INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836

K012864 · Boston Scientific Corp · FCG · Oct 24, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K012864
• Device Name: INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
• Applicant: Boston Scientific Corp
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Oct 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

Device Story

Interject Injection Therapy Needle is an endoscopic accessory; consists of catheter, needle, and hub. Used by physicians during endoscopic procedures to deliver therapeutic agents (sclerosing agents, vasoconstrictors, or saline) into digestive tract tissue. Enables control of actual or potential bleeding lesions, non-variceal hemorrhage, and facilitates EMR and polypectomy. Device is manually operated by clinician through endoscope working channel.

Clinical Evidence

No clinical data; bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results.

Technological Characteristics

Catheter-based injection needle; components include catheter, needle, and hub. Manual operation. Biocompatible materials. No electronic or software components.

Indications for Use

Indicated for endoscopic delivery of sclerosing agents, vasoconstrictors, or saline to control bleeding lesions or assist in EMR and polypectomy procedures in the digestive system.

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

• Interject™ Therapy Needle (Boston Scientific Corporation)
• Variject™ Needle Catheter (K961846)
• US Endoscopy Group, Coaxial Needle (K971842)

Submission Summary (Full Text)

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K012864
Page 1 of 2

# SECTION 10 510(k) SUMMARY

## FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

Date:

Common/Usual Names: Trade/Proprietary Name: Classification Name & Device Classification:

Name Needle, Endoscope Endoscope & Accessories

Device Panel/Branch:

Owner/Operator:

August 21, 2001 needle, endoscope Interject™ Injection Therapy Needle

Class II

| Number | 21 CFR Ref |
|--------|------------|
| 78 FBK | 876.1500 |
| 78 KOG | 876.1500 |

Gastroenterology-Urology (GU) GASTRO-RENAL (GRBD)

Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760

Contact Person:

James D. McMahon Regulatory Affairs Specialist

#### DESCRIPTION OF DEVICE

The Interject Injection Therapy Needle is an injection needle designed to be used with an endoscope to perform endoscopic injections.

## INDICATIONS FOR USE

The Interject Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system; and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

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K012864
Page 2 of 2

# DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Interject™ Injection Therapy Needle with additional indications is substantially equivalent to the currently marketed Boston Scientific Corporation's Interject™ Therapy Needle, Variject™ Needle Catheter (K961846) and US Endoscopy Goup, Coaxial Needle (K971842). The major components of the devices are the catheter, needle, and hub. A thorough comparison of the descriptive characteristics between the proposed Interject device and the predicate device show equivalence.

## PERFORMANCE CHARACTERISTICS

A biocompatibility assessment was performed on the patient- and fluid-contact materials of the predicate Interiect Injection Therapy Needle with satisfactory results. The proposed Interject device and predicate Interject device are identical therefore no additional biocompatibility was performed to include the new indication.

### CONCLUSION

BSC has demonstrated that the Interject™ Injection Therapy Needle with additional indications is substantially equivalent to BSC's currently marketed Interiect Injection Therapy Needle, Variject Needle Catheter and US Endoscopy Group, Coaxial Needle,

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Mr. James D. McMahon Regulatory Affairs Specialist Microvasive Endoscopy Boston Scientific Corporation One Boston Scientific Place NATICK MA 01760-1537

Re: K012864

Trade/Device Name: Interject™ Injection Therapy Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: 78 FCG Dated: August 24, 2001

Dear Mr. McMahon:

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.

Received: August 27, 2001

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

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.

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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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely 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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## SECTION 3 INDICATION FOR USE

510(k) Number:

To Be Determined K012864

Device Name:

Interject™ Injection Therapy Needle

Indication for Use:

The Interject™ Injection Therapy Needle Catheter is used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding Scierosmy agent of vasoconserver and the injection of saline to aid in Endoscopic Mucosal Resection (EMR), polypectomy procedures and to control non-variceal hemorrhage.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--------------------------------------------------|
| Prescription Use<br>(Per 21 CFR 801.1091) | OR |
| | Over-The-Counter Use<br>(Optional Format 1-2-96) |

Nanare Shoodon

(Division Sten-Off)
Division of Reproductive, Abdonlinel,
and Redietegical Devices K012864
510(k) Number