← Product Code [GEI](/productcode/GEI) · K152317 # Stretta Catheter (K152317) _Mederi Therapeutics, Inc. · GEI · Sep 23, 2015 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K152317 ## Device Facts - **Applicant:** Mederi Therapeutics, Inc. - **Product Code:** [GEI](/productcode/GEI.md) - **Decision Date:** Sep 23, 2015 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for Use Intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of Gastroesophageal Reflux Disease (GERD). ## Device Story Stretta Catheter is a single-use monopolar electrosurgical device used for GERD treatment. Device features flexible shaft, distal multi-arm basket, and proximal control handle. Trans-oral insertion; basket expanded via internal balloon (inflated with sterile water/air). Basket arms support electrode needles that penetrate esophageal tissue to deliver radiofrequency (RF) energy from Mederi RF Generator. Thermocouples in basket arms provide temperature feedback to generator. Procedure involves sequential positioning, activation, rotation, and repositioning. Operated by physician in clinical setting. RF energy delivery induces tissue coagulation; intended to reduce GERD symptoms. ## Clinical Evidence Bench testing only. Includes in vitro functional testing (union strength, balloon/basket performance, thermocouple accuracy, system seal integrity, needle function, visual/dimensional verification) and biocompatibility testing. ## Technological Characteristics Monopolar electrosurgical catheter; RF energy source. Features flexible shaft, multi-arm basket, internal balloon, and electrode needles. Includes thermocouples for temperature monitoring. Single-use; sterile. Connects to Mederi RF Generator via custom electrical connection. ## Regulatory 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. ## Predicate Devices - Conway Stuart Stretta System Catheter ([K000245](/device/K000245.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 23, 2015 Mederi Therapeutics, Inc. % Michele Lucey President Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing Newbury, NH 03255 Re: K152317 Trade/Device Name: Mederi Therapeutics Stretta® Catheter Regulation Number: 21 CFR§ 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 25, 2015 Received: August 28, 2015 Dear Michele Lucey, 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. {1}------------------------------------------------ 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 (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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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. Sincerely yours, # Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) ## K152317 Device Name Mederi Therapeutics Stretta® Catheter #### Indications for Use (Describe) Intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of Gastroesophageal Reflux Disease (GERD). Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/2/Picture/14 description: The image is blurry and lacks detail, making it difficult to discern specific objects or features. The colors are muted and indistinct, with a predominance of white and light blue. Due to the lack of clarity, it is challenging to provide a more detailed description of the image's content or composition. This section applies only to requirements of the Paperwork Reduction Act of 1995, # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### MEDERI THERAPEUTICS INC ## Special # 510(k) Summary This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c) Submitter Information: Submitter's Name: Mederi Therapeutics Inc. Oleg Shikhman – Chief Operating Officer Sponsor Contact : Address: 800 Connecticut Ave 1日01 Norwalk, CT 06854 Telephone: 203-9 30-9900 Fax: 203-9 39-1088 Submitter's Regulatory Contact: Michele Lucey Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing Newbury, NH 03255 603-763-3455 Date Prepared: August 15, 2015 Device Trade Name: Mederi Therapeutics Stretta® Catheter Common/Usual Name: Electrosurgical cutting and coagulation device and accessories Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Number: 21 CFR 878.4400 Class 2 Product Code GEI Predicate Device K000245 - Conway Stuart Stretta System Catheter | Intended Use | | |------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Intended for general use in the electrosurgical coagulation of
tissue and intended for use specifically in the treatment of
Gastroesophageal Reflux Disease (GERD). | | Device Description | The Stretta® Catheter is a single use monopolar electrosurgical
device. The catheter connects to the Mederi RF Generator by
means of a custom electrical connection. The catheter consists
of a flexible shaft with a multi-arm basket at the distal end and
a control handle at the proximal end. The catheter is
introduced trans-orally. The catheter has depth of insertion | | | indicators on the shaft to assist the user in inserting the device
to the proper location. Inside the basket is a balloon that when
inflated with sterile water or air to expands the basket during
use. The basket arms support electrode needles which contact
and penetrate esophageal tissue when the basket is expanded
and the electrode needles are advanced. The basket arms also
contain thermocouples to return temperature measurements to
the generator during activation. The balloon is inflated by
means of a syringe with an inline pressure relief valve. The
procedure, delivery of energy, occurs in several steps where
the catheter is positioned, activated, rotated and repositioned
during the course of the treatment. | | Technological Characteristics of
the Device Compared to the
Predicate Device | The Stretta® Catheter has the same technological
characteristics as the predicate device, CMS Stretta Catheter.
Both devices are sterile, single use catheters with the same
intended use, principles of operation, energy type, and
packaging. Both devices are similar in design and
construction. Any differences do not introduce new questions
regarding safety of performance. The modifications to the
device include change in some materials, additional markings
on the catheter shaft, replacement of bonded attachments with
mechanical attachments, and change in location of certain
electrical components. | | Principles of Operation: | The Stretta® Catheter is a single use monopolar electrosurgical
device. The catheter connects to the Mederi RF Generator by
means of a custom electrical connection. Once the catheter is
connected the device the user can activate the device to deliver
radiofrequency energy. The device may be activated multiple
times within the procedure to achieve the desired tissue effect. | | Performance Data | Design verification and validation testing including in vitro
functional testing (union strength, balloon/basket performance,
thermocouple accuracy, system seal integrity, needle function,
visual and dimensional verification), and biocompatibility
testing were conducted to confirm that the modifications do
not adversely affect safety and performance of the Stretta®
Catheter. | | Conclusion: | Based on the performance testing and comparison to the
predicate device, the Stretta® Catheter is substantially
equivalent to the Conway Stuart Stretta System Catheter. | {4}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/device/K152317](https://fda.innolitics.com/device/K152317) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com