(267 days)
No
The device description and performance studies focus on a mechanical suture system and its deployment under endoscopic visualization. There is no mention of AI/ML in the text, and the "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is used for the "treatment of symptomatic chronic gastroesophageal reflux disease (GERD)".
No
The device is described as an "application and suture system" indicated for the "treatment" of chronic gastroesophageal reflux disease (GERD), and its description details a procedure for affixing GI tissue using sutures. This indicates a therapeutic, not a diagnostic, function.
No
The device description explicitly details multiple physical components (Applicator, Tissue Retractor, Suture System, Guide Wire) and a surgical procedure involving their use. There is no mention of software as a primary or standalone component.
Based on the provided information, the GERDX®-System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- GERDX-System Function: The GERDX-System is a surgical device used to physically modify the gastrointestinal tract by creating a plication (folding and suturing) of tissue. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use is for the "treatment of symptomatic chronic gastroesophageal reflux disease (GERD)". This is a therapeutic indication, not a diagnostic one.
- Device Description: The description details a system for applying sutures to tissue within the body, which is a surgical procedure.
- Anatomical Site: The device operates directly on the gastrointestinal tract, not on specimens taken from the body.
Therefore, the GERDX®-System falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GERDX®-System is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
Product codes
ODE
Device Description
The GERDX-System is a sterile application and suture system indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
The GERDX-System consist of following procedural components: GERDX-Applicator, GERDX-Tissue Retractor, GERDX-Suture System and the GERDX-Guide Wire.
The Suture System and the Tissue Retractor are loaded onto the Applicator. The Guide Wire is placed within the antrum of the stomach by standard procedure. By use of the Guide Wire, the Applicator is introduced orally and advanced through the esophagus into the stomach. After removing the Guide Wire a thin profile gastroscope is inserted into a channel within the Applicator and the Applicator is positioned under direct endoscopic visualization at the target location within the gastrointestinal (GI) tract. The Tissue Retractor is advanced out of the distal tip of the Applicator. Gastric tissue is engaged by the Tissue Retractor and withdrawn into the Applicator, thereby pulling the tissue into the open arms of the Applicator. The arms of the Applicator are then closed to grasp and approximate the target tissue. The Suture System is then deployed to transmurally affix the GI tissue. The procedure is repeated to deploy additional Suture Systems if necessary. The number of Suture Systems that are placed will vary based on patient anatomy and physician's judgement. Parts of the Suture System remain within the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal (GI) tract, esophagus, stomach
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)
Bench tests:
Procedure-related bench tests were provided to assess the forces associated with a full thickness plication. Side by side tests were performed with GERDX-System and with the proposed predicate. The results of these tests confirm that the GERDX-System and Plicator EPS have equivalent technological characteristics, designs, and operational properties and support the performance and safety of the GERDX-System.
Biocompatibility of GERDX-System met the acceptance criteria according to ISO 10993-1:2018.
Clinical testing
Two peer-reviewed articles have been published whereas GERDX-System was proved as an effective minimally invasive endoscopic intervention to control GERD.
Animal testing
Animal studies performed on a porcine model in a GLP-conform laboratory demonstrated the safety and feasibility of GERDX-System.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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June 21, 2024
G-Surg GmbH % Anna Pocsai Consultant novineon CRO GmbH Friedrich-Miescher-StraBe 9 Tuebingen, Baden-Wuerttemberg 72076 Germany
Re: K233240
Trade/Device Name: GERDX-System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODE Dated: May 24, 2024 Received: May 24, 2024
Dear Anna Pocsai:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
GERDX-System
Indications for Use (Describe)
Indications for Use (Describe) The GERDX®-System is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
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)
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Table of Content of Volume 5: Premarket Notification 510(k) Summary
| TABLE OF CONTENT OF VOLUME 5: PREMARKET NOTIFICATION 510(K) SUMMARY | 5-1 |
|---|---|
| 5. PREMARKET NOTIFICATION 510(K) SUMMARY | 5-1 |
| 1. CONTACT DETAILS | 5-1 |
| 2. DEVICE NAME | 5-1 |
| 3. LEGALLY MARKETED PREDICATE DEVICES | 5-1 |
| 4. DEVICE DESCRIPTION SUMMARY | 5-1 |
| 5. INTENDED USE / INDICATIONS FOR USE: | 5-2 |
| 6. COMPARISON OF CHARACTERISTICS | 5-2 |
| 6.1 INDICATIONS FOR USE COMPARISON | 5-2 |
| 6.2 TECHNOLOGICAL COMPARISON | 5-2 |
| 7. NON-CLINICAL AND CLINICAL TESTS SUMMARY & CONCLUSION | 5-3 |
5. Premarket Notification 510(k) Summary
1. CONTACT DETAILS
G-SURG GmbH Weinbergstraße 28, 83370 Seeon-Seebruck Telephone: +49-8624 409160 E-Mail: j.mair@g-surg.com Contact: Julian Mair Date prepared: June 17, 2024
2. DEVICE NAME
Trade Name: GERDX-System Common Name: Endoscope accessory Classification Name: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd), Class: II Regulation Number: 876.1500 Product Code: ODE
3. LEGALLY MARKETED PREDICATE DEVICES
Endoscopic Plication System; Plicator™ (K071553); Product Code: ODE
4. DEVICE DESCRIPTION SUMMARY
5
The GERDX-System is a sterile application and suture system indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
The GERDX-System consist of following procedural components: GERDX-Applicator, GERDX-Tissue Retractor, GERDX-Suture System and the GERDX-Guide Wire.
The Suture System and the Tissue Retractor are loaded onto the Applicator. The Guide Wire is placed within the antrum of the stomach by standard procedure. By use of the Guide Wire, the Applicator is introduced orally and advanced through the esophagus into the stomach. After removing the Guide Wire a thin profile gastroscope is inserted into a channel within the Applicator and the Applicator is positioned under direct endoscopic visualization at the target location within the gastrointestinal (GI) tract. The Tissue Retractor is advanced out of the distal tip of the Applicator. Gastric tissue is engaged by the Tissue Retractor and withdrawn into the Applicator, thereby pulling the tissue into the open arms of the Applicator. The arms of the Applicator are then closed to grasp and approximate the target tissue. The Suture System is then deployed to transmurally affix the GI tissue. The procedure is repeated to deploy additional Suture Systems if necessary. The number of Suture Systems that are placed will vary based on patient anatomy and physician's judgement. Parts of the Suture System remain within the patient.
5. INTENDED USE / INDICATIONS FOR USE:
The GERDX®-System is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease (GERD) in patients who require and respond to pharmacological therapy.
6. COMPARISON OF CHARACTERISTICS
6.1 INDICATIONS FOR USE COMPARISON
With the exception of the device name, the indications for use statements are identical.
6.2 TECHNOLOGICAL COMPARISON
The proposed GERDX-System is clinically, biologically, and technologically identical of the proposed predicate device (K071553). The devices differ only in some technological details. Summary of differences:
- GERDX-Applicator: By the predicate device force is transmitted manually via cables and . pulls, whereas for the GERDX-System force is transmitted via a manually operated hydraulic system. However, this modification shows several improvements in safety-relevant aspects.
- . GERDX-System: All components of GERDX-System are sterile, while some components of predicate device are non-sterile and reusable. There are no labelling regarding of cleaning and disinfection is present on the label of the GERDX-System
- . GERDX-System contains an additional component, a Guide Wire, which had to be purchased separately by the predicate device. The component Guide Wire is identical for the two devices.
- . GERDX-Suture: same design, except of the material of the surgical suture used. However, the suture for the GERDX-System is cleared by FDA and its biocompatibility has been confirmed.
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7. NON-CLINICAL AND CLINICAL TESTS SUMMARY & CONCLUSION
Bench tests:
Procedure-related bench tests were provided to assess the forces associated with a full thickness plication. Side by side tests were performed with GERDX-System and with the proposed predicate. The results of these tests confirm that the GERDX-System and Plicator EPS have equivalent technological characteristics, designs, and operational properties and support the performance and safety of the GERDX-System.
Biocompatibility of GERDX-System met the acceptance criteria according to ISO 10993-1:2018.
Clinical testing
Two peer-reviewed articles have been published whereas GERDX-System was proved as an effective minimally invasive endoscopic intervention to control GERD.
Animal testing
Animal studies performed on a porcine model in a GLP-conform laboratory demonstrated the safety and feasibility of GERDX-System.
Based on indications for use, clinical evaluation, performance- and biocompatibility tests presented in this premarket notification, the GERDX-System is substantially equivalent to the Plicator and do not raise new issues of safety and effectiveness.