(34 days)
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.
The Confluent Surgical Dual Liquid Applicator will be configured using the following components: Y-Connector, Three Spray Tips; the Spray Tip consists of a polycarbonate Spray Tip, and a polycarbonate or nylon orifice cup, Plunger Cap.
The provided text is a 510(k) summary for a medical device called the "Confluent Surgical Dual Liquid Applicator." This type of document is for premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Key takeaway: This document describes a device that is a physical applicator, not an AI/ML powered device. Therefore, many of the questions related to AI/ML performance, training sets, ground truth establishment, and expert adjudication are not applicable.
Here's the information extracted and interpreted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this physical device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity or specificity. Instead, the acceptance criterion is that the device demonstrates substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (K042588) in terms of safety and performance. | "Testing conducted to characterize performance of the proposed device incorporating the modification discussed in this submission has demonstrated that it is substantially equivalent to the predicate device and that it is suitable for the intended use specified." |
| Similar technological characteristics to the predicate device. | "The proposed device incorporating the modification discussed in this submission has similar technological characteristics compared to the predicate device." |
| Suitable for intended use. | Tested and found suitable for the intended use. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a "test set" in the context of an AI/ML algorithm. The "testing" mentioned refers to characterization of the physical device's performance to demonstrate substantial equivalence. No specific sample size for a test set (e.g., number of images or cases) is provided or relevant for this type of device.
Data Provenance: Not applicable. The "data" refers to engineering and performance testing data for the physical device, not patient data in the typical sense of AI/ML studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a physical applicator, not an AI/ML algorithm that requires expert-established ground truth from medical images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of cases requiring adjudication for this physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical applicator, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. Ground truth, in the context of expert consensus, pathology, or outcomes data, is relevant for AI/ML diagnostic or prognostic devices, not for a physical fluid applicator. The "ground truth" for this device's performance would be engineering specifications and functional testing results.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML algorithm, no ground truth needed to be established in that context.
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510(k) Summary
JUN - 1 2006
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 14, 2006 | |
|---|---|---|
| Sponsor | Confluent Surgical, Inc. | |
| 101A First Avenue | ||
| Waltham, MA 02451 | ||
| Contact | Eric Ankerud | |
| (781) 693 2333Phone: | ||
| (781) 693 2363Fax: | ||
| 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) | Confluent Surgical Dual Liquid applicator (K042588) | |
| DEVICE DESCRIPTION | ||
| Product Description | The Confluent Surgical Dual Liquid Applicator will be | |
| configured using the following components: | ||
| Y-Connector | ||
| Three Spray Tips; the Spray Tip consists of a | ||
| polycarbonate Spray Tip, and a polycarbonate ornylon orifice cup. | ||
| 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. | ||
| Technological Characteristics: | The proposed device incorporating the modification | |
| discussed in this submission has similar technological | ||
| characteristics compared to the predicate device | ||
| Safety and Performance | Testing conducted to characterize performance of theproposed device incorporating the modification discussedin this submission has demonstrated that it is substantiallyequivalent to the predicate device and that it is suitable forthe intended use specified. | |
| 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. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2006
Mr. Eric P. Ankerud Vice President, Clinical, Regulatory & Quality Confluent Surgical, Incorporated 101A First Avenue Waltham, Massachusetts 02451
Re: K061183
Trade/Device Name: Confluent Surgical Dual Liquid Applicator Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: April 27, 2006 Received: May 2, 2006
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 Lederal Register.
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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 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,
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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Indications for Use Statement
Page 1_of 1
| 510(k) Number (if known): | KC61183 |
|---|---|
| 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-homogenous fluids or solutions onto a surgical site. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-the -Counter Use (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)
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on of Anas besiology, General Hospital Ja Contrul, Dental Devic
§ 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).