The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

Device Description

The proposed Microgyn Plus is a battery-powered device that delivers a regulated stimulus to the nerves and muscles of the pelvic floor. The stimulus is administered by attaching an anatomically shaped probe to the device and then inserting the probe into the patient's vagina or anus. When stimulation is delivered the body responds by contracting the muscles of the pelvic floor. The Microgyn Plus provides balanced biphasic stimulation pulse. The pulse has a positive and negative phase such that the net charge applied to the patient is zero. The proposed Microgyn Plus is a current controlled device that provides an output that is adjustable from 0-60 milliamperes. The device also has the ability to select between three frequencies (10, 50, 100 Hz) depending on the frequency selected by the caregiver and the individual needs of the patient.

AI/ML Overview

This submission is a 510(k) premarket notification, which means the device is being compared to a legally marketed predicate device to demonstrate substantial equivalence, rather than needing to meet specific acceptance criteria through a novel clinical study. Therefore, the information typically associated with acceptance criteria and a study proving a device meets them (like detailed performance metrics of a new device against predefined thresholds, large-scale clinical trial data with effect sizes, ground truth establishment for a test set, etc.) is not present in this document.

Instead, the "study" demonstrating the device meets the acceptance criteria is the comparison to the predicate device as outlined in the 510(k) submission. The "acceptance criteria" are implicitly met if the FDA determines the device is "substantially equivalent" in terms of safety and effectiveness to the predicate device.

Here's an analysis based on the provided text, addressing your points where possible, and indicating where information is not applicable due to the nature of a 510(k) submission:

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

This information is not provided in the document because this is a 510(k) submission focused on demonstrating substantial equivalence to a predicate device, not on meeting specific, prospectively defined clinical performance acceptance criteria for a novel device. The "performance" is implicitly considered equivalent 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 as there is no specific clinical "test set" and associated study described to demonstrate performance against predefined criteria. The submission relies on a comparison to a predicate device.

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 specific clinical "test set" with ground truth established by experts described in this 510(k) notification.

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

This information is not provided as there is no specific clinical "test set" with expert adjudication described in this 510(k) notification.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more relevant for diagnostic devices involving human interpretation, especially when AI is used as an aid. The device here is a therapeutic stimulation device.

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

Not Applicable. This device is a physical, battery-powered electrical stimulation device for rehabilitation, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

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

This information is not provided as no specific ground truth for a clinical study is described. The basis for safety and effectiveness is through demonstration of substantial equivalence to a predicate device.

8. The sample size for the training set

This information is not provided as the device is a physical medical device, not an AI/ML algorithm that would typically require a training set.

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.

Summary of the "Study" and "Acceptance Criteria" for this 510(k) Submission:

Acceptance Criteria (Implicit): The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device regarding intended use, technological characteristics, safety, and effectiveness. This implies that the new device should be as safe and effective as the predicate.
The "Study" (Demonstration of Substantial Equivalence):
- Basis: Comparison to legally marketed predicate devices:
  - InCare Microgyn Plus Device (K963222)
  - Elpha 2000 Conti Device (K964738)
- Methodology:
  1. Intended Use Comparison: The proposed Microgyn Plus Stimulation Device has the same intended use as the predicate device: "to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women."
  2. Technological Characteristics Comparison:
    - It is a battery-powered device delivering regulated stimulus to pelvic floor nerves and muscles.
    - Administered via an anatomically shaped probe inserted vaginally or anally.
    - Provides balanced biphasic stimulation pulse with net zero charge.
    - It is a current-controlled device with adjustable output (0-60 mA).
    - It has selectable frequencies (10, 50, 100 Hz).
    - Key Difference and Justification: The only noted difference from the primary predicate (K963222) is that 10 Hz has been substituted for 20 Hz in selectable frequencies. The submission implicitly argues that this change does not raise new questions of safety or effectiveness, or that the device is still substantially equivalent despite this change.
- Conclusion: "Based upon the information presented within this pre-market notification it is concluded that the proposed Microgyn Plus Stimulation Device is safe and effective for its intended use and is substantially equivalent to the predicate device."

In essence, for a 510(k), the "study" is the analytical comparison provided by the submitter to the FDA, demonstrating that the new device is fundamentally the same as (or as safe and effective as) a device already on the market. Clinical performance data against predefined metrics is generally not required unless the differences from the predicate raise new safety or effectiveness concerns.

Summary

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DEC 1 9 2001

Hollister Incorporated Microgyn Plus (w/10Hz) Stimulation Device

Safety and Effectiveness Summary

1. Submitter's name, Address and Contact Person

Submitter	Contact Person
Hollister Incorporated	Joseph S. Tokarz
2000 Hollister Drive	Manager, Regulatory Affairs
Libertyville, IL 60048	Ph: (847)680-2849
	Fax: (847)918-3860

Date Summary Prepared - December 18, 2001

2. Name of Device:

Hollister Microgyn Plus Stimulation Device

3. Name of Predicate Device(s)

InCare Microgyn Plus Device, K963222 Elpha 2000 Conti Device, K964738

4. Description of Device

The proposed Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of urinary incontinence in women.

5. Statement of Intended Use

6. Statement of Technological Characteristics of the Device

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Hollister Incorporated Microgyn Plus ( w/10Hz) Stimulation Device

pulse. The pulse has a positive and negative phase such that the net charge applied to the patient is zero.

The proposed Microgyn Plus is a current controlled device that provides an output that is adjustable from 0-60 milliamperes. The device also has the ability to select between three frequencies (10, 50, 100 Hz) depending on the frequency selected by the caregiver and the individual needs of the patient.

The proposed Microgyn Plus is identical to the predicate device (K963222) in electrical characteristics except that 10 Hz has been substituted for 20Hz.

7. Conclusion

Based upon the information presented within this pre-market notification it is concluded that the proposed Microgyn Plus Stimulation Device is safe and effective for its intended use and is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville . MD 20850

DEC 1 9 2001

Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive LIBERTYVILLE IL 60048-3781 Re: K013141 Trade/Device Name: Microgyn Plus Stimulation Device (10 Hz) Regulation Number: 21 CFR §876.5320 Regulation Name: Nonimplanted electrical continence device Regulatory Class: Class II Product Code: 78 KPI Dated: September 19, 2001 Received: September 20, 2001

Mr. Joseph S. 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.

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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 predicate 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 vours.

Nancy Croyden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Hollister Incorporated Microgyn Plus (w/10Hz) Stimulation Device

Statement of Intended Use

KO13141

510(k) Number (if Known): Device Name:

Microgyn Plus Stimulation Device

Indications For Use:

The Microgyn Plus Stimulation Device is intended to provide electrical stimulation for the The Microgyn Plus Sumulation Device is included to provide to the treatment of urinary incontinence in women.

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CONTINUE - CONTINUE FEDERA 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,
and Radiological Devices
510(k) Number: K013141

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).