(119 days)
Not Found
No
The description focuses on mechanical pressure measurement and biofeedback, with no mention of AI or ML terms or concepts.
Yes
The device is intended for "rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence," which is a therapeutic purpose.
No.
The device measures the strength of pelvic floor muscles to provide biofeedback for rehabilitation of weak muscles, which is a therapeutic purpose, not diagnostics.
No
The device description explicitly details physical probes (vaginal and anal) with silicone bladders and tubing connected to a pressure transducer, indicating it is a hardware device with a software component for biofeedback, not a software-only device.
Based on the provided information, this device 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.
- Device Function: The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are used in vivo (within the body) to measure the strength of pelvic floor muscles through pressure biofeedback. They do not analyze samples taken from the body.
- Intended Use: The intended use is for rehabilitation of weak pelvic floor muscles and treatment of urinary incontinence, which is a therapeutic application, not a diagnostic one based on analyzing biological samples.
Therefore, this device falls under the category of a therapeutic or rehabilitation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
Product codes
85 HIR
Device Description
The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are designed with a silicone bladder or sack that covers the probe body and tubing that connects the probe to a pressure transducer. Once the probe is inserted into the anus or vagina the bladder is filled with air. The probes measure the strength of the pelvic floor muscles by offering resistance to a patient's voluntary contractions of these muscles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic musculature, anus or vagina
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)
Product performance test results demonstrate the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774) are equivalent in product performance.
Biocompatibility assessment of the silicone bladder has been conducted based on the principles and guidelines established by various governmental regulatory agencies and standard setting organizations. Among these are the following: United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Evaluation of Medical Devices. Based upon the results of this assessment, the silicone bladder material is considered biocompatible and appropriate for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.1425 Perineometer.
(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).
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Hollister Incorporated 2000 Hollister Drive Libertyville, Illino s 60048-3781
MAR 5 2002
Hollister
Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes
510(k) Summary
1. Sponsor's name. Address and Contact Person
Sponsor Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048
Contact Person Cindy Roberts Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048 (847)918-3497 Ph: Fax: (847)918-3860
Date Summary Prepared -- November 5, 2001
2. Name of Device:
InCare Pressure Biofeedback Vaginal Pressure Probe InCare Pressure Biofeedback Anal Pressure Probe
3. Name of Predicate Device(s)
InCare Pressure Biofeedback Vaginal Pressure Probe -- 510(k) #K891774 InCare Pressure Biofeedback Anal Pressure Probe - 510(k) #K891774
4. Description of Device
The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are designed with a silicone bladder or sack that covers the probe body and tubing that connects the probe to a pressure transducer. Once the probe is inserted into the anus or vagina the bladder is filled with air. The probes measure the strength of the pelvic floor muscles by offering resistance to a patient's voluntary contractions of these muscles.
5. Statement of Intended Use
The InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
6. Statement of Technological Characteristics of the Device
The InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe are used as an accessory with the InCare Pelvic Floor Therapy devices to provide pressure biofeedback from pelvic floor musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence. To meet the changing needs of
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page 20f2 X D13653
Hollister
Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes
Hollister's customers the InCare Biofeedback Vaginal Pressure Probe and Anal Pressure Probe has been constructed with a silicone bladder.
The InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774 - 8/23/89) are equivalent in intended use, manufacturing processes and labeling as a biofeedback therapy device for the treatment of urinary incontinence. Furthermore, product performance test results demonstrate the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (with silicone bladder) and the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe (K891774) are equivalent in product performance.
Biocompatibility assessment of the silicone bladder has been conducted based on the principles and guidelines established by various governmental regulatory agencies and standard setting organizations. Among these are the following: United States Pharmacopoeia, General program memorandum #G95-1, United States Food and Drug Administration Office of Device Evaluation and The International Standards Organization ISO 10993-1 Biological Evaluation of Medical Devices. Based upon the results of this assessment, the silicone bladder material is considered biocompatible and appropriate for its intended use.
7. Conclusion
Based on information presented above and in the body of this premarket notification the InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe with silicone bladder are substantially equivalent to devices currently in commercial distribution.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 5 2002
Ms. Cindy Roberts Global Regulatory Affairs Analyst Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781
Re: K013653
Trade/Device Name: InCare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure Probe Non-Latex probe bladder Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: 85 HIR Dated: February 14, 2002 Received: February 19, 2002
Dear Ms. Roberts:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 nredicate 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 yours,
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Hollister Incorporated InCare Pressure Biofeedback Vaginal and Anal Pressure Probes
b. Statement of Intended Use
KOI 3653 510(k) Number (if Known): InCare Pressure Biofeedback Vaginal and Anal Pressure Probes Device Name:
Intended Use:
The InCare Biofeedback Vaginal Pressure Probes and Anal Pressure Probes are intended to provide pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles in the treatment of urinary incontinence.
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 11.0136 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V OR Prescription Use (Per 21 CFR 801.109)
Over-the-Counter-Use (Optional Format 1-2-96)