The LC Star is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The nasal adapter facilitates delivery to the upper airways. The LC Star with nasal adapter is intended for adult and pediatric patients consistent with the indications for aerosol medication.

Device Description

The LC Star reusable nebulizer with nasal adapter is a small, single patient use, reusable air-powered nebulizer for the inhalation treatment of aerosolized medications. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

AI/ML Overview

The provided text is a 510(k) summary for the LC Star Reusable Nebulizer with Nasal Adapter. It details the device, its intended use, and a non-clinical test summary. However, it explicitly states that clinical testing was not completed/is not required to show substantial equivalence. Therefore, it does not contain information about acceptance criteria for device performance based on a study, nor does it provide details about sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, or training set information.

Based on the provided information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state numerical acceptance criteria. Instead, it uses comparative language.

Acceptance Criteria (Implied)	Reported Device Performance
MMAD comparable to predicate devices	LC Star with nasal adapter MMAD is comparable to the predicate devices
RM comparable to predicate devices	LC Star with nasal adapter RM is comparable to the predicate devices
Total Mass comparable to predicate devices	LC Star with nasal adapter Total Mass is comparable to the predicate devices

2. Sample sized used for the test set and the data provenance:

Not applicable. The document states "Clinical testing was not completed/is not required." Non-clinical tests typically involve device measurements and performance characteristics rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical study for substantial equivalence was conducted, therefore no expert ground truth was established from patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No clinical study for substantial equivalence was conducted.

5. 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:

Not applicable. This device is a medical device (nebulizer) and not an AI-powered diagnostic tool. No MRMC study was mentioned or would be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a medical device and not an algorithm. Performance was assessed based on non-clinical measurements described in the summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. For the non-clinical tests (MMAD, RM, Total Mass), the "ground truth" would be the measured values from the predicate devices, against which the new device's measurements were compared.

8. The sample size for the training set:

Not applicable. No clinical study with a training set was conducted.

9. How the ground truth for the training set was established:

Not applicable. No clinical study with a training set was conducted.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria was non-clinical testing. The 510(k) summary explicitly states: "The LC Star with nasal adapter was tested to compare performance to the predicate devices, including: MMAD: LC Star with nasal adapter MMAD is comparable to the predicate devices, RM: LC Star with nasal adapter RM is comparable to the predicate devices, Total Mass: LC Star with nasal adapter Total Mass is comparable to the predicate devices."

The conclusion from this non-clinical testing was that "LC Star with nasal adapter meets performance requirements and raises no new issues of safety or effectiveness." This comparison to legally marketed predicate devices (MABIS NB-02 Ultrasonic Nebulizer and PARI LC® Star Nebulizer) forms the basis for the substantial equivalence determination and indicates that the device's technical specifications are within an acceptable range relative to established devices. No clinical data or human subject studies were required or performed to demonstrate equivalence.

Summary

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LC Star Reusable Nebulizer with Nasal Adapter 510(k) Submission 510(k) Summary

K061381

Submitter Information

Name:	PARI Innovative Manufacturers, Inc.	JUN - 2 2006
Address:	2943 Oak Lake Blvd.Midlothian, VA 23112
Phone Number:	804-253-7274 x269
Fax Number:	804-639-7244
Contact Name:	Michael Judge
Date Prepared:	March 8, 2006
Device Name
Common Name:	Nebulizer
Proprietary Name:	LC Star with Nasal Adapter
Classification Name:	Nebulizer (Direct Patient Interface), 21 CFR 868.5630, Product Code CAF

Legally Marketed Predicate Device(s)

Manufacturer	Device	510(k) Number
MABIS Healthcare	Mabis NB-02 Ultrasonic Nebulizer	K990506
PARI Innovative Manufacturers, Inc.	PARI LC® Star Nebulizer	K963924

Device Description

Indications For Use

Technological Characteristics Compared to Predicate Device

The LC Star with nasal adapter, MABIS NB-02, and LC Star are all nebulizers used to aerosolize medication for inhalation. The LC Star with nasal adapter and LC Star devices are air compressor-driven jet nebulizers using the same aerosolization method.

The LC Star with nasal adapter employs identical materials compared to the LC Star nebulizer and has a similar breath-enhanced design. The nasal adapter added to the system is similar to that used with the MABIS Mist Ultrasonic nebulizer.

Non-Clinical Test Summary

The LC Star with nasal adapter was tested to compare performance to the predicate devices, including:

MMAD: LC Star with nasal adapter MMAD is comparable to the predicate devices ■
. RM: LC Star with nasal adapter RM is comparable to the predicate devices
Total Mass: LC Star with nasal adapter Total Mass is comparable to the predicate devices

Clinical Performance Summary

Clinical testing was not completed/is not required to show substantial equivalence.

Conclusions from Testing

LC Star with nasal adapter meets performance requirements and raises no new issues of safety or effectiveness.

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Image /page/1/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 symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus symbol.

JUN - 2 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pari Innovative Manufacturers, Incorporated C/O Mr. Robert Mosenkis Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K061381

Trade/Device Name: LC Star with Nasal Adapter Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 17, 2006 Received: May 18, 2006

Dear Mr. Mosenkis:

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 Federal Register.

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Page 2 -Mr. Mosenkis

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 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 yours,

Chiu Lin, Ph.D.

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

510(k) Number (if known): N/A

Device Name: LC Star with Nasal Adapter

Indications for Use:

Prescription Use XXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auysufiom

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K061381

Page of (Posted November 13, 2003)

5.1

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).