NESSI OTC SPACER

K101532 · Pharmacaribe · NVO · Sep 1, 2010 · Anesthesiology

Device Facts

• Record ID: K101532
• Device Name: NESSI OTC SPACER
• Applicant: Pharmacaribe
• Product Code: NVO · Anesthesiology
• Decision Date: Sep 1, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.

Device Story

NESSI OTC Spacer is a holding chamber device designed to facilitate the delivery of aerosolized medication from pressurized Metered-Dose Inhalers (MDIs). The device consists of a translucent housing, a back piece, and either a mouthpiece or a face mask. It is intended for single-patient, multi-use. The device is used in home care, nursing homes, sub-acute institutions, and hospitals by patients or caregivers. By acting as a spacer between the MDI and the patient, it helps optimize the delivery of medication, potentially improving inhalation efficiency for the user. The device is operated manually by the user or caregiver.

Clinical Evidence

Bench testing only. Particle characterization was performed using an Anderson Cascade Impactor to compare performance with and without the spacer. A usability study was conducted to demonstrate that the instructions for use and user ability to operate the spacer are appropriate for an OTC designation.

Technological Characteristics

Translucent housing, back piece, and mouthpiece or face mask. Single-patient, multi-use. Materials are identical to predicate K091862. Mechanical spacer/holding chamber; no energy source or software.

Indications for Use

Indicated for any individual requiring administration of aerosolized medication from over-the-counter (OTC) pressurized Metered-Dose Inhalers (e.g., bronchodilators/epinephrine). 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

• PharmaCaribe NESSI (Rx) Spacer (K091862)
• Primatene Mist – OTC MDI

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare. The emblem is positioned to the right of the department's name, which is written in a circular arrangement around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".

#### Public Health Service

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

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Pharmacare C/O Mr. Paul Dryden Promedic 24301 Woodsage Drive Bonita Springs, Florida 34134

Re: K101532

Trade/Device Name: NESSI OTC Spacer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: NVO Dated: June 1, 2010 Received: June 3, 2010

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

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 (OS) 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 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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Enclosure

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14101532

## Indications for Use Statement

510(k) Number:

(To be assigned)

Device Name:

NESSI OTC Spacer

'SEP 0 1 2010

Indications for Use:

The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.

Prescription Use (Part 21 CFR 801 Subpart D) or

Over-the-counter use XX (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. Shulthis

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

510(k) Number: `K 101532

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# 510(k) Summary Page 1 of 3 01-Jun-2010

| PharmaCaribe<br>3513 Di Leuca St.<br>Punta Gorda, FL 33950 | Tel - [phone]<br>Fax - [phone] |
|------------------------------------------------------------|----------------------------------------------------------------------|
| Official Contact: | W. Randolph Warner - Managing Member |
| Proprietary or Trade Name: | NESSI OTC Spacer |
| Common/Usual Name: | Spacer / Holding Chamber |
| Classification Name: | Holding Chambers, Direct Patient Interface<br>NVO - CFR 868.5630 |
| Predicate Devices: | K091862 - PharmaCaribe NESSI (Rx) Spacer<br>Primatene Mist – OTC MDI |

## Device Description:

The NESSI is a spacer intended for use in the inhalations which are provided by OTC MDIs. The device consists of a translucent housing a back piece and mouth piece or face mask.

It is a single patient, multi-use device.

## Indications for Use:

The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.

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

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510(k) Summary

| Attribute | 510(k) K091862<br>PharmaCaribe<br>NESSI Rx Spacer | Primatene Mist<br>OTC MDI | Proposed<br>PharmaCaribe<br>NESSI OTC Spacer |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | 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. | MDI for use with asthma patients as a<br>bronchodilator with epinephrine as the<br>active ingredient | The NESSI OTC Spacer is intended to be<br>used to administer aerosolized medication<br>from pressurized Metered-Dose Inhalers,<br>which are over-the-counter (OTC), e.g.,<br>bronchodilator / epinephrine. |
| Environments of use | Home care, nursing homes, sub-acute<br>institutions, and hospitals | Home, hospitals and clinics. | Home care, nursing homes, sub-acute<br>institutions, and hospitals |
| Prescriptive | Yes | No - OTC | No - OTC |
| Patient population | All | All | All |
| Single patient reusable | Yes | N/A | Yes |
| Used with mouthpiece or<br>face mask | Yes | Mouthpiece only | Yes |
| Used with pressurized<br>metered dose inhalers | Yes | N/A | Yes |
| Materials Common<br>materials in contact with<br>gas and fluid pathway | Yes | N/A | Identical to K091862 |
| Performance testing | Particle characterization | Particle characterization | Particle characterization, compared to MDI<br>with and without spacer plus Usability Study |

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## 510(k) Summary Page 3 of 3 01-Jun-2010

## Performance Testing:

The NESSI OTC spacer was testing via Anderson Cascade Impactor testing for particle characterization and found to be equivalent and any differences did not raise any new safety or efficacy issues.

In addition a Usability study was performed to demonstrate that the instructions for use and ability of users to utilize the spacer were found to be appropriate for OTC designation.

## Substantial Equivalence:

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

### Indications -

Similar to predicates - K091862 – PharmaCaribe NESSI Rx spacer but for use with OTC MDIs, i.e., Primatene Mist a bronchodilator / epinephrine which is sold OTC.

### Technology -

Identical to predicate - K091862 - PharmaCaribe NESSI Rx spacer

## Materials –

Identical to predicate - K091862 - PharmaCaribe NESSI Rx spacer

## Environment of Use -

Identical to predicate – K091862 – PharmaCaribe NESSI Rx spacer

## Patient Population -

Identical to predicates – K091862 – PharmaCaribe NESSI Rx spacer and Primatene Mist OTC MDI