The PocketSpacer is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized MDI canisters with the associated activator elbow. The spacer device is indicated to assist in the treatment of patients with lung disease such as, but not limited to, asthma, emphysema, chronic bronchitis, and cystic fibrosis.

Device Description

The PocketSpacer is a cylindrical tube, approximately 10 cm long by 4.5 cm wide, and accepts the MDI manufacturer's mouthpiece. The MDI receptacle has an orifice of size and shape similar to the MDI mouthpiece. The device is designed to prevent off-center actuations. An open mesh with varying size circular orifices, but no valve, is in the round mouthpiece. The mesh with concentrically placed circular orifices removes the throat dose by permitting only respirable particles to be inhaled by the user.

AI/ML Overview

Here's an analysis of the provided text regarding the PocketSpacer device, focusing on acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for the PocketSpacer. Instead, it relies on a comparison to a predicate device (MicroChamber) and general performance improvements over MDI alone. The acceptance is implicitly based on the device performing "comparably" to the predicate for key metrics and "finer, more highly respirable aerosols" than MDI alone.

Acceptance Criteria (Implicit)	Reported Device Performance (PocketSpacer)
Comparable Total Dose	Performed comparably to MicroChamber
Comparable Respirable Dose	Performed comparably to MicroChamber
Comparable Mass Median Aerodynamic Diameter (MMAD)	Performed comparably to MicroChamber
Finer, More Highly Respirable Aerosols than MDI alone	Provided finer, more highly respirable aerosols compared to MDIs alone

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): The document states "four categories of drugs" were tested. It does not specify the number of individual tests, devices, or MDI actuations performed for each drug category.
Data Provenance: Not explicitly stated. However, given that Ferraris Medical Inc. is a US company and the submission is to the US FDA, it's highly probable the testing was conducted within the United States. The study appears to be prospective as it's a performance test for a new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device and study. The "ground truth" here is objective physical measurements (total dose, respirable dose, MMAD) obtained through a standardized laboratory test (Cascade Impactor Test), not expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable for this type of performance study. Adjudication methods like 2+1 or 3+1 are used for expert consensus in cases where subjective interpretation is involved (e.g., grading medical images). Here, the results are derived from objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted. This type of study involves multiple human readers interpreting cases, often with and without AI assistance, to assess the impact of AI on reader performance. The PocketSpacer is a physical medical device, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, a "standalone" performance test was done, although it's crucial to understand the context. The "Performance Data" section describes a laboratory test (Cascade Impactor Test) that directly measured the device's physical performance (total dose, respirable dose, MMAD) when used with MDIs. This is a standalone assessment of the device's physical capabilities, independent of human interaction beyond operating the test equipment.

7. The Type of Ground Truth Used

The "ground truth" was established by objective, quantitative laboratory measurements using the Cascade Impactor Test. These measurements directly assess the physical properties of the aerosol produced (total dose, respirable dose, mass median aerodynamic diameter).

8. The Sample Size for the Training Set

This information is not applicable as the PocketSpacer is a physical medical device, not an AI algorithm that requires a training set. The "training" for such devices involves engineering design, prototyping, and manufacturing process development.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" in the context of an AI algorithm. For a physical device, the equivalent would be the R&D and engineering processes, where design specifications and performance targets are set, and verified through various tests and simulations to ensure the device performs as intended.

Summary

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SEP d 1999

510(k) SUMMARY

Ferraris Medical Inc. PocketSpacer

Submitter's Name. Address. Telephone Number. Contact Person and Date Prepared

Mr. David R. Malys President Ferraris Medical Inc. 9681 Wagner Road Post Office Box 344 Holland. New York 14080 Jonathan S. Kahan. Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-1109 Telephone: (202) 637-5794 Facsimile: (202) 637-5910

Date Prepared:

June 16, 1999

Name of Device and Name/Address of Sponsor

Ferraris Medical Inc. PocketSpacer

Mr. David R. Malys President Ferraris Medical Inc. 9681 Wagner Road Post Office Box 344 Holland, New York 14080

Common or Usual Name Spacer; Aerosol Holding Chamber

Classification Name Accessory to a Nebulizer

Predicate Devices

Respiratory Delivery System's MicroChamber

Intended Use

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Technological Characteristics and Substantial Equivalence

Performance Data

Ferraris performed the Cascade Impactor Test comparing the PocketSpacer with the MicroChamber and an MDI actuator without a spacer device for four categories of drugs. The PocketSpacer performed comparably to the MicroChamber in terms of total dose, respirable dose, and mass median aerodynamic diameter. In addition, the PocketSpacer device with a commercial MDI provided finer, more highly respirable aerosols compared to the aerosols generated with the MDIs alone.

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DEPARTMENT OF HEALTH & HUMAN SERVICES.USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP g 1999

Mr. Jonathan S. Kahan Ferraris Medical, Inc. c/o Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, DC 20004-5600

Re: K992038 PocketSpacer Metered Dose Inhaler Spacer Requlatory Class: II (two) 73 CAF Product Code: Dated: June 16, 1999 Received: June 16, 1999

Dear Mr. Kahan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jonathan S. Kahan

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callehan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ferraris Medical Inc.'s PocketSpacer Device Name:

Indications for Use:

1992038

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovas and Neurological De 510(k) Numbe

Prescription Use
(Per 21 C.F.R. 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

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).