(33 days)
Not Found
No
The description focuses on basic image capture, display, and transmission, with no mention of AI/ML processing or analysis of the images.
No
The device is indicated for diagnostic and operative procedures to provide illumination and visualization of an interior cavity of the body, not to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in diagnostic and operative arthroscopic and endoscopic procedures".
No
The device description clearly outlines multiple hardware components including a probe with integrated camera and LED light source, a separate LCD monitor (mi-tablet 3) with internal battery and power supply, and a cable connecting the probe to the monitor. The device is a physical visualization system, not solely software.
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 illumination of an interior cavity of the body". This describes a procedure performed on the body to visualize internal structures, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a visualization tool (needlescope with camera and monitor) used to directly observe the inside of the body. It does not involve the analysis of biological samples like blood, urine, tissue, etc.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical/procedural tool for direct visualization.
N/A
Intended Use / Indications for Use
The mi-eye 3 needlescope™ with cannula, mi-eye tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination 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 mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is a portable visualization device that uses a probe with integrated camera and separate LCD monitor attached via a cable. The sterile, single-use needlescope probe includes the camera and image capture features with LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle.
The mi-eye 3 needlescope™ with cannula is available in 75 and 95mm lengths with 0 and 25 degree viewing angles, relative to the axis of the probe is packaged with a scalpel, cannula, obturator and switching stick for use in creating and maintaining the channel for the probe. The monitor has a 12" (diagonal) screen. The probe weight is under 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)
| Test | Method | Result |
|---|---|---|
| Biocompatibility | ISO 10993-1, ISO 10993-5 | Pass |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60529 | Pass |
| Packaging | ASTM D4169, ASTM F2096, ASTM F88/F88M, ISO 11607-1, ISO 11607-2 | Pass |
| Performance - Bench Irrigation Flow Tube strength | ISO 9626 | Pass |
| Shelf Life | ASTM F1980, ASTM F88/F88M, ISO 11607-1, ISO 11607-2 | Pass |
| Software V&V | IEC 62304 | Pass |
| Specification & Dimensional Analysis | ISO 594-1, ISO 594-2, ISO 7864, ISO 80369-7, ISO 9626 | Pass |
| Sterilization | ISO 11135, ISO 11737-1, ISO 10993-7 | Pass |
| Usability Validation | IEC 60601-1-6, IEC 62366-1 | Pass |
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.
0
September 15, 2021
Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Trice Medical, Inc. David Vancelette Vice President of Ouality Assurance & Regulatory Affairs 40 General Warren Blvd, Suite 100 Malvern, Pennsylvania 19355
Re: K212556
Trade/Device Name: mi-eye 3 needlescope™ with cannula, mi-tablet 3TM Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 12, 2021 Received: August 13, 2021
Dear David Vancelette:
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. 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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerely,
Laura C. Rose, 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K212556
Device Name
mi-eye 3 needlescope™ with cannula, mi-tablet 3TM
Indications for Use (Describe)
The mi-eye 3 needlescope™ with cannula, mi-eye tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination 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)
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."
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Image /page/3/Picture/0 description: The image shows the logo for Trice Medical. The logo consists of a blue circular icon on the left and the words "Trice Medical" in black on the right. The icon is a stylized design with three curved shapes arranged in a circular pattern.
1. 510(K) SUMMARY
| DATE | September 14, 2021 |
|---|---|
| APPLICANT | Trice Medical, Inc. |
| 40 General Warren Blvd | |
| Suite 100 | |
| Malvern, PA 19355 | |
| Tel: (610) 989-8080 | |
| Fax: (610) 706-5063 | |
| OFFICIAL | |
| CORRESPONDENT | David Vancelette |
| Trice Medical, Inc. | |
| 40 General Warren Blvd | |
| Suite 100 | |
| Malvern, PA 19355 | |
| dvancelette@tenexhealth.com | |
| Tel: (949) 238-8220 | |
| Fax: (949) 580-1270 | |
| TRADE NAME | mi-eye 3 needlescope™ with cannula, mi-tablet 3™ |
| COMMON NAME | Arthroscope |
| DEVICE | |
| CLASSIFICATION | Class II, 21 CFR §888.1100 |
| PRODUCT CODE | HRX: Arthroscope |
| PREDICATE DEVICE | mi-eye 2, mi-eye 2 monitor (K162475), now rebranded |
| as mi-eye 3, mi-tablet 3 | |
| SUBMISSION TYPE | Special 510(k). The subject device is a modification to |
| the previously cleared mi-eye 2, mi-eye 2 monitor | |
| (K162475). |
SUBSTANTIALLY EQUIVALENT TO:
The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is substantially equivalent to the previously cleared mi-eye 2, mi-eye 2 monitor (K162475).
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is a portable visualization device that uses a probe with integrated camera and separate LCD monitor attached via a cable. The sterile, single-use needlescope probe includes the camera and image capture features with
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Image /page/4/Picture/0 description: The image shows the logo for Trice Medical. The logo consists of a blue circular icon on the left and the words "Trice Medical" in black font on the right. The icon appears to be a stylized representation of three interconnected shapes.
LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle.
The mi-eye 3 needlescope™ with cannula is available in 75 and 95mm lengths with 0 and 25 degree viewing angles, relative to the axis of the probe is packaged with a scalpel, cannula, obturator and switching stick for use in creating and maintaining the channel for the probe. The monitor has a 12" (diagonal) screen. The probe weight is under 300 grams.
INDICATIONS FOR USE:
The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ 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.
| Property | Subject Device
mi-eye 3 needlescope™ with cannula, mi-
tablet 3™ | Predicate Device
mi-eye 2, mi-eye 2 monitor |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) Number | N/A | K162475 |
| Indications for Use | The mi-eye 3 with cannula 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. | Same |
| Operating Principles | Transmission of light to illuminate
and image an arthroscopic joint, then
relaying the image out of the surgical
site for processing and display. | Same |
| Property | Subject Device
mi-eye 3 needlescope™ with cannula, mi-
tablet 3™ | Predicate Device
mi-eye 2, mi-eye 2 monitor |
| Principle Components | • Imaging Probe with camera, rigid shaft, handle and output cable.
• LCD Display Monitor
• Irrigation channel for user supplied solution
• Scalpel, Cannula, Obturator and Switching Stick (for establishing arthroscope channel) | Same
Same
Same
N/A |
| Materials | | |
| Probe & Patient
contacting features | 304 Stainless Steel | Same |
| Battery | Lithium Ion | Same |
| Technological Characteristics | | |
| Probe Handle Size | 35 - 55mm diameter | Same |
| Probe Needle Outer
Diameter | 2.3mm | Same |
| Probe Cannula Outer
Diameter | 2.9mm | None |
| Working Probe
Lengths | 75 and 95mm | 50, 95, 120 and 160mm |
| Camera Angle | 0 and 25 degrees | 0 and 15 degrees |
| Camera + Display
Resolution | 400 x 400 | Same |
| Image leveling | Image stabilized for probe's position (display
does not rotate). Arrow indicating the top side
of probe handle rotates in the image. | Top of probe always
oriented at top of display
(display rotates as probe
rotates) |
| Tablet Operating
System | MS Windows 10 Pro | Same |
| Display output | HDMI and SDI | Same |
| Media capture | USB, DB9 and TRS | Same |
| Irrigation with Angled
View Probe | User attached solution is channeled through
the annulus between the two tubes to the distal
end of the probe | None |
| Packaging for Single
Use Probe | Sealed Tyvek lid and thermal formed tray | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Sterility Assurance
Level | 10-6 | Same |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
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Image /page/5/Picture/0 description: The image shows the logo for Trice Medical. The logo consists of a blue circular icon on the left and the words "Trice Medical" in black on the right. The icon is a stylized design with three curved shapes converging in the center, resembling a three-leaf clover or a stylized medical symbol.
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Image /page/6/Picture/0 description: The image shows the logo for Trice Medical. The logo consists of a blue circular icon with three curved shapes inside, resembling a stylized flower or a three-way intersection. To the right of the icon, the words "Trice Medical" are written in a simple, sans-serif font, with the first letter of each word capitalized.
PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
|---|---|---|
| Biocompatibility | ISO 10993-1 | |
| ISO 10993-5 | Pass | |
| Electrical Safety & EMC | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-18 | ||
| IEC 60529 | Pass | |
| Packaging | ASTM D4169, ASTM F2096, ASTM | |
| F88/F88M, ISO 11607-1, ISO 11607-2 | Pass | |
| Performance - Bench | ||
| Irrigation Flow | ||
| Tube strength | ISO 9626 | Pass |
| Shelf Life | ASTM F1980, ASTM F88/F88M, ISO 11607-1, | |
| ISO 11607-2 | Pass | |
| Software V&V | IEC 62304 | Pass |
| Specification & | ||
| Dimensional Analysis | ISO 594-1, ISO 594-2, ISO 7864, ISO 80369-7, | |
| ISO 9626 | Pass | |
| Sterilization | ISO 11135, ISO 11737-1, ISO 10993-7 | Pass |
| Usability Validation | IEC 60601-1-6, IEC 62366-1 | Pass |
CONCLUSION:
The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ Arthroscope is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the mi-eye 3 needlescope™ with cannula, mi-tablet 3™ Arthroscope when used as instructed.