(27 days)
No
The summary describes standard image processing software for display and does not mention any AI/ML capabilities or related performance metrics.
No.
Explanation: The device is indicated for providing illumination and visualization for diagnostic and operative procedures, which is a diagnostic function, not a therapeutic one.
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 states that the system includes hardware components such as a miniaturized, sterile, single-use disposable scope with an image sensor and LED, an Introducer Kit with cannula, trocar, and stopcock, and a reusable MIDASystem™ with an integrated LCD display. While software is mentioned for image processing and display, it is part of a larger hardware system.
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 and visualization of interior cavity joints and other body cavities". This describes a device used for direct visualization within the body, not for testing samples outside the body (in vitro).
- Device Description: The description details a scope, introducer kit, and a system for displaying images acquired from within the body. This aligns with an endoscopic or arthroscopic device, not an IVD.
- Input Imaging Modality: The input is "Optical (visualization)", which refers to capturing images of the internal anatomy. IVDs typically involve analyzing biological samples using various methods (chemical, immunological, molecular, etc.).
- Anatomical Site: The anatomical site is "interior cavity joints and other body cavities", confirming its use for internal examination.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on samples outside the body, which are hallmarks of IVD devices.
In summary, the MIDAScope™ and MIDASystem™ are devices used for direct visualization and imaging within the body for diagnostic and operative purposes, which falls under the category of medical devices used for internal examination, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MIDAScope™ and Introducer Kit, and MIDASystem™ are 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 (comma separated list FDA assigned to the subject device)
HRX, GCJ
Device Description
The MIDAScope™ is a miniaturized, sterile, single-use disposable scope. The image is acquired by an image sensor located at the distal tip. Illumination is provided by an LED and fibers when the disposable scope is connected to the reusable MIDASystem™ via an electrical cable. The scope is available in different lengths to accommodate different treatment locations. The scope is introduced into the joint space using the IntraVu disposable Introducer Kit, consisting of a cannula, trocar and stopcock, which are provided sterile in the same package as the scope.
The MIDASystem™ is a reusable device consisting of an integrated LCD display, and software that receives, processes and displays the images collected by the scope.
Mentions image processing
Yes
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
Prescription Use
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)
Performance testing of the MIDAScope and Introducer Kit, and MIDASystem included structural and functional performance, software validation, electrical and EMC, biocompatibility, packaging and sterilization studies. Devices were subjected to environmental conditioning and simulated distribution to assure devices will perform as intended during marketing distribution. All tests met the pre-determined acceptance criteria at baseline and after aging. The following FDA-recognized standards were followed and the acceptance criteria set forth in them were met:
Scope performance: ISO8600-1, ISO8600-3, and ISO8600-4
Biocompatibility: ISO10993-1
Packaging validation: ISO11607-1, ISO11607-2, ASTM D4169, ASTM F2096, ASTM F88/F88M
Sterilization validation: ISO11135, ISO10993-7, ISO11737-1
Aging: ASTM F1980
Environmental conditions: ASTM D4332
Electrical and EMC testing: IEC60601-1 and IEC60601-1-2
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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency's name in a lighter shade of blue.
August 21, 2018
IntraVu. Inc. % Mr. Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K181982
Trade/Device Name: MIDAScope and Introducer Kit, and MIDASystem Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GCJ Dated: July 23, 2018 Received: July 25, 2018
Dear Mr. Yungvirt:
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/cfpmr/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
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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 devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 entiled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Jennifer R. Stevenson
For 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) K181982
Device Name
MIDAScope™ and Introducer Kit, and MIDASystem™
Indications for Use (Describe)
The MIDAScope™ and Introducer Kit, and MIDASystem™ are 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) |
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510(K) SUMMARY
510(k) Applicant
IntraVu, Inc. 610 Price Avenue Redwood City, CA 94063 Phone: (650) 395-6067
Contact Person
Plamena Entcheva-Dimitrov, PhD Preferred Regulatory Consulting Inc. Phone: (650) 533-2253 Email: entcheva@preferredregulatoryconsulting.com
Date of Summary
20 Aug 2018
Device Overview
| Device Proprietary Name | MIDAScope™ and Introducer Kit, and MIDASystem™ |
|---|---|
| Product Class | II |
| Regulation Name | Arthroscope |
| Regulation Number | 888.1100 |
| Product Code | HRX |
| GCJ | |
| Panel | Orthopedic |
Predicate Device
| 510(k) Number | Product Name | Manufacturer |
|---|---|---|
| K162475 | mi-eye 2 and mi-eye 2 Monitor (primary predicate) | Trice Medical, Inc. |
| K141326 | NeedleView CHTM Scope Kits | BioVition Technologies, LLC |
| K152511 | Neo-ArthroscopeTM - Single Use Digital Video | |
| Arthroscopic System (reference device) | Prosurg, Inc. |
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Device Description
The MIDAScope™ is a miniaturized, sterile, single-use disposable scope. The image is acquired by an image sensor located at the distal tip. Illumination is provided by an LED and fibers when the disposable scope is connected to the reusable MIDASystem™ via an electrical cable. The scope is available in different lengths to accommodate different treatment locations. The scope is introduced into the joint space using the IntraVu disposable Introducer Kit, consisting of a cannula, trocar and stopcock, which are provided sterile in the same package as the scope.
The MIDASystem™ is a reusable device consisting of an integrated LCD display, and software that receives, processes and displays the images collected by the scope.
Intended Use
The device is intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.
Indications for Use
The MIDAScope™ and Introducer Kit, and MIDASystem™ are 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.
Comparison to Predicate Device
The MIDASystem and Introducer Kit and MIDAScope and predicate devices have the same intended use and thus fulfill the requirements of 513(i) of the FD&C Act (21 U.S.C. $ 360c(i)). Subject device and predicates are similar in design, principle of operation, components, users and use environment. The subject scope and its predicates are sterilized with ethylene oxide to yield SAL106. The subject system is reusable as are the predicate systems. The packaging of the MIDAScope (with the Introducer Kit), and MIDASystem and its predicates is similar and passed testing following the same internationally recognized standards. The subject device and the predicate devices were tested according to the same internationally recognized standards for electromagnetic compatibility, for electrical safety, and for biocompatibility and were shown to be safe and passed the standards' requirements.
Risks associated with the subject device and the predicates are similar. There are no significant technological differences between MIDASystem and MIDAScope (with the Introducer Kit) and the predicate devices.
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Therefore, in conclusion, the subject devices MIDAScope (with the Introducer Kit), and MIDASystem are substantially equivalent to the predicates.
Performance Testing
Performance testing of the MIDAScope and Introducer Kit, and MIDASystem included structural and functional performance, software validation, electrical and EMC, biocompatibility, packaging and sterilization studies. Devices were subjected to environmental conditioning and simulated distribution to assure devices will perform as intended during marketing distribution. All tests met the pre-determined acceptance criteria at baseline and after aging. The following FDA-recognized standards were followed and the acceptance criteria set forth in them were met:
| Scope performance: | ISO8600-1, ISO8600-3, and ISO8600-4 |
|---|---|
| Biocompatibility: | ISO10993-1 |
| Packaging validation: | ISO11607-1, ISO11607-2, ASTM D4169, ASTM |
| F2096, ASTM F88/F88M | |
| Sterilization validation: | ISO11135, ISO10993-7, ISO11737-1 |
| Aging: | ASTM F1980 |
| Environmental conditions: | ASTM D4332 |
| Electrical and EMC testing: | IEC60601-1 and IEC60601-1-2 |
Safety and Effectiveness and Conclusion
Based on the evaluation of intended use, performance characteristics and meeting FDArecognized standards for safety and performance, the MIDAScope™ and Introducer Kit, and the MIDASystem™ are substantially equivalent to the predicate device. The labeling of the MIDAScope and Introducer Kit, and MIDASystem contains instructions for use and any necessary cautions and warnings to assure safe and effective use of the device.