(90 days)
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.
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.
This 510(k) summary describes the NESSI OTC Spacer, intended for use with over-the-counter (OTC) Metered-Dose Inhalers (MDIs) like bronchodilators/epinephrine. The device is being compared to a predicate PharmaCaribe NESSI Rx Spacer (K091862) and a Primatene Mist OTC MDI.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document doesn't explicitly state numerical "acceptance criteria" for the NESSI OTC Spacer in terms of specific performance metrics like particle size distribution targets or usability scores. Instead, it frames the performance evaluation as demonstrating "equivalence" to predicate devices and appropriateness for OTC use.
Therefore, the table below will summarize the types of performance testing conducted and their general reported findings, rather than specific numerical criteria and results.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Particle Characterization: Equivalent particle delivery to a predicate spacer, or that any differences do not raise new safety/efficacy issues. | Particle Characterization: "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." (Compared to MDI with and without spacer.) |
| Usability: Instructions for use are clear and users can effectively utilize the spacer for OTC designation. | Usability Study: "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: Indication for Use, Technology, Materials, Environment of Use, and Patient Population are similar or identical to predicate devices. | 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" |
2. Sample size used for the test set and the data provenance
- Particle Characterization (Test Set): The document does not specify the sample size used for the Anderson Cascade Impactor testing. It also doesn't provide information about the data provenance (e.g., country of origin, retrospective/prospective).
- Usability Study (Test Set): The document does not specify the sample size used for the Usability study or the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document describes technical and usability testing, but not a process that would involve medical experts establishing a "ground truth" in the way it might for a diagnostic imaging device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. The performance tests described (particle characterization, usability) are not typically assessed using adjudication methods like 2+1 or 3+1, which are common in clinical trial settings for expert review of images or data.
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
This information is not applicable. The NESSI OTC Spacer is a medical device (spacer/holding chamber) designed to aid in the delivery of aerosolized medication, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance would not be relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The NESSI OTC Spacer is a physical medical device, not an algorithm, and does not operate in a "standalone" algorithmic capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Particle Characterization: The "ground truth" implicitly refers to established scientific methods for measuring particle size distribution (Anderson Cascade Impactor) and comparative data from predicate devices or MDIs. It's based on physical measurements and engineering principles.
- For Usability Study: The "ground truth" for usability would be derived from structured observations and feedback from users interacting with the device and its instructions, assessing their ability to correctly and effectively use the product as instructed. This doesn't typically involve expert medical consensus or pathology in the same way as a diagnostic tool.
8. The sample size for the training set
This information is not applicable/provided. This device is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
This information is not applicable. As it's not an AI/machine learning device, there is no training set or associated ground truth establishment process in that context.
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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
1
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 (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 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
2
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
| PharmaCaribe3513 Di Leuca St.Punta Gorda, FL 33950 | Tel - (941) 505-0793Fax - (941) 505-0718 |
|---|---|
| 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 InterfaceNVO - CFR 868.5630 |
| Predicate Devices: | K091862 - PharmaCaribe NESSI (Rx) SpacerPrimatene 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) K091862PharmaCaribeNESSI Rx Spacer | Primatene MistOTC MDI | ProposedPharmaCaribeNESSI OTC Spacer |
|---|---|---|---|
| Indications for Use | The NESSI Spacer is intended to be usedby 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. | MDI for use with asthma patients as abronchodilator with epinephrine as theactive ingredient | The NESSI OTC Spacer is intended to beused to administer aerosolized medicationfrom pressurized Metered-Dose Inhalers,which are over-the-counter (OTC), e.g.,bronchodilator / epinephrine. |
| Environments of use | Home care, nursing homes, sub-acuteinstitutions, and hospitals | Home, hospitals and clinics. | Home care, nursing homes, sub-acuteinstitutions, and hospitals |
| Prescriptive | Yes | No - OTC | No - OTC |
| Patient population | All | All | All |
| Single patient reusable | Yes | N/A | Yes |
| Used with mouthpiece orface mask | Yes | Mouthpiece only | Yes |
| Used with pressurizedmetered dose inhalers | Yes | N/A | Yes |
| Materials Commonmaterials in contact withgas and fluid pathway | Yes | N/A | Identical to K091862 |
| Performance testing | Particle characterization | Particle characterization | Particle characterization, compared to MDIwith 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
§ 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).