(268 days)
SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.
SOFTXIL is injection molded silicone implants used in facial surgery as nasal, paranasal, and chin implants. The SOFTXIL offers various shapes to meet the needs in different locations. The devices are also provided in various sizes. The SOFTXIL is individually packaged and sterilized by ethylene oxide, and is labeled for single use. It has smooth surface with tapered ends. SOFTXIL is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
This document is a 510(k) summary for a medical device called SOFTXIL. It describes that SOFTXIL is a facial silicone implant intended for augmentation or reconstruction of the nasal, malar, and/or chin contour. It is compared to a predicate device, the AART Silicone Carving Block.
Based on the provided text, there is no information about a study that used a test set, ground truth established by experts, or AI performance. The document focuses on non-clinical bench tests and a substantial equivalence discussion to a predicate device.
Here's a breakdown of the available information based on your request, with "Not Provided" for information not found in the text:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Test Type) | Reported Device Performance |
|---|---|
| Sterilization Validation (ISO11737-1) | Passed (Validation performed) |
| Shelf Life Test (ASTM F 1980): | Passed (Test performed) |
| - Appearance | Passed |
| - Sterility | Passed |
| - Tensile Strength | Passed |
| - Elongation Percentage | Passed |
| - Shore Hardness | Passed |
| - Tearing Strength | Passed |
| - Seal Strength | Passed |
| - Dye Penetration | Passed |
| Biocompatibility Test: | Passed (Tests performed) |
| - ISO 10993-5 (Cytotoxicity) | Passed |
| - ISO 10993-6 (Local Effects After Implantation) | Passed |
| - ISO 10993-10 (Irritation and Skin Sensitization) | Passed |
| - ISO 10993-11 (Systemic Toxicity) | Passed |
| - USP<51> (Antimicrobial Effectiveness) | Passed |
| Performance Tests: | Passed (Tests performed) |
| - Appearance | Passed |
| - Dimensions | Passed |
| - Extractable substances | Passed |
| - Hardness (ASTM F881) | Passed |
| - Tensile Strength (ASTM F881) | Passed |
| - Elongation at Break (ASTM F881) | Passed |
| - Tear Strength (ASTM F881) | Passed |
Note: The document states "The test results of the tests support that the subject device is substantially equivalent to the predicate devices," implying that the device met the acceptance criteria derived from these tests. Specific numerical values for the performance are not provided.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not Provided (The tests mentioned are non-clinical bench tests, not a clinical test set as typically understood for AI or diagnostic devices.)
- Data Provenance: Not Provided. The applicant is BISTOOL from Seoul, Republic of Korea, where the testing would likely have been conducted, but this is not explicitly stated for all tests.
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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 Provided (This type of expert evaluation for ground truth is not applicable to the non-clinical bench tests described.)
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Provided (Not applicable to the non-clinical bench tests described.)
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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 done. This is not a diagnostic device or an AI-assisted device. The document describes a silicone implant and its physical and chemical properties.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not done. This is not an AI algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical bench tests would be the established scientific and engineering standards and specifications (e.g., ISO, ASTM, USP standards) against which the device's material properties and performance are measured.
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The sample size for the training set
- Not applicable/Not Provided (There is no "training set" as this is not an AI or machine learning device.)
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How the ground truth for the training set was established
- Not applicable/Not Provided (There is no "training set" or corresponding ground truth to establish.)
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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2018
Bistool % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 690 Roosevelt Irvine, California 92620
Re: K171851
Trade/Device Name: SOFTXIL 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: February 12, 2018 Received: February 13, 2018
Dear Ms. Chung:
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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 1
Revised IFU Statement
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Indications for Use
510(k) Number (if known) K171581
Device Name SOFTXIL
Indications for Use (Describe)
SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary (K171581)
This 510(k) summary is being submitted in accordance with requirements of 21 CFR Part 807.92
Date: Mar 14, 2018
1. 510K Applicant / Submitter: BISTOOL
9, Gwangnaru-ro 6-gil, Seongdong-gu, Seoul, Republic of Korea, 04796
Contact Person: Eunhyun Bae, CEO Tel : +82-2-3446-7688
2. Submission Contact Person
LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Phone: 714.202.5789 Fax: 714.409.3357 Contact: Priscilla Chung Email: juhee.c@lkconsultinggroup.com
3. Device
- 트 Trade Name : SOFTXIL
- Common Name: Facial Silicone Implant
- I Classification: Elastomer. Silicone Block - 874.3620. Primary Product Code: MIB Additional product codes: LZK, FWP
4. Predicate Device
AART Silicone Carving Block by Aesthetic and Reconstructive Technologies, Inc. (AART) (K021820)
5. Device Description
SOFTXIL is injection molded silicone implants used in facial surgery as nasal, paranasal, and chin implants. The SOFTXIL offers various shapes to meet the needs in different locations.
The devices are also provided in various sizes. The SOFTXIL is individually packaged and sterilized by ethylene oxide, and is labeled for single use. It has smooth surface with tapered ends. SOFTXIL is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
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8. Indications for Use
SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.
9. Substantial Equivalence Discussion:
The SOFTXIL is substantially equivalent in material, design, function, and performance to the AART Silicone Carving Block marketed by Aesthetic and Reconstructive Technologies, Inc. (AART). All products have identical intended uses and are offered in similar shapes and sizes. The size might be different between the devices, however, since the physician can carve or cut the material to fit each patient so that this difference does not raise of safety and performance.
10. Performance Tests (Non-clinical)
Non-clinical bench tests were performed as followings:
- Sterilization Validation in accordance with ISO11737-1
- Shelf Life Test in accordance with ASTM F 1980; Appearance, Sterility, Tensile Strength, Elongation Percentage, Shore Hardness, Tearing Strength, Seal Strength, and Dye Penetration
- Biocompatibility Test in accordance with ISO 10993-5. ISO 10993-6. ISO 10993-10. ISO 10993-11, USP<51>
- · Performance Tests; Appearance, Dimensions, Extractable substances, Hardness (ASTM F881), Tensile Strength (ASTM F881), Elongation at Break (ASTM F881), Tear Strength (ASTM F881)
The test results of the tests support that the subject device is substantially equivalent to the predicate devices.
11. Conclusions:
Based on the information provided in this premarket notification. BISTOOL concludes that SOFTXIL is substantially equivalent to the predicate device as described herein in safety and effectiveness.
§ 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.