(127 days)
Not Found
No
The device description and intended use focus on a physical silicone implant that is manually trimmed by a surgeon. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is intended for "cosmetic correction of soft tissue deformities" and "aesthetic (cosmetic) correction," which aligns with cosmetic/reconstructive purposes rather than treating a disease or condition.
No
The device is an implant used for cosmetic correction and reconstruction of soft tissue deformities; it does not diagnose any condition.
No
The device is a physical silicone implant, not software. The description details its material, shapes, sizes, and intended use as a physical object for surgical implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The provided description clearly states that the Pre-Formed Silicone Block is an implant intended for cosmetic correction of soft tissue deformities. It is surgically placed inside the body.
- Lack of IVD Characteristics: The description does not mention any testing of bodily specimens, analysis of biological markers, or any other activity typically associated with IVD devices.
Therefore, based on the provided information, the Pre-Formed Silicone Block is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.
Product codes
MIB
Device Description
The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue deformities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
SUMMARY OF NON-CLINICAL TESTING
Previous testing (i.e., biocompatibility, sterilization, and non-clinical performance testing) was leveraged to support a demonstration of substantial equivalence.
SUMMARY OF CLINICAL TESTING
No additional testing was provided in this submission in order to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
February 3, 2023
International Medical Devices, Inc. % Lucie Dalet Senior Regulatory Consultant Ram+ 2251 San Diego Ave, Suite B-257 San Diego, California 92110
Re: K223051
Trade/Device Name: Pre-Formed Silicone Block Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, Nose, And Throat Synthetic Polymer Material Regulatory Class: Class II Product Code: MIB Dated: February 3, 2023 Received: September 29, 2022
Dear Lucie Dalet:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 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 (OS) 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 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,
Deborah A. Fellhauer -S
Deborah Fellhauer RN, BSN Assistant Director Plastic Surgery Skin and Wound Devices Team DHT4B: Division of Infection Control and Plastic Surgery Devices | OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality CDRH | Food and Drug Administration
Enclosure
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Indications for Use
510(k) Number (if known) K223051
Device Name Pre-Formed Silicone Block
Indications for Use (Describe)
The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 201 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for HMD International Medical Devices Inc. The logo consists of the letters "HMD" in black, with a blue horizontal line extending from the left of the "H" to the middle of the "M". To the right of "HMD" is the text "International Medical Devices Inc.", with "International" in black and "Medical Devices Inc." in blue.
510(k) Summary K223051
DATE PREPARED
February 3, 2023
MANUFACTURER AND 510(k) OWNER
International Medical Devices, Inc. 717 North Maple Drive, Beverly Hills, CA 90210, USA Telephone: (310) 657-0500 Fax: Official Contact: James Elist, MD
REPRESENTATIVE/CONSULTANT
Lucie Dalet, Ph.D. Allison C. Komiyama, Ph.D., RAC RQM+ Telephone: +1 (877) 652-0830 Email: ldalet@rqmplus.com, akomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Pre-Formed Silicone Block |
|---|---|
| Common Name: | Elastomer, Silicone Block |
| Regulation Number: | 21 CFR 874.3620 |
| Class: | Class II |
| Product Code: | MIB |
| Premarket Review: | Surgical and Infection Control Devices (OHT4)/ DHT4B |
| Review Panel: | General and Plastic Surgery |
PREDICATE DEVICE IDENTIFICATION
The Pre-Formed Silicone Block is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K042380 | Silicone Block / National Medical Devices, Inc.* | ✓ |
| K220760 | Pre-Formed Penile Silicone Block / International Medical Devices, Inc. | |
| K162624 / | ||
| K181387 | Pre-Formed Penile Silicone Block / International Medical Devices, Inc. |
- National Medical Devices, Inc. is now International Medical Devices, Inc.
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Image /page/4/Picture/0 description: The image shows the logo for HMD International Medical Devices Inc. The logo consists of the letters "HMD" in black, with a blue plus sign to the left of the "H". To the right of "HMD" are the words "International" in black and "Medical Devices Inc." in blue. The logo is simple and professional, and it clearly identifies the company.
DEVICE DESCRIPTION
The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.
INDICATIONS FOR USE
The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Pre-Formed Silicone Block is similar to the predicate devices based on the information summarized here:
The subject device has similar shapes and dimensions as the primary predicate cleared in K042380. The Pre-Formed Silicone Block is made from the same materials and manufacturing processes as the predicate devices cleared in K220760 and K181387. The main difference is the addition of new carvable shapes of implants in order to offer additional possibilities to surgeons to accommodate a larger variety of surgical techniques and implantation needs. Since the dimensions of the new shapes are not greater than the dimensions of the shapes of the predicate devices cleared in K042380, K220760, K162624, and K181387, they are not considered as new technological characteristics that would raise different questions of safety and effectiveness.
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Image /page/5/Picture/0 description: The image contains the logo for HMD International Medical Devices Inc. The logo consists of a blue plus sign followed by the letters "HMD" in black. To the right of "HMD" is the text "International" in black, with "Medical Devices Inc." in blue below it.
| Subject Device | Primary Predicate Device | Other Predicates | |
|---|---|---|---|
| International Medical Devices, Inc. | National Medical Devices, Inc. | International Medical Devices, Inc. | |
| Pre-Formed Silicone Block | Silicone Block | Pre-Formed Penile Silicone Block | |
| K042380 | K220760 | ||
| Indications for Use | The Pre-Formed Silicone Block is | ||
| intended for use in the cosmetic | |||
| correction of soft tissue | |||
| deformities, and is contoured at the | |||
| surgeon's discretion to create a | |||
| custom implant to aid in the | |||
| reconstruction process. | The Silicone Block is intended for | ||
| use in the cosmetic correction of | |||
| soft tissue deformities, and is | |||
| contoured at the surgeon's | |||
| discretion to create a custom | |||
| implant to aid in the | |||
| reconstruction process. | The Pre-Formed Penile Silicone | ||
| Block is intended for use in | |||
| augmentation, reconstructive and | |||
| cosmetic surgery, and is contoured | |||
| at the surgeon's discretion to | |||
| create a custom implant. When | |||
| used in augmentation procedures, | |||
| the device provides cosmetic | |||
| augmentation of the penis and is | |||
| intended for aesthetic purposes | |||
| Product Codes | MIB | MIB | MIB |
| Regulation | |||
| Number | 21 CFR 874.3620 | 21 CFR 874.3620 | 21 CFR 874.3620 |
| Class | Class II | Class II | Class II |
| Intended Location | |||
| of Use | Soft tissue deformities | Penis, calf, gluteal, other soft | |
| tissue deformities | Penis | ||
| Materials | Silicone | ||
| Sheeting | |||
| Coating | Silicone | ||
| Sheeting | Silicone | ||
| Sheeting | |||
| Coating (optional) | |||
| Shapes | Cup-shaped | ||
| Crescent-shaped | |||
| Block | Curvilinear | ||
| Oval | |||
| Block | Curvilinear | ||
| Surface | Smooth | Smooth | Smooth |
| Carvable? | Yes | Yes | Yes |
| Provided Sterile? | Provided sterile or non-sterile | Provided sterile or non-sterile | Provided sterile or non-sterile |
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Image /page/6/Picture/0 description: The image shows the logo for HMD International Medical Devices Inc. The logo features a blue horizontal line extending to the left of the letters "HMD", which are in black. To the right of "HMD" is the text "International Medical Devices Inc.", which is in blue.
SUMMARY OF NON-CLINICAL TESTING
Previous testing (i.e., biocompatibility, sterilization, and non-clinical performance testing) was leveraged to support a demonstration of substantial equivalence.
SUMMARY OF CLINICAL TESTING
No additional testing was provided in this submission in order to demonstrate substantial equivalence.
CONCLUSION
Based on the identical indications for use, identical materials, similar technological characteristics, and identical manufacturing processes, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate devices. The Pre-Formed Silicone Block is considered substantially equivalent to the predicate devices.