The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

Device Description

The Relieva Sinus Balloon Inflation Device is a disposable inflation device with a manometer that measures pressures ranging from vacuum to gauge capacity.

AI/ML Overview

The Relieva Sinus Balloon Inflation Device is a Class I manual surgical instrument for ear, nose, and throat procedures. Its intended use is to inflate, monitor pressure, and deflate balloons during dilation of sinus ostia and paranasal sinus cavities.

Here is a summary of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Pressure Accuracy	Not explicitly stated, but implied to meet product specifications.	"conformance to product specification"
Pressure Decay	Not explicitly stated, but implied to meet product specifications.	"conformance to product specification"
Predicate Comparison	Device is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics.	Deemed substantially equivalent to predicate devices (K043527, Pre-Amendments)
Pressure Integrity	Not explicitly stated, but implied to meet product specifications.	"conformance to product specification"

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing focuses on conformance to product specifications for the device itself rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for the device's technical specifications (pressure accuracy, decay, integrity) would be established through engineering and quality control standards, not by medical experts. The "predicate comparison" refers to regulatory comparison, not clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This type of device testing does not involve adjudication by experts as it is focused on technical specifications and substantial equivalence to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This device is a manual surgical instrument, not an AI or imaging diagnostic tool that would typically undergo MRMC studies to evaluate human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a manual medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

The ground truth used for this device's testing would be:

Engineering Specifications: For Pressure Accuracy, Pressure Decay, and Pressure Integrity, the ground truth would be defined by the device's design specifications and industry standards for pressure measurement and containment in medical devices.
Regulatory Substantial Equivalence: For the Predicate Comparison, the ground truth is established by the U.S. FDA's criteria for substantial equivalence to legally marketed predicate devices, which involves comparing intended use, technological characteristics, and safety and effectiveness.

8. Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The "testing" described refers to quality control and design verification.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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AUG 3 1 2005

510(k) Summary

General Information
Classification:	Class I
Classification Name:	Ear, Nose & Throat Manual Surgical Instrument
Regulation Code:	21 CFR 874.4420
Product Code:	LRC
Trade Name:	Relieva Sinus Balloon Inflation Device
Submitter:	Acclarent, Inc.1525-B O'Brien DriveMenlo Park, CA 94025
Contact:	Su-Mien ChongVP, Clinical, Regulatory and Quality
Date Revised:	25 August 2005

Intended Use

Device Description

The Relieva Sinus Balloon Inflation Device is a disposable inflation device with a manometer that measures pressures ranging from vacuum to gauge capacity.

Materials

All materials used in the manufacture of the Relieva Sinus Balloon Inflation Device are suitable for their intended use and have been used in numerous previously cleared products.

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Testing

Products were tested to ensure conformance to product specification. Testing included:

Pressure Accuracy .
Pressure Decay .
Predicate Comparison .
Pressure Integrity .

Summary of Substantial Equivalence

The Relieva Sinus Balloon Inflation Device is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics.

Comparison Chart of Relieva Sinus Balloon Inflation Device and Predicate Devices

	Relieva SinusInflationDevice	Relieva SinusBalloonCatheter	Circular CuttingPunch	Antrum Curette
Manufacturer	Acclarent	ExploraMed NC1	Karl StorzEndoscopyAmerica	Karl StorzEndoscopyAmerica
510(k) Number	K052198	K043527	Pre-Amendments	Pre-Amendments
CFR Section	874.4420	874.4420	874.4420	874.4420
DeviceClassification	I	I	I	I
Product Code	LRC	LRC	LRC	LRC
Intended Use	Inflation &deflation ofdilation balloon	Dilation of tissue	Dilation of tissue	Dilation of tissue
WorkingDiameter	8mm	3mm, 5mm,7mm	4.5mm	5mm
WorkingLength	20 cm	30cm	18cm	19cm

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings. The eagle is facing to the right.

Public Health Service

AUG 3 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acclarent, Inc. c/o Su-Mien Chong VP Cinical, Regulatory and Quality 1525-B O'Brien Drive Menlo Park, CA 94025

Re: K052198

Trade/Device Name: Relieva Sinus Balloon Inflation Device Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, nose, and throat manual surgical instrument Regulatory Class: Class I Product Code: LRC Dated: August 11, 2005 Received: August 12, 2005

Dear Ms. Chong

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave determined in the are and and the summer of the marketed in interstate for use stated in the enclosure) to regard mannent date of the Medical Device Amendments, or to comments to May 20, 1978, the exactions with the provisions of the Federal Food. Drug, devices that have been recalismed in abece approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, merciore, market the act include requirements for annual registration, listing of general controls provisions of the sice, 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 If your device is classified (see aborto) into Existing major regulations affecting your device can may be subject to suen additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that 1 Dri 3 issuated or a basevice complies with other requirements of the Act that TDA has made a determination an administered by other Federal agencies. You must of any Federal statutes and regulations and admited to: registration and listing (21 Comply with an the Her s requirements, and manufacturing practice requirements as set CFK Fart 807), adoling (21 CFR Part 820), good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Su-Mien Chong

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your antial equivalence of your device to a legally premitsel notification. The PDA miding of baction 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 If you desire specific advice for your ac 101 x 27-8910. Also, please note the regulation entitled, Colliact the Office of Complanoo at (301) SET 971 SET Part 807.97). You may obtain Misorananing by Telefone to premail.com in the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Mandracturers, International and Ocusal http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

David M. Whipple Acting 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

K052198

510(k) Number (if known):

Device Name:

Indications for Use:

Relieva Sinus Balloon Inflation Device

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K052498

Page 1 of 13

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.