(254 days)
Not Found
Not Found
No
The description focuses on sensory signal processing and calculation for image display, without mentioning AI/ML algorithms or training/test data for such models.
No
The device provides imaging for diagnostic purposes (visualizing an endoscope's position) and does not directly treat or prevent a disease or condition.
Yes
The device provides a three-dimensional image of an endoscope inside a patient, which assists physicians in understanding the endoscope's position. While it doesn't diagnose a patient's condition directly, it provides diagnostic information by visualizing the endoscope's location during an endoscopic procedure, which is often performed for diagnostic purposes. Its purpose is to provide information for "understanding" an internal condition or process, which aligns with the definition of a diagnostic device.
No
The device description explicitly lists multiple hardware components beyond just software, including a computer, signal processing unit, sensor catheter, sensor catheter transport unit, and a mobile stand.
Based on the provided information, the Imaging Jet System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The "in vitro" part means "in glass" or "in a test tube," referring to tests performed outside the living body.
- Imaging Jet System's Function: The Imaging Jet System provides a spatial image of an endoscope inside a patient. It measures the shape of the endoscope within the body using a sensor catheter inserted into the biopsy channel.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It is focused on visualizing the position and shape of a medical instrument within the body.
Therefore, the Imaging Jet System falls under the category of a medical device used for imaging or visualization in vivo (within the living body), rather than an IVD.
N/A
Intended Use / Indications for Use
The Imaging Jet System provides physicians with a three dimensional image of an endoscope inside a patient.
Product codes (comma separated list FDA assigned to the subject device)
78 KOG, 78 JAB
Device Description
The Imaging Jet is an endoscopic accessory that provides a spatial view of an endoscope inside a patient. When in use, the sensor catheter is inserted into the biopsy channel of an endoscope inside a patient. The sensor catheter measures the shape of a scope and sends sensory signals to a computer for calculating and displaying the image on the computer screen.
A complete Imaging Jet system consists of the following major components as shown in: (1). a computer which governs the operation of the whole system, calculates the scope spatial image and displays the image; (2). a signal processing unit which acquires and processes the sensory signals and supplies them to the computer for image calculation; (3). a sensor catheter which is a long flexible rod with sensors embedded inside in its head portion; (4). a sensor catheter transport unit which is used to insert and withdraw sensor catheter into and from the biopsy channel of a scope; and (5). a mobile stand for transporting the whole system. The signal processing unit houses all the electronics and power supplies to the system. The unit measures 400 mm × 300 mm × 100 mm (L×W×H) and weighs about 3 kg. The sensor catheter consists of two segments. At the tip of the catheter, there is a sensor head segment where sensors are embedded. The rest is used to provide the necessary length. The sensor catheter transport unit is used to automatically insert and withdraw sensor catheter into and from the biopsy channel of a colonoscope. This will reduce the work load on the physician, meanwhile maintains a smooth sensor motion that will result in good quality of sensor signals. The sensor catheter should be loaded into the transport unit prior to an operation by doctor's assistant. This unit also generates feedback to the control unit so that the actual insertion motion of the catheter can be monitored and controlled. The sensor catheter transport unit delivers the sensor catheter through the biopsy channel of an endoscope. During insertion, the catheter detects curvature of the path of the biopsy channel and sends electrical signals to the signal processing unit. The computer interfaces with the signal processing unit and calculates the image of the endoscope. After the computer calculates the image of the endoscope, it displays the image onto the computer screen in a three dimensional manner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
inside a patient, colon, small bowel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, doctor's office
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory tests were conducted to test the performance of the Imaging Jet system in terms of the overall image calculation capability. A colonoscope was used to form different shapes. Then the Imaging Jet system was used to measure these shapes. The images of the actual scope and the measured images using Imaging Jet were assessed and compared.
Key result: The Imaging Jet system is capable of generating images with sufficient accuracy for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The shape measurement accuracy of this device is ±4%. This accuracy is sufficient for its intended use.
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.
Not Found
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
§ 892.1660 Non-image-intensified fluoroscopic x-ray system.
(a)
Identification. A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a logo with the letters "IRI" inside of an oval. The letters are stylized and connected to each other. The logo is black and white and appears to be a simple design. The letters are bold and easy to read.
General Robotic Devices, Inc.
2069 Golfside Drive ● Ypsilanti, MI 48197 ● Tel: 313-572-1102 ● Fax: 313-572-1132
fi of ic.
510(K) SUMMARY
Company:
General Robotic Device, Inc. 2069 Golfside Drive Ypsilanti, Michigan 48197
Nov 13 1997
K970782
Contact Person:
Yansong Shan, Ph.D. Phone: 313-572-1102 Fax: 313-572-1132
Date of Summary Preparation
February 28, 1997
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1. DEVICE IDENTIFICATION
| Device Name: | Spatial Imaging Sensor for Endoscopy |
|---|---|
| Trade Name: | Imaging Jet |
| Proprietary Name: | Imaging Jet |
| Classification Name: | Endoscope and accessories |
| 21 CFR 876.1500 | |
| Classification: | Class II |
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2. Predicate Devices
-
- X-ray fluoroscopy instrument by Picker International, Inc. (Cleveland, OH)
-
- Endoscope and Accessories: Measuring Device by Olympus, Inc.
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Image /page/3/Picture/0 description: The image shows handwritten text on a white background. The text on the first line reads "P 4 of 16". The second line contains the numbers "1970782" written in a similar handwriting style.
3. Description of the Device
The Imaging Jet is an endoscopic accessory that provides a spatial view of an endoscope inside a patient. When in use, the sensor catheter is inserted into the biopsy channel of an endoscope inside a patient. The sensor catheter measures the shape of a scope and sends sensory signals to a computer for calculating and displaying the image on the computer screen.
A complete Imaging Jet system consists of the following major components as shown in: (1). a computer which governs the operation of the whole system, calculates the scope spatial image and displays the image; (2). a signal processing unit which acquires and processes the sensory signals and supplies them to the computer for image calculation; (3). a sensor catheter which is a long flexible rod with sensors embedded inside in its head portion; (4). a sensor catheter transport unit which is used to insert and withdraw sensor catheter into and from the biopsy channel of a scope; and (5). a mobile stand for transporting the whole system.
Image /page/3/Figure/4 description: The image shows a diagram of a sensor system with labeled components. The system includes a signal processing unit, a computer, a sensor transport unit, and a sensor rod, all connected by wires. The entire setup is supported by a stand, providing stability and height for the sensor system.
Figure 3-1. System overview
4
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The signal processing unit houses all the electronics and power supplies to the system. The unit measures 400 mm × 300 mm × 100 mm (L×W×H) and weighs about 3 kg. The signal processing unit is shown in Figure 3-2.
Image /page/4/Figure/2 description: The image shows a device labeled "Image Jet" with various ports and switches. The top section features a system switch and ports labeled "TO TRANSPOT UNIT" and "TO SENSOR CATHETER". The bottom section includes a port labeled "FRPSXWHU#LQWHUIDFH" and a power input labeled "DF#SRSZH#IRU FRPSXWHU" with a connected power cord.
Figure 3-2. Signal processing unit
The sensor catheter consists of two segments. At the tip of the catheter, there is a sensor head segment where sensors are embedded. The rest is used to provide the necessary length. The sensor catheter is shown in Figure 3-3. During application, only the sensor head and part of the insertion tube are inside the endoscope, the rest of the catheter including the rear part of the tube and sensor catheter connector are outside the scope (They remained inside the transport unit).
Image /page/4/Figure/5 description: The image shows a diagram of a sensor rod connector, insertion tube, and sensor head. The sensor rod connector is on the left side of the image, and it is connected to the insertion tube. The insertion tube is a long, thin tube that extends to the right side of the image. The sensor head is on the right side of the image, and it is connected to the insertion tube. The sensor head is a small, rectangular box.
Figure 3-3. The sensor catheter
5
The sensor catheter transport unit is used to automatically insert and withdraw sensor catheter into and from the biopsy channel of a colonoscope. This will reduce the work load on the physician, meanwhile maintains a smooth sensor motion that will result in good quality of sensor signals. The sensor catheter should be loaded into the transport unit prior to an operation by doctor's assistant. This unit also generates feedback to the control unit so that the actual insertion motion of the catheter can be monitored and controlled. The transport unit is shown in Figure 3-4.
Image /page/5/Figure/2 description: The image shows a technical drawing of a winding mechanism. The mechanism includes a driving plate with a locking part, a winding plate, and a handle connected to a transport unit base. A transport unit cable extends from the base, and a sliding groove is visible on the side of the mechanism.
Figure 3-4. The sensor catheter transport unit
The sensor catheter transport unit delivers the sensor catheter through the biopsy channel of an endoscope. During insertion, the catheter detects curvature of the path of the biopsy channel and sends electrical signals to the signal processing unit. The computer interfaces with the signal processing unit and calculates the image of the endoscope. After the computer calculates the image of the endoscope, it displays the image onto the computer screen in a three dimensional manner.
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4. Statement of Intended Uses
The Imaging Jet System provides physicians with a three dimensional image of an endoscope inside a patient.
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5. Substantial Equivalence Comparison
| | Imaging Jet | Predicate device Fluo-roscopy | Predicate device
Measuring Device |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | determine (1) overall
image of a scope, (2)
existence and direction
of loops, (3) number of
loops, and (4) location
of lesion. | determine (1) overall
image of a scope, (2)
existence and direction
of loops, (3) number of
loops, and (4) location
of lesion. | Measure the size of the
polyp. |
| Technology
char-
acteristics | This device uses sensors
to measure the curva-
ture of a scope along the
insertion length while
the catheter traveling
through the endoscope
biopsy channel. The 3D
position estimation is
obtained from the sen-
sor signals of the
catheter. Then the 3D
scope image is dis-
played on a computer
screen using computer
graphics techniques. | The x-ray cameras are
built based on the
penetration of the x-ray
into a patient. The
scope inside the patient
blocks the x-rays that
directly fall to the
scope. Therefore, there
is a difference on radia-
tion intensity on the re-
ceiver. The x-ray image
can be formed by dis-
playing the image on to
a screen. The screen
can directly show the
image of the scope in-
side the patient. | This device allows
doctors to measure the
size of a polyp by com-
pare it with the meas-
uring marks on the de-
vice. |
| Method of
application | The sensor catheter is
inserted through the bi-
opsy channel of the en-
doscope in concern and
reaches the distal end of
the endoscope. | An x-ray camera is out-
side the patient. | The measuring device is
inserted through the bi-
opsy channel of the en-
doscope in concern and
reaches the distal end of
the endoscope. |
| Target
population | Patients with "difficult"
colon while needing
colonoscopy and most
patients who need small
bowel endoscopy. | Patients with "difficult"
colon while needing
colonoscopy and most
patients who need small
bowel endoscopy. | Patients with polyps and
the size of the polyps is
in concern. |
| Biocompatib
ility | All exterior materials
are biocompatible. | Not applicable. | All exterior materials
are biocompatible. |
| Perform-
ance | (1) The shape meas-
urement accuracy of
this device is ±4%.
This accuracy is suffi-
cient for its intended
use. | (1) The accuracy of po-
sition estimation is at
best 10 mm, but in fact
much worse.
(2) Multiple pictures
need to be taken to pro- | Provide quantitative
measure of the size of a
polyp. |
| | | | K970782 |
| Radiation
safety | (2) Provide a three-
dimensional image in
one operation.
(3) User can manipulate
the image to facilitate
understanding. | vide three dimensional
information.
(3) In general, while
using fluoroscopy to
determine the location
of an endoscope, a phy-
sician uses a single two-
dimensional image and
attempts to extrapolate a
three dimensional im-
age. The error in this
extrapolation is great,
several centimeters at
least. This error is in-
creased by changing
rate of magnification as
the x-ray beam travels
from the x-ray emitter
to the x-ray receiver. | No radiation hazard. |
| | No radiation hazard. | Radiation health hazard
to patients, operators,
and other personnel in
the room. Possible
damage to the scope
overtime. | |
| Sterility and
cleaning | Cleaning and disinfec-
tion are needed after
each use. | Cleaning and steriliza-
tion are not needed. | Cleaning and disinfec-
tion are needed after
each use. |
| Energy used | Electricity | Electricity | No energy source
needed |
| Where used | Any doctor's office | Hospital or major clin-
ics | Any doctor's office |
| Physical ap-
pearance | The appearance of the
sensor catheter can be
characterized as a
"rod". | An x-ray emitter and a
receiver. | The appearance of same
this device can be char-
acterized as a "rod". |
Table 5-1. Substantial Equivalence Comparison Table
8
In summary, the Imaging Jet has the same intended use as that of the x-ray fluoroscopy instrument for endoscopy procedures. The effectiveness of this device is established through thorough mathematical analysis. The safety is established through material selection, system design, manufacturing quality control, and mathematical proof. This system provides similar information as an x-ray fluoroscopy instrument and offers several advantages over an x-ray fluoroscopy instrument: (1) There is no radiation hazard to patients and operators, (2) Low cost in both facility and usage, (3) Easy to use, no need to transport patients back and forth between x-ray unit and endoscopy unit, (4) It provides a full three-dimensional image, and (5) Users can manipulate the image to facilitate understanding. As a result of the above analysis, we consider the Imaging Jet is substan-
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tially equivalent to the x-ray fluoroscopy instrument for its intended use and the Image Jet is at least as safe and effective as the x-ray fluoroscopy.
The common technical characteristics of both Imaging Jet device and the Endoscope Measuring Device by Olympus can be summarized as: (1) When in use, the catheters of both the Endoscope Measuring Device by Olympus and the Imaging Jet are inserted into the biopsy channel of an endoscope. (2) Both devices contain no invasive tools, e.g., tools for biopsy forceps, at their distal ends. Their physical appearances can both be characterized as "rod". (3) During use, both devices may contact the interior tissue of a patient. The safety of both devices is ensured through the biocompatibility of the materials selected to construct the devices.
Therefore it is concluded that the Imaging Jet device achieves the same intended use as the predicate device (x-ray fluoroscopy instrument by Picker) and it is as safe and effective as the predicate devices (x-ray fluoroscopy instrument by Picker and Endoscope and Accessories: Measuring Device by Olympus, Inc.).
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Image /page/10/Picture/0 description: The image contains handwritten text. The first line reads "P of 16". The second line reads "K976782". The text appears to be written in black ink on a white background.
6. Performance
Laboratory tests were conducted to test the performance of the Imaging Jet system in terms of the overall image calculation capability, we used a colonoscope to form different shapes. Then we used the Imaging Jet system to measure these shapes. The follefein shapes. Then we asses and maging vote your scope images and the measured images using Imaging Jet.
Image /page/10/Picture/3 description: The image shows a spiral-shaped object. The object appears to be made of a dark material, possibly metal or plastic. The spiral has multiple turns, with the innermost turn being the smallest and the outermost turn being the largest. The object is placed on a light-colored surface, which provides contrast and helps to highlight the shape of the spiral.
(a1) Actual scope image
Image /page/10/Picture/5 description: The image shows a black spiral shape against a white background. The spiral appears to be drawn with a thick marker or pen, giving it a bold and defined look. The spiral starts from the lower left corner and curves inward, creating a visually engaging pattern. The image has a simple composition, focusing solely on the spiral and its form.
(a2) Measured image using Imaging Jet
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Image /page/11/Picture/1 description: The image shows a black and white picture of two intersecting circles. The circles are dark and thick, and they overlap in the center. The background is a mix of black and white, with the top portion being mostly black and the bottom portion being mostly white.
(b1) Actual scope image
Image /page/11/Picture/3 description: The image shows a black line that forms two loops. The loops are connected by a straight line. The line starts from the bottom left, goes up and around to form a loop, then continues to the right to form another loop, and then continues to the right.
(b2) Measured image using Imaging Jet
Image /page/11/Picture/5 description: The image is a black and white photograph. The top portion of the image is black, while the bottom portion is white. There is a small black object in the bottom right corner of the image.
(c1) Actual scope image
Image /page/11/Picture/7 description: The image shows a black line drawing on a white background. The line starts at the bottom left, curves into a small loop, and then extends to the right. The line then curves upward and to the right, ending at the top right of the image.
(c2) Measured image using Imaging Jet
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Image /page/12/Picture/1 description: The image shows a dark background with a bright, circular area in the lower left quadrant. A dark, curved line runs across the bright area, creating a contrast between light and shadow. The overall composition is simple, with the focus on the interplay of light and dark elements.
(d1) Actual scope image
Image /page/12/Figure/3 description: The image shows a black line drawing on a white background. The drawing consists of a single, continuous line that forms a complex shape. The line starts on the left side of the image, curves into a loop, and then extends to the right side, where it makes a wide, sweeping turn before ending at the top.
(d2) Measured image using Imaging Jet
Image /page/12/Figure/5 description: The image shows a black and white photograph of what appears to be a dark, thick cable or rope. The cable is curved in a wave-like pattern against a lighter background. The background has a grainy texture, and the cable appears to be the main subject of the image.
(e1) Actual scope image
Image /page/12/Figure/7 description: The image shows a black line drawing on a white background. The line starts on the left side of the image and curves into a loop. The line then extends to the right side of the image, curving up at the end. The line is thick and dark, and the background is light and grainy.
(e2) Measured image using Imaging Jet
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Image /page/13/Picture/1 description: In the image, there are two black cables that are curved. The cables are positioned against a white background. The cables appear to be connected to something on the right side of the image.
(f1) Top view of actual scope image
Image /page/13/Picture/3 description: The image shows a black line drawing on a white background. The line starts on the left side of the image and forms a loop. The line then extends to the right side of the image, where it curves upward and ends. The line is thick and has a slightly rough texture.
(f2) Top view of measured image using Imaging Jet
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Image /page/14/Picture/1 description: In the image, a dark, grainy photo shows a cylindrical object with a handle on top. The object appears to have some horizontal lines or ridges near the top. The bottom of the object is slightly visible, showing a rounded edge.
. (f3) Side view of actual scope image
Image /page/14/Picture/3 description: The image shows a black, flexible tube that is bent into an S shape. The bottom of the S is curled into a loop. The tube appears to be made of a smooth material, and there are a few small, light-colored spots on the tube.
(f4) Side view of measured image using Imaging Jet
Figure 6-1. Image comparison
From the above figures, we conclude that the Imaging Jet system is capable of generating images with sufficient accuracy for its intended use.
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Image /page/15/Picture/0 description: The image shows the text 'P 16 of 16' in a handwritten style. Below this text is the number 'K970782', also handwritten. The handwriting appears to be in black ink on a white background.
7. Conclusions
In summary, the Imaging Jet has the same intended use as that of the x-ray fluoroscopy instrument for endoscopy procedures. The effectiveness of this device is established through thorough mathematical analysis and laboratory tests. The safety is established through material selection, system design, manufacturing quality control, and mathematical proof.
Therefore it is concluded that the Imaging Jet device achieves the same intended use as the predicate device (x-ray fluoroscopy instrument by Picker) and it is as safe and effective as the predicate devices (x-ray fluoroscopy instrument by Picker and Endoscope and Accessories: Measuring Device by Olympus, Inc.).
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Image /page/16/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Yansong Shan, Ph.D. President General Robotic Devices, Inc. 2069 Golfside Drive Ypsilanti, Michigan 48197
Re: K970782
Imaging Jet System Dated: October 10, 1997 Received: October 20, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 KOG 21 CFR §892.1600/Product code: 78 JAB
NOV 1 3 1997
Dear Dr. Shan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
17
Page 1 of 1
510(k) Number (if known): _ __K970782
Device Name:
Indications For Use:
The Image Jet System provides physicians with a three dimensional image of an endoscope inside a patient.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Robert D. (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number 1970782 Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)