(71 days)
The Deployable Oxygen Concentration System (DOCS) is designed to reliably and continuously provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended for supplemental use in Department of Defense medical facilities or institutions, in nursing locations, health care facilities, in sub-acute care, and/or in acute care environments, whether in peacetime conditions or in deployed military scenarios.
DOCS has the capability to supply pressurized oxygen to fill gas cylinders that can be transported to remote locations away from the DOCS system or to fill cylinders for a patient's ambulatory use.
The device has no contraindications.
DOCS is intended to provide supplementary oxygen. The device is to be used by trained medical personnel for military use only.
The Deployable Oxygen Concentration System (DOCS) draws in normal air and produces concentrated oxygen. Air in nature is a mixture of roughly 78% nitrogen, 21% oxygen, and 1% other trace gasses. The DOCS separates the nitrogen from the air, producing an output of concentration oxygen at 93 percent, by volume, of O2, the remainder consisting mostly of argon and nitrogen.
DOCS employs an integral oxygen analyzer to provide control of oxygen purity.
The DOCS device is an electromechanical device consisting primarily of an oxygen concentrator module, and one or more oxygen collection cylinders. The oxygen concentrator operates on the principle of using a pressure differential to strip oxygen and nitrogen from filtered air. The resulting oxygen output is 240 liters per minute at pressure of 100 psi nominal and high pressure cylinder filling capability.
The provided document is a 510(k) summary for a medical device called the Deployable Oxygen Concentration System (DOCS). This document outlines the device's technical specifications, intended use, and its equivalence to predicate devices, but it does not contain the detailed information necessary to answer all parts of your request which are typically found in clinical studies for AI/ML-based devices.
The DOCS is an oxygen concentrator, a conventional medical device, not an AI/ML-based device. Therefore, many of your questions, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set" are not applicable to the information provided.
However, I can extract the acceptance criteria and the summary of performance testing that proves the device meets those criteria.
Acceptance Criteria and Device Performance for Deployable Oxygen Concentration System (DOCS)
The Deployable Oxygen Concentration System (DOCS) is a conventional oxygen concentrator and not an AI/ML-based device. Therefore, the detailed information requested regarding sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, and MRMC studies are not applicable and not present in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Basis) | Reported Device Performance |
|---|---|---|
| Oxygen Purity | Meets requirements of USP 24-NF 19 Oxygen 93% standard; Integral oxygen analyzer for purity control. (Voluntary standards and US Army specifications) | "concentrated oxygen at 93 percent from air... output of concentration oxygen at 95 percent, by volume, of O2" (Implies meeting at least 93%, with a reported performance of 95%) |
| Flow Rate | Established in voluntary standards and US Army specifications. | "concentrator operates at assess of actives per minute at pressure of 100 psi nominal and high pressure cylinder filling capability." |
| Electrical Safety | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
| Mechanical | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
| Controls | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
| Device Performance | Established in voluntary standards and US Army specifications. | "device met all required performance criteria and functioned as intended" |
Study Proving Device Meets Acceptance Criteria:
A "Verification and validation testing activities" study was conducted.
Summary of the Study:
- Study Description: Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the DOCS.
- Proof of Meeting Criteria: "In all instances the device met all required performance criteria and functioned as intended, meeting the acceptance criteria."
- Conclusion: "The combined testing and analysis of results conclude that the device meets its specifications, is safe and effective for its intended use, and is substantially equivalent to the currently marketed devices."
Parts of your request that are NOT APPLICABLE or NOT AVAILABLE in this document (as it concerns a conventional, not AI/ML, device):
- Sample size used for the test set and the data provenance: Not applicable/provided. This is a conventional medical device, not an AI/ML system requiring a defined test set for algorithmic evaluation. Performance testing would typically involve a small number of units tested under various conditions to verify engineering specifications.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth from experts is not relevant for verifying the performance of an oxygen concentrator.
- Adjudication method for the test set: Not applicable.
- 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-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is based on physicochemical measurements and engineering specifications, primarily the concentration of oxygen produced, flow rate, and adherence to electrical/mechanical safety standards.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image shows a black and white logo. The logo is a stylized triangle with the letters 'P', 'C', and 'A' incorporated into the design. The 'P' forms the top part of the triangle, the 'C' is in the middle, and the 'A' forms the base.
APR 1 2 2002
Deployable Oxygen Concentration System (DOCS)
510(k) Summary
Deployable Oxygen Concentration System (DOCS)
| Type of FDA Submission: | Abbreviated 510(k) |
|---|---|
| 510(k) Number: | K020330 |
| Submitter Information | |
| Submitter's Name: | Pacific Consolidated Industries |
| Submitter's Address: | 3430 West Carriage DriveSanta Ana, California 92704-6412 |
| Owner/Operator ID: | 9049531 |
| Contact Person: | Lee W. Smith |
| Submitter's Phone: | 714-979-9200 (Phone) 714-436-9150 (Fax) |
| Date of Preparation: | January 29, 2002 |
| Device Name | |
|---|---|
| Common Trade Name: | Deployable Oxygen Concentration System (DOCS) |
| Classification Name: | Portable Oxygen Generator |
| Device Classification: | 868.5440 |
| Product Code: | CAW |
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Image /page/1/Picture/0 description: The image shows a logo that is a stylized triangle with the letters 'PC' embedded within it. The triangle is formed by thick, black lines, giving it a bold appearance. The letters 'PC' are also in black and are positioned in the lower part of the triangle, with the 'P' on the left and the 'C' in the middle, sharing a vertical line. The overall design is simple, geometric, and appears to be a monogram or emblem.
Predicate Legally Marketed Device Equivalence
Substantial equivalence is claimed to the following legally marketed predicate devices:
K014078 - Portable Oxygen Generator by On Site Gas Systems K003472 - Model 6400-OM Oxygen Concentrator by SeQual Technologies Inc. K003939 - Venture IOH 200 Home Fill II Complete Home Oxygen System by Invacare Corporation
All three devices operate on the principle of using a pressure differential to strip oxygen from the An times a recor operate on the pilar sieve in an adsorption process, as does the DOCS device.
Compliance with Section 514 Performance Standards
The device meets the requirements of the FDA recognized standard covering Oxygen The concentrators, USP 24-NF 19 Oxygen 93%, and is substantially equivalent to the predicate devices.
Safe Medical Devices Act (SMDA) Statement
The oxygen supplied by the oxygen concentrator is supplemental and is not considered to be life supporting or life sustaining. The failure of the device would NOT have serious health consequences to the user.
Intended Use of Device
The Deployable Oxygen Concentration System (DOCS) is designed to reliably and continuously provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air that they breathe. It is intended for supplemental use in Department of Defense medical facilities or institutions, in nursing locations, health care facilities, in sub-acute care, and/or in acute care environments, whether in peacetime conditions or in deployed military scenarios.
DOCS has the capability to supply pressurized oxygen to fill gas cylinders that can be transported to remote locations away from the DOCS system or to fill cylinders for a patient's ambulatory use.
The device has no contraindications.
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Image /page/2/Picture/0 description: The image shows a black and white logo that appears to be an abstract design. It features a large triangle at the top, with the letters 'P', 'C', and 'A' integrated into the design. The letters are stylized and interconnected, forming a unique and recognizable emblem.
The oxygen supplied by the oxygen concentrator is supplemental and is not considered to be life supporting or life sustaining.
The system is not sold or labeled as sterile.
Description of Device
The Deployable Oxygen Concentration System (DOCS) draws in normal air and produces and The Deployable Oxygon Concernation on en in nature is a mixture of roughly 78% nitrogen, 21% oxygen, and 1% other trace gasses. The DOCS separates the nitrogen from the air, producing an oxygen, and 1 % oncentrated oxygen at 93 percent from air by the molecular sieve process. It contains not output of concentration oxygen at 95 percent, by volume, of O2, the remainder consisting mostly of argon and nitrogen.
DOCS employs an integral oxygen analyzer to provide control of oxygen purity.
The DOCS device is an electromechanical device consisting primarily of an oxygen concentrator The DOCD device is an elections of module, and one or more oxygen collection cylinders. that is more and to to type, and sitrogen from filtered air. The filtered air. The resulting The 0xygen concentrator operates of assess of actives per minute at pressure of 100 psi nominal and high pressure cylinder filling capability.
Device Labeling
Where oxygen is piped directly from the collecting tank to the point of use, each outlet is labeled "Oxygen 93 Percent." All safety and operational labeling is clearly imprinted and easy to understand.
The system is not sold or labeled as sterile.
Comparison of Technological Characteristics
The primary function of the Deployable Oxygen Concentration System (DOCS) is to provide supplemental oxygen, and has molecular sieve technology as the means of oxygen concentration as do the predicate devices. The technological characteristics of the device and its intended use to supply supplemental oxygen are basically the same and raise no new questions of safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows a black and white logo. The logo is a triangle with the letters 'P', 'C', and 'A' stacked on top of each other inside the triangle. The 'P' is at the top, the 'C' is in the middle, and the 'A' is at the bottom.
The technology is well established and has been used in other legally marketed products. There are no major technological differences.
The primary differences between the Deployable Oxygen Concentration System (DOCS) and predicate equipment are in:
- Overland mobility of the system using optional wheels 트
- Increased system size with volume output of up to 240 lpm 트
- Operation outside of the medical facility rather than inside with patients l
- Application by the Department of Defense under deployed military scenarios. 트
Special Controls/Conformance to Recognized Standards
Deployable Oxygen Concentration System (DOCS) conforms to the recognized standard USP 24-NF 19 (through supplement Four, December 31,2001).
DOCS employs an integral oxygen analyzer to provide control of oxygen purity in accordance with the standard.
Summary of Performance Testing
Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the Deployable Oxygen Concentration System (DOCS), to demonstrate performance as intended and substantial equivalency to predicate devices. Testing involved the following areas:
- Purity .
- 트 Flow Rate
- 이 Electrical Safety
- 트 Mechanical
- Controls 미
- 비 Device Performance
Acceptance criteria were based on US Army specifications (USAMMA), and those established in voluntary standards.
In all instances the device met all required performance criteria and functioned as intended, metting the acceptance criteria.
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Image /page/4/Picture/0 description: The image shows a black and white logo that appears to be a stylized letter 'A'. The 'A' is formed by thick lines, with a horizontal line cutting across the middle, creating a unique design. The logo is simple, bold, and easily recognizable.
Conclusions
In summary, Pacific Consolidated Industries has demonstrated that the Deployable Oxygen m summary, I don't Consoneated included effective. The combined testing and analysis of results concontation of that the device meets its specifications, is safe and effective for its intended use, and is substantially equivalent to the currently marketed devices.
Truthfulness and Accuracy Statement
Partner of Pacific Consolidated Industries certifies that all data and information submitted in the pre-market notification are truthful and accurate and that no material fact has been omitted.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2002
Mr. Lee W. Smith Pacific Consolidated Industries LLP 3430 West Carriage Drive Santa Ana, CA 92704
Re: K020330
Deployable Oxygen Concentration System (DOCS) Regulation Number: 868.5440 Regulation Name: Generator, Oxygen, Portable Regulatory Class: II (two) Product Code: 73 CAW Dated: March 7, 2002 Received: March 8, 2002
Dear Mr. Smith:
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. In addition, if you wish to change or expand your current indications for use to include non-military environments. you will need to submit a new 510(k) premarket notifications, and receive FDA clearance prior to marketing the device.
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. Lee W. Smith
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 or unry 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 Of It Fut 00779 weeks (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 and additionally 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,
NObat Tilla
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Deployable Oxygen Concentration System
INDICATIONS FOR USE STATEMENT
510(k) Number: K020330
Name: Deployable Oxygen Concentration System (DOCS)
DOCS is intended to provide supplementary oxygen. The device is to be used by trained medical personnel for military use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020330
PACIFIC CONSOLIDATED INDUSTRIES
510(k) Number: K020330
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).