The Medical Depot is intended to provide a source of compressed air for medical purposes for use in home health care. This device is used in conjunction with a pneumatic nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for both children and adults suffering from respiratory disorders.

Device Description

The Medical Depot Nebulizer Device is the same as our Power Neb II except with a membrane rather than a piston compressor. It is also the same as the Graham - Field Mini-Mist II which was originally cleared by John Bunn Company and has the same compressor as this device.

AI/ML Overview

The provided document is a 510(k) premarket notification summary for the Medical Depot Power Neb I, a nebulizer. This document primarily focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria, performance studies with specific metrics, or information on AI/ML models.

Based on the provided text, the device is a compressor for medical nebulization and does not appear to be an AI/ML-enabled device. Therefore, the questions related to AI/ML model evaluation, such as sample sizes for test and training sets, ground truth establishment methods, expert involvement, and MRMC studies, are not applicable in this context.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance:

The document does not specify quantitative acceptance criteria or detailed device performance metrics in the format of a table. The device's performance is implicitly evaluated through its substantial equivalence to predicate devices. The key performance aspect described is its ability to "provide a source of compressed air for medical purposes" and, "in conjunction with a pneumatic nebulizer, to produce a fine aerosol mist of medication for respiratory therapy."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This device is a mechanical compressor, not a diagnostic or AI/ML device that would require test sets with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth establishment with experts is not relevant for this type of medical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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:

Not applicable. This is not an AI-enabled device and no MRMC study information is provided.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable.

8. The sample size for the training set:

Not applicable.

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

Not applicable.

Summary based on the 510(k) document:

The Medical Depot Power Neb I is a nebulizer compressor. The "study" proving its acceptance criteria is the comparison to predicate devices (Medical Depot Power Neb II and John Bunn Model 510 Medication Compressor, along with the Graham-Field Mini-Mist II). The "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to these legally marketed devices, sharing similar technology (a membrane compressor, which is also present in one of the predicate devices) and intended use. The 510(k) clearance process focuses on demonstrating this equivalence rather than performing extensive novel clinical trials or performance studies with specific, quantifiable acceptance metrics as would be seen for new drugs or high-risk devices.

Summary

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K012006

JUL 1 3 2001

510(K) SUMMARY (as required by 807.92(c))

Submitter of 510(k):	Medical Depot, Inc.55 Sea LaneFarmingdale, NY 11735
	Phone:Fax:	631-420-4134631-420-4168
Contact Person:	Harvey Diamond
Date of Summary:	May 1, 2001
Trade Name:	Medical Depot Power Neb I
Classification Name:	Nebulizer
Predicate Device:	Medical Depot Power Neb IIJohn Bunn Model 510 Medication Compressor	K00334K86262

Device Comparison/Description:

Intended Use:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

Medical Depot, Inc. c/o Art Ward Regulatory and Marketing Services, Inc. 962 Allegro Lane Apollo Beach, FL 33572

Re: K012006

Medical Depot Power Neb I Regulation Number: 868.5630 Regulatory Class: II (two) Product Code: 73 CAF Dated: May 1, 2001 Received: June 27, 2001

Dear Mr. Ward:

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this

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Page 2 - Mr. Art Ward

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.

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR 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,

Arth A. CarhartL.

Yr James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K012006

Device Name: Medical Depot Power Neb I

Indications For Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Aoh A. Cia U. fr. IED

Number

Prescription Use
(Per 21 CFR 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).