The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Device Description

This submission is to add new magic Motion Abutment to the previously cleared device, IBS Implant System II (K162099).

The Magic Motion Abutment system is composed of Magic Motion Abutment, Housing and O-ring. The Magic Motion Abutment is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). Magic Motion is an attachment-retained prosthetic product, which is used with patients with a fully edentulous maxilla. It is a one-piece structure. Various collar heights of the magic motions can be selected based on the gingival height. Magic motion does not have movement and it is a solid type.

AI/ML Overview

This FDA 510(k) K200753 letter is for a dental device, specifically an endosseous dental implant abutment called "IBS Implant System II" with an added component called "Magic Motion Abutment". As such, the approval is based on substantial equivalence to a predicate device, not on clinical performance criteria like those typically found in AI/ML device clearances. The document focuses on mechanical and material properties rather than AI model performance metrics.

Therefore, many of the requested elements for an AI/ML device study are not applicable or cannot be extracted from this documentation.

Here's an attempt to answer the questions based on the provided text, while highlighting what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not directly applicable as this is a dental implant abutment, not an AI/ML device. The "acceptance criteria" here relate to meeting standards for mechanical properties, biocompatibility, and manufacturing, rather than statistical performance metrics like sensitivity/specificity for an AI model.

The document discusses demonstration of substantial equivalence with the predicate device through design control activities and specific tests.

Acceptance Criteria Type	Reported Device Performance	Comments (Not AI/ML specific)
Design/Dimensional Comparison	Subject device's diameter and hex are larger; neck and head diameter are larger and more round compared to the predicate. Magic Motion Housing height and diameter are larger.	Stated that these differences "don't impact product's substantial equivalence" as they improve connection. This implies the design changes still fall within acceptable parameters for function and safety compared to the predicate.
End User Steam Sterilization (AAMI TIR12:2010)	Tests performed on predicate device and leveraged for subject device; "met the criteria of the standards".	Confirms the device can be effectively sterilized by the end-user.
Biocompatibility (ISO 10993-1, -10, -11)	Tests performed on predicate device and leveraged for subject device; "met the criteria of the standards".	Confirms the device material is safe for contact with biological tissues.
Material Composition (Ti-6AL-4V Eli, ASTM F-136, Silicon rubber)	Confirmed materials used.	Demonstrates adherence to recognized material standards for medical implants.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for an AI/ML device. This is a mechanical device.

Test set sample size: Not specified in terms of clinical samples. Testing refers to mechanical and material property assessments on manufactured parts.
Data Provenance: Not mentioned in the context of clinical data. The tests performed are laboratory-based.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable as this is not an AI/ML device relying on human-established ground truth. Testing involves engineering standards and laboratory analyses.

4. Adjudication Method for the Test Set

Not applicable. This refers to methods for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC study was not done. This type of study is specifically for evaluating the effectiveness of an AI system with human readers, which is not relevant for a dental implant abutment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. There is no "algorithm" or "standalone performance" for this mechanical dental device.

7. The Type of Ground Truth Used

Not applicable in the context of AI/ML. For this device, "ground truth" would correspond to established engineering standards, material specifications, and regulatory requirements that the device's characteristics (dimensions, material, sterility, biocompatibility) must meet.

8. The Sample Size for the Training Set

Not applicable for an AI/ML device. There is no "training set" for a mechanical dental implant.

9. How the Ground Truth for the Training Set Was Established

Not applicable for an AI/ML device. There is no "training set ground truth" for this mechanical device. The design, materials, and manufacturing processes adhere to established engineering principles and regulatory guidelines for dental implants.

Summary

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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.

June 9, 2020

InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group, Inc. 106 Superior Irvine, California 92620

Re: K200753

Trade/Device Name: IBS Implant System II Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 8, 2020 Received: May 13, 2020

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.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200753

Device Name IBS Implant System II

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ 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

InnoBioSurg Co., Ltd. Bo-Yeon Lim 44-19, Techno 10-ro, Yuseong-gu Daejeon, 34027 Republic of Korea Email: bylim@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881

Device Information

. Trade Name: IBS Implant System II
. Common Name: Endosseous dental implant abutment
Classification Name: Endosseous dental implant abutment .
. Product Code: NHA
. Panel: Dental
. Regulation Number: 872.3630
. Device Class: Class II
Date prepared: 06/09/2020 .

Predicate Devices:

The subject device is substantially equivalent to the following predicate devices:

Primary Predicate

K162099, IBS Implant System II manufactured by InnoBioSurg Co., Ltd.

Indication for Use

The IBS Implant System II is intended to replace missing teeth to restore chewing function. The IBS Implant System II can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Device Description

This submission is to add new magic Motion Abutment to the previously cleared device, IBS Implant System II (K162099).

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

Official Correspondent

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The diameters and lengths of the Magic Motion Abutment are below:

Magic Motion

Product name	Diameter (Ø)	Cuff (mm)	Length (mm)
Magic Motion	3.9 (Cleared in K162099 -Changed product codes)	1	9.65
		2	10.65
		3	11.65
		4	12.65
		5	13.65
		6	14.65
		7	15.65
		8	16.65
	4 (Newly Added)	1.4	10.05
		2.4	11.05
		3.4	12.05
		4.4	13.05
		5.4	14.05
		6.4	15.05
		7.4	16.05

The subject device is compatible with the following Implants:

K number	Compatible Implants
K162099	IBS Implant System II

The Magic Motion Abutment is provided non-sterile and packaged separately. The abutment should be sterilized before use. The purpose of this submission is to change the product codes for the current cleared magic motion abutments add the new Magic Motion Abutments.

Materials

The Magic Motion Abutment and Housing are fabricated from Ti-6AL-4V Eli. The Magic Motion O-ring is fabricated from silicon rubber.

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Summaries of Technology Characteristics:

	Subject Device	Primary Predicate
Manufacturer	Innobiosurg Co., Ltd	Innobiosurg Co., Ltd
Device Name	Magic Motion Abutment	IBS Implant System II
510(k) No.	K200753	K162099
Indications for Use	The IBS Implant System II is intended toreplace missing teeth to restore chewingfunction. The IBS Implant System II canbe placed in support of single ormultiple-unit restorations including;cement retained, screw retained, oroverdenture restorations, and terminal orimmediate abutment support for fixedbridgework. This system is for one ortwo stage surgical procedures. Thissystem is intended for delayed loading.	The IBS Implant System II is intended toreplace missing teeth to restore chewingfunction. The IBS Implant System II canbe placed in support of single ormultiple-unit restorations including;cement retained, screw retained, oroverdenture restorations, and terminal orimmediate abutment support for fixedbridgework. This system is for one ortwo stage surgical procedures. Thissystem is intended for delayed loading.
Design	Image: Design of Subject Device	Image: Design of Primary Predicate
Connection Type	Internal Hex-Connected	Internal Hex-Connected
Hex	3.6	3.47
Diameters (Ø)	4.0 mm	3.9 mm
Lengths	10.05-16.05 mm	9.65-16.65 mm
G/H Length (mm)	1.4-7.4 mm	1-8 mm
Angle (°)	No Angulation	No Angulation
Material	Titanium Alloy(ASTM F 136)	Titanium Alloy(ASTM F 136)
Surface	Machine	Machine
Sterilization	End User Sterilization	End User Sterilization
Diameters andHeights of MagicMotion Housing	Diameter: 5.3 (Ø)Heights: 3.0 mm	Diameter: 5.0 (Ø)Heights: 3.0 mm

K162099, IBS Implant System II by InnoBioSurg Co., Ltd.

Similarities

The subject Magic Motion Abutment has a substantially equivalent intended use as the identified predicates. The subject device is similar in fundamental scientific technology, principle of operation, design, technology, functions, dimensions and materials.

Differences

New Magic Motion Abutment: Compared to the primary predicate device, the subject device's diameter and hex of subject device is larger. In addition, the neck and head diameter of the subject magic motion abutment is a bit larger than the predicate. Because of the larger neck and head diameter, the design of the

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head shape of the subject magic motion abutment is changed to more round. This difference is to improve the connection of Magic Motion and Magic Motion Housing and doesn't impact product's substantial equivalence.

New Magic Motion Housing: The height and diameter of subject device is larger than primary predicate device, however, it doesn't impact product's substantial equivalence.

Non-Clinical Data

Design Control Activity Summary was provided including dimensional comparison analysis with respective acceptance criteria to demonstrate that the subject device is substantially equivalent with the predicate device.

Below tests were performed for predicate device and leveraged for the subject device:

End User Steam Sterilization Test according to AAMI TIR12:2010 referenced in K140806 ●
Biocompatibility tests according to ISO 10993-1, ISO 10993-10 and ISO 10993-11 ● referenced in K162099

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device. Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments".

Conclusion

The subject Magic Motion Abutment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This abutment has the same intended use and fundamental scientific technology as its predicate device. Therefore, Magic Motion Abutment and its predicate are substantially equivalent.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)