(150 days)
Not Found
No
The 510(k) summary describes a simple mechanical spacer device for use with Metered-Dose Inhalers and makes no mention of AI or ML technology.
Yes
The device is described as a spacer for the inhalation of MDIs for therapy of the upper and lower respiratory system, administering aerosolized medication (corticosteroids, anticholinergics, ß2-sympathomimetics, non-steroidal chromones) prescribed by a physician. This indicates a therapeutic function.
No
The device is described as a spacer for administering aerosolized medication from metered-dose inhalers; it does not mention diagnosing any condition.
No
The device description explicitly states it consists of a translucent housing, a back piece, and a mouthpiece, which are physical hardware components.
Based on the provided information, the NESSI Spacer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to administer aerosolized medication from Metered-Dose Inhalers to patients for the treatment of respiratory conditions. This is a therapeutic function, not a diagnostic one.
- Device Description: The device is a spacer designed to facilitate the inhalation of medication. It does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Activities: The description does not mention any activities related to analyzing samples, detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device interacts with the respiratory system for drug delivery, not for obtaining or analyzing samples for diagnosis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NESSI Spacer does not fit this definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NVO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower respiratory system
Indicated Patient Age Range
Any individual, All
Intended User / Care Setting
Home care, nursing homes, sub-acute institutions, and hospitals. Under the care of treatment of a licensed healthcare professional or physician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K010680 - CT Spacer, K070674 – Trudell AeroChamber Plus
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
091862
510(k) Summary Page 1 of 3 14-Sep-2009
| PharmaCaribe | ||
|---|---|---|
| 1600 Mill Quarter Rd | ||
| Powhatan, VA 23139 | Tel (804) 339-4523 | |
| Fax (866) 489-2738 | 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 | |
| NVO - CFR 868.5630 | ||
| Predicate Devices: | K010680 - CT Spacer | |
| 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 |
1
| 14-Sep-2009 | K010680
Clinical Technologies
CT Spacer | K070674
Trudell Medical
AeroChamber Plus | Proposed
PharmaCaribe
NESSI | |
|------------------------------------------------|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Indications for Use | The CT Spacer is a spacer used with a
MDI or a nebulizer to deliver
inhalable drug aerosols to a patient.
The spacer is to be used by a single
patient, for a maximum of 28 days. | The AeroChamber Plus® a VHC
with Flow-Vu® IFI is intended to
be used by patients who are under
the care or treatment of a licensed
health care provider or physician.
The device is intended to be used
by these patients to administer
aerosolized medication from 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 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 |
| Environments of use | | Not specified | Home, hospitals and clinics. | Home care, nursing homes, sub-acute
institutions, and hospitals |
| Prescriptive | | Yes | Yes | Yes |
| Patient population | | Not specified | All | All |
| Single patient reusable | | Yes | Yes | Yes |
| Used with mouthpiece
or face mask | | Yes | Yes | Yes |
| Used with pressurized
metered dose inhalers | | Yes | Yes | Yes |
| Anti-static claim | | No | Yes | Yes |
:
510(k) Summary
.
Page S1.6
2
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
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows a circular seal with an eagle in the center. The eagle is facing left and has three lines above it, possibly representing feathers or wings. The text "DEPARTMENT OF HEALTH" is visible around the top of the circle, although it is somewhat blurry. The overall image quality is low, with some pixelation and blurriness.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
.
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.
:
4
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 (800) 638-2041 or (301) 796-7100 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
5
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: