(177 days)
Not Found
No
The summary describes a standard ultrasound imaging system with basic measurement and storage capabilities, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as "Endoscopic Ultrasonic Diagnostic Equipment" intended to "acquire and display real-time ultrasound images of the target organs." Its mode of operation and function are purely diagnostic, focusing on imaging and measurement, without any mention of directly treating or alleviating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "Endoscopic Ultrasonic Diagnostic Equipment" and is intended "to acquire and display real-time ultrasound images of the target organs." It also details its indication for "intraluminal ultrasound imaging" of various bodily organs.
No
The device description explicitly lists hardware components such as a main unit, control panel, driver box, trolley, display, and a disposable sterile ultrasonic probe. While software is mentioned for verification and validation, the device is clearly a system with significant hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- This Device's Function: This device uses ultrasound to create images of internal organs within the body (in vivo). It does not analyze specimens taken from the patient.
- Intended Use: The intended use clearly states it's for "acquiring and displaying real-time ultrasound images of the target organs" and "intraluminal ultrasound imaging." This is a diagnostic imaging device, not an in vitro diagnostic device.
The information provided describes a medical imaging system used for visualizing internal structures, which falls under the category of diagnostic imaging equipment, not IVDs.
N/A
Intended Use / Indications for Use
Endoscopic Ultrasonic Diagnostic Equipment/Disposable Sterile Ultrasonic Probe is intended to be used in conjunction with ultrasound endoscopes to acquire and display real-time ultrasound images of the target organs. This device is indicated for intraluminal ultrasound imaging of the upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs.
Mode of operation includes B mode. This device is intended for use by a qualified and trained healthcare professional in a hospital setting or medical clinic.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
Endoscopic Ultrasonic Diagnostic Equipment consist of main unit, control panel, driver box, trolley, and display,it is used in conjunction with Disposable Sterile Endoscopic Ultrasonic Probe to acquire and display high-resolution and high-penetration.real-time ultrasound images of the target organs. Disposable Sterile Endoscopic Ultrasonic Probe is single-use.
The subject system only has B mode.
The subject system provide measurements and calculations of distance,area,circumference, it also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external
recording device.
The subject system will be used with compatible endoscope system :
Bronchoscope System (EOS-H-01, Shanghai AnQin Medical Instrument Co.Ltd)cleared under K211169.
-working length maximum 600mm
-Insrument channel dimaeter minimum 1.7mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified and trained healthcare professional in a hospital setting or medical clinic.
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)
The following performance testing was conducted in support of the substantial equivalence determination.
Acoustic output in conformity with the requirement of IEC 60061-2-37:2015 and IEC 62359: 2017.
Leakage current , patient auxiliary current and Dielectric strength in conformity with the requirement of IEC 60601-1:2020.
Biocompatibility of Disposable Sterile Endoscopic Ultrasonic Probe was evaluated in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The following tests were performed:
- Cytotoxicity
- Sensitization
- Intradermal reactivity
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Electrical safety and EMC testing was conducted in accordance with the ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, and IEC 60601-1-2:2020 standards for EMC and IEC 60601-2-37:2015.
No animal study was performed to demonstrate substantial equivalence.
No clinical study was performed to demonstrate substantial equivalence.
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
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
December 21, 2023
Ultrasound Biotechnology (Shanghai) Co., Ltd. % Yingnan Zhang Vice President Room 401, Floor 4, No. 1 Building, 269 Lianchuang Rd. Pudong, Shanghai 200135 CHINA
Re: K231889
Trade/Device Name: Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1.USW140-S20MS) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, ITX Dated: November 17, 2023 Received: November 17, 2023
Dear Yingnan Zhang:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K231889
Device Name
Endoscopic Ultrasonic Diagnostic Equipment/ Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)
Indications for Use (Describe)
Endoscopic Ultrasonic Dispostic Equipment/Disposable Sterile Ultrasonic Probe is intended to be used in conjunction with ultrasound endoscopes to acquire and display real-time ultrasound images of the target organs. This device is indicated for intraluminal ultrasound imaging of the upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs.
Mode of operation includes B mode. This device is intended for use by a qualified and trained healthcare professional in a hospital setting or medical clinic.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
K231889
1. Submitter information
| Applicant Name | ULTRASOUND BIOTECHNOLOGY (SHANGHAI) CO., LTD. |
|---|---|
| Applicant Address | Room 401, Floor 4, No. 1 Building, 269 Lianchuang Rd., |
| Pudong, 200135 Shanghai, PR. China Shanghai 200135 China | |
| Applicant Contact Telephone | 021-50362882 |
| Applicant Contact | Yingnan Zhang |
| Contact Email | zhangyingnan@ultrasoundmed.com.cn |
2. Application correspondent
| Company | Landlink Healthcare Technology (Shanghai) Co., Ltd. |
|---|---|
| Address | Room 1308, Baohua International Plaza, West Guangzhou |
| Road 555, Jingan District | |
| Contact person | Eric Zhang |
| Contact Email | eric.zhang@landlink-health.com |
3. Device Name
| Device Trade Name | Endoscopic Ultrasonic Diagnostic Equipment/ Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) |
|---|---|
| Common Name | Ultrasonic pulsed echo imaging system, Diagnostic ultrasonic transducer |
| Regulation Number | 892.1560 Ultrasonic pulsed echo imaging system |
| 892.1570 Transducer, Ultrasonic, Diagnostic | |
| Product Code | IYO:System, Imaging, Pulsed Echo, Ultrasonic |
| ITX: Transducer, Ultrasonic, Diagnostic | |
| Regulation Class | Class II |
| Classification Panel | Radiology |
4
| Predicate # | Predicate Trade Name | Product Code |
|---|---|---|
| K951994(Primary ) | Olympus EU-M30 Endoscopic Ultrasound | |
| Center and ancillary equipment | IYO | |
| K944610(secondary) | OLYMPUS ULTRASONIC PROBES | ITX |
4. Legally Marketed Predicate Device
5. Device Description Summary
Endoscopic Ultrasonic Diagnostic Equipment consist of main unit, control panel, driver box, trolley, and display,it is used in conjunction with Disposable Sterile Endoscopic Ultrasonic Probe to acquire and display high-resolution and high-penetration.real-time ultrasound images of the target organs. Disposable Sterile Endoscopic Ultrasonic Probe is single-use.
The subject system only has B mode.
The subject system provide measurements and calculations of distance,area,circumference, it also allows for the storage and retrieval of images for reviewing and printing.
The subject system enables the user to print and record images to an external
recording device.
The subject system will be used with compatible endoscope system :
Bronchoscope System (EOS-H-01, Shanghai AnQin Medical Instrument Co.Ltd)cleared under K211169.
-working length maximum 600mm
-Insrument channel dimaeter minimum 1.7mm
6. Indications for Use
Endoscopic Ultrasonic Diagnostic Equipment/Disposable Sterile Ultrasonic Probe is intended to be used in conjunction with ultrasound endoscopes to acquire and display real-time ultrasound images of the target organs. This device is indicated for intraluminal ultrasound imaging of the upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs.
Mode of operation includes B mode. This device is intended for use by a qualified and trained healthcare professional in a hospital setting or medical clinic.
5
7. Technological Comparison
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Item | ||
| USW-S1 | EU-M30 | |
| Endoscopic Ultrasonic | ||
| Diagnostic | Olympus EU-M30 Endoscopic | |
| Ultrasound Center is designed to | ||
| be used inn combination with | ||
| Olympus | ||
| GF-UM20/JF-UM20/CF-UM20 | ||
| ultrasonic endoscopes.Olympus | ||
| UM-2R/UM-3R ultrasonic probes, | ||
| and Olympus MH-908 esophageal | ||
| ultrasonic probe for observation of | ||
| real-time ultrasound images of | ||
| upper GI tract,lower GI tract, and | ||
| adjacent structures. | ||
| Indications for Use | Equipment/Disposable Sterile | |
| Ultrasonic Probe is intended to | ||
| be used in conjunction with | ||
| ultrasound endoscopes to | ||
| acquire and display real-time | ||
| ultrasound images of the target | ||
| organs. This device is | ||
| indicated for intraluminal | ||
| ultrasound imaging of the | ||
| upper respiratory tract and | ||
| bronchus, digestive tract, and | ||
| hepatobiliary and pancreatic | ||
| organs. | ||
| Modes of operation:B. |
Operator qualifications:
Qualified and trained
healthcare professional.
Device use settings:
Hospital or medical clinic. | Modes of operation:B.
Operator qualifications:
Appropriately-trained
healthcare professional.
Device use settings:Hospital. |
| Acoustic scanning format | Mechanical scan | |
| Measurement & Analysis | Distance, Circumference Length/Area | |
| Mode of operation | B | |
| Available Frequency | 20 MHz | 7.5, 12, 20 MHz |
| Display range | 2cm | 1, 2, 3, 4, 6, 9, 12 cm |
Table 1 Comparison of the Subject and primary Predicate Device(host)
Table 2 Comparison of the Subject and Secondary Predicate Device(probe)
| Specification | Subject Device USW140-S20MS
Transducer | Secondary Predicate device
UM-S20-17S (K944610) |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Probe Type | Mechanic Radial scan | Mechanic Radial scan |
| Indications for Use | Endoscopic Ultrasonic Diagnostic
Equipment/Disposable Sterile
Ultrasonic Probe is intended to be
used in conjunction with ultrasound
endoscopes to acquire and display
real-time ultrasound images of the
target organs. This device is
indicated for intraluminal ultrasound | UM-S20-17S is designed for use
with Olympus endoscopic
ultrasound system to observe and
to store real-time ultrasound
images and indicated for use within
the gastrointestinal(GI)
tract,biliary ,pancreatic ducts and
surrounding organs,airways and |
6
| Specification | Subject Device USW140-S20MS
Transducer | Secondary Predicate device
UM-S20-17S (K944610) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| | imaging of the upper respiratory tract and bronchus, digestive tract, and hepatobiliary and pancreatic organs. | tracheobronchial tree,and urinary tract. |
| | Modes of operation:B. | Modes of operation:B. |
| | Operator qualifications:
Qualified and trained healthcare professional. | Operator qualifications:
Qualified and trained healthcare professional. |
| | Device use settings:
Hospital or medical clinic. | Device use settings:
Hospital or medical clinic. |
| Mode | Mode B | |
| Scanning method | Mechanical radial Scanning | |
| Ultrasonic frequency | 20 MHz | |
| Effective length | 1800 mm | 2150 mm |
| Full length | 1840 mm | 2250 mm |
| Outer diameter of
insertion tube | Ø 1.4 (distal end 1085 mm)
Ø 1.8 (proximal end) | Ø 1.4 (distal end 1085 mm)
Ø 1.7 (proximal end) |
| Maximum
diameter of
insertion portion | 1.8 mm | 1.8 mm |
| Array dimensions | N/A | N/A |
| Number of
elements in the
array | 1 | 1 |
| Single use/ Re-use | Single use | Re-use |
| Provided sterile or | Sterile | Not |
8. Non-Clinical Tests Summary
The following performance testing was conducted in support of the substantial equivalence determination.
Acoustic output
Acoustic output is in conformity with the requirement of IEC 60061-2-37:2015 and IEC 62359: 2017.
Leakage current , patient auxiliary current and Dielectric strength
7
Leakage current , patient auxiliary current and Dielectric strength is in conformity with the requirement of IEC 60601-1:2020.
Biocompatibility
Biocompatibility of Disposable Sterile Endoscopic Ultrasonic Probe was evaluated in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" . The following tests were performed, as recommended:
- Cytotoxicity
- Sensitization
- Intradermal reactivity
Software verification and Cybersecurity Test
Software verification and validation testing was conducted and documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and"Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing was conducted in accordance with the ANSI/AAMI ES 60601-1:2005/(R) 2012 and A1:2012, and IEC 60601-1-2:2020 standards for EMC and IEC 60601-2-37:2015.
Performance testing - Animal
No animal study was performed to demonstrate substantial equivalence.
Performance testing - Clinical
No clinical study was performed to demonstrate substantial equivalence.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and technological comparison to the predicate device, the subject device raises no new issue of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety, effectiveness and performance.