NAVIAID BGE DEVICE, MODEL 21-001

K060923 · Smart Medical Systems , Ltd. · FDA · Aug 15, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060923
• Device Name: NAVIAID BGE DEVICE, MODEL 21-001
• Applicant: Smart Medical Systems , Ltd.
• Product Code: FDA · Gastroenterology, Urology
• Decision Date: Aug 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The NaviAid™ BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization).

Device Story

NaviAid BGE is a disposable accessory kit for standard endoscopes to facilitate deep small intestine access. System includes two balloons (Guiding Balloon for Small Intestine and Stabilizing Balloon) and an Air Supply Unit (ASU). ASU controls balloon inflation/deflation via foot-pedals. Balloons attach to endoscope via clips/silicon bands. Procedure involves alternating inflation/deflation of balloons to anchor endoscope and advance it deeper into the intestine, effectively 'pleating' the intestine onto the endoscope. Used in clinical settings by physicians. Provides real-time video imaging and allows use of standard endoscopic tools (biopsy forceps, snares). Benefits include reaching intestinal depths otherwise inaccessible with standard endoscopes while maintaining standard endoscopic advantages.

Clinical Evidence

No clinical data. Evidence based on non-clinical bench testing including electrical/mechanical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993), software validation, and various mechanical performance tests (balloon burst, air leakage, bond strength, in-vitro validation).

Technological Characteristics

Disposable balloon system (Guiding Balloon, Stabilizing Balloon) and reusable Air Supply Unit. Materials: silicone bands, plastic tubing. Connectivity: foot-pedal interface. Sterilization: non-sterile. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993 (biocompatibility), IEC 60601-1-4 (software).

Indications for Use

Indicated for patients requiring deep small intestine endoscopic visualization using a standard 10-13 mm diameter endoscope.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Double Balloon Enteroscopy System (K040048)

Submission Summary (Full Text)

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**Appendix E**

# 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

NAVIAID™ BGE DEVICE

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## 510(k) Number K060923

## Applicant's Name:

| Company name: | Smart Medical Systems Ltd. |
|---------------|----------------------------|
| Address: | 10 Hayetsira Str. |
| | Ra'anana 43663 |
| | ISRAEL |
| Tel.: | [phone] |
| Fax: | [phone] |
| e-mail: | [e-mail] |

### Contact Person:

| Official Correspondent: Ahava Stein | |
|-------------------------------------|------------------------------------------|
| Company name: | A. Stein – Regulatory Affairs Consulting |
| Address: | Beit Hapaamon (Suite 213) |
| | 20 Hata'as Str. (Box 124) |
| | Kfar Saba 44425 |
| | ISRAEL |
| Tel: | + 972-9-7670002 |
| Fax: | [phone] |
| e-mail: | [e-mail] |

## Name of the device:

NaviAid™ BGE device

## Trade or proprietary name, if applicable:

NaviAid™ BGE device

## Common or usual name:

Balloon Guided Endoscope Accessory Device or Balloon Guided Endoscopy Accessory Device

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Appendix E

#### Establishment Registration No .:

Establishment registration form (Form FDA 2891) has been submitted but no registration number has been assigned yet.

#### Classification Name:

Gastrointestinal Tubes (and accessories)

### Classification:

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

#### Predicate Device:

The NaviAid™ BGE device is substantially equivalent to the Double Balloon Enteroscopy System (manufactured by Fujinon Inc. and the subject of 510(k) document no. K040048). A comparison table and detailed discussion are presented in Section 12 of this application.

#### Device Description:

The NaviAid™ BGE affords deep access into the small 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, working channel including biopsy and treatment.

The NaviAid™ Balloon Guided Endoscopy (BGE) system comprises an accessory kit containing the disposable balloon system and an air supply control unit for inflating and deflating the balloon system. The role of the Balloon Guided Endoscopy (BGE) disposable accessory kit is to facilitate advancement of a standard endoscope deeper into the small intestine. The NaviAid™ BGE system "upgrades" standard endoscopes to a double balloon endoscopy system. The NaviAid™ BGE accessory kit includes two balloons - the Guiding Balloon for Small Intestine ("GBS") and the Stabilizing Balloon ("SB"). Both balloons are inflated by ambient air. The Air Supply Unit ("ASU") operates and controls the inflation and deflation of the two balloons through two foot-pedals. Each balloon is connected to a dedicated tube that runs along the endoscope, and is connected at its proximal (user) end to the ASU. The balloon tubes are attached to the endoscope with clips and silicon bands.

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The NaviAid™ BGE accessory kit is mounted (deflated) on the tip of the endoscope, and is inserted with the endoscope into the gastrointestinal tract of the patient. The SB is the proximal balloon that is used to anchor the endoscope (near its tip) to the intestinal wall. The GBS is the distal balloon that can be advanced ahead of the endoscope tip or pulled back through pushing/pulling action on the GBS inflation tube at its proximal side, outside the patient body. When the GBS balloon is advanced and then inflated, it functions as a distal anchor, to which the endoscope tip (now with a deflated balloon) is advanced, and the GBS inflation tube serves as a "guidewire" that leads the endoscope as it is pushed towards the anchoring GBS balloon. The sequence of inflation and deflation of the balloons enables "pleating the small intestine on to the endoscope" or forming a rail on which the endoscope can be guided and advanced towards the GBS anchoring location.

The balloons and tubes do not compromise the endoscope's flexibility, although its field of view may be reduced by up to 8%. Additionally, the balloons do not significantly compromise the maneuverability of the endoscope's tip and do not limit the usage of any standard endoscopy tools, such as biopsy forceps, snare, needle etc.

The NaviAid BGE accessory kit is disposable and intended for single use, while the ASU is re-usable.

### Intended Use / Indication for Use:

The NaviAid™ BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization).

## Comparison of Technological Characteristics with the predicate device:

The BGE device is similar to the Fujinon Double Balloon Endoscopy System regarding intended use and regarding the technological characteristics of the device.

Both the NaviAid™ BGE device and the Fujinon System are intended to facilitate penetration of standard endoscopes deep into the small 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, working channel including biopsy and treatment. Both devices are based on the same basic principles of operation, that is, utilization of specialized double balloons based on an endoscopy system, that are alternately inflated and deflated in order to progress the endoscope and ensure complete positioning of the endoscope in the small intestine.

The devices both include the same basic components for achieving complete positioning of the endoscope in the small intestine, including an air supply unit & control pump and a double balloon system for advancing the endoscope. Although, in the Fujinon system one balloon is an integral part of the endoscope device (though it is disposable and replaced

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Appendix E

after every procedure) and the second balloon is positioned on an overtube, whereas, in the NaviAid™ BGE device both balloons are separate components not connected to the endoscope, thus enabling use of the device with any standard endoscope.

The balloon pressure specifications are also similar, as are the outer diameter of the fully inflated portion of the balloon. The working length of the systems is slightly different; the working length of the Fujinon System is 1,350 mm, whereas the working length of the NaviAid™ BGE device depends on the endoscope device and is typically 2,200 mm. Both devices are supplied non-sterile, for single use only.

The patient contact materials and accessories provided with the device are different. The Fujinon system is supplied with endoscopy accessories such as a light source, biopsy forceps, etc., whereas the NaviAid" BGE device is obviously not supplied with these accessories, as such accessories are supplied with the user supplied endoscope. Similar accessories include a foot pedal for additional control of the inflation/deflation sequencing. The NaviAid™ BGE device is also supplied with additional accessories to facilitate connecting the BGE disposable balloon system to the endoscope device (e.g. silicone bands and o-ring).

Both the NaviAid™ BGE device and the Fujinon 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 following performance tests were conducted on the NaviAid™ BGE device:

1. Electrical & Mechanical Safety Testing (IEC 60601-1)

2. Electromagnetic Compatibility Testing (IEC 60601-1-2)

3. Software Validation (IEC 60601-1-4 & FDA Guidelines)

- 4. Biocompatibility Testing (ISO 10993)
- 5. ASU Test
- 6. Bond Strength Test
- 7. Air Leakage Test
- 8. Balloon Burst Pressure Test

9. GBS Inflation Tube & Bending Radius Test

- 10. Endoscope Flexibility & Insertion Test
- 11. Components Degradation Test
- 12. Endoscope Diameter Test
- 13. GBS Inflation/Deflation Cycle Test
- 14. ASU Connections
- 15. Disposables Mounting Testing
- 16. In-Vitro Validation Test
- 17. Packaging Validation

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Appendix E

### Clinical Performance Data

Not Applicable

## Conclusions Drawn from Non-Clinical and Clinical Tests:

The non-clinical tests demonstrated that the NaviAid™ BGE device meets its design and performance specifications. Furthermore, the tests showed that the NaviAid™ BGE device is easy to use and user friendly and does not cause damage to the intestine.

The NaviAid™ BGE device may be safely and effectively used in Balloon Guided Endoscopy procedures in order to reach depths of the intestine that may not otherwise be accessible with a standard endoscope device.

## Substantial Equivalence:

In summary, the intended use and principle of operation of the NaviAid™ BGE device and the Fujinon Double Balloon Endoscopy System are the same. Furthermore, the basic technological characteristics of the devices, including basic components, design, specifications and safety requirements, are similar. The differences in the technological characteristics do not raise new questions of safety and effectiveness. Consequently, the NaviAid™ BGE device is substantially equivalent to the Fujinon Double Balloon Endoscopy System.

## Performance Standards:

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

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

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 5 2006

Smart Medical Technologies, Ltd. % Ms. Ahava Stein Regulatory Affairs Consultant Regulatory Affairs Consulting Beit Hapa'amon (Box 124) 20 Hata'as St., 44425 Kfar Saba ISRAEL

Re: K060923

Trade/Device Name: NaviAid™ BGE Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDA and KOG Dated: August 4, 2006 Received: August 8, 2006

#### Dear Ms. Stein:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/5/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a smaller font. There are three small stars below the word "Centennial". The logo is surrounded by a thick black border.

Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

| 510(k) Number (if known): | K060923 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | NaviAid ^TM BGE Device |
| Indications for use: | The NaviAid ^TM BGE device is an accessory to an endoscope and is intended to ensure complete positioning of a standard endoscope in the small intestine (i.e., an endoscope that is 10-13 mm in diameter and is used for standard intestinal endoscopic visualization). |

V Prescription Use (Per 21 C.F.R. 801 Subpart D) OR

Over-The-Counter Use (Optional Format Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy L. Brogdon
(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devic 510(k) Number_

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