(276 days)
The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye.
The B-Scan device is designed as an ultrasound B-Scan, which uses pulsed echo ultrasound to image the structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulse signals and provides a graphic display of returning pulse echoes to indicate the various structures.
All of the critical functions of the B-Scan are calculated in the same manner as in the predicate device, B-Scan Plus. The software algorithms for clinically critical functions remain the same as in the predicate device. However, the user interface and the workflow of B-Scan have enhancement to support cybersecurity implementation.
Both the subject device and predicate device are compatible with the Connect Software (K070943, K123349) and 4Sight (K152573). The software improvements in Connect were focused on enhancing features that optimize integration with the personal computer's processing, data storage, display, and printing capabilities.
The energy source for the B-Scan is USB power as in the predicate device, B-Scan Plus.
The software utilized on both the Connect and 4Sight platforms is fundamentally identical in core clinical functions, including image scanning, rendering, IOL calculations, data storage, and report formatting. Additionally, the key features within the B-Scan module do not differ significantly between the two systems, nor do they make an impact on the established clinical workflow.
Track 1 is being followed for this 510(k) submission.
Here's a breakdown of the acceptance criteria and the study details for the B-Scan Ultrasonic Imaging System, based on the provided FDA 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" for a novel device performance. However, we can infer acceptance criteria from the comparison table (Table 2) and the performance data section, where the subject device's performance is either "Same" or "SE" (Substantially Equivalent) to the predicate, or explicitly lists performance metrics.
For quantitative metrics, the "acceptance criteria" for the subject device can be interpreted as performing comparably or within acceptable limits relative to the predicate device, or meeting specific new specifications.
| Parameter | Acceptance Criteria (Inferred/Stated) | Reported Device Performance (B-Scan) | Remarks/Proof |
|---|---|---|---|
| Clinical Accuracy (Line) | ±3% (for 60mm Depth Setting) | 12MHz: 60mm Depth Setting Clinical Accuracy: ±3% | Bench Test: Physical Accuracy and Range Test |
| Accuracy Range (Line) | 60 mm (for 60mm Depth Setting) | 12MHz: 60mm Depth Setting Accuracy Range: 60 mm | Bench Test: Physical Accuracy and Range Test |
| Clinical Accuracy (Area) | ±15% (for 60mm Depth Setting) | 12MHz: 60mm Depth Setting Clinical Accuracy: ±15% | Bench Test: Physical Accuracy and Range Test |
| Accuracy Range (Area) | 60 mm (for 60mm Depth Setting) | 12MHz: 60mm Depth Setting Accuracy Range: 60 mm | Bench Test: Physical Accuracy and Range Test |
| Image Preview Time | Displayed within 2 seconds of pressing probe button | Image preview is displayed within 2 seconds of pressing probe button (average time recorded across 5 probes). | Bench Test: The specific bench test for this is not named explicitly, but is mentioned within the comparison table as part of the performance metrics. |
| Cleaning & Disinfection | Validation per procedures in Instruction for Use | Reprocessing validation test was conducted on the proposed device. | Reprocessing Validation Test |
| Biocompatibility | Meet requirements of ISO 10993 series (Cytotoxicity, Ocular Irritation, Skin Sensitization) | The proposed device has been tested and met the requirements according to the ISO 10993 series standard for Biocompatibility. | Biocompatibility Testing |
| Software V&V | Documentation provided as recommended by FDA guidance | Software verification and validation testing were conducted, and documentation was provided. | Software Verification and Validation Testing |
| Cybersecurity Compliance | Documentation provided in accordance with FDA guidance | Cybersecurity compliance was implemented, and documentation was provided. | Cybersecurity Implementation and Documentation |
| Electrical Safety & EMC | Meet requirements of IEC 60601-1, IEC 60601-1-2 | The proposed device has been tested and met the requirements. | Thermal, mechanical, and electrical safety and electromagnetic compatibility testing |
| Mechanical/Thermal Durability | Meet design specifications (implied) | Accelerated Thermal Cycling Test; Plastic Component UV Assessment; Transit Performance Test; USB cable Pull Test; B-Scan Integrated Life Testing Verification Report | Bench Tests (listed) |
| Button Actuation | Meet design specifications (implied) | Button actuator Validation Test | Bench Test: Button actuator Validation Test |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for patients or images used in any clinical or test set. The performance data mostly refers to bench testing and validation against standards.
- The only mention of a "sample" related to performance is "average time recorded across 5 probes" for the image preview time. This refers to hardware units, not patient data.
- Data Provenance: Not applicable, as no external data set or clinical study on patients is described beyond bench tests. The focus is on device specifications and in-house validation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a test set of images for diagnostic performance evaluation. The "Performance" section outlines bench tests and compliance with recognized standards.
4. Adjudication Method for the Test Set
Not applicable. Since there's no mention of a clinical test set requiring human expert review to establish ground truth, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify improvement in human readers with AI assistance. The device is purely an imaging system, and there is no mention of AI assistance for image interpretation.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance)
The device described is an "B-Scan Ultrasonic Imaging System," which is a diagnostic tool that produces images for human interpretation. It does not contain an AI algorithm for standalone diagnostic performance. Its performance is related to image acquisition parameters, accuracy of measurements, and adherence to safety/design standards.
7. Type of Ground Truth Used
For the quantitative performance claims (e.g., Clinical Accuracy Line/Area), the ground truth was established by physical measurements against known standards or calibrated references during bench testing ("Physical Accuracy and Range Test"). For other aspects, the ground truth is adherence to technical specifications, safety standards, and validated manufacturing/reprocessing procedures.
8. Sample Size for the Training Set
Not applicable. This device is an ultrasound imaging system, not an AI-driven diagnostic algorithm that requires a "training set" of data in the typical machine learning sense. The software aspects mentioned are primarily for device control, image rendering, data storage, and report formatting, enhanced for cybersecurity and usability – not for learning from data to perform a diagnostic task.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned for an AI algorithm.
FDA 510(k) Clearance Letter - B-Scan Ultrasonic Imaging System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 11, 2025
ACCUTOME, INC. Doing Business As Keeler USA
℅ Sonia Bargotta
Senior Regulatory Affairs Associate
Keeler Ltd
Clewer Hill Road
Windsor, Berkshire SL4 4AA
United Kingdom
Re: K243227
Trade/Device Name: B-Scan
Regulation Number: 21 CFR 892.1560
Regulation Name: Ultrasonic Pulsed Echo Imaging System
Regulatory Class: Class II
Product Code: IYO, ITX
Dated: June 10, 2025
Received: June 10, 2025
Dear Sonia Bargotta:
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.
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K243227 - Sonia Bargotta
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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).
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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K243227 - Sonia Bargotta
Page 3
assistance/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
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243227
Device Name
B-Scan
Indications for Use (Describe)
The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye.
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.
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Page 5
510(k) Summary
Page 1 of 9
I. SUBMITTER
ACCUTOME, INC. Doing Business As Keeler USA
3222 Phoenixville Pike
Malvern, PA 19355, USA
Contact Person:
- Name: Sonia Bargotta
- Title: Senior Regulatory Affairs Associate
- Phone Number: +44 1753 857177
- Email Address: sonia.bargotta@keeler.co.uk
Primary Correspondent Information:
- Name: Sonia Bargotta
- Title: Senior Regulatory Affairs Associate
- Phone Number: +44 1753 857177
- Email Address: sonia.bargotta@keeler.co.uk
Correspondent Information:
- Name: Arminder Purewal
- Title: Head of Global Regulatory Affairs and EMEA Quality Assurance
- Phone Number: +44 1753 857153
- Email Address: ArminderP@keeler.co.uk
Date Prepared: 18 March 2025
II. Device
- Trade Name of the Device: B-Scan
- Model Number:
- B-Scan - Connect
- B-Scan - 4Sight
- Common Name: Ultrasound B-Scan
- Classification: System, Imaging, Pulsed Echo, Ultrasonic
- Regulation Number:
- 21 CFR 892.1560 (Ultrasound pulsed echo imaging system)
- 21 CFR 892.1570 (Diagnostic ultrasonic transducer)
- Regulatory Class: Class II
- Review Panel: Radiology
- Product Code:
- IYO (21 CFR 892.1560)
- ITX (21 CFR 892.1570)
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Page 2 of 9
III. Predicate Device
B-Scan Plus, Manufactured by Accutome, Inc. (DBA Keeler USA) – K070943
IV. Reference Device
No reference devices were used in this submission
V. Indications for Use
The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye.
VI. Device Description
The B-Scan device is designed as an ultrasound B-Scan, which uses pulsed echo ultrasound to image the structure of the eye. It utilizes an eye-contact probe to generate and receive the ultrasound pulse signals and provides a graphic display of returning pulse echoes to indicate the various structures.
All of the critical functions of the B-Scan are calculated in the same manner as in the predicate device, B-Scan Plus. The software algorithms for clinically critical functions remain the same as in the predicate device. However, the user interface and the workflow of B-Scan have enhancement to support cybersecurity implementation.
Both the subject device and predicate device are compatible with the Connect Software (K070943, K123349) and 4Sight (K152573). The software improvements in Connect were focused on enhancing features that optimize integration with the personal computer's processing, data storage, display, and printing capabilities.
The energy source for the B-Scan is USB power as in the predicate device, B-Scan Plus.
The software utilized on both the Connect and 4Sight platforms is fundamentally identical in core clinical functions, including image scanning, rendering, IOL calculations, data storage, and report formatting. Additionally, the key features within the B-Scan module do not differ significantly between the two systems, nor do they make an impact on the established clinical workflow.
Track 1 is being followed for this 510(k) submission.
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VII. Comparison of Technological Characteristics with the Predicate Device
Table 1: General Comparison with Predicate Device
| Item | Subject Device (B-Scan) | Predicate Device (K070943) | Remarks |
|---|---|---|---|
| Product Code | IYO, ITX | IYO, ITX | Same |
| Regulation No. | 21 CFR 892.1560 (Ultrasound pulsed echo imaging system)21 CFR 892.1570 (Diagnostic ultrasonic transducer) | 21 CFR 892.1560 (Ultrasound pulsed echo imaging system)21 CFR 892.1570 (Diagnostic ultrasonic transducer) | Same |
| Class | Class II | Class II | Same |
| Indications for use | The B-Scan module is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. The probe is intended to be used on both adult and pediatric patients that require imaging of the eye. | The instrument is used for imaging the internal structure of the eye, including the opaque media and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. | Same |
| Single Use | No | No | Same |
| Prescription Use / Over-the Counter Use | Prescription Use | Prescription Use | Same |
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Table 2: Comparison of Technological Characteristics with Predicate Device
| Item | Subject Device (B-Scan) | Predicate Device (K070943) | Remark |
|---|---|---|---|
| Length | 18.72 cm | 17.78 cm | SE |
| Diameter | 3.11 cm | 3.18 cm | SE |
| Weight | 141 g | 101g | SE |
| Profile of membrane | Hyperbolic Paraboloid | Flat profile | SE |
Environmental conditions
| Operating environmental conditions | Temperature: 10°–35°C (50°–95°F)Relative Humidity: 20-80% (non-condensing)Atmospheric Pressure: 800-1060 hPa | Temperature: 10°–40°C (50°–104°F)Relative Humidity: 20-80% (non-condensing)Atmospheric Pressure: 700-1060 hPa | SE |
| Storage and transport environmental conditions | Temperature: -40°–70°C (-40°–158°F)Relative Humidity: 15-90% (non-condensing)Atmospheric Pressure: 700-1060 hPa | Temperature: -20°–60°C (-4°–140°F)Relative Humidity: 15-90% (non-condensing)Atmospheric Pressure: 500-1060 hPa | SE |
Specifications and properties
| Frequency | 12 MHz nominal | 12 or 15 MHz | SE |
| Axial resolution | <=0.02mm | 0.015 mm Electronic | SE |
| Lateral resolution | 0.5mm | 0.085 mm Electronic | SE |
| Gain | 0-112 dB | 0-110 dB | SE |
| Adjustable gamma | Default, Linear, S-Curve | Linear, S-Curve, Log, Color | SE |
| Scanning angle | 60° | 60° | Same |
| Field of view | 67mm | 12 MHz = 64 mm or 15 MHz = 52 mm | SE |
| Frame rate per second | 15, 20 | 15, 30 max | SE |
| Sampling rate | 4096 (points per line) | 2048 (points per line) | SE |
| Scan lines per frame | 256 | 256 | Same |
| Focal point | 24mm | 22 mm | SE |
| Time Gain Compensation (TGC) | Yes | Yes | Same |
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| Item | Subject Device (B-Scan) | Predicate Device (K070943) | Remark |
|---|---|---|---|
| Frozen image gain adjustment | Yes | Yes | Same |
| Zoom | 2x optical zoom, 8x max | 2x optical zoom, 8x max | Same |
| Reports | Same | ||
| Snapshot format | jpeg, bmp, png, tiff, gif | jpeg, bmp, png, tiff, gif | Same |
| Data archive / export capability | Yes | Yes | Same |
| Maximum number of frames per scan | 240 | 256 | SE |
| Size of cine loop | 30-240 MB | 16-128 MB | SE |
| Measurement calipers with velocity adjustment | 4 line, 2 area, 2 angle | 4 line, 2 area, 2 angle | Same |
| Depth of penetration | 60 mm | <54 mm | SE |
| Frame buffer size | 240 | 256 | SE |
| Nominal gain range in hardware | 60 dB | <50 dB | SE |
| Nominal focal length | 23 mm | 22 mm | SE |
| Host interface connector | USB 2 and 3 | USB 2 | SE |
| Power source | PC USB connection | PC USB connection | Same |
| Image preview | Same, image preview is displayed within 2 seconds of pressing probe button (average time recorded across 5 probes). | Same, image preview is displayed within 2 seconds of pressing probe button (average time recorded across 5 probes). | Same |
| Minimum PC specification | Windows 10 64bit OSCPU AMD or Intel Core i5 5th Generation minimumScreen resolution 1280 x 8004 GB RAM256 GB HDD recommended | Windows 7 64bit OSCPU AMD or Intel Core i3 5th Generation minimumScreen resolution 1280 x 10244 GB RAM256 GB HDD recommended | SE |
| Compatibility with standalone Connect Software and 4Sight | Connect Software, version - Connect Version 9.00.31 (Major software version | Current (released version):4Sight 2.08.00Connect 8.03.01 | SE |
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| Item | Subject Device (B-Scan) | Predicate Device (K070943) | Remark |
|---|---|---|---|
| release will be 9.01.00 during official release)4Sight, version - 4Sight Version 3.00.31 (Major software version release will be 3.01.00 during official release) | |||
| Transducer calibration data | Transducer calibration information is stored in the EEPROM located at the scan head. On power-up, the main board reads this data. The main board can be changed without losing transducer calibration data. | Transducer calibration information is stored in the EEPROM located on the main board. | SE |
| Warranty | 3 years | 3 years | Same |
Biological characteristics
| Uses the same materials or substances in contact with the same human tissues or body fluids | Membrane tip: TPX MX004 (Polymethylpentene) | Membrane tip: TPX (Polymethylpentene) | SE |
| Similar kind and duration of contact with the same human tissues or body fluids | The tip of the probe contacts the eye of the patient or contacts the eyelid of the patient.Contact is for a very short duration, and even with repeated use the total duration of contact will be much less than 24 hours | The tip of the probe contacts the eye of the patient or contacts the eyelid of the patient.Contact is for a very short duration, and even with repeated use the total duration of contact will be much less than 24 hours | Same |
Clinical characteristics
| Same clinical condition or purpose, including | Used for imaging the internal structure of the eye, including | Used for imaging the internal structure of the eye, including | Same |
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| Item | Subject Device (B-Scan) | Predicate Device (K070943) | Remark |
|---|---|---|---|
| similar severity and stage of disease | the opaque media, anterior, and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. | the opaque media, anterior, and posterior pathology, for the purpose of diagnosing pathological or traumatic conditions in the eye. | |
| Same site in the body | Probe is used on the eye/eyelid | Probe is used on the eye/eyelid | Same |
| Similar population, including as regards age, anatomy and physiology | Probe is intended to be used on both adult and pediatric patients that are requiring internal imaging of the eye. | Probe is intended to be used on both adult and pediatric patients that are requiring internal measurements of the eye. | SE |
| Same kind of user | The probe is intended to be used by any trained professional in an ophthalmic clinic, including ophthalmic assistants, ophthalmic photographers, technicians, optometrists or ophthalmologists. | The probe is intended to be used by any trained professional in an ophthalmic clinic, including ophthalmic assistants, ophthalmic photographers, technicians, optometrists or ophthalmologists. | Same |
| Scanning Mode | B-Scan only | B-Scan only | Same |
| B-Scan Controls | Fixed depth (60mm), variable gain (0-112 dB), fixed frequency (12MHz) | Depth, gain, frequency, power, contrast and brightness | SE |
| B-Scan Depth | 60 mm | 30/50/60/100 mm | SE |
| Performance | 12MHz:60mm Depth SettingLine:Clinical Accuracy: ±3%Accuracy Range: 60 mmArea:Clinical Accuracy: ±15%Accuracy Range: 60 mm | 12MHz:30mm Depth SettingDistance Range: 30mmDistance Accuracy: 7.5%Area Range: 30mmArea Accuracy: 40%60mm Depth SettingDistance Range: 60mmDistance Accuracy: 3%Area Range: 60mmArea Accuracy: 22% | SE |
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Page 8 of 9
| Item | Subject Device (B-Scan) | Predicate Device (K070943) | Remark |
|---|---|---|---|
| 15MHz:50mm Depth SettingDistance Range: 50mmDistance Accuracy: 3%Area Range: 50mmArea Accuracy: 20%100mm Depth SettingDistance Range: 50mmDistance Accuracy: 7%Area Range: 50mmArea Accuracy: 14% |
Table 3: Applied Standards
| Parameters | Subject Device (B-Scan) | Predicate Device (K070943) | Remark |
|---|---|---|---|
| Electrical Safety and EMC standards met | IEC 60601-1IEC 60601-1-2IEC 60601-2-37 | IEC 60601-1IEC 60601-1-2IEC 60601-2-37 | SE |
| Sterility | Provided non-sterile | Provided non-sterile | Same |
| Biocompatibility | - Cytotoxicity- Ocular Irritation- Skin Sensitization | Material used in probe window is TPX (PolyMethyl Pentane) | SE |
VIII. Performance Data
The subject device has been evaluated through a series of performance tests to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. All the tests conducted on the device are summarized below:
Cleaning and disinfection
Procedures related to the disinfection and cleaning have been detailed in the Instruction for Use. The reprocessing validation test was conducted on the proposed device.
Biocompatibility testing
The proposed device has been tested and met the requirements according to the ISO 10993 series standard for Biocompatibility.
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Page 9 of 9
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance, "Content of Premarket Submissions for Device Software Functions".
Cybersecurity compliance was implemented, and documentation was provided in accordance with FDA's guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Thermal, mechanical, and electrical safety and electromagnetic compatibility
The proposed device has been tested and met the requirements according with the safety standard IEC 60601-1, IEC 60601-1-2.
Bench Test
The bench tests conducted on the proposed device are listed below.
- Accelerated Thermal Cycling Test
- Plastic Component UV Assessment
- Transit Performance Test
- USB cable Pull Test
- Physical Accuracy and Range Test
- Button actuator Validation Test
- Repeated Reprocessing Validation Test
- B-Scan Integrated Life Testing Verification Report
IX. Substantial Equivalence Conclusion
The indications for use, intended use environment, and intended user profile of the new subject device, the B-Scan, are the same as those of the predicate device. The user interface of the new model has been enhanced to support cybersecurity and offers improved user interaction for enhanced usability. The technological characteristics, including the device design and system architecture, particularly how it interacts with different mechanical and electrical components, differ from the predicate device, B-Scan Plus. However, these differences do not raise any new questions regarding safety or effectiveness. The biological characteristics, clinical characteristics, and the application of the subject device are also the same as those of the predicate. The subject device operates in the same use setting and under the same environmental conditions. All performance testing met or exceeded the acceptance criteria, confirming that the subject device functions within its design specifications and demonstrates equivalent or superior performance to the predicate device. The conclusions drawn from the performance testing demonstrate that the subject device, the B-Scan is as safe and is substantially equivalent to the legally marketed device, B-Scan Plus (K070943).
§ 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.