(59 days)
No
The summary describes a mechanical vacuum pump and constriction ring system, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to treat erectile dysfunction by creating and maintaining an erection, which is a therapeutic purpose.
No
The device is described as assisting in creating and maintaining an erection for men with erectile dysfunction, which is a therapeutic function, not a diagnostic one. It doesn't identify or characterize a disease or condition.
No
The device description explicitly lists physical components such as a vacuum pump, plastic cylinder, tubing, rings, lubricant, and a travel case, indicating it is a hardware device with multiple physical parts.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The RESTORE Vacuum Erection Device is a mechanical device that physically interacts with the penis to create and maintain an erection. It does not perform any tests on bodily samples.
- Intended Use: The intended use statements clearly describe a physical process for treating erectile dysfunction, not a diagnostic test.
Therefore, this device falls under the category of a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows.
Vacuum Pump (intended use) - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid.
Constriction Ring (intended use) - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.
Product codes
78 LKY
Device Description
The RESTORE Vacuum Erection Device consists of a vacuum pump, ABS plastic vacuum cylinder, connecting PVC tubing, cylinder end cap, cushion seal, constriction rings, a tube of personal water-based lubricant and a convenient travel case.
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
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)
Erecaid System Classic (K841257), Erecaid System / Stay Erec System (K974173), Pro-Long Rings (K904485)
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
JUN 2 5 1998
Premarket Notification [510(k)] Summary
| Submitter's Name: | Repro-Med Systems, Inc. |
|---|---|
| Address: | 24 Carpenter Road |
| Chester, NY 10918 | |
| Telephone: | 800-624-9600 |
| Fax: | 914-469-5518 |
Contact Person: Andrew Sealfon
Date 510(k) Summary Prepared: June 24, 1998
510(k) Number:
1
| Trade or Proprietary Name(s): | RESTORE Vacuum Erection Device |
|---|---|
| Common Name: | External Penile Rigidity Device |
| Classification Name: | Vacuum Pump And Constriction Rings |
| Predicate Device(s): | Erecaid System Classic (K841257) |
| Erecaid System / Stay Erec System (K974173) | |
| Pro-Long Rings (K904485) |
Device Description:
The RESTORE Vacuum Erection Device consists of a vacuum pump, ABS plastic vacuum cylinder, connecting PVC tubing, cylinder end cap, cushion seal, constriction rings, a tube of personal water-based lubricant and a convenient travel case.
Intended Use:
Intended Use and Indications
The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction rings.
Vacuum Pump - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavemosa causing the penis to become erect and rigid.
Constriction Ring - used to maintain penile rigidity in me with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.
Summary of Technological Characteristics to Predicate Device:
The RESTORE Vacuum Erection Device vacuum pump is substantially equivalent to the first two (2) predicate devices listed above. Repro-Med Systems, Inc. owns the proprietary technology for the Osbon products (predicate devices) and has been the sole manufacturer for the Erecaid System Classic vacuum pump since 1989.
The RESTORE Vacuum Erection Device Constriction Rings are identical to the Pro-Long rings (predicate device). Repro-Med has entered into a contractual agreement to market the Pro-Long rings as a component of the RESTORE device.
All component materials are identical to the named predicate devices and, therefore, the RESTORE Vacuum Erection Device is substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows a logo with a stylized eagle design. The eagle is composed of three curved lines that resemble feathers or wings. Above the eagle is the text "USA", and below it is the text "DEPARTA". The logo appears to be a simplified or abstract representation of a government agency or organization.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 25 1998
Mr. Andrew I. Sealfon President Repro-Med Systems, Inc. 24 Carpenter Road Chester, New York 10918
Dear Mr. Andrew I. Sealfon:
Re: K981506
RESTORE™ Vacuum Erection Device - OTC Dated: April 24, 1998 Received: April 27, 1998 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 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 OS 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" (2) 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/dsmaldsmamain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Thre and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
RESTORE Vacuum Erection Device
Indications For Use:
The RESTORE Vacuum Erection Device consists of two main parts: the vacuum pump and constriction ring. Intended use statements for these are as follows.
Vacuum Pump (intended use) - used to create an erection in men with erectile dysfunction by means of an applied vacuum to the penis, which draws blood into the penile corpora cavernosa causing the penis to become erect and rigid.
Constriction Ring (intended use) - used to maintain penile rigidity in men with erectile dysfunction by restricting penile venous outflow after the patient has obtained an erection with the aid of a vacuum pump.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert P. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 11981506 510(k) Number_
OR
Prescription Use _
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)