(15 days)
No
The device description and performance studies focus on the physical properties and drug delivery characteristics of a valved holding chamber, with no mention of AI or ML.
No
The device is a valved holding chamber for use with metered-dose inhalers; it aids in drug delivery but does not directly provide therapeutic treatment itself.
No
The device, a valved holding chamber used with MDIs, is intended for drug delivery and not for diagnosing any condition.
No
The device description clearly states it is a "valved holding chamber" made of "anti-static plastic material," indicating it is a physical hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for delivering respiratory drugs to the lungs in combination with MDIs. This is a therapeutic delivery device, not a diagnostic one.
- Device Description: The description clearly states it's a "valved holding chamber for use with metered dose inhalers (MDIs)". This aligns with a drug delivery aid.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is solely to improve the delivery of medication.
N/A
Intended Use / Indications for Use
OptiChamber Advantage Anti-Static Valved Holding Chamber is intended to be used in combination with Metered Dose Inhalers (MDIs) for respiratory drug delivery. This device, as is the case with other spacer devices, is intended to leave larger non-respirable drug particles within the device and allows smaller respirable particles to be delivered to the lungs.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
OptiChamber Advantage Anti-Static (OCAS) is a Class II device. It is a valved holding chamber for use with metered dose inhalers (MDIs).
The OCAS is a valved holding chamber utilizing the same operating principles as the OptiChamber (K962822) and the AeroChamber Z-Stat (K052322). The difference between the OCAS and the OptiChamber is that, like the AeroChamber Z-Stat, the OCAS is made of an anti-static plastic material.
To use OCAS, the protective caps from both the MDI and the mouthpiece of the device are removed. The MDI (including the actuator) is inserted into the opening in the MDI adaptor at the distal end of the device. The MDI and OCAS combination should be shaken vigorously just prior to inhalation. The patient should exhale normally through the OCAS mouthpiece. The one-way valve prevents the patient's breathe from entering the chamber as air is exhaled through vents in the mouthpiece. The patient actuates the MDI into the OCAS and immediately inhales.
OptiChamber Advantage Anti-Static Valved Holding Chamber has a chamber and mouthpiece made of anti-static material. Non-anti-static valved holding chambers must be washed prior to use. The use of anti-static material in the aerosol path allows an unwashed device to produce the same drug delivery as a washed device.
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
Not Found
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)
The OCAS and the predicate device, the AeroChamber Z-Stat, were tested for particle size distribution and aerosol characterization according to methodology outlined in the FDA "Reviewer Guidance for Nebulizers, metered Dose Inhalers, Spacers and Actuators, 10/93". Testing documentation shows that the aerosol characteristics of the OCAS and the AeroChamber Z-Stat are substantially equivalent.
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
Section 5
510(K) SUMMARY
SEP 12 2007
Prepared: July 27, 2007
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
1. Submitter's Identification:
Respironics New Jersey, Inc. 41 Canfield Road Cedar Grove, New Jersey 07009 Phone: 973 571 2608 Fax: 973 857 9521 Contact Name: Lauren Ziegler e-mail: lauren.ziegler@respironics.com
Establishment Registration Number : 2243193
Official Correspondent:
Lauren Ziegler Director, QA, RA, and Clinical Affairs 41 Canfield Road Cedar Grove, NJ 07009 Phone: 973-571-2608 Fax: 973-857-9521 e-mail: Lauren.ziegler@respironics.com
2. Name of the Device:
OptiChamber Advantage Anti-Static Valved Holding Chamber Common Name or Classification Name (21 CFR Part 807.87) of Device: Metered Dose Inhaler Spacer, 21 CFR Part 868.5630
3. Predicate Device Information:
Identification of legally marketed device which we claim substantial equivalence to:
1
Respironics New Jersey, Inc. 41 Canfield Road Cedar Grove, New Jersey 07009
AeroChamber Z-Stat Plus Valved Holding Chamber K052332 Trudell Medical International 725 Third Street London, Ontario, CA NSV 5 G4
-11-Device Description:
OptiChamber Advantage Anti-Static (OCAS) is a Class II device. It is a valved holding chamber for use with metered dose inhalers (MDIs).
The OCAS is a valved holding chamber utilizing the same operating principles as the OptiChamber (K962822) and the AeroChamber Z-Stat (K052322). The difference between the OCAS and the OptiChamber is that, like the AeroChamber Z-Stat, the OCAS is made of an anti-static plastic material.
Image /page/1/Figure/5 description: The image shows an exploded view of a medical device, with labels indicating the different parts. The parts include a cap, mouthpiece, valve, chamber, reed, and MDI adaptor. There is also an assembled version of the device shown to the right of the exploded view.
Figure 5-1: OCAS and its Component Parts
The objective in using a spacer is to have patients breathe in only those acrosol particles that are of a respirable Mass Median Aerodynamic Diameter (MMAD) such that a therapeutically beneficial amount of drug is able to reach the lungs and a minimal amount of drug is deposited in the oropharynx. To
2
accomplish this. valved holding chambers slow down the aerosol exiting the MDI, evaporate the carrier propellant and gravimetrically retain larger, unrespirable particles.
To use OCAS, the protective caps from both the MDI and the mouthpiece of the device are removed. The MDI (including the actuator) is inserted into the opening in the MDI adaptor at the distal end of the device. The MDI and OCAS combination should be shaken vigorously just prior to inhalation. The patient should exhale normally through the OCAS mouthpiece. The one-way valve prevents the patient's breathe from entering the chamber as air is exhaled through vents in the mouthpiece. The patient actuates the MDI into the OCAS and immediately inhales.
OptiChamber Advantage Anti-Static Valved Holding Chamber has a chamber and mouthpiece made of anti-static material. Non-anti-static valved holding chambers must be washed prior to use. The use of anti-static material in the aerosol path allows an unwashed device to produce the same drug delivery as a washed device.
5. Intended Use:
OptiChamber Advantage Anti-Static Valved Holding Chamber is intended to be used in combination with Metered Dose Inhalers (MDIs) for respiratory drug delivery. This device, as is the case with other spacer devices, is intended to leave larger non-respirable drug particles within the device and allows smaller respirable particles to be delivered to the lungs.
6. Comparison to Predicate Devices:
The subject (OCAS) and predicate devices (OptiChamber, K962822 and AeroChamber Z-Stat, K052322) are indicated for the same intended use. The difference between the OCAS and the OptiChamber is the material for the housing and top. The anti-static material used for the mouthpiece and chamber of OCAS allow the user to get the same aerosol delivery without washing the device prior to use. This anti-static characteristic is common to OCAS to the the predicate AeroChamber Z-Stat. The performance characteristics of OCAS and AeroChamber Z-Stat are substantially equivalent. Both devices are portable and lightweight.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The OCAS and the predicate device, the AeroChamber Z-Stat, were tested for particle size distribution and aerosol characterization according to methodology outlined in the FDA "Reviewer Guidance for Nebulizers, metered Dose Inhalers, Spacers and Actuators, 10/93". Testing
3
documentation shows that the aerosol characteristics of the OCAS and the AeroChamber Z-Stat are substantially equivalent.
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
We have demonstrated that the OptiChamber Advantage Anti-Static Valved Holding Chamber is as safe and effective as a predicate device, the AeroChamber Z-Stat, presently on the market, based on substantially equivalent aerosol characterization testing. The performance of the OCAS before and after washing are also substantially equivalent and this is reflected in the labeling differences between the predicate OptiChamber and the OCAS. The three devices are also substantially equivalent in terms of their operating principle and indications for use.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
SEP 1 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Respironics New Jersey, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
Re: K072418
Trade/Device Name: OptiChamber Advantage Anti-Static Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: August 23, 2007 Received: August 28, 2007
Dear Mr. Devine:
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.
5
Page 2 -Mr. Devine
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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely yours,
Clara
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
6
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: OptiChamber Advantage Anti-Static Valved Holding Chamber
Indications for Use:
OptiChamber Advantage Anti-Static Valved Holding Chamber is intended to be used in OptiChamber Ranahageed Dose Inhalers (MDIs) for respiratory drug delivery. This confomation with there spacer devices, is intended to leave larger non-respirable dovice, as the the the device and allows smaller respirable particles to be delivered to the lungs.
Prescription Use X (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)
OF
Division of Anest Office of Device Evaluation (ODE) Infection Control, Denta
510(k) Number: K072418