The Mederi RF Generator when used with the Secca Disposable Handpiece is intended for the treatment of bowel incontinence in patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.
The Mederi RF Generator when used with the Stretta Disposable Catheter is intended for the treatment of gastroesophageal reflux disease (GERD).

Device Description

The Mederi Therapeutics RF Generator Control Module is a Radio Frequency Generator which is used with the Stretta and Secca disposable hand pieces and accessories including irrigation tubing and foot pedal. The Mederi Therapeutics RF Generator Control Module is part of a therapeutic platform for treatment of various medical conditions with radiofrequency (RF) energy. Specifically. for the treatment of two conditions:

Gastroesophageal reflux disease (GERD). Mederi's devices used for treatment of this condition include the Mederi RF generator and the "Stretta" disposable kit.
Fecal Incontinence (FI). Mederi's devices used for treatment of this condition include the Mederi generator and the "Secca" disposable kit.
The Mederi RF Generator Control Module is a multi-channel electrosurgical generator that produces low power, radiofrequency (RF) energy using a sinusoidal waveform of 460 kHz. Needle tip and surface tissue temperatures are measured through disposable hand pieces during treatment by thermocouples located at the tip and base of the needle, respectively. The electrode tip temperature measurement regulates the output power in a closed-loop fashion to maintain the target temperature, while monitoring of the surface tissue temperature prevents overheating.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a specific study proving the device meets those criteria with statistical data, sample sizes, or expert qualifications. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study report.

However, based on the information available, here's what can be extracted and inferred:

Acceptance Criteria and Device Performance

The acceptance criteria are not explicitly quantified in the provided text. Instead, the document generally states that "Verification testing of the Mederi Therapeutics RF Generator Control Module demonstrated that the device met the acceptance criteria." The performance testing focused on ensuring the modified RF Generator Control Module performed as intended and was substantially equivalent to predicate devices.

Here's a table summarizing the types of performance aspects tested, which would imply associated acceptance criteria, although the specific numerical targets are not given.

Acceptance Criteria Category	Reported Device Performance
Software Control Module (CM)	Met acceptance criteria (verified through review and performance testing)
Software CM functionality with Stretta Module	Met acceptance criteria
Software CM functionality with Secca Module	Met acceptance criteria
Audio Output	Met acceptance criteria
Equivalency to Predicate Devices	Demonstrated substantial equivalence (key finding of 510(k) submission)
Energy and Impedance	Met acceptance criteria
Pump Function	Met acceptance criteria
Mechanical Systems	Met acceptance criteria
Environmental Conditions	Met acceptance criteria (related to packaging, shipping, storage)
Packaging (shipping and storage)	Met acceptance criteria
Electrical Safety	Met required safety standards (verified by Intertek via EMC/EMI testing)
Failsafe Specifications	Met acceptance criteria
Product Energy Delivery Integrity	Met acceptance criteria (connected to Secca or Stretta applied part)

Detailed Response to Specific Questions:

A table of acceptance criteria and the reported device performance:
- See the table above. It lists the categories of testing and the general statement of "Met acceptance criteria" or "Demonstrated substantial equivalence" as the reported performance, as specific quantitative criteria and results are not provided.
Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for any of the performance tests.
- The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. The testing appears to be internal verification and validation against specified design requirements rather than a clinical study with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The performance testing described (e.g., software review, electrical safety) suggests engineering and regulatory compliance testing rather than clinical evaluation requiring expert ground truth establishment in a diagnostic context.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- An adjudication method is not mentioned. This type of method is typically used in clinical trials or studies where there are subjective assessments by multiple reviewers. The tests described are primarily objective engineering and performance verification.
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 MRMC study was conducted or mentioned. This device is an electrosurgical generator, not an AI-assisted diagnostic or imaging system, so such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device itself is a "Control Module" for an RF generator, implying it always operates in conjunction with human operation (human-in-the-loop) for therapeutic procedures. The "Software Code Review and performance testing on the Software Control Module (CM)" could be considered a form of standalone evaluation of the algorithm/software component. However, the overall device performance tests, especially those involving "Stretta Module" and "Secca Module," imply the software's functionality within the complete system, which is human-controlled.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the engineering and performance tests (e.g., energy output, impedance, pump function, electrical safety), the "ground truth" would be established by engineering specifications, regulatory standards (e.g., IEC standards for electrical safety), and design requirements. There's no indication of ground truth based on expert consensus, pathology, or outcomes data, as this is not a diagnostic device.
The sample size for the training set:
- There is no mention of a training set. This device is a hardware and software system for electrosurgical coagulation, not a machine learning or AI algorithm that requires a training set in the conventional sense. The "Software Control Module" was developed and verified, but not "trained" on data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device.

Summary

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510(k) Summary

JAN 2 0 2011

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).

Applicant/Sponsor:

Oleg Shikhman - Chief Operating Officer Mederi Therapeutics Inc. 8 Sound Shore Drive Suite 160 Greenwich, CT 06830 Ph: (203) 350-9818 Oleg@MederiTherapeutics.com

Submitter: Regulatory Contact:

Curt Raymond - Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: (203) 922-0105 Fax: (203) 922-0130 · Curt.raymond@orchid-orthopedics.com

Date Prepared: October 8, 2010

Device Information

Trade Name: Mederi Therapeutics RF Generator Control Module Common Name: Electrosurgical, cutting & coagulation device and accessories Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Product Code: GEI

Predicate Device(s):

K000245 for the Stretta system (submitted by Conway Stuart Medical) .
K010210 for the Control Module Algorithm Enhancement for Model S500-ST . and Model S400 (submitted by Curon Medical)
K014216 for the Secca system (submitted by Curon Medical) .

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K103017
Pg 2 of 3

Device Description

Gastroesophageal reflux disease (GERD). Mederi's devices used for treatment � of this condition include the Mederi RF generator and the "Stretta" disposable kit.
Fecal Incontinence (FI). Mederi's devices used for treatment of this condition . include the Mederi generator and the "Secca" disposable kit.

The Mederi RF Generator Control Module is a multi-channel electrosurgical generator that produces low power, radiofrequency (RF) energy using a sinusoidal waveform of 460 kHz. Needle tip and surface tissue temperatures are measured through disposable hand pieces during treatment by thermocouples located at the tip and base of the needle, respectively. The electrode tip temperature measurement regulates the output power in a closed-loop fashion to maintain the target temperature, while monitoring of the surface tissue temperature prevents overheating.

Modified Device Description

The modifications described in this submission include improvements to the design and performance of the RF Generator Control Module. Mederi Therapeutics is combining the functions of both previously marketed RF generators into a single compact RF generator utilizing the new hardware and software to improve the user interface and the overall performance of the system.

Indication for Use

The Mederi Therapeutics RF Generator Control Module is intended to for general use in the electrosurgical coagulation of tissue, specifically:

the RF Generator Control Module and Secca disposable hand piece is intended for . the treatment of fecal incontinence in those patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.
the RF Generator Control Module and Stretta disposable hand piece is intended . for the treatment of gastroesophageal reflux disease (GERD).

Technological Characteristics

Performance Testing and Safety

Specific performance tests and evaluations were conducted to assure the modified RF Generator Control Module performed as intended. Verification included Software Code

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Image /page/2/Picture/0 description: The image shows a handwritten fraction, "K103017", above the text "pg 3 of 3". The fraction is underlined, and the text is written in a casual, handwritten style. The background is plain and white.

Review and performance testing on the Software Control Module (CM), Software CM functionality with Stretta Module, Software CM functionality with Secca Module, Audio Output, Equivalency to predicate devices, Energy and Impedance, Pump Function, Mechanical Systems, Environmental Conditions, Packaging (shipping and storage), Electrical Safety, Failsafe Specifications and Product Energy Delivery Integrity connected to a Secca or Stretta applied part (Disposable).

Verification testing of the Mederi Therapeutics RF Generator Control Module demonstrated that the device met the acceptance criteria.

Electrical Safety Testing

EMC/EMI and Electrical Safety Testing was conducted on the Mederi RF Generator Control Module and the Disposable Hand Pieces by Intertek and results demonstrated the RF Generator Control Module with the disposable Hand Piece meet the required safety standards.

Conclusion

Based on the same intended uses, similar technological characteristics, and performance characteristics, the Mederi Therapeutics RF Generator Control Module is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mederi Therapeutics, Inc. % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, Connecticut 06484

JAN 2 0 201

Re: K103017

Trade/Device Name: Mederi Therapeutics RF Generator Control Module Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2011 Received: January 12, 2011

Dear Mr. Raymond:

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. 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.

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

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Page 2 - Mr. Curtis Raymond

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 (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For Peter A. Nardini

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

(revised)

510(k) Number: K103017

Device Name : Mederi Therapeutics RF Generator Control Module

Indications for Use 510K:

The Mederi Therapeutics RF Generator is intended for general use in the electrosurgical coagulation of tissue, specifically:

The Mederi RF Generator when used with the Secca Disposable Handpiece is intended . for the treatment of bowel incontinence in patients with incontinence to solid or liquid stool at least once per week and who have failed more conservative therapy.
The Mederi RF Generator when used with the Stretta Disposable Catheter is intended for . the treatment of gastroesophageal reflux disease (GERD).

Prescription Use: × (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103017

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.