(102 days)
Not Found
No
The description focuses on the material and physical characteristics of a silicone implant for facial augmentation, with no mention of AI or ML technology.
No.
The device is described as an implant used for augmentation of the nasal and/or chin contour, which is generally considered a cosmetic or reconstructive procedure, not a therapeutic one aimed at treating a disease or condition.
No
The device, ShiNeo Silicone Implant, is described as a silicone implant used for augmentation of nasal and/or chin contour, indicating it is a prosthetic or aesthetic device, not one for diagnosing medical conditions.
No
The device description explicitly states it is a "silicone implant" and describes its physical characteristics, sterilization method, and intended use as a physical implant in facial surgery. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "augmentation of the nasal and/or chin contour." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "silicone implant used in facial surgery." This describes a physical implant placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical implant.
N/A
Intended Use / Indications for Use
ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour
ShiNeo Silicone Implant is intended for the augmentation or reconstruction of the nasal and/or chin contour.
Product codes (comma separated list FDA assigned to the subject device)
MIB, LZK, FWP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and/or chin
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 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.
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.
Not Found
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
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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
1
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)
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
4
| Regulation Description: | Ear, nose, and throat synthetic polymer material. |
|---|---|
| Review Panel: | General & Plastic Surgery |
| Device Class: | II |
| Manufacturer information | Name: SHINEO TECHNOLOGY CO., LTD |
| Address: 5F, 207-4, Xinshu Rd.,New Taipei City, | |
| 24262 Taiwan |
2. Predicate Device(s)
| Proprietary/Trade name | BioSiCar Silicone Implant
K193392 |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| 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., LTD
Address: 5F, 207-4, Xinshu Rd.,New Taipei City,
24262 Taiwan |
3. Device Description
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.
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
5
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.