MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM

K990220 · Medi-Globe Corp. · FCG · Mar 31, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990220
• Device Name: MODIFICATION OF GIP/MEDI-GLOBE ULTRASOUND NEEDLE SYSTEM
• Applicant: Medi-Globe Corp.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Mar 31, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The GIP/ Medi-Globe Needle System for Ultrasonic FNA is specifically designed 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).

Device Story

Needle system designed for ultrasonically guided fine needle aspiration (FNA) of gastrointestinal lesions; used with Pentax FG32, 34, 36, 38 UA ultrasound endoscopes. Device facilitates tissue sampling of submucosal and extra-luminal masses (pancreatic, mediastinal, lymph nodes). Operated by clinicians in clinical settings; provides tissue samples for diagnostic evaluation. Enables minimally invasive biopsy; assists in clinical decision-making regarding lesion pathology.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasound-guided fine needle aspiration system; compatible with Pentax FG32, 34, 36, 38 UA ultrasound endoscopes. Mechanical biopsy instrument.

Indications for Use

Indicated for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal gastrointestinal lesions, including pancreatic, mediastinal, and peri-pancreatic masses and lymph nodes, using compatible Pentax 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 (K935844)

Submission Summary (Full Text)

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3/31/99

K990220
101

## 510(k) Summary

## GIP/Medi-Globe Needle System for Ultrasonic FNA

This 510(k) summary of safety and effectiveness is being submitted in accordance to with
the requirements of SMDA 1990 and 21 CFR, Section 807.92.

| Device Name : | GIP/Medi-Globe Needle System for Ultrasonic FNA |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/User Name : | Ultrasound Needle for Ultrasonic Fine Needle Aspiration |
| Classification : | Gastro-Urology Biopsy Instruments; 21 CFR 876-1075 |
| Proprietary Name : | Various Brand Names of Aspiration Needles |
| Predicate Device : | GIP/Medi-Globe GI Ultrasound Needle System<br>K935844 |
| Prepared & Submitted By : | Michelle L. Fields<br>Project Manager<br>Medi-Globe Corporation<br>6202 S. Maple Avenue, Suite 131<br>Tempe, Arizona 85283<br>[phone] |
| Preparation Date : | January 7, 1999 |
| Indications for Use : | The GIP/ Medi-Globe Needle System for Ultrasonic FNA is<br>specifically designed for ultrasonically guided fine needle<br>aspiration (FNA) of submucosal and extra-luminal lesions of<br>the Gastrointestinal tract (i.e., pancreatic masses, mediastinal<br>masses, peri-pancreatic masses, and lymph nodes). |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, superimposed over two human profiles facing each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the central emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 1999

Ms. Michelle L. Fields Project Manager Medi-Globe® Corporation 6202 S. Maple Avenue, #131 Tempe, AZ 85283

Re: K990220 GIP/Medi-Globe Ultrasound Needle System Dated: January 7, 1999 Received: January 13, 1999 Regulatory Class: II 21 CFR 876.1075/Procode: 78 FCG

Dear Ms. Fields:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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×990220 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:_GIP/Medi-Globe Ultrasound Needle System

Indications for Use:

The Medi-Globe Needle System for Ultrasonic FNA is designed to be used with the Pentax FG32, 34, 36, 38 UA ultrasound endoscopes 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).

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

Concurrence of CDRH, Office of Device Evaiuation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

David h. Slegman

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