(13 days)
No
The document describes a standard ultrasonic processor that converts ultrasonic signals into images. There is no mention of AI, ML, or any advanced image analysis beyond basic signal processing for image formation.
No.
The device is described as providing ultrasonic images for observation, recording, and aiding in diagnosis, specifically for imaging and fluid flow analysis. There is no mention of treating or curing any medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is intended to "aid in diagnosis during endoscopic evaluation" and is for "Diagnostic ultrasound imaging".
No
The device description explicitly states that the Fujinon Ultrasonic Processor SU-8000 consists of a "scan engine and a function box" and is controlled by a "keyboard," indicating it includes hardware components beyond just software.
Based on the provided information, the Fujinon ultrasonic processor SU-8000 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The description of the SU-8000 clearly states it is used in combination with an ultrasonic endoscope to provide ultrasonic images of submucosal and peripheral organs within the body. It processes signals from within the body, not from a sample taken from the body.
- The intended use is for in-vivo imaging and diagnosis. The purpose is to obtain images of internal structures to aid in diagnosis during an endoscopic evaluation. This is a form of medical imaging performed directly on the patient.
The device is a medical imaging processor used for diagnostic purposes, but it operates in vivo (within the living body) rather than in vitro (in glass or outside the living body).
N/A
Intended Use / Indications for Use
The Fujinon ultrasonic processor SU-8000 is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: General, Specific
Mode of Operation: B, M, PWD, Color Doppler, Combined
Specific Applications under General: Tran-esoph. (non-Card.), Other (includes gastro-intestinal tract and surrounding organs) (N= new indication; P = previously cleared by FDA; E = added under this appendix)
Product codes
FDS, IYN, IYO, ITX
Device Description
Fujinon Ultrasonic Processor SU-8000 is a new ultrasonic processor, which can be used with the previously-cleared ultrasonic gastrointestinal endoscopes, EG-530UR and EG-590UT via K063847.
Fujinon Ultrasonic Processor SU-8000 consists of a scan engine and a function box and SU-8000 is controlled by keyboard (model: CP-8000) SU-8000 connects to ultrasonic endoscopes, which emits ultrasound in a body cavity by driving ultrasonic transducers of the endoscope. SU-8000 also processes the reflection of ultrasonic signals the transducer and converts it to an ultrasound image.
SU-8000 is used in combination with ultrasonic endoscopes, video processor, light source, cart, recorder, foot switch and other peripheral devices (e.g. external monitor and printer), which is the same as the legally marketed device, SU-7000.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
submucosal and peripheral organs of the upper gastrointestinal tract
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
Fujinon Ultrasonic Processor (SU-8000) was evaluated in accordance with following safety and performance requirements in addition to the applicable quality system regulations: IEC 60601-1, IEC 60601-1-1, IEC60601-1-2, IEC60601-2-18, IEC 60601-2-37. No clinical test was conducted.
Key Metrics
Not Found
Predicate Device(s)
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.
0
FUJIFILI
MAY 16 2011
FUJIFILM GROUP
FUJINON INC.
10 High Point Drive
Wayne, NJ 07470
Tel: (973) 633-5600
K/// 2.43
page 1 of 2
510(k) Summary
Date: April 14, 2011
Submitter's Information:
Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 USA
Contact Person:
| Name: | Gina Walljasper |
|---|---|
| Title: | Director, Quality and Regulatory Compliance |
| Telephone: | (973) 633-5600 |
| Facsimile: | (973) 633-8818 |
| E-Mail: | gina.walljasper@fujinon.com |
Identification of the Proposed Device:
| Proprietary/Trade Name: | |
|---|---|
| Common Name: |
Fujinon Ultrasonic Processor SU-8000 Ultrasonic Processor for Ultrasonic Gastrointestinal Endoscopy Class 2
Device Class: Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Gastroscope | 21 CFR 876.1500 | FDS |
| Ultrasonic Pulsed Doppler Imaging System | 21 CFR 892.1550 | IYN |
| Ultrasonic Pulsed Eco Imaging System | 21 CFR 892.1560 | IYO |
| Diagnostic Ultrasonic Transducer | 21 CFR 892.1570 | ITX |
l. INDICATIONS FOR USE
The Fujinon ultrasonic processor SU-8000 is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
ll. DEVICE DESCRIPTION
Fujinon Ultrasonic Processor SU-8000 is a new ultrasonic processor, which can be used with the previously-cleared ultrasonic gastrointestinal endoscopes, EG-530UR and EG-590UT via K063847.
Fujinon Ultrasonic Processor SU-8000 consists of a scan engine and a function box and SU-8000 is controlled by keyboard (model: CP-8000) SU-8000 connects to ultrasonic endoscopes, which emits ultrasound in a body cavity by driving ultrasonic transducers of
Fujimon Ultrasonic Processor SU-8000
Image /page/0/Picture/21 description: The image shows the text "39 of 1027" at the top. Below that is the word "FUJINON" in large, bold, black letters. The text appears to be a page number or some other kind of identifier.
1
FUJKFILM
FUJIFILM GROUP
FUJINON INC.
10 High Point Drive
Wayne, NJ 07470
Tel: (973) 633-5600
K111243 page 2 of =
the endoscope. SU-8000 also processes the reflection of ultrasonic signals the transducer and converts it to an ultrasound image.
SU-8000 is used in combination with ultrasonic endoscopes, video processor, light source, cart, recorder, foot switch and other peripheral devices (e.g. external monitor and printer), which is the same as the legally marketed device, SU-7000.
= SUMMARY OF STUDIES
Fujinon Ultrasonic Processor (SU-8000) was evaluated in accordance with following safety and performance requirements in addition to the applicable quality system regulations:
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for
safety |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-1 | Medical electrical equipment - Part 1-1: General requirements for
safety - Collateral standard: Safety requirements for medical
electrical systems |
| IEC60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for
the basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests |
| IEC60601-2-18 | Medical electrical equipment - Part 2-18: Particular requirements
for the safety of endoscopic equipment |
| IEC 60601-2-37 | Medical electrical equipment - Part 2-37: Particular requirements
for the basic safety and essential performance of ultrasonic medical
diagnostic and monitoring equipment |
No clinical test was conducted.
IV. SUBSTANTIAL EQUIVALENCE
Fujinon Ultrasonic Processor SU-8000 is substantially equivalent to the following device:
| Legally Marketed Device | $§$ 510(k) # |
|---|---|
| Fujinon Ultrasonic Endoscope & Processor | |
| (EG-530UR, EG-530UT with SU-7000) | K063847 |
The proposed device, Fujinon Ultrasonic Processor SU-8000 has the same Indications for Use and very similar Functional and Technical requirements as our legally marketed device, Ultrasonic Processor (SU-7000) via K063847.
V. CONCLUSION
Fujinon Ultrasonic Processor SU-8000 is substantially equivalent to the legally marketed device and conforms to applicable medical device safety and performance standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Fujinon, Inc. c/o Mr. Mark Job Regulatory Affairs Specialist Regulatory Technology Services, Inc. 1394 25th Street, N.W. BUFFALO MN 55313
MAY 1 6 2011
Re: K11243
Trade/Device Name: Fujinon Ultrasonic Processor SU-8000 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, IYN, IYO and ITX Dated: May 2, 2011 Received: May 3, 2011
Dear Mr. Job:
We have reviewed your Section 510(k) premarket 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 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Fujinon Ultrasonic Processor SU-8000, as described in your premarket notification:
Transducer Model Number
EG-530UR and EG-530UT
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 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2
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.
This letter will allow you to begin marketing your device as described in your 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 market.
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.
If you have any questions regarding the content of this letter, please contact Mary Beth O'Brien, M.S.R.N., at (301) 796-6657.
Sincerely yours,
Roque M. Diaz
lerbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
4
K///243
Indications For Use Statement
510(k) Number (If Known):
): Killys
Device Name:
Fujinon Ultrasonic Processor SU-8000
Indications for Use:
The ultrasonic processor (SU-8000) is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Vorza M. Why
ductive, Gastro-Renal, and ાં 24
5
K///243
Diagnostic Ultrasound Indications For Use
510(k) Number (If Known):
System Name: Fujinon Ultrasonic Processor SU-8000
With All Ultrasonic Endoscopes (EG-530UR and EG-530UT) Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined1 | Other | ||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| General | Adult Cephalic | |||||||
| Application | Trans-rectal | |||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Tran-esoph. (non-Card.) | N | N | N | N | N1 | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify)2 | N | N | N | N | N1 | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Tran-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
= new indication; P = previously cleared by FDA; E = added under this appendix
Combined modes includes B+M, B+PWD, B+CD+PWD modes
2 Other includes gastro-intestinal tract and surrounding organs
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111243
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Prescription Use
(Per 21 CFR 801.109)
6
Diagnostic Ultrasound Indications For Use
11242
510(k) Number (If Known):
System Name: Fujinon Ultrasonic Processor SU-8000
Ultrasonic Endoscope (EG-530UT) Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | ||
| Doppler | Combined1 | Other | ||||||
| Ophthalmic | Ophthalmic | |||||||
| General | ||||||||
| Application | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ | ||||||||
| (Thyroid, Breast, Testes, etc.) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Tran-esoph. (non-Card.) | N | N | N | N | N1 | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify)2 | N | N | N | N | N1 | |||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Tran-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
w indication; P = previously cleared by FDA; E = added under this appendix
1 Combined modes includes B+M, B+PWD, B+CD+PWD modes
2 Other includes gastro-intestinal tract and surrounding organs
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
(División Sign-Off) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number: K111243
Prescription Use
(Per 21 CFR 801.109)
7
Diagnostic Ultrasound Indications For Use
510(k) Number (If Known): System Name: Fujinon Ultrasonic Processor SU-8000 Transducer: Ultrasonic Endoscope (EG-530UR)
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | Specific | B | M | PWD | CWD | Color | |||
| Doppler | Combined¹ | Other | |||||||
| Ophthalmic | Ophthalmic | ||||||||
| General | |||||||||
| Application | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ | |||||||||
| (Thyroid, Breast, Testes, etc.) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Tran-esoph. (non-Card.) | N | N | N | N¹ | |||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify)² | N | N | N | N¹ | |||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Tran-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N= new indication; P = previously cleared by FDA; E = added under this appendix
1 Combined modes includes B+M, B+PWD, B+CD+PWD modes
² Other includes gastro-intestinal tract and surrounding organs
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Joseph R. Whitely
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K111243
Prescription Use (Per 21 CFR 801.109)