INJECTRA INJECTION NEEDLE

K061222 · Medi-Globe Corp. · FBK · Jul 3, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061222
• Device Name: INJECTRA INJECTION NEEDLE
• Applicant: Medi-Globe Corp.
• Product Code: FBK · Gastroenterology, Urology
• Decision Date: Jul 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Injectra Injection Needle is a complete one-piece injection needle intended for endoscopic injection of solutions such as sclerosing agents into tissues of the digestive system to control bleeding and for injection of saline as a procedural aid in endoscopic polypectomy procedures. The Injectra Injection Needle is a disposable device and is intended for single patient use only.

Device Story

The Injectra Injection Needle is a single-use, disposable device designed for use with flexible endoscopes. It functions as a delivery conduit for therapeutic solutions, such as sclerosing agents for hemorrhage control or saline for polypectomy assistance. The device is operated by a clinician during endoscopic procedures. By providing a controlled means to inject fluids directly into digestive tract tissues, it facilitates therapeutic interventions, potentially improving patient outcomes in endoscopic surgery.

Clinical Evidence

Bench testing only. Design verification demonstrated performance equivalent to the predicate device. Biological safety testing was conducted due to changes in indirect patient-contacting materials, with results confirming no adverse impact on patient safety.

Technological Characteristics

One-piece disposable injection needle for use through endoscope accessory channels. Materials include indirect patient-contacting components verified for biological safety. No electronic, software, or energy-based components.

Indications for Use

Indicated for endoscopic injection of solutions (e.g., sclerosing agents) into digestive system tissues to control bleeding and for saline injection as a procedural aid during endoscopic polypectomy. Used in conjunction with legally marketed flexible endoscopes.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• GIP/Medi-Globe Sclerotherapy Needle (K955558)

Reference Devices

• Interject™ Injection Needle Therapy Needle (K012864)

Submission Summary (Full Text)

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K061222
Page 1 of 2

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

Submitter Information: A.

JUL - 3 2006

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] Ext. 208

Contact Person's FAX Number: [phone]

- B. Device Name: Injectra Injection Needle
- Predicate Devices: C.

GIP/Medi-Globe Sclerotherapy Needle, (K955558)

## Device Description: D.

The Injectra Injection Needle is a device that is used to deliver solutions into tissues of the digestive tract through the accessory channel of a legally marketed endoscope.

## E. Intended Use:

The Injectra Injection Needle is a complete one-piece injection needle intended for endoscopic injection of solutions such as sclerosing agents into tissues of the digestive system to control bleeding and for injection of saline as a procedural aid in endoscopic polypectomy procedures. The Injectra Injection Needle is a disposable device and is intended for single patient use only.

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K061222
Page 2 of 2

- Technological Characteristics Summary: F.
Medi-Globe believes that the proposed Injectra Injection Needle is substantially equivalent to the currently cleared GIP/Medi-Globe Sclerotherapy Needle, (K955558) in device function and overall design. The additional indications are also consistent with currently cleared devices marketed by Boston Scientific Corporations Interject™ Injection Needle Therapy Needle, (K012864).

- Performance Data: G.
Design verification data has demonstrated that the Injectra Injection Needle meets the same performance requirements and is as safe and effective as the predicate GIP/Medi-Globe device, (K955558). Biological testing has been performed on the proposed Injectra Injection Needle due to the change in indirect patient contacting materials. The results have indicated that the Injectra Needle does not affect the biological safety of the patient.

Prepared by: Scott Karler Date: May 1, 2006

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL - 3 2006

Mr. Scott Karler Regulatory Affairs Coordinator Medi-Globe® Corporation 110 West Orion Street, Ste. 136 TEMPE AZ 85283

Re: K061222

Trade/Device Name: Injectra Injection Needle Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: May 1, 2006 Received: May 2, 2006

Dear Mr. Karler:

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.

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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 (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.

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/cdrh/industry/support/index.lum1.

Sincerely vours.

Nancy C. Brogdon

Nancv 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): K061222

Device Name: Injectra Injection Needle

Indications for Use: The Medi-Globe® Injectra Needle is used in conjunction with various legally marked, FDA registered flexible endoscopes. The Injectra Needle is used for endoscopic injection of solutions into tissues of the digestive system and injection of saline as a procedural aid in endoscopic polypectomy procedures.

> Prescription Use (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)

V. Van der Meulen

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