(14 days)
Not Found
No
The device description focuses on mechanical pressure regulation and proportioning of gases, with no mention of computational processing, algorithms, or learning capabilities.
Yes
The device mixes medical grade air and oxygen for delivery to patients through respiratory care equipment, which constitutes a therapeutic application.
No
The device is described as a "precision pressure regulation and proportioning device" that mixes medical air and oxygen for delivery to patients. It does not perform any diagnostic functions or analyze patient data to determine a medical condition.
No
The device description clearly details a physical hardware device (pressure regulation and proportioning device, inlet/outlet connections, flowmeters, hoses) designed to mix gases, not a software-only application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mix medical gases for delivery to patients through respiratory care equipment. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details a device that regulates and proportions gases. It does not mention any analysis of biological samples or diagnostic testing.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on preparing and delivering gases for respiratory support.
N/A
Intended Use / Indications for Use
The intended use of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.
Product codes
73 BZR
Device Description
The Sechrist Series 3500HL Air-Oxygen Mixer is a precision pressure regulation and proportioning device which is designed to mix medical air with medical oxygen, for delivery to patients through a variety of respiratory care equipment.
The mixer receives air and oxygen at a nominal 50 psi via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi providing the pressures are within 20 psi of one another.
Two outlets for the mixed gas are provided. One is located on the side of the unit for the convenient connection of a flowmeter. The second outlet may be used to power other respiratory or cardiopulmonary care equipment requiring a controlled FI02.
The air-oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses. Flowmeters may also be purchased separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified personnel
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).
0
AUG 10 1999
510(K) SUMMARY 7-13-99
Device Name:
| Classification Name: | Breathing gas mixer |
|---|---|
| Common Name: | Gas Mixer |
| Proprietary Name: | Sechrist Air-Oxygen Mixer |
| Devices to which | |
| Equivalence is Claimed: | Sechrist Air-Oxygen Mixer K802226 |
| Contact: | Greg Godfrey, Vice President |
| Quality Assurance & Regulatory Affairs | |
| 4225 E. La Palma Avenue | |
| Anaheim, CA 92807 | |
| Phone: (714) 579-8400 Fax: (714) 579-0814 |
Indication for Use
The intended use of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.
Device Description
The Sechrist Series 3500HL Air-Oxygen Mixer is a precision pressure regulation and proportioning device which is designed to mix medical air with medical oxygen, for delivery to patients through a variety of respiratory care equipment.
The mixer receives air and oxygen at a nominal 50 psi via Diameter Index Safety System (D.I.S.S.) inlet connections. The unit will operate satisfactorily with inlet pressures of 30 to 70 psi providing the pressures are within 20 psi of one another.
Two outlets for the mixed gas are provided. One is located on the side of the unit for the convenient connection of a flowmeter. The second outlet may be used to power other respiratory or cardiopulmonary care equipment requiring a controlled FI02.
The air-oxygen mixers are configured with zero to three flowmeters. Accessories include air and oxygen hoses. Flowmeters may also be purchased separately.
Performance Standards
A performance standard regulation under Section 514 of the Food, Drug and Cosmetic Act has not been promulgated for this device type. However, the device is designed and manufactured in accordance with the following national and international standards:
| ISO 9001 | Quality Assurance Standard |
|---|---|
| ISO 13485 | Quality System Medical Devices |
| EN 46001 | Application of ISO 9001 to manufacturer of medical devices |
| 21CFR820 | Quality Systems Regulation |
: 天
1
510(K) SUMMARY 7-13-99
Summary of Substantial Equivalence
Flowmeter options were added to enable the user to adjust and control the gas flow rate. Additional specifications, not specified in the original 510(k), were also added to the User's Manual and include the following: high and low flow mixer specifications, nominal supply pressure, and bleed flows for high and low flow mixer configurations. There have been no changes in the material, technology, or intended use of the device.
Conclusion
Modifications made to the cleared device include flowmeter options and corresponding labeling changes made to the User's Manual that were not contained in the original 510(k). These changes do not affect the intended use or alter the fundamental scientific technology of the device. Therefore, the modified device is substantially equivalent to the cleared device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of a bird or other winged creature, with three lines representing the wings and a wavy line representing the body. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 10 1999
Mr. Greq Godfrey Sechrist Industries, Inc. 4225 E. La Palma Avenue Anaheim, CA 92807
Re: K992503 Air-Oxygen Mixer Regulatory Class: II (two) Product Code: 73 BZR Dated: July 23, 1999 Received: July 27, 1999
Dear Mr. Godfrey:
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 reqistration, 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 Requlations, 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 requlation (21 CFR Part 820) and that, through periodic QS 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 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.
3
Page 2 - Mr. Greg Godfrey
This letter will allow you to beqin 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) 594-4648. 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"(21 CFR 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,
sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):_K802226
Device Name: Sechrist 3500/3500HL Series Air-Oxygen Mixer
Indications for Use:
The purpose of the device is to enable qualified personnel to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery to patients through various types of respiratory care equipment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Jotwewkshausen 8.10.99 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter |
|---|---|---|
| ------------------------------------------ | ---- | ------------------ |
| Division Sign-Off) |
|---|
| Division of Cardiovascular, Respiratory, |
| and Neurological Devices |
| 510(k) Number | |
|---|---|
| --------------- | -- |
(Optional Format 1-1-96)
Sechrist Industries, Inc. Special 510(k) Air-Oxygen Mixer