mm x 30 mm | |||
| 30 mm x 40 mm | |||
| Single Use | Yes | Yes | Yes |
Device Comparison Table Table 1:
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7. PERFORMANCE DATA
Because the material of the subject device is identical to the reference device (K102531), the existing biocompatibility, sterilization, and shelf life information fully applies.
Bench, animal, and clinical data are not necessary to support the substantial equivalence of a wound dressing.
CONCLUSIONS 8.
The subject Geistlich Wound Matrix is nearly identical in indications to the predicate Miromatrix Wound Matrix. The exclusion of two predicate indications does not constitute a new intended use. There are similar technological characteristics between the subject Geistlich Wound Matrix and the predicate. The differences in technological characteristics do not raise any new questions of safety or effectiveness. The Geistlich Wound Matrix is identical in design and material to the reference device, the Geistlich MUCOGRAFT Collage Matrix (K102531). Accordingly, the Geistlich Wound Matrix is substantially equivalent to the predicate device.