(44 days)
Not Found
No
The device description lists only mechanical components and there is no mention of AI/ML terms or data processing.
Yes
The device is intended for the treatment or management of erectile dysfunction/impotence, which is a therapeutic purpose.
No
The device is described as being "intended for the treatment or management of erectile dysfunction/impotence" and "consists of a vacuum pump, tension rings, seal rings, clear plastic cylinder, and a tube of personal lubricant." This indicates a therapeutic or management function, not a diagnostic one.
No
The device description explicitly lists physical components like a vacuum pump, tension rings, seal rings, clear plastic cylinder, and lubricant, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment or management of erectile dysfunction/impotence." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The components listed (vacuum pump, tension rings, etc.) are physical devices used externally for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Impower device is used to assist in creating and maintaining an erection suitable for sexual intercourse. This device is intended for the treatment or management of erectile dysfunction/impotence.
Product codes
LKY
Device Description
The Imagyn Medical Technologies, Inc.'s Impower System vacuum erection device ("Impower") consists of a vacuum pump, tension rings, seal rings, clear plastic cylinder, and a tube of personal lubricant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Pinl
510(k) Summary Imagyn Medical Technologies, Inc. Impower™Vacuum Erection Device
I. General Information on Submitter:
Name: Imagyn Medical Technologies, Inc. Address: 5 Civic Plaza, Suite 100 Newport Beach, CA 92660 Phone: (714) 668-5858 Fax: (714) 668-5856
MAR 1 1 1998
| Name of Contact Person: | Ronald H. Bergeson |
|---|---|
| Date Summary Prepared: | January 23, 1998 |
- II. General Information on Device
Name:
Impower System Vacuum Erection System - OTC
III. Classification Name: External Penile Rigidity Device
IV. . Predicate Devices: Impower (Catalyst) System (510(k) No. K920409)
- I. Description of the Device:
The Imagyn Medical Technologies, Inc.'s Impower System vacuum erection device ("Impower") consists of a vacuum pump, tension rings, seal rings, clear plastic cylinder, and a tube of personal lubricant.
V. Intended Use:
f
The Impower device is used to assist in creating and maintaining an erection suitable for sexual intercourse. This device is intended for the treatment or management of erectile dysfunction/impotence.
VI. Substantial Equivalence
The Impower uses the same vacuum method and technological characteristics to create and maintain an erection as the predicate device. It also uses the same components and materials as the predicate device. Therefore, the Impower device is substantially equivalent to its predicate device.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ronald H. Bergeson Corporate Director of Regulatory Affairs Imagyn Medical Technologies 27651 La Paz Road Laguna Niguel, CA 92677
Re: K980291
Imagyn Medical Technologies Impower™ Vacuum Erection Device - OTC Dated: January 23, 1998 Received: January 26, 1998 MAR 19988 Unclassified/Procode: 78 LKY
Dear Mr. Bergeson:
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 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 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 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 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/odrh/dsmaldsmamain.html".
Sincerely yours.
Lillian Yin, Ph.D.
Director, Division of Reproducti Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ODE INDICATIONS FOR USE FORM
510 (k) Number (if known):
Impower Vacuum Erection Device-OTC Device Name:
Indications for Use:
This device is intended for the treatment or management of erectile dysfunction/impotence.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dale D. Antling
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1980291 510(k) Number_
Prescription Use (Per 21 CFR 801.1091 OR
Over-The-Counter Use
(Optional Format 1-2-96)
Impower™ Vacuum Erection Device Imagyn Medical Technologies, Inc.
01/23/98
8