A-VIEW BASIC AND PLUS

K070515 · Cordatec N.V. · ITX · Jul 30, 2007 · Radiology

Device Facts

• Record ID: K070515
• Device Name: A-VIEW BASIC AND PLUS
• Applicant: Cordatec N.V.
• Product Code: ITX · Radiology
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

A-View® catheters are intended for use in conjunction with TEE investigation of the upper mediastinum in anaesthetised patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View Catheters are limited for use in adult patients.

Device Story

A-View Basic and Plus are tracheal balloon catheters used during transesophageal echocardiography (TEE). The device consists of a catheter with a distal large balloon, a small pilot balloon, and a stopcock with luer connections. The catheter is inserted to displace the trachea, improving acoustic window access for TEE imaging of the distal ascending aorta. Used in clinical settings by physicians performing TEE on anaesthetised adult patients. The device provides a mechanical means to enhance ultrasound visibility, allowing clinicians to evaluate the condition of the ascending aorta before surgical intervention. A-View Plus includes a 50 ml syringe and swivel Y-connector for inflation/deflation. Benefits include improved diagnostic clarity of the aorta during cardiac procedures.

Clinical Evidence

Bench testing only. The device meets requirements for ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), EN 550 (Sterilization), and EN 868 (Packaging). No clinical data provided.

Technological Characteristics

Tracheal balloon catheter; includes distal balloon, pilot balloon, and stopcock with luer connections. Materials comply with ISO 10993. Sterilization per EN 550. Packaging per EN 868. Mechanical device; no electronic components or software.

Indications for Use

Indicated for adult patients undergoing TEE investigation of the upper mediastinum while anaesthetised to facilitate visualization and evaluation of the distal ascending aorta prior to surgery.

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

• Saline based upon its pre-amendment status in conjunction with ultrasonic water baths
• V5Ms Transesophageal Transducer (K052021)
• MPT7 Multiplane Transesophageal Transducer (K052021)
• HDI 1500/SA 8800 Ultrasound System with Multiplane (K994373)
• Site-Rite 5 Ultrasound System (K052517)

Submission Summary (Full Text)

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# cordateכ

JUL 30 2007 K070515

#### Section 4: 510(k) Summary

The assigned 510(k) number is: K070515

| Company: | Cordatec n.v.<br>Kwikaard 104<br>B-2980 Zoersel<br>Belgium<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Barbara DeBiase |
| Date Prepared: | June 25, 2007 |
| Proprietary Names: | A-View® Basic and A-View Plus |
| Classification Name: | Accessory to a Diagnostic Ultrasound Transducer |
| Common Name: | Tracheal Balloon Catheter |
| Classification: | 21 CFR 892.1570, Class II, Product Code MUI |
| Predicate Device: | • Saline based upon its pre-amendment status in<br>conjunction with ultrasonic water baths;<br>• K052021 V5Ms Transesophageal Transducer and MPT7<br>Multiplane Transesophageal Transducer by Siemens<br>Medical Solutions USA Inc.;<br>• K994373 HDI 1500/SA 8800 Ultrasound System with<br>Multiplane by Advanced Technology Laboratories Inc.; and<br>• K052517 Site-Rite 5 Ultrasound System by C.R. Bard Inc. |
| Device Description: | A-View Basic consists of only the catheter itself. The A-<br>View catheter has three tubes connected by a Y-connector<br>of which one holds a distal, large balloon, one holds a<br>small, pilot balloon and the third holds a stop cock with<br>two standard female luer connections. Both balloons are<br>clear and colorless. On the main shaft a distance mark<br>indicating 24 cm from the closest balloon shoulder is<br>pointed out. A-View Plus consists of the catheter plus a<br>standard 50 ml syringe with luer connector and a swivel Y-<br>connector. |
| Intended Use: | A-View® catheters are intended for use in conjunction<br>with TEE investigation of the upper mediastinum in<br>anaesthetised patients. They allow visibility of the distal<br>ascending aorta by TEE and permit the condition of the<br>ascending aorta to be evaluated before surgery. A-View<br>Catheters are limited for use in adult patients. |
| Performance Data | Data is contained within this 510(k) demonstrating A-View<br>catheters meet the requirements of ISO 14971 (Risk<br>Management), ISO 10993 (Biocompatibility), EN 550<br>(Sterilization), and EN 868 (Packaging). |
| Conclusion: | A-View catheters are substantially equivalent in function,<br>materials and intended use to the above referenced |

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## cordateכ

predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2007

Cordatec N.V. C/O Ms. Barbara DeBiase Regulatory Consultant 1467 Vigilante Avenue Bailey, Colorado 80421

Re: K070515

Trade/Device Name: A-View® Basic and Plus Catheters Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: II Product Code: ITX Dated: July 23, 2007 Received: July 24, 2007

Dear Ms. DeBiase:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. DeBiase

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Chres

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K070515

Device Name: A-View® Basic and Plus Catheters

Indications for Use:

A-View Catheters are intended for use in conjunction with TEE investigation of the upper mediastinum in anaesthetised patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View Catheters are limited for use in adult patients.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ita Ch (actrybc)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K070515