(174 days)
Various pre-amendment "penile splints."
Not Found
No
The device description details a purely mechanical support system with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is intended for men with impotence to enable sexual intercourse, which addresses a medical condition, fitting the definition of a therapeutic device.
No
The device description indicates that the Rejoyn Penile Support System is a physical support system (a semi-rigid split support sleeve) intended to assist with penile flaccidity, not to diagnose a condition.
No
The device description clearly outlines physical components made of medical-grade rubber, including a sleeve and strap, and mentions optional latex covers and lubricating jelly. There is no mention of software as a component of this system.
Based on the provided information, the Rejoyn Penile Support System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves testing blood, urine, tissue, or other bodily fluids to diagnose diseases, monitor health, or screen for conditions.
- The Rejoyn Penile Support System is a physical device applied externally to the body. Its function is to provide physical support to the penis to facilitate sexual intercourse. It does not involve the analysis of any biological specimens.
The intended use and device description clearly indicate a mechanical support system for external use, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.
Product codes (comma separated list FDA assigned to the subject device)
78 LKY
Device Description
The Rejoyn penile support system consists of a semi-rigid split support sleeve molded from medical grade rubber with an attachment strap. The sleeve is placed over the penis with the split side down and the strap is fastened behind the scrotum. The sleeve is approximately 2 1/4" long. The system may also include a lubricated latex cover which may be worn over the sleeve to enhance comfort.
Another version of the Rejoyn system includes a single-use, disposable support sleeve in lieu of the reusable support sleeve. The single-use sleeve is made of the same materials as the reusable sleeve but is removed after use by breaking off one end of the attachment strap at a specified location.
The Rejoyn system will be available in five different package variations: (1) one support sleeve, three covers and one tube of lubricating jelly; (2) one support sleeve and one tube of lubricating jelly; (3) one support sleeve and three covers; (4) three single-use support sleeves, three covers and one tube of lubricating jelly; and (5) three single-use support sleeves and three covers. Replacement covers and lubricating jelly also will be available separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis, scrotum
Indicated Patient Age Range
men (implied adult)
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)
Not Found
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.
Various pre-amendment "penile splints."
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.
Not Found
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
§ 876.5020 External penile rigidity devices.
(a)
Identification. External penile rigidity devices are devices intended to create or maintain sufficient penile rigidity for sexual intercourse. External penile rigidity devices include vacuum pumps, constriction rings, and penile splints which are mechanical, powered, or pneumatic devices.(b)
Classification. Class II (special controls). The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: External Penile Rigidity Devices.” See § 876.1(e) for the availability of this guidance document.
0
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Revised Appendix C
510(k) Summary American MedTech Rejoyn Penile Support System
OCT 16 1997
General Information on Submitter: I.
| Name: | American MedTech, Division of Gain, Inc. |
|---|---|
| Address: | 2124 University Avenue |
| St. Paul, MN 55114 | |
| Telephone: | (602) 659-2406 |
| Fax: | (602) 647-9261 |
| Name of Contact Person: | Mr. John C. Field |
| Date Summary Prepared: | September 30, 1997 |
General Information on Device II.
Rejoyn Penile Support System Name: External Penile Rigidity Device Classification Name:
Predicate Device: Various pre-amendment "penile splints." III.
Description of the Device: IV.
The Rejoyn penile support system consists of a semi-rigid split support sleeve molded from medical grade rubber with an attachment strap. The sleeve is placed over the penis with the split side down and the strap is fastened behind the scrotum. The sleeve is approximately 2 1/4" long. The system may also include a lubricated latex cover which may be worn over the sleeve to enhance comfort.
Another version of the Rejoyn system includes a single-use, disposable support sleeve in lieu of the reusable support sleeve. The single-use sleeve is made of the same materials as the reusable sleeve but is removed after use by breaking off one end of the attachment strap at a specified location.
The Rejoyn system will be available in five different package variations: (1) one support sleeve, three covers and one tube of lubricating jelly; (2) one support sleeve and one tube of lubricating jelly; (3) one support sleeve and three covers; (4) three single-use support sleeves, three covers and one tube of lubricating jelly; and (5) three single-use support sleeves and three covers. Replacement covers and lubricating jelly also will be available separately.
V. Intended Use:
The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.
1
Technological Characteristics of Device Compared to Predicate Device: VI. The technological characteristics of the Rejoyn system are very similar to those of the predicate devices: flexible, but firm, medical grade rubber sleeve; reusability; and easy cleanability.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white.
OCT 16 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
American MedTech A Division of Gain, Inc. c/o Mr. Donald R. Stone McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108
Dear Mr. Stone:
Re: K971576 Rejoyn Penile Support System Dated: August 14, 1997 Received: August 15, 1997 Regulatory Class: Unclassified Product Code: 78 LKY
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivation assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K971576 510(k) Number (if known):
Device Name: Rejoyn Penile Support System
Indications For Use:
.. .
.
The Rejoyn Penile Support System is intended for use by men who have an inability to engage in sexual intercourse due to a flaccid or partially erect penis resulting from impotence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diber R. Ratliff
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices ) ୧ ન 510(k) Number _ 11 1
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
10-1'