(32 days)
Not Found
No
The description focuses on the mechanical function of delivering two solutions and does not mention any computational or analytical capabilities that would suggest AI/ML.
No.
The device is an applicator for delivering solutions, not a device that directly treats or diagnoses a disease/condition.
No
The device is an applicator for delivering solutions to a surgical site, not for diagnosing conditions or diseases.
No
The device description clearly outlines a physical, single-use, disposable applicator with luer fittings, lumens, and a bendable shaft, 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 the "simultaneous delivery of two non-homogenous solutions onto a surgical site." This describes a device used during a surgical procedure to apply substances directly to tissue, not to perform tests on samples taken from the body.
- Device Description: The description focuses on the mechanical function of delivering solutions through separate lumens and its physical characteristics (bendable shaft, luer fittings). It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is clearly intended for surgical application of solutions, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The COVIDIEN Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The COVIDIEN Extended Tip Applicator is a single-use, disposable applicator intended for the simultaneous delivery of two non-homogenous solutions onto a surgical site. The COVIDIEN Extended Tip Applicator provides two (2) female luer fittings for connection to standard syringes containing two non-homogenous solutions. The shaft of the Extended Tip Applicator maintains two separate and independent lumens, which keep the two solutions separate and prevent premature mixing. The Extended Tip Applicator shaft is bendable up to 60 degrees to facilitate access to confined spaces at the surgical site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical site
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)
Safety and effectiveness of the Extended Tip Applicator have been demonstrated in this submission. Biocompatibility testing assures the device complies with applicable sections of industry and safety standards. Performance testing ensures that the Extended Tip Applicator meets all of its functional requirements and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN - 5 2009
Section 5: 510(k) Summary
This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990. The contents of the 510(k) summary have been provided in conformance with 21 CFR §807.98.
| Date Prepared: | April 21, 2009 |
|---|---|
| Sponsor | Covidien (formerly Confluent Surgical, Inc.) |
| 101A First Avenue | |
| Waltham, MA 02451 | |
| Contact | Sean Reynolds |
| Phone: (781) 839 1785 | |
| Fax: (781) 577 5808 | |
| E-mail: Sean.Reynolds@covidien.com | |
| Device Trade/Proprietary | |
| Name | COVIDIEN Extended Tip Applicator |
| Classification Name | Piston Syringe (21 CFR 880.5860) |
| Class II | |
| Product Code: FMF | |
| Common Name | Extended Tip Applicator |
| Predicate Device(s) | Confluent Surgical Extended Tip Applicator - K072790 |
| DEVICE DESCRIPTION | |
| Product Description | The COVIDIEN Extended Tip Applicator is a single-use, |
| disposable applicator intended for the simultaneous delivery of two | |
| non-homogenous solutions onto a surgical site. The COVIDIEN | |
| Extended Tip Applicator provides two (2) female luer fittings for | |
| connection to standard syringes containing two non-homogenous | |
| solutions. The shaft of the Extended Tip Applicator maintains two | |
| separate and independent lumens, which keep the two solutions | |
| separate and prevent premature mixing. The Extended Tip | |
| Applicator shaft is bendable up to 60 degrees to facilitate access to | |
| confined spaces at the surgical site. | |
| Indications for Use | The COVIDIEN Extended Tip Applicator is indicated for use in |
| the simultaneous delivery of two non-homogenous solutions onto a | |
| surgical site. | |
| Safety and Effectiveness | Safety and effectiveness of the Extended Tip Applicator have been |
| demonstrated in this submission. Biocompatibility testing assures | |
| the device complies with applicable sections of industry and safety | |
| standards. Performance testing ensures that the Extended Tip | |
| Applicator meets all of its functional requirements and performs as | |
| intended. | |
| Conclusion | Performance data, identical indications for use and identical |
| operating principle demonstrate the Covidien Extended Tip | |
| Applicator to be substantially equivalent to a predicate device | |
| under the Federal Food, Drug and Cosmetic Act. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.
Public Health Service
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Mr. Sean Reynolds Senior Associate, Regulatory Affairs Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451
JUN - 5 2009
Re: K091315
Trade/Device Name: Covidien Extended Tip Applicator Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 1, 2009 Received: May 4, 2009
Dear Mr. Reynolds:
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 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 - Mr. Reynolds
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony D. m
Susan Runner, D.D.S., MA Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
125 Indications for Use Statement
K091316 510(k) Number (if known):
Device Name: Extended Tip Applicator
Indications for Use: The Extended Tip Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.
Prescription Use _ X AND/OR
Over-the -Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
LCDR. Collum Second
(Division Sign-Off) Division of Anesthesiology, General Hosphal Infection Control, Dental Devices
KO91315 510(k) Number:
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