(329 days)
The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified as described in following table.
| Format | Syringe | Plug | Block |
|---|---|---|---|
| Indicationfor use | - Filling of periodontaldefects in conjunction withproducts intended forGuided TissueRegeneration (GTR)- Filling of peri-implantdefects in conjunction withproducts intended forGuided Bone Regeneration(GBR) | - Filling of extraction sockets- Augmentation orreconstructive treatment of thealveolar ridge-Elevation of maxillary sinusfloor | - Augmentation orreconstructive treatment ofthe alveolar ridge-Elevation of maxillary sinusfloor |
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenome® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
This document describes the Regenomer® Syringe, Regenomer® Plug, and Regenomer® Block devices, which are bone grafting materials. Based on the provided text, the device is being reviewed for substantial equivalence to existing predicate devices, not for novel claims that require extensive clinical trials with specific acceptance criteria and performance metrics as typically seen for AI/ML devices. Therefore, a direct breakdown of acceptance criteria and a study proving those criteria in the context of an AI-driven medical device is not available in this document.
However, I can extract information related to the performance, safety, and equivalence comparison of the Regenomer® device to its predicates.
Here's a breakdown of the available information, reframed to fit the requested structure as much as possible, focusing on the comparisons and data presented for substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission proving substantial equivalence, there are no predefined "acceptance criteria" in the sense of specific quantitative performance thresholds (e.g., sensitivity, specificity) for a diagnostic AI device. Instead, the "performance" is demonstrated through comparability to predicate devices in terms of characteristics, biological response, and intended use. The "acceptance criteria" in this context are implicitly met if the device demonstrates equivalent safety and effectiveness to the predicates.
| Criteria/Characteristic | Regenomer® Performance/Description | Predicate Devices (FOUNDATION® and Bio-Oss® Collagen) Performance/Description |
|---|---|---|
| Intended Use | Varies by format (Syringe, Plug, Block) for filling periodontal/peri-implant defects, extraction sockets, alveolar ridge augmentation, maxillary sinus floor elevation. | FOUNDATION®: Filling of extraction sockets. Bio-Oss® Collagen: Augmentation/reconstructive treatment of alveolar ridge, filling intrabony periodontal defects, defects after root resection/apicoectomy/cystectomy, extraction sockets, maxillary sinus floor elevation, periodontal defects with GTR/GBR, peri-implant defects with GBR. (Regenomer's indications are a subset or equivalent to predicates). |
| Material | Purified type I collagen derived from porcine skin. | FOUNDATION®: Type I collagen (85-95%) and Type III collagen (5-15%) from Bovine. Bio-Oss® Collagen: Anorganic derived osteoconductive hydroxyapatite, Collagen from Porcine. |
| Physical Morphology | Sponge-like absorbable and porous. | FOUNDATION®: Sponge. Bio-Oss® Collagen: Trabecular, interconnecting macro and micro pores. |
| Biocompatibility | Demonstrated through: Acute systemic injection test, AMES test, Cytotoxicity test, Implantation test, Intracutaneous reactivity test, Micronucleus Test for Genetic Toxicology, Maximization and sensitization test, Oral Mucosa Irritation test, Sterility test, Pyrogen test, Preclinical safety and efficacy test, Clinical case series. | Both predicates are described as Biocompatible (demonstrated via published literature/studies). |
| Performance (In vivo) | Found to grow new bone and be subsequently resorbed at similar rates in canine alveolar bone defects model. Clinical case series showed defect healing and new bone formation without inflammation. | FOUNDATION®: Bone filling. Bio-Oss® Collagen: Bone formation. (Implied similar performance in bone regeneration). |
| Sterilization | Sterile by Gamma Irradiation. | FOUNDATION®: Sterile by Gamma Irradiation. Bio-Oss® Collagen: Sterile by Gamma Irradiation. |
| Non-Pyrogenic | Yes. | Yes for both predicates. |
| Shelf-Life | 36 Months. | 36 Months for both predicates. |
| Chemical/Physical Characterization | pH, loss on drying, amino acid contents, FT-IR, SDS-PAGE comparable to FOUNDATION®. | FOUNDATION®: Comparable results for chemical and physical characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions two types of "test sets" or evaluations:
- Animal study: "canine alveolar bone defects model." The specific sample size for this animal study is not mentioned.
- Clinical case series: "clinical case series." The specific sample size for this human study is not mentioned.
- Data Provenance: The device is manufactured in South Korea from porcine skin sources. The animal study involved canines, and the clinical case series would have involved human subjects, but the geographical origin of these studies is not specified.
- Retrospective/Prospective: Not specified for either the animal study or the clinical case series. Given it's a "case series," it often implies a retrospective collection of cases, but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For animal studies or clinical case series, assessment and "ground truth" (e.g., histological analysis of new bone formation) would typically be performed by veterinary pathologists, oral surgeons, or radiologists, but no details on the number or qualifications of such experts are given.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not the focus of this 510(k) submission for a bone grafting material.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
Not applicable. This is a medical device (bone grafting material), not an AI algorithm.
7. The Type of Ground Truth Used
Based on the studies mentioned:
- Animal Study: The document states "found to grow new bone and be subsequently resorbed at similar rates in canine alveolar bone defects model." This suggests histological assessment (e.g., pathology reports) of bone growth and resorption in the animal model would have served as ground truth.
- Clinical Case Series: The document states "use of Regenomer® resulted in defect healing and formation of new bone without inflammation." This implies clinical and potentially radiographic assessments, possibly supported by biopsies/histology, would have served as ground truth.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a medical device, not an AI model.
Summary of Device Evaluation for Substantial Equivalence:
The submission focuses on chemical, physical, and biological characterization of Regenomer® alongside historical performance data from animal and human case series, demonstrating its equivalence to legally marketed predicate devices (FOUNDATION® and Bio-Oss® Collagen). The "study" proving the device meets its "acceptance criteria" (understood here as demonstrating comparable safety and effectiveness) consists of:
- Thorough chemical and physical characterization: Showing comparability of properties (pH, loss on drying, amino acid contents, FT-IR, SDS-PAGE) to FOUNDATION®.
- Biocompatibility tests: Conducted according to ISO 10993 and FDA guidance, covering a comprehensive range of tests (acute systemic injection, AMES, cytotoxicity, implantation, intracutaneous reactivity, micronucleus, sensitization, oral mucosa irritation, sterility, pyrogen tests).
- Preclinical safety and efficacy test: An animal study (canine model) demonstrating similar rates of new bone growth and resorption compared to an unspecified comparator or expected physiological response.
- Clinical case series: Reporting successful defect healing and new bone formation without inflammation in human subjects treated with Regenomer®.
The underlying principle for this 510(k) clearance is that the Regenomer® device presents the same types of potential risks as the predicate devices and manages those risks similarly, while having comparable specifications, physicochemical properties, and performance.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2015
Nibec Co., Ltd. c/o Takashi Yamada CEO and Regulatory Affairs Smile US 22395 South Western Avenue, Suite 304 Torrance, California 90501
Re: K150079
Trade/Device Name: Regenomer® Syringe, Regenomer® Plug, Regenomer® Block Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: November 3, 2015 Received: November 9, 2015
Dear Takashi Yamada:
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.
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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 (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.
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,
Tina Kiang -S
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
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1.0 Indications for Use Statement
INDICATION FOR USE
| 510(k) Number: | K150079 |
|---|---|
| Device Name: | Regenomer® Syringe |
| Regenomer® Plug | |
| Regenomer® Block |
INDICATIONS FOR USE:
The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified as described in following table.
| Format | Syringe | Plug | Block |
|---|---|---|---|
| Indicationfor use | - Filling of periodontaldefects in conjunction withproducts intended forGuided TissueRegeneration (GTR)- Filling of peri-implantdefects in conjunction withproducts intended forGuided Bone Regeneration(GBR) | - Filling of extraction sockets- Augmentation orreconstructive treatment of thealveolar ridge-Elevation of maxillary sinusfloor | - Augmentation orreconstructive treatment ofthe alveolar ridge-Elevation of maxillary sinusfloor |
Prescription Use
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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2.0 510(k) Summary
Sponsor/Applicant
NIBEC Co., Ltd. lwol electricity-electronic Agro-industrial Complex, 116, Bamdi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do, 27816, Korea Phone: 82-10-2889-8590 Fax: 82-2-744-8732 Contact: Dr. Park, Yoon-Jeong
Date Prepared : November 30, 2015
Prior Submission : There were no prior submissions.
Device Name and Identification
| Proprietary Name: | Regenomer® Syringe |
|---|---|
| Regenomer® Plug | |
| Regenomer® Block | |
| Common/Usual Name: | Bone Filling Augmentation Material |
| Classification Name: | Bone grafting material |
Predicate devices
Primary predicate
FOUNDATION Bone Filling Augmentation Material (K040783) Manufactured by: Terumo Corporation 44-1, 2 chome Hatagaya, Shibuya-ku Tokyo 151-0072 Japan
Reference predicates
Bio-Oss® Collagen (K092428, K033815, K974399) Manufactured by: Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland
Device Category/Class
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| Device Class: | Class II |
|---|---|
| Regulation Number: | 21 C.F.R. 872.3930 |
| Product Code: | NPM |
Indication for use
The Regenomer® is in general recommended for the filling of extraction sockets and periodontal defect. The indication for use depending on the device format is further classified in following table.
| Format | Syringe | Plug | Block |
|---|---|---|---|
| Indicationfor use | - Filling of periodontaldefects in conjunction withproducts intended forGuided TissueRegeneration (GTR)- Filling of peri-implantdefects in conjunction withproducts intended forGuided Bone Regeneration(GBR) | - Filling of extraction sockets- Augmentation orreconstructive treatment of thealveolar ridge-Elevation of maxillary sinusfloor | - Augmentation orreconstructive treatment ofthe alveolar ridge-Elevation of maxillary sinusfloor |
Device Description
Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Regenomer® is three types, Regenomer® Syringe (sheet shape in syringe and blister), Regenomer® Plug (bullet shape in blister), and Regenome® Block (block shape in blister). Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Basis for Substantial Equivalence
Regenomer® is substantially equivalent for purposes of the FDA's medical device regulations to FOUNDATION®, which is cleared for the filling of extraction sockets (K040783) and Bio-Oss® Collagen (K974399), which was cleared for the filling of extraction sockets and other bone augmentation procedures. The differences in indications for Regenome® compared to the predicates do not change the intended use because all are intended for bone augmentation procedures. While Regenomer® is indicated for more specific indications based on device shape and size, this is substantially equivalent to the predicates and does not change the intended use because all are intended for bone augmentation procedures. Bio-Oss® Collagen has block type product, the size range of 6X6X6, 7X8X9, 9X10X11 mm. The size dimension of Regenomer Block type is 6X5X7 and 8X7X9mm, which is 10% of size difference with the dimension of Bio-Oss® Collagen. Intended use, principles of operation, and technological characteristics are substantially equivalent to the corresponding characteristics of the predicate devices. Although minor technological differences exist, Regenomer® and the predicate device, these minor differences raise no new issues of equivalence of Regenomer® with predicate devices.
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The following is a table comparing Regenomer®, FOUNDATION®, and Bio-Oss® Collagen cleared for the filling of extraction sockets.
| Regenomer® | FOUNDATION®(K040783) | Bio-Oss® Collagen(K092428, K033815, K974399) | |
|---|---|---|---|
| ITEM | |||
| Syringe type- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | The FOUNDATION device is a collagen-based bone filling augmentation material for use in the filling of extraction sockets. | - Augmentation or reconstructive treatment of the alveolar ridge.- Filling of intrabony periodontal defects.- Filling of defects after root resection, apicoectomy, and cystectomy- Filling of extraction sockets- Elevation of maxillary sinus floor- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR) | |
| Intended Use | Plug type- Filling of extraction sockets- Augmentation or reconstructive treatment of the alveolar ridge-Elevation of maxillary sinus floor | ||
| Block type- Augmentation or reconstructive treatment of the alveolar ridge- Elevation of maxillary sinus floor | |||
| Targetpopulation | Human oral, periodontal | Human oral, periodontal | Human oral, periodontal |
| Dosageform | Syringe (sheet shape in syringe and blister, 25, 50mg) | Bullet shape (8X25, 15X25mm) | a block form in a blister |
| Plug (Bullet shape in blister, 10X20, 12X25mm) | sheet type (25X25, 50X25mm) | ||
| Block (Block shape in blister, 6X5X7, 8X7X9mm) | Heat-sealed aluminum package | ||
Table 1: Substantial Equivalence Comparison
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| Format | Sizes (mm) | Weight(mg/unit) | Format | Sizes (mm) | 0.25mm to 1.0mm or 1.0mmto 2.0mm granules | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Small | 20X10X1.8 | 25 | sheet | Small | 25X25 | |||||||||
| Syringe | Medium | 25X15X1.8 | 50 | Medium | 50X25 | |||||||||
| Dime | small | 10 x 20 | 40 | Plug | small | 8 x 25 | Shape | Dimension (mm) | Weight(g) | |||||
| nsion | Plug | medium | 12 X 25 | 100 | medium | 15 X 25 | Block | 6X6X6 | 100mg | |||||
| small | 6 X 5 X 7 | 10 | Block | 7X8X9 | 250mg | |||||||||
| Block | medium | 8 X 7 X 9 | 20 | Block | 9X10X11 | 500mg | ||||||||
| Materi | Type I collagen | Type I collagen 85-95% | Anorganic derivedosteoconductive | |||||||||||
| al | Type III collagen 5-15% | hydroxyapatite, Collagen | ||||||||||||
| Sourc | NA | NA | Bovine | |||||||||||
| e | ||||||||||||||
| bone | ||||||||||||||
| Sourc | Porcine | Bovine | Porcine | |||||||||||
| e of | ||||||||||||||
| collag | ||||||||||||||
| en | ||||||||||||||
| Physi | Sponge | Sponge | Trabecular, interconnecting | |||||||||||
| cal | macro and micro pores | |||||||||||||
| Morp | ||||||||||||||
| holog | ||||||||||||||
| y | ||||||||||||||
| Biocompatible,demonstrated by : | as | Biocompatibledemonstratedin | (aspublishedliterature) | Biocompatibledemonstratedin | (aspublishedliterature) | |||||||||
| - Acute systemic injection test | ||||||||||||||
| - AMES test | ||||||||||||||
| Bioco | - Cytotoxicity test | |||||||||||||
| mpatible | - Implantation test | |||||||||||||
| - Intracutaneous reactivity test | ||||||||||||||
| - Micronucleus Test for GeneticToxicology | ||||||||||||||
| - Maximization and |
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| sensitization test- Oral Mucosa Irritation test-Sterility test-Pyrogen test- Preclinical safety and efficacytest- Clinical case series | |||
|---|---|---|---|
| Performance | Bone filling | Bone filling | Bone formation |
| Compatibilityw/otherdevices | Can be used with GTRmembrane | ||
| SterilizationProcess | Sterile by Gamma Irradiation | Sterile by Gamma Irradiation | Sterile by Gamma Irradiation |
| Chemicalsafety | Biocompatible | Biocompatible | Biocompatible |
| Anatomicalsites | Oral, Periodontal | Oral, Periodontal | Oral, Periodontal |
| Non-Pyrogenic | Yes | Yes | Yes |
| Shelf-Life | 36 Months | 36 Months | 36 Months |
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Brief Summary of Data Submitted
The Sponsor evaluated the performance characteristics of Regenomer® and FOUNDATION® with a thorough chemical and physical characterization including pH, loss on drying, amino acid contents, FT-IR, SDS-PAGE, sterility, and bacterial endotoxin. The physical and chemical characteristics of Regenomer were found to be comparable with FOUNDATION®. Both products were found to grow new bone and be subsequently resorbed at similar rates in canine alveolar bone defects model. Finally, in a clinical case series, use of Regenomer® resulted in defect healing and formation of new bone without inflammation.
Regenomer® was the subject of the full range of biocompatibility tests recommended in the FDA's "Class II Special Controls Guidance Document: Dental Bone Grafting Devices" and in accordance with ISO 10993. Test results confirmed product biocompatibility. Regenomer® is made from pure type I collagen obtained by a standardized controlled manufacturing process. The type I collagen has been purified from veterinary certified porcine skin. Further, the product is sterilized by y-irradiation to achieve a sterility assurance level SAL 1 x 10-6.
Based on the information presented herein, it has been demonstrated that Regenomer® is substantially equivalent to FOUNDATION® for the proposed indications for use.
Conclusion
The Regenomer® presents the same types of potential risks to consumers as the predicate device FOUNDATION®, and has controlled these risks in a similar manner. Comparison with the predicate device shows that the device has similar specification, physico-chemical properties, and performance. In addition, biocompatibility tests show that Regenome® meets the requirements of those standards. Therefore, it is concluded that Regenomer® is substantially equivalent to the predicate device FOUNDATION®.
§ 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.