(59 days)
No
The device is a physical silicone implant and the description focuses on its material, dimensions, and surgical application. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as being for "aesthetic purposes" and "cosmetic augmentation," indicating it is not intended for treating or curing a disease or condition.
No
The device is described as an implant for augmentation, reconstructive, and cosmetic surgery, not for diagnosing conditions.
No
The device description clearly states it is a physical object made of silicone and polyester mesh, intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Description: The Pre-Formed Penile Silicone Block is an implantable device used in surgery within the body for augmentation, reconstructive, and cosmetic purposes.
- Intended Use: The intended use clearly states it's for surgical procedures to augment or reconstruct the penis. It does not involve testing samples from the body.
Therefore, based on the provided information, the Pre-Formed Penile Silicone Block is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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
Device Description
The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
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 Pre-Formed Penile Silicone Block is intended for use in visual augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. In a retrospective study, 526 patients underwent elective cosmetic penile surgery using the Pre-Formed Penile Silicone Block over a period of five years. Approval from the Institutional Review Board was obtained to perform a retrospective analysis of the cosmetic surgery outcomes. Of the 526 patients who underwent elective cosmetic penile surgery using the subject device, 400 patients responded to the study author's request for consent and were included in the study. The outcomes of their surgeries are summarized here. Clinical effectiveness of the subject device was evaluated via changes in penile measurements, changes in the Augmentation Phalloplasty Patient Selection and Satisfaction Inventory (APPSSI), changes in patient self-confidence and selfesteem, and a change in the incidences of adverse events.
Penile circumference was measured before, immediately after, and 30-90 days after the implant surgery. In the 400 patients, the implantation of the Pre-Formed Penile Silicone Block increased midshaft circumference from an average of 8.5 ± 1.2 cm to 13.4 ± 1.9 cm, a 56.7% increase (P
§ 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 contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
May 13, 2022
International Medical Devices, Inc. % Allison C. Komiyama, Ph.D., R.A.C. Principal Consultant Ram+ 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110
Re: K220760
Trade/Device Name: Pre-Formed Penile Silicone Block Regulation Number: 21 CFR§ 874.3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: II Product Code: MIB Dated: March 15, 2022 Received: March 15, 2022
Dear Allison C. Komiyama:
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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 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,
for Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220760
Device Name Pre-Formed Penile Silicone Block
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Production Use (Part 21 CFR 606 Subpart D) |
|---|
| Own-Use Testing (Part 21 CFR 606 Subpart F) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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510(k) Summary
DATE PREPARED
May 9, 2022
International Medical Devices, Inc. 717 North Maple Drive, Beverly Hills, CA 90210, USA Telephone: (310) 652-2600 (310) 657-0500 Fax: Official Contact: James Elist, MD
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., RAC Lucie Dalet, Ph.D. Matthieu Kirkland, M.S. RQM+ 2251 San Diego Avenue, Ste B-257, San Diego, CA 92110, USA Telephone: Email: akomiyama@rqmplus.com
PROPRIETARY NAME OF SUBJECT DEVICE
Pre-Formed Penile Silicone Block
COMMON NAME
Elastomer, Silicone Block
DEVICE CLASSIFICATION
21 CFR 874.3620, Product Code MIB, Class II
CLASSIFICATION NAME
Ear, nose, and throat synthetic polymer material
PREDICATE DEVICE IDENTIFICATION
The Pre-Formed Penile Silicone Block is substantially equivalent to the following predicate:
| 510(k) | Predicate Device Name / Manufacturer | Primary |
|---|---|---|
| Number | Predicate | |
| K181387 | Pre-Formed Penile Silicone Block / International Medical Devices, Inc. | ✓ |
DEVICE DESCRIPTION
The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height
4
510(k) Summary
of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
| Part # | Part Description | Materials |
|---|---|---|
| IMD006-L-S | IMD Block, Packaged Soft, Large, Sterile | Silicone and Polyester Mesh |
| IMD006-L-NS | IMD Block, Packaged Soft, Large, Non-sterile | |
| IMD006-XL-S | IMD Block, Packaged Soft, XL, Sterile | |
| IMD006-XL-NS | IMD Block, Packaged Soft, XL, Non-sterile | |
| IMD006-XXL-S | IMD Block, Packaged Soft, XXL, Sterile | |
| IMD006-XXL-NS | IMD Block, Packaged Soft, XXL, Non-sterile |
INDICATIONS FOR USE
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The subject device has identical dimensions, design, materials, and technological characteristics as the predicate device (K181387). The subject and predicate devices have the same intended use, as both are intended to be implanted in the penis as a space-occupying substance in cosmetic surgeries.
SUMMARY OF NON-CLINICAL TESTING
Because no changes in technological characteristics are made for the subject device compared to the predicate device, non-clinical testing, such as biocompatibility, sterilization, and non-clinical performance testing is not needed to support a substantial equivalence of the subject device to the predicate.
SUMMARY OF CLINICAL TESTING
The Pre-Formed Penile Silicone Block is intended for use in visual augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. In a retrospective study, 526 patients underwent elective cosmetic penile surgery using the Pre-Formed Penile Silicone Block over a period of five years. Approval from the Institutional Review Board was obtained to perform a retrospective analysis of the cosmetic surgery outcomes. Of the 526 patients who underwent elective cosmetic penile surgery using the subject device, 400 patients responded to the study author's request for consent and were included in the study. The outcomes of their surgeries are summarized here. Clinical effectiveness of the subject device was evaluated via changes in penile measurements, changes in the Augmentation Phalloplasty Patient Selection and Satisfaction Inventory (APPSSI), changes in patient self-confidence and selfesteem, and a change in the incidences of adverse events.
5
Penile circumference was measured before, immediately after, and 30-90 days after the implant surgery. In the 400 patients, the implantation of the Pre-Formed Penile Silicone Block increased midshaft circumference from an average of 8.5 ± 1.2 cm to 13.4 ± 1.9 cm, a 56.7% increase (P