ShiNeo Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The ShiNeo Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The ShiNeo Silicone Implant is individually packaged and sterilized by gamma radiation and is labeled for single use. ShiNeo Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.

AI/ML Overview

This document is a 510(k) summary for the ShiNeo Silicone Implant. It asserts that the device is "identical/substantially equivalent" to a predicate device, the BioSiCar Silicone Implant (K193392).

Because the submission claims identity between the proposed device and the predicate device, it explicitly states:

No performance data was submitted, and no new testing was provided.
No acceptance criteria were established or studies conducted to demonstrate performance against such criteria for the ShiNeo Silicone Implant.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance simply does not exist within this 510(k) summary, as it wasn't required given the claim of identity. The regulatory strategy relies on showing the new device is the same as an already cleared device, not that it independently meets specific performance metrics through new testing.

Summary

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12/23/2022 Shineo Technology Co., Ltd Wan-Chun Lai CEO 5f. 207-4. Xinshu Road., New Taipei City, New Taipei City 24262 Taiwan

Re: K222748

Trade/Device Name: ShiNeo Silicone Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose, and throat synthetic polymer material Regulatory Class: Class II Product Code: MIB, LZK, FWP Dated: October 9, 2022 Received: October 25, 2022

Dear Wan-Chun Lai:

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.

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

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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, Deborah A. Fellhauer -S

Deborah Fellhauer Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K222748

Device Name ShiNeo Silicone Implant

Indications for Use (Describe)

ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour

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

|X 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's Name, Address, Telephone Number, Contact Person

Address: SHINEO TECHNOLOGY CO., LTD Office address: 5F, 207-4, Xinshu Rd.,New Taipei City, 24262 Taiwan 10642, TAIWAN (R.O.C.) Tel: (O) +886 (02)22021511 Fax numbers:+886 (02)22020331

Contact Person Name and Address:

Name: Chiao-Min Chang Title: Regulatory Affairs E-mail: cherryamigo46@gmail.com Office address: 5F, 207-4, Xinshu Rd.,New Taipei City, 24262 Taiwan 10642, TAIWAN (R.O.C.) Tel: (O) +886 963361392

Alternate Contact:

Name: Leo Huang Title: General manager Office address: 5F, 207-4, Xinshu Rd.,New Taipei City, 24262 Taiwan 10642, TAIWAN (R.O.C.) Tel: (O) +886 (02)22021511 E-mail: oscar@shineotech.com

Date Summary Prepared: September 01, 2022 Type of submission: Traditional 510k

Proprietary/Trade name	ShiNeo Silicone Implant
Common or Usual Name:	MIB
Primary Product code:
Additional Product code	LZK, FWP
Regulation Number:	874.3620

1. Device Name and Classification

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Regulation Description:	Ear, nose, and throat synthetic polymer material.
Review Panel:	General & Plastic Surgery
Device Class:	II
Manufacturer information	Name: SHINEO TECHNOLOGY CO., LTDAddress: 5F, 207-4, Xinshu Rd.,New Taipei City,24262 Taiwan

2. Predicate Device(s)

Proprietary/Trade name	BioSiCar Silicone ImplantK193392
Common or Usual Name:Primary Product code:	MIB
Additional Product code	LZK, FWP
Regulation Number:	874.3620
Regulation Description:	Ear, nose, and throat synthetic polymer material.
Review Panel:	General & Plastic Surgery
Device Class:	II
Manufacturer information	Name: SHINEO TECHNOLOGY CO., LTDAddress: 5F, 207-4, Xinshu Rd.,New Taipei City,24262 Taiwan

3. Device Description

4. Intended Use / Indications for Use

ShiNeo Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour.

5. Substantial Equivalence

The ShiNeo Silicone Implant is identical to the predicate device and is as safe and

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effective as the BioSiCar Silicone Implant. The Subject device has the same intended uses and indications, technological characteristics, principles of operation and manufactory process as its predicate device. There are no technological differences between the Subject device and its predicate devices resulting in no new issues of safety or effectiveness. Thus, the ShiNeo Silicone Implant is identical/substantially equivalent to the predicate device.

• Indications for use	• FDA product codes
• Design intent	• Material formulation
• Classification	• Manufacturing Process
• Physico- chemical properties	• Sterilization process/Method/ Dose

The subject and primary predicate devices are identical in the following ways:

6. Performance Data

The subject and predicate devices are identical and therefore, no performance testing is necessary to demonstrate substantial equivalence. This submission is to apply for a new trade name to the predicate device, BioSiCar Silicone Implant, K193392. Metalware Technology Corp, the submitter of K193392 has authorized SHINEO TECHNOLOGY CO., LTD. as the manufacturer legally authorized to market the predicate device. No new testing was provided.

7. Conclusions:

The ShiNeo Silicone Implant has the same intended uses, indications, technological characteristics, principles of operation and manufactory process as its predicate device. Thus, the subject device is identical/substantially equivalent to the predicate device.

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.