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 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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the NESSI Spacer, which is a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies to prove acceptance criteria in the same way a PMA (Premarket Approval) would. Therefore, the information requested regarding a "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement, or details on training/test sets, ground truth, and expert adjudication, is largely not applicable or present in this type of document.

A 510(k) focuses on demonstrating that the new device is as safe and effective as a predicate device through comparison of indications for use, technological characteristics, materials, and other attributes.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally based on demonstrating "substantial equivalence" of the new device's attributes to those of predicate devices. The "reported device performance" is a comparison to the predicate devices.

Attribute/Acceptance Criteria (Similarity to Predicates)	NESSI Spacer Performance (Compared to Predicates)
Indications for Use:	Similar to K010680 (CT Spacer) and K070674 (Trudell AeroChamber Plus)
Technology:	Similar to K010680 (CT Spacer)
Materials:	Identical to those used in 510(k) K082092, with identical exposure characteristics. ISO 10993 testing provided for biocompatibility.
Environment of Use:	Identical to K070674 (Trudell AeroChamber Plus)
Patient Population:	Similar to K070674 (Trudell AeroChamber Plus)
Safety/Effectiveness Differences:	No significant differences that affect the safety or effectiveness of the intended device when compared to predicate devices.
Anti-static claim:	Yes (Similar to K070674 - Trudell AeroChamber Plus, which also has an anti-static claim; K010680 does not)
Other shared attributes:	Used with mouthpiece or face mask (Yes), Used with pressurized metered dose inhalers (Yes), Single patient reusable (Yes), Prescriptive (Yes - all predicates are)

Note: The "acceptance criteria" here are inherently tied to satisfying the substantial equivalence requirements by closely matching or being demonstrably as safe and effective as the predicates.

Regarding items 2-9 from your request:

The provided document does not contain information typically associated with a study proving clinical performance using specific metrics, test sets, ground truth establishment, or expert adjudication, as would be expected for a device requiring higher levels of clinical evidence. This is because the NESSI Spacer is a Class II device seeking 510(k) clearance based on substantial equivalence to existing predicate devices. The review focuses on comparing the new device's characteristics to the predicates, as detailed in the table above, not on a new clinical efficacy study with performance metrics in the way your questions imply for AI/software devices.

Therefore, the following points are not applicable (NA) or not provided in this 510(k) submission:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* NA: No clinical performance study with a test set of data is detailed. The substantial equivalence is based on device characteristics, materials, and indications, not a data-driven performance test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* NA: No test set or ground truth established by experts is mentioned for performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
* NA: No test set or adjudication method mentioned.

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
* NA: This is not an AI/software device, and no MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* NA: This is a physical medical device (spacer), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
* NA: No ground truth in the context of clinical performance evaluation is used. The "ground truth" for this submission is that the predicate devices are legally marketed and considered safe and effective for their intended use.

8. The sample size for the training set
* NA: No training set mentioned.

9. How the ground truth for the training set was established
* NA: No training set or ground truth mentioned.

Summary Rationale:

The NESSI Spacer received 510(k) clearance (K091862) based on demonstrating substantial equivalence to predicate devices (K010680 - CT Spacer and K070674 - Trudell AeroChamber Plus). This process generally involves comparing product descriptions, indications for use, technological characteristics, materials, and other non-clinical factors. For devices like this spacer, extensive new clinical performance studies with metrics, test sets, and expert adjudication (as typically required for AI/software or novel high-risk devices) are usually not part of the 510(k) submission. Therefore, the specific types of "acceptance criteria" and "study" details requested are not relevant or present in this document for this type of device and regulatory pathway.

Summary

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091862

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

PharmaCaribe
1600 Mill Quarter RdPowhatan, VA 23139	Tel (804) 339-4523Fax (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 InterfaceNVO - CFR 868.5630
Predicate Devices:	K010680 - CT SpacerK070674 – 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:

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	K010680Clinical TechnologiesCT Spacer	K070674Trudell MedicalAeroChamber Plus	ProposedPharmaCaribeNESSI
Attribute	Indications for Use	The CT Spacer is a spacer used with aMDI or a nebulizer to deliverinhalable drug aerosols to a patient.The spacer is to be used by a singlepatient, for a maximum of 28 days.	The AeroChamber Plus® a VHCwith Flow-Vu® IFI is intended tobe used by patients who are underthe care or treatment of a licensedhealth care provider or physician.The device is intended to be usedby these patients to administeraerosolized medication from mostpressurized Metered DoseInhalers, prescribed by a physicianor health care professional. Theintended environments for useinclude the home, hospitals andclinics.	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
Environments of use		Not specified	Home, hospitals and clinics.	Home care, nursing homes, sub-acuteinstitutions, and hospitals
Prescriptive		Yes	Yes	Yes
Patient population		Not specified	All	All
Single patient reusable		Yes	Yes	Yes
Used with mouthpieceor face mask		Yes	Yes	Yes
Used with pressurizedmetered dose inhalers		Yes	Yes	Yes
Anti-static claim		No	Yes	Yes

510(k) Summary

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

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 (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

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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:

Prescription Use XX (Part 21 CFR 801 Subpart D)

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:

Regulation Number and Section

§ 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).