K Number
K070330
Device Name
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM
Date Cleared
2007-04-24

(78 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.
Device Description
The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory. The system consists of both disposable portions, and facility equipment. The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope. The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eve Retroscope, the video output signals, and user input controls. The output video signals from the video processor are displayed on a monitor for viewing by the physician. Application software that runs on the video processor allows the user to adjust various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.
More Information

Not Found

No
The description focuses on the mechanical and electrical components of the device and the software's role in image display and basic adjustments. There is no mention of algorithms for image analysis, pattern recognition, or decision support that would typically indicate AI/ML.

No

The device is intended for diagnostic purposes (retrograde illumination and visualization), not for treating a disease or condition.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use...to provide retrograde illumination and visualization of the colon for diagnostic purposes."

No

The device description explicitly states that the system consists of both disposable portions (including the Retroscope with imaging sensor, light source, and circuitry) and facility equipment (including a video processor). This indicates the presence of significant hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is a medical device used during a colonoscopy procedure. It provides retrograde illumination and visualization within the colon. It does not analyze samples taken from the body.
  • Intended Use: The intended use is for "retrograde illumination and visualization of the colon for diagnostic purposes." This refers to the physician using the visual information provided by the device to make a diagnosis, not the device itself performing a diagnostic test on a sample.

Therefore, the device is an in vivo diagnostic tool (used within the living body) rather than an in vitro diagnostic tool.

N/A

Intended Use / Indications for Use

The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

Product codes

FDF, FCQ, KNW

Device Description

The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure.

After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope

The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory.

The system consists of both disposable portions, and facility equipment.

The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope.

The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the video processor are displayed on a monitor for viewing by the physician. Application software that runs on the video processor allows the user to adjust various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopic visualization

Anatomical Site

Colon

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physician

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)

in vitro bench testing

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K032177, K853585, K924106, K984358

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

0

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes extending from its body, representing health, human services, and well-being. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Avantis Medical System, Inc. Mr. Scott Rutherford Director of Regulatory and Quality Affairs 263 Santa Ana Ct. Sunnyvale, CA 94085

JUL 27 2015

Re. K070330

Trade/Device Name: Avantis Medical Systems, Inc. Third Eye™ Retroscope™ Auxiliary Endoscopy System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF, FDF, FCQ and KNW Dated (Date on orig SE ltr): April 5, 2007 Received (Date on orig SE ltr): April 6, 2007

Dear Mr. Rutherford,

This letter corrects our substantially equivalent letter of April 24, 2007.

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

1

Page 2 -

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 (reporting of medical device-related 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): _K070330

Device Name: Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System

Indications for Use:

The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Szymanski

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K070336

I vantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA. 94085 Tel: (408) 733-1901, FAX: (408) 733-1847

3

Колоззе

Section 1

APR 2 4 2007

Section 1: 510(k) Summary

This section is prepared in accordance with the requirements of 21 CFR 807.92.

Applicant Information:

Summary Date:February 2nd, 2007
Owners Name:Avantis Medical Systems, Inc
Address:263 Santa Ana Court
Sunnyvale, CA 94085
Phone:408-733-1901
Fax:408-733-1784
Contact Person:Scott Rutherford
Phone:408-733-1901 x227

Device Information:

Classification:Class II
Classification Name:Colonoscope, FDF / 21 CFR 876.1500
Trade Name:Third Eye™ Retroscope™ System
Common Name:Endoscope

Identification of Predicate Devices:

The Avantis Third Eye Retroscope is substantially equivalent in intended use and operation to a combination of predicate devices:

K032177Olympus Evis CF-140L/I/S Colonovideoscope (see note 1)
K853585Olympus Evis Video System Center CV-100 (see note 2)
K924106US Endoscopy, Disposable Biopsy Forceps, Colonoscope, and
fenestrated Oval cup with Spike and Sheath, part number
00711205
K984358Olympus Distal Attachment

Note 1 - No direct 510K was found for the CF-140L/V/S under FDF classification code. This product is currently available in the resale market. K032177 lists Olympus Colonoscope XCF-Q140ML/I in intended use which relates to the predicate CF-140L/S.

Note 2 - No direct 510 was found for the Evis Video Center CV-100. This product is currently available in the resale market under Olympus CV-100 Evis Video System Center. K853585 describes a full video system center for multiple modalities. The Third Eye Retroscope Video Processor indications are applicable to the colonoscopy section of the predicate video system center.

Avantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA 94085 Tel: (408) 733-1901, FAX: (408) 733-1847

4

Device Description Summary:

The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure.

After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope

The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory.

The system consists of both disposable portions, and facility equipment.

The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope.

The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eve Retroscope, the video output signals, and user input controls. The output video signals from the video processor are displayed on a monitor for viewing by the physician. Application software that runs on the video processor allows the user to adjust various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.

Intended Use:

រដ្ឋ

The Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

vantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA 94085 Tel: (408) 733-1901, FAX: (408) 733-1847

5

Comparison to Predicate Device

The Third Eye Retroscope Auxiliary Endoscopy System is intended to be used as an auxiliary imaging system for colonoscopes. The Third Eye Retroscope Auxiliary Endoscopy System is similar to the combination of listed predicate devices in indication for use, sterilization method, physician operation, materials, and safety.

The Third Eye Retroscope is inserted into the instrument channel of a colonoscope in a similar manner to the predicate biopsy forceps. Once in place, the Third Eye Retroscope is designed to provide images of the colon in a similar manner as the predicate colonoscope. However, the Third Eye Retroscope image provides a retrograde view of the colon whereas the colonoscone provides a forward view. The Third Eye Retroscope is controlled by the Third Eye Video Processor in a similar manner as a colonoscope is controlled by the predicate Video System Center.

Based on the intended use, descriptive information, and performance evaluation provide in this premarket notification, including in vitro bench testing, the Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System has been shown to be substantially equivalent to the currently marketed predicate devices.

vantis Medical Systems 263 Santa Ana Ct., Sunnyvale, CA 94085 Tel: (408) 733-1901, FAX: (408) 733-1847

6

The table below lists a summary of the predicate devices, and key similarities and differences:

Table 1-1 -- Comparison of Third Eye Retroscope Auxiliary Endoscopy System and Predicate Devices

| Avantis

ProductParameterPredicate Devices
Olympus Evis
CF-140L
Colono-
videoscopeOlympus Evis
Video System
Center
CV-100US Endoscopy,
Disposable Biopsy
Forceps
00711205Olympus Distal
Attachment
510K NumberK032177K853585K924106K984358
Third Eye
RetroscopeSimilarities:Indication for
Use,
Imaging
PerformanceDelivery method
into colon,
Sterility,
Single Patient Use
Size & shape
Differences from
predicate:Not steerable,
Less complex,
Auxiliary
deviceNot surgical
Includes electronics
Third Eye CapSimilarities:Attachment to
colonoscope,
Single Use,
Size & Shape
Differences from
predicate:Not Surgical
Third Eye
Video
ProcessorSimilarities:Indication for
Use,
Size & Shape,
performance
Differences from
predicate:No Light
Source,
Less Complex,
Split Screen
capability

Summary

Based on the intended use, descriptive information, and performance evaluation provided in this premarket notification, including in vitro bench testing, the Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System has been shown to be substantially equivalent to the currently marketed predicate devices.

Avantis Medical Systems
263 Santa Ana Ct., Sunnyvale, CA 94085
Tel: (408) 733-1901, FAX: (408) 733-1847