(136 days)
easy-graft™ is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillo-facial Indications may include:
- . Extraction defects (alveolar ridge preservation)
- Periodontal defects .
- Peri-implant defects .
- Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR) ・
- Sinus floor augmentation .
- Defects after surgical extractions -
- Defects after removal of bone cysts
- Defects after root resection or apicoectorny
- Defects after removal of autotogous bone .
easy-graft™ contains:
- Syringe containing beta-tricalcium phosphate (β-TCP) granules coated with poly(lactide-co-alvcolide) (PLGA)
- Ampule containing BioLinker™ (N-methyl-2-pyrrolidone and water) .
easy-graft™ is a bioresorbable, synthetic, porous bone graft substitute. It consists of two components: granules (supplied in a syringe) and BioLinker™ (supplied in an ampule). After mixing the components together, easy-graft" forms a moldable mass that can be applied directly from the syringe into the bone defect. easy-graft™ hardens in contact with body fluids, allowing a working time of approximately one minute after application into the bone defect. Depending on · blood inflow, hardening may take longer.
easy-graft™ is provided in the particle sizes of 500 – 630 µm for smaller defects and 500 – 1000 um for larger defects.
easy-graft™ is a biocompatible and osteoconductive material that allows for complete resorption by the body.
easy-graft™ can be used in combination with dental membranes.
easy-graft" contains no animal or human derived substances. β-TCP and PLGA are derived from synthetic raw materials.
This inquiry concerns a 510(k) Summary for the easy-graft™ bone grafting material, which focuses on device equivalence rather than diagnostic performance criteria or studies in the traditional sense of AI/CADe devices. Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory document.
However, based on the provided text, here's what can be gathered regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for easy-graft™ are primarily based on demonstrating substantial equivalence to predicate devices and adherence to relevant standards and guidance documents. The "reported device performance" in this context refers to the demonstration that easy-graft™ meets these equivalence criteria and is safe and effective for its intended use.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Summary) |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence | - Intended Use: Same as predicate devices (calc-i-oss, Cerasorb, Bio-Oss, FortOss Vital) for intraoral/maxillofacial osseous defects. - Materials: Equivalent materials to predicate devices (β-TCP to calc-i-oss, Cerasorb; PLA polymers and N-methyl-2-pyrrolidone to Atrisorb, Inion Membrane). - Form: Similar handling properties to predicate devices (CalMatrix, Fortoss Vital - moldable, implant, hardening in defect). Identical granule shape/size to calc-i-oss. - Porosity: Porous, like predicate devices (calc-i-oss, Cerasorb, BioOss). - Resorption/Bone Growth: Resorbs and replaced by bone during healing, like predicate devices (calc-i-oss, Cerasorb, FortOss Vital). - Mode of Action: Displays the same osteoconductive mode of action as predicate bone graft substitute devices (calc-i-oss, Cerasorb). | The document explicitly states: "The results of the chemical and physical characterization, biocompatibility and performance testing / evaluations demonstrate substantial equivalence of easy-graft™ to the predicate devices in intended use, technological characteristics and performance." |
| Risk Mitigation (as per FDA Guidance) | - Ineffective Bone Formation: Addressed by physical characterization (FDA Guidance Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices), chemical composition testing (same guidance), animal testing, and labeling. - Adverse Tissue Reaction: Addressed by physical characterization, chemical composition testing (same guidance), biocompatibility in accordance with #G95-1 (FDA Blue Book Memorandum, ISO-10993), animal testing, and labeling. - Infection: Addressed by sterilization according to ISO 11137 (SAL < 10^-6) and labeling. - Improper Use: Addressed by labeling. | - Chemical composition testing and physical characterization demonstrated equivalence. - Biocompatibility tests and sterility testing concluded the device is biologically safe. - Animal implantation test comparing easy-graft™ and Bio-Oss showed "No significant differences were detected in terms of osseointegration of the material, bone formation, or defect bridging. Degradation of the graft particles of easy-graft™ was evident." - Clinical case reports confirmed bone formation at the site of device application. - "No new issues of safety or effectiveness were identified during the testing of the device." |
| Sterility | Sterilization according to ISO 11137 (SAL < 10^-6) | "Sterility testing conclude[d] that easy-graft™ is biologically safe for its intended use." (Implies meeting SAL < 10^-6). |
| Biocompatibility | In accordance with #G95-1 (FDA Blue Book Memorandum, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing). | "Biocompatibility tests and the sterility testing conclude that easy-graft™ is biologically safe for its intended use." (Implies meeting ISO 10993 requirements). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions an "animal implantation test" and "Clinical case reports." It does not specify the sample size for the animal test nor the number of clinical case reports. The provenance (country of origin for data, retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not a diagnostic device or an AI/CADe device where expert review establishes "ground truth" for a test set. The "ground truth" in this context is based on biological response in animal models and clinical outcomes in case reports.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of expert adjudication for defining outcomes in the context of this device's evaluation.
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 is not an AI/CADe device, and no MRMC study was conducted or is relevant for this type of medical device submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a bone grafting material, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The closest concept to "ground truth" used for performance evaluation is:
- Histopathological analysis and biological outcomes from the animal implantation test (osseointegration, bone formation, defect bridging, material degradation).
- Clinical observation and outcomes data from the clinical case reports (confirmation of bone formation).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/CADe device that uses a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/CADe device that uses a "training set."
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510(k) Summary of Safety and Effectiveness Information ട്
| Applicant: | Degradable Solutions AGWagistrasse 23CH-8952 SchlierenSwitzerland |
|---|---|
| Phone Number: | +41 43 433 62 00 |
| Fax Number: | +41 43 433 62 01 |
| Official Correspondent: | M Squared Associates, Inc.Deborah Lavoie Grayeski901 King Street, Suite 101Alexandria, VA 22314Phone: 703-562-9800 ext. 250Fax: 703-562-9797Email: dgrayeski@msquaredassociates.com |
| Date of Preparation: | June 5, 2013 |
Submitter Information
Device Name
| Trade Name: | easy-graft™ |
|---|---|
| Common/Usual Name: | Bone Grafting Material, Synthetic |
| Classification Name: | Bone Grafting Material (21 CFR 872.3930, Product code LYC) |
Device Description
easy-graft™ contains:
- Syringe containing beta-tricalcium phosphate (β-TCP) granules coated with poly(lactide-co-alvcolide) (PLGA)
- Ampule containing BioLinker™ (N-methyl-2-pyrrolidone and water) .
easy-graft™ is a bioresorbable, synthetic, porous bone graft substitute. It consists of two components: granules (supplied in a syringe) and BioLinker™ (supplied in an ampule). After mixing the components together, easy-graft" forms a moldable mass that can be applied directly from the syringe into the bone defect. easy-graft™ hardens in contact with body fluids, allowing a working time of approximately one minute after application into the bone defect. Depending on · blood inflow, hardening may take longer.
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easy-graft™ is provided in the particle sizes of 500 – 630 µm for smaller defects and 500 – 1000 um for larger defects.
easy-graft™ is a biocompatible and osteoconductive material that allows for complete resorption by the body.
easy-graft™ can be used in combination with dental membranes.
easy-graft" contains no animal or human derived substances. β-TCP and PLGA are derived from synthetic raw materials.
Intended Use/Indications:
easy-graft™ is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillo-facial indications may include:
- Extraction defects (alveolar ridge preservation) -
- -Periodontal defects
- Peri-implant defects -
- -Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR)
- -Sinus floor augmentation
- -Defects after surgical extractions
- -Defects after removal of bone cysts
- ・ Defects after root resection or apicoectorny
- -Defects after removal of autologous bone
Technological Characteristics Summary
Comparison to Predicate Devices
The predicate devices of easy-graft™ are:
- · calc-i-oss™ bone graft substitutes (K042583) ("calc-i-oss"),
- · Cerasorb® M Dental and Cerasorb® Perio (K051443) ("Cerasorb"),
- Bio-Oss®, Bio-Oss® Blocks and Bio-Oss® Collagen (K952618 / K970321 / K033815) ("Bio-Oss"),
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- · CalMatrix™ (K041324) ("CalMatrix"),
- Fortoss® Vital (K082383) ("Fortoss Vital")
- · Atrisorb® Bioabsorbable Guided Tissue Regeneration (GTR) Barrier (K955838 / K982865) ("Atrisorb") and the
- . Inion GTR™ Biodegradable Membrane System (K033074) ("Inion Membrane").
Predicate Device Comparison Table
| Feature | Comparison |
|---|---|
| Intended Use | easy-graft™ is used in the same indications as the predicate devices.easy-graft™ and its predicate devices (calc-i-oss, Cerasorb, Bio-Oss andFortOss Vital) are intended to be used as a bone graft substitute for intraoral /maxillofacial osseous defects |
| Materials | easy-graft™ and the predicate devices calc-i-oss and Cerasorb are equivalentby using porous β-TCP and conform to the standard specifications of ASTM F1088-04a for a medical grade β-TCP.easy-graft™ and the predicated devices Atrisorb and Inion Membrane usePLA polymers and N-methyl-2-pyrrolidone as a temporal plasticizer. |
| Form | easy-graft™ has the same handling properties as the predicate devicesCalMatrix and Fortoss Vital (moldable, implant, hardening in the defect).easy-graft™ and the predicate device calc-i-oss are identical with regards tothe shape and the size of the granules. |
| Porosity | easy-graft™ is porous like its predicate devices calc-i-oss, Cerasorb andBioOss. |
| Resorption /Bone Growth | easy-graft™ resorbs and is replaced with bone during the healing process likeits predicate devices calc-i-oss, Cerasorb and FortOss Vital. |
| Mode of action | Newly forming autogenous bone tissue will grow into the pore volume of easy-graft™ and, in the course of material degradation, into the space previouslyoccupied by easy-graft™. easy-graft™ displays the same mode of action asits predicate bone graft substitute devices (calc-i-oss, Cerasorb). |
Risk Analysis and Test Methods:
The risks identified in the FDA Guidance Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices (4/28/2005) were addressed by the risk miligation measures suggested therein as suggested in the following Table.
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Risk Mitigation Measures
| Identified Risks | Mitigation Measures |
|---|---|
| Ineffective BoneFormation | Physical characterization according to FDA Guidance Class IISpecial Controls Guidance Document: Dental Bone Grafting MaterialDevices (4/28/2005) Chemical composition testing according to FDA Guidance Class IISpecial Controls Guidance Document: Dental Bone Grafting MaterialDevices (4/28/2005) Animal Testing Labeling |
| Adverse TissueReaction · | Physical characterization according to FDA Guidance Class IISpecial Controls Guidance Document: Dental Bone Grafting MaterialDevices (4/28/2005) Chemical composition testing according to FDA Guidance Class IISpecial Controls Guidance Document: Dental Bone Grafting MaterialDevices (4/28/2005) Biocompatibility in accordance with #G95-1 (FDA Blue BookMemorandum, Use of International Standard ISO-10993, "BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing). Animal Testing Labeling |
| Infection | Sterilization according to ISO 11137 (SAL < 106) Labeling |
| Improper Use | Labeling |
Summary of Nonclinical Testing
Chemical composition testing and physical characterization demonstrate the equivalence between easy-graft™ and its predicate devices. The biocompatibility tests and the sterility testing conclude that easy-graft™ is biologically safe for its intended use. easy-graft™ and the predicate device Bio-Oss were compared in an animal implantation test. No significant differences were detected in terms of osseointegration of the material, bone formation, or defect bridging. Degradation of the graft particles of easy-graft™ was evident. Clinical case reports confirmed bone formation at the site of device application of the device. No new issues of safety or effectiveness were identified during the testing of the device.
Substantial Equivalence
The results of the chemical and physical characterization, biocompatibility and performance testing / evaluations demonstrate substantial equivalence of easy-graft™ to the predicate devices in intended use, technological characteristics and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
September 27, 2013
Degradable Solutions Ag C/O Deborah Lavoic Grayeski Senior Project Manager M Squared Associated. Incorporated 901 King Street, Suite 101 Alexandria. VA 22314
Re: K131385
Trade/Device Name: easy-grafi™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: August 29, 2013 Received: August 30. 2013
Dear Ms. Grayeski:
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
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Page 2 - Ms. Grayeski
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4 Indications for Use Statement
510(k) Number:
· K131385
Device Name: easy-graft™
Indications for Use:
easy-graft™ is indicated for the treatment of intraoral / maxillofacial osseous defects. Dental and maxillo-facial Indications may include:
- . Extraction defects (alveolar ridge preservation)
- Periodontal defects .
- Peri-implant defects .
- Augmentation of deficient alveolar crest (e.g. Guided Bone Regeneration, GBR) ・
- Sinus floor augmentation .
- Defects after surgical extractions -
- Defects after removal of bone cysts
- Defects after root resection or apicoectorny
- Defects after removal of autotogous bone .
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew.J.Steen
2013.09.27 14:51:11 -04'00'
§ 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.