(132 days)
Not Found.
No
The summary describes a standard arthroscope system for visualization and image capture, with no mention of AI or ML capabilities for image analysis, diagnosis, or other functions.
No.
The device is strictly for visualization and image capture (diagnostic purposes) and does not perform any therapeutic intervention or treatment.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "intended for use in diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity." The mention of "diagnostic" directly indicates its diagnostic purpose.
No
The device description explicitly states it consists of a Hawkeye Control Unit (Medical Tablet plus Console Box) and an Eyas Endoscope, which are physical hardware components. The performance studies also include bench testing on these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic and operative arthroscopic and endoscopic procedures to provide visualization and image capture of an interior body cavity through a surgical incision." This describes a device used directly on the patient for visualization during a medical procedure.
- Device Description: The description details an arthroscope system with an endoscope, control unit, and tablet for image display and storage. This is consistent with a surgical imaging device used in vivo.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform tests on samples taken from the body.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, chemical reactions, or diagnostic assays typically associated with IVDs.
The device is clearly intended for direct visualization and imaging within the body during surgical procedures, which falls under the category of medical devices used in vivo, not in vitro.
N/A
Intended Use / 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.
Product codes
HRX
Device Description
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
Interior body cavity, interior cavity of the body, arthroscopic joint.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Operating rooms, treatment rooms, and clinics.
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)
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: 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
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:
IEC 60601-1 (2005 + AM1:2012)
IEC 60601-1-2 (2017 + AM1:2020)
IEC 60601-2-18 (2009)
IEC 62304 (2006+AM1:2015)
ISO 10993-1 (2018)
ISO 11135 (2014 + AM1: 2018)
ISO 11607-1 (2019)
ISO 11607-2 (2019)
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.
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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)
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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 (