(329 days)
No
The device description and performance studies focus on the material properties and biological performance of a collagen-based bone filling material, with no mention of AI or ML.
Yes
The device is intended for the filling of extraction sockets, periodontal and peri-implant defects, and augmentation or reconstructive treatment of the alveolar ridge, which are therapeutic interventions aimed at treating or alleviating a condition.
No
The device is described as a "sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material" for various dental and oral reconstructive procedures. Its intended use focuses on treatment and augmentation, not on diagnosis.
No
The device description clearly states that Regenomer® is a physical, sponge-like absorbable and porous collagen material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Regenomer® is for filling extraction sockets and periodontal defects, augmentation, and reconstructive treatment of the alveolar ridge, and elevation of the maxillary sinus floor. These are all therapeutic or reconstructive procedures performed directly on the patient's body.
- Device Description: The device is described as a "sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material." This is a material implanted or placed within the body to aid in healing and regeneration.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
Regenomer® is clearly designed for direct application within the body for therapeutic purposes, not for testing samples outside the body to provide diagnostic information.
N/A
Intended Use / 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 |
|---|---|---|---|
| Indication | |||
| for use | - 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) | - Filling of extraction sockets -
Augmentation or
reconstructive treatment of the
alveolar ridge
-Elevation of maxillary sinus
floor | - Augmentation or
reconstructive treatment of
the alveolar ridge
-Elevation of maxillary sinus
floor |
Product codes (comma separated list FDA assigned to the subject device)
NPM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, Periodontal
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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.
1
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
2
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 |
|---|---|---|---|
| Indication | |||
| for use | - 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) | - Filling of extraction sockets -
Augmentation or
reconstructive treatment of the
alveolar ridge
-Elevation of maxillary sinus
floor | - Augmentation or
reconstructive treatment of
the alveolar ridge
-Elevation of maxillary sinus
floor |
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)
3
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
4
| 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 |
|---|---|---|---|
| Indication | |||
| for use | - 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) | - Filling of extraction sockets -
Augmentation or
reconstructive treatment of the
alveolar ridge
-Elevation of maxillary sinus
floor | - Augmentation or
reconstructive treatment of
the alveolar ridge
-Elevation of maxillary sinus
floor |
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.
5
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 | | |
| Target
population | Human oral, periodontal | Human oral, periodontal | Human oral, periodontal |
| | | | |
| | | | |
| Dosage
form | 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
6
| | Form
at | | Sizes (mm) | Weight
(mg/unit) | | Format | | Sizes (mm) | | 0.25mm to 1.0mm or 1.0mm
to 2.0mm granules | | | | |
|----------|------------|-----------------------------------------------|---------------|---------------------|--|-------------------------------------|-------------------------|------------|---------------------------------|-----------------------------------------------|-----------------------------|---------------|---------------------------------|--|
| | | Small | 20X10X1
.8 | 25 | | sheet | Small | 25X25 | | | | | | |
| | Syringe | Medi
um | 25X15X1
.8 | 50 | | | Medium | 50X25 | | | | | | |
| Dime | | small | 10 x 20 | 40 | | Plug | small | 8 x 25 | Shape | Dimensio
n (mm) | | Weight
(g) | | |
| nsion | Plug | medi
um | 12 X 25 | 100 | | | medium | 15 X 25 | | Block | 6X6X6 | | 100mg | |
| | | small | 6 X 5 X 7 | 10 | | | | | | Block | 7X8X9 | | 250mg | |
| | Block | medi
um | 8 X 7 X 9 | 20 | | | | | | Block | 9X10X11 | | 500mg | |
| | | | | | | | | | | | | | | |
| Materi | | Type I collagen | | | | Type I collagen 85-95% | | | | Anorganic derived
osteoconductive | | | | |
| 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 | | Biocompatible
demonstrated
in | | | (as
published
literature) | Biocompatible
demonstrated
in | | | (as
published
literature) | |
| | | - Acute systemic injection test | | | | | | | | | | | | |
| | | - AMES test | | | | | | | | | | | | |
| Bioco | | - Cytotoxicity test | | | | | | | | | | | | |
| mpatible | | - Implantation test | | | | | | | | | | | | |
| | | - Intracutaneous reactivity test | | | | | | | | | | | | |
| | | - Micronucleus Test for Genetic
Toxicology | | | | | | | | | | | | |
| | | - Maximization and | | | | | | | | | | | | |
7
| | sensitization test
- Oral Mucosa Irritation test
-Sterility test
-Pyrogen test - Preclinical safety and efficacy
test - Clinical case series | | |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|----------------------------------|
| Perfor
manc
e | Bone filling | Bone filling | Bone formation |
| Comp
atibilit
y
w/oth
er
devic
es | | | Can be used with GTR
membrane |
| Sterili
zation
Proce
ss | Sterile by Gamma Irradiation | Sterile by Gamma Irradiation | Sterile by Gamma Irradiation |
| Chem
ical
safety | Biocompatible | Biocompatible | Biocompatible |
| Anato
mical
sites | Oral, Periodontal | Oral, Periodontal | Oral, Periodontal |
| Non-
Pyrog
enic | Yes | Yes | Yes |
| Shelf-
Life | 36 Months | 36 Months | 36 Months |
8
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®.