(136 days)
The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).
The NaviAid™ ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine. The NaviAid™ ICVI system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system. The ICVI disposable includes the ICVI Balloon and the ICVI inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU. The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. though not simultaneously while the device is applied. The NaviAid™ ICVI disposable is intended for single use, while the ASU and SB ASU are re-usable.
The provided document is a 510(k) summary for the NaviAid™ ICVI device, focusing on a modification involving a new "Single Balloon - Air Supply Unit" (SB ASU). The document outlines non-clinical performance data but explicitly states "Clinical Performance Data: Not Applicable." Therefore, information regarding acceptance criteria met by a clinical study is not available in this text.
However, based on the provided text, here's a breakdown of the available information regarding non-clinical testing and ground truth:
1. A table of acceptance criteria and the reported device performance:
The document describes several non-clinical tests performed on the modified NaviAid™ ICVI Device with the new SB ASU component. It states that these tests "demonstrated that the modified NaviAid™ ICVI device with the new SB ASU component meets its design and performance specifications." However, specific numerical acceptance criteria and reported performance values are not detailed in this summary. Instead, it lists the types of tests conducted:
| Test Type | Acceptance Criteria (Not Detailed) | Reported Device Performance (Summary) |
|---|---|---|
| SB ASU Performance Test (Doc. No. TP330001) | Implied: Meets design and performance specifications related to the SB ASU. | Met its design and performance specifications. |
| Electrical & Mechanical Safety Testing (IEC 60601-1) | Compliance with IEC 60601-1. | Complies with IEC 60601-1. |
| Electromagnetic Compatibility Testing (IEC 60601-1-2) | Compliance with IEC 60601-1-2. | Complies with IEC 60601-1-2. |
| Software Validation (IEC 60601-1-4 & FDA Guidelines) | Compliance with IEC 60601-1-4 and FDA Guidelines for software validation. | Complies with IEC 60601-1-4 & FDA Guidelines. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test set sample size: Not specified. The document only mentions "performance tests were conducted."
- Data provenance: Not specified, but given the applicant's address (Israel), it's likely the non-clinical testing was conducted there. The testing is non-clinical, so the terms "retrospective" or "prospective" are not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no human experts were involved in establishing ground truth for the non-clinical performance and safety tests. The ground truth for these tests would be defined by engineering specifications and recognized international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no human experts or adjudication were involved in these non-clinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or comparative effectiveness study was done as this is a non-clinical submission for a device modification, and the product is a mechanical accessory, not an AI-driven diagnostic or assistive tool for human readers.
- The document explicitly states: "Clinical Performance Data: Not Applicable".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical accessory, not an algorithm. The "software validation" refers to the control software for the SB ASU, but its performance is validated against engineering specifications, not as a standalone diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical performance tests (SB ASU Performance Test), the ground truth would be the design and performance specifications set by the manufacturer (Smart Medical Systems Ltd.).
- For the Electrical & Mechanical Safety Testing, Electromagnetic Compatibility Testing, and Software Validation, the ground truth is defined by recognized international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4) and FDA Guidelines.
8. The sample size for the training set:
- Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (See point 8)
{0}------------------------------------------------
JUN 1 7 2011
Image /page/0/Picture/1 description: The image shows the text "Pg 1 of 5" in a handwritten style. The letters and numbers are black against a white background. The text indicates that this is page 1 of a document that is 5 pages long.
SECTION 7 - 510(K) SUMMARY OF SAFETY & EFFECTIVENESS
NAVIAID™ ICVI DEVICE
510(k) Number_K||02011
ﻴﺔ ﺍﻟﺘﻲ ﺗﺘ
Applicant's Name:
| Company name: | Smart Medical Systems Ltd. |
|---|---|
| Address: | 10 Hayetsira Str.Ra'anana 43663ISRAEL |
| Tel.: | +972-9-7444478 |
| Fax: | +972-9-7444543 |
| e-mail: | ayoselzon@smartmedsys.com |
Contact Person:
| Official Correspondent: | Adva Yoselzon |
|---|---|
| Company name: | Smart Medical Systems Ltd. |
| Address: | 10 Hayetsira Str.Ra'anana 43663ISRAEL |
| Tel.: | +972-9-7444478 |
| Fax: | +972-9-7444543 |
| e-mail: | ayoselzon@smartmedsys.com |
Name of the device:
NaviAid™ ICVI device
Trade or proprietary name, if applicable:
NaviAid™ ICVI device
Common or usual name:
NaviAid™ ICVI Device
Establishment Registration No.:
3005261802
{1}------------------------------------------------
Classification Name:
Endoscope and accessories
Classification:
FDA has classified Endoscope and accessories devices as a Class II medical device, with product code ODC and 21 CFR classification code 876.1500. Review by the Gastroenterology/Urology Devices Panel.
Predicate Device:
The new NaviAid™ ICVI device is substantially equivalent to the previously cleared NaviAid™ ICVI device (manufactured by Smart Medical Systems Ltd. and the subject of 510(k) document no. K101191). A comparison table and detailed discussion are presented in Section 10 of this application.
Device Description:
The NaviAid110 ICVI is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to enable advancement and positioning of a standard endoscope in the small intestine.
The NaviAid™ ICVI system comprises a disposable balloon system and an Air Supply Unit ("ASU") or a Single Balloon - Air Supply Unit ("SB ASU") for inflating and deflating the balloon system.
Since the ASU was initially designed to support the BGE device (manufactured by Smart Medical Systems and the subject of K060923) which includes 2 balloons, the ASU includes 2 air ports. By closing 1 port using a standard stopcock the ASU is also used for the operation of a single balloon device such as the ICVI. In order to improve user's convenience and ease of use, several modifications were applied to the ASU so that it could support only a single balloon system (the new ASU is referred to as the Single Balloon - Air Supply Unitor "SB ASU"). Both the ASU and the SB ASU are compatible with the ICVI and the SB ASU will be an alternative component to the ASU.
The role of the ICVI disposable is to facilitate advancement of a standard endoscope into the small intestine. The NaviAid™ ICVI disposable includes the ICVI Balloon and the
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows handwritten text. The text at the top reads "K110291". Below that, the text reads "pg. 3 of 5". The handwriting is somewhat stylized, with rounded shapes.
ICVI inflation tube. The balloon is inflated by ambient air. The ASU or SB ASU operate and control the inflation and deflation of the balloon through a foot-pedal. The balloon is connected to a dedicated inflation tube that runs inside the instrument channel of the endoscope, and is connected at its proximal (user) end to the ASU or SB ASU.
い
The ICVI balloon can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the ICVI inflation tube at its proximal side, outside the patient's body. When the ICVI balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the ICVI inflation tube serves as a rail that leads the endoscope as it is pushed towards the anchoring ICVI balloon. The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the ICVI disposable negligibly compromise the maneuverability of the endoscope's tip and does not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc. though not simultaneously while the device is applied. The NaviAid™ ICVI disposable is intended for single use, while the ASU and SB ASU are re-usable.
Intended Use / Indication for Use:
The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).
Comparison of Technological Characteristics with the predicate device:
The SB ASU is an alternative component to the ASU, which is able to support and control the air flow into/out of a single balloon device which may be connected to it. Though, the Air Supply Unit (ASU) can support two balloons, it comprises two identical independent paths; each one of them controls one balloon. Once operated with a single balloon device (such as the NaviAid™ ICVI), the ASU is active in one air path only, while the other is idle throughout the procedure. Thus, it is relevant to compare the SB ASU with one air control path of the ASU. The two mechanisms are very similar, they both comprise vacuum and pressure sensors, an electrically controlled valve, which is opened and closed based on pressure readings, and a mechanical relief valve that is
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the text "K110291 Pg 4 of 5" in a handwritten style. The text appears to be a page number or document identifier. The numbers are clearly written, and the text is easy to read.
designed to relive excess pressure. Not only do these components exist in both mechanisms, these components are identical in both systems. The difference between the two systems arises only from the source of air flow. While the ASU comprises a tank which introduces compressed air into the balloon or extracts the air out of the balloon (using a piston), the SB ASU comprises two air pumps, one introduces air towards the balloon and the other extracts air out of it. in other words, air pump and vacuum pump. The pressure control algorithm is also very similar between the two systems. The operation of both is based on pressure sensor readings and opening and closing the electric valve based on these readings. Nevertheless, some differences do arise due to the difference in air flow source. Therefore a new electrical control board and new software were designed. Thus, electrical and mechanical safety and EMC tests were performed and the new software was validated. In summary, the ASU and the SB ASU comprise identical critical components which are operated in very similar way. The difference arises only due to the source of pressure/vacuum and thus some algorithmic changes were required. These changes were validated as part of the development process.
The ICVI disposable was not changed or altered.
Non-Clinical Performance Data
The performance tests include testing of the modified NaviAid™ ICVI Device with the new SB ASU component. All tests relating to the ICVI disposable are located in the original submission of the ICVI Device (K101191) and not repeated here, as this component was not changed.
Performance tests relating to the SB ASU component are provided in detail in section 11. The following performance tests were conducted on the modified NaviAid™ ICVI device with the new SB ASU component:
-
- SB ASU Performance Test (Doc. No. TP330001)
-
- Electrical & Mechanical Safety Testing (according to IEC 60601-1)
-
- Electromagnetic Compatibility Testing (according to IEC 60601-1-2)
-
- Software Validation (according to IEC 60601-1-4 & FDA Guidelines)
7-4
{4}------------------------------------------------
Clinical Performance Data
Not Applicable
Conclusions Drawn from Non-Clinical and Clinical Tests:
The non-clinical tests demonstrated that the modified NaviAid™ ICVI device with the new SB ASU component meets its design and performance specifications. The NaviAid™ ICVI device may be safely and effectively used in procedures in order to ensure the positioning of a standard endoscope in endoscopy of the small intestine and reach depths of the intestine that may not otherwise be accessible with a standard endoscope device.
Substantial Equivalence:
In summary, the new SB ASU component is a direct derivative of the ASU component. The intended use, basic technology, principle of operation specifications and safety requirements are similar. The difference in the source of air flow does not raise any new questions of safety and effectiveness. Consequently, the SB ASU component is substantially equivalent to the ASU and therefore, the modified NaviAid™ ICVI device is substantially equivalent to the previously cleared NaviAid™ ICVI device.
Performance Standards:
The modified NaviAid™ ICVI device with the new SB ASU component has been retested and complies with the following voluntary recognized standards:
-
- Electrical & Mechanical Safety Testing (IEC 60601-1)
-
- Electromagnetic Compatibility Testing (IEC 60601-1-2)
-
- Software Validation (IEC 60601-1-4 & FDA Guidelines)
{5}------------------------------------------------
Image /page/5/Picture/0 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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Ms. Adva Yoselzon QA Manager and Director of Clinical & Regulatory Affairs Smart Medical Systems, Ltd. 10 Havetsira Str. Ra'anana 43663 ISRAEL
JUN 1 7 2011
Re: K110291
Trade/Device Name: NaviAid™ ICVI Device Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC Dated: May 19, 2011 Received: May 20, 2011
Dear Ms. Yoselzon:
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. 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
{6}------------------------------------------------
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,
Hubert Lenoir us
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
SECTION 6
INDICATIONS FOR USE STATEMENT
KII0291 510(k) Number (if known):
Device Name:
NaviAid™ ICVI Device
Indications for use:
The NaviAid™ ICVI device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope in the small intestine (i.e., an endoscope that has an instrument channel that is at least 3.7mm and is used for standard intestinal endoscopic visualization).
Prescription Use V Use (Per 21 C.F.R. 801 Subpart D) OR
Over-The-Counter
(Optional Format Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carlos Neuld for Herb herner, miD.
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K110291
§ 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.