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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Shenzhen Konmed Technology Co.,Ltd. Biofeedback Nerve and Muscle Stimulator. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the specific acceptance criteria for performance or a detailed study proving the device meets those criteria, especially in terms of clinical effectiveness.

The document focuses on demonstrating substantial equivalence primarily through technical specifications and compliance with general safety and performance standards. While it mentions "Performance testing 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," this standard generally covers electrical safety and functional performance of the stimulator itself, not necessarily clinical efficacy for treating urinary incontinence.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth, and expert involvement are not available in this 510(k) summary.

Here's a breakdown of what can be gleaned from the document regarding the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of specific clinical acceptance criteria (e.g., reduction in incontinence episodes) and reported device performance against those criteria. It lists various safety and performance tests performed to demonstrate compliance with standards:

Acceptance Criteria (Implied by Standards)	Reported Device Performance
Compliance with IEC 60601-1 (Electrical safety)	Met the necessary specification
Compliance with IEC 60601-1-2 (Electromagnetic compatibility)	Met the necessary specification
Compliance with IEC 60601-1-11 (Home healthcare environment)	Met the necessary specification
Compliance with ISO 10993-1 (Biocompatibility)	Met the necessary specification
Compliance with IEC 60601-2-10 (Nerve and muscle stimulators - basic safety and essential performance)	Met the necessary specification
Compliance with IEC 60601-1-6 and IEC 62366-1 (Usability)	Met the necessary specification
Compliance with FDA guidance for Software verification and validation	Met the necessary specification
*Clinical Efficacy (Not explicitly defined or demonstrated in this document for the subject device beyond equivalence to predicate's indicated* efficacy)**	Not explicitly reported for the subject device in this document, instead relies on equivalence to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document primarily refers to technical testing against standards, not clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided as there is no mention of a test set requiring expert-established ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not conducted. This device is a biofeedback nerve and muscle stimulator, not an AI-assisted diagnostic or interpretation system that would involve "human readers" in that context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable in the typical sense for this type of device. The device itself is a standalone medical electrical device. Performance testing against relevant IEC standards (e.g., IEC 60601-2-10) would assess the algorithm/device's performance without a "human-in-the-loop" in terms of its core stimulator functions, but not in a way that relates to diagnostic accuracy or interpretation, which is what this question usually implies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device and the provided document, the "ground truth" used was compliance with established international electrical and medical device safety and performance standards (e.g., IEC 60601 series, ISO 10993). Clinical outcomes data for the subject device are not detailed in this summary; rather, its effectiveness is asserted through substantial equivalence to the predicate device, which presumably had established its own clinical effectiveness.

8. The sample size for the training set

This information is not provided. This device is not described as utilizing a machine learning algorithm that would require a "training set" in the context of AI.

9. How the ground truth for the training set was established

This information is not provided as it's not applicable to the type of device and submission described.

Summary

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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.

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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,

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

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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)

Type of Use (Select one or both, as applicable)
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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 LifeScience 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 PhoneNumber:	+86 755 8670 4556
Contact Person's FaxNumber:	+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 PhoneNumber:	+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

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The predicate has not been subjected to a design-related recall.

4.Device Description

5.Intended Use

	K220161 (Subject)	K202648 (Predicate)
Device Name	Biofeedback Nerve andMuscle Stimulator	Biofeedback Nerve and Muscle Stimulator
Indication ForUse	The device is intended toprovide electrical stimulationandneuromuscularre-education for the purpose ofrehabilitation of weak pelvicfloor muscles for the treatmentof stress, urge and mixedurinary incontinence in womenand to maintain urinarycontinence in women.	As a powered muscle stimulator the Biofeedback Nerve andMuscle 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 toprevent venous thrombosis• Maintaining or increasing range of motionAs a biofeedback device the Biofeedback Nerve and MuscleStimulator is indicated for the following conditions:• Biofeedback, relaxation and muscle re-education purposesAs a nonimplanted electrical continence device theBiofeedback Nerve and Muscle Stimulator is indicated forthe following conditions:• Acute and ongoing treatment of stress, urge or mixedurinary incontinence and where the following results mayimprove urinary control: Inhibition of the detruser musclesthrough reflexive mechanisms and strengthening of pelvicfloor muscles.• Incontinence treatment for assessing EMG activity of thepelvic floor and accessory muscles such as the abdominal

6.Comparison of The Technological Characteristics with Predicate Device:

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		and the gluteus muscles.
Prescription orOTC	OTC	Rx Only
Power source	7.4V DC/1200mAhrechargeable lithium battery	7.4V DC/1200mAhrechargeable lithium battery
MaximumOutput Current(±10%)	94.4mA @ 500Ω54mA @ 2kΩ15 mA @ 10kΩ	94.4mA @ 500Ω54mA @ 2kΩ15mA@ 10kΩ
MaximumPhase Charge	51.4μC@500Ω	51.4µC @ 500Ω
MaximumCurrent Density	6.01mA/ cm²@ 500ΩSurface = 15.7 cm²	6.01mA/ cm² @500Ω
MaximumPower 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

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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.

Regulation Number and Section

§ 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).