(243 days)
Not Found
No
The device description and performance studies focus on the material properties and physical characteristics of a silicone implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The intended use is "cosmetic correction" of soft tissue deformities, not treatment or therapy for a disease or condition.
No
The device is described as an implant for cosmetic correction, not for diagnosis. Its intended use and description focus on altering soft tissue, and there's no mention of it being used to identify or analyze medical conditions.
No
The device description clearly states it is a physical object made of silicone and polyester mesh, with specific dimensions and material properties, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly states that the Pre-Formed Penile Silicone Block is an implantable device used for the cosmetic correction of soft tissue deformities in the penis. It is a physical object surgically placed within the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely structural and cosmetic.
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 the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.
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 the cosmetic correction of soft tissue deformities in 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
No FDA performance standards have been established for the Pre-Formed Penile Silicone Block. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards:
- Biocompatibility Risk Assessment per ISO 10993-1
- Cytotoxicity testing per ISO 10993-5
- Extractable/Leachable Chemical Analysis (GC/MS, ICP/MS, ICP/AES, LC/MS)
- Toxicological Risk Assessment per ISO 10993-17
The results of these tests indicate that the Pre-Formed Penile Silicone Block is substantially equivalent to the predicate device.
Key Metrics
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 23, 2019
International Medical Devices, Inc. % Allison Komiyama, Ph.D., RAC Principal Consultant AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego, CA 92104
Re: K181387
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: Class II Product Code: MIB Dated: December 19, 2018 Received: December 26, 2018
Dear Allison 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
Glenn B. Bell -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Pre-Formed Penile Silicone Block
Indications for Use (Describe)
The Pre-Formed Penile 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K181387
DATE PREPARED
December 19, 2018
MANUFACTURER AND 510(k) OWNER
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., R.A.C. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.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
predicates:
| 510(k)
Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|------------------|------------------------------------------------------------------------|----------------------|
| K162624 | 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 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
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thickness of 1.1 cm and a height of 3.5 cm. The device is used in the cosmetic correction of soft tissue deformities in the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
INDICATIONS FOR USE
The Pre-Formed Penile 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
IMD believes that the Pre-Formed Penile Silicone Block is substantially equivalent to the predicate device based on the information summarized here:
The subject device has identical dimensions, the same indications for use, and the same design as the device cleared in K162624. The subject device has similar materials and similar technological characteristics to the device cleared in K162624. Testing submitted in this premarket notification demonstrates that including a new medical grade silicone material does not affect the safety and effectiveness of this device.
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Pre-Formed Penile Silicone Block. A summary of the following tests that were performed was provided in order to demonstrate safety based on current industry standards:
- Biocompatibility Risk Assessment per ISO 10993-1
- . Cytotoxicity testing per ISO 10993-5
- Extractable/Leachable Chemical Analysis (GC/MS, ICP/MS, ICP/AES, LC/MS)
- Toxicological Risk Assessment per ISO 10993-17 ●
The results of these tests indicate that the Pre-Formed Penile Silicone Block is substantially equivalent to the predicate device.
CONCLUSION
Based on the biocompatibility testing, extractable chemical analysis, and toxicological risk assessment performed, it can be concluded that the subject device does not raise new issues of safety and effectiveness compared to the predicate device. The identical indications for use and similar technological characteristics for the proposed Pre-Formed Penile Silicone Block are assessed to be substantially equivalent to the predicate device.