(140 days)
Not Found
No
The device description focuses on the material composition and physical properties of a collagen matrix for tissue regeneration, with no mention of AI or ML technology.
Yes
The device is intended for oral tissue regeneration and addresses conditions like localized gingival augmentation and recession defects for root coverage, which are therapeutic interventions.
No
The device description clearly states it is a "surgically implanted, fully resorbable device intended for oral tissue regeneration," making it a therapeutic device rather than a diagnostic one. Its stated "Intended Use / Indications for Use" are for covering implants, gingival augmentation, alveolar ridge reconstruction, and recession defects for root coverage, all of which are treatment-oriented actions, not diagnostic assessments.
No
The device description clearly states that Geistlich Mucograft® and Geistlich Mucograft® Seal are "surgically implanted, fully resorbable devices" and "collagen matrices obtained by a standardized controlled manufacturing process." This indicates a physical, implantable device, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for oral tissue regeneration and augmentation. These are therapeutic and reconstructive purposes, not diagnostic testing performed in vitro (outside the body).
- Device Description: The description details a surgically implanted, resorbable collagen matrix used for tissue regeneration. This aligns with a medical device used for treatment, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to facilitate tissue healing and regeneration in vivo (within the body).
N/A
Intended Use / Indications for Use
Geistlich Mucograft® and Geistlich Mucograft® Seal are 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
- Recession defects for root coverage
Product codes
NPL
Device Description
Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration.
Geistlich Mucograft® and Geistlich Mucograft® Seal are collagen matrices obtained by a standardized controlled manufacturing process. The matrices are made of collagen without further cross-linking. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.
Available Products:
- Geistlich Mucograft® 15x20 mm .
- Geistlich Mucograft® 20x30 mm .
- Geistlich Mucograft® Seal 8 mm diameter .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral tissue, gingival around teeth and implants, alveolar ridge, root
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
Bench-type evaluations confirmed that Geistlich Mucograft® Seal is easily sutured in two extraction socket models. Evaluations by Geistlich and by clinicians confirmed that the configuration can be sutured readily to an extraction socket. These evaluations also demonstrated that Geistlich Mucograft® Seal should be sutured in place in a dry state (rather than semi-wet or wet) in treating extraction sockets.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This submission relies upon data previously submitted in support of Mucograft® includina:
- Sterilization validation .
- Packaging materials .
- . Biocompatibility testing
- Performance testing (Animal and Clinical) .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mucograft® (K102531, K073711, K061244, K012423)
Reference Device(s)
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
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
1111 18 2014
510(k) Summary 2.
GEISTLICH MUCOGRAFT® and GEISTLICH MUCOGRAFT® SEAL
SPONSOR
Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
| Contact Person: | Daniel Kracov, Arnold & Porter, LLP |
|---|---|
| E-mail: | Daniel.Kracov@aporter.com |
| Phone: | 202-942-5120 |
| Fax: | 202-942-5999 |
| Date Prepared: | 03 February 2014 |
DEVICE NAME
| Proprietary Name: | Geistlich Mucograft® and Geistlich Mucograft® Seal |
|---|---|
| Common/Usual Names: | Collagen Matrix |
| Classification Name: | Barrier, Animal Source, Intraoral (NPL) |
| 21 CFR Part 872.3930 |
PREDICATE DEVICES
Mucograft® (K102531, K073711, K061244, K012423)
DEVICE DESCRIPTION
Geistlich Mucograft® and Geistlich Mucograft® Seal are surgically implanted, fully resorbable devices intended for oral tissue regeneration.
Geistlich Mucograft® and Geistlich Mucograft® Seal are collagen matrices obtained by a standardized controlled manufacturing process. The matrices are made of collagen without further cross-linking. The collagen is extracted from veterinary certified pigs and is carefully purified to avoid antigenic reactions. All configurations of the product are sterilized in a double package by gamma irradiation. Geistlich Mucograft® and Geistlich Mucograft® Seal are composed of two structures: one smooth structure and one porous structure. The device allows tissue adherence as a prerequisite for favorable wound healing. The "outer" side (i.e., turned towards the soft tissue) with a smooth surface consists of compact collagen and has a smooth texture with the appropriate elastic properties to accommodate suturing. The "inner" porous structure consists of collagen fibers in a loose, porous arrangement to allow cell invasion for soft tissue ingrowth. This roughened surface is placed next to the host tissue to facilitate tissue integration.
1
Available Products:
- Geistlich Mucograft® 15x20 mm .
- Geistlich Mucograft® 20x30 mm .
- Geistlich Mucograft® Seal 8 mm diameter .
INTENDED USE
Geistlich Mucograft® and Geistlich Mucograft® Seal are 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; .
- Recession defects for root coverage. .
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
Geistlich Mucograft® is the same as the predicate device, Mucograft® Geistlich Mucograft® Seal is a new size and shape, and has the same chemical composition and same materials as the predicate device, Mucograft®. Although the size and shape of Geistlich Mucograft® Seal has been modified, the differences do not change the intended use of the device.
Thus, with the exception of its size and shape, Geistlich Mucograft® Seal is identical to Geistlich Mucograft® and the predicate device, Mucograft®.
SUMMARY OF DATA TO SUPPORT SUBSTANTIAL EQUIVALENCE
Bench-type evaluations confirmed that Geistlich Mucograft® Seal is easily sutured in two extraction socket models. Evaluations by Geistlich and by clinicians confirmed that the configuration can be sutured readily to an extraction socket. These evaluations also demonstrated that Geistlich Mucograft® Seal should be sutured in place in a dry state (rather than semi-wet or wet) in treating extraction sockets.
This submission relies upon data previously submitted in support of Mucograft® includina:
- Sterilization validation .
- Packaging materials .
- . Biocompatibility testing
- Performance testing (Animal and Clinical) .
CONCLUSION
It is strongly believed that there are no new or different questions regarding safety and effectiveness if Geistlich Mucograft® and Geistlich Mucograft® Seal are used according to their intended use.
Based on the data provided within this 510(k) submission as summarized above, it can be concluded that Geistlich Mucograft® and Geistlich Mucograft® Seal are substantially equivalent to the predicate device Mucograft®.
2
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2014
Geistlich Pharma Ag C/O Mr. Daniel Kracov Arnold & Porter LLP 555 Twelfth Street, NW Washington, DC 20004
Re: K140518
Trade/Device Name: Geistlich Mucograft® and Geistlich Mucograft® Seal Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPL Dated: June 17, 2014 Received: June 18, 2014
Dear Mr. Kracov:
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.
3
Page 2 - Mr. Kracov
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 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.
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,
Tejastri Purchit-Sheth, M.D. Tejashri Purofist-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
510{k) Number (if known)
Device Name
Geistlich Mucograft(R) and Geistlich Mucograft(R) Seal
Indications for Use (Describe)
Geistlich Mucograft@ and Geistlich Mucograft@ Seal are 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
- Recession defects for root coverage
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sheena A. Green -S 2014.07.17 18:49:51 -04'00'
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