The LC Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and prescribed by a physician. The LC Sprint is intended for adult and pediatric patients consistent with the indications for the aerosol medication.

Device Description

The LC Sprint 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 describes the LC Sprint Reusable Nebulizer, its indications for use, and a comparison to predicate devices, but it contains limited information regarding specific acceptance criteria and the detailed study proving the device meets accepted criteria.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on predicate device equivalence)	Reported Device Performance (LC Sprint)
Aerosolization Efficiency	Comparable MMAD (Mass Median Aerodynamic Diameter) to predicate devices (Airlife® Misty Max 10TM Nebulizer, PARI LC® Star Nebulizer)	MMAD is comparable to the predicate devices.
Residual Medication	Comparable RM (Residual Medication) to predicate devices	RM is comparable to the predicate devices.
Total Mass Delivery	Comparable Total Mass to predicate devices	Total Mass is comparable to the predicate devices.
Safety and Effectiveness	Meets performance requirements and raises no new issues of safety or effectiveness.	Meets performance requirements and raises no new issues of safety or effectiveness.
Technological Characteristics	Similar materials, breath-enhanced design, and 2-way valve system to predicate devices.	Employs similar materials, similar breath-enhanced design, and utilizes a 2-way valve system similar to the I.C Star (predicate).

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

The document does not explicitly state the sample size used for the performance tests (MMAD, RM, Total Mass). It is only stated that the LC Sprint was "tested to compare performance to the predicate devices." The data provenance (e.g., country of origin, retrospective or prospective) is not mentioned.

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

This information is not applicable and not provided. The study focuses on objective performance metrics of the device compared to predicate devices, not on expert interpretations or diagnoses that would require ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The study involves measuring physical device performance metrics, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a nebulizer for medication delivery, and its performance is assessed through physical characteristics (MMAD, RM, Total Mass) rather than through diagnostic interpretation by human readers.

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

This information is not applicable. The device is a physical medical device, not an AI algorithm. Its performance is inherent in its design and operation.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the independent measurement of the physical properties related to aerosolized medication delivery, specifically:

MMAD (Mass Median Aerodynamic Diameter): A measure of the particle size of the aerosol.
RM (Residual Medication): The amount of medication remaining in the nebulizer after use.
Total Mass: The total quantity of medication delivered.

These metrics are considered objective and measurable, and their values are compared directly to those of legally marketed predicate devices to establish substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The LC Sprint is a physical medical device, not a machine learning algorithm, and therefore does not have a "training set" in the computational sense.

9. How the Ground Truth for the Training Set was Established

This information is not applicable, as there is no "training set" for this type of device.

Summary

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K060399

MAR 2 2006

I.C Sprint Reusable Nebulizer 510(k) Submission 510(k) Summary

Submitter Information

Name:	PARI Innovative Manufacturers, Inc.
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:	November 22, 2005
Device Name
Common Name:	Nebulizer

Proprietary Name: Multiple Nebulizer (Direct Patient Interface), 21 CFR 868.5630, Product Code CAF Classification Name:

Legally Marketed Predicate Device(s)

Manufacturer	Device	510(k) Number
Allegiance Healthcare Corporation	Airlife® Misty Max 10TM Nebulizer	K023602
PARI Innovative Manufacturers, Inc.	PARI LC® Star Nebulizer	K963924

Device Description

Indications For Use

Technological Characteristics Compared to Predicate Device

I.C Sprint, Misty Max 10, and I.C Star are all nebulizers used to aerosolize medication for inhalation. All three devices are air compressor-driven jet nebulizers using the same acrosolization method.

LC Sprint employs similar materials compared to the I.C. Star nebulizer, has a similar breath-enhanced design, and utilizes a 2-way valve system similar to that used by the I.C Star.

Non-Clinical Test Summary

I.C Sprint was tested to compare performance to the predicate devices, including:

. MMAD: LC Sprint MMAD is comparable to the predicate devices
. RM: I.C. Sprint RM is comparable to the predicate devices
Total Mass: LC Sprint 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

I.C Sprint meets performance requirements and raises no new issues of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three wing strokes, symbolizing service, strength, and skill. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 2

Mr. Robert Mosenkis President Citech 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298

Re: K060399

Trade/Device Name: LC Sprint Reusable Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 14, 2006 Received: February 15, 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. Robert Mosenkis

Please be advised that FDA's issuance of a substantial equivalence determination Joes 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,

Susan Runyes
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): K060399

Device Name: LC Sprint

Indications for Use:

The LC Sprint is a handheld nebulizer, designed to aerosolize medication approved for nebulization and The LO Ophili is a handinor, as a manufact for adult and pediatric patients consistent with the indications for the aerosol medication.

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)

Quysehom

(Division Sian-Off) Division o hesthesiology, General Hos Infection ontrol, Dental Devi

510(k), sumber:

(Posted November 13, 2003)

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).