CAPTION Applicators consists of two medical syringes, a 12cc syringe and a 1cc syringe, held in parallel alignment in a molded syringe holder. The plungers of the syringes are joined together by a molded link that allows simultaneous actuation of the syringes. The liquids may be applied through either a dual spray or dual cannula tip.

AI/ML Overview

The provided text is a 510(k) summary for the CAPTION Applicator, a medical device for simultaneously applying two fluids. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot provide the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document only states:

Device Description: CAPTION Applicators consist of two syringes in a molded holder, with linked plungers for simultaneous actuation.
Intended Use: For the simultaneous application of two nonhomogeneous fluids to a treatment site.
Technological Characteristics: Similar to legally marketed devices in indications for use, materials, and technological characteristics.
Substantial Equivalence Information: Based on similarities in design features, overall indications for use, and material composition to predicate devices (Micromedics Surgical Sealant Dispenser K881020 and Baxter Healthcare Duploject K973510).

This type of submission typically relies on comparing the new device's design, materials, and intended use to existing, legally marketed devices to demonstrate that it is as safe and effective, rather than conducting a de novo performance study with specific acceptance criteria.

Summary

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K063535

510k Summary of Safety and Effectiveness

B 26 2007

Submitted by:	Smith & Nephew, Inc. Orthopaedics Division1450 Brooks Rd.Memphis TN, 38116
Date:	February 13, 2007 (revised)
Contact Person:	Kim Kelly, Manager, Regulatory AffairsTelephone: (901) 399-6566Fax: (901) 399-1557
Proprietary Name:	CAPTION Applicator
Common Name:	Syringe
Classification Name &Reference:	21 CFR 880.5860, Piston syringe- Class II
Device Product Code &Panel Code:	FMF, General Hospital

Device Description:

Intended Use:

CAPTION Applicators are intended for the simultaneous application of two nonhomogeneous fluids to a treatment site.

Technological Characteristics:

CAPTION Applicators are similar to legally marketed devices listed below in that they share similar indications for use, are manufactured from similar materials, and incorporate similar technological characteristics.

Substantial Equivalence Information:

When compared to the predicates listed below, substantial equivalence was based on similarities in design features, overall indications for use, and material composition

o Micromedics Surgical Sealant Dispenser K881020
Baxter Healthcare Duploject K973510 ਼

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is facing to the right, and its head is slightly tilted upwards. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim P. Kelly Manager, Regulatory Affairs Smith & Nephew, Incorporated 1450 Brooks Road Memphis, Tennessee 38116

FEB & 6 2007

Re: K063535

Trade/Device Name: Smith & Nephew CAPTION Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 21, 2006 Received: November 28, 2006

Dear Ms. Kelly:

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 (PMA), 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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Page 2 -Ms. Kelly

Please be advised that FDA's issuance of a substantial cquivalence 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours. WALF

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K065535

Premarket Notification Indications for Use Statement

510(k) Number (if known):

Device Name: Smith & Nephew CAPTION Applicator

Indications for Use:

For the simultaneous application of two non-homogeneous fluids to a treatment site.

Prescription Use: _ × OR (Per 21 CFT 801.109)

Over-The-Counter _____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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大�6:35 SJ

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).