(15 days)
No
The summary describes standard ultrasound technology and image processing without mentioning AI, ML, or related concepts.
No
The device is used for imaging (diagnostic purposes) rather than treatment, as indicated by its function of converting sound waves to images for display.
Yes
The device is described as creating and displaying images from ultrasound signals, which is a diagnostic function used to visualize internal structures for medical evaluation.
No
The device description explicitly states it is designed to be used with an OLYMPUS endoscopic ultrasound center, light source, documentation equipment, display monitor, endotherapy accessories, and other ancillary equipment, indicating it is part of a hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Intraluminal ultrasound for upper airways and tracheobronchial tree." This describes a procedure performed within the body for imaging purposes.
- Device Description: The description details a device used with endoscopic equipment for "endoscopic ultrasonic imaging." This is an in vivo imaging technique.
- Mechanism: The device uses sound waves to create images of internal structures. This is a form of medical imaging, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are designed to perform tests on biological specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device is clearly designed for in vivo imaging.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intraluminal ultrasound for upper airways and tracheobronchial tree.
Product codes
PSV, ITX, ODG
Device Description
This subject device has been designed to be used with an OLYMPUS endoscopic ultrasound center, light source, documentation equipment, display monitor, endotherapy accessories and other ancillary equipment for endoscopic ultrasonic imaging of the upper airways and trancheobronchial tree.
Mentions image processing
Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic pulsed doppler imaging system
Anatomical Site
Upper airways and tracheobronchial tree
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)
K011886, K982323, K963033, K910423
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAY 1 7 2017
Olympus America, Inc. c/o Mr. Donald James Sherratt Medical Stream Director Intertek Testing Services 70 Cadman Hill Road Boxborough, MA 01719
Re: K021204
Trade/Device Name: Olympus BF Type UM40 Ultrasonic Bronchofiberscope Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: PSV, ITX, ODG Dated: April 15, 2002 Received: April 16, 2002
Dear Mr. Sherratt,
This letter corrects our substantially equivalent (SE) letter of May 1, 2002 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
1
Page 2 - Mr. Donald James Sherratt
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 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/ResourcesforYowIndustry/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 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 14:12:01 -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
2
4.3.1 Indications for Use Form for Ultrasonic Bronchofiberscope OLYMPUS BF TYPE UM40
Diagnostic Ultrasound Indications for Use Form
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| Other (specify) | N |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as tollows:
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Note 1: Specification for "Other"
Intraluminal ultrasound for upper airways and tranche obronchial tree.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED] Concurrence of CDRH, Office of Device Evaluation (ODE)
.
Prescription Use Per 21 CFR 801.109)
Rate Pulla
(Division Sign-Off) Division of Reproductive, A and Radiological Devic 5 10(k) Number
Section 4.3 Page 2
3
4.3.1 Indications for Use Form For
Indications FU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER With Olympus GF Type UM40 Ultrasonic Endoscopic Transducer
Diagnostic Ultrasound Indications for Use Form
Intended Use of new transducer: Intraluminal ultrasound for upper airways and tracheobronchial tree
| 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 | P | |||||||||
| Transrectal | P | |||||||||
| Transvaginal | P | |||||||||
| Transurethral | P | |||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Other (specify) | P |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments: Olympus EU-M60 EUS EXERA Endoscopic Ultrasound Center Previously cleared for use for
Intraluminal ultrasound for upper airways and tracheobronchial tree under K011886
Specification for "Other": Gastrointestinal tract, biliary, pancreatic duct and surrounding organs,
Intraluminal ultrasound for upper alrways and tracheobronchial tree, urinary tract,
female reproductive tract.
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Ra. a. Pally
Division Sign-Off
Division Sign-Off Division of Reproduc and Radiological Device 510(k) Number
Section 4.3 Page 3
4
4.3.1 Indications for Use Form For Olympus EU-M30 ENDOSCOPIC ULTRASOUND CENTER With Olympus GF Type UM40 Ultrasonic Endoscopic Transducer
Diagnostic Ultrasound Indications for Use Form
Intended Use of new transducer: Intraluminal ultrasound for upper airways and tracheobronchial tree
| 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 | P | |||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal Conventional | ||||||||||
| Other (specify) | P |
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
Intraluminal ultrasound for upper airways and tracheobronchial tree with transducer UM 2R/3R under K902323
Specification for "Other": Gastrointestinal tract, biliary, pancreatic duct and surrounding organs. Cleared under
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Ra-C. Phillips
Sian-Off Division of Reproductive, and Radiological Devices 510(k) Number
Section 4.3 Page 4
5
MAY 01 2002
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
2-3-1 Shinjukuku Monolis Nishi-Shinjuku Shinjuku-ku, Tokyo, 163-0914 Japan 810047 2951 Ishikawa-cho Hachioji-shi, Tokyo 192-8507 Japan TEL 81-426-42-2891 FAX 81-426-46-5613
2. 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:
Tsuyoshi Yanai Regulatory Affairs Manager, 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
6
B. Device Name, Common Name
-
- Common/Usual Name
Ultrasonic endoscope
- Common/Usual Name
2. Device Name
· Ultrasonic Bronchofiberscope OLYMPUS BF TYPE UM40
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 UM160 | K011886 |
| Olympus UM-2R/ 3R Ultrasonic Probes and associated | |
| ancillary equipment (for bronchial use) | K982323 |
| BF-240/P240/1T240 Bronchovideoscope & Accessories | K963033 |
| Bronchoscope BF-N20 | K910423 |
D. Device Description
1. Summary
This subject device has been designed to be used with an OLYMPUS endoscopic ultrasound center, light source, documentation equipment, display monitor, endotherapy accessories and other ancillary equipment for endoscopic ultrasonic imaging of the upper airways and trancheobronchial tree.
2. Design
This subject device is designed to comply with the standards listed below.
| IEC 60601-1 |
|---|
| IEC 60601-1-1 |
| IEC 60601-1-2 |
| IEC 60601-2-18 |
| CISPR11 |
7
3. Materials
The material for Insertion Tube Outer Surface of this subject device has a new patientr no metional aterial. 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 this subject device, as defined by FDA guidance documents, is: Other
1)Intraluminal ultrasound for upper airways and tracheobronchial tree
F. Technological Characteristics:
This device operates identically to the predicate devices in that the transducer of the endoscope that is inserted into the body cavity mechanically scans the targeted site. Chaooops that is interial in the transducer is used as an ultrasound source to transmit sound waves. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as images.
Technological Characteristics of this device is identical to the predicated devices identified in item C.