EUCLID (TM) TIER 1-GW ACCESS SYSTEM

K111426 · Houston Medical Robotics · ITX · Mar 1, 2012 · Radiology

Device Facts

• Record ID: K111426
• Device Name: EUCLID (TM) TIER 1-GW ACCESS SYSTEM
• Applicant: Houston Medical Robotics
• Product Code: ITX · Radiology
• Decision Date: Mar 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

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.

Device Story

Euclid™ Tier 1 Mini Access System facilitates needle and guidewire insertion into vessels. System includes sterile disposable needle (18/21 Gauge), Nitinol guidewire (0.018"), and ultrasound imaging screen overlay; includes transducer adapter. Used by medical practitioners in clinical settings to provide ultrasound-guided vascular access. Practitioner uses external ultrasound equipment to visualize target; device provides adjustable needle path and visual display of vessel access. System improves accuracy and reliability of guidewire placement; reduces risk of complications during vascular access procedures.

Clinical Evidence

No clinical trials in humans. Evidence consists of bench testing and animal model validation. Bench testing included functional verification (guidewire insertion at 5mm and 60mm extremes), shipping integrity, and accelerated aging (6 months). Biocompatibility testing performed per ISO 10993, including systemic toxicity, intracutaneous toxicity, implantation, cytotoxicity, hemolysis, pyrogenicity, and sensitization. Animal validation confirmed successful guidewire insertion by end-user.

Technological Characteristics

System includes 18/21 Gauge thin-walled stainless steel needle and 0.018" Nitinol guidewire. Features adjustable needle path and ultrasound visibility. Materials tested per ISO 10993. Sterilized via EtO. Device is a mechanical accessory for use with commercially available ultrasound systems; no internal electronic sensing or software algorithms.

Indications for Use

Indicated for facilitating the placement of a needle and guidewire into a targeted anatomical location in patients requiring vascular access.

Regulatory Classification

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.

Predicate Devices

• The WAND (K081697)
• Ultra-Pro II Needle Guidance System (K093713)

Submission Summary (Full Text)

{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.<br>17225 El Camino Real, Suite 350<br>Houston, Texas 77058 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Darla J. Elkin<br>Elkin RC, LLC<br>42 North Chantsong Circle<br>The Woodlands, TX 77382<br>Telephone: [phone]<br>Facsimile: [phone] |
| 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)<br>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<br>System | The WAND<br>Microaccess Safety<br>Introducer | Ultra-Pro II Needle Guidance<br>System |
|------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------|
| K# | K111426 | K093022 | K093713 |
| Disposable Components | Sterile Disposable:<br>• Needle<br>• Guidewire | Sterile Disposable:<br>• Needle<br>• Guidewire<br>• Sheath | Sterile Disposable:<br>• Disposable Needle Guide<br>• Cover |
| Reusable Component | None | None | Bracket to hold Ultrasound<br>Transducer |
| Guidewire | Nitinol 0.018" | Nitinol 0.018" | N/A |
| Angle Needle Path | Yes (Adjustable & Fixed During<br>Use) | No | Yes (Fixed) |
| Placement | Manual | Manual | Manual |
| Ultrasound Guided<br>Procedure | Yes<br>Couples with commercially<br>available ultrasound | Yes<br>Labeling suggests use of<br>commercially available<br>image guidance. | Yes<br>Couples with commercially<br>available ultrasound. |
| Vessel Depth Setting | Yes | No | Yes |
| Needle | 18 /21 GA thin-walled stainless<br>steel | 21 GA thin-walled<br>stainless steel | N/A |
| Ultrasound Visibility | Yes | Yes | No |
| Visual Display of Vessel<br>Access | Yes, external Ultrasound Screen | Yes, Flashback window | Yes, external<br>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

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.

{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 [phone] or [phone] 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