Who is the manufacturer of Hawkeye Control Unit with Eyas Endoscope?

E Surgical, LLC filed the 510(k) submission for Hawkeye Control Unit with Eyas Endoscope (K233115).

What is the FDA product code for Hawkeye Control Unit with Eyas Endoscope?

HRX. It is classified under 21 CFR 888.1100 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Hawkeye Control Unit with Eyas Endoscope?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Hawkeye Control Unit with Eyas Endoscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Hawkeye Control Unit with Eyas Endoscope

K233115 · E Surgical, LLC · HRX · Feb 6, 2024 · Orthopedic

Device Facts

Record ID	K233115
Device Name	Hawkeye Control Unit with Eyas Endoscope
Applicant	E Surgical, LLC
Product Code	HRX · Orthopedic
Decision Date	Feb 6, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.1100
Device Class	Class 2

Intended Use

The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision.

Device Story

The Hawkeye Control Unit with Eyas Endoscope is an arthroscopic system comprising a medical tablet, a console box, and a single-use, hand-held Eyas endoscope. The system is used in operating rooms, treatment rooms, and clinics by healthcare professionals. The endoscope captures real-time images of interior body cavities through a small incision; the console box acts as an interface, powering the tablet and endoscope. The medical tablet provides image display, system control, and data storage. The device uses LED illumination to visualize the surgical site and relays images for processing and display. The system includes audio indicators for operation and warnings. The output is viewed by the clinician on the tablet to assist in diagnostic and operative decision-making, potentially benefiting the patient by providing minimally invasive visualization of joint or body cavity interiors.

Clinical Evidence

Bench testing only. Performance testing included electrical safety (IEC 60601-1, 60601-1-2, 60601-2-18), optical performance (luminance, sensitivity, white balance, SFR, uniformity, color response, field of view), mechanical integrity (activation force, strain relief, leakage, fluid ingress), and package integrity. No clinical data was provided.

Technological Characteristics

System includes a medical tablet, console box, and single-use endoscope. Materials include SUS 304, ABS, polycarbonate, copper clad laminate, polyimide, CaZrO3, epoxy resin, acrylate urethane, and silicone. Illumination via LED (SMD type). Connectivity includes USB, HDMI, and audio jack. Sterilization of endoscope via Ethylene Oxide. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993-1, and ISO 11135.

Indications for Use

Indicated for diagnostic and operative arthroscopic and endoscopic procedures requiring visualization and image capture of interior body cavities via surgical incision.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

Trice medical mi-eye2, mi-eye 2 monitor (K162475)

Related Devices

K253217 — MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700) · Medimaging Integrated Solution, Inc (Miis) · Dec 23, 2025
K243020 — MIDASVu · Intravu, Inc. · Dec 2, 2024
K162475 — mi-eye 2, mi-eye 2 monitor · Trice Medical · Sep 16, 2016
K141119 — CAMERA ENABLED PROBE · Trice Medical, Inc. · Jul 29, 2014
K212556 — mi-eye 3 needlescope with cannula, mi-tablet 3 · Trice Medical, Inc. · Sep 15, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 6, 2024 E Surgical, LLC % Craig Coombs President Coombs Medical Device Consulting, Inc. 427 14th Ave San Francisco, California 94118 Re: K233115 Trade/Device Name: Hawkeye Control Unit with Eyas Endoscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 8, 2024 Received: January 9, 2024 Dear Craig Coombs: 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. {1}------------------------------------------------ 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 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-reportingcombination-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. 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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). {2}------------------------------------------------ Sincerely, Digitally signed by Jesse Muir Jesse Muir -S Date: 2024.02.06 -5 08:00:02 -05'00' Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K233115 Device Name Hawkeye Control Unit with Eyas Endoscope Indications for Use (Describe) The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision. X 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." {4}------------------------------------------------ # 510(k) Summary ### A. Device Information: | Category | Comments | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | E SURGICAL, LLC 150 Isidor Ct, Ste 203, Sparks, NV 89441 | | Correspondent Contact Information: | Mr. Craig Coombs President Coombs Medical Device Consulting, Inc. 427 14th Ave, San Francisco, CA, 94118 Tel: 650-380-2474 Email: craigJcoombs@gmail.com | | Device Common Name: | Arthroscope | | Device Classification Number: | 21 CFR 888.1100 | | Device Classification & Product Code: | Class II, HRX | | Device Proprietary Name: | Hawkeye Control Unit with Eyas Endoscope | #### Predicate Device Information: | Predicate Device : | Trice medical mi-eye2, mi-eye 2 monitor | |----------------------------------------------------|-----------------------------------------| | Predicate Device Manufacturer: | Trice Medical | | Predicate Device Common Name: | Arthroscope | | Predicate Device Premarket Notification #: | K162475 | | Predicate Device Classification: | 21 CFR 888.1100 Arthroscope | | Predicate Device Classification & Product Code: | Class II, HRX | # B. Date Summary Prepared 30 January 2024 ## C. Description of Device The E Surgical Hawkeye Control Unit with Eyas Endoscope is an arthroscope system, consisting of the Hawkeye Control Unit (Medical Tablet plus Console Box), and the {5}------------------------------------------------ ## E Surgical, LLC Eyas Endoscope. The Medical Tablet is a touch panel computer for the system function control, endoscope image displays and operation data storage. The Eyas Endoscope is a hand-held, single-use device for accessing the interior of a joint to capture the real-time image of the target site through a small incision. The Console Box is an interface between the Medical Tablet and Eyas Endoscope. There are 10 models of Eyas Endoscope in this system; including 2 different directions of view (0° and 30°) in combination with 5 different working lengths. All these models must be used in conjunction with Hawkeye Control Unit to perform as intended. The E Surgical Hawkeye Control Unit with Eyas Endoscope is also capable recording and storing the images in the system for later review. ## D. Indications for Use The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision. # E. Comparison to Predicate Device The comparison between E Surgical Hawkeye Control Unit with Eyas Endoscope and the predicate devices are: | Feature | Application Device: E Surgical Hawkeye Control Unit with Eyas Endoscope | Predicate: Trice medical mi-eye2, mi-eye 2 monitor (K162475) | Pertinence of Feature to Consideration of Substantial Equivalence | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Hawkeye Control Unit with Eyas Endoscope is intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision. | The mi-eye2 is indicated for use in diagnostic and operative arthroscopic and endoscopic procedure to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. | Identical | | Product Code | HRX | HRX | Identical | | Feature | Application Device: E Surgical Hawkeye Control Unit with Eyas Endoscope | Predicate: Trice medical mi-eye2, mi-eye 2 monitor (K162475) | Pertinence of Feature to Consideration of Substantial Equivalence | | Operating Principle | Transmission of light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display. | Transmission of light to illuminate and image an arthroscopic joint, then relaying the image out of the surgical site for processing and display. | Identical | | Input Power | 100 - 240 V | 100 - 240 V | Identical | | Technology | | | | | Light source | LED(SMD Type) | LED(SMD Type) | Identical | | Image File Format | PNG | PNG | Identical | | Video file Format | MPG | AVI(or MP4) | Functionally identical. These two video formats are applied for different media players. | | Output port | USB,HDMI, Audio jack | USB | Functionally identical. Per cybersecurity report, image and audio output through HDMI and audio jack do not raise safety or effectiveness concerns. | | Physical Specification (Tablet) | | | | | Principle Component | Tablet, Console Box, Endoscope | Tablet, Endoscope | Similar. The application device has a console box that powers the tablet and endoscope, and severs as a stand to position the tablet. This design difference does not affect the safety and performance of the product. | | Feature | Application Device: E Surgical Hawkeye Control Unit with Eyas Endoscope | Predicate: Trice medical mi-eye2, mi-eye 2 monitor (K162475) | Pertinence of Feature to Consideration of Substantial Equivalence | | Dimensions | Tablet: 28 cm x 18 cm x 1.83 cm Console Box: 16.9 cm x 19.6 cm x 12.2 cm | Tablet: 33.5 cm x 21.6 cm x 3.8 cm | Similar. The difference in design mechanisms does not raise any safety or effectiveness concerns. | | Weight | Tablet:2.2 lb (1 kg) Console: 2.2 lb (1 kg) | 3.72 lb (< 1.69 kg) | | | Display | 10.1" LCD | 12.3" LCD | | | Working Condition | Temperature range: 10°C to 30°C Humidity range: $30\% \le RH \le 75\%$ Atmospheric Pressure: 700 hPa to 1013 hPa | Temperature range: 10°C to 32°C Humidity range: $30\% \le RH \le 95\%$ Atmospheric Pressure: 700 hPa to 1060 hPa | Minor Differences. The internal circuit design and components chosen are different, but have specifications for similar working, transport and storage conditions. The temperature, RH and atmospheric pressure specifications are similar and are typical working conditions. These specifications are considered to be substantially equivalent. | | Transport and Storage Condition | Ambient temperature: -20°C to +60°C Humidity range: 25% to 85%, non- condensing. Atmospheric pressure: 500 hPa to 1013 hPa | Ambient temperature: -20°C to +60°C Humidity range: 10% to 100%, non-condensing. Atmospheric pressure: 500hPa to 1060 hPa | | | Materials | | | | | Probe & Patient contacting features | SUS 304, ABS, PC (polycarbonate), Copper Clad Laminate, Polyimide, CaZrO3, Expoy Resin, Acrylate Urethane, Silicone | SUS 304 | Biologically identical | | Feature | Application Device: E Surgical Hawkeye Control Unit with Eyas Endoscope | Predicate: Trice medical mi-eye2, mi-eye 2 monitor (K162475) | Pertinence of Feature to Consideration of Substantial Equivalence | | Audio indicator | Yes, operating & warning tone | No | The application device has operating and warning tone to remind use, while the predicate has visual signal only. | | Flushing feature | Yes. The Eyas endoscope requires connecting to a cannula to achieve the flushing feature. | Yes. The integrated rigid shaft that extends from the mi-eye2 endoscope handle can be utilized to achieve flushing feature. | Functionally identical. | | Others | | | | | Endoscope Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical | | Operation Environment | Operating rooms, treatment rooms, and clinics. | Operating rooms, treatment rooms, and clinics. | Identical | | Standard Met | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO 10993-1 ISO 11135 | IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO 10993-1 ISO 11135-1 | Almost identical, application device is in conformance with latest version of the listed standards | {6}------------------------------------------------ ### Hawkeye Control Unit with Eyas Endoscope K233115 # E Surgical, LLC {7}------------------------------------------------ ### Hawkeye Control Unit with Eyas Endoscope K233115 # E Surgical, LLC {8}------------------------------------------------ #### Hawkeye Control Unit with Eyas Endoscope K233115 # E Surgical, LLC # F. Bench Testing Summary The Bench Testing for the Hawkeye Control Unit with Eyas Endoscope is summarized below. | Hawkeye Control Unit | | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | | | Console Box | Visual Inspection/ Power Supply/ Plug Insertion & Extraction Force | | Medical Tablet | Visual Inspection/ Luminance Adjustment/ Capturing and Recording / Battery Capacity Check/ Tablet Charging/ Software Version/ Firmware Version/ HDMI Signal Output/ Image Function/ USB Storage/Tone (button operation)/ Tone (warning alert) | | Package | | {9}------------------------------------------------ E Surgical, LLC # Hawkeye Control Unit | Package Inspection | Package and Device Integrity, Label Visibility | |--------------------|------------------------------------------------| |--------------------|------------------------------------------------| | Eyas Endoscope | | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | | | Electrical | EEPROM Function/ Continuity Resistance | | Optical | Luminance Intensity/ Sensitivity/ White Balance/ SFR/ Uniformity/ Color Response/ Dust Spot/ Dark/ Noise/ Stray Light/ Color Performance/Direction of View/ Field of View | | Mechanical | Activation Force/ Plug Insertion & Extraction Force/ Dynamic Strain Relief/ Static Strain Relief/ Weld Integrity / Camera Tube Wobble/ Activation Over Time/ Leakage/Fluid Ingress Test | | Package | | | Package Integrity | Visual Inspection/Peel Open / Seal Width/ Seal Strength / Dye Leak | ## G. Summary of Supporting Data The application E Surgical Hawkeye Control Unit with Eyas Endoscope were tested and found to be in compliance with the pertinent portions of the following standards, | Standards Body & # | Standard Name | Standard Version | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2005 + AM1:2012 | | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | 2017 + AM1:2020 | | IEC 60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment | 2009 | | IEC 62304 | Medical device software — Software life cycle processes | 2006+AM1:2015 | | ISO 10993-1 | Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. | 2018 | | ISO 11135 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices | 2014 + AM1: 2018 | {10}------------------------------------------------ ## E Surgical, LLC | Standards Body & # | Standard Name | Standard Version | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems; | 2019 | | ISO 11607-2 | Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes | 2019 | ## G. Conclusion After comparing the indications for use, technology and design of the E Surgical Hawkeye Control Unit with Eyas Endoscope, along with all electrical safety (including IEC 60601-1; IEC 60601-1-2; IEC 60601-2-18) and relevant performance, in accordance with FDA-recognized consensus standards for electrical safety, E Surgical concludes that the Hawkeye Control Unit with Eyas Endoscope is substantially equivalent to the predicate Trice medical mi-eye2, mi-eye 2 monitor (K162475).