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.

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.

AI/ML Overview

The device in question is the Pre-Formed Penile Silicone Block.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in a quantitative format for the clinical study. Instead, it describes observed outcomes and improvements. Based on the "Clinical effectiveness" section, we can infer the measures of performance.

Performance Metric (Implied Acceptance Criteria)	Reported Device Performance (Achieved)
Penile Circumference Increase	Increased from 8.5 ± 1.2 cm to 13.4 ± 1.9 cm (56.7% increase, P<.001)
Self-confidence and Self-esteem Improvement	83% of patients noted a 2-category improvement 6-8 weeks postoperatively
APPSSI Score Improvement (Long-term)	72% patients maintained a 2-category improvement upon long-term follow-up (2-6 years, mean 4 years)
Patient Satisfaction	81% of subjects reported "high" or "very high" levels of satisfaction
Adverse Events requiring device removal	3% of patients
Impact on Sexual Function	No reports of any changes to sexual function, erections, or ejaculations
Most Frequent Postoperative Complications	Seroma (4.8%), Scar formation (4.5%), Infection (3.3%)

2. Sample Size and Data Provenance for the Test Set

Sample Size (Test Set):
- Initial retrospective study included 526 patients.
- 400 patients responded to the request for consent and were included in the analysis.
Data Provenance: Retrospective study. The country of origin is not explicitly stated, but the submission is from "International Medical Devices, Inc." in Beverly Hills, CA, USA, suggesting the study likely took place in the USA.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the clinical outcomes. The clinical effectiveness was evaluated via patient-reported outcomes (APPSSI, self-confidence/self-esteem, satisfaction) and objective measurements (penile circumference) taken by clinical staff, and complication rates observed by the surgeons.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the study relies on patient-reported outcomes, objective measurements, and observed complications rather than expert consensus on interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a clinical effectiveness study of the device itself, not an evaluation of an AI system with or without human assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone (algorithm only) study was not done. The device is a physical implant, and the study evaluates its clinical performance in human patients. This document does not describe an AI medical device.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's clinical effectiveness was a combination of:

Objective Measurements: Penile circumference measurements taken before, immediately after, and 30-90 days after surgery.
Patient-Reported Outcomes: Changes in the Augmentation Phalloplasty Patient Selection and Satisfaction Inventory (APPSSI), changes in patient self-confidence and self-esteem, and patient-reported satisfaction levels.
Clinical Observations: Incidence of adverse events (seroma, scar formation, infection) and events necessitating device removal, as well as absence of changes to sexual function.

8. Sample Size for the Training Set

The document describes a clinical study evaluating the performance of the device; it does not mention a training set in the context of machine learning or AI. This is a study of a physical medical device.

9. How the Ground Truth for the Training Set was Established

As there is no mention of a training set or an AI algorithm, this question is not applicable to the provided document.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K220760

Device Name Pre-Formed Penile Silicone Block

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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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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

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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

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.

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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<.001). Six to eight weeks postoperatively, 83% of the surveyed patients noted a 2-category improvement in their self-confidence and self-esteem, and upon long-term follow-up (2-6 years, mean 4 years), 72% patients maintained a 2-category improvement in their APPSSI score, and 81% of subjects reported "high" or "very high" levels of satisfaction with their surgical outcome.

The most frequently reported postoperative complications were seroma (4.8%), scar formation (4.5%), and infection (3.3%). 3% of patients experienced adverse events that necessitated device removal. There were no reports of any changes to sexual function, erections, or ejaculations.

CONCLUSION

The subject device is identical in dimensions, design, materials, and technological characteristics and has the same intended use as the predicate device (K181387). It was determined that the subject device is as safe and effective as the predicate device because they have the same intended use and identical technological characteristics. Therefore, the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.