(37 days)
Not Found
No
The device description and performance studies focus on electrosurgical principles, mechanical components, and basic temperature feedback, with no mention of AI or ML algorithms for decision-making, data analysis, or control.
Yes
The device is intended for the treatment of Gastroesophageal Reflux Disease (GERD) and uses electrosurgical coagulation to achieve a therapeutic effect on tissue.
No
The "Intended Use / Indications for Use" section states the device is "Intended for general use in the electrosurgical coagulation of tissue and intended for use specifically in the treatment of Gastroesophageal Reflux Disease (GERD)." This indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly details a physical catheter with a flexible shaft, basket, electrodes, balloon, and thermocouples, which are all hardware components. The summary also mentions design verification and validation testing related to these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrosurgical coagulation of tissue" and "treatment of Gastroesophageal Reflux Disease (GERD)". This describes a therapeutic procedure performed directly on a patient's tissue.
- Device Description: The description details a catheter with electrodes, a balloon, and thermocouples designed to be inserted trans-orally and deliver energy to esophageal tissue. This is a medical device used for treatment, not for analyzing samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are used to examine specimens in vitro (outside the body) to provide information about a person's health.
The Stretta® Catheter is a therapeutic medical device used for a surgical procedure.
N/A
Intended Use / 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).
Product codes
GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophageal tissue
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
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.
Key Metrics
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.
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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.
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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 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. |
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