(294 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on the mechanical and material properties of a physical implant, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is implanted to provide adequate penile rigidity for sexual intercourse in men diagnosed with erectile dysfunction, which is a condition treated to improve a patient's physical and psychological well-being.
No
The device is a malleable penile prosthesis designed for implantation to provide penile rigidity for sexual intercourse in men diagnosed with erectile dysfunction. Its purpose is therapeutic, not diagnostic.
No
The device description clearly states it is a sterile, non-pyrogenic, single-use surgical implant with a physical structure made of stainless steel, titanium, PTFE, and silicone. It is surgically implanted and has physical dimensions and mechanical properties tested through bench performance tests. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a surgical implant intended to be placed directly into the corpora cavernosa of the penis to treat erectile dysfunction. It is a physical device that provides mechanical support.
- Lack of Diagnostic Function: The device does not analyze any biological samples or provide diagnostic information. Its function is purely therapeutic and mechanical.
Therefore, the Rigi10 Malleable Penile Prosthesis is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FAE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corpora cavernosa of the penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Specialized physicians (e.g. urologists and surgeons)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Coloplast (formerly Mentor Corp.) Genesis Penile Prosthesis, K040959
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font, also in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known) K181673
Device Name RIGI 10 MALLEABLE PENILE PROSTHESIS
Indications for Use (Describe)
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.
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)
3
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.
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
4
Image /page/4/Picture/1 description: The image shows the text "K181673 Page 2 of 4" at the top. The number 10 is in the middle of the image. The image also contains a blue and white graphic design.
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.
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 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, ●
- 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.