(283 days)
Not Found
No
The summary describes a mechanical system for needle and guidewire placement with an ultrasound overlay, and there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is used to facilitate the placing of a needle and guidewire, which are tools for procedures, not a therapeutic intervention itself. Its function is to provide access to a targeted anatomical location, rather than treating a condition.
No
The device is described as facilitating the placing of a needle and guidewire into a targeted anatomical location and for accurately and reliably inserting a guidewire into a vessel. This indicates a procedural aid rather than a device intended for diagnosis.
No
The device description explicitly lists physical components such as a needle, guidewire, and transducer adapter, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the placing of a needle and guidewire into a targeted anatomical location, specifically for vessel access. This is a procedural device used in vivo (within the body) for a medical intervention.
- Device Description: The components are a needle, guidewire, ultrasound imaging screen overlay, and transducer adapter. These are tools used for a medical procedure, not for analyzing biological samples in vitro.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The device is a medical device used for image-guided access during a procedure, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Euclid™ Tier 1 Mini Access System is used to facilitate the placing of a needle and guidewire into a targeted anatomical location.
Product codes (comma separated list FDA assigned to the subject device)
ITX
Device Description
The Euclid™ Tier 1 Mini Access System is designed to provide the medical practitioner with the capability to accurately and reliably insert a guidewire into a vessel. The device consists of (1) the Euclid™ Tier 1 Mini Base Kit containing the sterile disposable device assembly consisting of a needle (18/21 Gauge) and guidewire (0.18" diameter x 40 cm length), a Euclid™ Ultrasound Imaging Screen Overlay, and IFU; and (2) the Euclid™ Tier 1 Mini Transducer Adapter Kit which contains a Euclid™ Transducer Adapter and IFU.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
targeted anatomical location
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioner
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)
Results of bench studies conducted on the Euclid™ Tier 1 Mini Access System demonstrate the System to be as safe and as effective as the predicate device based on the biocompatibility of the materials used, sterilization validation, bench testing and verification and validation in animal models. The following studies were conducted on the EuclidTM Tier 1 Mini Access System and acceptance criteria were met:
. Functional Verification
Benchtop testing (Guidewire insertion) to the functional extremes (5mm and 60mm;
. Shipping Integrity
Simulated shipping conditions followed by device and packaging inspection, guidewire insertion in benchtop model to functional extremes (5mm and 60mm), pouch seal strength testing, and dye penetration testing;
. Accelerated Aging
Aging to 6 months followed by functional testing (guidewire insertions to 5mm and 60mm), pouch seal strength testing, and dye penetration testing;
. Animal Validation
· Guidewire insertion in animal model by end user; and
. Biocompatibility Testing
Materials tested per ISO 10993, including: Systemic Toxicity, Intracutaneous Toxicity, Implantation, Cytotoxicity, Hemolysis, Pyrogenicity, and Sensitization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) SUMMARY Houston Medical Robotics, Inc. Euclid™ Tier 1 Mini Access System
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, section 807.92.
| Sponsor's Name and Address: | Houston Medical Robotics, Inc.
17225 El Camino Real, Suite 350
Houston, Texas 77058 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Darla J. Elkin
Elkin RC, LLC
42 North Chantsong Circle
The Woodlands, TX 77382
Telephone: (281) 450-8163
Facsimile: (281) 298-7277 |
| Date Summary Prepared: | May 20, 2011 |
| Device Trade Name: | EuclidTM Tier 1 Mini Access System |
| Product Code: | ITX |
| Regulation Number: | 21CFR 892.1570 |
| Classification: | Class II |
| Common Name: | Diagnostic ultrasonic transducer |
| Predicate Devices: | The WANDTM (K081697)
Ultra-Pro II Needle Guidance System (K093713) |
Device Description:
The Euclid™ Tier 1 Mini Access System is designed to provide the medical practitioner with the capability to accurately and reliably insert a guidewire into a vessel. The device consists of (1) the Euclid™ Tier 1 Mini Base Kit containing the sterile disposable device assembly consisting of a needle (18/21 Gauge) and guidewire (0.18" diameter x 40 cm length), a Euclid™ Ultrasound Imaging Screen Overlay, and IFU; and (2) the Euclid™ Tier 1 Mini Transducer Adapter Kit which contains a Euclid™ Transducer Adapter and IFU.
Intended Use:
The Euclid™ Tier 1 Mini Access System is used to facilitate the placing of a needle and guidewire into a targeted anatomical location.
1
| Features | Euclid™ Tier 1 Mini Access
System | The WAND
Microaccess Safety
Introducer | Ultra-Pro II Needle Guidance
System |
|------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------|
| K# | K111426 | K093022 | K093713 |
| Disposable Components | Sterile Disposable:
• Needle
• Guidewire | Sterile Disposable:
• Needle
• Guidewire
• Sheath | Sterile Disposable:
• Disposable Needle Guide
• Cover |
| Reusable Component | None | None | Bracket to hold Ultrasound
Transducer |
| Guidewire | Nitinol 0.018" | Nitinol 0.018" | N/A |
| Angle Needle Path | Yes (Adjustable & Fixed During
Use) | No | Yes (Fixed) |
| Placement | Manual | Manual | Manual |
| Ultrasound Guided
Procedure | Yes
Couples with commercially
available ultrasound | Yes
Labeling suggests use of
commercially available
image guidance. | Yes
Couples with commercially
available ultrasound. |
| Vessel Depth Setting | Yes | No | Yes |
| Needle | 18 /21 GA thin-walled stainless
steel | 21 GA thin-walled
stainless steel | N/A |
| Ultrasound Visibility | Yes | Yes | No |
| Visual Display of Vessel
Access | Yes, external Ultrasound Screen | Yes, Flashback window | Yes, external
Ultrasound Screen |
| EtO Sterilized | Yes | Yes | Yes |
Comparison of the Technological Characteristics of the New Device and Predicate Devices:
Performance Testing
Results of bench studies conducted on the Euclid™ Tier 1 Mini Access System demonstrate the System to be as safe and as effective as the predicate device based on the biocompatibility of the materials used, sterilization validation, bench testing and verification and validation in animal models. The following studies were conducted on the EuclidTM Tier 1 Mini Access System and acceptance criteria were met:
. Functional Verification
Benchtop testing (Guidewire insertion) to the functional extremes (5mm and 60mm;
. Shipping Integrity
Simulated shipping conditions followed by device and packaging inspection, guidewire insertion in benchtop model to functional extremes (5mm and 60mm), pouch seal strength testing, and dye penetration testing;
. Accelerated Aging
Aging to 6 months followed by functional testing (guidewire insertions to 5mm and 60mm), pouch seal strength testing, and dye penetration testing;
2
Houston Medical Robotics, Inc. Euclid™ Tier 1 Mini Access System
pg. 3 of 3
Animal Validation .
· Guidewire insertion in animal model by end user; and
. Biocompatibility Testing
Materials tested per ISO 10993, including: Systemic Toxicity, Intracutaneous Toxicity, Implantation, Cytotoxicity, Hemolysis, Pyrogenicity, and Sensitization.
Conclusion
The Euclid™ Tier 1 Mini Access System is substantially equivalent to the predicate devices. The indication for the devices is substantially equivalent. The technological design and functional characteristics of placement of a guidewire using ultrasound guidance with a sterile disposable device are all substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 1 2012
Houston Medical Robotics, Inc. c/o Ms. Darla J. Elkin Elkin RC, LLC 42 North Chantsong, Circle The Woodlands, TX. 77382
Re: K111426
Trade Name: Euclid™ Tier 1 Mini Access System Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: II (two) Product Code: ITX Dated: February 24, 2012 Received: February 27, 2012
Dear Ms. Elkin:
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.
4
Page 2 - Ms. Darla J. Elkin
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
M.A. Zilleben
& Bram D. Zuckerman; M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K111426
Device Name: Euclid™ Tier 1 Mini Access System
Indications for Use:
The Euclid™ Tier 1 Mini Access System is used to facilitate the placing of a needle and guidewire into a targeted anatomical location.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
82
M.L. Nelson APRIL 2, 21
mocof CDRH, Office of Device Evaluation (ODE) liovascular Devices
510(k) N