SONOTIP II ULTRASOUND NEEDLE SYSTEM

K051247 · Medi-Globe Corp. · FCG · Jun 16, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051247
• Device Name: SONOTIP II ULTRASOUND NEEDLE SYSTEM
• Applicant: Medi-Globe Corp.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jun 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

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 extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes).

Device Story

SonoTip II Ultrasound Needle System is a disposable, one-piece instrument for fine needle aspiration (FNA). Device features adjustable outer metal sheath to precisely match working length of specific ultrasound endoscopes. Used in clinical settings by physicians; device is guided to target lesions (pancreatic, mediastinal, peri-pancreatic masses, lymph nodes) via ultrasound endoscope. Provides tissue samples for diagnostic evaluation. Benefits include precise targeting of submucosal and extra-luminal lesions under ultrasonic guidance.

Clinical Evidence

Bench testing only. Design verification data demonstrated that the SonoTip II Ultrasound Needle System meets all requirements and is as safe and effective as the predicate device.

Technological Characteristics

Disposable, one-piece needle system. Features adjustable outer metal sheath for length calibration. Utilizes endoscopic ultrasound guidance. No electronic components or software.

Indications for Use

Indicated for ultrasonically guided fine needle aspiration (FNA) of submucosal and extra-luminal gastrointestinal lesions, including pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes, in patients requiring biopsy via ultrasound endoscope.

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)

Submission Summary (Full Text)

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JUN 16 2005

K05 1247
Page 1 of 2

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

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

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

Contact Person: Scott Karler

Contact Person's Telephone Number: [phone]

Contact Person's FAX Number: [phone]

- Device Name: B. SonoTip 11 Ultrasound Needle System
- ட் Predicate Devices: GIP/Medi-Globe GI Ultrasound Needle System (K990220)

#### Device Description: D.

The SonoTip 11 Ultrasound Needle System is complete one-piece needle system for Fine Needle Aspiration and is a disposable instrument intended for single 101 I mo Noode Aspirature allowing the length of the outer metal sheath to be adjusted has been incorporated into the SonoTip II needle system. This provides adjusted has been miss to precisely adjust the working length of the instrument to that of the specific ultrasound endoscope scope being used.

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K051247
Page 2 of 2

#### Intended Use: E.

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 extra-luminal lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses and lymph nodes).

- Technological Characteristics Summary: F.
The SonoTip Il Ultrasound Needle System utilizes endoscopic ultrasound The BonoTip in Ottasound with an ultrasound endoscope guides the biopsy needle to its intended target within or adjacent to the gastrointestinal system.

- Performance Data: G.
Design verification data has demonstrated that the SonoTip II Ultrasonic Needle Dosign verfication autamas requirements and is as safe and effective as Bystem mobile portonio por comoTip II Needle System is considered to have the same intended diagnostic/therapeutic effect, method of introduction/use, technical sharacteristics and general range of descriptive features as the predicate Medi-Globe Ultrasound Needle System (K990220).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The caduceus is depicted with a staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville*MD 20050

JUN 16 2005

Mr. Scott Karler Product Manager Medi-Globe Corporation 110 West Orion Street, Suite 136 TEMPE AZ 85248

Re: K051247

Trade/Device Name: SonoTip II Ultrasound Needle System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: II Product Code: FCG Dated: May 11, 2005 Received: May 18, 2005

Dear Mr. Karler:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have fevelved your botten beees is substantially equivalent (for the indications for use stated in above and have decemined the ed predicate devices marketed in interstate commerce prior to the enclosure) to tegary matterical Device Anendments, or to devices that have been May 20, 1770, and chanance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordation than exproval application (PMA). You may, therefore, market the do not require approval or a premiance approvisions of the Act. The general controls provisions of the Act device, subjox to the general ookies, prion, 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 If your de riod is oldssined (000 acch additional controls. Existing major regulations affecting your Apployal), it they of subject to seen aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA device our of found mouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FICASE or advirsed that I DA s issualled of eevice complies with other requirements of the Act or any FDA has made a decemination administered by other Federal agencies. You must comply with all the read and roguirements, including, but not limited to registration and listing (21 CFR Part 807); labeling ACL S requirements, moduling, but not a mactice requirements as set forth in the quality systems (QS) (ZT CFR Part 8017, good manatacallang Peace, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 iegal This letter will allow you to oegni marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FDA Inding of substantial equil 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), pleased
and the may be and of the one of the consumbers, based on the regulation If you desire specific advice for your device on our laceming regarities (
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Risonation on your responsibilities under the Act from the 807.97). You may obtain other gelleral intornational on your repeat its toll-free number [phone] or [phone] or at its Internet address

050-2011 or (3.gov/cdrh/industry/support/index.html.

Sincercly yours,

Nancy C. Brogdon

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 Statement

| 510(k) Number (if known): | TBD |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | SonoTip 11 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. |

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S OF THE WRITE BELOW THIS VEFENED) IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________

:

# Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | ✓ |
|------------------------------------------|--------------------------------------------------|
| OR | Over-The-Counter Use<br>(Optional Format 1-2-96) |

Nancy Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K051247 |
|---------------|---------|
|---------------|---------|

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