(281 days)
No
The device description explicitly states "There is no software integrated or used in conjunction with this device" and describes it as a mechanical device with no detection or alarm capabilities.
Yes
The device is described as "intended for use in the treatment of lung disease" and helps deliver "respirable medical aerosols," which clearly indicates a therapeutic purpose.
No
Explanation: The device is a spacer used with metered dose inhalers to assist with drug delivery, as clearly stated in the "Intended Use" and "Device Description" sections. It is not designed to diagnose any condition; its purpose is to facilitate treatment.
No
The device description explicitly states, "There is no software integrated or used in conjunction with this device."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to effectively deliver respirable medical aerosols from MDIs to a patient during inhalation for the treatment of lung disease. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a mechanical spacer designed to improve the delivery of medication. It does not perform any tests on biological samples (in vitro) to diagnose a condition.
- Lack of Diagnostic Function: The description explicitly states the device has "no detection capabilities" and is "mechanical." It does not analyze or measure any biological markers or substances.
IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart E)
Product codes (comma separated list FDA assigned to the subject device)
CAF
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 The device is made from polycarbonate injoining. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
all patients
Intended User / Care Setting
patients who have been prescribed MDI treatment by their physician; hospital and homecare environments.
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
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) .
- Plume Analysis Testing .
- Single patient use testing (life testing) .
No clinical testing was performed on this product.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
OptiHaler (Healthscan Products, Inc.), K911807.
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.
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
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.
-
- Submitter Information
Eric Fugelsang President BirdSong Medical Devices, Inc. 1456 Rt. 22, Suite A103 Brewster, NY 10509
- Submitter Information
-
- Name of Device
Proprietary Name: LeverHaler Spacer Common Name is Handheld Spacer Classification Name: Nebulizer Accessory
- Name of Device
-
- Substantially equivalent to: OptiHaler (Healthscan Products, Inc.), K911807.
-
- Device Description and System Overview:
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.
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
1
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) .
10
2
- 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: | Birdsong
Medical | Healthscan
Products, Inc. | Monaghan
Medical |
|-------|--------------------------------|----------------------------------|----------------------------------|----------------------------------|
| | Model: | LeverHaler
Spacer | OptiHaler | AeroChamber |
| 4. | Spacer Material | Clear
Polycarbonate | Clear
Polycarbonate | Clear Polyester |
| 5. | Mouthpiece and Valve | Silicone | Polycarbonate | Polyethelene
and 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 patient
up to 365 days | Single patient
Not stipulated | Single patient
Not stipulated |
| 8. | Effective Size of mixing area: | Approximately
170 ml | Approximately
90 ml | Approximately
140 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.
75
3
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.
4
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
5
INDICATIONS FOR USE
[510(k)] Number: K031982
Device Name: Birdsong Medical Devices LeverHaler Spacer
Indications For Use:
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.
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