(63 days)
The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.
The In-Probe II Urodynamic System is a compact and portable urodynamic system capable of performing cystometrography (CMG) for both men and women. In addition, for women, the device can provide objective measurement of the changes in urethral angle that occur during patient straining.
The provided text states that the In-Probe II Urodynamics System is "substantially equivalent" to two predicate devices: Influence, Inc.'s In-Probe Urodynamics System and Andronic Devices, Ltd.'s Insight electronic alignment indicator. The document also mentions "Performance testing and information in the application demonstrated that the In-Probe II system is biocompatible and provides equivalent performance to the original In-Probe Urodynamics System."
However, the provided text does not include specific acceptance criteria or details of a study that proves the device meets those criteria. It mainly focuses on the FDA 510(k) clearance process based on substantial equivalence to predicate devices. Therefore, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as these details are not present in the provided document.
To properly answer your request, more detailed performance study reports or technical specifications for the In-Probe II Urodynamics System would be required.
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NOV 2 4 1998
510(k) Summary Influence, Inc.'s In-Probe II Urodynamics System 510(k) Number
Submitter's Name:
Peter A. Bick, M.D., President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, California 94105 Telephone: 415-546-7700/Fax: 415-546-7744
Trade Name:
In-Probe II Urodynamics System
Classification Name:
Urodynamics Measurement System (78 FEN)
Predicate Devices:
In-Probe II Urodynamics System is substantially equivalent to Influence, Inc.'s In-Probe Urodynamics System, which is 510(k) exempted and was listed under A0995505. The In-Probe II Urodynamics System has an angle sensor that is substantially equivalent technologically to Andronic Devices, Ltd.'s Insight electronic alignment indicator cleared under K940812, and to the preamendments Q-tip test in terms of intended use.
Indication for Use:
The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.
Device Description:
The In-Probe II Urodynamic System is a compact and portable urodynamic system capable of performing cystometrography (CMG) for both men and women. In addition, for women, the device can provide objective measurement of the changes in urethral angle that occur during patient straining.
Technological Characteristics and Performance:
The In-Probe II is very similar to the In-Probe Urodynamics system, but has one additional capability - urethral angle measurement. Performance testing and information in the application demonstrated that the In-Probe II system is biocompatible and provides equivalent performance to the original In-Probe Urodynamics System.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 24 103488
Peter A. Bick. M.D. President and CEO Influence, Inc. 71 Stevenson Street, Suite 1120 San Francisco, CA 94105
Re: K983325
Influence, Inc.'s In-Probe Urodynamic System Dated: September 15, 1998 Received: September 22, 1998 Regulatory Class: II 21 CFR 876.1620/Procode: 78 FEN
Dear Dr. Bick:
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 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 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 i 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 ciagnostic devices), piease 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/odri/dsmaldsmam.html".
Sincerely vou
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductive
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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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | |
|---|---|
| Device Name: | In-Probe II Urodynamic System, consisting of the In-Probe controller, urethral rectal and angle probes, and other accessories. |
| Indications for Use: | The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off)
Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
| 510(k) Number | |
|---|---|
| --------------- | -- |
| Prescription Use (Per 21 CFR 801.109) | ✓ OR Over-The-Counter-Use |
|---|---|
| --------------------------------------- | -------------------------------------------------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K983325 |
|---|---|
| --------------- | --------- |
§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.