(10 days)
Not Found
No
The description focuses on basic visualization technology (camera, monitor, light source) and does not mention any AI/ML capabilities or image processing beyond real-time display. The performance studies listed are standard for medical devices and do not indicate AI/ML validation.
No
The device is indicated for diagnostic and operative arthroscopic procedures to provide illumination and visualization, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The mi-eye 2 is indicated for use in diagnostic and operative arthroscopic procedures".
No
The device description clearly outlines hardware components including a probe with an integrated camera, LED light source, and a separate LCD monitor connected via cable. It also mentions mechanical and electrical testing, indicating a physical device.
Based on the provided information, the mi-eye 2 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "diagnostic and operative arthroscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening." This describes a device used for direct visualization within the body, not for testing samples outside the body.
- Device Description: The description details a probe with a camera and light source for internal visualization, a monitor to display the real-time video, and features for insertion into the body. This aligns with an endoscopic or arthroscopic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The mi-eye 2's function is to provide visual information directly from within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interior cavity of the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Functional and Safety Testing: To verify that device design meets its functional and performance requirements, representative samples of the device underwent biocompatibility, software, electrical, and mechanical testing 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 process
ANSI / AAMI / EN-60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance
ISO-11135-1 > Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices
ISO-9626 > Stainless Steel Needle Tubing for the Manufacture of Medical Devices
ISO-7864 > Sterile Hypodermic Needles for Single Use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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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
1
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 240
King of Prussia, PA 19406 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tiffini Diage
Consulting Director Regulatory Affairs
Phone: 707.799.6732
E-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 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. |
| Indication for Use: | The mi-eye 2 device is indicated for use in diagnostic and
operative arthroscopic and endoscopic procedures to provide
illumination and visualization of an interior cavity of the body
through either a natural or surgical opening. |
| Functional and
Safety Testing: | To verify that device design meets its functional and
performance requirements, representative samples of the device
underwent biocompatibility, software, electrical, and mechanical
testing 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 process
ANSI / AAMI / EN-60601-1-2 Medical Electrical Equipment --
Part 1-2: General Requirements for Basic Safety and Essential
Performance
ISO-11135-1 > Sterilization of Health Care Products. Ethylene
Oxide. Requirements for Development, Validation and Routine
Control of a Sterilization Process for Medical Devices
ISO-9626 > Stainless Steel Needle Tubing for the Manufacture
of Medical Devices
ISO-7864 > Sterile Hypodermic Needles for Single Use |
| Conclusion: | The changes made to the previously cleared mi-eye Camera
Enabled Probe (now called mi-eye 2) device do not affect the
established safety and efficacy of the device. Mi-eye 2 is
equivalent to the predicate device. This conclusion is based
upon the devices' identical indications for use, principles of
operation, technology, and performance specifications. 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. |
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