(108 days)
Not Found
No
The device description focuses on a mechanical attachment to the endoscope that physically manipulates tissue to improve visualization. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are also focused on mechanical and functional aspects.
No.
The device facilitates endoscopic therapy by improving visualization and maintaining view field depth, but it does not directly treat a condition or disease itself. Its function is to aid in diagnosis and assist other therapeutic procedures.
No
The device is described as facilitating endoscopic therapy and helping with visualization and insertion, not for making a diagnosis. Its function is to manipulate tissue and stabilize the endoscope, thereby aiding in examination, but it does not perform any diagnostic function itself (e.g., detecting, analyzing, or interpreting medical conditions).
No
The device is described as a physical, sterile, single-use, disposable medical device made of injection molded polymer, designed to be attached to the distal end of an endoscope. It has flexible wings and undergoes physical performance testing (force to remove, force to deflect) and sterilization validation, indicating it is a hardware device.
No, 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 described device, AmplifEYE, is a physical attachment for an endoscope. Its function is to physically manipulate the gastrointestinal tract to improve visualization during an endoscopic procedure. It does not analyze any biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use is to facilitate endoscopic therapy by improving visualization and aiding insertion. This is a procedural aid, not a diagnostic test.
- Device Description: The description focuses on the physical design and how it interacts with the anatomy during the procedure. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document lacks any information typically associated with IVDs, such as:
- Analysis of biological samples.
- Detection of biomarkers, pathogens, or other substances.
- Performance metrics like sensitivity, specificity, PPV, NPV (which are relevant to diagnostic accuracy).
- Training or test sets related to diagnostic data.
In summary, the AmplifEYE is a medical device used during a procedure to improve visualization, not a device that performs a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
Product codes
FED
Device Description
The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract, colon
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)
Medivators has conducted the following testing to demonstrate the safety and effectiveness of AmplifEYE:
- Design Verification
- Force to Remove Testing
- Force to Deflect Testing
- Animal Testing
- Shelf-life Validation
- Functional Testing
- Sterile Barrier Integrity Testing
- Sterilization Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Medivators, Inc. Kristin Bergeson Padilla Regulatory Affairs Associate 14605 28th Ave. North Minneapolis, MN 55447
K160846 Re: Trade/Device Name: AmplifEYE Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: June 10, 2016 Received: June 13, 2016
Dear Kristin Bergeson Padilla:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
as set forth in the quality systems (OS) 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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education 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,
Joyce M. Whang -S
for
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
510(k) Number (if known) K160846
Device Name
AmpliEYE
Indications for Use (Describe)
To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be used for the following:
- Keeping the suitable depth of endoscope's view field
- Helping the endoscope with being inserted into the gastrointestinal tract
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue capital letters. Below the company name is the text "A Cantel Medical Company" in a smaller blue font. The logo is simple and professional, with a focus on the company name.
Section 05 - 510(k) Summary
| Manufacturer: | Medivators Inc., a Cantel Medical Company |
|---|---|
| Address: | 3150 Pollok Drive |
| Conroe, TX 77303 | |
| (800) 328-3345 | |
| Official Contact: | Kristin Bergeson Padilla |
| Regulatory Affairs Associate, Medivators Inc. | |
| Trade Name: | AmplifEYE |
| Common Name: | Endoscopic Access Overtube, Gastroenterology-Urology |
| Classification Name: | Endoscope and accessories |
| Product Code: | FED |
| Device Class: | II |
| Regulation No: | 876.1500 |
Medivators Inc. has supplied the following information to the US Food and Drug Administration to support substantial equivalence of AmplifEYE to other endoscopic overtube visualization devices currently cleared for sale in the United States of America.
1. Intended Use
AmplifEYE is intended to be used to facilitate endoscopic therapy by keeping the suitable depth of the endoscope's view field and by helping the endoscope with being inserted into the gastrointestinal tract.
2. Device Description
The subject device is a sterile, single use, disposable medical device. It is designed to be placed on the distal end of an endoscope during endoscopic procedures to improve the physician's ability to visualize and examine the mucosa. AmplifEYE is made of injection molded polymer and consists of a main body tube with flexible wings arranged in a single row around one end of the main body tube. In a standard colonoscopy procedure, the endoscope is intubated through the rectum and advanced forward through the length of the colon. The endoscope is then retracted while the physician visually examines the colon mucosa for polyps or other abnormalities. The AmplifEYE wings fold down during intubation and movements that advance the endoscope forward so that forward movement is not hindered. During endoscope withdrawal, the wings open and fold outward to keep the depth of the endoscope's view field by manipulating the colonic folds and stabilizing the position of the endoscope within the intestinal lumen, thus aiding in the physician's ability to visualize and examine the mucosa.
3. Comparison to Other Devices in Commercial Distribution Within the United States
AmplifEYE is equivalent in function, intended use and scientific technology to its predicate devices, Arc EndoCuff cleared under 510(k) K122565 and Arc Endocuff Vision cleared under 510(k) K151801.
CONFIDENTIAL
4
Image /page/4/Picture/0 description: The image contains the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic with curved lines inside, followed by the word "MEDIVATORS" in a bold, sans-serif font, also in blue. Below the company name, there is a smaller line of text that reads "A Cantel Medical Company".
Similarities Between Subject and Predicate Devices
AmplifEYE and the predicate devices, Arc EndoCuff and Arc Endocuff Vision, have the same intended use, principle of operation and scientific technology. They are provided sterile and must be disposed of after a single use.
Differences Between Subject and Predicate Devices
The only notable differences between the subject device and the predicate devices are the method of sterilization and the open wings diameter. AmplifEYE is sterilized by ethylene oxide and the predicate devices, Arc EndoCuff and Arc Endocuff Vision, are sterilized by irradiation. The sterilization validation of AmplifEYE has demonstrated that the method of sterilization difference provides equivalent sterility assurance. AmplifEYE has an open wing diameter slightly greater than both of the predicate devices; however, bench testing and animal testing have demonstrated the open wing diameter difference results in equivalent performance and raises no questions of safety or efficacy.
A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below:
| Device | Subject Device - | Predicate Device - Arc | Predicate Device – Arc |
|---|---|---|---|
| Parameters | AmplifEYE | EndoCuff (K122565) | Endocuff Vision (K151801) |
| Trade Name | AmplifEYE | Arc EndoCuff AEC 110; | |
| AEC 120; AEC 140 | Arc Endocuff Vision | ||
| Regulation | |||
| Number | 876.1500 | 876.1500 | 876.1500 |
| Device Class | Class II | Class II | Class II |
| Certification | |||
| Panel | Gastroenterology/Urology | Gastroenterology/Urology | Gastroenterology/Urology |
| Product Code | FED | FED | FED |
| Indications for | To be attached to the distal | To be attached to the distal | To be attached to the distal |
| Use | end of the endoscope to | ||
| facilitate endoscopic therapy, | |||
| to be used for the following: | |||
| ● | |||
| Keeping the suitable | |||
| depth of endoscope's | |||
| view field | |||
| Helping the endoscope | |||
| ● | |||
| with being inserted into | |||
| the gastrointestinal tract | end of the endoscope to | ||
| facilitate endoscopic therapy, | |||
| to be used for the following: | |||
| Keeping the suitable | |||
| ● | |||
| depth of endoscope's | |||
| view field | |||
| Helping the endoscope | |||
| ● | |||
| with being inserted into | |||
| the gastrointestinal tract | end of the endoscope to | ||
| facilitate endoscopic therapy, | |||
| to be used for the following: | |||
| Keeping the suitable | |||
| ● | |||
| depth of endoscope's | |||
| view field | |||
| Helping the endoscope | |||
| ● | |||
| with being inserted into | |||
| the gastrointestinal tract | |||
| Single Use | Yes | Yes | Yes |
| Supplied | |||
| sterile | Yes | Yes | Yes |
| Method of | |||
| Sterilization | Ethylene Oxide | Irradiation | Irradiation |
Table 1 - Device Comparison Table
CONFIDENTIAL
5
Image /page/5/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, which is made up of several curved lines. To the right of the graphic is the word "MEDIVATORS" in a large, blue, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue.
| Direct/Indirect Patient Contact | Yes | Yes | Yes |
|---|---|---|---|
| Material | Polymer conforming to ISO 10993-1 for biocompatibility | Polymers conforming to USP class VI | Polymers |
| Dimensions | Length: 0.97" | ||
| Open wings diameter: 1.6" | |||
| Folded wings diameter: 0.7"-0.74" | Length: 0.94" | ||
| Open wings diameter: 1.27" | |||
| Folded wings diameter: 0.63"-0.74" | Length: 0.98" | ||
| Open wings diameter: 1.38" | |||
| Folded wings diameter: 0.59" |
4. Summary of Non-Clinical Performance Data
Medivators has conducted the following testing to demonstrate the safety and effectiveness of AmplifEYE:
- . Design Verification
- o Force to Remove Testing
- o Force to Deflect Testing
- Animal Testing ●
- Shelf-life Validation .
- Functional Testing o
- Sterile Barrier Integrity Testing O
- Sterilization Validation .
5. Conclusion
AmplifEYE is substantially equivalent to predicate devices Arc EndoCuff cleared under 510(k) K122565 and Arc Endocuff Vision cleared under 510(k) K151801. Based on the intended use, technological characteristics, performance data and nonclinical tests performed, the subject device AmplifEYE is substantially equivalent to and as effective as the legally marketed predicate devices.
CONFIDENTIAL