The malleable penile prosthesis is indicated for implantation into the corpora cavernosa of the penis in men who are diagnosed with erectile dysfunction. The prosthesis is implanted to provide adequate penile rigidity for sexual intercourse. The prosthesis is designed for the treatment of organic erectile dysfunction in men due to:

Pelvic fracture, Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes

mellitus, Arteriosclerosis, Hypertensive vascular disease, Priapism, Peyronie's disease, Selectively for psychogenic impotence.

Device Description

Rigi10 malleable penile prosthesis is a sterile, non-pyrogenic, single-use surgical implant.

The device core consists of a malleable stainless-steel core, with titanium caps on both ends, and a PTFE (Polytetrafluoroethylene) tube cover. The entire outside surface of the cylinder is made out of silicone. The malleable stainlesssteel core enables the prosthesis to be moved into an erect position when desired and also enables the concealment of the prosthesis under clothing. All components consist of implantable, biocompatible materials.

The device consists of two cylinders, and extenders. The cylinders are surgically implanted, one into each corpus cavernosum, to provide penile rigidity.

The prosthesis comes in two lengths. This includes 23 cm and 25 cm. The length is determined by the diameter of the prosthesis. Rigi10 Malleable Penile Prosthesis is available in five different diameter sizes; 9 mm, 10 mm, 11 mm, 12 mm, and 13 mm. Cylinders with 9 mm and 10 mm diameters are available in 23 cm length while cylinders with 11mm, 12 mm and 13 mm diameters are available in 25 cm length. There are four extenders (two pieces of 0.5 cm and two pieces of 1.0 cm) included in each product package. The extenders are accessories of the device and are available for adjusting the length of the prosthesis to match the total corporal measurement of the patient.

AI/ML Overview

The document describes the acceptance criteria and the study conducted for the Rigi10 Malleable Penile Prosthesis.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Type	Acceptance Criteria (Established Prior to Testing)	Reported Device Performance
Biocompatibility Tests	Adherence to ISO 10993-1 "Biological evaluation of medical devices" guideline.	Device met all biocompatibility test specifications.
In Vitro Cytotoxicity	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Skin Sensitization	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Intracutaneous Reactivity	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Acute Systemic Toxicity	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Pyrogen	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Bacterial Endotoxin	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Implantation	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Chemical Characterization	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Toxicological Risk Assessment	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Rabbit Blood Hemolysis	Not explicitly stated, but implied to meet ISO 10993-1 requirements.	Met specifications.
Bench Performance Tests	Adherence to "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants" January 16, 2000. Demonstrate statistically significant substantial equivalence to the predicate device.	Device met all performance test specifications and passed all tests.
Simulated Life/Fatigue	Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence.	Met acceptance criteria.
Positioning/Concealability	Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence.	Met acceptance criteria.
Buckling	Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence.	Met acceptance criteria.
Tip Extender Joint Strength	Not explicitly stated, but acceptance criterion established prior to testing for substantial equivalence.	Met acceptance criteria.
Sterilization	Validated for ethylene oxide sterilization.	Validated for ethylene oxide sterilization.

2. Sample Size for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the biocompatibility or bench performance tests. However, it indicates that the tests were conducted in accordance with recognized standards (ISO 10993-1 for biocompatibility and FDA guidance for penile rigidity implants for bench tests). The data provenance is laboratory testing conducted by Rigicon, Inc. or their designated testing facilities. It does not mention any human patient data for the purpose of primary device evaluation, as a clinical study was not conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the studies described are bench (laboratory) and biocompatibility tests, not clinical studies involving human experts to establish ground truth on patient outcomes or diagnoses. The "ground truth" for these tests are the established specifications within the relevant ISO standards and FDA guidance documents.

4. Adjudication Method for the Test Set:

Not applicable. As described above, these were laboratory tests against established physical/chemical/biological specifications, not human expert adjudication of clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:

Not applicable. The document describes a medical device (penile prosthesis), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. This device is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used:

The ground truth for the biocompatibility tests was established by the specifications and methodologies outlined in ISO 10993-1 "Biological evaluation of medical devices" guideline.

The ground truth for the bench performance tests was established by the specifications and methodologies outlined in the "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants" January 16, 2000, and the need to demonstrate "statistically significant substantial equivalence to the predicate device."

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

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

Not applicable, as there is no training set for this device.

Summary

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April 15, 2019

Rigicon, Inc. Ahmet Melih Luleci Regulatory Representative 2805 Veterans Highway, Suite 13 Ronkonkoma, NY 11779

Re: K181673

Trade/Device Name: RIGI 10 MALLEABLE PENILE PROSTHESIS Regulation Number: 21 CFR§ 876.3630 Regulation Name: Penile Rigidity Implant Regulatory Class: II Product Code: FAE Dated: March 13, 2019 Received: March 13, 2019

Dear Ahmet Melih Luleci:

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/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) K181673

Device Name RIGI 10 MALLEABLE PENILE PROSTHESIS

Indications for Use (Describe)

Pelvic fracture, Spinal cord injury or disease, Prostatectomy,Multiple sclerosis, Diabetes

mellitus, Arteriosclerosis, Hypertensive vascular disease, Priapism, Peyronie's disease, Selectively for psychogenic impotence.

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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FORM FDA 3881 (7/17)

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Rigicon Inc. Malleable Penile Prosthesis Abbreviated 510(k)

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Section 5 - 510(k) Summary

1) SUBMITTER

Rigicon, Inc. 2805 Veterans Highway Suite 13, Ronkonkoma, NY 11779 Phone: 631-676-3376

Contact Person : Ahmet Melih Luleci Rigicon, Inc. Requlatory Representative regulatory@rigicon.com

: March 08, 2019

Date Prepared

2) DEVICE

Name of Device	: Rigi10™ Malleable Penile Prosthesis
Common or Usual Name	: Penile Prosthesis
Classification Name	: Penile Rigidity Implant
Regulatory Class	: Class II
Regulation	: 21 CFR 876.3630
Product Code	: FAE

3) PREDICATE DEVICE

Coloplast (formerly Mentor Corp.) Genesis Penile Prosthesis, K040959 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

REASON FOR 510(K) SUBMISSION

Rigi10 Malleable Penile Prosthesis is a new model.

5) DEVICE DESCRIPTION

Rigi10 malleable penile prosthesis is a sterile, non-pyrogenic, single-use surgical implant.

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prosthesis under clothing. All components consist of implantable, biocompatible materials.

The device consists of two cylinders, and extenders. The cylinders are surgically implanted, one into each corpus cavernosum, to provide penile rigidity.

Patients diagnosed with erectile dysfunction are candidates for Rigi10 Malleable Penile Prosthesis implantation. The device should only be implanted by specialized physicians (e.g. urologists and surgeons)

6) INDICATIONS FOR USE

The prosthesis is designed for the treatment of organic erectile dysfunction in men due to:

Pelvic fracture, ●
Spinal cord injury or disease, ●
Prostatectomy, ●
Multiple sclerosis,
Diabetes mellitus,
Arteriosclerosis, ●
Hypertensive vascular disease, ●
0 Priapism,
Peyronie's disease, ●
Selectively for psychogenic impotence. ●

The Indications for Use statement for the Rigi10 Malleable Penile Prosthesis is not identical to the predicate device (i.e. K040959) however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and

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effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for the treatment of erectile dysfunction, by providing adequate penile rigidity for sexual intercourse.

7) SUBSTANTIAL EQUIVALENCE CLAIM

Rigi10 Malleable Penile Prosthesis is substantially equivalent to the predicate device (i.e. Coloplast (formerly Mentor Corp.) Genesis Penile Prosthesis) The devices have same intended use, indications for use and target population. The devices are mainly manufactured with similar material (i.e. silicone elastomer) with minor differences such as stainless-steel core and PTFE cover in Rigi10 while the predicate device has a silver core and a polvester cover. Subject and predicate devices are sterilized with the same sterilization methods (i.e. EtO sterilization).

Testing rationale was provided to support the equivalence of the Rigi10 Malleable Penile Prosthesis and shows that no new concerns of safety and effectiveness have been introduced with this device.

The safety and effectiveness of the Rigi10 Malleable Penile Prosthesis are adequately supported by the testing rationale, substantial equivalence information, materials information, and comparison of design characteristics provided with the submission document.

Because the intended use and the fundamental scientific technology of the predicate device are similar with the subject device a clinical study was not conducted for Rigi10 Malleable Penile Prosthesis.

8) PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility tests:

In Vitro Cytotoxicity Test ●
Skin Sensitization Test ●
Intracutaneous Reactivity Test ●
Acute Systemic Toxicity Test
Pyrogen Test ●
Bacterial Endotoxin Test
Implantation Tests
Chemical Characterization Test ●
Toxicological Risk Assessment
Rabbit Blood Hemolysis Test ●

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The device met all biocompatibility test specifications. The tests were carried out in accordance with the ISO 10993-1 "Biological evaluation of medical devices" guideline.

Bench performance tests:

Simulated Life/Fatique Testing. .
Positioning/Concealability Testing. .
Buckling Testing, .
· Tip Extender Joint Strength Testing.

Sterilization by ethylene oxide has been validated for Rigi10 Malleable Penile Prosthesis.

For each bench performance test, an acceptance criterion was established prior to testing and the outcome of each test was that the acceptance criteria would be met to demonstrate statistically significant substantial equivalence to the predicate device.

The device met all performance test specifications and passed all tests.

9) CONCLUSION

Biocompatibility evaluation for Rigi10 malleable penile prosthesis was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. These tests confirm that Rigi10 malleable penile prosthesis is as safe as the predicate device.

Bench test evaluations for Rigi10 malleable penile prosthesis was conducted in accordance with the "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants" January 16, 2000. These tests confirm that Rigi10 malleable penile prosthesis is as safe and effective as the predicate device.

The performance data support the safety of Rigi10 malleable penile prosthesis and demonstrate that Rigi10 is as safe, as effective, and performs as well as the legally marketed device predicate (i.e. Coloplast (formerly Mentor Corp.) Genesis Penile Prosthesis. K040959) that is currently marketed for the same intended use.

Regulation Number and Section

§ 876.3630 Penile rigidity implant.

(a)
Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.(b)
Classification. Class II. The special control for this device is the FDA guidance entitled “Guidance for the Content of Premarket Notifications for Penile Rigidity Implants.”