(251 days)
Not Found
No
The document describes a mechanical and electronic stapling system with a camera and ultrasonic range finding, but there is no mention of AI or ML in the device description, intended use, or performance studies. The software validation mentioned is standard for medical devices and does not imply AI/ML.
Yes.
The device is intended for the endoscopic placement of surgical staples in the esophagus and stomach to create anterior partial fundoplication for the treatment of symptomatic chronic Gastro Esophageal Reflux Disease, which is a medical condition.
No
The device is an endoscopic surgical stapling system intended for creating anterior partial fundoplication, which is a therapeutic procedure, not a diagnostic one. While it has a video camera for visualization, its primary function is to deliver staples.
No
The device description clearly outlines multiple hardware components including an endoscopic stapler, control console, and various accessories, none of which are solely software. While software is mentioned as an improvement, it is part of a larger hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the placement of surgical staples in the esophagus and stomach to treat GERD. This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a surgical stapling system used to physically alter tissue within the body. It includes components like a stapler, console, and accessories for performing a surgical procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition. The camera and ultrasonic range finding are used for visualization and positioning during the surgical procedure, not for diagnostic testing of biological samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
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 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 Surgical Stapling System. The system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.
The endoscopic stapler is a single use, sterile device which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil.
The distal tip is retroflexed to align with the staple cartridge located in the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application.
The control console includes the insufflation, light and camera electronics.
The associated accessories include:
- . Irrigation bottle with liquids for irrigation of the camera lens
- Silicon tubes for connecting the console and other accessories to the stapler .
- . Standard overtube for protecting patient's pharynx
- Tweezers to remove and replace staple cartridge .
- . Staple cartridges
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
soft tissue of the 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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following non-clinical performance data was provided in support of the substantial equivalence determination:
- Biocompatibility testing
- . Electrical safety and electromagnetic compatibility
- Software validation .
- . Sterilization validation
- Mechanical and acoustic testing .
- LED photobiological and thermal safety testing .
- . Camera/optics characterization testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K120299 Medigus SRS Endoscopic Stapling System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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MAR 19 2014
510(k) Summary
Medigus SRS Endoscopic Stapling System
| Criteria | Information |
|---|---|
| 510(k) Owner | Medigus Ltd. |
| Building 7A | |
| Omer Industrial Park | |
| Omer, 84965 Israel | |
| Phone: +972-8-6466880 | |
| Fax: +972-8-6466770 | |
| Date Prepared | March 18, 2014 |
| Contact Person | Sheila Stevens, PhD |
| US Clinical and Regulatory Affairs | |
| Device Name | Medigus SRS Endoscopic Stapling System |
| Trade Name/ | |
| Proprietary Name | Medigus Ultrasonic Surgical Endostapler |
| (MUSE) | |
| Common Name | Endostapler, endoscopic stapler |
| Classification Name | Endoscopic Suture/Plication System, Gastroesophageal |
| Reflux Disease (GERD) | |
| 21 CFR 876.1500- Endoscope and Accessories; Class II; | |
| Product code: ODE | |
| Predicate Device | K120299 Medigus SRS Endoscopic Stapling System |
| 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 in patients who require and | |
| respond to pharmacological therapy. |
Device Description
The Medigus SRS is an Endoscopic Surgical Stapling System. The system enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, entirely through the mouth, without any incisions. The system consists of three main parts: the endoscopic stapler, the control console and several accessories.
The endoscopic stapler is a single use, sterile device which resembles an endoscope in appearance and material construction. The distal tip of the device contains a video camera, ultrasonic range finding sight, illumination, irrigation port, insufflation port, and the staple anvil.
1
The distal tip is retroflexed to align with the staple cartridge located in the stapler. An alignment pin in the distal tip is used for initial positioning of the anvil against the cartridge. The cartridge is provided sterile and contains standard, 4.8 mm titanium surgical staples. Each application of the device fires five staples in 3 staggered rows. A new cartridge is loaded for each application.
The control console includes the insufflation, light and camera electronics.
The associated accessories include:
- . Irrigation bottle with liquids for irrigation of the camera lens
- Silicon tubes for connecting the console and other accessories to the stapler .
- . Standard overtube for protecting patient's pharynx
- Tweezers to remove and replace staple cartridge .
- . Staple cartridges
Differences between the predicate device and subject device are summarized as follows:
- � The subject device has a single console whereas the predicate had two consoles.
- The subject device has an improved user interface and software controls . compared to the predicate.
- . The subject device uses an electric motor to power staple ejection, whereas the predicate device manually ejected staples.
- . The subject device contains an alignment pin mechanism to allow accurate alignment of the stapling anvil and cartridge.
- The subject devices uses an LED for illumination, whereas the predicate . contained a Xenon lamp.
- . The subject device contains a CMOS camera, whereas the predicate contained a CCD camera.
Performance Data
The following non-clinical performance data was provided in support of the substantial equivalence determination:
- Biocompatibility testing
- . Electrical safety and electromagnetic compatibility
- Software validation .
- . Sterilization validation
- Mechanical and acoustic testing .
- LED photobiological and thermal safety testing .
- . Camera/optics characterization testing
Substantial Equivalence
The Mediqus SRS Endoscopic Stapling System has the same intended use and indications and similar principles of operation, and technological characteristics as the cleared, predicate version of the device. The minor differences in the subject device's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the subject device is as safe and effective as the predicate SRS Endoscopic Stapling System. Thus, the subject device is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of an eagle with three lines forming its wings and body. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA," which is arranged in a circular fashion around the emblem.
Public Health Service
ood and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 19, 2014
Medigus, Ltd. Sheila S. Stevens, Ph.D. US Regulatory and Clinical Affairs 2121 North California Blvd., Suite 290 Walnut Creek, CA 94596
Re: K132151
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: March 13, 2014 Received: March 18, 2014
Dear Sheila S. Stevens,
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.
3
Page 2 - Sheila S. Stevens, Ph.D.
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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,
Image /page/3/Picture/8 description: The image shows the text "Benjamin Fisher-S". The text is in a bold, sans-serif font. The letters "DA" are stylized with a geometric pattern.
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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Attachment 13
Indications for Use Statement
510(k) Number (if known):_K132151
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 × (Per 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin-S
2014.03 -04'00'
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