(108 days)
No
The document does not mention AI, ML, deep learning, neural networks, or any related terms. The device description focuses on mechanical and optical components, and the performance studies evaluate standard clinical and mechanical metrics.
Yes
The device is intended to treat symptomatic chronic Gastro Esophageal Reflux Disease (GERD) by creating anterior partial fundoplication, which is a therapeutic intervention.
No
The device description and intended use clearly state that this is a surgical stapling system for creating fundoplication, which is a therapeutic procedure, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a flexible endoscope with a video camera, ultrasound sensor, and stapler mechanism, as well as endoscopy suite consoles and various accessories. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the endoscopic placement of surgical staples in the esophagus and stomach to treat GERD. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a stapling system with an endoscope, consoles, and accessories used for a surgical procedure.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are designed for testing samples in vitro.
The device is a surgical tool used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease (GERD) in patients who require and respond to pharmacological therapy.
Product codes (comma separated list FDA assigned to the subject device)
ODE
Device Description
The Medigus SRS is an Endoscopic Stapling System. The device consists of the following components and accessories:
- . The flexible endoscope combines a video camera, ultrasound sensor (range finder) and a stapler mechanism. The distal end of the endoscope is capable of retroflexion. The system enables creation of an endoluminally anterior partial fundoplication by stapling together the soft tissue of the fundus (upper part of the stomach) and the esophagus.
- The endoscopy suite includes the ISL (Insufflation, Suction and Light) console and the CCU . (Camera Control Unit) console.
- The associated accessories include: .
- Irrigation bottle with liquids for irrigation of the camera lens l
- Suction canister for extracting liquids during the procedure .
- . Silicon tubes for connecting the ISL and other accessories to the endoscope
- . Disposable air filter of the suction ISL input channel
- I Overtube for protecting patient's pharynx
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video camera, ultrasound sensor (range finder)
Anatomical Site
Esophagus and 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)
Performance Data was provided including biocompatibility testing, electrical safety and electromagnetic compatibility, mechanical and acoustic testing, animal testing, and clinical testing.
Animal testing: "In the GLP animal study, 16 pigs underwent endoscopy with the SRS System. Twelve pigs underwent fundoplication, and 4 pigs served as a sham (control) group. There were no procedure related complications or mortality in this study, at 2, 4 and 6 weeks follow-up (4 in pigs in each group)." "These studies demonstrated that the Medigus SRS® device can safely create an anterior partial fundoplication, equivalent to that which is constructed using conventional laparoscopic or open surgical techniques."
Clinical testing: "Clinical testing of the device included an initial feasibility study of 6 patients, a pilot study consisting of 13 patients and a pivotal study of 72 patients."
"Pilot Study": "All pilot-study patients were treated with the SRS and recovered from the procedure without sequelae. There was one anticipated procedure related adverse event, benign pneumoperitoneum, which resolved spontaneously within 48 hours." "The main success criterion of the pilot study, improvement in GERD HRQL score by 50% or more at six weeks post-procedure, was met by 12 of the 13 subjects, and was very close to 50% (48.3%) in the thirteenth patient. All subjects reduced their PPI use. Twelve of the subjects were off daily PPI and met the secondary success criterion (reduction to 50% improvement in their GERD-HRQL score off PPI at six months compared to baseline. Hence the study met its primary endpoint with the required 95% confidence level." "The reduction in the median score for the SRS of 23.0 units (from 29.0 to 6.0) represents a 79.3% improvement. This value is almost identical to the result reported by Cadiere et al (1) for the pivotal trial of the EsophyX system (79.2%), and slightly better than the result reported by Von Renteln et al (2) for the NDO Plicator (76.0%). Therefore, the efficacy of the SRS system in successfully treating chronic symptoms of GERD is similar to the efficacy reported by both predicate devices." "The median value of the percent of time pH
§ 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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MAY 1 8 2012
510(k) SUMMARY
Medigus' SRS Endoscopic Stapling System
l. SUBMITTER
Medigus Ltd. 7A Industrial Park, P.O. Box 3030 Omer 84965, Israel
Phone: +972-8-6466770 Facsimile: +972-8-6466770
Contact Person: Jon Griver Date Prepared: May 16, 2012
II. DEVICE
Name of Device and Name/Address of Sponsor
- Medigus Ltd. 7 A Industrial Park, P.O. Box 3030 Omer 84965, lsrael
Common or Usual Name
SRS Endoscopic Stapling System (abbreviated in this document to 'SRS')
Classification Name
Endoscope and Accessories (21 CFR §876.1500)
Regulatory Class: ll
Product Code: ODE
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Predicate Devices
Endoscopic Plication System, also referred to as Plicator™, manufactured by NDO Surgical Inc. of Mansfield, Massachusetts, cleared under 510(k) #K023234, #K031262 and #K071553.
EsophyX System with EGS SerosaFuse™, manufactured by EndoGastric Solutions Inc. of Redmond, Washington and cleared under 510(k) # K071651.
Intended Use / Indications for Use
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease (GERD) in patients who require and respond to pharmacological therapy.
Technological Characteristics
The Medigus SRS is an Endoscopic Stapling System. The device consists of the following components and accessories:
- . The flexible endoscope combines a video camera, ultrasound sensor (range finder) and a stapler mechanism. The distal end of the endoscope is capable of retroflexion. The system enables creation of an endoluminally anterior partial fundoplication by stapling together the soft tissue of the fundus (upper part of the stomach) and the esophagus.
- The endoscopy suite includes the ISL (Insufflation, Suction and Light) console and the CCU . (Camera Control Unit) console.
- The associated accessories include: .
- Irrigation bottle with liquids for irrigation of the camera lens l
- Suction canister for extracting liquids during the procedure .
- . Silicon tubes for connecting the ISL and other accessories to the endoscope
- . Disposable air filter of the suction ISL input channel
- I Overtube for protecting patient's pharynx
Comparison of Technological Characteristics with Predicate Devices
The candidate device and both predicate devices are based on the same technological elements:
- l Endoscope - used to reach the target tissue
- I Device inserted through an overtube - to protect the esophagus
- . Creation of a gastric (or gastroesophageal) plication in close proximity to the gastroesophageal junction - either by the retroflexed device (SRS and EsophyX) or by a retractor (Plicator)
- l Use of a permanent implant made of titanium (SRS, EPS) or polypropylene (EsophX)
- Delivery of the elements needed to complete the procedure through the endoscopic device
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- Visual control of the device's position and orientation before releasing the implant; an ■ ultrasound range-finder provides added positioning accuracy for the SRS system
- l Use of a mechanical component for positioning and launching the implant: a stylet (EPS, EsophyX) or positioning screws (SRS)
- . User-controlled mechanical trigger (or knob) to launch the fastener (implant)
- . Mechanically securing the plication by a permanent implant fastener (SRS and EsophyX) or a sutured bridge (EPS)
The candidate and predicate devices have the same principle of operation, using a device-delivered, permanent implant to secure a plication, intended to create an anatomical fold that will serve as a valve close to the gastroesophageal junction, thereby preventing flow of gastric contents into the esophagus. The unique aspects of SRS are intended to improve the precision of positioning the anvil and cartridge (ultrasound range finder) and the use of staples as fasteners.
The use of staples for permanently attaching soft tissues is a well-established surgical technique. The specific staple used in the SRS System is substantially equivalent to the Auto Suture Surgical Staples manufactured by United States Surgical of Norwalk, Connecticut and cleared by FDA under 510(k) #K013860 on December 19, 2001.
Neither element represents a significant change in the principle of operation or the technological manifestation of the device, and therefore the candidate device is substantially equivalent to the predicate devices in its technological features.
Performance Data
The following performance data was provided in substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation program for the SRS System was based on demonstrating compliance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." The testing program included cytotoxicity, sensitization, irritation, and pyrogenicity.
Electrical safety and electromagnetic compatibility
Electrical safety and electromagnetic compatibility (EMC) testing was conducted on the SRS System, consisting of the ISL console, the CCU console and endoscope. The system complies with the IEC 60601-1, IEC 60601-2-18 and IEC 60601-2-37 standards for safety and the IEC 60601-1-2 standard for EMC,
Mechanical and acoustic testing
Following a detailed risk analysis, a series of mechanical tests concerning the manual operation of the system and its mechanical performance were formulated. The system successfully passed all The acoustic transducer included in the system was tested to its the mechanical tests. specifications.
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Animal testing
In the course of the development of the device, Medigus conducted numerous tests with prototype devices on a porcine model. These included survival and non-survival studies, as well as staple longevity for up to 13 months.
All of these experiments were carried out at the Animal Research facility of the Institute for Animal Research, Lahav, Israel, and were authorized, according to the Israeli animal welfare act, by the institutional review board for animal research of the health sciences of Ben-Gurion University of the Negev, Beer Sheva, Israel.
The main animal study was performed in conformity with GLP standards by an external subcontractor (ECON AG Mecklenbureger str. 233 D-23568 Lubeck, Germany). The experiments were conducted at the animal research facilities of the Virchow Institute in Berlin, Germany. The complete study report was submitted in the original IDE (G070138).
In the GLP animal study, 16 pigs underwent endoscopy with the SRS System. Twelve pigs underwent fundoplication, and 4 pigs served as a sham (control) group. There were no procedure related complications or mortality in this study, at 2, 4 and 6 weeks follow-up (4 in pigs in each group).
The safety and feasibility of the Medigus SRS device were evaluated by macroscopic and histological evaluation of the tissue in the treatment stapled areas.
These studies demonstrated that the Medigus SRS® device can safely create an anterior partial fundoplication, equivalent to that which is constructed using conventional laparoscopic or open surgical techniques.
Clinical testing
Clinical testing of the device included an initial feasibility study of 6 patients, a pilot study consisting of 13 patients and a pivotal study of 72 patients.
Pilot Study
All pilot-study patients were treated with the SRS and recovered from the procedure without sequelae. There was one anticipated procedure related adverse event, benign pneumoperitoneum, which resolved spontaneously within 48 hours.
The main success criterion of the pilot study, improvement in GERD HRQL score by 50% or more at six weeks post-procedure, was met by 12 of the 13 subjects, and was very close to 50% (48.3%) in the thirteenth patient. All subjects reduced their PPI use. Twelve of the subjects were off daily PPI and met the secondary success criterion (reduction to 50% improvement in their GERD-HRQL score off PPI at six months compared to baseline. Hence the study met its primary endpoint with the required 95% confidence level.
The reduction in the median score for the SRS of 23.0 units (from 29.0 to 6.0) represents a 79.3% improvement. This value is almost identical to the result reported by Cadiere et al (1) for the pivotal trial of the EsophyX system (79.2%), and slightly better than the result reported by Von Renteln et al
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(2) for the NDO Plicator (76.0%). Therefore, the efficacy of the SRS system in successfully treating chronic symptoms of GERD is similar to the efficacy reported by both predicate devices.
The median value of the percent of time pH Trade/Device Name: SRS Endoscopic Stapling System Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: May 1, 2012 Received: May 1, 2012
Dear Mr. Kahan:
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 FD'A'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 (reporting of medical
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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/CDRHOffices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Eubanks
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
8
Indications for Use Statement
510(k) Number (if known):
Device Name:
SRS Endoscopic Stapling System
Indications for Use:
The SRS Endoscopic Stapling System is intended for endoscopic placement of surgical staples in the soft tissue of the esophagus and stomach in order to create anterior partial fundoplication for treatment of symptomatic chronic Gastro Esophageal Reflux Disease in patients who require and respond to pharmacological therapy.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amm In Wly
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _ K120299
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