(90 days)
No
The summary describes a bronchoscope with ultrasound capabilities and mentions its use with specific ultrasound systems, but there is no mention of AI or ML in the device description, intended use, or any other section.
No
The intended use is strictly for diagnostic imaging and fluid flow analysis, not for treatment. While it can be used with "endo-therapy accessories," its core function as described is diagnostic imaging for guiding procedures like FNA, which itself is a diagnostic sampling technique.
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 that the device is designed for "endoscopic real-time ultrasound imaging" and "EUS guided fine needle aspiration (FNA) within the airway, tracheobronchial tree, esophagus, and surrounding organs," which are diagnostic procedures. The "Input Imaging Modality" also confirms it uses "Diagnostic ultrasound imaging."
No
The device description explicitly states it is a "ULTRASONIC BRONCHOFIBERVIDEOSCOPE" and is designed to be used with diagnostic ultrasound systems, video system centers, light sources, and other hardware components. This indicates it is a physical medical device with hardware components, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states the device is an "ULTRASONIC BRONCHOFIBERVIDEOSCOPE" used for "Diagnostic ultrasound imaging or fluid flow analysis of the human body" and for "endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airway, tracheobronchial tree, esophagus, and surrounding organs."
- Direct imaging: This device is used for direct imaging and intervention within the body, not for analyzing samples outside the body.
Therefore, the OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE is a diagnostic imaging and interventional device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Trans-esoph. (non-Card.) - B, M, PWD, Color Doppler, Amplitude Doppler, Combined (Spec.) (Note 2) Other (spec.) (Note 1) - B, M, PWD, Color Doppler, Amplitude Doppler, Combined (Spec.) (Note 2)
Note 1: Specification for "Other": Airways and tracheobronchial tree.
Note 2: "Combined mode operation" includes: B/M,B/PWD,B/CD/PWD
Product codes
PSV, IYN, ITX, 90-ITX, 78-KOG, 90IYN
Device Description
OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE has been designed to be used with the SSD-Alpha5 (K041916) and SSD-Alpha10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, display monitor, and endo-therapy accessories such as aspiration blopsy needle. The subject device is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airway, tracheobronchial tree, esophagus, and surrounding organs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging
Anatomical Site
Airways, tracheobronchial tree, esophagus, and surrounding organs (Trans-esophageal (non-cardiac)), human body.
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
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAY 1 7 2017
Olympus Medical Systems Corporation Ms. Laura Storms-Tyler Director, Regulatory Affairs & Quality Assurance Olympus America, Inc. 3500 Corporate Parkway, P.O. Box 610 Center Valley, PA 18034-0610
Re: K070983
Trade/Device Name: XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: PSV, IYN, ITX Dated: May 29, 2007 Received: May 31, 2007
Dear Ms. Storms-Tyler,
This letter corrects our substantially equivalent (SE) letter of July 5, 2007 and our subsequent corrected SE letter of July 27, 2015.
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
1
Page 2 - Ms. Laura Storms-Tyler
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 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 Industry and Consumer Education 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/ReportalProblem/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 Industry and Consumer Education 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.
Eric A. Mann -S 2017.05.17 14:13:13 -04'00'
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4.3.1 Diagnostic Ultrasound Indications for Use Form
70943 LYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track I only) | Specific | |||||||||
| (Tracks I & III) | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative (specify) | ||||||||||
| Intraoperative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | N | N | N | N | N | N | (Note 2) | |||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Other (spec.) | ||||||||||
| (Note 1) | N | N | N | N | N | N | (Note 2) | |||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other" :
Airways and tracheobronchial tree.
Note 2: "Combined mode operation" includes: B/M,B/PWD,B/CD/PWD
Signature
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
3
4.3.1 Diagnostic Ultrasound Indications for Use Form
7.5 MHz linear array transducer used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| General | ||||||||||
| (Track I only) | Specific | |||||||||
| (Tracks I & III) | A | B | M | PWD | CWD | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Combined | |||||||||
| (Spec.) | Other | |||||||||
| (Spec.) | ||||||||||
| Ophthalmic | Ophthalmic | |||||||||
| Fetal Imaging | ||||||||||
| & Other | Fetal | |||||||||
| Abdominal | ||||||||||
| Intra-operative (specify) | ||||||||||
| Intraoperative (Neuro.) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | P | P | P | P | P | (Note 2) | ||||
| Musculo-skel. (Convent.) | ||||||||||
| Musculo-skel. (Superfic.) | ||||||||||
| Other (spec.) | ||||||||||
| (Note 1) | P | P | P | P | P | (Note 2) | ||||
| Cardiac | Cardiac Adult | |||||||||
| Cardiac Pediatric | ||||||||||
| Trans-esophageal (card.) | ||||||||||
| Other (spec.) | ||||||||||
| Peripheral | ||||||||||
| Vessel | Peripheral vessel | |||||||||
| Other (spec.) |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other" :
Airways and tracheobronchial tree.
Note 2: "Combined mode operation" includes: B/M,B/PWD,B/CD/PWD
Helut leen
(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
4
510(k) SUMMARY
JUL - 5 2007
March 26, 2007
ー General Information
4.2.1
XBF-UC180F-DT8
Manufacture's Name: OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT
Address:
Address:
34-3 Hirai Hinode-Machi. Nishitama-gun, Tokyo 190-0182, Japan
Corresponding Official: Laura Storms-Tyler Executive Director Regulatory Affairs & Quality Assurance
484-896-5688
Olympus America Inc. 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610,
Telephone:
FacsImile: 484-896-7128
E-mall:
Laura storms-tyler@olympus.com
2951 Ishikawa-cho, Hachioji-shi,
Applicant's Name: OLYMPUS MEDICAL SYSTEMS CORP.
Address:
4.2.2
Initial Distributor Name/Title/Firm:
Address:
Olympus America Inc.
Tokyo, Japan 192-8507
3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610,
Telephone:
484-896-5688
SSD-Alpha 5 / 10
ALOKA CO., LTD.
6-22-1, Mure Mitaka-Shi, Tokyo 181-8622, Japan
Richard J Cehovsky RA/QA Coordinator
ALOKA CO. LTD USA 10 Fairfield blvd. Wallingford, CT 06492
203-269-5088
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2 Device Identification
. Device Trade Name:
OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM
| Common Name: | Ultrasonic Endoscope |
|---|---|
| Regulation Number: | 892.1570 Diagnostic Ultrasound Transducer |
| 892.1550 Ultrasonic Pulsed Doppler Imaging System | |
| 876.1500 Endoscope and Accessories | |
| Regulatory Class: | II |
- Product Code: 90-ITX/78-KOG/90IYN
ਡ Predicate Device Information
Ultrasonic Endoscope
| Subject device | Predicate device | |
|---|---|---|
| Name | Control number | |
| XBF-UC180F-DT8 | ||
| ULTRASONIC | ||
| BRONCHOFIBERVIDEOSCOPE | BF-UC160F-OL8 | |
| EVIS EXERA ULTRASONIC | ||
| BRONCHOFIBERVIDEOSCOPE | K042140 | |
| SSD-Alpha 5 | ALOKA SSD-ALPHA 5 | |
| ULTRASOUND SYSTEM | K041916 | |
| SSD-Alpha 10 | ALOKA SSD-ALPHA 10 | |
| ULTRASOUND SYSTEM | K043196 |
4 Device Description
OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE has been designed to be used with the SSD-Alpha5 (K041916) and SSD-Alpha10(K043196) diagnostic ultrasound systems (ALOKA CO.,LTD.), video system center, light source, documentation equipment, display monitor, and endo-therapy accessories such as aspiration blopsy needle. The subject device is designed for endoscopic real-time ultrasound imaging, for performing endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) within the airway, tracheobronchial tree, esophagus, and surrounding organs.
5 Indications for Use
The use of of OLYMPUS XBF- UC180F-DT8 indications for ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM are as follows:
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- Transesophageal(non-cardiac) l
- I Airways and tracheobronchial tree
6 Comparison of Technological Characteristics
When the OLYMPUS XBF- UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE used with the ALOKA SSD-Alpha 5/10 ULTRASOUND SYSTEM is compared to its predicate device, the device does not incorporate any significant changes in its intended use, method of operation, material or design that could affect the safety and effectiveness, Technological characteristics of ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM is identical to the predicate devices identified in above item 3.