K Number
K072790
Device Name
CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
Date Cleared
2008-01-11

(102 days)

Product Code
Regulation Number
880.5860
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Confluent Surgical Extended Tip Applicator is indicated for use in the simultaneous delivery of two non- homogenous solutions onto a surgical site.
Device Description
The Confluent Surgical Extended Tip Applicator will be configured using a Y-Connector, a Malleable Shaft and three Spray Tip Assemblies.
More Information

Not Found

No
The summary describes a mechanical applicator for delivering solutions and does not mention any AI/ML components or functions.

No.
The device is used for the simultaneous delivery of solutions onto a surgical site, which is a procedural aid rather than a direct therapeutic intervention on the patient's condition.

No
The device is described as an applicator for delivering solutions to a surgical site, and its intended use and description do not involve diagnosing a condition, but rather applying substances.

No

The device description clearly outlines physical components (Y-Connector, Malleable Shaft, Spray Tip Assemblies), 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 for the "simultaneous delivery of two non-homogenous solutions onto a surgical site." This describes a device used during a surgical procedure on a patient's body, not for testing samples outside the body (in vitro).
  • Device Description: The description of the components (Y-Connector, Malleable Shaft, Spray Tip Assemblies) aligns with a device for applying substances directly to a surgical area.
  • Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory results.

IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for the application of solutions during surgery.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

FMF

Device Description

The Confluent Surgical Extended Tip Applicator will be configured using a Y-Connector, a Malleable Shaft and three Spray Tip Assemblies.

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 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.

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.

K061183

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

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
SponsorConfluent Surgical, Inc.
101A First Avenue
Waltham, MA 02451
ContactVirginia Vetter
Phone: (781) 839 1755
Fax: (781) 839 1731
E-mail: Virginia.Vetter@covidien.com
Device Trade/Proprietary NameConfluent Surgical Extended Tip Applicator
Classification NamePiston Syringe (21 CFR 880.5860)
Class II
Product Code: FMF
Common NameExtended Tip Applicator
Predicate Device(s)Confluent Surgical Dual Liquid Applicator
K061183
DEVICE DESCRIPTION
Product DescriptionThe Confluent Surgical Extended Tip Applicator
will be configured using a Y-Connector, a Malleable
Shaft and three Spray Tip Assemblies.
Indications for UseThe Confluent Surgical Extended Tip Applicator is
indicated for use in the simultaneous delivery of two
non- homogenous solutions onto a surgical site.
Safety and EffectivenessSafety 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.
ConclusionSafety and effectiveness data, same indications for
use and same operating principle show the Confluent
Surgical Extended Tip Applicator to be substantially
equivalent to a predicate device under the Federal
Food, Drug and Cosmetic Act
Confluent Surgical, Inc.

September 2007

1

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.

2

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

3

CONFIDENTIAL

Section 4: Indications for Use Statement

Page 1_of 1

510(k) Number (if known): Unknown

K072790

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 ApplicatorSeptember 2007