NESSI SPACER

K091862 · Pharmacaribe · NVO · Nov 20, 2009 · Anesthesiology

Device Facts

• Record ID: K091862
• Device Name: NESSI SPACER
• Applicant: Pharmacaribe
• Product Code: NVO · Anesthesiology
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NESSI 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.

Device Story

NESSI Spacer is a holding chamber for pressurized Metered-Dose Inhalers (MDIs); facilitates inhalation of aerosolized drugs including corticosteroids, anti-cholinergics, ß2-sympathomimetics, and non-steroidal chromones. Device comprises translucent housing, back piece, and mouthpiece. Used in home care, nursing homes, sub-acute institutions, and hospitals. Operated by patients under physician supervision. Acts as interface between MDI and patient to improve aerosol delivery. Single-patient, multi-use design.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological comparison and biocompatibility testing (ISO 10993).

Technological Characteristics

Holding chamber/spacer for MDIs. Materials identical to K082092. Features anti-static properties. Single-patient, multi-use. Compatible with mouthpiece or face mask. No electronic components or software.

Indications for Use

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

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 AeroChamber Plus (K070674)

Reference Devices

• K082092

Submission Summary (Full Text)

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# 091862

510(k) Summary Page 1 of 3 14-Sep-2009

| PharmaCaribe | | |
|--------------------------------------------|------------------------------------------------------------------|-------------|
| 1600 Mill Quarter Rd<br>Powhatan, VA 23139 | Tel [phone]<br>Fax [phone] | NOV 20 2005 |
| Official Contact: | Werner Gutmann COO | |
| Proprietary or Trade Name: | NESSI Spacer | |
| Common/Usual Name: | Spacer / Holding Chamber | |
| Classification Name: | Holding Chambers, Direct Patient Interface<br>NVO - CFR 868.5630 | |
| Predicate Devices: | K010680 - CT Spacer<br>K070674 – Trudell AeroChamber Plus | |

#### Device Description:

The NESSI is a spacer intended for use in the inhalation of MDIs for the therapy of the upper and lower respiratory system. The device consists of a translucent housing a back piece and mouth piece.

The NESSI Spacer can be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:

- · Corticosteroids (anti-inflammatory medications)
- · Anti-cholinergics and ß2-sympathomimetics (bronchodilater medications)
- · Non-steroidal chromones (DNCG)

It is a single patient, multi-use device.

### Indications for Use:

The NESSI 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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| 14-Sep-2009 | K010680<br>Clinical Technologies<br>CT Spacer | K070674<br>Trudell Medical<br>AeroChamber Plus | Proposed<br>PharmaCaribe<br>NESSI | |
|------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Indications for Use | The CT Spacer is a spacer used with a<br>MDI or a nebulizer to deliver<br>inhalable drug aerosols to a patient.<br>The spacer is to be used by a single<br>patient, for a maximum of 28 days. | The AeroChamber Plus® a VHC<br>with Flow-Vu® IFI is intended to<br>be used by patients who are under<br>the care or treatment of a licensed<br>health care provider or physician.<br>The device is intended to be used<br>by these patients to administer<br>aerosolized medication from most<br>pressurized Metered Dose<br>Inhalers, prescribed by a physician<br>or health care professional. The<br>intended environments for use<br>include the home, hospitals and<br>clinics. | The NESSI Spacer is intended to be used<br>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 |
| Environments of use | | Not specified | Home, hospitals and clinics. | Home care, nursing homes, sub-acute<br>institutions, and hospitals |
| Prescriptive | | Yes | Yes | Yes |
| Patient population | | Not specified | All | All |
| Single patient reusable | | Yes | Yes | Yes |
| Used with mouthpiece<br>or face mask | | Yes | Yes | Yes |
| Used with pressurized<br>metered dose inhalers | | Yes | Yes | Yes |
| Anti-static claim | | No | Yes | Yes |

:

510(k) Summary

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Page S1.6

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## 510(k) Summary Page 3 of 3 14-Sep-2009

The NESSI Spacer is viewed as substantially equivalent to the predicate devices because:

### Indications -

Similar to predicates - K010680 - CT Spacer and K070674 - Trudell AeroChamber Plus

### Technology -

Similar to predicate - K010680 - CT Spacer

### Materials -

The materials used are identical to those used in 510(k) K082092, with the identical exposure characteristics and we have provided ISO 10993 testing as well.

#### Environment of Use -

Identical to K070674 – Trudell AeroChamber Plus

### Patient Population -

Similar to K070674 - Trudell AeroChamber Plus

### Differences -

The NESSI Spacer is viewed as substantially equivalent to the following predicate devices -K010680 - CT Spacer and K070674 - Trudell AeroChamber Plus.

There are no significant differences that affect the safety or effectiveness of the intended device when compared to the predicate devices.

し

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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 Room -WO66-0609 Silver Spring, MD 20993-0002

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PharmaCaribe C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958

NOV 2 0 2009

Re: K091862

Trade/Device Name: NESSI Spacer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVO Dated: November 12, 2009 Received: November 16, 2009

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.

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

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 l'abeling 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.

Wh for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, 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 1 of 1

510(k) Number: K091862 (To be assigned)

Device Name: NESSI Spacer

Indications for Use:

The NESSI 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.

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. Schultheis

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

4091862 510(k) Number: