(10 days)
The mi-eye 2 is indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the camera, illumination, and imaging optics. The mi-eye 2 devices are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor has a 10.8" (diagonal) screen. The entire unit weight is less than 300 grams.
This document, a 510(k) Summary for the mi-eye 2 and mi-eye 2 Monitor, provides some, but not all, of the requested information. The device is an arthroscope used for diagnostic and operative arthroscopic and endoscopic procedures.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the mi-eye 2 underwent various testing in accordance with industry standards to verify that its design meets functional and performance requirements. However, it does not provide a specific table detailing the acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests conducted:
| Test Category | Standards Referenced | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Not specified |
| Software | Not specified | Not specified |
| Electrical | ANSI / AAMI / EN-60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance | Not specified |
| Mechanical | ISO-11135-1 > Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical DevicesISO-9626 > Stainless Steel Needle Tubing for the Manufacture of Medical DevicesISO-7864 > Sterile Hypodermic Needles for Single Use | Not specified |
The conclusion states: "The changes made were tested using the same acceptance criteria as the predicate device and provide objective evidence that there are no new risks and the device is substantially equivalent." This implies that the mi-eye 2 met the acceptance criteria established for its predicate device (K141119 – mi-eye Camera Enabled Probe), but the specific criteria and performance values are not detailed here.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for the test set for any of the listed tests (biocompatibility, software, electrical, mechanical). It generally refers to "representative samples of the device."
The data provenance is not mentioned. It is implied to be from the manufacturer's internal testing as part of the 510(k) submission process, but no details regarding the country of origin of data or whether it was retrospective or prospective are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided because the testing described (biocompatibility, electrical, mechanical, software) are typically engineering and laboratory-based tests, not clinical studies requiring expert ground truth for interpretation. The device itself provides visualization, and its performance testing focuses on its ability to generate images, not on the interpretation of medical images by experts.
4. Adjudication Method for the Test Set:
Not applicable, as the tests described are technical performance evaluations, not clinical interpretations requiring adjudication.
5. 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:
No MRMC comparative effectiveness study is mentioned. This device is an arthroscope for direct visualization, not an AI-powered diagnostic tool that assists human readers in interpreting medical images. Therefore, the concept of human readers improving with or without AI assistance is not relevant to the described device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The mi-eye 2 is a visualization device, not an algorithm. Its performance is inherent in its ability to capture and display images, which is directly observed and used by a human operator (the surgeon or clinician).
7. The Type of Ground Truth Used:
For the technical performance tests (biocompatibility, electrical, mechanical, software), the "ground truth" would be established by the specifications and standards themselves (e.g., a certain level of electrical safety, material biocompatibility, mechanical durability). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for these types of tests.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
In summary, the provided document focuses on the technical and safety aspects of the mi-eye 2 device as part of a 510(k) submission, confirming its substantial equivalence to a predicate device. It does not contain information related to clinical performance studies involving interpretation of medical images or AI algorithms.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
Trice Medical, Inc. Ms. Tiffini Diage Consulting Director, Regulatory Affairs 1000 Continental Dr. Suite 240 King Of Prussia, Pennsylvania 19406
Re: K162475
Trade/Device Name: mi-eye 2, mi-eye 2 Monitor Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 30, 2016 Received: September 7, 2016
Dear Ms. Diage:
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 (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. 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.
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 devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth
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in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Christopher J. Ronk -S
Fox Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162475
Device Name mi-eye 2, mi-eye 2 monitor
Indications for Use (Describe)
The mi-eye 2 is indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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
| Submitter: | Trice Medical, Inc.1000 Continental Drive, Suite 240King of Prussia, PA 19406 |
|---|---|
| Contact Person: | Tiffini DiageConsulting Director Regulatory AffairsPhone: 707.799.6732E-mail: tdiage@raechelon.com |
| Trade Name: | mi-eye 2, mi-eye 2 Monitor |
| Common Name: | Arthroscope |
| Classification: | Class II |
| Product Code: | HRX, 888.1100 |
| 510(k) Number | K162475 |
| Predicate Device(s): | The subject device is equivalent to the following devices:• K141119 – mi-eye Camera Enabled Probe |
| Device Description: | The Camera Enabled Probe is a battery operated, portable,visualization device that uses a probe with integrated cameraand separate LCD monitor attached via cable. The sterile,single-use probe includes the camera and image capture featureswith LED light source. The LCD Monitor displays real-timevideo from the probe and is attached via cable to provide powerto the probe. The probe scope extends from the handle as a rigidshaft with retractable needle and flushing port for cleaning thefield of view. The distal tip of the probe contains the camera,illumination, and imaging optics.The mi-eye 2 devices are identical in design and function andavailable in three lengths: 50mm, 95mm, and 160mm. Themonitor has a 10.8" (diagonal) screen. The entire unit weight isless than 300 grams. |
| Indication for Use: | The mi-eye 2 device is indicated for use in diagnostic andoperative arthroscopic and endoscopic procedures to provideillumination and visualization of an interior cavity of the bodythrough either a natural or surgical opening. |
| Functional andSafety Testing: | To verify that device design meets its functional andperformance requirements, representative samples of the deviceunderwent biocompatibility, software, electrical, and mechanicaltesting in accordance with the following industry standards.ISO 10993-1:2009 Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management processANSI / AAMI / EN-60601-1-2 Medical Electrical Equipment --Part 1-2: General Requirements for Basic Safety and EssentialPerformanceISO-11135-1 > Sterilization of Health Care Products. EthyleneOxide. Requirements for Development, Validation and RoutineControl of a Sterilization Process for Medical DevicesISO-9626 > Stainless Steel Needle Tubing for the Manufactureof Medical DevicesISO-7864 > Sterile Hypodermic Needles for Single Use |
| Conclusion: | The changes made to the previously cleared mi-eye CameraEnabled Probe (now called mi-eye 2) device do not affect theestablished safety and efficacy of the device. Mi-eye 2 isequivalent to the predicate device. This conclusion is basedupon the devices' identical indications for use, principles ofoperation, technology, and performance specifications. Thechanges made were tested using the same acceptance criteria asthe predicate device and provide objective evidence that there areno new risks and the device is substantially equivalent. |
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§ 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.