BioSiCar Silicone Implant

K193392 · Metalware Technology Corp. · MIB · Jul 20, 2020 · Ear, Nose, Throat

Device Facts

• Record ID: K193392
• Device Name: BioSiCar Silicone Implant
• Applicant: Metalware Technology Corp.
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Jul 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Silicone elastomer implant; used in facial surgery for nasal and/or chin contour augmentation or reconstruction. Provided in various sizes and shapes; can be carved or cut by physician to fit patient anatomy. Single-use; sterilized by gamma radiation. Implanted by surgeon in clinical setting. Provides structural support to soft tissue; improves aesthetic contour.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility, performance, shelf-life, and sterilization verification.

Technological Characteristics

Material: Silicone elastomer. Form factor: Pre-shaped nasal and chin implants, trimmable. Sterilization: Gamma radiation. Single-use.

Indications for Use

Indicated for patients requiring augmentation or reconstruction of the nasal and/or chin contour.

Regulatory Classification

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.

Predicate Devices

• SOFTXIL (K171851)

Submission Summary (Full Text)

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

July 20, 2020

Metalware Technology Corp. Megan Chang Product Manager 10F, No. 117, Minquan Rd., Xindian Dist. New Taipei City, 231 Tw

## Re: K193392

Trade/Device Name: BioSiCar Silicone Implant Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIB Dated: June 19, 2020 Received: June 22, 2020

Dear Megan Chang:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Cindy Chowdhury, Ph.D., M.B.A. Acting 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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# Indications for Use

510(k) Number (if known) K193392

Device Name BioSiCar Silicone Implant

Indications for Use (Describe)

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

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

| 5.1 Type of Submission: | Traditional |
|-------------------------|-----------------------------------------------------------------------------------|
| 5.2 Date of Summary: | 11/26/2019 |
| 5.3 Submitter: | Metalware Technology Corp. |
| Address: | 10F, No.117, Minquan Rd., Xindian Dist., New<br>Taipei City, 231, Taiwan (R.O.C.) |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact: | Megan Chang<br>([e-mail]) |

# 5.4 Identification of the Device:

| Proprietary/Trade name: | BioSiCar Silicone Implant |
|------------------------------|---------------------------------------------------|
| Classification Product Code: | |
| 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 |

# 5.5 Identification of the Predicate Device:

| Predicate Device Name: | SOFTXIL |
|------------------------------|---------------|
| Manufacturer: | Bistool |
| Classification Product Code: | MIB, LZK, FWP |
| Regulation number: | 874.3620 |
| Device Class: | II |
| 510(k) Number: | K171851 |

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## 5.6 Indications for Use / Intended Use of the Device

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

## 5.7 Device Description

BioSiCar Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The BioSiCar 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 BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use. BioSiCar Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.

#### 5.8 Non-clinical Testing

A series of safety and performance tests were conducted on the subject device, BioSiCar Silicone Implant:

- . Biocompatibility
- . Performance & Shelf life
- Sterilization verification

All the test results demonstrate BioSiCar Silicone Implant meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

#### 5.9 Clinical and Usability Testing

No clinical test data was used to support the decision of substantial equivalence.

#### 5.10 Substantial Equivalence Determination

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The subject device has similar intended use, same technology/mechanism of action, same claim of safety and performance, and similar technological specification as the predicate device, SOFTXIL (K171851). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

| Item | Subject device | Predicate device | Substantial equivalence determination |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Metalware Technology Corp. | BISTOOL | |
| Trade Name | BioSiCar Silicone Implant | SOFTXIL | |
| 510(k) No. | (to be assigned) | K171851 | |
| Product Code | MIB, LZK, FWP | MIB, LZK, FWP | Same |
| Regulation<br>Number | 874.3620 | 874.3620 | Same |
| Intended Use<br>Indications for<br>Use | BioSiCar Silicone Implant is<br>intended for the augmentation<br>or reconstruction of the nasal<br>and/ or chin contour. | SOFTXIL is intended for the<br>augmentation or reconstruction<br>of the nasal, malar, and or chin<br>contour. | Similar<br>Subject device is for nasal<br>and/ or chin contour,<br>while the predicate device<br>has a wider usage that<br>includes nasal, chin, and<br>malar. |
| Material | Silicone elastomer | Silicone elastomer | Same |
| Design | Offers two major shapes to<br>meet the needs in nasal and<br>chin locations. | Offers various shapes to meet<br>the needs in different<br>locations. | Same |
| Function | Augmentation/ Reconstruction<br>of the nasal and/or chin<br>contour. | Augmentation of the nasal,<br>malar, and or chin contour. | Similar<br>Subject device is for nasal<br>and or chin contour, while<br>the predicate device has a<br>wider usage that includes<br>nasal, chin, and malar. |

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| Size | Provided in various sizes<br>(Please see Section 11 for<br>detailed sizes). Can be carved<br>or cut by the physician to fit<br>each patient. | Provided in various sizes. Can<br>be carved or cut by the<br>physician to fit each patient. | Same |
|---------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|------|
| Usage | For single use only | For single use only | Same |
| Sterile | Yes | Yes | Same |

## 5.11 Similarity and Difference

The BioSiCar Silicone Implant has been compared with "SOFTXIL". The subject device has similar intended use, same technology/mechanism of action, same safety and performance, and similar technological specification as the predicate device. Although there are some different specifications between these devices, the performance test was completed and demonstrated similar test results (please refer to Section 18). The subject device has also undergone safety and performance tests, and the results complied with the test requests (referring to Section 14 and 15). Therefore, the differences between the subject device and the predicate device do not raise any new issue of substantial equivalence.

#### 5.12 Conclusion

In conclusion, Metalware Technology Corp. believes that BioSiCar Silicone Implant maintains the same safety and effectiveness, and thus, is substantially equivalent to the predicate device.