(132 days)
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Not Found
No
The device description focuses on mechanical principles of blood flow restriction and does not mention any computational or learning-based components.
Yes
The device is intended to treat impotence and premature ejaculation, which are medical conditions, and achieves its effect by physically altering blood flow to maintain an erection.
No
The device description indicates its purpose is to provide or maintain an erection, which is a therapeutic function, not a diagnostic one. It describes how the device physically achieves its effect (blood vessel constriction), rather than how it identifies or analyzes a condition.
No
The device description clearly describes a physical device that applies external pressure to the penis and surrounding areas, indicating it is a hardware device, not software-only.
Based on the provided information, the Max-It 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Max-It Device Function: The description clearly states the Max-It device is intended to provide or maintain an erection by applying external pressure to the penis and surrounding areas to control blood flow. This is a physical, external intervention on the body, not a test performed on a sample.
The device's function and intended use fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation.
Product codes
78 LKY
Device Description
The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation. This is achieved as a result of blood vessel constriction which allows blood to flow into the penis but not to freely flow out (the valvular effect). The external pressure applied by the Max-It device restricts the free flow of blood out of the penis, but not into the penis.
It is equivalent to the venous flow controller in that it constricts the blood flow at the dorsal vein on top of the penis.
It differs from the venous flow controller in that not only does it constrict blood flow at the dorsal vein on top of the penis, the Max-It device also constricts the three cavernous cylinders. These cylinders originate in the anus and transverses the perineum area to the pubis area which forms the base of the penis and extends into and forms the shaft of the penis. Pressure applied to this perineum area and dorsal vein and artery on the dorsal base of the penile shaft at the pubis, will provide the valvular control, which is the formula to natural erection.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
penis, dorsal vein, three cavernous cylinders, perineum area, pubis area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
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
11983438
510(k)SUMMARY
The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation.This is achieved as a result of blood vessel constriction which allows blood to flow into the penis but not to freely flow out (the valvular effect). The external pressure applied by the Max-It device restricts the free flow of blood out of the penis,but not into the penis.
It is equivalent to the venous flow controller in that it constricts the blood flow at the dorsal vein on top of the penis.
It differs from the venous flow controller in that not only does it constrict blood flow at the dorsal vein on top of the penis,the Max-It device also constricts the three cavernous cylinders.These cylinders originate in the anus and transverses the perineum area to the pubis area which forms the base of the penis and extends into and forms the shaft of the penis.Pressure applied to this perineum area and dorsal vein and artery on the dorsal base of the penile shaft at the pubis,will provide the valvular control,which is the formula to natural erection.
1
Image /page/1/Picture/0 description: The image shows a logo or emblem that appears to be from a government department, possibly the Department of Health and Human Services. The logo features a stylized abstract symbol, consisting of three curved lines that resemble a human figure or a wave-like design. The text "DEPARTMENT OF HEA" is visible, arranged vertically along the left side of the emblem.
8 1999 FEB
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard V. Moses, Jr. Official Correspondent Dorea Incorporated 1112 N. Madison Albany, GA 31708-3401 Re: K983438 Max-ItTM Dated: December 23, 1998 Received: December 29, 1998 Unclassified/Procode: 78 LKY
Dear Mr. Moses:
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 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 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 requlations 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 (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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 requlations.
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
2
Page__________________________________________________________________________________________________________________________________________________________________________ o(
K983438 510(k) Number (if known): ر
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
"The Max-It device is intended to provide or maintain an erection in men with impotence or premature ejaculation".
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use X
(Optional Formst 1-2-96)
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