(15 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the device description is consistent with a standard nebulizer.
Yes
The device is a nebulizer designed to aerosolize medication for treatment, which constitutes a therapeutic purpose.
No
The device is described as a nebulizer intended for aerosolizing and delivering medication, not for diagnosing conditions.
No
The device description explicitly states it is a "handheld nebulizer" and a "reusable air-powered nebulizer," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is designed to aerosolize and deliver medication for inhalation treatment. This is a therapeutic function, not a diagnostic one.
- Device Description: It's described as an air-powered nebulizer for delivering aerosolized medications. This aligns with a drug delivery device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status, diagnose a condition, or monitor treatment.
IVD devices are specifically designed to perform tests in vitro (outside the body) on specimens to provide diagnostic information. This device operates in vivo (within the body) by delivering medication.
N/A
Intended Use / Indications for Use
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.
Product codes
CAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper airways
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Prescription Use XXX (Part 21 CFR 801 Subpart D)
hospital, clinic, or home environments.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
LC Star Reusable Nebulizer with Nasal Adapter 510(k) Submission 510(k) Summary
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
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.
Indications For Use
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.
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.
1
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.
2
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
3
Indications for Use
510(k) Number (if known): N/A
Device Name: LC Star with Nasal Adapter
Indications for Use:
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.
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)
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