(96 days)
Not Found
No
The device description and intended use describe a mechanical applicator for fluids, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also "Not Found".
Yes
The device is described as an applicator for fluids to a treatment site, and its predicates are surgical sealant dispensers, indicating a therapeutic purpose.
No
Explanation: The device is described as an applicator for applying fluids, not for diagnosing conditions. Its function is to deliver substances to a treatment site, which is a therapeutic rather than diagnostic action.
No
The device description explicitly details physical components like syringes, a syringe holder, plungers, a molded link, and application tips (spray or cannula), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "simultaneous application of two nonhomogeneous fluids to a treatment site." This describes a device used on or in the body for therapeutic or procedural purposes, not for testing samples outside the body to diagnose a condition.
- Device Description: The description details syringes, a holder, and tips for application. This aligns with a device used for delivering substances to a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
CAPTION Applicators are intended for the simultaneous application of two nonhomogeneous fluids to a treatment site.
For the simultaneous application of two non-homogeneous fluids to a treatment site.
Product codes
FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510k Summary of Safety and Effectiveness
B 26 2007
| Submitted by: | Smith & Nephew, Inc. Orthopaedics Division
1450 Brooks Rd.
Memphis TN, 38116 |
|--------------------------------------|--------------------------------------------------------------------------------------------|
| Date: | February 13, 2007 (revised) |
| Contact Person: | Kim Kelly, Manager, Regulatory Affairs
Telephone: (901) 399-6566
Fax: (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:
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.
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
1
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.
2
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
3
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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