(100 days)
No
The description focuses on standard electrosurgical technology with closed-loop temperature control, and there are no mentions of AI, ML, or related concepts.
Yes.
The device is intended for the treatment of specific medical conditions (bowel incontinence and GERD) by delivering radiofrequency energy to tissue, which aligns with the definition of a therapeutic device.
No
The device is described as an RF generator for electrosurgical coagulation of tissue, intended for therapeutic treatment of conditions like bowel incontinence and GERD, not for diagnosis.
No
The device description explicitly states it is a "Radio Frequency Generator" and a "multi-channel electrosurgical generator" that produces RF energy. It also mentions disposable hand pieces, accessories, and a foot pedal, all of which are hardware components. The performance studies also include testing of mechanical systems and electrical safety, further indicating it is a hardware device with integrated software.
Based on the provided information, the Mederi Therapeutics RF Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "electrosurgical coagulation of tissue" for the treatment of bowel incontinence and GERD. These are therapeutic procedures performed directly on the patient's body.
- Device Description: The description details a "Radio Frequency Generator" that produces energy for therapeutic treatment. It measures tissue temperature during the procedure to regulate the energy output.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic or other health information. The Mederi Therapeutics RF Generator is a therapeutic device used to treat conditions directly within the body.
N/A
Intended Use / Indications 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).
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Specific performance tests and evaluations were conducted to assure the modified RF Generator Control Module performed as intended. Verification included Software Code 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.
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
§ 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.
0
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) .
1
K103017
Pg 2 of 3
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.
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
2
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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.
3
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
4
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
5
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