(102 days)
The Confluent Surgical Extended Tip Applicator is indicated for use in the simultaneous delivery of two non- homogenous solutions onto a surgical site.
The Confluent Surgical Extended Tip Applicator will be configured using a Y-Connector, a Malleable Shaft and three Spray Tip Assemblies.
The provided text details a 510(k) summary for the "Confluent Surgical Extended Tip Applicator." However, it does not describe acceptance criteria for a device, nor does it present a study proving the device meets acceptance criteria. Instead, it outlines the device's technical specifications, intended use, and claims of substantial equivalence to a predicate device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study from the provided input.
Here's a breakdown of what the document does provide, and why it doesn't contain the requested information:
- Document Type: This is a 510(k) summary, which is a premarket notification to the FDA. It's a regulatory document demonstrating that a new device is as safe and effective as a legally marketed predicate device.
- Focus: The core of a 510(k) is to establish "substantial equivalence." This means the device has the same intended use and technological characteristics as a predicate device, or if it has different technological characteristics, it does not raise different questions of safety and effectiveness, and the device is as safe and effective as the predicate device.
- Instead of Acceptance Criteria and Studies: The document states: "Safety and effectiveness of the Confluent Surgical Extended Tip Applicator have been demonstrated in this submission. The biocompatibility and in vitro bench testing data provide support that the Extended Tip Applicator is substantially equivalent to the currently 510(k)-cleared Dual Liquid Applicator."
To reiterate, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is not present in the provided 510(k) summary. These details would typically be found in a more comprehensive study report or a different section of a regulatory submission, not generally in the public 510(k) summary focused on substantial equivalence.
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Image /page/0/Picture/0 description: The image shows the text "K072790" in a handwritten style, with the word "CONFIDENTIAL" printed in block letters below it. The text is likely a code or reference number, possibly indicating the document's classification status. The contrast between the handwritten code and the printed word adds a sense of formality and importance to the document.
JAN | | 2006
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: | September 28, 2007 |
|---|---|
| Sponsor | Confluent Surgical, Inc.101A First AvenueWaltham, MA 02451 |
| Contact | Virginia VetterPhone: (781) 839 1755Fax: (781) 839 1731E-mail: Virginia.Vetter@covidien.com |
| Device Trade/Proprietary Name | Confluent Surgical Extended Tip Applicator |
| Classification Name | Piston Syringe (21 CFR 880.5860)Class IIProduct Code: FMF |
| Common Name | Extended Tip Applicator |
| Predicate Device(s) | Confluent Surgical Dual Liquid ApplicatorK061183 |
| DEVICE DESCRIPTION | |
| Product Description | The Confluent Surgical Extended Tip Applicatorwill be configured using a Y-Connector, a MalleableShaft and three Spray Tip Assemblies. |
| Indications for Use | The Confluent Surgical Extended Tip Applicator isindicated for use in the simultaneous delivery of twonon- homogenous solutions onto a surgical site. |
| Safety and Effectiveness | Safety and effectiveness of the Confluent SurgicalExtended Tip Applicator have been demonstrated inthis submission. The biocompatibility and in vitrobench testing data provide support that the ExtendedTip Applicator is substantially equivalent to thecurrently 510(k)-cleared Dual Liquid Applicator. |
| Conclusion | Safety and effectiveness data, same indications foruse and same operating principle show the ConfluentSurgical Extended Tip Applicator to be substantiallyequivalent to a predicate device under the FederalFood, Drug and Cosmetic Act |
| Confluent Surgical, Inc. |
|---|
September 2007
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Image /page/1/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three wings, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the top of the seal in a circular fashion.
JAN 11 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Virginia Vetter Regulatory Affairs Specialist Confluent Surgical, Incorporated 101 A First Avenue Waltham, Massachusett 02451
Rc: K072790
Trade/Device Name: Confluent Surgical Extended Tip Applicator Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 28, 2007 Received: November 5, 2007
Dear Ms. Vetter:
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 Eederal Register.
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Page 2 - Ms. Vetter
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/industry/support/index.html.
Sincerely vours,
Clues
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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CONFIDENTIAL
Section 4: Indications for Use Statement
Page 1_of 1
510(k) Number (if known): Unknown
Device Name: Confluent Surgical Extended Tip Applicator
Indications for Use:
The Confluent Surgical Extended Tip Applicator is indicated for use in the simultaneous delivery of two non- homogenous solutions onto a surgical site.
Prescription Use X (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)
Antony D. Moore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: __ K Φ72799
| Confluent Surgical, Inc. | Traditional Premarket Notification 510(k) |
|---|---|
| 10 | |
| Confluent Surgical Extended Tip Applicator | September 2007 |
§ 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).