(97 days)
No
The description of the software focuses on image enhancement (removing pixilation) and recording/archiving capabilities, with no mention of AI or ML algorithms for analysis, interpretation, or decision support.
No
The device is described as a "Diagnostic Scope System" used for visualization, recording, and imaging during diagnostic and operative arthroscopic and endoscopic procedures, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures..."
No
The device description explicitly lists multiple hardware components (Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece, scope, supplementary instruments, procedural kits) in addition to the software.
Based on the provided information, the InnerVue™ Diagnostic Scope System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc. The tests are performed in vitro (in glass, or outside the body).
- The InnerVue™ Diagnostic Scope System is used for in vivo (within the body) visualization. Its intended use is to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening. This is a direct examination of the body's internal structures, not an analysis of a specimen taken from the body.
The device is clearly described as an arthroscopic and endoscopic system used for diagnostic and operative procedures within the body. This falls under the category of surgical or diagnostic imaging devices used in vivo, not IVD devices.
N/A
Intended Use / Indications for Use
The InnerVue™ Diagnostic Scope System 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. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.
Product codes
HRX, GCJ
Device Description
The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).
Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.
Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.
Scope: A rigid fiber optic scope designed for one-time use.
Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.
Procedural Kits: Supplementary items to assist in the surgical procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.
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)
Clinical Testing: None provided as a basis for substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043395, K040604, K030096, K002931, K920800
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.
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- 1 e.t 2
BIOMET
INC.
510(k) Summary InnerVue™ Diagnostic Scope System
| Preparation Date: | December 20, 2007 | JAN 1 4 2008 |
|---|---|---|
| Applicant/Sponsor: | Biomet Sports Medicine | |
| 56 East Bell Drive | ||
| Warsaw, Indiana 46582 | ||
| Contact Person: | Susan Alexander | |
| Regulatory Affairs Specialist | ||
| Proprietary Name: | InnerVue™ Diagnostic Scope System | |
| Common Name: | Arthroscope, endoscope | |
| Classification Name: | Arthroscope, 21 CFR §888.1100, HRX | |
| Endoscope, 21 CFR §876.1500, GCJ |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
| Video Arthroscope | K043395 | Smith & Nephew |
|---|---|---|
| InnerVue™ Diagnostic Scope System | K040604 | Arthrotek, Inc. (Biomet Sports Medicine) |
| Arthrex Arthroscopes | K030096 | Arthrex, Inc. |
| METRx™ System | K002931 | Medtronic Sofamor Danek |
| Integrated Endoscopy System | K920800 | Integrated Endoscopy System |
Device Description: The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).
Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.
Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.
Scope: A rigid fiber optic scope designed for one-time use.
Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.
Procedural Kits: Supplementary items to assist in the surgical procedure.
Clinical Testing: None provided as a basis for substantial equivalence.
Mailing Address: PO Box 587 Warsaw, IN 46581-0587 Toll Free: 800,348,9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomet.com
Shipping Address: 56 Fast Roll Drive Warsaw, IN 46582
1
072879
: 01 2
Indications for Use: The InnerVue™ Diagnostic Scope System 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. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.
Summary of Technologies: The technological characteristics of the InnerVue™ Diagnostic Scope System are the same as, or similar to, the predicate devices.
Performance and Safety Testing
The InnerVue™ Diagnostic Scope System complies with Can/CSA C22.2 No 601.1-M90 - Safety of Medical Electrical Equipment, part 1., General; CSA 601.1 Supplement 1:1994 - Requirements for Safety, CSA 601.1 Amendment 2:1998, CAN/CSA C22.2 No. 60601-2-18-01 - Particular Requirements for the Safety of Endoscopic Equipment, UL Std No 60601-1(1st Edition) - Safety of Medical Equipment , Part I: General Requirements for Safety and IEC 60601-2-18(1996) 2nd Edition.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human form or a caduceus, rendered in black.
Public Health Service
JAN 1 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Manufacturing Corp. % Ms. Susan Alexander Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K072879
Trade/Device Name: InnerVue™ Diagnostic Scope System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: December 20, 2007 Received: December 21, 2007
Dear Ms. Alexander:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Susan Alexander
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):_
Device Name: InnerVue™ Diagnostic Scope System
Indications for Use:
The InnerVue™ Diagnostic Scope System 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. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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State bill Be Division of Ge and Neurologica
510 Number 16072875