(78 days)
Not Found
No
The device description and intended use describe a mechanical applicator for delivering fluids, with no mention of AI/ML or related concepts.
No.
The device is used for the simultaneous delivery of two fluids onto a surgical site and functions as an applicator, not a device that provides therapy itself.
No
The device is used for the simultaneous delivery of two non-homogeneous fluids or solutions onto a surgical site, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description explicitly lists physical components (Y-Connector, Three Spray Tips, Plunger Cap) and the performance studies mention bench testing, indicating 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-homogeneous fluids or solutions onto a surgical site." This describes a device used during a surgical procedure to apply substances to the body, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The components (Y-Connector, Spray Tips, Plunger Cap) are consistent with a device designed for applying liquids, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for the application of substances during surgery.
N/A
Intended Use / Indications for Use
The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogeneous fluids or solutions onto a surgical site.
Product codes
FMF
Device Description
The Confluent Surgical Dual Liquid Applicator will be configured using the following components: • Y-Connector • Three Spray Tips • Plunger Cap
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
Biocompatibility data and results of bench testing have been provided to support the safety and performance of the Confluent Surgical Dual Liquid Applicator. The data provided support that the Dual Liquid Applicator is substantially equivalent to the currently marketed Duoflo Dispenser Kit.
Key Metrics
Not Found
Predicate Device(s)
DuoFlo™ Dispenser Kit (K872526)
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
K042588
CONFIDENTIAL
DEC - 9 2004
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: | September 20, 2004 | |
|---|---|---|
| Sponsor | Confluent Surgical, Inc. | |
| 101A First Avenue | ||
| Waltham, MA 02451 | ||
| Contact | Eric Ankerud | |
| Phone: | (781) 693 2333 | |
| Fax: | (781) 693 2363 | |
| E-mail: | eankerud@confluentsurgical.com | |
| Device Trade/Proprietary Name | Confluent Surgical Dual Liquid Applicator | |
| Classification Name | Piston Syringe (21 CFR 880.5860) | |
| Class II | ||
| Product Code: FMF | ||
| Common Name | Confluent Surgical Dual Liquid Applicator | |
| Predicate Device(s) | DuoFlo™ Dispenser Kit (K872526) | |
| DEVICE DESCRIPTION | ||
| Product Description | The Confluent Surgical Dual Liquid Applicator will be configured using the following components: | |
| • Y-Connector | ||
| • Three Spray Tips | ||
| • Plunger Cap | ||
| Indications for Use | The Confluent Surgical Dual Liquid Applicator is indicated | |
| for use in the simultaneous delivery of two non- | ||
| homogenous fluids or solutions onto a surgical site. |
1
CONFIDENTIAL
| Safety and Performance | Biocompatibility data and results of bench testing have
been provided to support the safety and performance of
the Confluent Surgical Dual Liquid Applicator.
The data provided support that the Dual Liquid Applicator
is substantially equivalent to the currently marketed
Duoflo Dispenser Kit. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based on 1) safety and performance data, and 2)
similarities in indication for use, operating principle,
component shape and dimensions, materials and
manufacturing processes, the Confluent Surgical Dual
Liquid Applicator has been shown to be substantially
equivalent to a predicate device under the Federal Food,
Drug and Cosmetic Act. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Mr. Eric Ankerud, J.D. Vice President, Clinical, Regulatory & Quality Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451
Re: K042588
Trade/Device Name: Confluent Surgical Dual Liquid Applicator Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 20, 2004 Received: September 22, 2004
Dear Mr. Ankerud:
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.
3
Page 2 - Mr. Ankerud
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.
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 vour 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/dsma/dsmamain.html
Sincerely yours,
Supar Quora
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
4
Indications for Use
510(k) Number (if known):_K042588
Device Name: Confluent Surgical Dual Liquid Applicator
Indications For Use:
The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogeneous fluids or solutions onto a surgical site.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antin Donk
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_长442588
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