(51 days)
No reference devices were used in this submission.
No
The description focuses on mechanical and optical components and does not mention any AI/ML capabilities or data processing beyond basic imaging and ultrasonic range finding.
Yes
The device is intended to create anterior partial fundoplication for the treatment of symptomatic chronic Gastro Esophageal Reflux Disease, which is a medical condition. The stapling procedure directly addresses and treats the disease.
No
The device is designed for surgical staple placement in the esophagus and stomach to treat GERD, and its description focuses on its mechanical function for performing a procedure, not on diagnosing a condition.
No
The device description clearly outlines multiple hardware components including an endoscopic stapler with a camera, ultrasonic range finder, and stapling mechanism, a control console, and various accessories like irrigation bottles and staple cartridges. This is not a software-only device.
Based on the provided information, the Medigus Ultrasonic Surgical Endostapler (MUSE™) System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is 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". This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device is a surgical stapler used to physically alter tissue within the body. It includes components like a video camera, ultrasonic range finding, and a stapling mechanism. These are all tools for performing a surgical intervention.
- Lack of IVD Characteristics: IVD devices are typically used to examine samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. The MUSE system does not perform any such analysis on patient samples.
Therefore, the MUSE system is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Medigus Ultrasonic Surgical Endostapler (MUSE™) 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
ODE
Device Description
The Medigus Ultrasonic Surgical Endostapler (MUSE™) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed 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 (EtO) 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 shaft of 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 (EtO) 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
video camera, ultrasonic range finding sight
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
The following performance data summaries were provided in support of the substantial equivalence determination:
- Dimensional comparisons
- Mechanical Testing
- Biocompatibility Testing
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. 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 graphic of three human profiles facing right, layered on top of each other, with a flowing ribbon-like element extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 5, 2015
Medigus, Ltd. % Sheila S. Stevens, Ph.D. US Clinical and Regulatory Affairs Consultant 2121 North California Blvd. Suite 290 Walnut Creek, CA 94596
Re: K151001
Trade/Device Name: Medigus Ultrasonic Surgical Endostapler (MUSE™) System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODE Dated: May 15, 2015 Received: May 18, 2015
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.
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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 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,
Herbert P. Lerner -S
for 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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I. Statement of Indications for Use
510(k) Number (if known): K151001
Device Name: Medigus Ultrasonic Surgical Endostapler (MUSE™) System
Indications for Use: The Medigus Ultrasonic Surgical Endostapler (MUSE™) 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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II. 510(k) Summary
Medigus Ultrasonic Surgical Endostapler (MUSE™) System
I. SUBMITTER
Medigus Ltd. Building 7A Omer Industrial Park Omer, 84965 Israel
Phone: +972-8-6466880 Fax: +972-8-6466770
Sheila S. Stevens, PhD Contact Person: US Regulatory and Clinical Affairs Consultant
Date Prepared: May 26, 2015
II. DEVICE
Name of Device: Medigus Ultrasonic Surgical Endostapler (MUSE) System Common or Usual Name: Endoscopic Stapling System Classification Name: Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (GERD) 21 CFR 876.1500- Endoscope and Accessories Regulatory Class: II Product Code: ODE Special Controls: N/A
III. PREDICATE DEVICE
K143634 Medigus SRS Endoscopic Stapling System (Trade Name MUSE) This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Medigus Ultrasonic Surgical Endostapler (MUSE™) System enables the operator to staple the fundus of the stomach to the esophagus, in 2 or more locations around the esophageal circumference, thereby creating a permanent surgical fundoplication. The procedure is completed 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 (EtO) 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,
4
insufflation port, and the staple anvil. The distal tip is retroflexed to align with the staple cartridge located in the shaft of 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 (EtO) 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 ●
V. INDICATIONS FOR USE
The Medigus Ultrasonic Surgical Endostapler (MUSE™) 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.
The Indications for Use statement for the modified device is identical to that of the predicate.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The modified device shares all technological characteristics with the predicate with the exception of the following differences:
- The subject device contains an overtube manufactured by Medigus, ● whereas the predicate device contained a commercially available overtube not manufactured by Medigus.
VII. PERFORMANCE DATA
The following performance data summaries were provided in support of the substantial equivalence determination:
- Dimensional comparisons
- Mechanical Testing
- Biocompatibility Testing ●
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VIII. CONCLUSIONS
The modified Medigus Ultrasonic Surgical Endostapler (MUSE™) System has the same intended use, indications, principles of operation and fundamental technology as the cleared, predicate version of the device. The minor differences in the subject device's overtube do not raise any new or different questions of safety or effectiveness. Performance data demonstrates that the subject device performs comparably to the predicate device that is currently marketed for the same intended use. Thus, the subject device is substantially equivalent to the predicate.