(140 days)
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
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 .
The provided text does not contain information about acceptance criteria or a study proving that the GEISTLICH MUCOGRAFT® and GEISTLICH MUCOGRAFT® SEAL device meets specific acceptance criteria in the way described by the request (e.g., performance metrics like sensitivity, specificity, accuracy for an AI/device output).
Instead, this document is a 510(k) summary for a medical device (collagen matrix) indicating substantial equivalence to a predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to the data submitted to demonstrate substantial equivalence to legally marketed predicate devices, not typically a clinical trial with pre-defined performance acceptance criteria for a novel AI or diagnostic device.
The "acceptance criteria" here are largely implicit in the substantial equivalence determination process, which involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved by showing it has:
- The same intended use as the predicate.
- The same technological characteristics as the predicate; OR
- Different technological characteristics, but the information submitted demonstrates that the device is as safe and effective as the legally marketed device, and it does not raise different questions of safety and effectiveness.
Here’s a breakdown based on the information provided, recognizing that it doesn't fit the typical format for AI/diagnostic device performance studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary of Data Provided) |
|---|---|
| Safety: Device is as safe as the predicate device. | - Biocompatibility testing: Relied upon data previously submitted in support of Mucograft®. - Sterilization validation: Relied upon data previously submitted in support of Mucograft®. - Packaging materials: Relied upon data previously submitted in support of Mucograft®. - Materials and Manufacturing: Made of collagen from veterinary certified pigs, purified, sterilized by gamma irradiation. Composed of two structures (smooth and porous) for tissue adherence and cell invasion. The materials, extraction, purification, and sterilization processes are consistent with the predicate. |
| Effectiveness: Device is as effective as the predicate device (i.e., performs as intended). | - Intended Use: The device shares the same intended uses as the predicate: covering implants, localized gingival augmentation, alveolar ridge reconstruction, and recession defects for root coverage. - Technological Characteristics: Geistlich Mucograft® is stated to be "the same as the predicate device, Mucograft®." Geistlich Mucograft® Seal is a "new size and shape" but has "the same chemical composition and same materials as the predicate device." It is noted that the differences in size and shape "do not change the intended use of the device." - Bench-type evaluations: Confirmed that Geistlich Mucograft® Seal is "easily sutured in two extraction socket models." Evaluations by Geistlich and clinicians showed it could be "sutured readily to an extraction socket" and should be sutured "in a dry state." (These are more functional validation points rather than clinical effectiveness metrics). - Performance testing (Animal and Clinical): Relied upon data previously submitted in support of Mucograft®. |
| No new or different questions of safety and effectiveness. | - The submission concluded 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." This is the overarching "acceptance criterion" for 510(k) clearance. |
2. Sample size used for the test set and the data provenance:
- The document primarily refers to "bench-type evaluations" and reliance on "data previously submitted in support of Mucograft®."
- For the bench evaluations of Geistlich Mucograft® Seal: "two extraction socket models" were used. No sample size for clinical or animal data for the new device is explicitly stated; instead, it relies on the predicate device's data.
- Data Provenance: The document does not specify country of origin for the studies underlying the predicate device. The bench evaluations for the new device were conducted by "Geistlich and by clinicians," but geographical location is not mentioned. The studies appear to be retrospective in the sense that existing data from the predicate device was leveraged.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "evaluations by Geistlich and by clinicians" for suturing properties do not detail the number or qualifications of these clinicians. In a 510(k) for a device like this, ground truth is typically established by physical testing, animal studies, and clinical results from the predicate device, rather than expert consensus on diagnostic interpretations.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. Given the nature of a collagen matrix and the substantial equivalence pathway, an adjudication method for a "test set" in the context of diagnostic performance (e.g., 2+1, 3+1) is not relevant to this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a collagen matrix for tissue regeneration, not an AI or diagnostic tool designed to assist human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- For the overall substantial equivalence determination, the "ground truth" is that the predicate device (Mucograft®) is legally marketed and deemed safe and effective for its indications.
- For the new device's specific evaluations, the ground truth relates to physical properties (e.g., ease of suturing in extraction socket models) and, presumably, the clinical outcomes linked to the predicate device via animal and clinical performance testing. This would be physical testing results, animal study outcomes, and clinical outcomes data from the predicate device.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
{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'
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.