(88 days)
No
The description of the software focuses on image enhancement (removing pixelation) and recording/archiving capabilities, with no mention of AI or ML algorithms for analysis, interpretation, or decision support.
No.
The device is used for viewing the interior cavity of the human body for diagnostic purposes, not for treating any condition.
Yes
The device description explicitly names the product as the "InnerVue™ Diagnostic Scope System." The intended use also mentions viewing the interior cavity of the human body, a common purpose for diagnostic medical devices.
No
The device description explicitly lists multiple hardware components (Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece, etc.) in addition to the 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 "viewing the interior cavity of the human body through either a surgical or natural opening." This describes a device used for direct visualization within the body, not for testing samples outside the body.
- Device Description: The components described (scope, light source, camera, etc.) are consistent with an endoscope or similar visualization device used for internal examination. There is no mention of reagents, assays, or any components typically associated with in vitro testing of biological samples.
- Anatomical Site: The device is used within the "interior cavity of the human body," which is the site of examination, not the source of a sample for testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device is for direct visual inspection of internal structures.
N/A
Intended Use / Indications for Use
This device is to be used by a trained physician for viewing the interior cavity of the human body through either a surgical or natural opening.
Intended Use: Single use (disposable) scope.
Product codes
GCJ
Device Description
The InnerVue™ Diagnostic Scope System consists of 5 main parts; the hardware, the software, the scope, the instrumentation and the procedural kit.
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 pixelation. 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 fiberoptic scope designed for one time use.
Supplemental Instruments: Supplemental instruments consist of 4 pieces that can be used interchangeably throughout the procedure. The four components of the instrumentation are the cannula, the trocar, the obturator, and the cannula plug.
Procedural Kit: The procedural kit contains many sterile items to aid in the procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Interior cavity of the human body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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)
Non-Clinical Testing: Establishment of equivalence is based on similarities of intended use, Non-offinour Footing, busical characteristics and geometry between the InnerVue™ Diagnostic Scope System and Davlite Microendoscope (K020310)
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Davlite Microendoscope, K020310
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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JUN - 4 2004
BIOMET
510(k) Summary
| Applicant/Sponsor: | Arthrotek, Inc.
(A wholly owned subsidiary of Biomet, Inc.)
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kacy Arnold, RN, MBA
Regulatory Specialist |
| Proprietary Name: | InnerVue™ Diagnostic Scope System |
| Common Name: | Diagnostic Endoscope |
| Classification Name: | Endoscope |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Davlite Microendoscope, K020310 .
Device Description:
The InnerVue™ Diagnostic Scope System consists of 5 main parts; the hardware, the software, the scope, the instrumentation and the procedural kit.
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 pixelation. 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 fiberoptic scope designed for one time use.
Supplemental Instruments:
Supplemental instruments consist of 4 pieces that can be used interchangeably throughout the procedure. The four components of the instrumentation are the cannula, the trocar, the obturator, and the cannula plug.
MAILING ADDRESS - MAILENG ADDRESS
Wasaw, IN 46581-0587 - 1587 - 19 - 30- - 36 - Bell Drives.
Wasaw, IN 46581-0587 - 15-87 - 1 - - Warsaw, IN - 06583
- 10-587 - 10-46581-0587 - 1 - FAX
.
SHIPPING ADDRESS Warsaw, IN 16582
()FFICIC ) /s / 1 . 2(s / (s(s 34) 1574267 8137 8137 8137 878 878 878 87 87 87 87 157 113 41 41 41 41 41 11 41 11 41 11 41 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 158
. E MAHI. Diomet@biomet con
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Procedural Kit:
The procedural kit contains many sterile items to aid in the procedure.
Indications for Use: This device is to be used by a trained physician for viewing the interior cavity of the human body through either a surgical or natural opening.
Intended Use: Single use (disposable) scope.
Summary of Technologies: The InnerVue™ Diagnostic Scope System technological characteristics are similar to predicate devices.
Non-Clinical Testing: Establishment of equivalence is based on similarities of intended use, Non-offinour Footing, busical characteristics and geometry between the InnerVue™ Diagnostic Scope System and Davlite Microendoscope (K020310)
Clinical Testing: Clinical testing was not used to establish substantial equivalence to predicate devices.
All trademarks are property of Biomet, Inc.
2
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN = 4 2004
Ms. Kacy Arnold, RN, MBA Arthrotek, Inc. 56 E. Bell Drive P.O. Box 587 Warsaw, Indiana 46581
Re: K040604
R0400 F
Trade/Device Name: InnerVue™ Diagnostic Scope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 5, 2004 Received: March 8, 2004
Dear Ms. Arnold:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative) it stgms J the Medical Device Amendments, or to commerce phor to may 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Costience Act (71ct) that to neview, subject to the general controls provisions of the Act. The r our may, merelore, mains of the Act include requirements for annual registration, listing of general controls proficions a ractice, 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 If your device is classified (600 worrols. Existing major regulations affecting your device can may be subject to such additional resultations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outseenents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean F lease oe advised that i Dri brisantes or our device complies with other requirements of the Act that I DA has made a actor manalations administered by other Federal agencies. You must of ally it cacal statutes and registments, including, but not limited to: registration and listing (21 Compry will an the Fiel 310ccases and 01); good manufacturing practice requirements as set CTN i at 807), adocing (21 OF R Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Kacy Arnold, RN, MBA
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manothing of substantial equivalence of your device to a legally premarket notification. The PDA midnig of bassantal experience 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 If you desire specific advice for your as (301) 594-4659. Also, please note the regulation entitled, Colliact the Office of Complanes as (sot notification" (21CFR Part 807.97). You may obtain Misbraining by reference to premainters so premainter the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Sincerery, yours,
Mark A. Millerson
Celia M. Witten, Ph.D., M.D. 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):
KOAD604 ______________________________________________________________________________________________________________________________________________________________________
Device Name:
InnerVue™ Diagnostic Scope System
Indications For Use:
This device is to be used by a trained physician for viewing the interior cavity of the human body this device a surgical or natural opening.
Prescription Use X AND/OR Over-The-Counter Use _______
(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
for
Mule
Concurrence of
Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K040604 |
|---|---|
| --------------- | --------- |
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