(183 days)
Not Found
No
The device description details a system that uses magnetic field detection and geometric calculations to determine and display the endoscope's position. There is no mention of AI or ML algorithms being used for signal processing, image creation, or any other function. The processing described is based on direct calculation of spatial coordinates from detected magnetic fields.
No
The device is described as detecting and displaying the shape and position of an endoscope, which is an imaging and navigation function, not a direct therapeutic action.
No
The device is designed to detect and display the shape of an endoscope once inserted into a patient, which is an imaging and positioning function, not diagnostic. It does not provide medical results or interpretations directly related to a disease or condition.
No
The device description explicitly details multiple hardware components: the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003), a RECEIVER DISH (MAJ-1868), and various cables (MAJ-1875, MAJ-1927, MAJ-1881). The device's function relies on the interaction of these hardware components (generating and detecting magnetic fields) to process data and create a visual image. While software is involved in processing the signals and creating the image, the device is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The core function of an IVD is to examine biological samples (like blood, urine, tissue, etc.) to provide information about a person's health.
- This device detects and displays the physical position of an endoscope. Its purpose is to visualize the shape and location of a medical instrument inside the patient's body using magnetic field detection. It does not analyze any biological specimens.
The device is a medical instrument used in conjunction with an endoscope system for procedural guidance and visualization, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
Product codes (comma separated list FDA assigned to the subject device)
FDF
Device Description
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
The device detects the magnetic field generated by magnetic coils built directly into the endoscope or the probe inserted into the endoscope's instrument channel.
This device consists of the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) and a RECEIVER DISH (MAJ-1868). The RECEIVER DISH is connected to the UPD-Y0003 via a RECEIVER DISH CABLE (MAJ-1875 or MAJ-1927).
The ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) supplies "driving" signals to the source coils in 1) the endoscope or probe, 2) the Hand Coil and 3) the Reference Plate. The endoscope and probe have plural source coils. The Hand Coil has one source coil. The Reference Plate has plural source coils. The driving signals are sent to each source coil. The driving signal is delivered to the endoscope or probe through a UPD CABLE (MAJ-1881). The driving signal is delivered to the Hand Coil through an integrated cable and the Reference Plate through an integrated cable.
When the source coils receive the driving signal, a magnetic field is generated. The magnetic field is then detected by the sense coils built into the RECEIVER DISH. The signals detected by each sense coil are processed in the UPD-Y0003. The UPD-Y0003 calculates the spatial coordinates for the specific source coil. This calculation is repeated for every source coil built into the endoscope or probe. The UPD-Y0003 then creates the visual image of the endoscope on the monitor, by then putting the spatial coordinates of the multiple source coils in order (distal to proximal) and connects them.
Akin to the methodology described above, the same process takes place for the reference plate and hand coil. The spatial coordinates data obtained from the source coils in the reference plate are used to create the standard plane of endoscope's position. The source coil in the "hand coil" is used to create an independent reference point in the field of view, as displayed on the video monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
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
§ 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.
0
510(k) SUMMARY
MAY 1 2 2011
ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003
May 11, 2011
1 General Information
- l OLYMPUS MEDICAL SYSTEMS CORP. Applicant: 2951 Ishikawa-cho, Hachioji-shi, Tokyo, 192-8507, Japan Establishment Registration No.: 8010047
- . Stacy Abbatiello Kluesner, M.S., RAC Official Correspondent: Regulatory Affairs & Quality Assurance Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610, USA Phone: 484-896-5405 FAX: 484-896-7128 Email: stacy kluesner@olympus.com 를
- Shirakawa Olympus Co., Ltd. Manufacturer: 3-1, Aza-Ookamiyama, Ooaza-Odakura, Nishigo-mura, Nishishirakawa-gun, Fukushima, Japan 961-8061 Establishment Registration No .: 3002808148
2 Device Identification
Device Trade Name: | UPD-Y0003 |
---|---|
Common Name: | ENDOSCOPE POSITION DETECTING UNIT |
Regulation Number: | 21 CFR 876.1500 |
Regulation Name: | Endoscope and accessories |
Regulatory Class: | II |
Classification Panel: | Gastroenterology/Urology |
Product Code: | FDF |
. 3 Legally Marketed Device to which Substantial Equivalence is Claimed
The following table shows the primary component (part of this submission) of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 and the device to which we claim substantial equivalence (predicate device).
1
Table 12-1 Primary Component & Predicate Device of the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003
| Subject Device
(Part of this Submission) | Predicate Device | PD's
510(k)
No. |
|------------------------------------------------|---------------------------------------------|-----------------------|
| ENDOSCOPE POSITION DETECTING
UNIT UPD-Y0003 | Endoscope Contour Detection Device
3DX45 | K002749 |
ঞ্চ Device Description
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
The device detects the magnetic field generated by magnetic coils built directly into the endoscope or the probe inserted into the endoscope's instrument channel.
This device consists of the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) and a RECEIVER DISH (MAJ-1868). The RECEIVER DISH is connected to the UPD-Y0003 via a RECEIVER DISH CABLE (MAJ-1875 or MAJ-1927).
The ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003) supplies "driving" signals to the source coils in 1) the endoscope or probe, 2) the Hand Coil and 3) the Reference Plate. The endoscope and probe have plural source coils. The Hand Coil has one source coil. The Reference Plate has plural source coils. The driving signals are sent to each source coil. The driving signal is delivered to the endoscope or probe through a UPD CABLE (MAJ-1881). The driving signal is delivered to the Hand Coil through an integrated cable and the Reference Plate through an integrated cable.
When the source coils receive the driving signal, a magnetic field is generated. The magnetic field is then detected by the sense coils built into the RECEIVER DISH. The signals detected by each sense coil are processed in the UPD-Y0003. The UPD-Y0003 calculates the spatial coordinates for the specific source coil. This calculation is repeated for every source coil built into the endoscope or probe. The UPD-Y0003 then creates the visual image of the endoscope on the monitor, by then putting the spatial coordinates of the multiple source coils in order (distal to proximal) and connects them.
Akin to the methodology described above, the same process takes place for the reference plate and hand coil. The spatial coordinates data obtained from the source coils in the reference plate are used to create the standard plane of endoscope's position. The source coil in the "hand coil" is used to create an independent reference point in the field of view, as displayed on the video monitor.
2
The following two modifications were made to the fundamental technology of the Subject
Device from the Predicate Device's:
-
The mechanism to drive the source coils
-
Calculation method of the spatial coordinate of each source coil
5 Indications for Use
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women
6 Comparison of Technological Characteristics
ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 is basically identical to its predicate device in intended use, and similar in specifications. Comparison between the subject and predicate devices is shown in Table 12-2.
Table 12-2 Comparison of Specifications
Subject Device: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 Predicate Device: Endoscope Contour Detection Device Olympus 3DX45 (K002749) Main unit
| Specifications | Subject Device
ENDOSCOPE POSITION
DETECTING UNIT UPD-Y0003 | Predicate Device
System Controller Unit
X301811 |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rated voltage | Voltage: 100-240V AC ±10%
Frequency: 50/60Hz ±1Hz | Voltage: 120V AC ±10%
Frequency: 50/60Hz ±1Hz |
| Power consumption | 110VA | 480VA |
| Unit composition | Monitor and receiver dish are
separated. | Monitor, receiving unit and the main
unit are built in one unit. |
| Dimensions | 370(W) x 482(D) x 81(H)mm | 490(W) x 500(D) x 1820(H) mm |
| Weight | 9kg | 59kg |
| Specification for Scope
Model display | -The Display now shows the
insertion portion even where a
source coil is not installed, areas
outside the detection area, and
areas in which a source coil is
broken, | -Displayed in a shaft shape or in a
polygonal line graph.
-The part of The insertion portion
where source coil is not installed is
not displayed. |
| Display of overlapping
intersection area | Available | Not available |
| Scope/probe/reference
plate/hand marker
Connection Indicator | Available | Not available |
| Viewpoint indicator display | Select from the following:
-Operating image model
-Figure image model | Select from the following:
-Operating table model
-Coordinate axis model
-Simultaneous display of Operating
table model and Coordinate axis
model |
| Patient data display | Patient ID, patient name, age and
sex. | Patient ID |
| Error message display | Available | Not available |
| Display rotation | -Scope model is rotated by 90
degrees to left and right by one
push of the switch.
-Depending on the setting on the
menu, scope model is rotated by
every 2.5 degrees vertically and
horizontally. | -Scope model is rotated by every
2.5 degrees vertically and
horizontally. |
| Setting for the display start
position of the scope model
(Scope position) | -Setting method: Using external
marker or the position of the distal
end of the endoscope.
-Display start position: Bottom
center or top center of display. | -Setting method: Using external
marker.
-Display start position: Center of
display. |
| Marking | Available | Not available |
| Background color | The user can choose from three
predefined background colors. | -It is set by adjusting the RGB
density. |
| Display of the distal end of
scope model | The distal end of a scope model is
displayed in yellow. | -The user can choose whether to
display the distal end of a scope
model in yellow or not. |
| Detection of the source coil
wire break | Source coil wire break is detected
automatically and reflected on the
scope model display. | Manually input the number of the
broken source coil to reflect it on
the scope model display. |
| Change of the display mode | Display of the scope model can be
set by the user:
-Displayed from the bottom
(standard setting)
-Displayed from the top | Not available |
| Scope model thickness
setup | Adjustable.
The size of external marker
changes depending on the scope
model thickness. | Adjustable.
The size of external marker does
not change. |
| Show/hide information | Show/Hide various information
individually. | Show/Hide information cannot be
set individually. It is either show or
hide all information. |
| Saving and recalling the
setting | Save 20 presets. | Save only one preset. |
| Patient data | Input via a communication
connector via video system center.
And patient data is displayed. | Input with Ten-key pad. And patient
data is displayed. |
| Video signal output | -Y/C: 1
-SD-SDI: 1
-XGA: 1 | VGA: 1 |
| Communication terminal | RS232C: 1 | Not available |
| Receiving antenna input
terminal | One. | Not available |
| Driving signal output
terminal for external marker | Two. | One. |
| Driving signal output
terminal for reference plate | Two. | One. |
| Safety standards | IEC 60601-1 Ed.2
IEEE Std C95.1, 2005 +
Amendment 1:2010 | IEC 60601-1
IEEE Std C95.1, 1999 |
| EMC compliance | Class B | Class A |
| Plate cover | REFERENCE PLATE COVER
MAJ-1880 is provided | Not provided |
| Installation on the patient: | Fasten the reference plate with a
belt on the patient (body surface). | Attach the reference place on the
patient's body (over the gown) with
surgical tape. |
3
4
7 Summary of non-clinical testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verifications tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.
The software validation activities were performed in accordance with the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The device software is considered a "Minor Level of Concern."
The following standards have been applied to the ENDOSCOPE POSITION DETECTING UNIT (UPD-Y0003):
-IEC 60601-1: 1988, Amendment 1: 1991, Amendment 2: 1995 -IEC 60601-1-1: 2000 -IEC 60601-2-18: 1996, Amendment 1: 2000 -IEC 60601-1-2: 2007 -ISO 14971: 2007 -IEEE Std C95.1: 2005+ Amendment 1: 2010
8 Conclusion
When compared to the predicate device, the ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003 does not incorporate any significant changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G6 Silver Spring, MD 20993-0002
MAY 1 2 2011
Olympus Medical Systems Corporation c/o Stacy Abbatiello Kluesner, M.S., RAC Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway P.O. Box 610 CENTER VALLEY PA 18034-0610
Re: K103312
Trade/Device Name: ENDOSCOPE POSITION DETECTION UNIT UPD-Y0003 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDF Dated: April 12, 2011 Received: April 14, 2011
Dear Ms. Kluesner:
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. 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
6
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Hubert H Humphrey
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known):
Device Name: ENDOSCOPE POSITION DETECTING UNIT UPD-Y0003
Indications for Use:
This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient.
Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
(Division Sign-Off) |
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Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K1033/2
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