The LeverHaler Spacer is a spacer device that is designed to effectively deliver respirable medical aerosols produced by most MDI's to a patient during inhalation. This product is intended for use in the treatment of lung disease. The device has been designed for use by all patients who have been prescribed MDI treatment by their physician. It is intended for use in both the hospital and homecare environments.

Device Description

The LeverHaler Spacer (Spacer) is an injection molded polycarbonate spacer device intended for use with FDA approved metered dose inhalers (MDI's). The MDI canister fits through a slot in a lever located on the top of the spacer. Activation of the MDI canister can be done by manually pressing down on the MDI (typical activation), or the MDI may be actuated by depressing the Lever Actuator down towards the top of the spacer body. The device is made from polycarbonate injection molded plastic and is designed to be used with FDA approved MDI drugs for treatment of lung disease. When not in use, up to two MDI canisters can be stored inside of the LeverHaler Chamber. The product is sold non-sterile, and is a single-patient device intended to be used for up to one year. This device does not generate aerosols. Its purpose is to provide an effective mixing chamber for the aerosols produced by a metered dose inhaler to assure proper concentration for inhalation by the patient. This is a prescription device. The device has no detection capabilities. It is mechanical and has no alarm functions or capabilities. There is no software integrated or used in conjunction with this device.

AI/ML Overview

The provided document describes a medical device, the Birdsong Medical LeverHaler Spacer, which is not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies proving the device meets those criteria, as typically applied due to AI/ML devices, are not directly applicable in their entirety.

However, I can extract information related to the device's performance, testing, and basis for market clearance, reinterpreting the provided headings to fit the context of this traditional medical device.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, "acceptance criteria" are implied by the performance characteristics of predicate devices and the regulatory guidance. The reported performance aimed for equivalence or superiority to the predicate devices.

Characteristic	Acceptance Criteria (Implied by Predicate & Guidance)	Reported Device Performance (LeverHaler Spacer)
Particle size distribution	Comparable to predicate devices	Met design requirements; comparable or superior to predicate devices (OptiHaler, AeroChamber)
Dose output (quantity & total mass)	Comparable to predicate devices	Met design requirements; comparable or superior to predicate devices
Mean Median Aerodynamic Diameter (MMAD)	Comparable to predicate devices	Met design requirements; comparable or superior to predicate devices
Geometric Standard Deviation (GSD)	Comparable to predicate devices	Met design requirements; comparable or superior to predicate devices
Plume Analysis Testing	Comparable to predicate devices	Included; results used to support equivalence/superiority
Single patient use testing (life testing)	Up to one year (as per device description)	Passed validation and comparative product testing, ensuring functionality for up to one year single-patient use
Spacer Material	Clear Polycarbonate	Clear Polycarbonate (identical to a predicate device)
Mouthpiece and Valve Material	Biocompatible (e.g., Silicone, Polycarbonate)	Silicone
Single Patient Use	Yes	Yes
Sterility	Non-Sterile	Non-sterile
Ventilator Use	No	No
Maximum Length of Use	Up to 365 days	Up to 365 days (single patient)
Effective Size of Mixing Area	Effectively allows sufficient mixing and delivery	Approximately 170 ml (larger than OptiHaler, similar to AeroChamber)
Method of Operation	Mechanical	Mechanical
Prescription Device	Yes	Yes
Port Protection	Yes	Yes

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

The document does not explicitly state the specific sample sizes (e.g., number of units tested, number of drug actuations) for each test. It states "All tests included comparative testing of the two predicate devices and the LeverHaler Spacer."

Test Set Sample Size: Not explicitly quantified with numbers of units or repetitions. The tests involved "3 drugs" for particle size distribution and dose output testing.
Data Provenance: The testing was conducted by an independent medical device manufacturer and test laboratory contracted by Birdsong Medical. This suggests the data is prospective as it was generated specifically for this premarket notification. The country of origin is not specified but is implicitly the US, given the FDA submission.

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

Not applicable for this type of mechanical medical device. The "ground truth" for its performance is established through objective physical and chemical measurements (e.g., particle size, drug quantity) as per recognized guidance documents, not expert consensus interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Testing involved objective measurements in a laboratory setting, not subjective human assessment requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other data. The LeverHaler Spacer is a mechanical drug delivery aid.

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

Not applicable. This is a non-software, mechanical device. Its performance is inherent to its design and how it functions with an MDI, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on in vitro measurements and established engineering/physical principles. This includes:

Physicochemical measurements: Particle size distribution, overall dose output (drug quantity and total mass), mean median aerodynamic diameter (MMAD), and geometric standard deviation (GSD).
Functional testing: Life testing to assess durability over time/use.
Comparative data: Performance against established predicate devices, which serve as benchmarks for safety and effectiveness.
Regulatory guidance: Compliance with the "Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators: Reviewer Guidance 10-01-93."

8. The Sample Size for the Training Set

Not applicable. This is a traditional mechanical device, not an AI/ML device that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the text "K031982" in a handwritten style. The text is oriented diagonally, with the characters slightly tilted to the right. The handwriting appears somewhat casual and the numbers are clearly distinguishable.

Birdsong Medical LeverHaler Spacer 510(k) Summary:

In accordance with 21 CFR section 807.92 BirdSong Medical is submitting the following safety and effectiveness summary.

1. Submitter Information
  Eric Fugelsang President BirdSong Medical Devices, Inc. 1456 Rt. 22, Suite A103 Brewster, NY 10509
1. Name of Device
  Proprietary Name: LeverHaler Spacer Common Name is Handheld Spacer Classification Name: Nebulizer Accessory
1. Substantially equivalent to: OptiHaler (Healthscan Products, Inc.), K911807.
1. Device Description and System Overview:

Image /page/0/Picture/11 description: The image shows a diagram of a medical device, specifically an inhaler. The different parts of the inhaler are labeled, including the mouthpiece, lever actuator, MDI (metered dose inhaler), air inlets, air outlets, housing, and chamber. The diagram provides a clear visual representation of the inhaler's components and their arrangement.

Figure 1: Diagram of LeverHaler Spacer

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The device is made from polycarbonate injection molded plastic and is designed to The device is made from polycurson injoning. When not in use, up to two MDI canisters can be stored inside of the LeverHaler Chamber.

The product is sold non-sterile, and is a single-patient device intended to be used The product is sold non-sichie, and to a sing or cleaning and use of the device. All for up to one year. Easoning couring of this device are identical to a defined predicate device.

This device does not generate aerosols. Its purpose is to provide an effective mixing chamber for the aerosols produced by a metered dose inhaler to assure milking chamber for the doneentration for inhalation by the patient. This is a prescription device.

The device has no detection capabilities. It is mechanical and has no alarm functions or capabilities. There is no software integrated or used in conjunction with this device.

Product testing has been completed according to the "Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators (10-01-93)." Product testing performed by Birdsong Medical provides clear proof that the LeverHaler Spacer is superior to the MDI and is comparable or superior to the predicate devices tested. The premarket notification submitted to FDA contains a full discussion of product testing, which includes delivered aerosol potency, MMAD, GSD, particle distribution, retained aerosols (Plume Analysis) and life testing. All tests included comparative testing of the two predicate devices and the LeverHaler Spacer.

Design Considerations and Operation of the Device:

The device is intended to be used with FDA approved MDI drugs for treatment of lung disease. The Lever Actuator is designed for patients with limited hand strength, coordination or dexterity. The MDI can be actuated easily with the Lever or may be actuated by depressing the MDI downwards (typical MDI activation).

Testing:

All product and comparative in vitro testing performed was based upon the requirements of the "Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators: Reviewer Guidance 10-01-93." Testing was conducted by an independent medical device manufacturer and test laboratory contracted by Birdsong Medical. All tests were performed according to documented test protocol.

The following tests were completed for the LeverHaler Spacer, and the predicate devices: OptiHaler and AeroChamber (specified in this premarket notification):

Particle size distribution (using 3 drugs) .
Dose output testing (drug quantity and total mass using 3 drugs) .
Mean median aerodynamic diameter (MMAD) .
Geometric standard deviation (GSD) .

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Plume Analysis Testing .
Single patient use testing (life testing) .

No clinical testing was performed on this product.

Software Validation: Not applicable: there is no software in this product.

Sterilization Validation: Not applicable: this product is sold and used as a non-sterile product.

Biocompatibility: All materials used in this device are incorporated in other predicate devices, as well as nebulizers, connectors and mouthpieces currently sold in the uevices, as well as nobles on appropriate for the intended use described herein.

Comparative Product Matrix

Table 2: 510(k) Summary - Substantial Equivalence to Predicate Devices

item:	Characteristic:	BirdsongMedical	HealthscanProducts, Inc.	MonaghanMedical
	Model:	LeverHalerSpacer	OptiHaler	AeroChamber
4.	Spacer Material	ClearPolycarbonate	ClearPolycarbonate	Clear Polyester
5.	Mouthpiece and Valve	Silicone	Polycarbonate	Polyetheleneand Silicone
5.	Single Patient Use?	Yes	Yes	Yes
6.	Sterility?	Non-Sterile	Non-Sterile	Non-Sterile
7.	Ventilator Use?	No	No	Yes
8.	Maximum Length of Use:	Single patientup to 365 days	Single patientNot stipulated	Single patientNot stipulated
8.	Effective Size of mixing area:	Approximately170 ml	Approximately90 ml	Approximately140 ml
9.	Method of Operation:	Mechanical	Mechanical	Mechanical
10.	Prescription Device?	Yes	Yes	Yes
11.	Provided as Kit?	No	No	No
12.	Port Protection?	Yes	Yes	Yes
	Premarket Submission:	Pending	(K911807)	(K930574)(K884803)

The Birdsong Medical Spacer met all design requirements Conclusions of all Testing: and passed all validation and comparative product testing. The device is manufactured from the identical materials used in a predicate device noted in the 510(k) submission. LeverHaler performance in all in vitro tests was equivalent or superior to the comparative predicate device noted in the table above.

Based upon these results, it is our conclusion that the LeverHaler Spacer is as safe, as effective and performs as well as or better than the legally marketed predicate OptiHaler Spacer device used in comparative product testing.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three horizontal bars. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 2 2004

Mr. Eric Fugelsang President Birdsong Medical Devices, Incorporated 1456 Rt. 22. Suite A103 Brewster, NY 10509

Re: K031982

Trade/Device Name: Leverhaler Spacer Regulation Number: 868,5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: February 13, 2004 Received: February 13, 2004

Dear Mr. Fugelsang:

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 such 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. Fugelsang

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Chiu Lin, Ph.D.

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

[510(k)] Number: K031982

Device Name: Birdsong Medical Devices LeverHaler Spacer

Indications For Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 807 Subpart €)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

fthuh

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Denta

510(k) Number: K031982

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).