The NaviAid™ BGC device is an accessory to an endoscope and is intended to ensure positioning of a standard endoscope during endoscopy of the small and large intestine (standard endoscope-i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization).

Device Description

The NaviAid™ BGC Disposable is an on-demand disposable that is inserted through the instrument channel of the endoscope in order to ensure positioning of a standard endoscope during endoscopy of the large or small intestine (standard endoscope - i.e., an endoscope that has an instrument channel that is at least 3.7mm diameter and is used for standard endoscopic visualization). The NaviAid™ BGC system comprises a disposable balloon system and an Air Supply Unit for inflating and deflating the balloon system. The role of the BGC disposable is to facilitate advancement of a standard endoscope into the large and/or small intestine. The NaviAid™ BGC Disposable includes the BGC Balloon and the BGC inflation tube. The balloon is inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the balloon through a footpedal. 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. The BGC balloon can be advanced ahead of the endoscope tip or pulled back by pushing/pulling action on the BGC inflation tube at its proximal side, outside the patient's body. When the BGC balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip is advanced, and the BGC inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring BGC balloon.

AI/ML Overview

The NaviAid™ BGC device is designed as an accessory to an endoscope to facilitate its positioning in the small and large intestine. The device's performance was evaluated through a series of non-clinical tests to demonstrate its conformance to design specifications and safety requirements.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit from Test Type)	Reported Device Performance (as stated in the document)
BGC Handle and Instrument Channel Compatibility	Ensure proper fit and function within various endoscope instrument channels.	Device meets design and performance specifications, easy to use, does not cause damage to the endoscope.
BGC Air Leakage	Maintain integrity of the balloon system and prevent air leaks during inflation.	Device meets design and performance specifications.
BGC Bending Radius	Maintain flexibility and maneuverability of the device within the endoscope.	Device meets design and performance specifications, negligibly compromises endoscope's flexibility.
Endoscope Flexibility	Not significantly impede the endoscope's flexibility and maneuverability.	Device meets design and performance specifications, negligibly compromises endoscope's flexibility or tip maneuverability.
BGC Assembly Degradation Test	Demonstrate durability and integrity of the device components over its intended single use.	Device meets design and performance specifications.
BGC Inflation/Deflation Test	Ensure reliable and controlled inflation and deflation of the balloon.	Device meets design and performance specifications.
BGC In-Vitro Validation Test	Verify the anchoring and advancement mechanism of the balloon in a simulated environment.	Device meets design and performance specifications, easy to use, does not cause damage to the intestine.
Packaging Validation (ISO 111607)	Maintain sterility and integrity during storage and transport (for non-sterile components).	Device meets design and performance specifications. (Note: Device is supplied non-sterile.)
BGC Balloon (Material and Design)	Demonstrate suitability of balloon material and design for intended use.	Device meets design and performance specifications.
Component Bond Strength	Ensure robust attachment of device components.	Device meets design and performance specifications.
BGC Balloon Cover	Ensure proper function and protection of the balloon.	Device meets design and performance specifications.
Electrical & Mechanical Safety Testing (IEC 60601-1)	Compliance with international standards for electrical and mechanical safety.	Complies with voluntary recognized standards.
Electromagnetic Compatibility Testing (IEC 60601-1-2)	Compliance with international standards for electromagnetic compatibility.	Complies with voluntary recognized standards.
Software Validation (IEC 60601-1-4 & FDA Guidelines)	Ensure software functionality and safety (for the Air Supply Unit).	Complies with voluntary recognized standards.
Biocompatibility Testing (ISO 10993)	Ensure patient contact materials are biocompatible.	All patient contact materials comply with biocompatibility testing and voluntary recognized standards.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states "Clinical Performance Data: Not Applicable." Therefore, there was no test set involving human subjects. The performance evaluations were conducted through non-clinical, in-vitro testing. The data provenance is internal to Smart Medical Systems Ltd., Israel, as all listed test document numbers appear to be internal company documents (e.g., Doc. No. TP310001).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as no clinical test set with human subjects requiring expert ground truth establishment was conducted. The non-clinical tests would have been evaluated against engineering and design specifications by internal company engineers and quality assurance personnel.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted. The document states "Clinical Performance Data: Not Applicable."

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Since this is a mechanical accessory device, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply in the typical AI context. The device itself is designed as an accessory to be used with a human-operated endoscope. Its performance was evaluated in terms of its mechanical, electrical, and material properties. The non-clinical tests listed serve as the "standalone" performance evaluation of the device's technical specifications and safety attributes independent of clinical human performance outcomes.

7. Type of Ground Truth Used

For the non-clinical tests, the ground truth was established by adherence to:

Engineering and Design Specifications: Each test (e.g., BGC Air Leakage, Component Bond Strength) would have specific quantitative or qualitative criteria defined during the device's design phase.
International Standards: Compliance with recognized standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and ISO 10993 served as the ground truth for safety, electrical, mechanical, software, and biocompatibility aspects.
Simulated Conditions: The "BGC In-Vitro Validation Test" implies testing in a simulated environment to assess the device's functional performance in a context mimicking its intended use.

8. Sample Size for the Training Set

Not applicable. The NaviAid™ BGC device is a mechanical accessory, not an AI or machine learning algorithm, and therefore does not have a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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SECTION 5 - 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

NaviAid™ BGC device

DEC 3 0 2010

510(k) Number K_10 a 6 / 6 / 6 / 26

Jeg 1 of 7

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 43663
	ISRAEL
Tel.:	+972-9-7444478
Fax:	+972-9-7444543
e-mail:	ayoselzon@smartmedsys.com

Name of the device:

NaviAid™ BGC device

Trade or proprietary name, if applicable:

NaviAid™ BGC device

Common or usual name:

Balloon Guided Colonoscopy Device

Establishment Registration No.:

3005261802

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K102616
pg 2 of 7

Classification Name:

Endoscope and accessories

Classification:

FDA has classified Endoscope and accessories devices as a Class II medical device, with product code KOG and 21 CFR classification code 876.1500. Review by the Gastroenterology/Urology Devices Panel.

Predicate Device:

The NaviAid™ BGC device is substantially equivalent to the NaviAid™ ICVI device (manufactured by Smart Medical Systems Ltd. and the subject of 510(k) document no. K101191) and the Double Balloon Colonoscope (manufactured by Fujinon and the subject of 510(k) document no. K090116). A comparison table and detailed discussion are presented in Section 12 of this application.

Device Description:

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as a "guide wire" that leads the endoscope as it is pushed towards the anchoring BGC balloon.

The balloon and tube negligibly compromise the endoscope's flexibility, or its field of view. Additionally, the BGC 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. The BGC disposable can be pulled back at any time during the procedure in order to allow use of therapy tools.

The NaviAid™ BGC disposable is intended for single use, while the ASU is re-usable.

Intended Use / Indication for Use:

Comparison of Technological Characteristics with the predicate device:

a. Comparison between the NaviAid™ BGC device and the NaviAid™ ICVI device

The NaviAid™ BGC device is similar to the NaviAid™ ICVI device regarding the intended use, technological characteristics, principle of operation, specifications, materials and safety requirements of the device.

Both the NaviAid™ BGC device and the NaviAid™ ICVI device are intended to ensure positioning of standard endoscopes in the intestine, while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, instrument channel including biopsy and treatment. During both the NaviAid™ BGC procedure and the NaviAid™ ICVI procedure the disposables can be removed from the instrument channel of the endoscope and a therapy tool may inserted instead. The NaviAid™ BGC device is intended for the large and small intestine while the NaviAid™ ICVI device is intended for the small intestine.

The NaviAid™ BGC includes a single balloon; similarly to the NaviAid™ ICVI balloon. The balloon traverses ahead of the endoscope through the endoscope's instrument

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channel, thus it can be applied on demand and there is no need for a pre-procedure preparation of the device. The utilization of the BGC balloon and the ICVI balloon is the same and their characteristics are similar. They are both designed to anchor the intestine at similar pressure and be maneuvered manually in a similar form.

Both the NaviAid™ BGC and the NaviAid™ ICVI utilizes specialized single balloon system used with standard endoscopy system (standard endoscope i.e. an endoscope that is used for the intestinal visualization and has an instrument channel that is at least 3.7mm diameter).

Both the ICVI balloon BGC Balloon can be advanced ahead of the endoscope tip or pulled back by pushing/pulling action on the inflation tube at its proximal side, outside the patient's body. When the balloon is advanced and then inflated, it functions as a distal anchor, towards which the endoscope tip is advanced, and the inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring balloon.

Both the BGC Disposable and the ICVI Disposable are supplied non-sterile, for single use only and is supplied in a Tyvek pouch.

All patient contact materials comply with biocompatibility testing.

The NaviAid™ ASU is identical in both the BGC device and the NaviAid™ ICVI device and complies with the electrical and mechanical safety testing requirements and the electromagnetic compatibility testing requirements for electronic medical devices.

b. Comparison between the NaviAid™ BGC device and the Double Balloon Colonoscope

The NaviAid™ BGC device is similar to the Double Balloon Colonoscope regarding the intended use, technological characteristics, principle of operation and safety requirements.

Both the NaviAid™ BGC device and the Double Balloon Colonoscope are intended to facilitate positioning of an endoscope in the intestine while maintaining all the advantages of an endoscopic procedure, such as back-and-forth navigation, stopping propagation if needed, real-time operation, video imaging, instrument channel including biopsy and treatment. During the NaviAid™ BGC procedure the NaviAid™ BGC

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K1026/G

Pg 5 of 7

disposable can be removed from the instrument channel of the endoscope and a therapy tool may inserted instead. The Double Balloon Colonoscope's instrument channel may be used for the insertion of a therapy tool during the procedure.

Both devices include similar components for achieving positioning of the endoscope in the intestine, including an Air Supply Unit / Air Pump and a balloon system for advancing the endoscope. In both devices the balloon system utilizes an endoscope and is controlled by the balloon pump. The pump controls inflation and deflation of the balloon system.

The Fujinon Double Balloon Colonoscope System features two balloons, one attached to the distal end of the endoscope and the other attached to a tube sliding over the Colonoscope (an over-tube). The balloon and over-tube are mounted on the endoscope prior to the Double Balloon Colonoscopy procedure. When inflated with air, the balloons anchor onto the intestine and facilitate the advancement of the endoscope deeper into the intestine. The NaviAid ™ BGC device features a single balloon system. The balloon traverses ahead of the endoscope through the endoscope's instrument channel, thus it can be applied on demand and there is no need for a pre-procedure mounting and preparation of the device. Similarly to the Double Balloon Colonoscope, when inflated with air, the NaviAid™ BGC balloon anchors onto the intestine and facilitates advancement of the endoscope deeper into the intestine.

The NaviAid™ BGC utilizes specialized single balloon used with standard endoscopy system (standard endoscope-i.e. an endoscope that is used for intestinal visualization and has an instrument channel that is at least 3.7mm diameter). The balloon can be moved back and forth ahead of the endoscope tip by pushing/pulling action on the inflation tube at its proximal side, outside the patient's body. When the balloon is advanced and then inflated, it functions as a distal anchor, towards which the endoscope tip is advanced, and the inflation tube serves as a "guide wire" that leads the endoscope as it is pushed towards the anchoring balloon.

The air supply unit and control pump are much the same with similar dimensions, weight, electrical input and indicators.

The BGC Disposable is supplied non-sterile, for single use only and is supplied in a Tyvek pouch. The Fujinon Double Balloon Colonoscope System disposable components are supplied sterile.

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K102616
pg 6 of 7

All patient contact materials comply with biocompatibility testing

Both the NaviAid™ BGC device and the Fujinon Double Balloon Colonoscope System comply with the electrical and mechanical safety testing requirements and the electromagnetic compatibility testing requirements for electronic medical devices.

Non-Clinical Performance Data

The performance tests include testing of the NaviAid™ BGC Device. The following performance tests were conducted on the NaviAid™ BGC device:

1. BGC Handle and Instrument Channel Compatibility (Doc. No. TP310001)
1. BGC Air Leakage (Doc. No. TP310003)
1. BGC Bending Radius (Doc. No. TP310005)
1. Endoscope Flexibility (Doc. No. TP310006)
1. BGC Assembly Degradation Test (Doc. No. TP310007)
1. BGC Inflation/Deflation Test (Doc. No. TP310009)
1. BGC In-Vitro Validation Test (Doc. No. TP310014)
1. Packaging Validation (ISO 111607/Doc. No. TP310015)
1. BGC Balloon (Doc. No. TP310019)
1. Component Bond Strength (Doc. No. TP320034)
1. BGC Balloon Cover (Doc. No. TP310077)

Clinical Performance Data

Not Applicable

Conclusions Drawn from Non-Clinical and Clinical Tests:

The non-clinical tests demonstrated that the NaviAid™ BGC device meets its design and performance specifications. Furthermore, the tests showed that the NaviAid™ BGC device is easy to use and does not cause damage to the intestine or to the endoscope. The NaviAid™ BGC device may be safely and effectively used in procedures in order to ensure positioning of a standard endoscope into the small and large intestine.

Clinical Performance Data

Not Applicable

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K 10 26 16

pg 7 of 7

Substantial Equivalence:

In summary, the NaviAid™ BGC Device is a similar to both the NaviAid™ ICVI device and the Double Balloon Colonoscope in intended use, basic technology, principle of operation and safety requirements. The minor differences in specifications do not raise new questions of safety and effectiveness. Consequently, the NaviAid™ BGC device is substantially equivalent to the NaviAid™ ICVI Device and to Double Balloon Colonoscope and no new questions of safety and effectiveness are raised.

Performance Standards:

The NaviAid™ BGC device complies with the voluntary recognized standards:

1. Electrical & Mechanical Safety Testing (IEC 60601-1)
1. Electromagnetic Compatibility Testing (IEC 60601-1-2)
1. Software Validation (IEC 60601-1-4 & FDA Guidelines)
1. Biocompatibility Testing (ISO 10993)

Note: Though the Air Supply Unit (ASU) is identical for both the NaviAid™ BGC and the NaviAid™ ICVI, and performance tests relating to standards 1-2 listed above are described is K101191 of the NaviAid™ ICVI , for the reviewer's convenience the performance tests relating to standards 1-2 listed above are described in detail again in section 17 of this 510(k).

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure. The logo is presented in black and white.

Food and Drug Administration l 0903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Adva Yoselzon Director of Regulatory and Clinical Affairs SMART® Medical Systems Ltd. 10 Hayetsira St. Ra'anana 43663 ISRAEL

DEC 30 2010

Re: K102616 Trade/Device Name: NaviAid™ BGC Device Regulation Number: 21 CFR 8876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: December 2, 2010 Received: December 8, 2010

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

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Page 2

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/CDRHQffices/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,

Huker Lemur MD

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

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INDICATIONS FOR USE STATEMENT SECTION 4

510(k) Number (if known):

Device Name:

NaviAid™ BGC Device

Indications for use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ 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)

Shafigh Khor

ﺰﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K102616

4-1

Regulation Number and Section

§ 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.