This product is a nebulizer used to generate aerosols that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. This product is a single patient use, non-sterile prescription device and is designed to be used in either a hospital or homecare environment.

Device Description

The Salter Labs Modified Nebulizer is a modification to the existing Salter Labs Nebutech Nebulizer (K961476). The Cone assembly has been changed to incorporate the lens deflector that was originally contained in the Lid assembly of the Nebutech Nebulizer and a horizontal baffle has been added. All materials used in the Modified Nebutech are identical to the original Nebutech product. The cone assembly fits against a molded stop so that it sits firmly on the base of the jar. There are no other modifications to this product. This product is designed to be a single patient use device.

AI/ML Overview

Here's an analysis of the provided text, focusing on acceptance criteria and a hypothetical study, as the provided document is a 510(k) summary for a medical device and not a study report. The document describes a "Modified Nebutech Nebulizer" and its substantial equivalence to a predicate device.

Key takeaway: The provided document is a 510(k) summary demonstrating substantial equivalence to a predicate device. It does not contain a detailed study report with specific acceptance criteria directly tied to performance metrics or individual device performance other than stating "Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer." Therefore, the information below is reconstructed based on the typical requirements for nebulizer performance and the limited data provided.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Since specific acceptance criteria are not explicitly listed with numerical targets in the provided 510(k) summary, the table below infers typical performance parameters for nebulizers based on general regulatory guidance and the statement of equivalence. The "Reported Device Performance" is derived from the summary's qualitative statement.

Acceptance Criteria (Inferred from Regulatory Guidance for Nebulizers)	Reported Device Performance (as stated in 510(k) Summary)
Aerosol Particle Size (Fine Particle Fraction/Mass Median Aerodynamic Diameter - MMAD): Consistent and within a respirable range suitable for drug delivery to the lungs.	"A horizontal circular baffle integral to the cone... prevents large aerosol particles from forming on the walls... and ensures the particles... are consistently sized and meet the requirements for respirable aerosol." "Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer" regarding aerosol performance.
Nebulization Rate: Efficient delivery of medication within a clinically acceptable timeframe.	"Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer."
Residual Volume: Minimal medication remaining in the nebulizer after use.	"Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer."
Material Biocompatibility: Materials are safe for patient contact.	"All materials used in this device are identical to the Salter Labs Nebutech (predicate device) and are therefore appropriate for the intended use as described."
Ease of Use/Assembly: Meets design specifications for proper assembly and function.	"The nebulizer is disassembled and assembled according to product labeling." (Implied to be straightforward)

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

Sample Size for Test Set: Not explicitly stated. The document mentions "Product performance testing was performed according to the 'Reviewer Guidance for Nebulizers Metered Dose Inhalers (10-01-93),' and Salter Labs testing requirements." It also notes that "all testing was performed in the Salter Labs R&D test laboratory" and that the "testing was performed on the Pari LC Plus Nebulizer" for comparison. This implies a comparative in-vitro study was conducted using a sample of the Modified Nebutech Nebulizer and the predicate Pari LC Plus Nebulizer. The specific number of units tested for each, however, is not provided.
Data Provenance: The data was generated in an "in-vitro" setting within the "Salter Labs R&D test laboratory." This is a controlled, laboratory-based study. The country of origin for the data is the USA (Salter Labs, Arvin, CA). The study is prospective in the sense that data was collected specifically for this 510(k) submission, but it is an in-vitro study, not a clinical trial involving patients.

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

This section is not applicable as the study described is an in-vitro performance test, not a study requiring human expert evaluation to establish ground truth (e.g., image interpretation, disease diagnosis). The "ground truth" for this type of study would be the scientifically established physical performance characteristics of the comparator device and regulatory requirements for nebulized particle dispersion.

4. Adjudication Method for the Test Set

This section is not applicable as the reported study is an in-vitro performance test, not a study requiring human expert evaluation or adjudication. The measurements would be objective, machine-derived data points.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed on this product."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This section is not applicable as the device is a physical medical device (nebulizer), not a software algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the in-vitro performance testing was based on:

Predicate Device Performance: The established, regulated performance characteristics of the "Pari LC Plus Nebulizer," which served as the benchmark for equivalence.
Regulatory Guidance: The "Reviewer Guidance for Nebulizers Metered Dose Inhalers (10-01-93)," which outlines acceptable performance parameters for nebulizers.
Salter Labs Testing Requirements: Internal company standards aligned with regulatory expectations and predicate device performance.

8. The sample size for the training set

This section is not applicable as this is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this product.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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K014056

Salter Labs Modified Nebutech Nebulizer 510(k) Summary: 10.

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

Submitter Information

Duane Kazal Director Operations Salter Labs 100 W. Sycamore Road Arvin, CA 93203 (661) 854-6818

Name of Device

Proprietary Name: Modified Nebutech Nebulizer (trade name to be determined) Common Name is Nebulizer Classification Name: Nebulizer

Substantially equivalent to: Modification to the Ultramist Nebulizer, K961476.

1. Device Description and System Overview:
  The Salter Labs Modified Nebulizer is a modification to the existing Salter Labs Nebutech Nebulizer (K961476). The Cone assembly has been changed to incorporate the lens deflector that was originally contained in the Lid assembly of the Nebutech Nebulizer and a horizontal baffle has been added. All materials used in the Modified Nebutech are identical to the original Nebutech product. The cone assembly fits against a molded stop so that it sits firmly on the base of the jar. There are no other modifications to this product.

This product is designed to be a single patient use device.

Nebulizer Component:	Salter Labs Ultramist(Nebutech: K961476)	Salter Labs ModifiedNebutech
Cup: material and SalterLabs component materialspecification number:	Polystyrene, FDACompliance Compound	Polystyrene, FDACompliance CompoundSame as Nebutech
Top: material and SalterLabs component materialspecification number:	Polypropylene	Polypropylene, Same asNebutech
Insert: material and SalterLabs component materialspecification number:	Polystyrene, FDACompliance Compound,Transparent Green FDACompliance Colorant	Polypropylene, Same asNebutechTransparent Green FDACompliance Colorant, Sameas Nebutech

Table 1: Comparison of Modified Nebutech Materials to predicate Ultramist (Nebutech) Nebulizer:

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5) Principles of operation:

The modified Nebutech Nebulizer is a hand-held pneumatically powered nebulizer that consists of a Nebulizer Top that is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. A third component, the cone assembly, fits over a mating conical surface within the Nebulizer Cup. The device consists of two basic operational units: the nebulizer portion (which forms and conveys an aerosol) and a reservoir portion (which contain non-aerosolized drug).

Cup: Nebulizer Portion:

The Nebulizer portion of the device consists of the following elements:

. the inlet port for the nebulizing gas;
. a liquid medication cup with a conical seat;
. a cone assembly, which rests on the seat and meters the liquid to the jet; and a jet which directs a high velocity stream of nebulizing gas and entrained liquid to an impact target which is integral to the cone assembly. A horizontal baffle is located directly above the impact target and helps transmit a consistent sized aerosol to the upper part of the nebulizer. This component is the primary modification to the existing Nebutech Nebulizer product, in that the target is now located on the cone assembly rather than on the aerosol reservoir section of the device.

The materials used in the Modified Nebutech Nebulizer are identical to the materials qualified for use in the original predicate Ultramist device, K961476.

Top: Aerosol Reservoir Section:

This portion of the Modified Nebulizer contains an internal reservoir for the aerosol. The reservoir is equipped with an inhalation valve that opens to admit ambient air when the patient inhales and which closes when the patient exhales. Exhaled breath is thereby routed to an expiratory port, such as an exhalation valve in a mouthpiece or an expiratory port of a mask that is attached to the nebulizer. NOTE: The inhalation valve uses the identical valve assembly defined in the original Ultramist Nebulizer, K962476, in terms of design, specifications and materials used.

The Modified Nebutech Nebulizer contains a port for the fitting of an external mouthpiece that is identical to and serves the same purpose as the predicate Ultramist nebulizer. The mouthpiece, when attached, contains a breath-actuated exhalation valve which works in conjunction with the inhalation valve in the top of the nebulizer top to minimize re-breathing of expired gas. This allows the patient to utilize more of the aerosol that might otherwise be wasted if the nebulizer were connected to a conventional patient circuit.

6) Operation:

The nebulizer is disassembled and assembled according to product labeling. Medication is placed in the nebulizer cup when the unit is disassembled. The Nebulizer Housing is screwed onto the Cup and seated snugly and the supply line from the nebulizing gas source is then connected to the bottom of the nebulizer cup.

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When pressurized nebulizing gas is applied to the nebulizer, the solution in the cup when pressunzed nebuiling gas to upplied to the cup and overlaying cone assembly is sucked up between the mating ourlues on the liquid is broken into extremely
and ejected at great velocity against the target. The integral to the conn and ejected at great velocity against the targed it circular baffe integral to the cone
small particles, forming an aerosol. A horizontal circular baffler of the small particles, forming an acrosoft of homeones into the upper portion of the adapter prevents large acrosof particles from on the walls and internal baffler portiologic nebulizer. These larger dropieto form on the end in and and and and the particles in the hebuilter and fall back into the oup for subscription of the nebulizer and are more occupy the space in the uppor portion of the are consistently sized and meet the requirements for respirable aerosol.

1. In-Vitro Performance Testing:
  Product performance testing was performed according to the "Reviewer Guidance t Product performance testing was portonned as a lotuators (10-01-93)," and Salter for Nebulizers Metered Dood innalet the time demonstrates that the Modified Labs testing requirements. Froudst tooling as more as a comment of the predicate device tested.

All testing was performed in the Salter Labs R&D test laboratory according to All testing was performed in the Saltor Labor Labor Schools and Serformed on the Pari LC Plus Nebulizer.

Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer.

1. Clinical Testing: No clinical testing was performed on this product.
1. Software Validation: Not applicable: there is no software in this product.
1. Sterilization Validation: Not applicable: this product is sold and used as a non-sterile product.
1. Biocompatibility: All materials used in this device are identical to the Salter Labs Nebutech Droompanishilly. And are therefore appropriate for the intended use as described.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Mr. Duane Kazal Salter Labs 100 W. Sycamore Road Arvin, CA 93203

Re: K014056

Salter Labs Modified Nebutech Nebulizer Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: II (two) Product Code: CAF Dated: January 17, 2002 Received: January 22, 2002

Dear Mr. Kazal:

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 for use stated in the encreated of 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 r ou may , ateres, mains 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 rr your de rio to such additional controls. Existing major regulations affecting your device can may or days. It is 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. Duane Kazal

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that I Dr Pressunts of wour device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any I cochar statutes and registerients, including, but not limited to: registration and listing (21 Comply with an the 71et 31equirements, as a manufacturing practice requirements as set CFN Fart 607), labeling (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (QD) roggisterials (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) This iction will anow your to FDA finding of substantial equivalence of your device to a legally premarket notification: "The President 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 and IT you desire specific ad roo for you witro diagnostic devices), please contact the Office of additionally 21 CFTC Far 80719 Additionally, for questions on the promotion and advertising of Compliance at (301) 59 ( 1 t t t t t t t t t t ) 594-4639. Also, please note the your device, prease connectance to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oincl general information of Small Manufacturer 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,

signature

Bram D Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use

Salter Labs Modified Nebutech Nebulizer

Division of Cardiovascular & Respiratory Devices
510(k) Number 1019056

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).