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.

AI/ML Overview

This document is a 510(k) summary for the Mederi Therapeutics Stretta® Catheter. It does not contain information about a study proving the device meets acceptance criteria in the format requested. The document describes the device, its intended use, and compares it to a predicate device to claim substantial equivalence. The "Performance Data" section briefly mentions design verification and validation testing but does not provide specific acceptance criteria, reported performance, sample sizes, ground truth details, or any information about AI or human reader studies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study that proves the device meets them based on the provided text. The document focuses on regulatory approval through substantial equivalence, not on detailed clinical or performance validation studies with measurable acceptance criteria as you've outlined.

Summary

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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.

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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

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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)

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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 oftissue and intended for use specifically in the treatment ofGastroesophageal Reflux Disease (GERD).
Device Description	The Stretta® Catheter is a single use monopolar electrosurgicaldevice. The catheter connects to the Mederi RF Generator bymeans of a custom electrical connection. The catheter consistsof a flexible shaft with a multi-arm basket at the distal end anda control handle at the proximal end. The catheter isintroduced trans-orally. The catheter has depth of insertion
	indicators on the shaft to assist the user in inserting the deviceto the proper location. Inside the basket is a balloon that wheninflated with sterile water or air to expands the basket duringuse. The basket arms support electrode needles which contactand penetrate esophageal tissue when the basket is expandedand the electrode needles are advanced. The basket arms alsocontain thermocouples to return temperature measurements tothe generator during activation. The balloon is inflated bymeans of a syringe with an inline pressure relief valve. Theprocedure, delivery of energy, occurs in several steps wherethe catheter is positioned, activated, rotated and repositionedduring the course of the treatment.
Technological Characteristics ofthe Device Compared to thePredicate Device	The Stretta® Catheter has the same technologicalcharacteristics as the predicate device, CMS Stretta Catheter.Both devices are sterile, single use catheters with the sameintended use, principles of operation, energy type, andpackaging. Both devices are similar in design andconstruction. Any differences do not introduce new questionsregarding safety of performance. The modifications to thedevice include change in some materials, additional markingson the catheter shaft, replacement of bonded attachments withmechanical attachments, and change in location of certainelectrical components.
Principles of Operation:	The Stretta® Catheter is a single use monopolar electrosurgicaldevice. The catheter connects to the Mederi RF Generator bymeans of a custom electrical connection. Once the catheter isconnected the device the user can activate the device to deliverradiofrequency energy. The device may be activated multipletimes within the procedure to achieve the desired tissue effect.
Performance Data	Design verification and validation testing including in vitrofunctional testing (union strength, balloon/basket performance,thermocouple accuracy, system seal integrity, needle function,visual and dimensional verification), and biocompatibilitytesting were conducted to confirm that the modifications donot adversely affect safety and performance of the Stretta®Catheter.
Conclusion:	Based on the performance testing and comparison to thepredicate device, the Stretta® Catheter is substantiallyequivalent to the Conway Stuart Stretta System Catheter.

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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.