AugMENTA Penile Implant

K200073 · Augmenta, LLC · MIB · Sep 30, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K200073
• Device Name: AugMENTA Penile Implant
• Applicant: Augmenta, LLC
• Product Code: MIB · Ear, Nose, Throat
• Decision Date: Sep 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.

Device Story

Augmenta Penile Implant is a silicone-based, implantable device designed for cosmetic correction of soft tissue deformities. It is provided sterile for single-use. The device is available in 175 size variations to accommodate different anatomical dimensions (natural girth 5.5–13.0 cm; augmented girth 8.5–16.0 cm; length 8.0–18.0 cm). During surgery, the physician may trim the proximal end to customize the fit based on patient anatomy and surgical technique. The device functions as a physical implant to provide structural augmentation. It is intended for use by surgeons in a clinical setting. The implant provides a permanent cosmetic improvement for the patient.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and performance were established through biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, implantation, genotoxicity), extractables/leachables analysis, toxicological risk assessment, and product/packaging integrity testing (visual, seal strength, shipping, burst, sterilization validation, EO residuals, and image artifact evaluations).

Technological Characteristics

Silicone implant; hydrophilic coating. Dimensions: 8.0–18.0 cm length; 2.3–3.4 cm height; 0.54–0.8 cm thickness. Sterilization: Ethylene Oxide. Standards: ISO 10993-1 (biocompatibility), ASTM D4169-16 (shipping), ASTM F88/F88M-15 (seal strength), ASTM F1140/F1140M-13 (burst), ISO 11135:2014 (sterilization), ISO 10993-7:2008 (EO residuals), ASTM F2119-07 (image artifacts).

Indications for Use

Indicated for cosmetic correction of soft tissue deformities in patients requiring penile augmentation.

Regulatory Classification

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.

Predicate Devices

• Pre-Formed Penile Silicone Block (K181387)

Submission Summary (Full Text)

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September 30, 2022

Augmenta LLC % Lisa L. Pritchard, BSEEE Vice President, Regulatory, Quality, Clinical & Engineering DuVal & Associates, P.A. 1820 Medical Arts Building 825 Nicollet Mall Minneapolis, MN 55402

Re: K200073

Trade/Device Name: Augmenta Penile Implant Regulation Number: 21 CFR& 874,3620 Regulation Name: Ear, Nose, and Throat Synthetic Polymer Material Regulatory Class: II Product Code: MIB Dated: August 4, 2022 Received: August 4, 2022

Dear Lisa L. Pritchard:

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.

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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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 medical devices and radiation-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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K200073

Device Name Augmenta Penile Implant

Indications for Use (Describe)

The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.

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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K200073 Page 1 of 3

Image /page/3/Picture/1 description: The image contains the logo for Augmenta. The logo consists of a stylized, abstract symbol in blue, resembling a curved line that forms a loop or a stylized letter 'a'. Below the symbol, the word "AUGMENTA" is written in bold, uppercase letters. The font appears to be sans-serif, and the overall design is clean and modern.

## 510(k) Summary

| 510(k) Owner: | Augmenta LLC<br>1315 St. Joseph Parkway<br>Suite 1700<br>Houston, TX 77002<br>Telephone: [phone]<br>Contact: Robert J. Cornell, MD<br>Date prepared: September 28, 2022 |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Trade Name: Augmenta Penile Implant<br>Common Name: Elastomer, Silicone Block<br>Classification Name: Ear, Nose, and Throat Synthetic Polymer Material<br>Regulation: 21 CFR §874.3620<br>Regulatory Classification: 2<br>Product Code: MIB |
| Predicate Device: | Pre-Formed Penile Silicone Block (K181387) |

## Device Description:

The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant. The Augmenta Penile Implant is made of silicone. The Augmenta Penile Implant comes in 175 sizes with a range of dimensions. The proximal end of the device may be trimmed by the physician to further customize the fit. The device is provided sterile and is intended for single-use only.

The predicate device has not been subject of a design-related recall.

| Measurement | Augmenta Size Range |
|--------------------------------------------------------|---------------------|
| Natural Girth Circumference (Inner<br>Circumference) | 5.5 – 13.0 cm |
| Augmented Girth Circumference (Outer<br>Circumference) | 8.5 – 16.0 cm |
| Ventral Gap | 1.5 – 3.0 cm |

Table 1: Augmenta Penile Implant Size Ranges

## Indications for Use

Total Length (L)

The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.

8.0 - 18.0 cm

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## Comparison of Technological Characteristics with the Predicate Device

The Augmenta Penile Implant has similar technological characteristics as the predicate device, the Preformed Penile Silicone Block cleared via K181387. A comparison of the devices is provided in Table 2.

| Device Comparison | Subject Device<br>Augmenta Penile Implant | Predicate Device<br>Pre-formed Penile Silicone Block<br>(Penuma)<br>(K181387) |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Augmenta Penile Implant | Pre-Formed Penile Silicone Block<br>(Penuma) |
| Manufacturer | Augmenta, LCC | International Medical Devices, Inc |
| FDA Product Code | MIB | MIB |
| Indications for Use | The Augmenta Penile Implant is<br>intended for use in the cosmetic<br>correction of soft tissue<br>deformities, and is trimmed to<br>length at the surgeon's discretion<br>for a custom implant. | The Pre-Formed Penile Silicone<br>Block is intended for use in the<br>cosmetic correction of soft tissue<br>deformities, and is contoured at<br>the surgeon's discretion to create a<br>custom implant. |
| Principles of Operation | The Augmenta Penile Implant may<br>be used in a variety of surgical<br>techniques. Therefore, the surgeon<br>is best advised to use the method<br>that his/her own practice and<br>discretion dictate to be best for the<br>patient. | The Penuma device may be used in<br>a variety of surgical techniques.<br>Therefore, the surgeon is best<br>advised to use the method that<br>his/her own practice and discretion<br>dictate to be best for the patient. |
| Device Material | Silicone | Medical grade silicone with an<br>embedded polyester mesh. |
| Device Coating | Hydrophilic coating | No coating |
| Device Offerings | 175 device offerings<br>Augmented Girth: 8.5 - 16.0 cm<br>Natural Girth: 5.5 – 13.0 cm<br>Ventral Gap: 1.5 — 3.0 cm<br>Length: 8.0 – 18.0 cm | 3 device offerings (L, XL, XXL) |
| Device Length | 8.0 - 18.0 cm length | 12 – 18 cm length |
| Device Size | Calculated:1<br>Height: 2.3 - 3.4 cm<br>Thickness: 0.54 - 0.8 cm | Height: 2.0 - 3.5 cm<br>Thickness: 0.5 - 1.1 cm |
| Condition of Use | Single Use | Single Use |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |

#### Table 2: Comparison with Predicate Device

1Height and thickness are calculated measurements for Augmenta; specifications are for natural girth (inner circumference), augmented girth (outer circumference), and ventral gap.

## Non-Clinical Performance Data

No FDA performance standards have been promulgated that are applicable to the Augmenta Penile Implant.

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The Augmenta Penile Implant is considered an implantable medical device with permanent (greater than 30 day) tissue/bone contact. The following assessments demonstrated safety in accordance with ISO 10993-1:

- Cytotoxicity
- Sensitization
- Irritation/intracutaneous reactivity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity ●
- Implantation
- Genotoxicity
- . Extractables and Leachables
- Toxicology Risk Assessment

Additional non-clinical performance testing included evaluations of product and packaging integrity and acceptability of the sterilization processing These included visual integrity, seal strength, shipping, burst test, sterilization validation, EO residual, and image artifact evaluations. These assessments were conducted in accordance with the following recognized standards:

- . ASTM D4169-16
- ASTM F88/F88M-15
- ASTM F1140/F1140M-13
- ISO 111135: 2014
- ISO 10993-7: 2008
- F2119-07 (2013)

## Conclusion

The biocompatibility testing, extractable chemical analysis, toxicological risk assessment, product and packaging integrity, sterilization assessments, and image artifact testing conducted provides evidence that the Augmenta Penile Implant performs comparable to the legally marketed predicate device. The Augmenta Penile Implant has the same intended use as the predicate device. The data provided supports substantial equivalence of the Augmenta Penile Implant to the predicate device.