(90 days)
No
The summary describes a physical silicone implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an implant for augmentation of various body contours, not for treating a disease or injury.
No
The device is an implant for augmenting body contours, not for diagnosing medical conditions. The performance studies listed are for material properties and biocompatibility, not diagnostic accuracy.
No
The device description explicitly states it is made of "implant grade silicone elastomer," indicating it is a physical hardware device, not software. The performance studies also focus on physical properties and biocompatibility of the material.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour." This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The description details a silicone implant designed to be placed within the body for cosmetic or reconstructive purposes.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory tests. The performance studies listed are related to the physical and biological compatibility of the implant material, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used for structural augmentation.
N/A
Intended Use / Indications for Use
MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.
Product codes (comma separated list FDA assigned to the subject device)
MIB, LZK, FWP, MIC
Device Description
The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral.
The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal, malar, chin, gluteal, calf, pectoral, mid-face, forehead, temple
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 following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Sterilization Validation .
- " Appearance
- Dimensional inspection
- = Extraction
- Hardness (ASTM D2240 (Type A))
- · Tensile strength (ASTMD412)
- · Elongation (ASTM D412)
- Tear strength (ASTM D624)
- · Cytotoxicity (ISO 10993-5)
- · Skin Sensitization (ISO 10993-10)
- · Intracutaneous Reactivity (ISO 10993-23)
- Pyrogen (ISO 10993-11)
- · Acute Systemic Toxicity (ISO 10993-11)
- Subchronic Toxicity (ISO 10993-11)
- · Implantation (ISO 10993-6)
- · Genotoxicity (Ames) (ISO 10993-3)
- Genotoxicity (In vitro) (ISO 10993-3)
The following biocompatibility tests were not performed but the rationale for not performing them was provided.
- Chronic toxicity
- · Carcinogenicity
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.
K052504, K052505, K952708, K200610
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 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 24, 2024
Keosan Trading Co. % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine, California 92612
Re: K241150
Trade/Device Name: MISTI 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. MIC Dated: April 25, 2024 Received: April 25, 2024
Dear Priscilla 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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Digitally signed by Manuel Manuel Bayona -Swayona -s Date: 2024.07.24 15:35:36 -04'00'
For Alicia L. Hemphill Assistant Director Breast Implant Team DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery OHT4: Office of Surgerv and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241150
Device Name MISTI Silicone Implant
Indications for Use (Describe)
MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral 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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3
510(k) Summary
(K241150)
Date: July 24, 2024
Applicant / Submitter: 1.
KEOSAN TRADING CO. #805, #806, Human Teco B/D, 57, Achasan-ro 17-gil Seongdong-gu, Seoul, Republic of Korea Tel: +82-2-466-1188
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160 Irvine CA 92620 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device:
| Proprietary Name: | MISTI Silicone Implant |
|---|---|
| Common Name: | Silicone Implant |
| Classification: | 21CFR§874.3620 MIB (Elastomer, Silicone Block); |
| 21CFR§878.3550 LZK (Implant, Malar); | |
| 21CFR§878.3550 FWP (Prosthesis, Chin, Internal) | |
| 21CFR§874.3620 MIC (Implant, Muscle, Pectoralis) |
Predicate Device: 4.
- Primary Predicate Device: SOFTXIL (K171851) by BISTOOL Inc.
- . Reference Devices: Gluteal Implant, models RND 5-X, TRD 6-X (K052504) by Implantech Associates, Inc. Calf Implant, model EC17-X (K052505) by Implantech Associates, Inc. Pectoralis Implant (K952708) by Spirit Ridge Technologies Customized Contour Implant (K200610) by Implantech Associates, Inc.
4
Device Description: 5.
The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral.
The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region.
6. Indications for Use:
MISTI Silicone Implant is intended for the augmentation or reconstruction of the nasal, malar, chin, gluteal, calf and/or pectoral contour.
7. Performance Data (Non-Clinical):
The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices.
- Sterilization Validation .
- " Appearance
- Dimensional inspection
- = Extraction
- Hardness (ASTM D2240 (Type A))
- · Tensile strength (ASTMD412)
- · Elongation (ASTM D412)
- Tear strength (ASTM D624)
- · Cytotoxicity (ISO 10993-5)
- · Skin Sensitization (ISO 10993-10)
- · Intracutaneous Reactivity (ISO 10993-23)
- Pyrogen (ISO 10993-11)
- · Acute Systemic Toxicity (ISO 10993-11)
- Subchronic Toxicity (ISO 10993-11)
- · Implantation (ISO 10993-6)
- · Genotoxicity (Ames) (ISO 10993-3)
- Genotoxicity (In vitro) (ISO 10993-3)
The following biocompatibility tests were not performed but the rationale for not performing them was provided.
- Chronic toxicity
- · Carcinogenicity
5
8. Substantial Equivalence
8.1. Comparison Chart
- Primary Predicate Device
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Device Name | MISTI Silicone Implant | SOFTXIL |
| Manufacturer | KEOSAN TRADING CO. | BISTOOL Inc. |
| 510k # | K241150 | K171851 |
| Product Code | MIB, LZK, FWP, MIC | MIB, LZK, FWP |
| Indications for | ||
| Use | MISTI Silicone Implant is intended for the | |
| augmentation or reconstruction of the | ||
| nasal, malar, chin, gluteal, calf and/or | ||
| pectoral contour. | SOFTXIL is intended for the | |
| augmentation or reconstruction of the | ||
| nasal, malar, and/or chin contour. | ||
| Material | Silicone elastomer | Silicone elastomer |
| Design | Chin Implant | |
| Features | Image: Chin Implant - MISTI | Image: Chin Implant - SOFTXIL |
| Mid-face Implant | ||
| Image: Mid-face Implant - MISTI | Image: Mid-face Implant - SOFTXIL | |
| Nasal Implant |
6
Image /page/6/Picture/1 description: The image shows different types of implants. The implants are block, forehead, temple, and gluteal implants. Each implant type is shown in two different images.
7
| - | ||
|---|---|---|
| Calf Implant | ||
| - | ||
| Pectoral Implant | ||
| Principle of Operation | It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line. | It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line. |
8
Reference devices .
| Subject Device | Reference Device | |
|---|---|---|
| Device Name | MISTI Silicone Implant | Gluteal Implant, models RND 5-X, TRD |
| 6-X | ||
| Manufacturer | KEOSAN TRADING CO. | Implantech Associates, Inc. |
| 510k # | K241150 | K052504 |
| Product Code | MIB, LZK, FWP, MIC | MIB |
| Indications for | ||
| Use | MISTI Silicone Implant is intended for | |
| the augmentation or reconstruction of | ||
| the nasal, malar, chin, gluteal, calf | ||
| and/or pectoral contour. | The Gluteal Implants (Silicone Carving | |
| Blocks) are for augmentation and | ||
| reconstructive surgery. The Implantech | ||
| Gluteal Implants are carvable to allow the | ||
| surgeon to shape the device should | ||
| additional shaping be desired. | ||
| Material | Silicone elastomer | Silicone elastomer |
| Gluteal Implant | ||
| Design | ||
| Features | Image: Gluteal Implant | Image: Gluteal Implant |
| Subject Device | Reference Device | |
|---|---|---|
| Device Name | MISTI Silicone Implant | Calf Implant, model EC17-X |
| Manufacturer | KEOSAN TRADING CO. | Implantech Associates, Inc. |
| 510k # | K241150 | K052505 |
| Product Code | MIB, LZK, FWP, MIC | MIB |
| Indications for | ||
| Use | MISTI Silicone Implant is intended for | |
| the augmentation or reconstruction of | ||
| the nasal, malar, chin, gluteal, calf | ||
| and/or pectoral contour. | The Calf Implants (Silicone Carving | |
| Blocks) are for augmentation and | ||
| reconstructive surgery. The Implantech | ||
| Calf Implants are carvable to allow the | ||
| surgeon to shape the device should | ||
| additional shaping be desired. | ||
| Material | Silicone elastomer | Silicone elastomer |
| Design | Calf Implant |
9
Image /page/9/Picture/1 description: The image shows two different depictions of an object. The object appears to be a white, oval-shaped item with a pointed end. In the first depiction, the object is shown against a black background, while in the second, it is shown floating in a blue liquid, possibly water. The image also contains the word "Features" in the upper left corner.
| Subject Device | Reference Device | |
|---|---|---|
| Device Name | MISTI Silicone Implant | Pectoralis Implant |
| Manufacturer | KEOSAN TRADING CO. | Spirit Ridge Technologies |
| 510k # | K241150 | K952708 |
| Product Code | MIB, LZK, FWP, MIC | FZE, FWP, LZK, MIB, MIC |
| Indications for | ||
| Use | MISTI Silicone Implant is intended for | |
| the augmentation or reconstruction of | ||
| the nasal, malar, | ||
| chin, gluteal, calf and/or pectoral | ||
| contour. | - | |
| Material | Silicone elastomer | Silicone elastomer |
| Pectoral Implant | ||
| Design | ||
| Features | Image: MISTI Silicone Implant | Image: Pectoralis Implant |
| Subject Device | Reference Device | |
|---|---|---|
| Device Name | MISTI Silicone Implant | Customized Contour Implant |
| Manufacturer | KEOSAN TRADING CO. | Implantech Associates, Inc. |
| 510k # | K241150 | K200610 |
| Product Code | MIB, LZK, FWP, MIC | FWP, KKY, MIB, MIC |
10
| Indications for
Use | MISTI Silicone Implant is intended for
the augmentation or reconstruction of
the nasal, malar, chin, gluteal, calf
and/or pectoral contour. | The Customized Contour Implant is
intended for augmentation, reconstructive
and cosmetic surgery. The Customized
Contour Implant is pre-shaped to the
surgeon's specification to meet the needs
of a particular patient, for example facial
implants, gluteal implants, calf implants,
or pectoralis implants. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Silicone elastomer | Silicone elastomer |
8.2. Substantial Equivalence Discussion
The MISTI Silicone Implant is substantially equivalent in material, design, function, and performance to predicate devices. We identified the reference devices for different areas to be used on patients.
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 an issue of safety and performance.
We have performed the performance and biocompatibility tests and the test results support that the subject device is substantially equivalent to the predicate devices in the market.
Conclusion: 9.
Based on the information submitted herein, KEOSAN TRADING CO. concludes that the MISTI Silicone Implant is substantially equivalent to the predicate device.