The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 - 450 kPa, 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital environment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.

Device Description

Compressor Mini will provide a supply of dry and filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vimin at 50-64 psi (350 - 450 kPa). The compressor is of light weight and compact design. It runs quietly, which makes it suitable for bedside use. It may be employed as a primary or secondary source of compressed air. The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air. The Compressor Mini is fitted with two alarm parameters, temperature and pressure. The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Compressor Mini:

The provided document describes a 510(k) submission for the Compressor Mini, a device intended to provide dry and filtered compressed air for medical respiratory ventilators or anesthesia machines. The submission claims substantial equivalence to a predicate device, the ALRECO 40400.

Crucially, the provided text DOES NOT contain a detailed study report with specific acceptance criteria, sample sizes, ground truth establishment methods, or statistical performance metrics (like sensitivity, specificity, AUC). This document is a 510(k) summary, which focuses on device description, intended use, and substantial equivalence to a predicate device, rather than a standalone performance study.

Therefore, many of the requested items cannot be answered directly from this document. However, I can infer some aspects based on the nature of a 510(k) submission and the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not present a formal table of acceptance criteria with specific performance metrics. The "performance" described is largely functional equivalence to the predicate device and the new device's specifications.

Acceptance Criteria (Inferred from device description and substantial equivalence claim)	Reported Device Performance (From document)
Output Air Quality: Dry and filtered compressed air.	Stated as intended use: "provide a supply of dry, filtered, compressed air". (No specific filtration level or dryness metric provided).
Capacity: Sufficient flow and pressure for ventilator/anesthesia machine.	"Capacity is approximately 30 l/min at 50-64 psi (350 - 450 kPa)."
Operational Sound Level: Suitable for bedside use.	"It runs quietly, which makes it suitable for bedside use." (No specific decibel level provided).
Alarm Parameters: Functioning alarms for critical parameters.	"The Compressor Mini is fitted with two alarm parameters, temperature and pressure." (No performance details on alarm accuracy or trigger points provided).
Standby Functionality: Automatic switch to deliver compressed air if central supply fails.	"The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air." (No specific testing or reliability data provided here).
Materials/Technology: Similar to predicate device.	"The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400."
Intended Use: Match predicate device and specified applications.	"The functionality for the Compressor mini is equivalent to the ALRECO 40400. Compressor mini and ALRECO 40400 have the same technological characteristics, intended use, materials, method of operation, performance claims and energy source..."
Physical Characteristics: More compact and lighter than predicate.	"A more compact design and lighter weight." (Specific dimensions or weight not provided, but stated as a design feature).
Power Consumption: Less than predicate device.	"Less power consumption." (No specific power consumption figures provided).
Flow/Reservoir: Lower continuous flow and smaller reservoir due to single ventilator focus.	"Lower continuous flow and smaller built-in reservoir, since the Compressor Mini is designed to supply only one ventilator with compressed air." (Specific flow/reservoir size not provided).

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

Sample Size for Test Set: Not specified in the provided document. As this is a 510(k) summary for a medical device (a compressor, not an imaging algorithm), the "test set" would likely refer to engineering verification and validation testing, not a diagnostic accuracy study with a "test set" of patient data.
Data Provenance: Not specified. Based on the regulatory filing, the testing would generally be internal engineering and performance testing conducted by the manufacturer (Siemens), likely at their facilities in Sweden or another location where R&D/manufacturing occurs. It would be retrospective in the sense that the device was designed and then tested to meet specifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable / Not specified. For a device like a medical air compressor, "ground truth" is established through engineering specifications, validated test methods (e.g., pressure transducers, flow meters, air quality sensors), and compliance with international standards (e.g., for medical electrical equipment, compressed air quality). It would not typically involve human expert adjudication in the way diagnostic imaging studies do.

4. Adjudication Method for the Test Set

Not Applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic studies. For a physical device, testing involves objective measurements against predefined engineering specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic algorithms or imaging systems where human readers interpret medical images or data. The Compressor Mini is a physical medical device (an air compressor) that supplies air; it does not involve human interpretation of output data in a diagnostic context.

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

Yes, a standalone performance assessment (device only) would have been performed. This is implicit in the device's development and regulatory submission. The device is designed to operate autonomously to provide compressed air. Its performance (flow, pressure, air quality, alarm functions, standby function) would have been validated independently through engineering tests without human intervention as part of its core functionality. While the document doesn't detail these tests, they are a fundamental part of a medical device submission.

7. The Type of Ground Truth Used

Engineering Specifications and International Standards. The "ground truth" for the Compressor Mini would be defined by its design specifications, performance requirements (e.g., specific flow rates, pressure ranges, air quality parameters as per medical gas standards), and compliance with relevant healthcare device standards (e.g., IEC 60601 for electrical safety, specific standards for medical air compressors if applicable). These are objective, measurable criteria.

8. The Sample Size for the Training Set

Not Applicable / Not specified. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense. The device's design and parameters are determined by engineering principles and iterative development, not by training on a dataset.

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

Not Applicable. As there is no training set, this question is not relevant. The device's "ground truth" (its optimal performance and validated parameters) would be established through a combination of engineering design calculations, component testing, sub-system testing, and full-device verification and validation against its specifications and relevant regulatory standards.

Summary

{0}------------------------------------------------

K02354

SEP - 5 2003

SIEMENS		Document Type510(k) Notification	Page19
Obiect/SubiectCompressor Mini - 510(k) Summary		Doc-IDEVU-113162	Issue no.01

510(K) Summary as required by section 807.92(c) 1 October 2002

Subscribers Name & Address: F.1

Siemens-Elema AB Electromedical Systems Division, Life Support Systems Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: +46 8 730 7000 Fax: +46 8 98 78 38 Official Correspondent: Richard Flynn.

(Manager Regulatory Affairs/Quality Assurance, Siemens Medical Solutions USA, Inc. /S.S.G. -R.A. 16 Electronics Avenue Danvers, MA USA 01923) Veronica Ekström

Contact Person for this submission:

F.2 Trade Name:

Device name: Compressor Mini

Common Name	Classification Number	Class	Regulation Number
Compressor Mini	BTI	II	21.CFR.868.6250

F.3 Predicate Device Identification:

Compressor Mini is a first time application. Substantial equivalence to a predicate device, ALRECO 40400 Allan Rehnström AB K951926, is claimed.

F.4 Device Description:

The compressor is of light weight and compact design. It runs quietly, which makes it suitable for bedside use.

It may be employed as a primary or secondary source of compressed air. The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air.

The Compressor Mini is fitted with two alarm parameters, temperature and pressure. The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400.

{1}------------------------------------------------

	Document Type510(k) Notification	Page
Object/SubjectCompressor Mini - 510(k) Summary		20
		Doc-IDEVU-113162	Issue no.01

Intended Use of the Device: F.5

The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 - 450 kPa). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is to be used only for bedside application within the hospital environment. Compressor Mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

F.6 Summary of technological characteristics of Device and Predicate Device

The functionality for the Compressor mini is equivalent to the ALRECO 40400. Compressor mini and ALRECO 40400 have the same technological characteristics, intended use, materials, method of operation, performance claims and energy source but the compressor mini is scaled down for smaller size.

The differences are:

A more compact design and lighter weight. ●
Less power consumption.
Lower continuous flow and smaller built-in reservoir, since the Compressor Mini is . designed to supply only one ventilator with compressed air. The Compressor Compact could support multiple ventilators.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a simple, sans-serif font.

SEP - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens-Elema AB C/O Mr. Timothy W. Capehart Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K023354

Trade Name: Compressor Mini, 115 V, Model 64 81 779 EH81E Regulation Number: 868.6250 Regulation Name: Compressor, Air, Portable Regulatory Class: II Product Code: BTI Dated: August 8, 2003 Received: August 15, 2003

Dear Mr. Capehart:

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.

{3}------------------------------------------------

Page 2 -Mr. Timothy W. Capehart

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 (QS) 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

Qui- S. Lyon

Susan Runner, DDS, Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K023354

Device Name: Compressor Mini

Indications For Use:

The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 -- 450 kPa, 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital environment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.

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

----------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(21 CFR 868.6250)

Over-The-Counter Use

E. Antrach for JXH

General Hospital.

510(k) Number: K023354

Regulation Number and Section

§ 868.6250 Portable air compressor.

(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.