(217 days)
Not Found
No
The description focuses on the physical probes and their compatibility with existing stimulation/biofeedback devices, with no mention of AI or ML capabilities.
Yes.
The device is intended to provide electrical stimulation for the rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence, which is a therapeutic purpose.
No
Explanation: The device is described as providing electrical stimulation or transmitting EMG signals for rehabilitation and treatment, not for diagnosing conditions. While it transmits EMG signals, this is in the context of biofeedback for treatment, not for diagnostic interpretation.
No
The device description explicitly details physical probes made of stainless steel and ABS, intended for insertion into the body to transmit electrical signals. This is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing is performed outside of the body.
- Device Function: The Incontinence Probes are used inside the body (rectum or vagina) to either:
- Provide electrical stimulation: This is a therapeutic intervention, not a diagnostic test.
- Transmit EMG signals: While EMG measures electrical activity, in this context, it's used for biofeedback and rehabilitation of muscle function, not for diagnosing a disease or condition based on a bodily specimen.
The device's intended use and mechanism of action clearly fall outside the scope of In Vitro Diagnostics. It's a therapeutic and biofeedback device used directly on the patient's body.
N/A
Intended Use / Indications for Use
The Incontinence Probes are intended to provide electromyographic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Product codes
KPI, HIR
Device Description
The Incontinence Probe models PE0001, PE0002, PE0004, PE0005, PE0006, PE0007 , PE0008, PE0009, and PE0010 are stand-alone probes/electrodes, which can be placed inside the adult rectum or female vagina to transmit electrical stimulation signals or pelvic floor EMG signals when connected to pelvic electrical stimulators or EMG biofeedback devices during the treatment of urinary incontinence . All the models are reusable for a single patient except PE0003, which is a disposable vaginal probe. The probes are not packaged with specific floor muscle stimulators and EMG/biofeedback equipment but are compatible with low-frequency (less than 1000Hz working frequency) stimulators or EMG/biofeedback devices that meet the standards of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 and use 2.0 DIN connection. The probes are made of S304 stainless steel and Acrylonitrile-Butadiene-Styrene (ABS). The probes are designed for use in home or clinic by a single user. The probes do not require sterilization but need cleaning for reuse according to the cleaning instructions provided in the instructions for use manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic musculature, adult rectum or female vagina
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home or clinic by a single user
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)
The sponsor provided the following performance testing to support substantial equivalence:
- Biocompatibility per ISO 10993 Cytotoxicity, Sensitization, Vaginal irritation, and Rectal irritation
- Shelf-life validation -functional testing
- Electrical Safety testing per IEC 60601-1
- Performance Bench Testing .
- On the probes visual testing, electrical output verification testing after connecting the probe with a compatible host, cable dielectric strength testing, and lead wire plug to instrument connector contact resistance testing
- On the lead wires per ANSI/AAMI EC53
The protocol and results of the provided non-clinical testing are acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).
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September 17, 2021
Shenzhen Med-link Electronics Tech Co, Ltd Yongfen Yang Regulatory Affairs Specialist 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community Dalang Street Shenzhen, Guangdong 518109 China
K210441 Trade/Device Name: Incontinence Probe Regulation Number: 21 CFR& 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI, HIR Dated: August 10, 2021 Received: August 13, 2021
Dear Yongfen Yang:
Re:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen -S
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210441
Device Name Incontinence Probe
Indications for Use (Describe)
The Incontinence Probes are intended to provide electromyographic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter Information:
| Name and Address: | Shenzhen Med-link Electronics Tech Co., Ltd.
4th and 5th Floor, Building Two,
Hualian Industrial Zone, Xinshi Community,
Dalang Street, Longhua District, Shenzhen,
Guangdong 518109 .
People's Republic of China |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Yongfen Yang (Regulatory Affairs Specialist)
E-mail: mdl012@medlinket.com
Tel: 0086-755-61568825
Fax: 0086-755-61120055 |
| Data of Preparation: | September 15, 2021 |
2. Device Information:
| Trade Name: | Incontinence Probe |
|---|---|
| Common Name: | Incontinence Probe |
| Classification Number: | 21 CFR 876.5320 |
| Classification Name: | Nonimplanted Electrical Continence Device |
| Product Code: | KPI, HIR |
| Regulatory Class: | II |
| Review Panel: | Gastroenterology/Urology |
3. Identification of the Predicate Device:
| Device Name | Common Name | Manufacture | 510(k) |
|---|---|---|---|
| Fuji Dynamics | |||
| Incontinence | |||
| Stimulation Electrode | Incontinence | ||
| Probe | Fuji Dynamics | ||
| Ltd. | K161055 |
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4. Device Description:
The Incontinence Probe models PE0001, PE0002, PE0004, PE0005, PE0006, PE0007 , PE0008, PE0009, and PE0010 are stand-alone probes/electrodes, which can be placed inside the adult rectum or female vagina to transmit electrical stimulation signals or pelvic floor EMG signals when connected to pelvic electrical stimulators or EMG biofeedback devices during the treatment of urinary incontinence . All the models are reusable for a single patient except PE0003, which is a disposable vaginal probe. The probes are not packaged with specific floor muscle stimulators and EMG/biofeedback equipment but are compatible with low-frequency (less than 1000Hz working frequency) stimulators or EMG/biofeedback devices that meet the standards of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 and use 2.0 DIN connection. The probes are made of S304 stainless steel and Acrylonitrile-Butadiene-Styrene (ABS). The probes are designed for use in home or clinic by a single user. The probes do not require sterilization but need cleaning for reuse according to the cleaning instructions provided in the instructions for use manual.
5. Indication for Use:
The Incontinence Probes are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
| Characteristic | Vaginal Probe | Rectal Probe | ||
|---|---|---|---|---|
| Predicate device | Subject device | Predicate device | Subject device | |
| 510(K) | ||||
| Submitter | Fuji Dynamics Ltd. | Shenzhen Med-link | ||
| Electronics Tech | ||||
| Co. Ltd. | Fuji Dynamics Ltd. | Shenzhen Med-link | ||
| Electronics Tech | ||||
| Co., Ltd. | ||||
| Model | Fuji Dynamics | |||
| Fuji-01/ 02 / 03/ 04 / | ||||
| 05/ 06/ 07/ 14/ 15 | PE0002,PE0003,PE0 | |||
| 005,PE0007,PE000 | ||||
| 9, | ||||
| PE0010 | Fuji Dynamics | |||
| Fuji- 08/ 09/ 10/ 11/ 12 | ||||
| 13/ 14/ 15 | PE0001,PE0004 | |||
| PE0006,PE0008 | ||||
| Number of | ||||
| Electrode | 2-Stimulation / EMG | Same | 2-Stimulation / EMG | Same |
6. Comparison of the Technological Characteristics with Predicate Device:
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| Usage
Conditions | Reusable - single
patient | Except the model
PE0003 which is
disposable, the other
models are
reusable-single use | Reusable - single
patient | Same |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------|
| Electrode
Material | Stainless Steel & ABS | Same | Stainless Steel & ABS | Same |
| Electrode
Placement | Vagina | Same | Rectum | Same |
| Contact
Duration | Intermittent mucosal
contact