The SinuFlush Lavage System is intended for nasal and sinus irrigation in patients who are under the care of a physician. The SinuFlush Lavage System is a prescription use product that is to be used by adults in either the physician's office or in the home after obtaining instructions from a health care provider.

Device Description

The SinuFlush Lavage System is a hand held 25 cc syringe with a plunger to control the force of delivery and volume markings on its side in order to measure the amount of irrigant to be delivered. The tip consists of soft silicone to occlude the nasal ostium during irrigation. The mixing container consists of a 25 cc container with markings on its side for volume measurement in cc, and a plastic screw top to secure the contents of the container during shaking.

AI/ML Overview

This 510(k) summary does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or training/test set ground truth details. The document focuses on regulatory submission for a medical device (SinuFlush Lavage System) and its substantial equivalence to a predicate device (Sinusense Nasal Rinse).

The provided text is a 510(k) summary for a medical device, the SinuFlush Lavage System. It outlines the device description, its intended use, and its comparison to a predicate device. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed device rather than presenting detailed performance studies against specific acceptance criteria like those found for AI/ML-driven devices.

Therefore, the following information is not present in the provided text:

A table of acceptance criteria and the reported device performance: This document does not establish specific performance metrics or acceptance criteria beyond demonstrating substantial equivalence to a predicate device in terms of intended use, principle of operation, and nose contact mechanism.
Sample size used for the test set and the data provenance: No test set or related performance data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is mentioned.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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: This device is a manual lavage system, not an AI-assisted diagnostic or treatment device, so MRMC studies are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of manual device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Summary

510(k) Number: K131177

Device Name: SinuFlush Lavage System

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter's Name and Address

HedgePath, LLC Suite 350 324 S. Hyde Park Ave Tampa, FL 33606

Contact: Frank E. O'Donnell, Jr MD. Acting Director of Regulatory Affairs (314) 258-6446 (941) 387-9150

Device Name

Trade Name:	SinuFlush Lavage System
Common Name:	Ear, nose, and throat manual surgical instrument
Classification Name:	Ear, nose, and throat manual surgical instrument(21 CFR 874.4420)
Product Code:	KAR

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Predicate Device

	New Device	Predicate
Device Name	SinuFlush Lavage System	Sinusense Nasal Rinse
Manufacturer	HedgePath, LLC	Water Pik, Inc.
RegulationNumber/Product Code	874.4420, KAR (Proposed)	874.4420, KAR (Exempt)
Indication forUse	The SinuFlush Lavage System isintended for nasal and sinusirrigation in patients who are underthe care of a physician. TheSinuFlush Lavage System is aprescription use product that is to beused by adults in either thephysician's office or in the home afterobtaining instructions from a healthcare provider.	Sinusense Nasal Rinse: "Sinus washhas been used for centuries as a naturaldaily routine to keep sinus passagesclear of congestion, allergens andeveryday debris. It's an all-naturalapproach to better breathing that makesperfect sense when you consider all ofthe other remedies on the market. TheWaterpik® SinuSenseTM Sinus Washproducts and the uniquely formulatedSoothing Saline Easy- Pour Packs clearsinuses to make breathing easier."
Principle ofOperation	Irrigant is delivered by pushing theplunger of the 25 cc syringe under themanual control of the patient.	Irrigant is delivered by manual pressureby the user.
Nose contactmechanism	The nose is occluded by bespecifically designed silicon tip.	The nose is occluded by a specificallydesigned non-rubber, non-latex tip.

Device Description

The SinuFlush Lavage System is substantially equivalent to the Sinusense Nasal Rinse.

Intended Use

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2014

HedgePath, LLC c/o Frank E. O'Donnell, Jr., M.D. Acting Director of Regulatory Affairs 324 S. Hyde Park Avenue, Suite 350 Tampa, FL 33606

Re: K131177

Trade/Device Name: SinuFlush Lavage System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class 1 Product Code: KAR Dated: August 7, 2013 Received: August 8, 2013

Dear Dr. O'Donell:

This letter corrects our substantially equivalent letter of September 20, 2013.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Form (Text Version) Indications for Use

510(k) Number (if known): ___K131177 Device Name: SinuFlush Lavage System Indications for Use:

× Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Page ___ of __________________________________________________________________________________________________________________________________________________________________

Vasant G. Malshet

Digitally signed by Vasant G. Malshet DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Vasant G. Malshet, 0.9.2342.19200300.100.1.1=130008785

Date: 2013.09.19 10:23:31 -04'00'

Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.