(78 days)
The Clear Guide ONE is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, and for predicting its future path on a display which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization.
The Clear Guide ONE is a medical device that tracks instrument positioning during ultrasound-guided procedures to provide instrument guidance to the end user. The device attaches directly to the transducer probe, and through optical detection technology, the Clear Guide ONE identifies and tracks any needle or needle-like rigid object entering the field of view. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The Clear Guide ONE is an accessory to an existing ultrasound machine and transducer probe.
The provided text describes the Clear Guide ONE device, its intended use, and a summary of performance data used to support its substantial equivalence to a predicate device. However, it does not explicitly provide a table of acceptance criteria or detailed results of a specific study proving the device meets those criteria in the format requested. Instead, it states that "Bench testing was performed to demonstrate that the Clear Guide ONE device could accurately achieve its intended use."
Based on the provided document, here's what can be extracted and inferred regarding the acceptance criteria and study:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. It generally claims that "the Clear Guide ONE is as safe and as effective as the predicate device" and that "its intended function" was accurately achieved.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accurately track instrument positioning | Achieved |
| Display projected instrument pathway | Achieved |
| Safe and effective as predicate device | As safe and effective as the predicate device (AIM, K121479) |
| Compliance with IEC 60601-1-2 | Complies |
| Compliance with IEC 60601-1 | Complies |
2. Sample size used for the test set and the data provenance
The document does not specify a numerical sample size for the test set. It mentions "Bench testing was performed by physicians to validate the device through end users." The data provenance is implied to be from internal bench testing, but no country of origin is specified. The testing seems to be prospective as it was performed to demonstrate performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that "Bench testing was performed by physicians." It does not specify the number of physicians or their detailed qualifications (e.g., years of experience, specialty).
4. Adjudication method for the test set
The document does not mention any adjudication method for the test set.
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
An MRMC comparative effectiveness study is not mentioned. The device, Clear Guide ONE, is an "accessory to an existing ultrasound machine" for augmenting images and predicting needle paths, implying an assistance role, but a study specifically measuring human reader improvement with and without this assistance is not detailed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device "overlays instrument positioning data onto an existing ultrasound image through proprietary software algorithms," which suggests a standalone algorithmic component. However, the performance data discussed (bench testing with physicians) implies a human-in-the-loop context for validation. No separate "algorithm-only" performance is detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth used for the bench testing is not explicitly defined. Given the nature of tracking and projecting needle paths, it would likely involve direct observation and confirmation of accurate tracking and projection by the performing physicians during the bench tests, compared to the actual physical needle position. This would fall under a form of expert observation/review rather than pathology or outcomes data.
8. The sample size for the training set
The document does not provide information about a training set or its sample size. The focus is on demonstrating performance for substantial equivalence to a predicate device.
9. How the ground truth for the training set was established
Since no training set information is provided, how its ground truth was established is also not discussed.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
Clear Guide Medical % Mr. Jack Kent Director of Regulatory Affairs 40 Warrenton Road BALTIMORE MD 21210
Re: K141806 Trade/Device Name: Clear Guide ONE Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: September 5, 2014 Received: September 8, 2014
Dear Mr. Kent:
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. 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 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Clear Guide ONE
Indications for Use (Describe)
The Clear Guide ONE is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, and for predicting its future path on a display which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image contains the logo for Clear Guide Medical. The logo consists of a stylized letter "L" on the left, with the words "CLEAR GUIDE" stacked on top of each other in bold, black letters on the right. Below "CLEAR GUIDE" is the word "MEDICAL" in a smaller, gray font.
510(k) Summary (per 21 CFR § 807.92)
Submitter's Information
| Name | Clear Guide Medical |
|---|---|
| Address | 40 Warrenton Road |
| Baltimore, MD 20210 | |
| Phone Number | (410) 504-6540 |
| Contact Person | Jack Kent, Director of Regulatory Affairs |
| Date Prepared | September 4, 2014 |
Device Information
| Trade Name | Clear Guide ONE |
|---|---|
| Common Name | Tracking or Guidance System |
| Classification | Ultrasonic pulsed echo imaging system21 CFR § 892.1560 (Product Code IYO) |
Predicate Device Information
| Device Name | AIM |
|---|---|
| 510(k) Number | K121479 |
Device Description
The Clear Guide ONE is a medical device that tracks instrument positioning during ultrasound-guided procedures to provide instrument guidance to the end user. The device attaches directly to the transducer probe, and through optical detection technology, the Clear Guide ONE identifies and tracks any needle or needle-like rigid object entering the field of view. By coupling positioning information with the ultrasound image, the projected instrument pathway is displayed to the user for guiding instrumentation. The Clear Guide ONE is an accessory to an existing ultrasound machine and transducer probe.
Intended Use / Indications for Use
The Clear Guide ONE is indicated for augmenting the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle, an aspiration needle, or ablation needle, and for predicting its future path on a display, which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended to be used in procedures where ultrasound is currently used for visualization.
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Image /page/4/Picture/0 description: The image shows the logo for Clear Guide Medical. The logo consists of a stylized letter "L" on the left, with two horizontal lines extending from the "L". To the right of the "L" is the text "CLEAR GUIDE" in bold, black letters, with the word "MEDICAL" underneath in gray letters. The logo is simple and modern, and the use of black and gray gives it a professional look.
Technological Characteristics
As previously stated, the Clear Guide ONE operates using optical detection technology, instead of electromagnetic (EM) technology employed by the predicate device. Although both technologies can be used to track instrumentation and provide guidance, the optical detection technology does not require specialized instruments or calibration at the point of use. Performance data was collected to demonstrate that the Clear Guide ONE achieves its intended function in a manner that is as safe and as effective as the predicate device.
Similar to the predicate device, the Clear Guide ONE overlays instrument positioning data onto an existing ultrasound image through proprietary software algorithms.
Performance Data
Bench testing was performed to demonstrate that the Clear Guide ONE device could accurately achieve its intended use, showing that differences in technological characteristics from the predicate device did not affect device performance. Bench testing was performed by physicians to validate the device through end users. The results of bench testing show that the Clear Guide ONE is as safe and as effective as the predicate device. No clinical data was collected to support a substantial equivalence determination.
The Clear Guide ONE complies with the following recognized consensus standards:
IEC 60601-1-2 – Edition 3-2007 – Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility
IEC 60601-1 3rd Edition: Medical Electrical Equipment; Part 1 General Requirements for Safety
Conclusions
The Clear Guide ONE has the same intended use as the predicate device. Changes to the specific indications for use statement were made to account for technological differences, without impacting intended use. Differences in technology do not raise different questions of safety or effectiveness. Additionally, bench tests confirm that the Clear Guide ONE is as safe and as effective as the predicate device. Therefore, the Clear Guide ONE is substantially equivalent to its predicate device.
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