(111 days)
No reference devices were used for this submission.
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a malleable penile implant, with no mention of AI or ML technologies.
Yes.
The device is intended for "treatment of chronic, organic, erectile dysfunction (impotence) in adult males," which clearly signifies a therapeutic purpose.
No
The device description clearly states its purpose is for treatment ("treatment of chronic, organic, erectile dysfunction") and provides physical rigidity, not for diagnosing a condition.
No
The device description explicitly states it is a "malleable implant which consists of a pair of cylinders which are surgically implanted". This clearly indicates a physical hardware device, not software only.
Based on the provided information, 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 Tactra Penile Prosthesis is a surgical implant designed to provide penile rigidity for the treatment of erectile dysfunction. It is physically placed within the body.
- Lack of Diagnostic Function: The device does not analyze biological samples or provide diagnostic information. Its function is purely mechanical and therapeutic.
Therefore, the Tactra Penile Prosthesis falls under the category of a medical device, specifically an implantable device, rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The TactraTM device is designed to provide penile rigidity and malleability, and the device can be placed in either an erect or a concealed position.
The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.
Product codes
FAE
Device Description
The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.
The Tactra Penile Prosthesis is a malleable implant which consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity for adult males with erectile dysfunction. The two cylinders are available in diameters of 9.5 mm, 11 mm, and 13 mm. The proximal end of each cylinder has an 8 cm trimmable zone for length adjustment as desired by the physician. The working length of each cylinder is the total length including the "0" cm Rear Tip Extenders (RTE). Since each cylinder has an 8 cm zone to be trimmed, the working length for each diameter cylinder encompasses the range shown in the table below. If additional length is needed, alternate RTEs (0.5 cm or 1 cm) can be attached to the proximal end of each cylinder prior to implantation.
All components consist of implantable, biocompatible materials and are provided as sterile, single-use implants. These implants may not be re- sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penile
Indicated Patient Age Range
adult males
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To demonstrate substantial equivalence of the Tactra Penile Prosthesis to the predicate devices, technological characteristics and performance criteria were evaluated using bench testing, and biocompatibility testing.
The results from this testing demonstrate that the technological characteristics and performance criteria of the Tactra Penile Prosthesis do not raise new questions of safety and effectiveness in comparison to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AMS Spectra™ Concealable Penile Prosthesis (K090663), Mentor (Coloplast) Genesis™ (K040959)
Reference Device(s)
No reference devices were used for this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for Boston Scientific. The logo is in a dark blue color. The words "Boston Scientific" are stacked on top of each other, with "Boston" on the top line and "Scientific" on the bottom line.
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 508-683-4000 www.bostonscientific.com
510(k) Summary
| Submitter | Boston Scientific Corporation |
|---|---|
| 10700 Bren Road West | |
| Minnetonka, MN 55343 | |
| USA | |
| Phone: 952-930-6252 | |
| Contact Person: Laura Kelly | |
| Date Prepared: December 21, 2018 | |
| Device: | Name of Device: Tactra™ Penile Prosthesis |
| Common or Usual Name: Malleable Penile Prosthesis | |
| Classification Name: Penile Rigidity Implant (per 21 CFR 876.3630) | |
| Regulatory Class: II (Special Controls) | |
| Product Code: FAE | |
| Predicate Device | AMS Spectra™ Concealable Penile Prosthesis (K090663) |
| Mentor (Coloplast) Genesis™ (K040959) | |
| No reference devices were used for this submission. | |
| Device Description | The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery. |
| The Tactra Penile Prosthesis is a malleable implant which consists of a pair of cylinders which are surgically implanted, one into each corpus cavernosum, to provide penile rigidity for adult males with erectile dysfunction. The two cylinders are available in diameters of 9.5 mm, 11 mm, and 13 mm. The proximal end of each cylinder has an 8 cm trimmable zone for length adjustment as desired by the physician. The working length of each cylinder is the total length including the "0" cm Rear Tip Extenders (RTE). Since each cylinder has an 8 cm zone to be trimmed, the working length for each diameter cylinder encompasses the range shown in the table below. If additional length is needed, alternate RTEs (0.5 cm or 1 cm) can be attached to the proximal end of each cylinder prior to implantation. | |
| All components consist of implantable, biocompatible materials and are provided as sterile, single-use implants. These implants may not be re- sterilized. |
1
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 508-683-4000
| Configuration | Outer Diameter | Working Length | RTE Offering |
|---|---|---|---|
| 1 | 9.5 mm | 14 - 23 cm | 0 cm, +0.5 cm, +1 cm |
| 2 | 11 mm | 16 - 25 cm | 0 cm, +0.5 cm, +1 cm |
| 3 | 13 mm | 18 - 27 cm | 0 cm, +0.5 cm, +1 cm |
| Indications for Use | The TactraTM device is designed to provide penile rigidity and malleability, and the device can be placed in either an erect or a concealed position. | ||
| The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery. | |||
| Comparison of | |||
| Technological | |||
| Characteristics with | |||
| the Predicate Device | The Tactra Penile Prosthesis incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices, AMS Spectra Concealable Penile Prosthesis (K090663) and the Mentor (Coloplast) Genesis (K040959). | ||
| Performance Data | To demonstrate substantial equivalence of the Tactra Penile Prosthesis to the predicate devices, technological characteristics and performance criteria were evaluated using bench testing, and biocompatibility testing. | ||
| The results from this testing demonstrate that the technological characteristics and performance criteria of the Tactra Penile Prosthesis do not raise new questions of safety and effectiveness in comparison to the predicate devices. | |||
| Conclusion | As the intended use and fundamental scientific technology have not changed, non-clinical data supports a determination that there are no new questions of safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate devices, and that it is at least as safe and effective for its intended use. |
The Tactra Penile Prosthesis will be available in the following configurations:
2
Image /page/2/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, 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.
April 16, 2019
Boston Scientific Corporation Laura Kelly Regulatory Affairs Specialist II 10700 Bren Road West Minnetonka, MN 55343
Re: K183619
Trade/Device Name: Tactra™ 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 14, 2019
Dear Laura Kelly:
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.
3
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,
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
4
Indications for Use
510(k) Number (if known)
K183619
Device Name
TactraTM Penile Prosthesis
Indications for Use (Describe)
The Tactra™ device is designed to provide penile rigidity and the device can be placed in either an erect or a concealed position.
The Tactra Penile Prosthesis is a sterile, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in adult males who are determined to be suitable candidates for implantation surgery.
| 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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