(63 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard urodynamic measurements without mentioning any AI/ML capabilities.
No
The device is indicated as an aid in diagnosis and provides objective measurements, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females."
No
The device description explicitly states it is a "system" and mentions performing cystometrography, which typically involves hardware components like pressure transducers and catheters. The performance studies also mention biocompatibility, which is relevant to hardware that comes into contact with the patient.
Based on the provided information, the In-Probe II Urodynamic System 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. They are used to examine these samples outside of the body.
- In-Probe II Function: The description clearly states that the In-Probe II Urodynamic System is used to perform cystometrography (CMG) and measure urethral angle in vivo (within the living body) of patients. It involves inserting probes or sensors into the body (urethral).
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient. Its function is to measure physiological parameters directly within the body.
Therefore, the In-Probe II Urodynamic System falls under the category of a medical device used for diagnosis, but not specifically an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
78 FEN
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
A0995505, K940812
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
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 |
|---|---|
| --------------- | --------- |