(78 days)
Not Found
No
The description focuses on optical tracking and coupling positioning information with the ultrasound image, without mentioning AI or ML.
No
The device is described as an accessory that augments the ultrasonic image of an interventional needle and predicts its future path to guide instrumentation. It does not directly treat or diagnose a disease or condition, but rather assists in performing a procedure.
No
The device is used to augment the ultrasonic image of an interventional needle and predict its future path. It provides instrument guidance and tracks instrument positioning during ultrasound-guided procedures. It is an accessory to an existing ultrasound machine and does not diagnose disease or conditions itself.
No
The device description explicitly states that the Clear Guide ONE "attaches directly to the transducer probe" and uses "optical detection technology" to track instruments. This indicates the presence of hardware components beyond just software.
Based on the provided information, the Clear Guide ONE is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Clear Guide ONE is used to augment the ultrasonic image of an interventional needle during a procedure on a patient. It does not analyze biological samples.
- The intended use describes a device that assists in guiding a needle during a medical procedure. This is a procedural guidance device, not a diagnostic test performed on a sample.
- The device description focuses on tracking instrument positioning and displaying a projected pathway. This is related to real-time guidance during a procedure, not analyzing a sample for diagnostic information.
Therefore, the Clear Guide ONE falls under the category of a medical device used for procedural guidance, not an In Vitro Diagnostic device.
N/A
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, 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.
Product codes
IYO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic image
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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.
1
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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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 system |
| 21 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.
4
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.