(209 days)
No
The description focuses on the mechanical function of the balloon and the inflation system, with no mention of AI/ML for image analysis, decision support, or automated control based on complex data.
No.
The device is designed to improve visualization during a diagnostic procedure (colonoscopy) by maintaining central positioning and straightening colonic folds, which assists in examination but does not directly treat a disease or condition. Its intended use is described as an aid for endoscopic examination and surgery.
No
The device is described as a colonoscope intended for improved visualization and navigation within the lower gastrointestinal tract, primarily for endoscopic procedures and surgery. While it aids in visualization, its primary function is not to diagnose specific conditions but rather to facilitate the conduct of interventional procedures.
No
The device description clearly outlines hardware components, including a colonoscope with a balloon and an inflation pump (SPARKC). The performance studies also include hardware-related testing like reprocessing validation, biocompatibility, electrical safety, and bench testing of the hardware components.
Based on the provided information, the G-EYE® colonoscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for direct visualization and intervention within the lower gastrointestinal tract. This is an in vivo procedure (within a living organism), not an in vitro procedure (performed outside the body, typically on biological samples).
- Device Description: The description details a physical instrument (colonoscope with a balloon) used for navigating and interacting with the internal anatomy. This aligns with a medical device used for diagnosis and treatment within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the G-EYE® colonoscope is a medical device used for endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope positioning.
Product codes
FDF
Device Description
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC ("SPARKC") inflation pump. The G-EYE® Colonoscope includes a reprocessable, reusable balloon (the G-EYE® balloon) that is attached to a standard, commercially available colonoscope which is remanufactured by Smart Medical to include the balloon at its bending section. The balloon onto the standard colonoscope is considered remanufacturing of the standard colonoscope by Smart Medical, which assumes responsibility for the final device including the G-EYE® balloon and the remanufactured colonoscope. The G-EYE® balloon is inflated by the dedicated SPARKC inflation system, which enables automatic control of the required balloon pressure in one of several user-selected, system-controlled pressure levels such that the balloon conforms to the colonic lumen diameter. The G-EYE® Colonoscope is advanced by the endoscopist with the balloon deflated, which essentially preserves the standard colonoscope's diameter and insertion technique. At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique. Withdrawal of the inflated balloon mechanically straightens the colonic folds and anatomic flexures, centers the colonoscope optics within the colonic lumen, and minimizes uncontrolled bowel slippage during withdrawal, therefore maintaining the endoscope's field of view
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopy
Anatomical Site
lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve
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 testing conducted includes: Reprocessing validation testing consistent with FDA's guidance, Biocompatibility testing in accordance with ISO 10993-1, Software verification and validation, Electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1 and IEC 60601-1-2, and Verification bench testing of the SPARKC and G-EYE® Colonoscope including operational and functional testing. Each of these tests met its acceptance criteria.
Clinical data from three clinical studies outside the United States, including over 1000 subjects, further support safety and performance. All three studies demonstrated the device functioned as intended with no serious device-related adverse events. The studies also showed that the device served its intended function, and that mechanical straightening of colonic folds and anatomic flexures provided by the G-EYE® System facilitates visualization of the colonic mucosa surface area.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pentax EC Video Colonoscopes (K181084)
Reference Device(s)
EndoRings (K133359), NaviAid™ BGC Device (K111760)
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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April 15, 2020
SMART Medical Systems Ltd. % Janice Hogan Regulatory Counsel Hogan Lovells US LPP 1735 Market Street Floor 23 Philadelphia, PA 19103
Re: K192588
Trade/Device Name: G-EYE System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: March 17, 2020 Received: March 17, 2020
Dear Janice Hogan:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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).
Sincerely,
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
510(k) Number (if known)
Device Name
G-EYE® System Indications for Use (Describe)
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope positioning.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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510(k) SUMMARY
SMART Medical Systems Ltd.'s G-EYE® System
Submitter's Name, Address. Telephone Number, Contact Person and Date Prepared
Adva Yoselzon VP of Requlatory & Clinical Affairs Smart Medical Systems Ltd. 5 Hanofar. Raanana 4366404 Tel: +972-9-7444321 Fax: +972-9-7444543 Mobile: +972-52-8911112 Email: ayoselzon@smartmedsys.com
Date Prepared: March 16, 2020
Name of Device
G-EYE® System
Common or Usual Name
Endoscope and accessories, Gastroenterology-Urology
Classification
21 CFR 876.1500, Class II, product code FDF
Predicate Devices
Pentax EC Video Colonoscopes (K181084) (predicate)
EndoRings (K133359) (reference device)
NaviAid™ BGC Device (K111760) (reference device)
Intended Use / Indications for Use
The G-EYE® Colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the colonoscope to maintain central positioning within the lumen and help control the endoscope's view field and/or endoscope's positioning.
Device Description
The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC ("SPARKC") inflation pump. The G-EYE® Colonoscope includes a reprocessable, reusable balloon (the G-EYE® balloon) that is attached to a standard, commercially available colonoscope which is remanufactured by Smart Medical to include the balloon at its bending section. The balloon onto the standard colonoscope is considered remanufacturing of the standard colonoscope by Smart Medical, which assumes responsibility for the final device including the G-EYE® balloon and the remanufactured colonoscope. The G-EYE® balloon is inflated by the dedicated SPARKC inflation system, which enables automatic control of the required balloon pressure in one of several user-selected, system-controlled pressure levels such that the balloon conforms to
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the colonic lumen diameter. The G-EYE® Colonoscope is advanced by the endoscopist with the balloon deflated, which essentially preserves the standard colonoscope's diameter and insertion technique. At the cecum, the balloon is inflated to engage the colon walls, and the colonoscope is then withdrawn by the endoscopist using standard withdrawal technique. Withdrawal of the inflated balloon mechanically straightens the colonic folds and anatomic flexures, centers the colonoscope optics within the colonic lumen, and minimizes uncontrolled bowel slippage during withdrawal, therefore maintaining the endoscope's field of view
Technological Characteristics
The G-EYE® System is very similar to the previously cleared Pentax EC Video Colonoscopes series (K180285). Both the subject device and predicate device have the same intended use and substantially similar materials and principles of operation.
The subject device and predicate device are both multi-use and intended to be reprocessed. Similar to the predicate colonoscope, the G-EYE® Colonoscope is reprocessed in accordance with the reprocessing instructions of the original endoscope manufacturer with supplemental instructions for reprocessing of the G-EYE® balloon. This difference does not raise different questions of safety and effectiveness, as confirmed by the company's reprocessing validation testing.
The materials of the G-EYE® Colonoscope are substantially similar to those of the predicate device, and any differences in the materials of the G-EYE® Colonoscope and the predicate device do not raise different questions of safety or effectiveness. This was confirmed through the company's biocompatibility testing and performance testing.
Both the G-EYE® System and the Pentax EC Video Colonoscopes feature a standard colonoscope. All compatible colonoscopes are 510(k) cleared and have an insertion tube diameter of 11.0mm - 13.2mm. The primary difference between the G-EYE® Colonoscope and its predicate is the installation of the G-EYE® balloon at the bending section of the G-EYE® Colonoscope. As all standard colonoscopes underlying the G-EYE® Colonoscopes (namely remanufactured by balloon installation, to become G-EYE® Colonoscopes) are identical to existing, 510(k) cleared colonoscopes, except for the G-EYE® balloon at the bending section, the minor differences among the various models of G-EYE® Colonoscopes included in the G-EYE® System do not raise new or different questions of safety or effectiveness compared to the cleared predicate device.
The G-EYE® balloon, the EndoRings reference device and the BGC reference device are designed to increase/decrease in diameter to help control the endoscopes view field and/or endoscope positioning, Specifically, the method of engaging the colon tissue to manipulate the colonic folds and conform to the lumen size is similar between the G-EYE® balloon and the EndoRings reference device. The EndoRings reference device achieves this sizing through three layers of "wings" that fold back (contract radially) upon insertion, and come forward (expand radially) upon withdrawal. The G-EYE® balloon and the EndoRings device share similar properties in this respect. The G-EYE® balloon is deflated (contracted radially) during insertion of the colonoscope into the colon, and subsequently inflated (expands radially) upon withdrawal. By manipulating the colonic folds, maintaining central position in the lumen, and avoiding sudden slippage, the "wings" of the EndoRings and the G-EYE® balloon both allow the user to maintain the endoscope's field of view during endoscopic procedure and therapy. Both devices help stabilize and view the mucosa without interfering with the endoscope's field of view, as both the wings and balloon are designed to engage the colon rearwardly of the distal tip of the endoscope and to not interfere with the endoscopic image.
The principle of operation of the G-EYE® System is substantially similar to that of its predicate device. The G-EYE® Colonoscope functions equivalent to its predicate colonoscope, with the exception of the added function of the G-EYE® balloon. Specifically, the functionality and operation of the standard colonoscope underlying the G-EYE® Colonoscope, do not change following its remanufacturing by installing the G-EYE® balloon.
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Performance Data
In support of this 510(k) premarket notification, Smart Medical conclinical testing to evaluate the performance of the G-EYE® System for its intended use. The performance testing conducted includes the following:
- ∑ Reprocessing validation testing consistent with FDA's guidance in Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
- 2 Biocompatibility of patient-contacting components has been established in accordance with ISO 10993-1.
- Software verification and validation was performed, and demonstrated that the software performs as intended.
- Σ Electrical safety and electromagnetic compatibility testing was conducted and results were passing in accordance with IEC 60601-1 and IEC 60601-1-2.
- 2 Verification bench testing of the SPARKC and G-EYE® Colonoscope which included operational and functional testing.
Each of these tests met its acceptance criteria, supporting substantial equivalence to the predicate.
Although not required to demonstrate substantial equivalence, clinical data is available from three clinical studies outside the United States that further support the safety and performance of the device for its intended In total, the studies included over 1000 subjects. All three studies demonstrated that the device use. functioned as intended, with no serious device-related adverse events. In addition, the studies demonstrated that the device served its intended function, and that the mechanical straightening of the colonic folds and anatomic flexures provided by the G-EYE® System facilitates visualization of the colonic mucosa surface area.
Substantial Equivalence
The G-EYE® System and its predicate device have the same intended use and similar indications, technological characteristics and principles of operation. Technological different questions of safety or effectiveness than the predicate device, and accepted scientific methods exist to evaluate the performance of the G-EYE® System compared to its predicate and reference devices. Performance data has demonstrated that the G-EYE® System is as safe and effective as its predicate. Thus, the G-EYE® System is substantially equivalent to the Pentax EC Video Colonoscopes (K181084).