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 - Home, hospitals and clinics 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.

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.

AI/ML Overview

This document describes the InspiraChamber® Anti-Static Valved Holding Chamber, a device designed to assist in the inhalation of medications delivered via Metered Dose Inhalers (MDIs). The device's performance was evaluated through non-clinical testing, primarily focusing on comparative particle characterization.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the comparison to the predicate device, K872037 - Trudell AeroChamber. The presented data demonstrates the InspiraChamber's performance in terms of aerosol characteristics, aiming for equivalence with or suitable performance compared to MDI only or the predicate.

Performance Metric	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (InspiraChamber® - 95% Confidence Intervals)	Comments
Particle Characterization (28 lpm)	Equivalent to MDI only or predicate device		Particle size and dose metrics reported for three drugs. See Tables 1, 2, 3 below.
Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (ProAir HFA)	Implied to be effective for drug delivery	40.9 - 59.3 (MDI-Spacer) vs. 37.5 - 46.8 (MDI only)	Improved or comparable respirable dose with spacer.
Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (Atrovent HFA)	Implied to be effective for drug delivery	5.3 - 7.0 (MDI-Spacer) vs. 7.5 - 8.1 (MDI only)	Slightly lower but potentially acceptable respirable dose with spacer.
Total Respirable Dose Delivered (0.5-5.0 microns) ug/burst (QVAR 40)	Implied to be effective for drug delivery	9.4 - 11.7 (MDI-Spacer) vs. 12.1 - 14.8 (MDI only)	Slightly lower but potentially acceptable respirable dose with spacer.
Total Delivered Dose - ug/burst (ProAir HFA)	Similar to MDI only or predicate device	55.0-69.4 (MDI-Spacer) vs. 102.7-104.8 (MDI only)	Expected reduction in total dose with spacer, as some drug deposits in chamber.
Total Delivered Dose - ug/burst (Atrovent HFA)	Similar to MDI only or predicate device	11.2-13.3 (MDI-Spacer) vs. 19.0-21.0 (MDI only)	Expected reduction in total dose with spacer.
Total Delivered Dose - ug/burst (QVAR 40)	Similar to MDI only or predicate device	21.4-25.3 (MDI-Spacer) vs. 33.6-38.4 (MDI only)	Expected reduction in total dose with spacer.
Particle Size (MMAD) (um) (ProAir HFA, 28lpm)	Within acceptable range for respiratory delivery	1.52-1.68	Fine particle size, suitable for lung deposition.
Particle Size (MMAD) (um) (Atrovent HFA, 28lpm)	Within acceptable range for respiratory delivery	1.54-1.77	Fine particle size, suitable for lung deposition.
Particle Size (MMAD) (um) (QVAR 40, 28lpm)	Within acceptable range for respiratory delivery	0.44-0.52	Very fine particle size, suitable for deep lung deposition.
Particle Characterization (12 lpm)	Equivalent to MDI only or predicate device		Particle size and dose metrics reported for three drugs. See Table 4 below.
Mechanical Testing	Meets relevant standards for durability	Performed as part of Simulated life cycle testing	Includes high/low temperature, drop test. Implied successful.
Environmental Testing	Meets relevant standards for environmental conditions	Performed as part of Simulated life cycle testing	Implied successful.
Simulated Life Cycle (Cleaning)	Maintains performance after repeated cleaning	Performed (Pre and post-exposure)	Implied successful.
ISO 10993 Testing (Biocompatibility)	Meets ISO 10993 for indirect contact (aerosol) and direct (skin) contact	Cytotoxicity, Sensitization, Intracutaneous Irritation. BPA extractables - non-BPA.	Implied successful, indicating biocompatibility.
Anti-static surface resistivity	Within acceptable range	Performed	Implied successful.
Differential Pressure	Comparable to predicate	Performed (comparative)	Implied successful, indicating proper valve function.
Performance of Auditory alert	Functional and effective	Performed	Implied successful.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size:
- For particle characterization at 28 lpm: 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
- For particle characterization at 12 lpm: 3 samples of the device were tested with 3 drugs, 3 times for a total of 9 sample points.
- For MDI only tests: 3 samples were tested with 3 drugs.
Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of a 510(k) submission, this is typically new data generated specifically for the submission and would be considered prospective for the purpose of demonstrating substantial equivalence. The testing was performed internally or by a contracted lab for InspiRx, Inc., a company based in New Brunswick, NJ, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of device (valved holding chamber) does not typically involve expert ground truth establishment in the same way an imaging AI device would. The "ground truth" for its performance is established through quantitative physical and chemical measurements (e.g., particle size, dose delivery) using standardized laboratory methods (e.g., cascade impaction, ISO 10993 biocompatibility tests). Therefore, there were no "experts" in the clinical sense establishing ground truth in terms of diagnoses or interpretations. The expertise lies in the certified laboratory technicians and engineers who performed the tests and analyzed the data according to established protocols.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" is based on objective laboratory measurements, not expert consensus or clinical adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical accessory (valved holding chamber) and not an AI-powered diagnostic or interpretive device that would involve human readers or an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as it is not an algorithm-based device. The device's performance is standalone in the sense that it mechanically modifies aerosol delivery.

7. The Type of Ground Truth Used

The ground truth used for this study is based on objective, quantitative laboratory measurements using established scientific and engineering methodologies, including:

Particle Characterization: Measured using an 8-stage cascade impactor according to standard protocols (e.g., those referenced in USP <601>). This provides quantitative data on particle size distribution (MMAD, GSD) and dose delivery (total dose, respirable dose).
Biocompatibility: Evaluated against ISO 10993 standards, using tests like cytotoxicity, sensitization, and intracutaneous irritation.
Mechanical and Environmental Testing: Standardized tests for durability, temperature stability, drop resistance, etc.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set" in the conventional sense. The development of the device would involve engineering design and iterative physical testing, but not data-driven training of an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an algorithm, there is no corresponding ground truth to be established for it.

Summary

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K 130598

JUN 0 5 2013

510(k) Summary Page 1 of 5

Date Prepared:	04-Jun-2013
InspiRx, Inc.11-D Jules LaneNew Brunswick, NJ 08901	Tel - 609-853-0295Fax - 732-246-7215
Official Contact:	Ronnie Toddywala, Ph.D., MBACEO, InspiRx, Inc.
Proprietary or Trade Name:	InspiraChamber® Anti-Static Valved Holding Chamber
Common/Usual Name:	Spacer / Holding Chamber
Classification Name:	Holding Chambers, Direct Patient InterfaceNVP - CFR 868.5630Class II
Predicate Devices:	K872037 - Trudell AeroChamber

Device Description:

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:

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.

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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 areunder the care or treatment of a licensedhealth care provider or physician. Thedevice is intended to be used by thesepatients to administer aerosolizedmedication from most pressurized MeteredDose Inhalers, prescribed by a physician orhealth care professional. The intendedenvironments for use include the home.hospitals and clinics.	The InspiraChamber® Anti-Static ValvedHolding Chamber is intended to be used bypatients who are under the care or treatmentof a licensed health care professional. Thedevice is intended to be used by thesepatients to administer aerosolizedmedication from most pressurized MeteredDose Inhalers, (pMDIs).
Environments of use	Home, hospitals, clinics	Home, hospitals and clinics where patientsmay require the use of a holding chamberwith pMDIs.
Prescriptive	Yes	Yes
Patient population	All	The intended patient population is 3 yearsand older who have been prescribed pMDImedications.
Single patient, multi-use	Yes	Yes
Patient interface	MouthpieceFace Mask	MouthpieceFace Mask
Basic components	HousingOne-way valve to prevent exhalation intochamberEnd caps - removable	HousingOne-way valve to prevent exhalation intochamberEnd caps - removableAudible Signal Alert
Performance testing	Particle characterizationComparison results found to be equivalent	Particle characterizationMechanicalEnvironmentalSimulated life cycle (cleaning)ISO 10993 testingBPA 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.

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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

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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 <601> 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

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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 StandardDeviation (GSD)	1.92-2.21	3.0-3.91	2.55-3.04
Total Delivered Dose byDevice - 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	45.6-62.4	6.8-8.3	20.2-23.9
Ultra-Fine Particle Dose <1.0microns - ug/burst	14.0-22.0	2.8-3.6	16.4-19.2

Table 3 – MDI – Spacer with 3 Drugs @ 28 Ipm

Table 4 - MDI - Spacer with 3 Drugs @ 12 Ipm

・

	ProAir HFA	Atrovent HFA	Qvar 40
Particle Size (MMAD) (um)	1.74-2	1.8-2.06	0.57-0.7
Geometric StandardDeviation (GSD)	2.16-2.26	2.72-3.1	2.48-2.67
Total Delivered Dose byDevice - ug / burst	49.4-55.5	11.8-13.4	16.4-20.7
Total Respirable Dose(0.5 - 5 um) - ug/burst	37.2-43.4	6.2-8.2	8.7-11.4
Coarse Particle Dose>4.7 microns - ug/burst	9.6-11.8	4.3-5	1.9-2.4
Fine Particle Dose<4.7 microns - ug/burst	38.9-44.6	6.8-9.1	14.5-18.4
Ultra-Fine Particle Dose <1.0microns - ug/burst	9.1-10.2	2.2-2.9	9.8-12.9

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 5, 2013

InspiRx, Incorporated C/O Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS, FL 34134

Re: K130598

Trade/Device Name: InspiraChamber® Anti-Static Valved Holding Chamber Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: March 5, 2013 Received: March 7, 2013

Dear Mr. Dryden:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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Page 2 - Mr. Dryden

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Kwame-Ulmer .- M.S .-Acting Division Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and -Radiological Health

Enclosure

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Indications for Use Statement

Page I of 1

510(k) Number:

K130598

Indications for Use:

Environment of use - Home, hospitals and clinics 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.

Prescription Use XX (Part 21 CFR 801 Subpart D)

Over-the-counter use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anya C. Harry	Digitally signed by Anya C. HarryDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People, cn=Anya C. Harry,0.9.2342.19200300.100.1.1=0011315590Date: 2013.06.05 08:52:51 -04'00'
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Division Sign-Off)

Division of Anesthesiology, General Hospital

Division of Infection Control, Dental Devices
510(k) Number: K130598

6598

Regulation Number and Section

§ 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).