(90 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and aerosol delivery performance of a valved holding chamber, with no mention of AI or ML.
No.
Explanation: The device is an anti-static valved holding chamber intended to administer aerosolized medication from a Metered Dose Inhaler. It assists in the delivery of medication but is not a therapeutic device itself.
No
The device is a valved holding chamber intended to aid in the administration of aerosolized medication from a Metered Dose Inhaler (MDI). It is a passive device that facilitates drug delivery and does not collect or analyze data for diagnostic purposes.
No
The device description clearly outlines physical components (translucent housing, mouthpiece/face mask, one-way valve) and the performance studies involve physical testing of these components and their interaction with aerosolized medication. This indicates a hardware device, not software only.
Based on the provided information, the InspiraChamber® Anti-Static Valved Holding Chamber is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to administer aerosolized medication from pressurized Metered Dose Inhalers (pMDIs) to patients for inhalation into the respiratory system. This is a therapeutic delivery device, not a diagnostic one.
- Device Description: The description focuses on the physical components and function of a holding chamber for medication delivery.
- Performance Studies: The performance studies described are related to the aerosol characteristics and delivery of the medication through the device (particle size, dose delivered, etc.). These are relevant to the performance of a drug delivery device, not a diagnostic test.
- Key Metrics: The key metrics measured (Total Respirable Dose Delivered, Particle Size, etc.) are related to the efficiency and characteristics of drug delivery, not to the detection or measurement of substances in a biological sample.
- No mention of biological samples: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVD devices.
In summary, the InspiraChamber® is a medical device designed to facilitate the delivery of medication to the respiratory system. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The InspiraChamber® Anti-Static Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use - The proposed device may be used in home, hospitals and clinical settings where patients may require the use of a holding chamber with pMDIs.
The intended patient population is 3 years and older who have been prescribed pMDI medications.
Product codes
NVP
Device Description
The InspiraChamber® is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber.
The InspiraChamber® is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use, non-sterile device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper and lower respiratory system
Indicated Patient Age Range
3 years and older
Intended User / Care Setting
Environment of use - The proposed device may be used in home, hospitals and clinical settings where patients may require the use of a holding chamber with pMDIs.
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
A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rates of 28 lpm and 12 lpm, equipped with a USP induction port throat. Aerosol was sampled directly from the outlet. A summary of the results is listed below with 95% confidence intervals.
@ 28 Ipm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
@ 12 lpm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
MDI only - 3 samples were tested with 3 drugs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing Summary
Performance Testing including Comparative:
We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated equivalent performance. This testing included:
- . Particle Characterization testing via Cascade Impactor
- 0 Adult 28 lpm
- 0 Pediatric 12 lpm
- Intra- and Inter-sample variance
- Simulated life testing
- o Pre and post- exposure
- o Cleaning
- Environmental and mechanical testing (part of Simulated Life Cycle testing)
- o High and Low temperature
- Drop test o
- Anti-static surface resistivity
- . Differential Pressure - comparative
- . Performance of Auditory alert
A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rates of 28 lpm and 12 lpm, equipped with a USP induction port throat. Aerosol was sampled directly from the outlet.
@ 28 Ipm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
@ 12 lpm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
MDI only - 3 samples were tested with 3 drugs.
Drugs used: ProAir HFA, Atrovent HFA, QVAR 40.
Key results presented in tables with 95% Confidence Intervals for:
Table 1 - Total Respirable Dose Delivered @ 28 lpm flow rate MDI vs. MDI-Spacer (0.5-5.0 microns) ug/burst.
Table 2 - Total Dose Delivered @ 28 lpm flow rate MDI vs. MDI-Spacer - ug/burst.
Table 3 – MDI – Spacer with 3 Drugs @ 28 Ipm, showing Particle Size (MMAD) (um), Geometric Standard Deviation (GSD), Total Delivered Dose by Device - ug/burst, Total Respirable Dose (0.5 - 5 um) - ug/burst, Coarse Particle Dose >4.7 microns - ug/burst, Fine Particle Dose 4.7 microns - ug/burst, Fine Particle Dose
§ 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
K 130598
JUN 0 5 2013
510(k) Summary Page 1 of 5
| Date Prepared: | 04-Jun-2013 |
|---|---|
| InspiRx, Inc. | |
| 11-D Jules Lane | |
| New Brunswick, NJ 08901 | Tel - 609-853-0295 |
| Fax - 732-246-7215 | |
| Official Contact: | Ronnie Toddywala, Ph.D., MBA |
| CEO, InspiRx, Inc. | |
| Proprietary or Trade Name: | InspiraChamber® Anti-Static Valved Holding Chamber |
| Common/Usual Name: | Spacer / Holding Chamber |
| Classification Name: | Holding Chambers, Direct Patient Interface |
| NVP - CFR 868.5630 | |
| Class II | |
| Predicate Devices: | K872037 - Trudell AeroChamber |
Device Description:
The InspiraChamber® is intended for use in the inhalation of medications delivered via an MDI and for which the medication is to be delivered to the upper and lower respiratory system. The device consists of a translucent housing and mouth piece or face mask and a one-way valve to prevent exhaling into the chamber.
The InspiraChamber® is intended to be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:
- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and B2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)
It is a single patient, multi-use, non-sterile device.
Indications for Use:
The InspiraChamber® Anti-Static Valved Holding Chamber is intended to be used by patients who are under the care or treatment of a licensed health care professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers, (pMDIs).
Environment of use - The proposed device may be used in home, hospitals and clinical settings where patients may require the use of a holding chamber with pMDIs.
The intended patient population is 3 years and older who have been prescribed pMDI medications.
1
510(k) Summary Page 2 of 5 04-Jun-2013
| Attribute | K872073 | Proposed |
|---|---|---|
| Trudell Medical AeroChamber | InspiraChamber® | |
| Intended Use | For use with pMDIs | For use with pMDIs |
| Indications for Use | Intended to be used by patients who are | |
| under the care or treatment of a licensed | ||
| health care provider or physician. The | ||
| device is intended to be used by these | ||
| patients to administer aerosolized | ||
| medication from most pressurized Metered | ||
| Dose Inhalers, prescribed by a physician or | ||
| health care professional. The intended | ||
| environments for use include the home. | ||
| hospitals and clinics. | The InspiraChamber® Anti-Static Valved | |
| Holding Chamber is intended to be used by | ||
| patients who are under the care or treatment | ||
| of a licensed health care professional. The | ||
| device is intended to be used by these | ||
| patients to administer aerosolized | ||
| medication from most pressurized Metered | ||
| Dose Inhalers, (pMDIs). | ||
| Environments of use | Home, hospitals, clinics | Home, hospitals and clinics where patients |
| may require the use of a holding chamber | ||
| with pMDIs. | ||
| Prescriptive | Yes | Yes |
| Patient population | All | The intended patient population is 3 years |
| and older who have been prescribed pMDI | ||
| medications. | ||
| Single patient, multi- | ||
| use | Yes | Yes |
| Patient interface | Mouthpiece | |
| Face Mask | Mouthpiece | |
| Face Mask | ||
| Basic components | Housing | |
| One-way valve to prevent exhalation into | ||
| chamber | ||
| End caps - removable | Housing | |
| One-way valve to prevent exhalation into | ||
| chamber | ||
| End caps - removable | ||
| Audible Signal Alert | ||
| Performance testing | Particle characterization | |
| Comparison results found to be equivalent | Particle characterization | |
| Mechanical | ||
| Environmental | ||
| Simulated life cycle (cleaning) | ||
| ISO 10993 testing | ||
| BPA levels |
Substantial Equivalence Discussion
The above table compares the key features of the proposed InspiraChamber® with the identified predicate and demonstrates that the device can be found to be substantially equivalent.
In summary one can conclude that substantial equivalence is met based upon the following:
Indications for Use -
The indications for use are nearly identical for the proposed device when compared to the predicate - K872037 - Trudell AeroChamber.
Discussion - Each device is indicated for use with pMDIs of the same category of medications.
2
510(k) Summary Page 3 of 5 04-Jun-2013
Technology and construction -
The design, fabrication, shape, size, etc. are equivalent to the predicate - K872037 - Trudell AeroChamber.
Discussion - This design incorporates a housing, end caps, one way valve for inhalation, and patient interface of a mouthpiece which is the same for the predicate
Environment of Use -
The environments of use are home, hospital and clinics.
Discussion - The environments of use are identical to the predicate K872037 - Trudell AeroChamber.
Patient Population -
The patient population of pediatrics > 3 years old is equivalent to the predicate - K872037 -Trudell AeroChamber.
Discussion - The patient populations are equivalent to the predicate K872037 - Trudell AeroChamber.
Technology and construction -
Non-clinical Testing Summary =
Materials:
.
.
We have performed ISO 10993 testing on the component materials of the InspiraChamber@ which is considered as Indirect contact (aerosol mediated) and direct (skin) contact with the patient which means the following tests are required if a material certification cannot be provided.
- . Cytotoxicity
- . Sensitization
- Intracutaneous Irritation .
- . BPA extractables - non-BPA
- . Device not manufacturer with natural rubber latex
Performance Testing including Comparative:
We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated equivalent performance. This testing included:
- . Particle Characterization testing via Cascade Impactor
- 0 Adult 28 lpm
- 0 Pediatric 12 lpm
- Intra- and Inter-sample variance ୍
- Simulated life testing
- o Pre and post- exposure
- o Cleaning
- Environmental and mechanical testing (part of Simulated Life Cycle testing)
- o High and Low temperature
- Drop test o
3
510(k) Summary Page 4 of 5
04-Jun-2013
- Anti-static surface resistivity
- . Differential Pressure - comparative
- . Performance of Auditory alert
A series of aerosol performance tests were performed using an 8 stage cascade impactor at a sampling flow rates of 28 lpm and 12 lpm, equipped with a USP induction port throat. Aerosol was sampled directly from the outlet. A summary of the results is listed below with 95% confidence intervals.
@ 28 Ipm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
@ 12 lpm - 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
MDI only - 3 samples were tested with 3 drugs.
ProAir HFA Atrovent HFA QVAR 40
Table 1 - Total Respirable Dose Delivered @ 28 lpm flow rate MDI vs. MDI-Spacer - 95% Confidence Intervals
| Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst | |||
|---|---|---|---|
| ProAir HFA | Atrovent HFA | QVAR 40 | |
| MDI only | 37.5 - 46.8 | 7.5 - 8.1 | 12.1 - 14.8 |
| MDI - Spacer | 40.9 - 59.3 | 5.3 - 7.0 | 9.4 - 11.7 |
Table 2 - Total Dose Delivered @ 28 lpm flow rate MDI vs. MDI-Spacer - 95% Confidence Intervals
| Total Dose Delivered - ug/burst | |||
|---|---|---|---|
| ProAir HFA | Atrovent HFA | QVAR 40 | |
| MDI only | 102.7-104.8 | 19.0-21.0 | 33.6-38.4 |
| MDI - Spacer | 55.0-69.4 | 11.2-13.3 | 21.4-25.3 |
4
510(k) Summary
Page 5 of 5 04-Jun-2013
.
| ProAir HFA | Atrovent HFA | Qvar 40 | |
|---|---|---|---|
| Particle Size (MMAD) (um) | 1.52-1.68 | 1.54-1.77 | 0.44-0.52 |
| Geometric Standard | |||
| Deviation (GSD) | 1.92-2.21 | 3.0-3.91 | 2.55-3.04 |
| Total Delivered Dose by | |||
| Device - ug/burst | 55.0-69.4 | 11.2-13.3 | 21.4-25.3 |
| Total Respirable Dose | |||
| (0.5 - 5 um) - ug/burst | 40.9-59.3 | 5.3-7.0 | 9.4-11.7 |
| Coarse Particle Dose |
4.7 microns - ug/burst | 6.7-9.7 | 4.2-5.2 | 0.9-1.6 |
| Fine Particle Dose
4.7 microns - ug/burst | 9.6-11.8 | 4.3-5 | 1.9-2.4 |
| Fine Particle Dose