(10 days)
Not Found
No
The document describes standard ultrasound image processing and does not mention AI, ML, or related concepts.
No
The device is described as being for "Diagnostic ultrasound imaging or fluid flow analysis" and "for endoscopic real-time ultrasonic imaging," indicating its primary function is diagnostic, not therapeutic. While it can be used with "endo-therapy accessories," the device itself, as described, performs imaging and guidance for procedures, rather than directly delivering therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." Additionally, the "Device Description" mentions its use for "endoscopic real-time ultrasonic imaging" and the "Mentions image processing" section details how sound waves are converted to electrical signals and displayed as images, all indicating a diagnostic purpose.
No
The device description explicitly states it is designed to be used with hardware components like an ultrasound system, video system center, light source, and endo-therapy accessories. It is not solely software.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: This device uses ultrasound imaging to visualize the gastrointestinal tract and surrounding organs within the body. It also facilitates procedures like fine needle aspiration and endoscopic surgery.
- Lack of Sample Analysis: The description focuses on real-time imaging and procedural guidance, not the analysis of biological samples.
The device is a medical device used for diagnostic imaging and interventional procedures, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Transesophageal (non-cardiac)
Other: the gastrointestinal tract and the surrounding organs
Product codes
ODG, FET, FDS, ITX
Device Description
These subject devices have been designed to be used with the HDI5000 Ultrasound system (Philips Ultrasound), Olympus video system center, light Source, documentation equipment, video monitor, endo-therapy accessories such as an aspiration biopsy needle and electrosurgical unit except for endoscopic ultrasound (EUS) guided electrosurgery.
These subject devices are designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper gastrointestinal tract and surrounding orgains.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
trans-esophageal (non-cardiac), gastrointestinal tract and the surrounding organs
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Olympus America, Inc. % Ms. Laura Danielson Responsible Third Party Official TUV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
JUL 2 7 2015
Re: K031347
Trade/Device Name: Ultrasonic Gastrovideoscope OLYMPUS GF Type UC160P-AT8 and UCT160-AT8 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG, FET, FDS, ITX Dated (Date on orig SE Itr): April 28, 2003 Received (Date on orig SE Itr): April 29, 2003
Dear Ms. Danielson,
This letter corrects our substantially equivalent letter of May 9, 2003.
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
1
Page 2 -
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 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
2
KD31347
4.3.1 Indications for Use Form for Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UC160P-AT8 Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UCT160-AT8
Diagnostic Ultrasound Indications for Use Form
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical | |||||||||||
| Application | A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | N | N | N | N | N | Note1 | Non- | ||||
| Cardiac | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | |||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| Other (specify) | |||||||||||
| Note2 | N | N | N | N | N | Note1 |
N= new Indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note1: Combined mode operation: B/M.B/PWD,B/Color Doppler,B/Amplitude Doppler,B/PWD/Color Doppler, B/Amplitude Doppler/PWD
Note2: the gastrointestinal tract and the surrounding organs
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Ingram
(Division Sign-Off) Division of Reproductive, and Radiological Devic 510(k) Number
Prescription Use {Per 21 CFR 801.109}
Section 4.3 Page 2
3
MAY - 9 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR, Part 807, Subpart E, Section 807.92.
A. Submitter's name, address, telephone number, initial importer, contact person
1. Manufacturer of the subject device
Name & Address of Manufacturer, Olympus Optical Co., Ltd.
Registration Number : Address, Phone and Fax of R & D Department Endoscope Division
34-3 Hirai Hinode-machi, Nishitama-gun, Tokyo, 190-0182 Japan 30036370927 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507 Japan TEL 81-426-42-2891 FAX 81-426-46-5613
- Initial Importer
Name: Address:
Olympus America Inc. Two Corporate Center Drive Melville, NY 11747-3157 TEL 516-844-5688 FAX 516-844-5416
3. Name of Contact Person
Name:
Ichiro Funabashi Supervisor Regulatory Affairs Quality and Engineering Department Medical System Group Olympus Optical Co., Ltd.
Address, Phone and Fax:
2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507 Japan TEL 81-426-42-2891 FAX 81-426-46-5613
4
B. Device Name, Common Name
1. Common/Usual Name
Ultrasonic endoscope
2. Device Name
- · Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UC160P-AT8
- · Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UCT160-AT8
3.Classification Name
| | FR Number | Product
Code | Class |
|----------------------------------|-----------|-----------------|-------|
| Endoscope and accessories | 876.1500 | KOG | II |
| Diagnostic Ultrasound Transducer | 892.1570 | ITX | II |
C. Identification of the predicate or legally marketed device
The following devices information demonstrates that this device is substantially equivalent to a legally marketed, predicate medical device.
| Device Name | #K |
|---|---|
| EUS EXERA Ultrasonic Gastrovideoscope OLYMPUS GF | |
| TYPE UC160P-OL5 / OLYMPUS GF TYPE UCT160-OL5 | K010591 |
| Ultrasonic Gastrovideoscope OLYMPUS GF TYPE UC140P- | |
| AL5 | K011314 |
| HDI-5000 Ultrasound system | K961459 |
D. Device Description
1. Summary
These subject devices have been designed to be used with the HDI5000 Ultrasound system (Philips Ultrasound), Olympus video system center, light Source, documentation equipment, video monitor, endo-therapy accessories such as an aspiration biopsy needle and electrosurgical unit except for endoscopic ultrasound (EUS) guided electrosurgery.
These subject devices are designed for endoscopic real-time ultrasonic imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper gastrointestinal tract and surrounding orgains.
5
2. Design
These subject devices are designed to comply with the standards listed below.
| IEC 60601-1 |
|---|
| IEC 60601-1-1 |
| IEC 60601-1-2 |
| IEC 60601-2-18 |
| CISPR11 |
3. Materials
The material for Distal Tip of these subject devices has a new patient-contacting material. The biocompatibility test reports of the new material show that the new material is safe for its intended use.
E. Intended Use:
The intended use of these subject devices, as defined by FDA guidance documents, is:
Trans-esophageal(non-cardiac) Other 1) Gastrointestinal tract and the surrounding organs
F. Technological Characteristics:
These devices operate identically to the predicate device in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images. Doppler shift caused by blood flow is displayed as Color Flow, or as spectrum analysis.