(97 days)
Not Found
Not Found
No
The device description and intended use clearly describe a manual vacuum pump system with no mention of AI or ML components or functionalities.
Yes
The device is intended to manage erectile dysfunction by creating an erection suitable for sexual activity, which is a therapeutic purpose.
No
The device is described as assisting in the creation of an erection for sexual activity (therapeutic), not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components (manual vacuum pump, cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant).
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.
- Device Function: The Elite Custom is a mechanical device used externally on the body (the penis) to physically induce an erection. It does not analyze any biological samples.
- Intended Use: The intended use is to manage erectile dysfunction through a physical process, not through the analysis of biological markers.
Therefore, the Elite Custom falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elite Custom's intended use is to manage erectile dysfunction by allowing the creation of a full erection suitable for sexual activity.
Product codes
78 LKY
Device Description
The Elite Custom consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant. This is accomplished through the use of the manual vacuum pump to remove air from the cylinder, creating vacuum pressure within the cylinder. Blood is thereby drawn into the penis, causing it to become erect. The constriction ring is then placed around the base of the erect penis to restrict the outflow of blood. When activity is complete, the ring is removed from the base of the penis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
penis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per CFR 801.109)
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.
Not Found
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
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is made up of three stylized human profiles facing to the right, stacked on top of each other.
DEC 27 1999
Mr. John M. Mitchell Vice President Renaissance Medical™, LLC
Division of SOMA Blue™, Inc. P.O. Box 1447 1025 Broad Street Augusta, GA 30903
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K993142 Elite Custom™, Vacuum Erection Device Dated: December 8, 1999 Received: December 15, 1999 Unclassified/Procode: 78 LKY
Dear Mr. Mitchell:
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 legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the 4% Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, 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 (Special Controls) or class III (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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) 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 the Electronic Product 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/dsma/dsmamain.html".
Sincerely vours
CAPT Daniel G. Schultz, M.D Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: Elite Custom™
Indications for Use:
The Elite Custom consists of a manual vacuum pump, a cylinder, cushion inserts, constriction ring loader, constriction rings, and lubricant. The Elite Custom's intended use is to manage erectile dysfunction by allowing the creation of a full erection suitable for sexual activity. This is accomplished through the use of the manual vacuum pump to remove air from the cylinder, creating vacuum pressure within the cylinder. Blood is thereby drawn into the penis, causing it to become erect. The constriction ring is then placed around the base of the erect penis to restrict the outflow of blood. When activity is complete, the ring is removed from the base of the + penis.
This product is intended for prescription use.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per CFR 801.109) | ✓ |
|---|---|
| ------------------------------------ | --- |
OR
| Over-The-Counter Use | ________________ |
|---|---|
| ---------------------- | ------------------ |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K9931421500+ |
|---|---|
| --------------- | -------------- |
(Optional Format 1-2-96)