(134 days)
Not Found
No
The summary describes a system for electrical stimulation and biofeedback for pelvic floor therapy. It mentions data manipulation and presentation on a personal computer and patient therapy actions controlled by an instrumentation unit. There is no mention of AI, ML, or related concepts in the intended use, device description, or the specific sections for AI/ML mentions, training/test sets, or performance studies.
Yes.
The device's intended use is for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence through electrical stimulation and biofeedback, which are therapeutic actions.
No
The device is intended for rehabilitation and treatment through electrical stimulation and biofeedback, not for diagnosing conditions.
No
The device description explicitly states that the system is comprised of a combination of an instrumentation unit and a personal computer, indicating the presence of hardware components beyond just software.
Based on the provided text, 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 Pelvic Floor Therapy System works by providing electrical stimulation and biofeedback directly to the patient's pelvic muscles. It is a therapeutic device used for rehabilitation and treatment, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states "rehabilitation of weak pelvic floor muscles" and "treatment of urinary incontinence," which are therapeutic goals, not diagnostic ones.
- Device Description: The description details an "office based instrument" that interacts directly with the patient's body via electrical stimulation and biofeedback.
Therefore, the InCare Pelvic Floor Therapy System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
Product codes
78 KPI, 85 HIR
Device Description
The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence.
The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The proposed InCare Pelvic Floor Therapy System is comprised of a combination of an instrumentation unit and a personal computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. The personal computer and instrumentation unit are physically separate devices "linked" to each other by a communication pathway. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features or functions that are" patient therapy" actions are controlled by the instrumentation unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic musculature, pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital
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)
K930530/c, K961872, K974048, K964738
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
MAR 1 9 2002
Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048-3781 Telephone: 847.680.1000 Facsimile: 847.918.3860
K013612
PAGE 1 OF 2
Hollister Incorporated InCare Pelvic Floor Therapy System
Safety and Effectiveness Summary
1. Submitter's name, Address and Contact Person
Submitter Hollister Incorporated 2000 Hollister Drive Libertyville, IL 60048
Contact Person Joseph S. Tokarz Manager, Regulatory Affairs Ph : (847) 680-2849 Fax: (847) 918-3860
Date Summary Prepared - November 2, 2001
2. Name of Device:
InCare Pelvic Floor Therapy System.
3. Name of Predicate Device(s)
-
- Elpha 2000 Conti Device, K964738
4. Description of Device
The InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence.
The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
5. Statement of Intended Use
The electrical stimulation component of the InCare Pelvic Floor Therapy System provides r it e clource. band it is that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
1
Hollister
Hollister Incorporated InCare Pelvic Floor Therapy System
6. Statement of Technological Characteristics of the Device
The proposed InCare Pelvic Floor Therapy System is an office based instrument that is intended to be used by physicians, nurses, nurse clinicians, and physiotherapists in a physicians office, clinic, or hospital for the purpose of providing electromyography or pressure biofeedback from pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and the restoration of neuromuscular control for the treatment of urinary incontinence. The InCare Pelvic Floor Therapy System also provides electrical stimulation capabilities for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The proposed InCare Pelvic Floor Therapy System is comprised of a combination of an instrumentation unit and a personal computer. Other peripheral devices such as monitors and printers can be added for convenience or ease of use. The personal computer and instrumentation unit are physically separate devices "linked" to each other by a communication pathway. Features or functions that are "data manipulation and presentation" activities are properly associated with the personal computer. Features or functions that are" patient therapy" actions are controlled by the instrumentation unit.
7. Conclusion
Based upon the information presented within this pre-market notification it is concluded that the proposed InCare Pelvic Floor Therapy System with expanded stimulation parameter of 10 Hz and updated clinician application software is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white photograph with a grainy texture. The composition is abstract, with no clear focal point or recognizable objects. The overall impression is one of simplicity and minimalism. The contrast between the black and white tones creates a sense of depth and dimension, while the grainy texture adds a layer of visual interest.
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures.
MAR 1 9 2002
Mr. Joseph S. Tokarz Manager Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K013612 Trade/Device Name: InCare PRS9500 Pelvic Floor Therapy System Regulation Number: 21 CFR 876.5320 Regulation Name: Nonimplanted electrical continence device Product Code: 78 KPI Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Product Code: 85 HIR Regulatory Class: II Dated: February 13, 2002 Received: February 27, 2002
Dear Mr. Tokarz:
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.
3
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will anow you to begin nationing , "
notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Drice 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 II you desire specific advice for your de rest on 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Compilance at (2017 22ation" (21 CFR Part 807.97). Other general information on by responsibilities under the Act may be obtained from the Division of Small Manufacturers, your responsibilition and Consumer 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
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Hollister Incorporated InCare Pelvic Floor Therapy System
Statement of Intended Use
510(k) Number (if Known): Device Name:
013612
InCare Pelvic Floor Therapy Stimulation/Biofeedback Device
Indications For Use:
The electrical stimulation component of the InCare Pelvic Floor Therapy System provides stimulation capabilities that are intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence.
The biofeedback components of the InCare Pelvic Floor Therapy System are intended to provide electromyography or pressure biofeedback from the pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control for the treatment of urinary incontinence.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-the-Counter-Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, | Page 6 |
and Radiological Devices 510(k) Number