(132 days)
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 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.
This document is a 510(k) Premarket Notification from the FDA regarding the "Hawkeye Control Unit with Eyas Endoscope." It details the device, its intended use, a comparison to a predicate device, and summaries of bench testing and compliance with standards.
However, the provided text does not contain information about studies proving the device meets acceptance criteria related to a comparative effectiveness study involving AI or human readers, nor does it provide details about ground truth establishment with experts, adjudication methods, or standalone AI performance.
The document focuses on demonstrating substantial equivalence to a predicate device (Trice medical mi-eye2, mi-eye 2 monitor (K162475)) through comparison of features, operating principles, technology, and compliance with various recognized standards (electrical safety, biocompatibility, sterilization, software lifecycle, packaging).
The "Bench Testing Summary" section describes various tests performed on the device components (Console Box, Medical Tablet, Eyas Endoscope, and their packaging) to verify their functionality and performance against specifications. These are typical engineering and quality assurance tests, not clinical performance studies for diagnostic accuracy or comparative effectiveness with human readers, especially not for an AI component.
Given the provided text, it's not possible to fully answer the request as it pertains to AI model acceptance criteria and validation studies. The device as described is an arthroscope system for visualization and image capture, not an AI-powered diagnostic tool.
Therefore, for the specific questions asked that relate to AI model validation, the answer is: This document does not contain the requested information about AI model acceptance criteria or validation studies, as the device described is an arthroscope system, not an AI-powered diagnostic or assistive tool.
If we interpret "acceptance criteria" in the context of this document as the criteria for demonstrating substantial equivalence for an arthroscope system, then the "reported device performance" is its adherence to technical specifications and relevant safety/performance standards, as summarized in the bench testing.
Here's what can be extracted based on the provided text, focusing on the device's technical acceptance and testing, not AI:
Acceptance Criteria and Device Performance (Based on Technical Specifications and Bench Testing)
The document implicitly defines acceptance criteria through its comparison to a predicate device and its demonstrated compliance with international standards. The performance is reported as meeting these standards and having features functionally equivalent to the predicate.
1. Table of acceptance criteria and the reported device performance (Interpreted as technical and functional equivalence):
| Acceptance Criterion (Implicit from comparison/standards) | Reported Device Performance (from document) |
|---|---|
| Indications for Use: Provide visualization and image capture of interior body cavity through surgical incision. | Identical to predicate. "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 Code: HRX (Arthroscope) | HRX (Identical) |
| Operating Principle: Transmission of light to illuminate and image arthroscopic joint, relaying image for processing and display. | Identical to predicate. |
| Input Power: 100-240 V | 100-240 V (Identical) |
| Light Source: LED (SMD Type) | LED (SMD Type) (Identical) |
| Image File Format: PNG | PNG (Identical) |
| Video File Format: Standard video format | MPG (Functionally identical to predicate's AVI/MP4; applied for different media players, no safety/effectiveness concerns raised). |
| Output Port: Data/Image/Audio output | USB, HDMI, Audio jack (Functionally identical to predicate's USB; HDMI/Audio jack outputs do not raise safety/effectiveness concerns per cybersecurity report). |
| Component Design: System components | Tablet, Console Box, Endoscope (Similar to predicate's Tablet, Endoscope. Console box provides power/stand, no safety/performance impact). |
| Physical Dimensions/Weight: Reasonable for use | Tablet: 28 x 18 x 1.83 cm (vs. 33.5 x 21.6 x 3.8 cm for predicate) Console Box: 16.9 x 19.6 x 12.2 cm. Weight: 2.2lb (tablet and console each). (Similar; differences in design mechanisms do not raise safety/effectiveness concerns). |
| Display: Integrated viewing screen | 10.1" LCD (vs. 12.3" LCD for predicate). |
| Working Conditions: Temperature, Humidity, Pressure | Temp: 10-30°C, RH: 30-75%, Pressure: 700-1013 hPa (Minor differences but similar to predicate; typical working conditions; considered substantially equivalent). |
| Transport/Storage Conditions: Temperature, Humidity, Pressure | Temp: -20-60°C, RH: 25-85%, Pressure: 500-1013 hPa (Minor differences but similar to predicate; considered substantially equivalent). |
| Patient Contact Materials: Biocompatible | SUS 304, ABS, PC, Copper Clad Laminate, Polyimide, CaZrO3, Expoy Resin, Acrylate Urethane, Silicone (Biologically identical to predicate's SUS 304). |
| Audio Indicator: Operation/Warning Tones | Yes (vs. No for predicate, which has visual signal only. This is an additional feature, not a deficiency). |
| Flushing Feature: Present and functional | Yes, requires cannula (Functionally identical to predicate). |
| Endoscope Sterilization Method: EO | Ethylene Oxide (Identical) |
| Operation Environment: Clinical settings | Operating rooms, treatment rooms, and clinics (Identical). |
| Standard Compliance: Electrical safety, biocompatibility, software, sterilization, packaging. | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 62304, ISO 10993-1, ISO 11135, ISO 11607-1, ISO 11607-2. (Almost identical to predicate; application device conforms to latest versions). |
| Console Box Bench Testing: | Visual Inspection, Power Supply, Plug Insertion & Extraction Force (Passed). |
| Medical Tablet Bench Testing: | Visual Inspection, Luminance Adjustment, Capturing and Recording, Battery Capacity Check, Tablet Charging, Software/Firmware Version, HDMI Signal Output, Image Function, USB Storage, Tone (button/warning) (Passed). |
| Package Bench Testing: (Control Unit) | Package and Device Integrity, Label Visibility (Passed). |
| Eyas Endoscope Electrical Testing: | EEPROM Function, Continuity Resistance (Passed). |
| Eyas Endoscope Optical Testing: | Luminance Intensity, Sensitivity, White Balance, SFR, Uniformity, Color Response, Dust Spot, Dark, Noise, Stray Light, Color Performance, Direction of View, Field of View (Passed). |
| Eyas Endoscope Mechanical Testing: | Activation Force, Plug Insertion & Extraction Force, Dynamic Strain Relief, Static Strain Relief, Weld Integrity, Camera Tube Wobble, Activation Over Time, Leakage, Fluid Ingress Test (Passed). |
| Package Bench Testing: (Eyas Endoscope) | Visual Inspection, Peel Open, Seal Width, Seal Strength, Dye Leak (Passed). |
Since the device is not an AI-powered diagnostic system, the following questions cannot be answered from the provided document:
- Sample size used for the test set and the data provenance: Not applicable for an AI test set. The document describes bench testing on the device itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI model is not established here.
- Adjudication method 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.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance is its adherence to engineering specifications and international standards, demonstrated by bench testing.
- The sample size for the training set: Not applicable, as this is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA 510(k) document indicates substantial equivalence for an arthroscope system based on standard engineering and performance tests, not on AI model validation.
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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.
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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 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).
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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
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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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510(k) Summary
A. Device Information:
| Category | Comments |
|---|---|
| Sponsor: | E SURGICAL, LLC150 Isidor Ct,Ste 203, Sparks, NV 89441 |
| Correspondent ContactInformation: | Mr. Craig CoombsPresidentCoombs Medical Device Consulting, Inc.427 14th Ave,San Francisco, CA, 94118Tel: 650-380-2474Email: 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 888.1100Arthroscope |
| 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
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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 HawkeyeControl Unit with EyasEndoscope | Predicate:Trice medical mi-eye2, mi-eye 2monitor (K162475) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
|---|---|---|---|
| Indications forUse | The Hawkeye Control Unitwith Eyas Endoscope isintended for use indiagnostic and operativearthroscopic andendoscopic procedures toprovide visualization andimage capture of aninterior body cavitythrough a surgical incision. | The mi-eye2 is indicated for usein diagnostic and operativearthroscopic and endoscopicprocedure to provideillumination and visualization ofan interior cavity of the bodythrough either a natural orsurgical opening. | Identical |
| Product Code | HRX | HRX | Identical |
| Feature | Application Device:E Surgical HawkeyeControl Unit with EyasEndoscope | Predicate:Trice medical mi-eye2, mi-eye 2monitor (K162475) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
| OperatingPrinciple | Transmission of light toilluminate and image anarthroscopic joint, thenrelaying the image out ofthe surgical site forprocessing and display. | Transmission of light toilluminate and image anarthroscopic joint, thenrelaying the image out of thesurgical site for processing anddisplay. | Identical |
| Input Power | 100 - 240 V | 100 - 240 V | Identical |
| Technology | |||
| Light source | LED(SMD Type) | LED(SMD Type) | Identical |
| Image FileFormat | PNG | PNG | Identical |
| Video fileFormat | MPG | AVI(or MP4) | Functionally identical.These two video formatsare applied for differentmedia players. |
| Output port | USB,HDMI, Audio jack | USB | Functionally identical.Per cybersecurity report,image and audio outputthrough HDMI and audiojack do not raise safety oreffectiveness concerns. |
| Physical Specification (Tablet) | |||
| PrincipleComponent | Tablet, Console Box,Endoscope | Tablet, Endoscope | Similar.The application device hasa console box that powersthe tablet and endoscope,and severs as a stand toposition the tablet. Thisdesign difference does notaffect the safety andperformance of theproduct. |
| Feature | Application Device:E Surgical HawkeyeControl Unit with EyasEndoscope | Predicate:Trice medical mi-eye2, mi-eye 2monitor (K162475) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
| Dimensions | Tablet:28 cm x 18 cm x 1.83 cmConsole 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 designmechanisms does not raiseany safety or effectivenessconcerns. |
| 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 | |
| WorkingCondition | Temperature range:10°C to 30°CHumidity range:$30% \le RH \le 75%$Atmospheric Pressure:700 hPa to 1013 hPa | Temperature range:10°C to 32°CHumidity range:$30% \le RH \le 95%$Atmospheric Pressure:700 hPa to 1060 hPa | Minor Differences.The internal circuit designand components chosenare different, but havespecifications for similarworking, transport andstorage conditions. Thetemperature, RH andatmospheric pressurespecifications are similarand are typical workingconditions. Thesespecifications areconsidered to besubstantially equivalent. |
| Transport andStorageCondition | Ambient temperature:-20°C to +60°CHumidity range:25% to 85%, non-condensing.Atmospheric pressure:500 hPa to 1013 hPa | Ambient temperature:-20°C to +60°CHumidity range:10% to 100%, non-condensing.Atmospheric pressure:500hPa to 1060 hPa | |
| Materials | |||
| Probe & Patientcontactingfeatures | SUS 304,ABS, PC (polycarbonate),Copper Clad Laminate,Polyimide, CaZrO3, ExpoyResin, Acrylate Urethane,Silicone | SUS 304 | Biologically identical |
| Feature | Application Device:E Surgical HawkeyeControl Unit with EyasEndoscope | Predicate:Trice medical mi-eye2, mi-eye 2monitor (K162475) | Pertinence of Feature toConsideration ofSubstantial Equivalence |
| Audio indicator | Yes, operating & warningtone | No | The application device hasoperating and warningtone to remind use, whilethe predicate has visualsignal only. |
| Flushing feature | Yes.The Eyas endoscoperequires connecting to acannula to achieve theflushing feature. | Yes.The integrated rigid shaft thatextends from the mi-eye2endoscope handle can beutilized to achieve flushingfeature. | Functionally identical. |
| Others | |||
| EndoscopeSterilizationMethod | Ethylene Oxide | Ethylene Oxide | Identical |
| OperationEnvironment | Operating rooms,treatment rooms, andclinics. | Operating rooms, treatmentrooms, and clinics. | Identical |
| Standard Met | IEC 60601-1IEC 60601-1-2IEC 60601-2-18ISO 10993-1ISO 11135 | IEC 60601-1IEC 60601-1-2IEC 60601-2-18ISO 10993-1ISO 11135-1 | Almost identical,application device is inconformance with latestversion of the listedstandards |
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Hawkeye Control Unit with Eyas Endoscope K233115
E Surgical, LLC
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Hawkeye Control Unit with Eyas Endoscope K233115
E Surgical, LLC
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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 CapacityCheck/ Tablet Charging/ Software Version/ Firmware Version/ HDMI Signal Output/ Image Function/USB Storage/Tone (button operation)/ Tone (warning alert) |
| Package |
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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/ DustSpot/ Dark/ Noise/ Stray Light/ Color Performance/Direction of View/ Field of View |
| Mechanical | Activation Force/ Plug Insertion & Extraction Force/ Dynamic Strain Relief/ Static StrainRelief/ Weld Integrity / Camera Tube Wobble/ Activation Over Time/ Leakage/Fluid IngressTest |
| 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,
| StandardsBody & # | Standard Name | Standard Version |
|---|---|---|
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance | 2005 + AM1:2012 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements forbasic 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 forthe 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 andtesting within a risk management process. | 2018 |
| ISO 11135 | Sterilization of health-care products — Ethylene oxide —Requirements for the development, validation and routine control ofa sterilization process for medical devices | 2014 + AM1: 2018 |
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E Surgical, LLC
| StandardsBody & # | Standard Name | Standard Version |
|---|---|---|
| ISO 11607-1 | Packaging for terminally sterilized medical devices – Part 1:Requirements for materials, sterile barrier systems and packagingsystems; | 2019 |
| ISO 11607-2 | Packaging for terminally sterilized medical devices – Part 2: Validationrequirements 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).
§ 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.