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.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Houston Medical Robotics, Inc. Euclid™ Tier 1 Mini Access System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Study	Acceptance Criteria	Reported Device Performance
Functional Verification	Expected to perform reliably at functional extremes (5mm and 60mm guidewire insertion).	Benchtop testing (guidewire insertion) demonstrated performance at functional extremes (5mm and 60mm).
Shipping Integrity	Device and packaging integrity maintained after simulated shipping; guidewire insertion at functional extremes successful; pouch seal strength and dye penetration maintained.	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 all met acceptance criteria.
Accelerated Aging	Device function (guidewire insertion) maintained after accelerated aging; pouch seal strength and dye penetration maintained.	Aging to 6 months followed by functional testing (guidewire insertions to 5mm and 60mm), pouch seal strength testing, and dye penetration testing all met acceptance criteria.
Animal Validation	Successful guidewire insertion in an animal model by end-user.	Guidewire insertion in animal model by end-user was successful.
Biocompatibility Testing	Materials meet ISO 10993 standards for systemic toxicity, intracutaneous toxicity, implantation, cytotoxicity, hemolysis, pyrogenicity, and sensitization.	Materials tested per ISO 10993, including: Systemic Toxicity, Intracutaneous Toxicity, Implantation, Cytotoxicity, Hemolysis, Pyrogenicity, and Sensitization, all met acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state the sample sizes for the benchtop tests (Functional Verification, Shipping Integrity, Accelerated Aging) nor for the Animal Validation. It mentions these tests were conducted, and acceptance criteria were met, but not the number of units tested.

The data provenance is retrospective for the tests mentioned, as they were conducted as part of the 510(k) submission process to demonstrate equivalence. The location of the animal study (country of origin) is not specified.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The studies listed (benchtop tests, animal model) do not inherently require "experts" to establish a ground truth in the way a diagnostic imaging study would. Performance was assessed against predefined functional and safety criteria. In the animal model, the "end user" performed the insertion, but their specific qualifications or how "ground truth" (e.g., successful access) was formally established beyond direct observation are not detailed.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the types of performance tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple readers interpret results and discrepancies need to be resolved. The studies here are bench and animal model performance tests.

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. This device is a mechanical access system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This device is a medical instrument and does not feature an "algorithm only" component in the sense of AI or software for diagnosis or analysis. Its performance is always physical and directly involves a human operator.

7. The Type of Ground Truth Used

For Functional Verification, Shipping Integrity, and Accelerated Aging: The ground truth was based on pre-defined engineering specifications and quantifiable performance metrics (e.g., successful guidewire insertion within specific depth ranges, maintaining pouch seal strength, passing dye penetration tests).
For Animal Validation: The ground truth was successful guidewire insertion into the target anatomical location by the end-user, likely confirmed by visual inspection or subsequent procedures within the animal model.
For Biocompatibility Testing: The ground truth was adherence to ISO 10993 standards, which involves established laboratory testing protocols and reference materials to determine biological safety.

8. The Sample Size for the Training Set

This information is not applicable as this is a hardware device submission, not a software or AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above; there is no training set for this type of device.

Summary

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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 350Houston, Texas 77058
Contact Person:	Darla J. ElkinElkin RC, LLC42 North Chantsong CircleThe Woodlands, TX 77382Telephone: (281) 450-8163Facsimile: (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:

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.

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Features	Euclid™ Tier 1 Mini AccessSystem	The WANDMicroaccess SafetyIntroducer	Ultra-Pro II Needle GuidanceSystem
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 UltrasoundTransducer
Guidewire	Nitinol 0.018"	Nitinol 0.018"	N/A
Angle Needle Path	Yes (Adjustable & Fixed DuringUse)	No	Yes (Fixed)
Placement	Manual	Manual	Manual
Ultrasound GuidedProcedure	YesCouples with commerciallyavailable ultrasound	YesLabeling suggests use ofcommercially availableimage guidance.	YesCouples with commerciallyavailable ultrasound.
Vessel Depth Setting	Yes	No	Yes
Needle	18 /21 GA thin-walled stainlesssteel	21 GA thin-walledstainless steel	N/A
Ultrasound Visibility	Yes	Yes	No
Visual Display of VesselAccess	Yes, external Ultrasound Screen	Yes, Flashback window	Yes, externalUltrasound 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;

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Houston Medical Robotics, Inc. Euclid™ Tier 1 Mini Access System

K111426

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.

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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.

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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

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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)

M.L. Nelson APRIL 2, 21

mocof CDRH, Office of Device Evaluation (ODE) liovascular Devices

510(k) N

Regulation Number and Section

§ 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.