(181 days)
Not Found
No
The summary describes an ultrasonic endoscope and processor, focusing on hardware modifications and standard performance testing. There is no mention of AI, ML, or advanced image processing beyond basic ultrasonic image generation.
Yes
The "Intended Use / Indications for Use" section states that the device is intended for "endoscopic treatment."
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are intended "for observation, diagnosis and endoscopic treatment." The ability to provide information for diagnosis classifies it as a diagnostic device.
No
The device description explicitly states that the device is an ultrasonic endoscope, which is a physical hardware device used for imaging. It also mentions being used in combination with other hardware components like a processor, video endoscope processor, light source, monitor, etc.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The description clearly states that the Fujinon/Fujifilm Ultrasonic Endoscopes are used inside the body (upper gastrointestinal tract) to provide ultrasonic images for observation, diagnosis, and treatment.
- Modality: The input imaging modality is Ultrasonic, which is an in-vivo imaging technique, not an in-vitro diagnostic test.
The device is an in-vivo imaging device used for diagnostic and therapeutic purposes within the body.
N/A
Intended Use / Indications for Use
Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
Product codes (comma separated list FDA assigned to the subject device)
FDS, ITX
Device Description
Fuiinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2 are modified versions of our previously-cleared EG-530UR and EG-530UT via K063847. The modified models are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment when used with a Fujinon/Fujifilm's ultrasonic processor, which remains the same as K063847.
The modified models are used in combination with a Fujinon/Fujifilm's ultrasonic processor. video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EG-530UR2 and EG-530UT2 model emits ultrasound wave and scans the reflected signals to provide ultrasonic images.
Mentions image processing
Not Found
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
This product is not intended for use on children and infants.
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)
Fujinon/Fujifilm Ultrasonic endoscope EG-530UR2 were 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
IEC60601-1-1 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
ISO10993 Biological evaluation of medical devices
The reprocessing instructions were updated and validated using a third party lab. No clinical test was conducted.
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
AUG 1 3 2012
Date: December 16, 2011
Submitter's Information:
Fujinon Inc. 10 High Point Drive Wayne, NJ 07470 USA FDA Establishment Registration Number: 2431293
Contact Person:
| Name: | Gina Walljasper |
|---|---|
| Title: | Director, Quality and Regulatory Compliance |
| Telephone: | (973) 633-5600 Ext. 484 |
| Facsimile: | (973) 633-8818 |
| E-Mail: | gwalljasper@fujifilm.com |
Identification of the Proposed Device:
| Proprietary/Trade Name: | Fujinon/Fujifilm Ultrasonic endoscope
EG-530UR2 and EG-530UT2 |
|-----------------------------|------------------------------------------------------------------|
| Common Name: | Ultrasonic Endoscope |
| Device Class: | Class 2 |
| Review Panel: | Gastroenterology/Urology |
| Classification Information: | |
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Gastroscope and accessories, flexible/rigid | 21 CFR 876.1500 | FDS |
| Diagnostic Ultrasonic Transducer | 21 CFR 892.1570 | ITX |
INDICATIONS FOR USE l.
Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
II. DEVICE DESCRIPTION
Fuiinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2 are modified versions of our previously-cleared EG-530UR and EG-530UT via K063847. The modified models are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment when used with a Fujinon/Fujifilm's ultrasonic processor, which remains the same as K063847.
Image /page/0/Picture/16 description: The image shows the word "FUJINON" in bold, black letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.
1
FUJIFILM
The modified models are used in combination with a Fujinon/Fujifilm's ultrasonic processor. video endoscope processor, light source, monitor, cart, foot switch, endoscope accessories and other peripheral devices. When used with a Fujinon/Fujifilm's ultrasonic processor, EG-530UR2 and EG-530UT2 model emits ultrasound wave and scans the reflected signals to provide ultrasonic images.
Detailed information on the modifications for the proposed endoscopes EG-530UR2 and EG-530UT2 are provided in the submission.
III. SUMMARY OF STUDIES
Fujinon/Fujifilm Ultrasonic endoscope EG-530UR2 were 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 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC60601-1-1 | 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 |
| ISO10993 | Biological evaluation of medical devices |
The reprocessing instructions were updated and validated using a third party lab. No clinical test was conducted.
SUBSTANTIAL EQUIVALENCE IV.
Fujinon/Fujifilm Ultrasonic endoscope EG-530UR2 and EG-530UT2 are substantially equivalent to the following device(s):
| Legally Marketed Device(s) | 510(k) # |
|---|---|
| Fujinon Ultrasonic Endoscopes & Processor | |
| (EG-530UR, EG-530UT and SU-7000) | K063847 |
| Fujinon Ultrasonic Processor SU-8000 | K111243 |
See Section 12 Comparison Matrix for detailed comparison.
V. CONCLUSION
Fuiinon/Fuilfilm Ultrasonic endoscope EG-530UR2 and EG-530UT2 are substantially equivalent to the legally marketed devices and conforms to applicable medical device safety and performance standards.
Image /page/1/Picture/13 description: The image shows the word "FUJINON" in bold, black letters. The font is sans-serif and the letters are tightly spaced. The word appears to be a logo or brand name, possibly for a company or product.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
AUG 13 2012
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FUJIFILM Medical System U.S.A., Inc. % Mr. Mark Job Responsible=Third-Party Official= Regulatory Technology Services LLC . 1394 25th Street NW BUFFALO MN 55313
Re: K120446
Trade/Device Name: Fujinon/Fujifilm Ultrasonic endoscope (EG-530UR2 and EG-530UT2) {to be used with Fujinon/Fujifilm ultrasonic processor (SU-7000/SU-8000)]
Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDS, ITX Dated: August 2, 2012 Received: August 3, 2012
Dear Mr. Job:
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 (reporting of medical
3
device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) 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/Genters9ffices/CDRH/CDRHOffices/ucm1115809.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.
Sincerély yours,
Sincerely yours,
Benjamin K-tarko
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use Statement
570(k) Number (If Known): - K120446
Device Name:
Fujinon/Fujifilm Ultrasonic endoscope (EG-530UR2 and EG-530UT2) [to be used with Fujinon/Fujifilm ultrasonic processor (SU-7000/SU-8000)]
Indications for Use:
Fujinon/Fujifilm Ultrasonic Endoscopes, EG-530UR2 and EG-530UT2, are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. The product is intended to be used with a Fujinon/Fujifilm ultrasonic processor. This product is not intended for use on children and infants.
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 Device Evaluation (ODE)
Besicuer R. Devis 13 August 2012
(Division Sign-Off)
(División Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120446
5
Diagnostic Ultrasound Indications For Use
K120446 510(k) Number (If Known): Fujinon Ultrasonic Processor (SU-7000/SU-8000) System Name: Transducer: Ultrasonic Endoscope (EG-530UR2)
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 | P | P | P | P | P¹ | |||
| Tran-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify)² | P | P | P | P | P¹ | |||
| 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 Device Evaluation (ODE) | |
|---|---|
| DRGUD 13 AUGUST 2012 |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K120446 |
6
Diagnostic Ultrasound Indications For Use
510(k) Number (If Known): K120441
Fujinon Ultrasonic Processor (SU-7000/ SU-8000) System Name: 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.) | P | P | P | P | P1 | |||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify)2 | P | P | P | P | P1 | |||
| 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
13 August 2012
3 DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices K120446
510(k) Number
Fujinon/Fujifilm Ultrasonic Endoscopes EG-530UR2 and EG-530UT2