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.

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.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the EvoEndo Single-Use Endoscopy System (K250900) do not describe a study involving acceptance criteria for device performance in the context of an AI/human reader study. Instead, this submission focuses on extending the indicated age range for an existing medical device (an endoscope system) and increasing its shelf life.

The "performance testing summary" sections (1.7, 1.8, 1.9, 1.10) refer to:

Non-clinical functional and performance testing (e.g., visual, dimensional, tip deflection, air/water/suction flow rates, optical performance, electrical safety, EMC). These tests have specific acceptance criteria typical for medical device engineering, but they are not related to AI performance, clinical accuracy, or human reader performance.
Biocompatibility testing
Human factors/usability engineering testing
Literature review to support the age extension. This is a scientific review, not a performance study with acceptance criteria of the type requested in the prompt.

Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and studies typical for AI-enabled medical devices or comparative effectiveness studies with human readers. The document does not contain information about:

A table of acceptance criteria and reported device performance (in the context of clinical accuracy or AI performance).
Sample sizes used for a test set (clinical images) or the data provenance.
Number of experts or their qualifications to establish ground truth for a test set.
Adjudication methods for a test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study or related effect sizes.
Standalone (algorithm only) performance.
Type of ground truth used for clinical validation.
Sample size for a training set or how its ground truth was established.

The prompt's requirements are designed for AI/imaging analysis devices, which this clearance document does not pertain to. This document is for a physical endoscopy system.

However, I can extract information related to the device and its predicate, as well as the justification for the Indication for Use extension:

Device: EvoEndo Single-Use Endoscopy System
Submission: K250900 (for indication extension and shelf-life extension)
Predicate Device: EvoEndo Single-Use Endoscopy System (K213606)

Summary of Device and Changes:

Subject Device: EvoEndo Single-Use Endoscopy System (K250900)
- Components: EvoEndo Model LE Single-Use Gastroscope & EvoEndo Controller
- Intended Use: Visualization of the upper digestive tract (esophagus, stomach, duodenal bulb) for observation, diagnosis, and endoscopic treatment in adult and pediatric patients (extended from "patients over the age of five years" in predicate). Sterile, single-use, oral or transnasal insertion.
- Key Differences from Predicate (K213606):
  1. Indicated Age: Removal of "in patients over the age of five years."
  2. Shelf Life: Extended from 6 months to 14 months.
Predicate Device: EvoEndo Single-Use Endoscopy System (K213606)
- Intended Use: Same as above, but "in patients over the age of five years."
- Shelf Life: 6 months.

Acceptance Criteria and "Study" for Indication Extension:

Since this is not an AI-enabled device or a diagnostic device relying on accuracy metrics, the "acceptance criteria" here relate to demonstrating equivalence and safety for the extended indications and shelf life.

Acceptance Criteria (Implicit for this type of submission)	Reported "Device Performance" (or Justification)
Safety and Effectiveness for Extended Age Range	Clinical Literature Search: "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."
Extended Shelf Life Validation	Additional Testing: "Additional testing done using the protocol described in K213606 was performed to extend the shelf life of the subject device to 14 months." (Implies meeting pre-defined stability/performance criteria over 14 months).
Maintenance of Predicate Device Performance	Substantial Equivalence Claim: "No changes to the design of the device as compared to K213606." Previous performance testing (biocompatibility, non-clinical functional, optical, photobiological, human factors, electrical safety, EMC, software) conducted on the predicate device (K213606) is deemed applicable to the subject device and supports substantial equivalence.

Regarding the specific questions in the prompt, based solely on the provided document:

A table of acceptance criteria and the reported device performance: As explained above, the "acceptance criteria" for this specific submission relate to the justification for the extended Indication for Use and shelf life, not typical AI/diagnostic performance. The table above attempts to capture this contextually.
Sample size used for the test set and the data provenance: Not applicable. No "test set" of clinical images or data was used for a performance validation in this submission type. The justification for age extension was a literature review.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data (like diagnostic accuracy) was not established or presented in this 510(k) for an endoscope.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the current submission, the "ground truth" for the expanded age indication was supported by a clinical literature review and anatomical considerations, along with a risk/benefit evaluation. This is not "ground truth" in the sense of a definitive diagnostic label for performance evaluation.
The sample size for the training set: Not applicable. There is no AI training set mentioned.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document is for the clearance of an endoscope and its extended indications, not an AI-enabled diagnostic device. Therefore, the detailed requirements for AI/diagnostic performance studies cannot be addressed from this document.

Summary

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

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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."

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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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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)

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 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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	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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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.

Regulation Number and Section

§ 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.