The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the needle in order to flush the injection site for better visualization.

Device Description

The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the order to flush the injection site for better needle in visualization.

AI/ML Overview

This document is a 510(k) summary for a Coaxial Needle and does not contain the acceptance criteria or a study demonstrating the device meets those criteria.

The provided text focuses on:

Product Description: How the Coaxial Needle is used (endoscopic injection for bleeding control or polyp lifting) and its components (irrigation tube/syringe attachment).
Contraindications: Uncooperative patient and severe coagulopathy.
Manufacturing and Quality Assurance: Mentions U.S.E.'s adherence to performance specifications, Quality Systems Regulations, and MIL-STD-9858.
Sterilization: EtO sterilization is used.
Bibliography: Lists general references related to gastroenterologic procedures.
FDA 510(k) Clearance Letter: Confirms the device's substantial equivalence to predicate devices and clearance to market.
Indications for Use Statement: Reiterates the intended uses of the device.

Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets them because it is not present in the provided text.

To answer your questions, the document would need to include information such as:

Specific performance metrics (e.g., needle sharpness measurements, flow rates, durability tests).
Quantifiable targets for these metrics (the acceptance criteria).
Details of a study (e.g., experimental design, methodology, results) that evaluated the device against these metrics.

Summary

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K971842

JUN 20 1997

SECTION II 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

COAXIAL NEEDLE

Summary of Safety and Effectiveness on the Coaxial Needle The reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.

Procedure/Product Overview

The Coaxial Needle is used for endoscopic injection to control bleeding or lift sessile polyps using various media. An irrigation tube or syringe may be attached to the aspiration port of the order to flush the injection site for better needle in visualization.

Contraindications for the Coaxial Needle

The use of a Coaxial Needle is contraindicated in the following:

Uncooperative patient 1.
Severe Coagulopathy 2.

The physician will determine the patient's appropriateness for the procedure.

Manufacturing Overview

manufactures and tests the product to performance U.S.E. specifications based on predicated and/or substantially equivalent devices.

U.S.E.'s manufacturing processes and procedures are based on the Quality assurance methods and Ouality Systems Regulations. procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.

Materials used in the manufacturing process are certified to standards appropriate for their use.

Sterilization

The Coaxial Needle will be sterilized using EtO.

Bibliography

D.A. (Editor). (1987). Manual of Gastroenterologic Drossman, Procedures (2nd Edition). New York: Raven Press

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Ravenscroft, M.M. and Swand, C.H.J. Gastrointestinal Endoscopy and Related Procedures: A Handbook for Nurses and Assistants. Baltimore: Williams & Wilkens, 1984.

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Society of Gastroenterology Nurses & Associates. SGNA Manual of Gastroenterology Procedures. Rochester: SGNA, 1989.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head.

Public Health Service

JUN 20 1907

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gretchen Younker Cohen Director Regulatory Affairs United States Endoscopy Group, Inc. 9330 Progress Parkway Mentor, Ohio 44060

Re: K971842 Coaxial Needle ........ Dated: March 13, 1997 Received: May 19, 1997 Regulatory class: II 21 CFR §876.1075/Product code: 78 FCG

Dear Ms. Cohen:

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 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). 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D 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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510(k) Number if Known K 971842

Device Name: Coaxial Needle

Indications for Use:

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Prescription Use -(Per 21 CFR 801.109)

Over-the Counter Use_

Robert R. Sattler/
(Division Sign-Off)
14

Division of Reproductive, Abdominal, EN and Radiological Devic

510(k) Number

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.