SONOTIP II ULTRASOUND NEEDLE SYSTEM

K070129 · Medi-Globe Corporation · FCG · Jan 31, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070129
• Device Name: SONOTIP II ULTRASOUND NEEDLE SYSTEM
• Applicant: Medi-Globe Corporation
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The SonoTip II Ultrasound Needle System for Fine Needle Aspiration (FNA), is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II needle system is used for ultrasonically guided, fine needle aspiration (FNA) of submucosal and extraluminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peripancreatic masses and lymph nodes).

Device Story

SonoTip II is a single-use, disposable endoscopic ultrasound needle system for fine needle aspiration (FNA). Device features an adjustable outer metal sheath to precisely set working length relative to the endoscope. Used in clinical settings by physicians during endoscopic ultrasound procedures to target submucosal and extraluminal GI lesions. Provides tissue samples for diagnostic evaluation; assists in clinical decision-making for masses and lymph nodes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Disposable endoscopic ultrasound needle system; metal sheath construction; adjustable working length mechanism; used with external ultrasound endoscope for guidance. No software or electronic components.

Indications for Use

Indicated for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal gastrointestinal tract lesions, including pancreatic, mediastinal, and peripancreatic masses and lymph nodes, in conjunction with FDA-registered ultrasound endoscopes.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• GIP/Medi-Globe GI Ultrasound Needle System (K990220)
• Medi-Globe SonoTip II Ultrasound Needle System (K051247)

Submission Summary (Full Text)

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K070129

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

- A. Submitter Information:
Submitter's Name: Medi-Globe Corporation

Submitter's Address: 110 West Orion Street #136 Tempe, Arizona 85283

JAN 3 1 2007

Contact Person: Scott Karler

Contact Person's Telephone Number: [phone] ext. 208

Contact Person's FAX Number: [phone]

- B. Device Name: Medi-Globe SonoTip II Ultrasound Needle System
- c. Predicate Devices: GIP/Medi-Globe GI Ultrasound Needle System (K990220)

Medi-Globe SonoTip II Ultrasound Needle System (K051247)

- D. Device Description:
The SonoTip II Endoscopic Ultrasound Needle System is a complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single patient use only. A feature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This feature provides the user with the ability to precisely adjust the working length of the instrument relative to the endoscope being used.

- E. Intended Use:
The SonoTip II Ultrasound Needle System for Fine Needle Aspiration (FNA), is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II needle system is used for ultrasonically guided, fine needle aspiration (FNA) of submucosal and extraluminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peripancreatic masses and lymph nodes).

- F. Technological Characteristics Summary:
The SonoTip II Ultrasound Needle System utilizes endoscopic ultrasound technology which, when used with an ultrasound endoscope, allows the user to ultrasonically guide the biopsy needle, to its intended target within or adjacent to the gastrointestinal system.

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## Performance Data: ్ర.

Design verification data has demonstrated that the modified SonoTip II Ultrasonic Needle System meets the same performance requirements and is as safe and effective as the currently cleared predicate device. The modified SonoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical characteristics and general range of descriptive features as the predicate Medi-Globe SonoTip II Ultrasound Needle System (K051247).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services: USA. The logo features a stylized abstract symbol resembling a bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES: USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Medi-Globe Corporation c/o Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087

JAN 3 1 2007

K070129 Re:

Trade/Device Name: Medi-Globe SonoTip II Ultrasound Needle System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: FCG Dated: January 12, 2007 Received: January 16, 2007

Dear Mr. Devine:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial of an organization, with the years "1906-2006" displayed at the top. The letters "FDA" are prominently featured in the center of the logo. The word "Centennial" is written in a stylized font below the letters.

Protecting and Promoting Public Health

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Page 2 -

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 one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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/cdrl/industry/support/index.html.

Sincerely vours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): 500 KOJO 29

Device Name: SonoTip II Ultrasound Needle System

Indications for Use: The SonoTip II Ultrasound Needle System is used in conjunction with various legally marketed, FDA registered Ultrasound Endoscopes. The SonoTip II Needle System is used for ultrasonically guided fine needle aspiration, (FNA) of submucosal and extra-luminal lesions of the Gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number