The Fisio Chamber Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.

Environments of use - Home care, nursing homes, sub-acute institutions, and hospitals

Device Description

The Fisio Chamber Spacer 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 Fisio Chamber Spacer 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

Here's a breakdown of the acceptance criteria and study information for the Fisio Chamber Spacer, based on the provided text:

Acceptance Criteria and Device Performance

The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance against those criteria in a tabular format. The "acceptance criteria" here are implicitly defined by the performance of the predicate device, K070674 - Trudell AeroChamber Plus, particularly for particle characterization.

Implicit Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Derived from Predicate)	Reported Fisio Chamber Spacer Performance (Reported as Equivalence)
Particle Characterization	Equivalent particle characterization to K070674 - Trudell AeroChamber Plus.	Equivalent performance via Cascade Impactor testing.
Mechanical Integrity	Maintain performance after mechanical testing.	"Passed or met its performance specifications."
Environmental Stability	Maintain performance after environmental testing.	"Passed or met its performance specifications."
Simulated Life Cycle/Cleaning	Maintain performance after cleaning validation.	"Passed or met its performance specifications."
Biocompatibility	Meet ISO 10993 testing standards.	Not explicitly stated as "passed" for Fisio, but implied by overall equivalence claim for a similar device. The predicate device (K010680 - CT Spacer) also undergoes ISO 10993 testing.

Study Information

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in the provided text. The comparative particle characterization testing was performed, but the number of devices or measurements is not mentioned.
Data Provenance: The document does not specify the country of origin of the data. The study was conducted by the manufacturer, Koo (Shanghai) Industries Co., Ltd. The study appears to be a prospective test specifically designed to compare the Fisio Chamber Spacer against the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a medical device (spacer/holding chamber), not a diagnostic algorithm requiring expert-established ground truth from images or other complex data. The performance evaluation is based on objective physical and functional characteristics (e.g., particle size distribution, mechanical integrity).

4. Adjudication method for the test set:

Not applicable. See point 3.

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:

No. This is a physical medical device, not an AI or imaging-based diagnostic tool that would involve human readers or AI assistance.

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

No. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for comparative performance, particularly for particle characterization, was the established, measured performance of the predicate device (K070674 - Trudell AeroChamber Plus), specifically its particle characterization via Cascade Impactor. For other tests (mechanical, environmental, cleaning), the "ground truth" was likely predefined performance specifications that the device needed to pass.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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Premarket Notification 510(k) Section 5 - 510(k) Summary

ﺎ

510(k) Summary Page 1 of 3 20-Apr-2010

JAN 2 8 2011

KOO (Shanghai) Industries Co., Ltd.			510(k) K010680Clinical TechnologiesCT Spacer	K070674Trudell MedicalAeroChamber Plus	ProposedKoo Spacer
100 Zhongde Road, Dakun Industrial Park			For use with MDIs	For use with MDIs	For use with MDIs
Songjiang Shanghai 201614 China			The CT Spacer is a spacer used with aMDI or a nebulizer to deliver inhalabledrug aerosols to a patient. The spacer isto be used by a single patient, for amaximum of 28 days.	The AeroChamber Plus® a VHC with Flow-Vu® IFIis intended to be used by patients who are under thecare or treatment of a licensed health care provideror physician. The device is intended to be used bythese patients to administer aerosolized medicationfrom 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 Fisio Chamber Spacer is intended to beused by patients who are under the care oftreatment of a licensed healthcareprofessional or physician. The device isintended to be used by these patients toadminister aerosolized medication frompressurized Metered-Dose Inhalers,prescribed by a physician or healthcareprofessional
Official Contact:	Chris Koo - President		Not specified	Home, hospitals and clinics.	Home care, nursing homes, sub-acuteinstitutions, and hospitals
Proprietary or Trade Name:	Fisio Chamber Spacer		Yes	Yes	Yes
Common/Usual Name:	Spacer / Holding Chamber		Not specified	All	All
Classification Name:	Holding Chambers, Direct Patient InterfaceNVP - CFR 868.5630		Yes	Yes	Yes
Predicate Devices:	K010680 – CT SpacerK070674 – Trudell AeroChamber Plus		MouthpieceFace Mask	MouthpieceFace Mask	MouthpieceFace Mask
	T – 011 86 21 57858410		Housing	Housing	Housing
	F – 011 86 21 57858410 x.107		One-way valve to prevent exhalation intochamber	One-way valve to prevent exhalation into chamber	One-way valve to prevent exhalation intochamber
	End caps - removable	End caps - removable	End caps - removable
		Particle characterizationComparison results found to be equivalent	Particle characterizationMechanicalEnvironmentalSimulated life cycle (cleaning)ISO 10993 testing

Device Description:

The Fisio Chamber Spacer 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:

Patient Population:	Any individual
Environment of Use:	Home care, nursing homes, sub-acute institutions, and hospitals
Contraindications:	None

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Premarket Notification 510()
Section 5 – 510(k) Summary

Fisio Spacer

510(k) Summary

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510(k) Summary Page 3 of 3 20-Apr-2010

Substantial Equivalence Discussion

The above table compares the key features of the proposed Fisio Chamber Spacer with the identified predicates 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 form the proposed device when compared to the predicates - K010680 - CT Spacer and K070674 - Trudell AeroChamber Plus.

Each device is indicated for use with MDIs of the same category of medications.

Technology and construction -

The design, fabrication, shape, size, etc. are equivalent to the predicate - K010680 - CT Spacer. This design incorporates a housing, end caps, one way valve for inhalation, patient interface of either a mouthpiece or face mask.

Environment of Use -

The environments of use are identical to predicate - K070674 - Trudell AcroChamber Plus.

Patient Population -

The patient population is equivalent to the predicate - K070674 - Trudell AeroChamber Plus.

Comparative Performance -

We performed comparative particle characterization testing via Cascade Impactor and the results demonstrated equivalent performance to the predicate K070674 - Trudell AeroChamber Plus.

In addition, we performed testing related to simulation life / cleaning validation, environmental and mechanical testing. The results demonstrated that the proposed device either passed or met its performance specifications after each test

All testing demonstrated that the proposed device is substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol on the right side. The symbol consists of three stylized, curved lines that resemble a human form or a stylized representation of health and well-being.

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

Koo (Shanghai) Industries Company, Limited C/O Mr. Paul Dryden Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134

JAN 2 8 201

Re: K101136

Trade/Device Name: Fisio Chamber Spacer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVP Dated: January 5, 2011 Received: January 10, 2011

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, listing 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.

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Page 2- Mr. Dryden

Enclosure

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); 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony v. m

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

Page 1 of 1

510(k) Number: K101136

Device Name:

Fisio Chamber Spacer

Indications for Use:

Environments of use - Home care, nursing homes, sub-acute institutions, and hospitals

Prescription Use XX (Part 21 CFR 801 Subpart D) or

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)

L. Shulthe

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Antonio, Dental Devices

510(k) Number: K101136

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).