(66 days)
Not Found
No
The document describes a standard imaging system with image processing hardware, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is indicated for diagnostic and operative 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 MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures".
No
The device description explicitly states that the system is comprised of sterile, single-use scopes with camera, image capture, and LED light source features, and a reusable tablet. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the MIDASVu 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 and visualization of interior cavity joints and other body cavities". This describes a device used in vivo (within the living body) for direct visualization during medical procedures.
- Device Description: The description details a system for acquiring, displaying, and recording images from within the body. It involves scopes inserted into body cavities.
- Input Imaging Modality: The input is "Optical (arthroscopic/endoscopic)", which is a method of imaging within the body.
- Anatomical Site: The anatomical sites are "interior cavity joints and other body cavities", which are locations within the living body.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) outside of the body (in vitro) to provide information about a patient's health. The MIDASVu operates inside the body to provide visual information during a procedure.
N/A
Intended Use / Indications for Use
The MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.
Product codes
HRX, GCJ
Device Description
MIDASVu is an advanced imaging system comprised of sterile, single-use scopes (0° and 30° viewing angle) and a reusable tablet. The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and tablet work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.
Mentions image processing
A lens is located on the distal tip of the scope, which forms the image onto the CMOS sensor (400 x 400 pixels) and the digital signal is transmitted via electrical wires to image processing hardware.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interior cavity joints and other body cavities
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)
The MIDASVu underwent non-clinical testing to confirm safety, effectiveness, and performance. Electrical safety and EMC testing met IEC 60601 standards, while software validation ensured intended functionality. Biocompatibility testing per ISO 10993 confirmed material safety, and performance and environmental tests verified durability under stress. Software and cybersecurity measures were validated. Results demonstrate the device is as safe and effective as the predicate for its intended use.
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
December 2, 2024
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
IntraVu, Inc. Jenna Rapoport VP, Quality 610 Price Ave Redwood City, California 94063
Re: K243020
Trade/Device Name: MIDASVu Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GCJ Dated: August 27, 2024 Received: September 27, 2024
Dear Jenna Rapoport:
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.
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).
1
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature includes the name "JESSE MUIR -S" on the left side of the image. On the right side, it states "Digitally signed by JESSE MUIR -S" followed by the date "2024.12.02" and the time "14:41:29 -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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
MIDASVu
Indications for Use (Describe)
The MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
IlntraVu®
K243020
MIDASVU
510(K) SUMMARY
| Date | November 26, 2024 |
|---|---|
| Submitter: | IntraVu Inc. |
| Address: | 610 Price Avenue |
| Redwood City, CA 94063 | |
| Contact Person: | Jenna Rapoport |
| Telephone: | 650-771-9373 |
| Email: | jenna@intravu.com |
| Device Trade Name: | MIDASVu |
| Common Name: | Arthroscope |
| Classification Name | |
| and Number: | Arthroscope |
| 21 CFR 888.1100 | |
| Device Classification: | II |
| Product Code: | HRX |
| Legally Marketed | |
| Predicate Device: | MIDAScope and Introducer Kit, and MIDASystem (K181982) |
| Product Code HRX, 21 CFR 888.1100 | |
| Description of the | |
| MIDASVu | MIDASVu is an advanced imaging system comprised of sterile, |
| single-use scopes (0° and 30° viewing angle) and a reusable tablet. | |
| The scopes include camera and image capture features with LED | |
| light source. The distal tip of the scopes contains the camera, | |
| illumination, and imaging optics. The scopes are available in three | |
| lengths: 60mm, 90mm, and 120mm. The scopes and tablet work in | |
| concert as a system to acquire, display and record an intra-articular | |
| image as well as store images and video taken during the | |
| procedure. | |
| Indications for Use of | |
| the MIDASVu | MIDASVu is indicated for use in diagnostic and operative |
| arthroscopic and endoscopic procedures to provide illumination and | |
| visualization of interior cavity joints and other body cavities through | |
| a natural or surgical opening. |
5
118
MIDASVU 510(K) SUMMARY
Performance Data: The MIDASVu underwent non-clinical testing to confirm safety, effectiveness, and performance. Electrical safety and EMC testing met IEC 60601 standards, while software validation ensured intended functionality. Biocompatibility testing per ISO 10993 confirmed material safety, and performance and environmental tests verified durability under stress. Software and cybersecurity measures were validated. Results demonstrate the device is as safe and effective as the predicate for its intended use. None
Results of Clinical Studies:
Summary of Technological Characteristics:
| IntraVu, Inc: MIDAScope and Introducer Set, and MIDASystem (K181982) | IntraVu, Inc: MIDASVu | |
|---|---|---|
| Components | Disposable scope + reusable system | Same |
| Usage | Single use, disposable scope and reusable system | Same |
| Scope | ||
| Imaging Optics | Scope contains camera, illumination (LED light source) and imaging optics | Same |
| Scope Shaft | Rigid stainless-steel shaft | Same |
| Sterility | Sterile (ethylene oxide), SAL 10-6 | Same |
| Rigidity | Rigid | Same |
| Maximum Insertion Portion width | 1.5 mm | Similar |
| Working Lengths | 60 mm, 90 mm, and 120 mm | Same |
| Field of View (FOV) | 90° in air | Similar |
| Direction of View | 0° | Different, due to addition of 30° scope |
| Optics and Image Acquisition | A lens is located on the distal tip of the scope, which forms the image onto the CMOS sensor (400 x 400 pixels) and the digital signal is transmitted via electrical wires to image processing hardware. Light fibers run in the shaft to provide illumination from an LED that is housed inside the disposable handle. | Same |
| Scope to System Connection | The MIDAScope is connected via a proximal (permanently attached) electrical cable and proximal electrical connector to the MIDASystem for viewing. | Same |
6
MIDASVU
510(K) SUMMARY
| | IntraVu, Inc: MIDAScope and Introducer Set, and
MIDASystem (K181982) | IntraVu, Inc: MIDASVu |
|------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Tablet | |
| Electrical Power | The reusable MIDASystem with integrated LCD monitor
provides power to the scope via a cable from the scope to
the system. | Same |
| Display Type | HD touch screen; color LCD | Same |
| Resolution | 1024 x 768 (124 pixels per inch) | Same |
| Media Capture | None | Different, added feature |
| Data Transfer | None | Different, added feature |
The IntraVu's MIDASVu is substantially equivalent to the predicate Conclusion: device, IntraVu's MIDAScope and Introducer Kit, and MIDASystem (510(k) Number: K181982). Both devices share the same intended use, fundamental design, and core technology. The MIDASVu includes minor enhancements that do not affect the established safety and efficacy of the device. Non-clinical testing, including performance testing and safety assessments, demonstrated that the MIDASVu performs comparably to the predicate device and meets all applicable requirements. Therefore, the MIDASVu is as safe and effective as the predicate for its intended use.