(157 days)
The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode
The FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 consists of five components: 1) processor (SP-900), 2) probe (PB2020-M2), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in PB2020-M2, which is inserted through the forceps channel of an endoscope. SP-900 processes the reflected ultrasound signals which PB2020-M2 receives in the body cavity and further converts the processed electrical signals to relay to a monitoring system. SP-900 can acquire and display real-time ultrasound data in B-mode. CP-900 is used to control operational features of SP-900. RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to SP-900.
This FDA 510(k) summary describes the substantial equivalence of the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 to their predicate devices. It focuses on the comparison of technological characteristics and safety testing, rather than an AI/ML-driven device's performance evaluation against specific acceptance criteria related to diagnostic accuracy or clinical outcomes.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device, such as those related to diagnostic performance (sensitivity, specificity, AUROC), expert ground truth establishment, MRMC studies, and training/test set details, are not applicable to this submission.
This submission is for a medical imaging device (ultrasound processor and probe), not an AI/ML diagnostic or assistive device. The "performance data" section focuses on electrical safety, EMC, biocompatibility, and reprocessing validation, which are standard for such hardware devices to demonstrate safety and effectiveness.
However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) based on the provided document.
Device Name: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
Device Type: Medical Ultrasonic Processor and Probe
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (ultrasound hardware), the "acceptance criteria" are related to safety, electrical performance, biocompatibility, and reprocessing effectiveness, not diagnostic accuracy metrics typically seen with AI/ML algorithms. The document asserts that the device meets these criteria through various tests.
| Acceptance Criteria Category | Specific Test/Standard Applied | Reported Device Performance / Conclusion |
|---|---|---|
| Reprocessing | Cleaning, Disinfection, and Sterilization (PB2020-M2) | Validated on PB2020-M2. (Specific effectiveness metrics are not detailed but the conclusion suggests successful validation.) |
| STERRAD Sterilization (PB2020-M2) | Conducted and applicable. (This is an addition of a reprocessing method compared to the predicate, and its efficacy was presumably validated.) | |
| Biocompatibility | ISO 10993-1 (Guidance) | Evaluated in accordance with guidance. |
| ISO 10993-5 (Cytotoxicity) | Evaluated according to standard. (Implied acceptance - "conclusion" states no new safety concerns.) | |
| ISO 10993-10 (Sensitization and Irritation) | Conducted according to standard. (Implied acceptance - "conclusion" states no new safety concerns.) | |
| Electrical Safety | ANSI/AAMI ES60601-1 (for PB2020-M2) | Testing conducted to ensure electrical safety. (Implied successful completion.) |
| IEC 60601-2-37:2007 (for PB2020-M2) | Testing conducted to ensure electrical safety. (Implied successful completion.) | |
| Predicate Device SP-900 Electrical Safety (for SP-900) | The subject device SP-900 has the same electrical components and can be adopted into electrical safety of the predicate device SP-900. (Implied substantial equivalence in electrical safety.) | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 (for SP-900 and PB2020-M2) | Evaluated for electromagnetic compatibility. (Implied successful completion.) |
| Software Validation | IEC 62304 (for SP-900) | Conducted in accordance with standard. (Implied successful completion.) |
| Acoustic Output | Spatial Peak Temporal Average Intensity (≤ 720 mW/cm²) | Same as predicate (≤ 720 mW/cm²) |
Mechanical Index (< 1.0) | Same as predicate (< 1.0)) | |
Thermal Index (< 1.0) | Same as predicate (< 1.0) | |
| Physical/Performance Specifications | Various (Size, Weight, Power, Scan Spec, Frequency, Resolution, Depth of Penetration) | All "Same" as predicate (values listed in Tables 1 & 2 implying these are within acceptable ranges for intended use). For PB2020-M2, "Maximum outer diameter of insertion portion (mm)" is 1.98 (subject) vs 2.0 (predicate), which is a slight variation deemed equivalent. |
2. Sample size(s) used for the test set and the data provenance:
N/A - This document describes validation for hardware components (electrical safety, biocompatibility, reprocessing validation), not performance evaluation on a clinical test dataset for diagnostic accuracy. The "test sets" would refer to components/materials undergoing specific engineering and biological tests, not a dataset of patient images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A - Ground truth as typically defined for AI/ML diagnostic devices (e.g., expert radiological reads, pathology) is not relevant for the hardware validation tests performed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A - Not applicable for hardware validation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No - An MRMC study is not relevant for this hardware device. It's designed to provide general ultrasonic images, not to assist humans in interpretation in an AI-augmented manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No - This is hardware, not an algorithm, so standalone performance in the sense of an AI model's accuracy is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
N/A - "Ground truth" in the diagnostic sense is not used for hardware validation. The "ground truth" for the tests performed effectively comes from established engineering standards (e.g., electrical safety limits, biocompatibility guidelines, successful sterilization parameters).
8. The sample size for the training set:
N/A - The device is hardware; there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established:
N/A - As there is no training set, this is not applicable.
{0}------------------------------------------------
June 3, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The U.S. Food & Drug Administration logo is on the right and features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Fujifilm Corporation % Kotei Aoki Senior Regulatory Affairs Specialist Fujifilm Healthcare Americas Corporation 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421
Re: K214089
Trade/Device Name: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: ODG, IYO, ITX Dated: May 2, 2022 Received: May 3, 2022
Dear Kotei Aoki:
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. 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 located 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.
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
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
For
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K214089
Device Name
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
Indications for Use (Describe)
FUJIFILM Ultrasonic Processor SP-900
The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices.
The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation.
Modes of Operation: B-mode
FUJIFILM Ultrasonic Probe PB2020-M2
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities.
Modes of Operation: B-mode
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary - K214089
FUJIFILM Corporation
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
Date: December 27, 2021
Submitter's Information:
FUJIFILM Corporation 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN, KANAGAWA 258-8538 JAPAN
Contact Person:
Kotei Aoki Senior Requlatory Affairs Specialist E-Mail: Kotei.Aoki@fujifilm.com Telephone: (765) 246- 2931
ldentification of the Subject Device:
| Device Name | FUJIFILM Ultrasonic ProcessorSP-900 | FUJIFILM Ultrasonic ProbePB2020-M2 |
|---|---|---|
| Common Name | Ultrasonic Processor | Ultrasonic Probe |
| Product Code | • ODG• IYO | • ITX |
| Device Class | Class 2 | Class 2 |
| Regulation Number | • 876.1500• 892.1560 | • 892.1570 |
| Regulation Description | • Endoscopic Ultrasound System,Gastroenterology-Urology;• System, Imaging, Pulsed Echo,Ultrasonic | • Transducer, Ultrasonic,Diagnostic |
| Review Panel | • Gastroenterology/Urology• Radiology | • Radiology |
Predicate Device(s):
- FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M (K171207) ●
Intended Use / Indications for Use:
FUJIFILM Ultrasonic Processor SP-900
The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode
FUJIFILM Ultrasonic Probe PB2020-M2
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode
{4}------------------------------------------------
Device Description:
The FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 consists of five components: 1) processor (SP-900), 2) probe (PB2020-M2), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in PB2020-M2, which is inserted through the forceps channel of an endoscope. SP-900 processes the reflected ultrasound signals which PB2020-M2 receives in the body cavity and further converts the processed electrical signals to relay to a monitoring system. SP-900 can acquire and display real-time ultrasound data in B-mode. CP-900 is used to control operational features of SP-900. RS-900 provides the mechanical scanning for acquiring a twodimensional image. The power cord supplies power to SP-900.
Comparison of Technological Characteristics:
Comparisons of technological characteristics between the subject devices and the predicate devices are provided in the tables below:
| Subject device modelSP-900 | Predicate device modelSP-900 | Remark | |
|---|---|---|---|
| Device name | Ultrasonic processor | Ultrasonic processor | |
| 510(k) number | K214089 | K171207 | |
| Indications for use (IFU) | The FUJIFILM Ultrasonic Processor SP-900 is intended to be usedin combination with FUJIFILM Ultrasonic Probe, video processor,light source, monitor, recorder, and various peripheral devices. Theproduct is intended to provide ultrasonic images of thegastrointestinal tract, biliary and pancreatic ducts and surroundingorgans, airways and tracheobronchial tree for observation,recording and to aid in diagnosis during endoscopic evaluation.Modes of Operation: B-mode | Same | |
| Compatible transducer | PB2020-M2, PB2020-M | PB2020-M | |
| Physical specification | |||
| Size (mm) | 377(W) x 480(D) x 80(H) | Same | |
| Weight (kg) | 8.0 | Same | |
| Power requirements (V) | AC 100-240 | Same | |
| Scan specification | |||
| Probe type | Radial scan | Same | |
| Scanning method | Mechanical scan | Same | |
| Image mode | B-mode | Same | |
| Frequency (Mhz) | 20 | Same | |
| Measuring functions | Distance; Circumference Length/Area | Same | |
| Output specification | |||
| Display range (mm) | 20, 30, 40, 60, 90, 120 in diameter | Same | |
| Data format | JPEG, TIFF | Same | |
| Electrical Safety | |||
| Spatial Peak TemporalAverage Intensity | ≤ 720 mW/cm² | Same | |
| Mechanical Index | < 1.0 | Same | |
| Thermal Index | < 1.0 | Same | |
| Compatible Peripherals | |||
| Control | CP-900 | Same | |
| Mechanical drive | RS-900 | Same | |
| Other compatibleperipherals | Video Processor, Light Source, Cart, Monitor, Recorder, Printer,Foot Switch, USB Memory | Same |
Table 1
{5}------------------------------------------------
Table 2
| Subject device modelPB2020-M2 | Predicate device modelPB2020-M | Remark | |
|---|---|---|---|
| Device name | Ultrasonic probe | Ultrasonic probe | |
| 510(k) number | K214089 | K171207 | |
| Indications for use (IFU) | This product is a medical ultrasonic probe. It is intended for theobservation and diagnosis of the gastrointestinal tract, biliary andpancreatic ducts and surrounding organs, airways andtracheobronchial tree under the management of physicians atmedical facilities.Modes of Operation: B-mode | Same | |
| Probe specification | |||
| Diameter of insertionportion (mm) | 1.4~1.9 | Same | |
| Working length (mm) | 2150 | Same | |
| Maximum outer diameterof insertion portion (mm) | 1.98 | 2.0 | |
| Reprocessing method | |||
| Manual cleaning | Applicable | Same | |
| High-Level Disinfection | Applicable | Applicable | Same |
| EOG Sterilization | Applicable | Same | |
| STERRAD Sterilization | Applicable | Not applicable | |
| Compatibility | |||
| Applicable system | SP-900 | Same | |
| Applicable scope | FUJIFILM endoscopes thatmeet the following conditions• Channel diameter: ≥2.0mm• Working length: ≤1330mm• Any of the following types ofendoscopeo Bronchoscopeo Upper gastrointestinalendoscopeo Lower gastrointestinalendoscopeo Duodenoscope | FUJIFILM endoscopes thatmeet the following conditions• Channel diameter: ≥2.0mm• Working length: ≤1330mm• Any of the following types ofendoscopeo Bronchoscopeo Upper gastrointestinalendoscopeo Large intestineendoscopeo Duodenoscope | Same |
| Ultrasound specification | |||
| Scanning method | Mechanical radial | Same | |
| Acoustic operatingfrequency (Mhz) | 20 | Same | |
| Resolution (mm) | Axial: ≤ 2.0Lateral: ≤ 2.0 | Same | |
| Penetration depth (mm) | 7.0 | Same |
Performance Data:
FUJIFILM Ultrasonic Processor SP-900 is supplied non-sterile but has no potential for patient contact. FUJIFILM Ultrasonic Probe PB2020-M2 is also 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 PB2020-M2. The STERRAD sterilization was also conducted.
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
{6}------------------------------------------------
management process", issued September 4, 2020. The cytotoxicity was evaluated according to ISO 10993-5. The sensitization and irritation testing were conducted according to ISO 10993-10.
The subject devices SP-900 and PB2020-M2 contain electronic components. The subject device SP-900 has the same electrical components and can be adopted into electrical safety of the predicate device SP-900. Meanwhile, the software validation for the SP-900 was conducted in accordance with IEC 62304. The testing was conducted to ensure the electrical safety of the subject device PB2020-M2 according to ANSI/AAMI ES60601-1 and IEC 60601-2-37:2007. The subject devices SP-900 and PB2020-M2 were evaluated for the electromagnetic compatibility according to IEC 60601-1-2:2014.
Conclusions:
The subject device FUJIFILM Ultrasonic Processor SP-900 is intended to be used with the FUJIFILM Ultrasonic Probe PB2020-M2. The subject devices share intended use and indications, technological characteristics, principles of operation, and reprocessing methods as the respective predicate devices. The key differences are the modification to the materials of construction in PB2020-M2 and the addition of STERRAD sterilization method for reprocessing PB2020-M2. The validation and test results demonstrate that the key differences between the subject devices and the predicate devices do not raise new concerns regarding safety and effectiveness.
The subject devices FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 are substantially equivalent to the respective predicate devices FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Processor PB2020-M (K171207).
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.