(990 days)
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.
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 provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostic tools. Instead, it is an FDA 510(k) clearance letter for a physical medical device, the "Augmenta Penile Implant," which is a silicone implant for cosmetic correction of soft tissue deformities.
The document focuses on demonstrating substantial equivalence to a predicate device (Pre-Formed Penile Silicone Block, K181387) rather than proving performance against specific acceptance criteria for an AI/ML algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. These concepts are not applicable to the type of device and clearance described in the provided text.
The closest analogue to "acceptance criteria" in this document are the non-clinical performance data listed on page 5, which are primarily related to biocompatibility, material integrity, and sterilization for an implantable device, usually demonstrated through adherence to recognized standards like ISO 10993 and ASTM standards.
Non-Clinical Performance Data (related to material and sterilization safety, not algorithmic performance):
- Biocompatibility Assessments (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
- Product and Packaging Integrity Assessments (in accordance with recognized standards):
- Visual integrity
- Seal strength
- Shipping
- Burst test
- Sterilization validation (ISO 111135: 2014)
- EO residual (ISO 10993-7: 2008)
- Image artifact evaluations (F2119-07 (2013))
- ASTM D4169-16
- ASTM F88/F88M-15
- ASTM F1140/F1140M-13
- Conclusion: The claim is that these assessments provide evidence that the Augmenta Penile Implant "performs comparable to the legally marketed predicate device."
In summary, none of the requested information regarding AI/ML device performance and validation can be provided from this document.
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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 (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
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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 LLC1315 St. Joseph ParkwaySuite 1700Houston, TX 77002Telephone: 713.205.4674Contact: Robert J. Cornell, MDDate prepared: September 28, 2022 |
|---|---|
| Device Name: | Trade Name: Augmenta Penile ImplantCommon Name: Elastomer, Silicone BlockClassification Name: Ear, Nose, and Throat Synthetic Polymer MaterialRegulation: 21 CFR §874.3620Regulatory Classification: 2Product 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 (InnerCircumference) | 5.5 – 13.0 cm |
| Augmented Girth Circumference (OuterCircumference) | 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 DeviceAugmenta Penile Implant | Predicate DevicePre-formed Penile Silicone Block(Penuma)(K181387) |
|---|---|---|
| Name | Augmenta Penile Implant | Pre-Formed Penile Silicone Block(Penuma) |
| Manufacturer | Augmenta, LCC | International Medical Devices, Inc |
| FDA Product Code | MIB | MIB |
| Indications for Use | The Augmenta Penile Implant isintended for use in the cosmeticcorrection of soft tissuedeformities, and is trimmed tolength at the surgeon's discretionfor a custom implant. | The Pre-Formed Penile SiliconeBlock is intended for use in thecosmetic correction of soft tissuedeformities, and is contoured atthe surgeon's discretion to create acustom implant. |
| Principles of Operation | The Augmenta Penile Implant maybe used in a variety of surgicaltechniques. Therefore, the surgeonis best advised to use the methodthat his/her own practice anddiscretion dictate to be best for thepatient. | The Penuma device may be used ina variety of surgical techniques.Therefore, the surgeon is bestadvised to use the method thathis/her own practice and discretiondictate to be best for the patient. |
| Device Material | Silicone | Medical grade silicone with anembedded polyester mesh. |
| Device Coating | Hydrophilic coating | No coating |
| Device Offerings | 175 device offeringsAugmented Girth: 8.5 - 16.0 cmNatural Girth: 5.5 – 13.0 cmVentral Gap: 1.5 — 3.0 cmLength: 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:1Height: 2.3 - 3.4 cmThickness: 0.54 - 0.8 cm | Height: 2.0 - 3.5 cmThickness: 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.
§ 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.