(133 days)
Not Found
No
The description focuses on the mechanical function of balloons and an air supply unit to facilitate endoscope advancement. There is no mention of AI, ML, or any computational analysis of data for decision-making or image processing beyond standard video imaging.
No.
The device is described as an accessory to an endoscope to facilitate its complete positioning in the small intestine, not for direct therapeutic intervention. While it enables the endoscope to reach depths for potential therapeutic procedures using the endoscope's working channel, the device itself is for guidance and positioning, not therapy.
No
The device is an accessory to an endoscope, designed to facilitate deeper access into the small intestine for visualization. It does not perform any diagnostic function itself, but rather aids in the performance of an endoscopic procedure.
No
The device description clearly outlines physical components including a disposable balloon system, an air supply control unit, balloons, tubes, clips, and silicon bands. While software is mentioned in the performance studies, the device itself is a hardware accessory to an endoscope.
Based on the provided information, the NaviAid™ BGE device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- NaviAid™ BGE Function: The NaviAid™ BGE is an accessory to an endoscope. Its primary function is to facilitate the physical advancement of the endoscope deeper into the small intestine. It aids in the procedure of visualization and potential intervention (like biopsy), but it does not analyze any biological specimens in vitro.
- Intended Use: The intended use clearly states it's for "ensuring complete positioning of a standard endoscope in the small intestine" for "standard intestinal endoscopic visualization." This is a procedural aid, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the mechanical function of the balloons and air supply unit to manipulate the endoscope's position within the body. There is no mention of analyzing or testing any biological material.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Measurement of biomarkers or analytes.
- Diagnostic interpretation of test results.
- Performance metrics like sensitivity, specificity, PPV, or NPV related to a diagnostic test.
The NaviAid™ BGE is a medical device used during an endoscopic procedure to improve access and visualization, which can then be used for diagnostic purposes (e.g., visual inspection, biopsy). However, the device itself is not performing the diagnostic test.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
KNT, FDA, KOG
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.
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 GBS anchoring location. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small intestine
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)
Clinical Performance Data: Not Applicable
Non-Clinical Performance Data: The following performance tests were conducted on the NaviAid™ BGE device:
- Electrical & Mechanical Safety Testing (IEC 60601-1)
- Electromagnetic Compatibility Testing (IEC 60601-1-2)
- Software Validation (IEC 60601-1-4 & FDA Guidelines)
- Biocompatibility Testing (ISO 10993)
- ASU Test
- Bond Strength Test
- Air Leakage Test
- Balloon Burst Pressure Test
- GBS Inflation Tube & Bending Radius Test
- Endoscope Flexibility & Insertion Test
- Components Degradation Test
- Endoscope Diameter Test
- GBS Inflation/Deflation Cycle Test
- ASU Connections
- Disposables Mounting Testing
- In-Vitro Validation Test
- Packaging Validation
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
A. STEIN – REGULATORY AFFAIRS CONSULTING
. .
Appendix E
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
NAVIAID™ BGE DEVICE
Page 1 of 5
510(k) Number K060923
Applicant's Name:
| Company name: | Smart Medical Systems Ltd. |
|---|---|
| Address: | 10 Hayetsira Str. |
| Ra'anana 43663 | |
| ISRAEL | |
| Tel.: | +972-9-7444478 |
| Fax: | +972-9-7444543 |
| e-mail: | gluria@smartmedsys.com |
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: | +972-9-7668534 |
| e-mail: | asteinra@netvision.net.il |
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
1
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A. STEIN - REGULATORY AFFAIRS CONSULTING
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.
2
Page 3 of 5
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
3
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A. STEIN - REGULATORY AFFAIRS CONSULTING
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:
-
Electrical & Mechanical Safety Testing (IEC 60601-1)
-
Electromagnetic Compatibility Testing (IEC 60601-1-2)
-
Software Validation (IEC 60601-1-4 & FDA Guidelines)
-
- Biocompatibility Testing (ISO 10993)
-
- ASU Test
-
- Bond Strength Test
-
- Air Leakage Test
-
- Balloon Burst Pressure Test
- GBS Inflation Tube & Bending Radius Test
-
- Endoscope Flexibility & Insertion Test
-
- Components Degradation Test
-
- Endoscope Diameter Test
-
- GBS Inflation/Deflation Cycle Test
-
- ASU Connections
-
- Disposables Mounting Testing
-
- In-Vitro Validation Test
-
- Packaging Validation
4
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A. STEIN - REGULATORY AFFAIRS CONSULTING
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:
-
- Electrical & Mechanical Safety Testing (IEC 60601-1)
-
- Electromagnetic Compatibility Testing (IEC 60601-1-2)
-
- Software Validation (IEC 60601-1-4 & FDA Guidelines)
-
- Biocompatibility Testing (ISO 10993)
5
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
6
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 (800) 638-2041 or (240) 276-3150
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
7
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)
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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