(409 days)
No
The device analyzes breathing patterns and adapts, but the description does not use terms like AI, ML, or deep learning, suggesting a rule-based or algorithmic approach rather than a learned model.
Yes.
The device is designed to aerosolize liquid medication for inhalation, which is a therapeutic intervention.
No
The device is described as a jet nebulizer system designed to aerosolize liquid medication for inhalation, indicating its purpose is to deliver treatment, not to diagnose a condition.
No
The device description clearly outlines hardware components such as a base unit with an air compressor, a hand-piece, a medication chamber, a baffle, and a mouthpiece. It also mentions a disc with an embedded transponder and memory. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to aerosolize liquid medication for inhalation by a patient. This is a therapeutic delivery method, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a system for delivering medication based on breathing patterns. It does not mention analyzing biological samples (blood, urine, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting analytes (substances in the body).
- Providing diagnostic information.
- Using reagents or calibrators.
The device is clearly designed for drug delivery, which falls under the category of therapeutic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
A jet nebulizer system designed to aerosolize commonly prescribed liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institutions or hospital environment.
Product codes
CAF
Device Description
The Prodose AAD system is a single patient reusable portable pneumatic jet nebulizer, designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a base unit containing a dedicated air compressor and a hand-piece containing a pressure or a base ann versant control system, a medication chamber, a baffle, and a mouthpiece. The pre-set dose volume is stored on a disc, which has a bi-directional inductively coupled transponder with data storage capacity in a non-volatile memory (EEPROM) embedded in the disc.
The Prodose AAD system analyses the patient's breathing pattern to determine the acrosol pulse time. The system then pulses aerosol during patient inspiration only. The length of each pulse of acrosol is calculated according to the measured inspiratory time. Prodose continues to monitor the breathing pattern throughout treatment in order to adapt to changes in the breathing pattern. When the pre-set dose of medication has been delivered, the system indicates that the treatment is complete.
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
Not Found
Intended User / Care Setting
Home care, nursing home, sub-acute institutions or hospital.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
HaloLite AAD System, K 981772, K991685, AutoNeb K935693, MiniMed Model 508 K990801
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
Prodose AAD System Premarket Notification Page 1 of 3
APR 2 2 2004
| Section 3 Non-Confidential Summary of Safety and Effectiveness | |
|---|---|
| Proprietary or Trade Name: | Prodose AAD System |
| Common / Usual Name: | Jet Nebulizer |
| Classification Name: | Nebulizer, Direct Patient Interface |
| Official Contact: | Dr Neil Purcell |
| Profile Therapeutics plc | |
| Heath Place, Bognor Regis | |
| West Sussex, PO22 9SL, UK | |
| Predicate Device | HaloLite AAD System, K 981772, K991685 |
| AutoNeb K935693 | |
| MiniMed Model 508 K990801 |
Device Description
The Prodose AAD system is a single patient reusable portable pneumatic jet nebulizer, designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a base unit containing a dedicated air compressor and a hand-piece containing a pressure or a base ann versant control system, a medication chamber, a baffle, and a mouthpiece. The pre-set dose volume is stored on a disc, which has a bi-directional inductively coupled transponder with data storage capacity in a non-volatile memory (EEPROM) embedded in the disc.
The Prodose AAD system analyses the patient's breathing pattern to determine the acrosol pulse time. The system then pulses aerosol during patient inspiration only. The length of each pulse of acrosol is calculated according to the measured inspiratory time. Prodose continues to monitor the breathing pattern throughout treatment in order to adapt to changes in the breathing pattern. When the pre-set dose of medication has been delivered, the system indicates that the treatment is complete.
1. Intended use
A jet nebulizer system designed to aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by the patient.
- Environment of Use -
Home care, nursing home, sub-acute institutions or hospital.
- Patient Population –
Patients requiring nebulized drug delivery via a mouthpiece.
Profile Therapeutics plc
1
Image /page/1/Picture/1 description: The image shows the word 'profile' written vertically. Below the word 'profile' are three bullet points, and the words 'human systems' are written below the bullet points. The text is written in a simple, sans-serif font and is likely part of a larger document or presentation.
Comparison to Other Legally Marketed Predicate Devices
The following comparison table details the primary attributes of the intended device and a legally marketed predicate device. The most significant attributes have been listed.
| Attribute | HaloLite AAD
System
K981772, K991685 | Prodose AAD
System |
|-----------------------------------------------------------------------|--------------------------------------------|--------------------------------------------|
| Use | | |
| Intended to nebulize drugs | Yes | Yes |
| Jet Nebulizer System | Yes | Yes |
| Synchronized Delivery of Nebulized drug | Yes | Yes |
| Drug Delivery on demand | Yes | Yes |
| Used in hospitals, home care,
nursing home, sub-acute institutions | Yes | Yes |
| Single Patient reusable | Yes | Yes |
| Design | | |
| Flow Rates | 6 LPM | 6 LPM |
| Gas Source - Compressed Air | Yes | Yes |
| Software Driven | Microprocessor | Microprocessor |
| Mode of Operation | Breathe activated | Breathe activated |
| Drug delivery triggered by | Patient Inhalation | Patient Inhalation |
| Used with Mouthpiece | Yes | Yes |
| Materials | | |
| Materials in Contact
with Patient | Polycarbonate
Polyethylene | Polycarbonate
Polyethylene |
| Packaging | | |
| Provided clean, non-sterile | Yes | Yes |
| Performance Standards / Specifications | | |
| Applicable under Section 514 | None | Various
3.7
Profile Therapeutics plc |
Heath Place, Bognor Regis, West Sussex, PO22 9SL UK
2
Image /page/2/Picture/1 description: The image shows the word "profile" written vertically. Below the word, there are three bullet points, with the words "human systems" written below the first two bullet points. The text is written in a small font size and is difficult to read.
Differences Between Other Legally Marketed Predicate Device
The main differences between the intended device, Prodose AAD System, and the predicate device HaloLite AAD System are -
-
- The Prodose AAD System provides a user-friendly LCD graphic display to show visual information such as "treatment completed", "error message codes" and "pause mode" compared with the flashing LED lights used in HaloLite for visual feedback.
-
- The Prodose user interface is a microprocessor disc. This permits pre-set dose information to be stored in the disc rather than relying on users selecting the correctly colored button on the front of HaloLite. The microprocessor disc also prevents multiple doses being delivered by inappropriate button pressing, as the compressor needs to be restarted to deliver further doses.
-
- The Prodose handpiece is powered by an internal DC supply from the 115 v mains power supply unit. The HaloLite handpiece has an internal replaceable 9-volt battery.
-
- The Prodose air compressor system is able to supply longer aerosol pulses into long inhalation cycles, shortening treatment times for patients with these breathing patterns.
-
- The Prodose AAD System firmware utilizes a larger number of data points to compensate for inhalation airflows compared to HaloLite.
There are no other differences between the intended device and the predicate device, which would be significant to patient safety or effectiveness.
3
Image /page/3/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 a stylized symbol that resembles an abstract representation of a human figure or a flame. The symbol is composed of three curved lines that converge at the bottom.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 2 2004
Profile Therapeutics PLC C/O Mr. Paul Dryden Promedic Inc. 6329 W. Waterview Ct. McCordsville, IN 46055-9501
Re: K030747
Trade/Device Name: Prodose AAD System Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: March 24, 2004 Received: March 25, 2004
Dear Mr. Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your and have determined the device is substantially equivalent (for the relerenced above and have determines res to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to hear reclassified in accordance with the provisions of Amenditions, of to devrees man in to a Act (Act) that do not require approval of a premarket the Federal P 000, Drug, and Ocsment 1 100 ( + Fore, market the device, subject to the general approvin uppreation (1 he Act. The general controls provisions of the Act include controls provisions of the rea. " in Justices, 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 If your device is classified (500 additional controls. Existing major regulations affecting (FMA), it may of subject to back address and Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South nouncements concerning your device in the Federal Register.
4
Page 2 -Mr. Dryden
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease oe advisod that I Dr. 3 to the mained on that your device complies with other requirements Incan that I DIT has made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal statues and Including, but not limited to: registration r ou inust comply with an the Heeling (21 CFR Part 801); good manufacturing practice and allu listing (21 CFR Part 607), laceling systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality bjoceans (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) I mis letter will anow you to begal finding of substantial equivalence of your device to a premarket notification. The PDF milling or 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), If you desire specific at 7.0 xet your mance at (301) 594-5613. Also, please note the regulation prease contact the Other or Sompe to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generalational 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/dsma/dsmamain.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
5
| Section 2a | (Revised) Indications for Use | |
|---|---|---|
| 510(k) Number: | K030747 (To be assigned) | |
| Device Name: | Prodose AAD System | |
| Indications for Use: | A jet nebulizer system designed to aerosolize commonly prescribed liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institutions or hospital environment. | |
| Prescription Use X | ||
| (Per CFR 801.109) | or | Over-the-counter use __ |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Auh
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K030747
Profile Therapeutics pic Heath Place, Bognor Regis, West Sussex, PO22 9SL UK Tel: + 44 (0) 870 770 2000 Fax: + 44 (0) 870 770 2001 info@profilehs.com צוואַווייַטלען.com