(84 days)
Not Found
No
The document describes a mechanical device (balloon sheath) used with an ultrasonic probe for imaging. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a "Balloon Sheath for bronchial use" designed for "intraluminal ultrasonic imaging." Its function is diagnostic (imaging), not therapeutic (treating a condition).
Yes
Explanation: The device is described as being used for "intraluminal ultrasonic imaging," which is a diagnostic procedure used to visualize internal structures.
No
The device description clearly outlines physical components such as a balloon, insertion tube, adapter, connector body, rings, and an irrigation port, indicating it is a hardware device.
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 to provide information for diagnosis, monitoring, or screening.
- Device Function: The MH-246R Balloon Sheath is used in vivo (within the body) for ultrasonic imaging of the airways. It facilitates the use of an ultrasonic probe to visualize internal structures.
- No Sample Analysis: The device itself does not analyze any biological samples taken from the patient. Its purpose is to aid in the acquisition of imaging data directly from within the body.
Therefore, the MH-246R Balloon Sheath falls under the category of a medical device used for imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MH-246R Balloon Sheath for bronchial use is designed to be used with the Olympus Ultrasonic Probe UM 2R/3R for intraluminal ultrasonic imaging of the upper airways and tracheobronchial use.
Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the upper airways and the tracheobronchial tree.
Product codes (comma separated list FDA assigned to the subject device)
90 ITX
Device Description
The MH-246R Balloon Sheath for bronchial use consists of two sections - insertion section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe locking ring, sheath locking ring, and irrigation port.
The insertion section is connected to the connector body through a sheath locking ring, while the ultrasonic probe in inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic imaging
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): 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
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.
0
510(k) Summary Olympus MH-246R Balloon Sheath
| Device Name: | Olympus MH-246R Balloon Sheath (for bronchial use) |
|---|---|
| Common/Usual Name: | Balloon Sheath |
| Classification Number | |
| and Name: | Class II, 21 CFR 892.1570, Diagnostic Ultrasound |
| Transducer | |
| Class II, 21 CFR 874.4680 | |
| Bronchoscope and accessories | |
| Predicate Devices: | Olympus MH-246R (for GI use), K961048 |
| Submitted by: | Laura Storms-Tyler |
| Olympus America Inc. | |
| Regulatory Affairs | |
| Two Corporate Drive | |
| Melville, NY 11747-3157 | |
| phone (516) 844-5688, facsimile (516) 844-5416 |
Summary Preparation Date: August 4, 1998
Statement of Intended Use
The MH-246R Balloon Sheath for bronchial use is designed to be used with the Olympus Ultrasonic Probe UM 2R/3R for intraluminal ultrasonic imaging of the upper airways and tracheobronchial use.
Device Description
The MH-246R Balloon Sheath for bronchial use consists of two sections - insertion section and connector section. The insertion section is constructed of a balloon with the light shielding cover, insertion tube, and adapter. The connector section consists of a connector body, probe locking ring, sheath locking ring, and irrigation port.
The insertion section is connected to the connector body through a sheath locking ring, while the ultrasonic probe in inserted into the balloon sheath through a probe locking ring. The water filled syringe is connected to the irrigation port via an extension tube and three-way stopcock. The insertion section with the balloon will be provided sterile and intended for single use only. The connector section can be reused after proper cleaning and sterilization as outlined in the instruction manual.
General Safety
When compared to the predicate device, the Olympus MH-246R Balloon Sheath does not incorporate any significant change in method or operation, material, or design that could affect the safety or effectiveness.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three abstract human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.
OCT 2 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Dr. Melville, NY 11747-3157
Re:
K982733 Olympus MH-246R Balloon Sheath, for Bronchial I Ise Dated: August 4, 1998 Received: August 5, 1998 Regulatory class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) 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 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. . You may, therefore, market the device, subject to the general controls provisions of 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR-Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97)." Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/odri/dsmaldsmamain.html".
Sincerely yours,
William Yip, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal. Ear. Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): _ K982733 Olympus MH-246R Balloon Sheath Device Name: (for bronchial use)
Indications for Use:
්යුං
Olympus MH-246R Balloon Sheath have been designed to be used with the Olympus Ultrasonic Probe UM-2R/UM-3R, for intraluminal ultrasonic imaging of the upper airways and the tracheobronchial 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) | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K982733 |
| (Optional Format 1-2-96) |