FISIO CHAMBER SPACE

K101136 · Koo (Shanghai) Industries Co., Ltd. · NVP · Jan 28, 2011 · Anesthesiology

Device Facts

• Record ID: K101136
• Device Name: FISIO CHAMBER SPACE
• Applicant: Koo (Shanghai) Industries Co., Ltd.
• Product Code: NVP · Anesthesiology
• Decision Date: Jan 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Fisio Chamber Spacer is a holding chamber for use with pressurized Metered-Dose Inhalers (MDIs). Device consists of a translucent housing, removable end caps, and a one-way valve to prevent exhalation into the chamber; patient interface options include a mouthpiece or face mask. Used in home care, nursing homes, sub-acute institutions, and hospitals by patients under physician care. Device facilitates delivery of aerosolized corticosteroids, anti-cholinergics, B2-sympathomimetics, and non-steroidal chromones to the respiratory system. Patient inhales medication through the chamber; one-way valve ensures unidirectional flow. Benefits include improved aerosol delivery efficiency compared to MDI alone. Device is single-patient, multi-use, and non-sterile.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including comparative particle characterization via cascade impactor, mechanical testing, environmental testing, and simulated life-cycle/cleaning validation. Results demonstrated performance equivalent to the predicate device.

Technological Characteristics

Non-sterile, single-patient, multi-use holding chamber. Components: translucent housing, removable end caps, one-way inhalation valve, mouthpiece or face mask interface. Materials and design equivalent to K010680. No energy source. Manual operation.

Indications for Use

Indicated for any individual under the care of a licensed healthcare professional or physician requiring administration of aerosolized medication from pressurized Metered-Dose Inhalers (MDIs). No contraindications stated.

Regulatory Classification

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.

Predicate Devices

• CT Spacer (K010680)
• Trudell Medical AeroChamber Plus (K070674)

Submission Summary (Full Text)

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

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

JAN 2 8 2011

| KOO (Shanghai) Industries Co., Ltd. | | | 510(k) K010680<br>Clinical Technologies<br>CT Spacer | K070674<br>Trudell Medical<br>AeroChamber Plus | Proposed<br>Koo 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 a<br>MDI or a nebulizer to deliver inhalable<br>drug aerosols to a patient. The spacer is<br>to be used by a single patient, for a<br>maximum of 28 days. | The AeroChamber Plus® a VHC with Flow-Vu® IFI<br>is intended to be used by patients who are under the<br>care or treatment of a licensed health care provider<br>or physician. The device is intended to be used by<br>these patients to administer aerosolized medication<br>from most pressurized Metered Dose Inhalers,<br>prescribed by a physician or health care professional.<br>The intended environments for use include the home,<br>hospitals and clinics. | The Fisio Chamber Spacer is intended to be<br>used by patients who are under the care of<br>treatment of a licensed healthcare<br>professional or physician. The device is<br>intended to be used by these patients to<br>administer aerosolized medication from<br>pressurized Metered-Dose Inhalers,<br>prescribed by a physician or healthcare<br>professional |
| Official Contact: | Chris Koo - President | | Not specified | Home, hospitals and clinics. | Home care, nursing homes, sub-acute<br>institutions, 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 Interface<br>NVP - CFR 868.5630 | | Yes | Yes | Yes |
| Predicate Devices: | K010680 – CT Spacer<br>K070674 – Trudell AeroChamber Plus | | Mouthpiece<br>Face Mask | Mouthpiece<br>Face Mask | Mouthpiece<br>Face Mask |
| | T – 011 86 21 57858410 | | Housing | Housing | Housing |
| | F – 011 86 21 57858410 x.107 | | One-way valve to prevent exhalation into<br>chamber | One-way valve to prevent exhalation into chamber | One-way valve to prevent exhalation into<br>chamber |
| | End caps - removable | End caps - removable | End caps - removable | | |
| | | Particle characterization<br>Comparison results found to be equivalent | Particle characterization<br>Mechanical<br>Environmental<br>Simulated life cycle (cleaning)<br>ISO 10993 testing | | |

### 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.

### Indications for Use:

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

| 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 [phone] or [phone] 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:

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

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