(147 days)
The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.
The Essex MR Conditional CGA 870 pressure regulator is designed to be installed on a medical CGA 870 post valve cylinder, regulate high pressure oxygen from 500 to 2,000 psig nominal, deliver a specific amount of oxygen to an attached flow selector, and be ignition resistant.
The device consists of:
- A yoke style inlet fitting per CGA 870.
- A pressure regulator section is to reduce the pressure from 500-2,000 psig to 50 psig nominal.
- A flow selector valve to control the flow at the regulated pressure between 0 and 25 L/min.
- Made of materials which meet the MR Conditional requirements of ASTM F2052-15.
This is identical to our Class I, exempt model CGA 870 except for different materials to allow for the device to meet the ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
This document is a 510(k) Pre-market Notification for a medical device called the "MR Conditional CGA 870" pressure regulator. The device is intended for use with portable oxygen delivery systems for adults in various healthcare settings, including during MRI imaging.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a single, clear format as would typically be found in a study report. Instead, it lists various non-clinical tests performed according to recognized standards. The "acceptance criteria" are implied by compliance with these standards, and the "reported device performance" is indicated by the statement that the device meets or is found to be substantially equivalent to these standards and the predicate device.
However, based on the Non-clinical Testing Summary and the Bench Testing sections, we can infer some criteria and the device's claimed performance:
| Acceptance Criteria (Implied by Standard Compliance) | Reported Device Performance (Claimed) |
|---|---|
| CGA E-4: Standard for Gas Pressure Regulators | Compliant |
| - Operating Temperature Range | Meets standard |
| - Resistance to Ignition (Oxygen Service) | Meets standard |
| - Gas Tightness | Meets standard |
| - Mechanical Resistance | Meets standard |
| - Endurance | Meets standard |
| - Pressure Relief Devices (par 5.4) | Meets standard |
| - Pressure Regulation Coefficient, i (par 6.1) | Meets standard |
| - Static Increment, SI (par 6.2) | Meets standard |
| - Flow Regulation (par 6.3) | Meets standard |
| - Flow Capacity (par 6.4) | Meets standard |
| CGA E-7: American National Standard for Medical Gas Regulators and Flowmeters | Compliant |
| - Relief Valves (par 5.4) | Meets standard |
| - Minimum Burst Strength (par 5.6.1) | Meets standard |
| - Leakage (par 5.6.2) | Meets standard |
| - Temperature for Storage and Operation (par 5.7) | Meets standard |
| ISO 10524: Pressure Regulators and Pressure Regulators with Flow-Metering Devices for Medical Gas Systems | Compliant |
| - Pressure relief valve (par 7.3) | Meets standard |
| - Resistance to ignition (par 7.5) | Meets standard |
| - Gas tightness (par 7.8) | Meets standard |
| - Mechanical resistance (high pressure section burst) (par 7.9.3) | Meets standard |
| - Mechanical resistance (low pressure section burst) (par 7.9.4) | Meets standard |
| - Environmental temperatures (par 8.0) | Meets standard |
| EN 738-1: Pressure Regulators for use with Medical Gases | Compliant |
| - Performance, functional, and flow characteristics (par 5.4.2.7) | Meets standard |
| - Relief valve (par 5.4.2.8) | Meets standard |
| - Leakage (par 5.4.2.9) | Meets standard |
| - Mechanical Strength (par 5.4.2.10) | Meets standard |
| - Resistance to ignition (par 5.4.2.11) | Meets standard |
| ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment | MR-conditional for static magnetic fields of 3.0T or less (Meets standard) |
| Biocompatibility (VOC and PM2.5) | Materials were found to be biocompatible for their intended use. |
| Overall Comparison for Substantial Equivalence | Found to be substantially equivalent to predicate and reference devices in performance, intended use, and technical characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes (e.g., number of devices tested) for the non-clinical tests performed. It generally states that "a number of tests appropriate for the proposed device" were performed.
- Data Provenance: The tests are "Non-clinical Testing" and "Bench Testing," implying they were conducted in a laboratory setting by the manufacturer (Essex Industries, Inc.). The data is prospective in the sense that it was generated specifically for this 510(k) submission. There is no mention of country of origin for the data other than the manufacturer being based in the U.S.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document describes non-clinical, bench testing of a hardware device. Ground truth, in the context of expert review, typically applies to studies involving interpretation (e.g., medical imaging, clinical assessments) where human experts determine a definitive diagnosis or finding. For hardware performance, the "ground truth" is typically defined by the test methods and acceptance criteria within the referenced engineering standards.
4. Adjudication Method for the Test Set
This is not applicable for the same reason as above. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving human assessment to resolve discrepancies in expert opinions. The testing described here is objective measurement against established engineering standards.
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
This is not applicable. An MRMC study is a type of clinical comparative effectiveness study, usually for diagnostic devices, that assesses the performance of human readers (e.g., radiologists) with and without the assistance of a new diagnostic tool (often AI). The "MR Conditional CGA 870" is a physical medical device (pressure regulator) and not an AI-powered diagnostic tool, nor does it involve human readers for interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This question pertains to the performance of artificial intelligence algorithms. The device described in the document is a mechanical pressure regulator.
7. The Type of Ground Truth Used
For this device, the "ground truth" for evaluating its performance is based on established engineering standards and specifications. The device's performance characteristics (e.g., pressure regulation, flow rates, mechanical resistance, ignition resistance, MR-conditionality) are measured directly against the quantifiable requirements outlined in standards like CGA E-4, CGA E-7, ISO 10524, EN 738-1, and ASTM F2052-15. Biocompatibility was assessed against relevant criteria (VOC and PM2.5).
8. The Sample Size for the Training Set
This is not applicable. The concept of a "training set" refers to data used to train machine learning models. This document describes the evaluation of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Essex Industries, Inc. % Paul Dryden Consultant 7700 Gravois St. Louis, Missouri 63123
Re: K162811
Trade/Device Name: MR Conditional CGA 870 Regulation Number: 21 CFR 868.2700 Regulation Name: Pressure Regulator Regulatory Class: Class I Product Code: CAN Dated: January 27, 2017 Received: January 31, 2017
Dear Paul Dryden:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Lori A. Wiggins -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162811
Device Name MR Conditional CGA 870
Indications for Use (Describe)
The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Page 1 of 6 3/2/2017
Essex Industries, Inc. 7700 Gravois St. Louis, MO 63123
| Official Contact: | Russ Jacobsmeyer - Vice President of EngineeringTel – 314.338.8723 |
|---|---|
| Proprietary or Trade Name: | Essex MR Conditional CGA 870 |
| Common/Usual Name: | Cylinder, Compressed Gas, and Valve |
| Classification Name/Code: | CAN - Cylinder, Compressed Gas, and ValveClass I, 21 CFR 868.2700 |
| Predicate Device:Reference Device: | Essex CGA 870 oxygen pressure regulator (Class 1, exempt)K101792 – Linde – LIV Portable Oxygen System |
Device Description:
The Essex MR Conditional CGA 870 pressure regulator is designed to be installed on a medical CGA 870 post valve cylinder, regulate high pressure oxygen from 500 to 2,000 psig nominal, deliver a specific amount of oxygen to an attached flow selector, and be ignition resistant.
The device consists of:
- A yoke style inlet fitting per CGA 870. .
- The regulator can be installed on any cylinder with a CGA 870 connection. O
- A pressure regulator section is to reduce the pressure from 500-2,000 psig to 50 psig nominal. ●
- A flow selector valve to control the flow at the regulated pressure between 0 and 25 L/min. ●
- Made of materials which meet the MR Conditional requirements of ASTM F2052-15.
This is identical to our Class I, exempt model CGA 870 except for different materials to allow for the device to meet the ASTM F2052-15 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
Indications for Use:
The Essex MR Conditional CGA 870 pressure regulators are used with a portable oxygen delivery system intended to provide supplemental oxygen to adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and may be used during MR imaging for static magnetic fields of 3.0 T or less.
Environments of Use: Their environments of use include all healthcare settings including:
- Hospital, including intra-hospital transport ●
- Outpatient
- Imaging center (MRI Suite) ●
- Pre-hospital ●
Contraindications: None.
Summary of substantial equivalence
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510(k) Summary Page 2 of 6 3/2/2017
The proposed device has been compared to the predicate Essex CGA 870 oxygen pressure regulator (Class 1, exempt) for the technical characteristics, see Table 1 and the reference device for environment of use, MR Conditional, and see Table 2.
Device Comparison
| Description | Predicate | Subject Device |
|---|---|---|
| CGA 870 Device, Class I, exempt | MR Conditional CGA 870 | |
| Device Name | CGA 870 | MR Conditional CGA 870 |
| Device Classification& Product code | Class I / CAN | Class I / CAN |
| Prescription Device | Yes | Yes |
| Indications for Use | The Essex CGA 870 pressure regulatoris a portable oxygen delivery systemintended to provide supplementaloxygen too pediatrics and adults inhospital, sub-acute care, and pre-hospital/ ground transport settings. | The Essex MR Conditional CGA 870pressure regulators are used with aportable oxygen delivery systemintended to provide supplementaloxygen to adults in hospital, sub-acutecare, and pre-hospital / groundtransport settings. It is offered inmodels that are MR-conditional (perASTM F2052-15), and may be usedduring MR imaging for static magneticfields of 3.0 T or less. |
| Flow selector andFlow Outlet | Yes | Yes |
| Fixed pressureoutlet | Yes ~ 50 psig | Yes ~ 50 psig |
| Cylinder On/Off | Yes | Yes |
| Filling Port | NoWhen cylinder is empty the device isattached to a new cylinder | NoWhen cylinder is empty the device isattached to a new cylinder |
| Contents Gauge | Yes / active | Yes / active |
| Excess Flow | No | No |
| Burst Disk | Burst Disk is located on the cylinderpost valve. | Burst Disk is located on the cylinderpost valve. |
| Single stage pistontype | Yes | Yes |
| MR Conditional | N/A | 3.0 Tesla or less |
| Pressure Inlet | 2000 psig | 2000 psig |
| Flow rates | 0-25 L/min | 0-25 L/min |
| Operating Pressurerange | 500-2000 psig | 500-2000 psig |
| OperatingTemperature Range | -20°F to 130°F | -20°F to 130°F |
Table 1 - Comparison of Predicate Essex CGA 870 to the Subject Device -MR Conditional CGA 870
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510(k) Summary Page 3 of 6 3/2/2017
| Description | Predicate | Subject Device |
|---|---|---|
| Standards | CGA 870 Device, Class I, exempt | MR Conditional CGA 870 |
| ISO 10524-1 | ISO 10524-1 | |
| CGA E-4 | CGA E-4 | |
| CGA E-7 | CGA E-7 | |
| EN 738-1 | EN 738-1 | |
| ASTM F2052-15 | ||
| Biocompatibility | Externally communicating, Tissue, | Externally communicating, Tissue, |
| Permanent duration | Permanent duration | |
| VOC | VOC | |
| PM2.5 | PM2.5 |
Table 2 - Comparison of Reference Linde LIV (K101792) to the Subject Device -MR Conditional CG 870
| Description | Reference Device | Subject Device |
|---|---|---|
| Linde LIV - K101792 | MR Conditional CGA 870 | |
| Device Name | LIV | MR Conditional CGA 870 |
| Device Classification& Product code | Unclassified/ECX | Class I / CAN |
| Prescription Device | Yes | Yes |
| Indications for Use | The LIV is an integrated portable oxygendelivery system intended to providesupplemental oxygen to pediatrics andadults. The device is MR-conditional (perASTM F2503-05*), and intended for useduring MR imaging for MRI systems up to3.0T.Compressed gas cylinders in service or instorage shall be stabilized or otherwisesecured to prevent falling and rolling. | The Essex MR Conditional CGA 870pressure regulators are used with aportable oxygen delivery system intendedto provide supplemental oxygen to adultsin hospital, sub-acute care, and pre-hospital / ground transport settings. It isoffered in models that are MR-conditional(per ASTM F2052-15), and may be usedduring MR imaging for static magneticfields of 3.0 T or less. |
| Flow selector andFlow Outlet | Yes | Yes |
| Fixed pressureoutlet | Yes ~ 50 psig | Yes ~ 50 psig |
| Cylinder On/Off | Yes | Yes |
| Filling Port | Yes | When cylinder is empty the device isattached to a new cylinder |
| Contents Gauge | Yes / active | Yes / active |
| Excess Flow | No | No |
| Burst Disk | Yes integral to the system | Burst Disk is located on the cylinder postvalve. |
| Single stage pistontype | Yes | Yes |
| Hand grip | Yes | No |
| Access ports | Yes | No |
| MR Conditional | 3.0 Tesla | 3.0 Tesla or less |
| Pressure Inlet | 2000 psig | 2000 psig |
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510(k) Summary Page 4 of 6 3/2/2017
| Description | Reference Device | Subject Device |
|---|---|---|
| Linde LIV - K101792 | MR Conditional CGA 870 | |
| DISS 1240 fittings | Yes | NoNot applicable |
| Flow rates | 0-25 L/min | 0-25 L/min |
| Operating Pressure range | Up to 3000 psig | 500-2000 psig |
| Operating Temperature Range | -20°F to 130°F | |
| ISO 10524-3ASTM G173-03CGA E-7CGA 540ASTM F2503-05* | ISO 10524-1CGA E-4CGA E-7EN 738-1ASTM F2052-15* | |
| Standards | ||
| Biocompatibility | Externally communicating, Tissue,Permanent duration | Externally communicating, Tissue,Permanent durationVOCPM2.5 |
*Note ASTM F2503-05 is a device marking and labeling standard whereas ASTM F2052-15 is the Testing and Performance standard.
The proposed MR Conditional CGA 870 is viewed as substantially equivalent to the predicate device for the performance, intended use and technical characteristics and the reference device for the addition of the MR conditional environment of use. In the tables above, we have outlined the similarities and differences, if any, between the subject device, the predicate and reference devices.
Indications -
- The MR Conditional CGA 870 is a standalone oxygen pressure regulator intended to provide supplemental oxygen.
- Discussion - The indications for the predicate and reference are similar with the predicate. One can find the indications for use to be similar and the differences do not raise any concerns of safety or effectiveness compared to the predicate or reference devices.
Patient Population -
- It is intended for adult patients requiring supplemental oxygen ●
- Discussion The patient population is similar to the predicate and reference device. There are ● no differences that raise any concerns of safety or effectiveness compared to the predicate or reference devices.
Environment of Use -
- For use in all healthcare settings hospitals, ambulatory, imaging centers, pre-hospital. ●
- Discussion The environments of use are similar to the predicate and reference devices. The . addition of MR Conditional use has been demonstrated to meet the standard which would not raise any new concerns of safety and effectiveness.
Technology -
- The principle of pressure regulating is based upon a single stage piston style with adjustable flow rates, flow gauge, burst disk and use of a separate cylinder.
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510(k) Summary Page 5 of 6 3/2/2017
- . Discussion - This technology is identical to the predicate device and similar to the reference.
Differences
The only difference between the reference and the subject device is the change in materials to be MR Conditional. The difference between the reference and the subject device is that the predicate is an integrated regulator and the subject device is not. Discussion - These differences do not raise any new concerns of safety or effectiveness.
Non-clinical Testing Summary -
We have performed a number of tests appropriate for the proposed device. These tests include:
- CGA E-4: Standard for Gas Pressure Regulators ●
- o par. 4.1 Operating Temperature Range
- par. 4.2.2.3 Resistance to Ignition (Oxygen Service) O
- par. 4.4 Gas Tightness O
- par. 4.5 Mechanical Resistance O
- par. 4.6 Endurance O
- par. 5.4 Pressure Relief Devices O
- par. 6.1 Pressure Regulation Coefficient, i O
- par. 6.2 Static Increment, SI O
- par. 6.3 Flow Regulation O
- par. 6.4 Flow Capacity O
- o par. 4.1 Operating Temperature Range
- CGA E-7: American National Standard for Medical Gas Regulators and Flowmeters ●
- par. 5.4 Relief Valves റ
- par. 5.6.1 Minimum Burst Strength O
- par. 5.6.2 Leakage o
- o par. 5.7 Temperature for Storage and Operation
- ISO 10524: Pressure Regulators and Pressure Regulators with Flow-Metering Devices for Medical Gas Systems
- o par. 7.3 Pressure relief valve
- par. 7.5 Resistance to ignition O
- par. 7.8 Gas tightness O
- par. 7.9.3 Mechanical resistance (high pressure section burst) O
- par. 7.9.4 Mechanical resistance (low pressure section burst) O
- par. 8.0 Environmental temperatures O
- EN 738-1: Pressure Regulators for use with Medical Gases ●
- par. 5.4.2.7 Performance, functional, and flow characteristics o
- O par. 5.4.2.8 Relief valve
- par. 5.4.2.9 Leakage o
- par. 5.4.2.10 Mechanical Strength O
- par. 5.4.2.11 Resistance to ignition O
- MR Conditional Testing per ASTM F2052-15 (Note testing was done according to ASTM ● F2052-06 but there are no testing differences between the 2006 version and the 2015 version.
- Biocompatibility (VOC and PM2.5) ●
Bench Testing -
- The performance testing is based upon standards for material, construction, ignition, MRI ● compatibility, and accuracy.
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510(k) Summary Page 6 of 6 3/2/2017
- . Discussion - Based upon the testing and comparison to the standards, we can find the subject device and the predicate and reference devices to be substantially equivalent.
Biocompatibility of Materials -
- ISO 10993-1 would consider the materials in the gas pathway as - Externally communicating, Tissue / Dentin / Bone contact, Permanent Duration.
- The materials were evaluated per CGA E-4 for ignition and for biocompatibility via VOC and . PM23.5 The testing demonstrated that the materials were biocompatible for their intended use.
- Discussion – The materials were found to be compatible for their intended use and identical to the reference.
Animal Testing:
There was no animal testing.
Clinical Testing:
There was no clinical testing.
Substantial Equivalence Conclusion:
The sponsor has demonstrated through performance testing and non-clinical testing that the proposed device is substantially equivalent to the predicate and reference devices.
§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general 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.