(230 days)
The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures.
The diameter of the GBR screw is 1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm.
These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile.
The subject device is compatible with the OssBuilder membrane cleared in K172354.
The provided document is a 510(k) premarket notification for the "SAVE GBR" device, which is an intraosseous fixation screw or wire used in guided bone/tissue regeneration in the oral cavity. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone clinical study.
Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy, or human reader improvement with AI) is not applicable to this type of regulatory submission.
The document describes non-clinical testing performed to demonstrate the safety and effectiveness of the device compared to its predicates. The "acceptance criteria" here are typically compliance with relevant international standards and equivalence to predicate devices in terms of material, design, and performance characteristics.
Here’s a breakdown of the information that can be extracted from the provided text, addressing the points where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The FDA 510(k) process for this device type doesn't establish numerical "performance" criteria in the way a diagnostic AI device might have sensitivity/specificity targets. Instead, "acceptance criteria" are compliance with standards and demonstration of equivalence to legally marketed predicates. The "reported device performance" reflects how the device met these engineering and material standards.
| Acceptance Criterion (Standard/Requirement) | Reported Device Performance / Assessment |
|---|---|
| Material Composition | Ti-6Al-4V ELI (ASTM F136 compliant) |
| Biocompatibility | Demonstrates biocompatibility (leveraged results from K210080 due to same material/manufacturing) |
| Sterilization | Gamma Sterilization (ISO 11137-1, ISO 11137-2 compliant) |
| Shelf Life | 8 years (ASTM F1980-07 compliant) |
| Packaging | Compliant with relevant standards |
| Bacterial Endotoxin Test | Compliant (ANSI/AAMI ST72:2011, USP <161>, USP <85> referenced) |
| Mechanical Properties (GBR screw): | Torsion: Conducted |
| Driving Torque: Conducted | |
| Axial Pullout Strength: Conducted (ISO 19023, ASTM F543-17 compliant) | |
| Mechanical Properties (Bone Tack): | Torsion: Conducted |
| Axial Pullout Strength: Conducted | |
| MR Environment Condition | Evaluated using scientific rationale and published literature per FDA guidance. |
| Substantial Equivalence (GBR Screw) | Demonstrated to K170697 (Primary Predicate) and K182881 (Reference Device) in dimensions, material, indications, and technological characteristics. Differences in screw design, anodizing, and sterilization addressed. |
| Substantial Equivalence (Bone Tack) | Demonstrated to K170697 (Primary Predicate) and K182881 (Reference Device) in designs, material, indications, and technological characteristics. Difference in sterilization addressed. |
The following questions are not applicable to this 510(k) submission as it concerns a physical medical device (implants) and not a diagnostic or AI-driven system that would typically undergo such evaluations.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes non-clinical (biocompatibility, mechanical, sterilization) testing of a physical implant device, not a diagnostic algorithm tested on a dataset of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth for a diagnostic algorithm is not relevant here. The ground truth for device safety and performance relies on validated laboratory methods and engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This pertains to expert review of diagnostic cases, which is not relevant for this physical device.
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. MRMC studies are for diagnostic interpretation improvement with AI. This document is for a physical implantable device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This refers to the performance of an algorithm; it is not relevant for this physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's regulatory clearance is compliance with recognized international standards (e.g., ISO, ASTM for materials, sterilization, mechanical properties) and demonstration of substantial equivalence to legally marketed predicate devices through comparative testing and analysis. This is based on objective measurements and verified material properties, not clinical expert consensus on diagnostic images or patient outcomes.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an AI algorithm for this device. Testing involves samples of the physical device for non-clinical evaluations.
9. How the ground truth for the training set was established
- Not Applicable. No training set; ground truth is established by engineering and materials science standards.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
3/23/23
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K222367
Trade/Device Name: SAVE GBR Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: February 19, 2023 Received: February 21, 2023
Dear April Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222367
Device Name SAVE GBR
Indications for Use (Describe)
The device is intended for use in stabilizing and fixating bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Submitter
Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922
Device Information
- . Trade Name: SAVE GBR
- . Common Name: GBR System
- Classification Name: Intraosseous fixation screw or wire .
- . Product Code: DZL
- Panel: Dental
- Regulation Number: 872.4880
- Device Class: Class II
- . Date prepared: 03/23/2023
Primary Predicate:
K170697, GBR System by Surgident
Reference Device:
K182881, Bone Screw, Bone Tack by Osstem Implant Co., Ltd.
Indications for Use:
The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.
Device Description:
SAVE GBR is manufactured by Ti-6Al-4V ELI. The SAVE GBR is composed of GBR Screw and Bone Tack and these screws and tacks are used to fix barrier membranes in bone regeneration procedures.
The diameter of the GBR screw is $1.4 and length is 3.9, 4.38, 5.9, 6.38, 7.9 and 8.38mm. The diameter of the Bone Tack is 2.5 and length is 2.6 and 4.1mm.
These screws and tacks are implanted for a maximum duration of 6 months. The SAVE GBR is provided sterile.
The subject device is compatible with the OssBuilder membrane cleared in K172354.
Materials:
- GBR Screw and Bone Tack are manufactured by Ti-6Al-4V ELI according to ASTM F136 .
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
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Summaries of Technology Characteristics
The subject device is substantially equivalent to the current cleared devices. They are substantially equivalent in intended use, material and product spec as diameter and length. Comparison demonstrating Substantial Equivalence follows: 1. GBR Screw
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Applicant | Dentis Co., Ltd. | Surgident | Osstem Implant Co., Ltd |
| Trade Name | SAVE GBR | GBR System | Bone Screw, Bone Tack |
| 510(k) No. | K222367 | K170697 | K182881 |
| Classification Name | Intraosseous Fixation screw or wire | Intraosseous Fixation screw or wire | Intraosseous Fixation screw or wire |
| Product Code | DZL | JEY, DZL | DZL |
| Class | Class II | Class II | Class II |
| Description | Image: A screw | Image: Screws and plates | Image: Screws |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Screw Diameter (mm) | Ø1.4 | Ø0.85, Ø1.4, Ø1.6 and Ø2.0 | Ø1.4 and Ø1.95 |
| Screw Length (mm) | 3.9, 5.9 and 7.9 | 3.0, 4.0, 5.0, 6.0, 8.0, 10.0 and 12.0 | 4.0, 6.0, 8.0, 10.0, 12.0, 14.0 and 16.0 |
| Single Use | Yes | Yes | Yes |
| Sterile | Gamma Sterilization | End User Sterilization | Gamma Sterilization |
| Shelf Life | 8yearsrs | N/A | 8years |
| Surface Treatment | N/A | Anodizing | N/A |
| Indications For Use | The device is intended for use instabilizing and fixating bone grafts,bone filling material and/or barriermembranes used for guidedbone/tissue regeneration in the oralcavity. Single patient use only. | The device is intended for use instabilizing and fixating bone grafts,bone filling material and/or barriermembranes used for guided bone/tissueregeneration in the oral cavity. Singlepatient use only. | Bone Screw is used to stabilize and fixatebone grafts, bone filling material, and/orbarrier membranes used for regeneration ofbone in the oral cavity. Bone Tack isindicated for use to stabilize and supportbone graft and/or fractured bone segmentswith or without bone plates or titaniummesh in oral and maxillofacial site defects. |
| Substantial EquivalenceComparison | The subject GBR screw is substantially equivalent in dimensions, material, indications, and technological characteristicswith the identified primary predicate device(K170697). The difference between the subject and primary predicate is thescrew design, anodizing and sterilization. However, the general shapes of both devices are very similar and anodizing doesnot affect product's fundamental technologies or indications. To support the difference of sterilization, K182881 was added.Therefore, the subject device is substantial equivalent. |
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2. Bone Tack
| Subject Device | Primary Predicate | Reference Device | |
|---|---|---|---|
| Applicant | Dentis Co., Ltd. | Surgident | Osstem Implant Co., Ltd |
| Trade Name | SAVE GBR | GBR System | Bone Screw, Bone Tack |
| 510(k) No. | K222367 | K170697 | K182881 |
| Classification Name | Intraosseous Fixation screw or wire | Intraosseous Fixation screw or wire | Intraosseous Fixation screw or wire |
| Product Code | DZL | JEY, DZL | DZL |
| Class | Class II | Class II | Class II |
| Description | Image: Subject Device Description | Image: Primary Predicate Description | Image: Reference Device Description |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Head Diameter | Ø2.5 | Ø2.5 | Ø2.5 |
| Screw Diameter (mm) | Ø0.85 | Ø0.85 | Ø0.7 |
| Length (mm) | 3.5 and 5.0 | 3.5 and 5.0 | 3.0 |
| Surface Treatment | Anodizing (Purple, Blue) | Anodizing (Purple, Blue) | Anodizing (Purple, Blue) |
| Sterile | Gamma Sterilization | End User Sterilization | Gamma Sterilization |
| Indications For Use/Intended Use | The device is intended for use instabilizing and fixating bone grafts,bone filling material and/or barriermembranes used for guided bone/tissueregeneration in the oral cavity. Singlepatient use only. | The device is intended for use instabilizing and fixating bone grafts,bone filling material and/or barriermembranes used for guidedbone/tissue regeneration in the oralcavity. Single patient use only. | Bone Screw is used to stabilize andfixate bone grafts, bone filling material,and/or barrier membranes used forregeneration of bone in the oral cavity.Bone Tack is indicated for use tostabilize and support bone graft and/orfractured bone segments with orwithout bone plates or titanium mesh inoral and maxillofacial site defects. |
| SubstantialEquivalenceComparison | The subject bone Tack is substantially equivalent in designs, material, indications and technological characteristicswith the identified primary predicate device(K170697). The difference between two products is sterilization. Tosupport this discrepancy, K182881 was added. Therefore, the subject device is substantial equivalent. |
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Non-Clinical Testing
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
Sterilization and Shelf Life:
The sterilization, shelf-life, and packaging testing was conducted on a worst-case test article representative of the final, finished subject device according to ISO 11137-1, ISO 11137-2 and ASTM F1980-07.
Bacterial Endotoxin Test according to ANSI/AAMI ST72:2011, USP <161>, and USP <85> for subject device was referenced in K192688.
Since endotoxin testing cannot be conducted on every batch in our company, alternative to batch testing was chosen with the sampling plan used for the in-process testing and/or finished product release, as recommended in the FDA guidance, Pyrogen and Endotoxins Testing: Questions and Answers". According to this guidance, we determined that begin with maximum coverage and adjust our sampling plans as they gain confidence in the prevention of endotoxins in their manufacturing processes.
Biocompatibility Evaluation:
Biocompatibility tests such as cytotoxicity, sensitization testing according to ISO 10993-1 performed on the abutments of K210080 can be leveraged for the subject device because both devices have the same material and manufacturing process. The results of the testing demonstrated the subject device is biocompatible.
Mechanical Properties:
Mechanical tests such as torsion, driving torque and axial pullout strength for subject device SAVE GBR and predicate device are conducted under the worst-case scenario in accordance with ISO 19023 and ASTM F543-17 Standard Specification that test method for metallic medical bone screw to support the requirement of subject device.
For GBR screw, 3 tests as torque, torsion and pull-out were conducted.
For Bone Tack, 2 tests as torsion and pull-out were conducted. Toque test is not conducted for Bone Tack since the bone tack is inserted by hitting with mallet. Torque test require for only implantation medical device that is implanted by turning, which is not subject to the subject Bone Tack.
MR Environment Condition:
Non-clinical worst-case MRI review was performed to evaluate the SAVE GBR in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque
Conclusion
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In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, Dentis Co., Ltd. concludes that the SAVE GBR is substantially equivalent to the predicate devices as herein.
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.