(78 days)
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.
The Confluent Surgical Dual Liquid Applicator will be configured using the following components:
• Y-Connector
• Three Spray Tips
• Plunger Cap
The provided text describes a 510(k) submission for the Confluent Surgical Dual Liquid Applicator. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics described in the prompt's requested format.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or cannot be extracted from this particular 510(k) summary.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The overarching "acceptance criterion" is demonstrating substantial equivalence to the predicate device. | Biocompatibility: The device provided biocompatibility data. |
| Bench Testing: The device provided results of bench testing. | Safety and Performance: The data provided support that the Dual Liquid Applicator is substantially equivalent to the currently marketed Duoflo Dispenser Kit in terms of safety and performance. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The summary focuses on equivalence to a predicate device based on manufacturing, materials, and general performance data, not a direct clinical test set with human subjects or specific data provenance details. The evaluation appears to be based on design and engineering characteristics, and potentially pre-clinical (biocompatibility) data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth is not established in the context of this 510(k) summary, as it's not a study designed to evaluate diagnostic accuracy or human interpretation.
4. Adjudication method for the test set:
- Not applicable / Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is a liquid applicator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used:
- Not applicable / Not provided. The "ground truth" in this context would be whether the device physically performs its function safely and effectively, and is chemically and physically equivalent to its predicate. This is assessed through engineering tests and material comparisons, not typically a "ground truth" derived from expert consensus, pathology, or outcomes data in the way it applies to diagnostic devices.
8. The sample size for the training set:
- Not applicable / Not provided. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of the Study (510(k) Submission for Substantial Equivalence):
The "study" presented here is a 510(k) premarket notification for the Confluent Surgical Dual Liquid Applicator. The objective of such a submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving performance against independent acceptance criteria through a clinical trial or a statistically powered study as described in the prompt's questions.
How Substantial Equivalence was demonstrated:
The submission provided:
- Biocompatibility data: To ensure the materials used are safe for patient contact.
- Results of bench testing: To confirm the device's functional performance and mechanical integrity.
The conclusion states that based on this data, and based on similarities in:
- Indications for use
- Operating principle
- Component shape and dimensions
- Materials
- Manufacturing processes
The Confluent Surgical Dual Liquid Applicator was shown to be substantially equivalent to the predicate device, the DuoFlo™ Dispenser Kit (K872526).
Therefore, the "acceptance criteria" here are met by demonstrating sufficient similarity and equivalent safety/performance to the predicate device as mandated by the 510(k) regulatory pathway. Specific numerical performance targets or clinical trial outcomes in human subjects are not typically required or provided for this type of device in a 510(k) unless specific performance issues or new risks are identified.
{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 indicatedfor 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 havebeen provided to support the safety and performance ofthe Confluent Surgical Dual Liquid Applicator.The data provided support that the Dual Liquid Applicatoris substantially equivalent to the currently marketedDuoflo Dispenser Kit. |
|---|---|
| Conclusion | Based on 1) safety and performance data, and 2)similarities in indication for use, operating principle,component shape and dimensions, materials andmanufacturing processes, the Confluent Surgical DualLiquid Applicator has been shown to be substantiallyequivalent 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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).