(181 days)
Not Found
No
The description focuses on biofeedback, electrical stimulation, and pre-set programs, with no mention of AI or ML terms or concepts.
Yes
The device description explicitly states it is a "biofeedback and neuromuscular electrical stimulation therapy device" and describes its use for "strengthen[ing] weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women," which are therapeutic applications.
No
The device is primarily a therapy device for stimulating pelvic floor muscles and biofeedback, aimed at treating urinary incontinence. While it evaluates myoelectric signals, this evaluation is part of the biofeedback and treatment process, rather than a standalone diagnostic function to identify a condition.
No
The device description explicitly states it is a "Biofeedback Nerve and Muscle Stimulator (Model: KM530B, KM531B, KM537)" and describes it as a "battery-powered with a touch screen Liquid Crystal Display (LCD)". It also mentions electrical stimulation and myoelectric signal acquisition, which are hardware functions. Furthermore, the performance studies include electrical safety, electromagnetic compatibility, and biocompatibility testing, all of which are relevant to hardware components. While software verification and validation are mentioned, the device is clearly not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device Function: The description clearly states the device provides electrical stimulation and neuromuscular re-education for the purpose of rehabilitating pelvic floor muscles. It also uses biofeedback by acquiring myoelectric signals (electrical signals from muscles).
- Mechanism of Action: The device works by directly interacting with the body's muscles and nerves through electrical stimulation and by providing feedback based on muscle activity. This is an in vivo (within the body) process, not an in vitro process.
- Intended Use: The intended use is to treat urinary incontinence by strengthening pelvic floor muscles, which is a physical therapy/rehabilitation approach, not a diagnostic test on a sample.
The device is a therapeutic device that uses biofeedback and electrical stimulation, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Product codes
KPI, HCC
Device Description
The Biofeedback Nerve and Muscle Stimulator (Model: KM530B, KM531B, KM537) is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction. Through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment it helps to strengthen weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
The device is battery-powered with a touch screen Liquid Crystal Display (LCD) and offers the user a choice of electromyography (EMG) triggered stimulation (ETS) mode (The device provides a passive pulse stimulation when the level of active contraction of the pelvic floor muscles reaches a threshold by means of electrical feedback from the pelvic floor muscles. 17 (KM536, KM537) or 22 (KM530B, KM531B) pre-set sow-frequency pulses stimulate pelvic floor muscles Electrical Stimulation (STIM) programs with 6 pre-set biofeedback response-based EMG games and the EMG therapy are available for the users. The differences between the model KM536 are only the model's name and the number of STIM Programs. The differences between the model KM531B and KM537 are also only the model's name and the number of STIM Programs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
- Electrical safety test according to IEC 60601-1, Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
- Electromagnetic compatibility test according to IEC 60601-1-2, Medical electrical ● equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . Performance testing according to IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Biocompatibility test according to ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- Performance test according to IEC 60601-2-10, Medical electrical equipment -- Part 2-● 10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- Usability Study according to IEC 60601-1-6, Medical electrical equipment Part 1-6: ● General requirements for basic safety and essential performance - Collateral standard: Usability and IEC 62366-1, Medical devices - Part 1: Application of usability engineering to medical devices
- Software verification and validation test according to the FDA guidance document . "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"
All testing results confirmed that the products described in this submission met the necessary specification.
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).
0
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July 20, 2022
Shenzhen Konmed Technology Co.,Ltd. % Cassie Lee Manager Guangzhou Glomed Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, Guangdong 510530 China
Re: K220161 Trade/Device Name: Biofeedback Nerve and Muscle Stimulator. Models: KM530B, KM531B, KM536, KM537 Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Code: KPI, HCC Dated: June 14, 2022 Received: June 21, 2022
Dear Cassie Lee:
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.
1
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,
For 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
2
Indications for Use
510(k) Number (if known) K220161
Device Name
Biofeedback Nerve and Muscle Stimulator, Models: KM530B, KM531B, KM536, KM537
Indications for Use (Describe)
The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
| 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
1.Submitter Information
| 510 (k) submitter: | Shenzhen Konmed Technology Co., Ltd. | |
|---|---|---|
| Address: | 601, Building B4, Shenchengtou Creative Factory Life | |
| Science Park, Julongshan A Road, Xiuxin Block, | ||
| Kengzi Street, Pingshan District, Shenzhen, | ||
| Guangdong, CHINA, Postal Code: 518118 | ||
| Contact Person Name: | Shuishan Yin | |
| Contact Title: | General manager | |
| Contact Person's email: | 2519021651@qq.com | |
| Contact Person's Phone | ||
| Number: | +86 755 8670 4556 | |
| Contact Person's Fax | ||
| Number: | +86 755 8670 4556 | |
| Preparation date: | July 19, 2022 |
Application Correspondent
| Contact Person Name: | Ms. Cassie Lee |
|---|---|
| Contact Title: | Manager, Guangzhou GLOMED Biological Technology Co., |
| Ltd. | |
| Contact Person's email: | regulatory@glomed-info.com |
| Contact Person's Phone | |
| Number: | +86 20 8266 2446 |
2.Device Information
| Trade Name of the Device: | Biofeedback Nerve and Muscle Stimulator,
Models: KM530B, KM531B, KM536, KM537 |
|---------------------------|----------------------------------------------------------------------------------|
| Common Name: | Nonimplanted electrical continence device |
| Classification Name: | Nonimplanted electrical continence device,
Biofeedback Device |
| Classification Number: | 21 CFR 876.5320, 21 CFR 882.5050 |
| Regulatory Class: | II |
| Review Panel | Gastroenterology/Urology, Neurology |
| Product Code | KPI, HCC |
3.Predicate Devices
| 510(k) number | K202648 |
|---|---|
| Trade name of the Device | Biofeedback Nerve and Muscle Stimulator |
4
The predicate has not been subjected to a design-related recall.
4.Device Description
The Biofeedback Nerve and Muscle Stimulator (Model: KM530B, KM531B, KM537) is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction. Through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment it helps to strengthen weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
The device is battery-powered with a touch screen Liquid Crystal Display (LCD) and offers the user a choice of electromyography (EMG) triggered stimulation (ETS) mode (The device provides a passive pulse stimulation when the level of active contraction of the pelvic floor muscles reaches a threshold by means of electrical feedback from the pelvic floor muscles. 17 (KM536, KM537) or 22 (KM530B, KM531B) pre-set sow-frequency pulses stimulate pelvic floor muscles Electrical Stimulation (STIM) programs with 6 pre-set biofeedback response-based EMG games and the EMG therapy are available for the users. The differences between the model KM536 are only the model's name and the number of STIM Programs. The differences between the model KM531B and KM537 are also only the model's name and the number of STIM Programs.
5.Intended Use
The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
| K220161 (Subject) | K202648 (Predicate) | |
|---|---|---|
| Device Name | Biofeedback Nerve and | |
| Muscle Stimulator | Biofeedback Nerve and Muscle Stimulator | |
| Indication For | ||
| Use | The device is intended to | |
| provide electrical stimulation | ||
| and | ||
| neuromuscular | ||
| re- | ||
| education for the purpose of | ||
| rehabilitation of weak pelvic | ||
| floor muscles for the treatment | ||
| of stress, urge and mixed | ||
| urinary incontinence in women | ||
| and to maintain urinary | ||
| continence in women. | As a powered muscle stimulator the Biofeedback Nerve and | |
| Muscle Stimulator is indicated for the following conditions: | ||
| • Relaxation of muscle spasm | ||
| • Prevention or retardation of disuse atrophy | ||
| • Increasing local blood circulation | ||
| • Muscle re-education | ||
| • Immediate post-surgical stimulation of calf muscles to | ||
| prevent venous thrombosis | ||
| • Maintaining or increasing range of motion | ||
| As a biofeedback device the Biofeedback Nerve and Muscle | ||
| Stimulator is indicated for the following conditions: | ||
| • Biofeedback, relaxation and muscle re-education purposes | ||
| As a nonimplanted electrical continence device the | ||
| Biofeedback Nerve and Muscle Stimulator is indicated for | ||
| the following conditions: | ||
| • Acute and ongoing treatment of stress, urge or mixed | ||
| urinary incontinence and where the following results may | ||
| improve urinary control: Inhibition of the detruser muscles | ||
| through reflexive mechanisms and strengthening of pelvic | ||
| floor muscles. | ||
| • Incontinence treatment for assessing EMG activity of the | ||
| pelvic floor and accessory muscles such as the abdominal |
6.Comparison of The Technological Characteristics with Predicate Device:
5
| and the gluteus muscles. | ||
|---|---|---|
| Prescription or | ||
| OTC | OTC | Rx Only |
| Power source | 7.4V DC/1200mAh | |
| rechargeable lithium battery | 7.4V DC/1200mAh | |
| rechargeable lithium battery | ||
| Maximum | ||
| Output Current | ||
| (±10%) | 94.4mA @ 500Ω | |
| 54mA @ 2kΩ | ||
| 15 mA @ 10kΩ | 94.4mA @ 500Ω | |
| 54mA @ 2kΩ | ||
| 15mA@ 10kΩ | ||
| Maximum | ||
| Phase Charge | 51.4μC@500Ω | 51.4µC @ 500Ω |
| Maximum | ||
| Current Density | 6.01mA/ cm²@ 500Ω | |
| Surface = 15.7 cm² | 6.01mA/ cm² @500Ω | |
| Maximum | ||
| Power Density | 0.2814mW/ cm²@ 500Ω | 0.2814mW(12mW) / |
| cm²@ 500Ω | ||
| Frequency (Hz) | 2-100Hz | 2 -100Hz |
| Pulse Duration | ||
| (usec) | 50-450µs | 50- 450 µs |
| Net charge | For pulsed symmetric, | |
| biphasic: | ||
| 0µC @ 500Ω; | For pulsed symmetric, | |
| biphasic: 0µC @ 500Ω; |
As evidenced by the above table, both the subject and the predicate devices have the same intended use. Additionally, the subject device has identical technological characteristics to the predicate except the predicate device was cleared for prescription only use and the subject device is an over the counter (OTC) use device. However, this difference does not raise different questions of safety or effectiveness and the testing mentioned below showed that the subject is substantially equivalent with the predicate.
7. Performance Data
In support of this premarket notification, Shenzhen Konmed Technology conducted the following safety and performance testing on the subject device-
- Electrical safety test according to IEC 60601-1, Medical electrical equipment Part 1: ● General requirements for basic safety and essential performance
- Electromagnetic compatibility test according to IEC 60601-1-2, Medical electrical ● equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . Performance testing according to IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- Biocompatibility test according to ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- Performance test according to IEC 60601-2-10, Medical electrical equipment -- Part 2-● 10: Particular requirements for the basic safety and essential performance of nerve and
6
muscle stimulators
- Usability Study according to IEC 60601-1-6, Medical electrical equipment Part 1-6: ● General requirements for basic safety and essential performance - Collateral standard: Usability and IEC 62366-1, Medical devices - Part 1: Application of usability engineering to medical devices
- Software verification and validation test according to the FDA guidance document . "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices"
All testing results confirmed that the products described in this submission met the necessary specification.
8. Conclusion
Based on the information presented in this submission, it can be concluded that the subject device is substantially equivalent to the predicate.