(83 days)
No.
The document indicates that the device's primary function is visualization and video output, explicitly stating that it "Mentions AI, DNN, or ML: Not Found" and "Mentions image processing: Not Found". These details strongly suggest the absence of an AI model within this specific device.
Yes
The device is intended for the "endoscopic treatment of the esophagus, stomach, and duodenal bulb," indicating a therapeutic purpose in addition to diagnosis and observation.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for the visualization of the upper digestive tract... specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb." It also mentions "endoscopic diagnosis" in the context of the EvoEndo Controller.
No
The device is a physical gastroscope with hardware components like a handle, umbilical bundle, and HD camera, and the description includes physical performance testing of these components (e.g., tip deflection, air/water/suction flow, optical performance). This clearly indicates it is a hardware medical device, not software-only.
No.
The device is for visualization, diagnosis, and endoscopic treatment of the upper digestive tract, which involves direct observation of anatomy, not in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single‐use device and can be inserted orally or transnasally.
The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.
Product codes
FDS, FET
Device Description
The EvoEndo Endoscopy System is comprised of two regulated components:
- EvoEndo Model LE Single‐Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
- EvoEndo Controller (hereafter referred to as the Controller)
The EvoEndo Endoscope is a sterile, single‐use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:
- Handle
- Umbilical Bundle that includes air, water, and suction lines, as well as the video connector
- Endoscope shaft with HD Camera
The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper digestive tract (esophagus, stomach, and duodenal bulb)
Indicated Patient Age Range
adults and pediatric patients
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
This submission is specific to the indication extension. There are no changes to the design of the device as compared to K213606. No testing was performed specific to this submission. Please refer to K213606 for performance testing associated with this device.
To support the removal of "in patients 5 years and above" from the indication a clinical literature search was conducted.
Clinical Testing: Published literature was evaluated for the safety of endoscopy procedures in patients under 5 years as well as review anatomical considerations of using the EvoEndo Endoscopy system in the smaller patient population. A risk/benefit evaluation was also completed. The evaluation supported the removal of the specific age of 5 years and above.
Summary of Previous Biocompatibility Testing: Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material‐ mediated pyrogenicity testing was performed per ISO 10993‐1 and the FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993‐1, 'Biological evaluation of medical devices ‐ Part 1: Evaluation and testing within a risk management process.'" There were no cytotoxicity, sensitization, irritation, acute systemic toxicity, or material‐mediated pyrogenicity concerns associated with the EvoEndo Endoscopy System.
Summary of Previous Non‐Clinical Functional and Performance Testing: Visual, dimensional, functional, and transit simulation verification testing was performed on final sterilized EvoEndo Endoscopes. In functional testing, devices were verified for camera and video control unit functioning; tip deflection; air, water, and suction flow rates; functionality with accessory device; functionality after 360° bend shaft orientation; functionality with simulated repeated use; and post simulated use functionality. The maximum bending angle of the device in each direction is shown in the table below. The deflection achieved with the EvoEndo Endoscope is consistent with that of the identified predicate device in all directions, indicating substantial equivalence.
Table 3: Deflection of EvoEndo Endoscope
| Deflection Direction | Maximum Bending Angle |
|---|---|
| Up | 210° |
| Down | 90° |
| Left | 100° |
| Right | 100° |
In transit simulation testing, test units underwent environmental conditioning, distribution simulation, and packaging testing to confirm the integrity of the sterile barrier and functionality of the device under expected transportation conditions. The EvoEndo Endoscopy System met acceptance criteria set for all verification testing procedures.
Optical performance testing was performed on the EvoEndo Endoscope and compared to the predicate device. The testing evaluated the resolution, depth of field, geometric distortion, image intensity uniformity, and color performance of the endoscope. The test results suggest equivalent performance across all metrics assessed, demonstrating substantial equivalence between the EvoEndo Endoscope and the predicate device.
Photobiological safety testing was performed per FDA recognized consensus standard IEC/TR 62471 First Edition 2006‐07: Photobiological safety of lamps and lamp systems. Based on the measured output of the EvoEndo's light source, it was deemed to be below the limits of the exempt risk group.
Summary of Previous Human Factors / Usability Engineering Testing: EvoEndo conducted a two‐stage usability study of representative intended users. The study assessed the overall usability of the EvoEndo Endoscopy System and the ability for users to perform critical tasks. Participants were asked to perform the entire workflow of the device across a benchtop model session and a representative animal model session with prior training provided. Tests were performed in a simulated clinic‐office setting. Throughout the procedure, there were no significant device or user malfunctions or errors that would result in patient harm during an actual procedure.
Summary of Previous Animal and Clinical Data: Animal testing was not required for this device.
Key Metrics
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.
FDA 510(k) Clearance Letter - EvoEndo Single-Use Endoscopy System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 16, 2025
EvoEndo, Inc.
℅ Keira Jessop
Regulatory Affairs Consultant
AlvaMed, Inc.
935 Great Plain Avenue
Unit 166
Needham, Massachusetts 02492
Re: K250900
Trade/Device Name: EvoEndo Single-Use Endoscopy System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: Class II
Product Code: FDS, FET
Dated: March 24, 2025
Received: March 25, 2025
Dear Keira Jessop:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K250900 - Keira Jessop
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
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K250900 - Keira Jessop
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
SIVAKAMI VENKATACHALAM -S
for
Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250900
Device Name: EvoEndo Single-Use Endoscopy System
Indications for Use (Describe)
The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single-use device and can be inserted orally or transnasally.
The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.
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."
Page 5
K250900
Page 1 of 7
510(k) Summary
K250900
1.1 Name and Address of Submitter
Paul Imaoka
EvoEndo, Inc.
888 East Belvidere Road
Suite 212
Grayslake, IL 60030
(303) 223‐7445
pimaoka@evoendo.com
1.2 Correspondent/Primary Contact Person
Keira Jessop, M.S., RAC
Regulatory Affairs Consultant
AlvaMed, Inc.
935 Great Plain Avenue, Unit 166
Needham, MA 02492 USA
kjessop@alvamed.com
Phone: +1 (888) 331‐3485 Fax: +1 (617) 249‐0955
1.3 Submission Information
Date Summary Prepared: May 7, 2025
Subject Device:
- Trade/Device Name: EvoEndo Single‐Use Endoscopy System
- Manufacturer: EvoEndo, Inc.
- Common Name: Gastroscope and accessories, flexible/rigid Endoscopic video imaging system/ Component, Gastroenterology‐Urology
- Regulation Number: 21 CFR 876.1500
- Regulation Name: Endoscope and accessories
- Regulation Class: Class II
- Product Code: FDS, FET
- Review Panel: Gastroenterology/Urology
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K250900
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Predicate Device:
- Clearance: K213606
- Trade/Device Name: EvoEndo Single‐Use Endoscopy System
- Manufacturer: EvoEndo, Inc.
- Regulation Number: 21 CFR 876.1500
- Regulation Name: Endoscope and accessories
- Regulation Class: Class II
Valid Predicate Discussion
EvoEndo Single‐Use Endoscopy System was selected as the valid predicate device used to support the 510(k) submission because it was cleared using well‐established methods and this submission is to extend the indicated age from the previously submitted device. The only differences between the subject and predicate device are the indicated age and the shelf life. After conducting a search on the Manufacturer and User Facility Device Experience (MAUDE) Database, Medical Device Reporting (MDR), MedSun Reports Database, Medical Device Safety and CBER Safety & Availability (Biologics) and Recall Database websites it was confirmed that there are no known unmitigated use‐related or design safety issues and the predicate device has not been subject to a design‐related recall.
Table 1: Valid Predicate Device
| Valid Predicate Device | A - Well established methods | B - Meets or exceeds expected predicate performance | C - Unmitigated use‐related or design‐related safety issues | D – Associated design‐related recall |
|---|---|---|---|---|
| EvoEndo Single‐Use Endoscopy System | Used relevant methods that were published in the public domain. | History of Safe use, established due to duration of device on the market | No known unmitigated use‐related or design related safety issues | No design‐ related recall identified |
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1.4 Device Description
The EvoEndo Endoscopy System is comprised of two regulated components:
- EvoEndo Model LE Single‐Use Gastroscope (hereafter referred to as the EvoEndo Endoscope)
- EvoEndo Controller (hereafter referred to as the Controller)
The EvoEndo Endoscope is a sterile, single‐use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of:
- Handle
- Umbilical Bundle that includes air, water, and suction lines, as well as the video connector
- Endoscope shaft with HD Camera
The Controller of the EvoEndo Endoscopy System translates the images or video captured by the camera at the distal end of the EvoEndo Endoscope to a monitor via an HDMI cable.
1.5 Indications for Use
The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single‐use device and can be inserted orally or transnasally.
The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.
1.6 Summary of Technological Characteristics
The following table provides an overview of general technological characteristics in comparison to the predicate device.
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Table 2: Comparison of Predicate Device and Subject Device
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K250900 | K213606 |
| Sponsor | EvoEndo, Inc | EvoEndo, Inc |
| Device Name | EvoEndo Endoscopy System | EvoEndo Endoscopy System |
| Product Code | FDS, FET | FDS, FET |
| Indications for Use | The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile single‐ use device and can be inserted orally or transnasally. |
The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation. | The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb in patients over the age of five years. The gastroscope is a sterile single‐ use device and can be inserted orally or transnasally.
The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation. |
| Sterilization Method | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Shelf Life | 14 months | 6 months |
| Endoscope Outer Diameter | 3.5mm | 3.5mm |
| Working Channel Diameter | 2.0mm | 2.0mm |
| Working Length | 1100mm | 1100mm |
| Field of View | 120° | 120° |
| Steering Method | 4‐way | 4‐way |
| Maximum Bending Angle | Up 210°
Down 90°
Left 100°
Right 100° | Up 210°
Down 90°
Left 100°
Right 100° |
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K250900
Page 5 of 7
| Subject Device | Predicate Device | |
|---|---|---|
| 510(k) Number | K250900 | K213606 |
| Air, Water, Suction (AWS) Functionality | Yes | Yes |
| Video Inputs | Ferric HDMI Cable & USB 3.0 Cable | Ferric HDMI Cable & USB 3.0 Cable |
| Monitor Compatibility | Medical grade monitor (27‐inch, 1080p HD resolution recommended) | Medical grade monitor (27‐inch, 1080p HD resolution recommended) |
| Illumination Technology | Located in EvoEndo Endoscope | Located in EvoEndo Endoscope |
| Electrical Specifications Input Voltage | 100 – 240 VAC, 50‐60 Hz 0.5A | 100 – 240 VAC, 50‐60 Hz 0.5A |
| U.S. Power Cord Specifications | 115 VAC Length – 1.5 meters Voltage Rating – 240 VAC Current Rating – 12 A Connector Type – Horizontal | 115 VAC Length – 1.5 meters Voltage Rating – 240 VAC Current Rating – 12 A Connector Type – Horizontal |
| Controller Physical Specifications | ||
| Material | Aluminum | Aluminum |
| Height | 6.0 cm | 6.0 cm |
| Weight | 15.0 cm | 15.0 cm |
| Depth | 21.5 cm | 21.5 cm |
1.7 Performance Testing Summary
This submission is specific to the indication extension. There are no changes to the design of the device as compared to K213606. No testing was performed specific to this submission. Please refer to K213606 for performance testing associated with this device.
To support the removal of "in patients 5 years and above" from the indication a clinical literature search was conducted.
Clinical Testing
Published literature was evaluated for the safety of endoscopy procedures in patients under 5 years as well as review anatomical considerations of using the EvoEndo Endoscopy system in the smaller patient population. A risk/benefit evaluation was also completed. The evaluation supported the removal of the specific age of 5 years and above.
Summary of Previous Biocompatibility Testing:
Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material‐ mediated pyrogenicity testing was performed per ISO 10993‐1 and the FDA Guidance for Industry and
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K250900
Page 6 of 7
FDA Staff, "Use of International Standard ISO 10993‐1, 'Biological evaluation of medical devices ‐ Part 1: Evaluation and testing within a risk management process.'" There were no cytotoxicity, sensitization, irritation, acute systemic toxicity, or material‐mediated pyrogenicity concerns associated with the EvoEndo Endoscopy System.
Summary of Previous Non‐Clinical Functional and Performance Testing
Visual, dimensional, functional, and transit simulation verification testing was performed on final sterilized EvoEndo Endoscopes. In functional testing, devices were verified for camera and video control unit functioning; tip deflection; air, water, and suction flow rates; functionality with accessory device; functionality after 360° bend shaft orientation; functionality with simulated repeated use; and post simulated use functionality. The maximum bending angle of the device in each direction is shown in the table below. The deflection achieved with the EvoEndo Endoscope is consistent with that of the identified predicate device in all directions, indicating substantial equivalence.
Table 3: Deflection of EvoEndo Endoscope
| Deflection Direction | Maximum Bending Angle |
|---|---|
| Up | 210° |
| Down | 90° |
| Left | 100° |
| Right | 100° |
In transit simulation testing, test units underwent environmental conditioning, distribution simulation, and packaging testing to confirm the integrity of the sterile barrier and functionality of the device under expected transportation conditions. The EvoEndo Endoscopy System met acceptance criteria set for all verification testing procedures.
Optical performance testing was performed on the EvoEndo Endoscope and compared to the predicate device. The testing evaluated the resolution, depth of field, geometric distortion, image intensity uniformity, and color performance of the endoscope. The test results suggest equivalent performance across all metrics assessed, demonstrating substantial equivalence between the EvoEndo Endoscope and the predicate device.
Photobiological safety testing was performed per FDA recognized consensus standard IEC/TR 62471 First Edition 2006‐07: Photobiological safety of lamps and lamp systems. Based on the measured output of the EvoEndo's light source, it was deemed to be below the limits of the exempt risk group.
Summary of Previous Human Factors / Usability Engineering Testing:
EvoEndo conducted a two‐stage usability study of representative intended users. The study assessed the overall usability of the EvoEndo Endoscopy System and the
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ability for users to perform critical tasks. Participants were asked to perform the entire workflow of the device across a benchtop model session and a representative animal model session with prior training provided. Tests were performed in a simulated clinic‐office setting. Throughout the procedure, there were no significant device or user malfunctions or errors that would result in patient harm during an actual procedure.
Summary of Previous Animal and Clinical Data
Animal testing was not required for this device.
1.8 Shelf Life and Sterilization
The EvoEndo Endoscope is packaged individually, provided sterile, labeled for single use only, and sterilized using 100% ethylene oxide (EO) gas in a fixed chamber. Validation performed for the sterilization technique met all acceptance criteria. Functional testing confirmed that sterilization did not impact product safety or effectiveness. The predicate device (K213606) was cleared with a shelf life of 6 months. Additional testing done using the protocol described in K213606 was performed to extend the shelf life of the subject device to 14 months.
1.9 Previous Electrical Safety and EMC Testing:
The Electrical Safety (ES) and Electromagnetic Compatibility (EMC) testing conformed to IEC 60601‐1:2005/(R)2012 and A1:2012, IEC 60601‐1‐2:2014, and IEC 60601‐2‐18:2009. All acceptance criteria were met.
1.10 Previous Software Testing:
The firmware used in the EvoEndo Controller has been determined to be a moderate level of concern. The software in the controller consisting of 6 embedded firmware items is considered off‐the‐shelf software and, as such, is documented in accordance with the FDA Guidance "Off‐ The‐Shelf Software Use in Medical Devices" (Sep 27, 2019).
1.11 Conclusion
There have been no technological changes between the subject and predicate device. Therefore, previous testing conducted on the predicate device applies to the subject device and supports substantial equivalence of the EvoEndo Endoscopy System subject device to the legally marketed predicate device.
To support the removal of the specific age from the indication, a literature review was conducted. The evaluation supported the removal of the specific age of 5 years and above.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification that it can be concluded that the subject device is substantially equivalent with predicate device.