(189 days)
No
The summary describes a standard ultrasonic probe and its technical specifications. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The intended use statement explicitly states that the product is "intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs," indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs." The presence of "diagnosis" directly indicates its diagnostic function.
No
The device description explicitly states it is a medical ultrasonic probe that converts electrical signals into ultrasonic waves and receives reflected waves, indicating it is a hardware device with a transducer.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: This device is an ultrasonic probe that is used inside the body (in vivo) to generate images of internal organs. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "observation and diagnosis of the gastrointestinal tract and surrounding organs," which is an in vivo diagnostic procedure.
Therefore, based on the provided information, this medical ultrasonic probe is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults.
Modes of Operation: B-mode
Never use this product for any other purposes.
Product codes
ITX
Device Description
FUJIFILM Endoscopic Ultrasonic Probe converts the electrical signal from the ultrasonic observation device connected via the probe scanner into ultrasonic waves by the ultrasonic transducer placed and emits it and receives reflected waves from the human body. The received wave is converted into an electric signal by transducer and sent to an ultrasonic device to create an ultrasonic image. The scanning method is a mechanical radial method by using a probe scanner.
Based on the guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 2023), this device follows the track 3 designation, as it does conform to IEC 60601-2- 37. The transducer model designation and type are a mechanical radial scan, with a size and spacing of elements of 1.9×2.0×0.6mm(M×L×T). There is one element in the array, with array dimensions of one and the maximum number of active elements for a single pulse is one. The nominal ultrasonic frequency of the P2612S-L is 10MHz and for P2620S-L is 17MHz, both in combination with SP-900.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
gastrointestinal tract and surrounding organs
Indicated Patient Age Range
adults
Intended User / Care Setting
physicians at medical facilities
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)
Clinical testing is not applicable to this submission.
The cleaning, disinfection, and sterilization were validated on P2612S-L/P2620S-L.
The biocompatibility was evaluated in accordance with FDA's guidance. Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued 2018. The cytotoxicity was evaluated according to ISO 10993-5. The sensitization study was conducted according to 10993-10 and irritation testing was conducted according to ISO 10993-23.
The subject device P2612S-L/P2620S-L contains electronic components. The testing was conducted to ensure the electrical safety of the subject device P2612S-L/P2620S-L according to ANSI/AAMI ES60601-1 and IEC 60601-2-37:2007. The subject device P2612S-L/P2620S-L along with the applicable system (SP-900) was evaluated for the electromagnetic compatibility according to IEC 60601-1-2:2014.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 13, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fujifilm Healthcare Americas Corporation % Chaitrali Kulkarni Sr. Regulatory Affairs Specialist 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN
Re: K231666
Trade/Device Name: Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: Class II Product Code: ITX Dated: November 7, 2023 Received: November 7, 2023
Dear Chaitrali Kulkarni:
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
Submission Number (if known)
Device Name
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
Indications for Use (Describe)
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults.
Modes of Operation: B-mode
Never use this product for any other purposes,
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
K231666
FUJIFILM Corporation
FUJIFILM Ultrasonic Probe P2612S-L/P2620S-L
Date: December 13, 2023
Submitter's Information:
FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN
Contact Person:
Chaitrali Kulkarni Senior Regulatory Affairs Specialist E-Mail: chaitrali.kulkarni@fujifilm.com Telephone: (704) 517 4886
Identification of the Subject Device:
| Device Name | Endoscopic Ultrasonic
Probe (P2612S-L);
Endoscopic Ultrasonic
Probe (P2620S-L) |
|------------------------|-----------------------------------------------------------------------------------------|
| Common Name | Ultrasonic Probe |
| Product Code | • ITX |
| Device Class | Class 2 |
| Regulation Number | • 892.1570 |
| Regulation Description | • Diagnostic ultrasonic
transducer |
| Review Panel | • Radiology |
Predicate Device:
- OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT . FOR GASTROINTESTINAL TRACT (K994103)
Reference Device:
- Modifications to EUB-525 Diagnostic Ultrasound Scanner; EUB-2000 Diagnostic Ultrasound ● Scanner; Sp-711 Sonoprobe System (K012239)
Intended Use / Indications for Use:
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract and surrounding organs under the management of physicians at medical facilities. This product is intended for adults.
Modes of Operation: B-mode
Never use this product for any other purposes.
4
Device Description:
FUJIFILM Endoscopic Ultrasonic Probe converts the electrical signal from the ultrasonic observation device connected via the probe scanner into ultrasonic waves by the ultrasonic transducer placed and emits it and receives reflected waves from the human body. The received wave is converted into an electric signal by transducer and sent to an ultrasonic device to create an ultrasonic image. The scanning method is a mechanical radial method by using a probe scanner.
Based on the guidance, Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (Feb. 2023), this device follows the track 3 designation, as it does conform to IEC 60601-2- 37. The transducer model designation and type are a mechanical radial scan, with a size and spacing of elements of 1.9×2.0×0.6mm(M×L×T). There is one element in the array, with array dimensions of one and the maximum number of active elements for a single pulse is one. The nominal ultrasonic frequency of the P2612S-L is 10MHz and for P2620S-L is 17MHz, both in combination with SP-900.
Comparison of Technological Characteristics:
Comparisons of technological characteristics between the subject devices are provided in the tables below:
Table 1
| Device name | Predicate Device | Reference Device: | Proposed Device | Equivalence |
|---|---|---|---|---|
| Olympus Ultrasonic Probe | Endoscopic Ultrasonic | |||
| Probe | ||||
| UM-S30-25R | PL2226-12 | P2612S-L/P2620S-L | ||
| P2226-20 | ||||
| 510(k) number | K994103 | K012239 | K231666 |
5
| Indications for use (IFU) | The Olympus UM-S30-25R
Ultrasonic Probe has been
designed to be used with an
Olympus Endoscopic Ultrasound
center, Probe Driving Unit and an
endoscope for
intraluminal ultrasonic imaging of
the gastrointestinal tract and
surrounding organs. Modes of
Operation: B-mode | The intended use of the
subject device is for
endoscopic observation
of the gastrointestinal
tract (esophagus,
stomach, duodenum,
large intestine) and
biliary system (pancreato-
biliary ducts). The
Ultrasound Device
Indications Statements
for each application and
mode of the
system/transducers are
included with this
document. | This product is a medical
ultrasonic probe. It is
intended for the
observation and diagnosis
of the gastrointestinal
tract and surrounding
organs under the
management of
physicians at medical
facilities. This product is
intended for adults.
Modes of Operation: B-
mode
Never use this product for
any other purposes. | Same | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Probe specification | | | | | |
| Diameter of insertion portion | 2.4mm | 2.6mm | 2.5mm | The proposed device
and the predicate
device have different
insertion portion
diameters, however the
proposed device has a
smaller insertion
portion diameter than
the reference device,
therefore there is no
new concern for safety
and efficacy. | |
| Maximum diameter of insertion
portion | | 2.7mm | 2.6mm | The proposed device
and the reference
device have different
maximum diameter of | |
| | | | | | |
| | | | | | insertion portion, however the proposed device has a smaller insertion portion diameter than the reference device, therefore there is no new concern for safety and efficacy. |
| Working length | | 2050mm | 2180mm | 2620mm | Although the length of the proposed device is longer, the working length of the proposed device is compatible with the working length of its compatible endoscope, therefore there are no new concerns for the safety and efficacy of the proposed device. |
| Applicable reprocess method | Manual cleaning | | Applicable | Applicable | Same as reference device |
| | Manual disinfection | | Applicable | Applicable | Same as reference device |
| | Endoscope automatic cleaning and disinfection | | Not Applicable | Applicable | The proposed device does have automatic cleaning and disinfection although the reference device does not. The difference in applicable reprocess methods does not affect the safety and efficacy of the device and cleaning instructions have been provided in the operation manual. |
| | EOG | | Not Applicable | Applicable | EOG sterilization is |
| | Sterilization | | | | applicable to the
proposed device but
not the reference
device. The difference
in applicable reprocess
methods does not affect
the safety and efficacy
of the device and
cleaning instructions
have been provided in
the operation manual. |
| | Stellad
Sterilization | | Not applicable | Not applicable | Same as reference
device |
| Applicable system | | Olympus Endoscopic Ultrasound
center, Probe Driving Unit and an
endoscope for
intraluminal ultrasonic imaging of
the gastrointestinal tract and
surrounding organs. | SP-711 | SP-900 | The difference in
applicable systems
between the subject
device and predicate
device do not affect the
safety or efficacy of the
subject device. The
subject device has been
tested with the SP-900
processor and the
applicable system is
listed in the operation
manual. |
| Applicable scope | | Flexible endoscope: inner channel
is 2.8mm, 3.2mm,4.2mm,6mm and
5.Smm.
Rigid endoscopes: minimum
capacity is 9Fr. | Direct-viewing type
endoscopes with a
forceps channel diameter
of 2.8 mm or more and a
working
length of 1700 mm or
less | FUJIFILM endoscope
-Upper gastrointestinal
endoscope
-Lower gastrointestinal
endoscope
*1 The instrument
channel diameter of each
endoscope must be 2.8
mm or more and its
working
length 2200 mm or less.
*2 This product is not
applied in combination | The differences in the
applicable scope do not
affect the safety or
efficacy of the subject
device. The subject
device has been tested
with its applicable
scope and no new
concerns for safety or
efficacy was seen. |
| | | | with Duodenoscope and
Ultrasonic endoscope. | | |
| Ultrasound specification | | | | | |
| Scanning method | Mechanical radial | Mechanical radial | Mechanical radial | same | |
| Sound operating frequency | 30MHz | PL2226-12 :
12MHz±20%
PL2226-20 :
18MHz±20% | P2612S-L :
10MHz±15%
P2620S-L :
17MHz±15% | The differences in the
ultrasound
specification from the
predicate device and
the proposed device
have been tested
according to 60601-2-
37 | |
| Resolution | | Axial: 1.5mm or less
Lateral: 3.0mm or less | Axial: 1.0mm or less
Lateral: 3.0mm or less | The differences in the
ultrasound
specification from the
predicate device and
the reference device
have been tested
according to 60601-2-
37. | |
| Penetration | | PL2226-12 : 15mm
PL2226-20 : 5mm | P2612S-L : 20mm
P2620S-L: 5mm | The differences in the
ultrasound
specification from the
predicate device and
the proposed device
have been tested
according to 60601-2- | |
6
7
8
9
| 37. | |||
|---|---|---|---|
| Patient contact materials | |||
| Insertion portion | Distal end cap : | ||
| Polyethylene | |||
| • Distal ring : Stainless | |||
| steel rod | |||
| • Bonded part : Epoxy | |||
| resin | |||
| • Sheath : | |||
| Polytetrafluoroethylene | Distal end cap : | ||
| Polyethylene | |||
| • Distal ring : Stainless | |||
| steel rod | |||
| • Bonded part : Epoxy | |||
| resin | |||
| • Sheath : | |||
| Polytetrafluoroethylene | Same as reference | ||
| device |
10
Performance Data:
FUJIFILM Ultrasonic P2612S-L/P2620S-L is supplied non-sterile and must be properly reprocessed prior to each use in accordance with its reprocessing instructions. The cleaning, disinfection, and sterilization were validated on P2612S-L/P2620S-L.
The biocompatibility was evaluated in accordance with FDA's quidance. Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued 2018. The cytotoxicity was evaluated according to ISO 10993-5. The sensitization study was conducted according to 10993-10 and irritation testing was conducted according to ISO 10993-23.
The subject device P2612S-L/P2620S-L contains electronic components. The testing was conducted to ensure the electrical safety of the subject device P2612S-L/P2620S-L according to ANSI/AAMI ES60601-1 and IEC 60601-2-37:2007. The subject device P2612S-L/P2620S-L along with the applicable system (SP-900) was evaluated for the electromagnetic compatibility according to IEC 60601-1-2:2014.
Clinical Testing:
Clinical testing is not applicable to this submission.
Conclusions:
The subject device FUJIFILM Ultrasonic Probe P2612S-L/P2620S-L and predicate device, Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract, have slight differences in the technological characteristics. Although there are differences in technological characteristics those differences do not raise any new concerns for safety and efficacy.
The subject device FUJIFILM Ultrasonic Probe P2612S-L/P2620S-L is substantially equivalent to the respective predicate device Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Gastrointestinal Tract (K994103)