(15 days)
Not Found
No
The document describes a standard nebulizer and explicitly states "Mentions AI, DNN, or ML: Not Found".
Yes
The device is a nebulizer designed to aerosolize medication for inhalation treatment, which is a therapeutic purpose.
No
The device is a nebulizer designed to aerosolize medication for treatment, not to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is a "handheld nebulizer" and a "reusable air-powered nebulizer," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "aerosolize medication approved for nebulization and prescribed by a physician." This is a therapeutic function, delivering medication to the patient.
- Device Description: The description clearly states it's a "handheld nebulizer" for "inhalation treatment of aerosolized medications." This is a drug delivery device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological specimens.
The LC Sprint is a medical device, specifically a drug delivery device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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.
Indications For Use
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.
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.
1
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.
2
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
3
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)