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510(k) Data Aggregation
(270 days)
The Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator that operates within the C4500 Compressor manufacturer specifications.
The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for medical
The Oricare C4500 Medical Air Compressor is a medical device designed to supply dry, filtered, and compressed air to medical ventilators. The submission provides a "Substantial Equivalence Summary" rather than a detailed study report with acceptance criteria and direct performance metrics. However, it implicitly demonstrates that the device meets acceptance criteria by establishing substantial equivalence to a legally marketed predicate device, the EKOM DK50 D Medical Compressor (K060781). This is achieved by comparing various operational and physical characteristics of the Oricare C4500 against those of the predicate device.
Here's an analysis based on the provided text, outlining the acceptance criteria (inferred from predicate device characteristics) and the reported performance of the Oricare C4500:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the specifications of the predicate device, the EKOM DK50 D Medical Compressor (K060781). The reported device performance is that of the Oricare C4500 Air Compressor, demonstrating that it either matches or has minor, non-adverse differences compared to the predicate.
| # | Item of Comparison | Acceptance Criteria (Predicate: EKOM DK50 D) | Reported Device Performance (Oricare C4500) | Discussion of Differences |
|---|---|---|---|---|
| 1 | Intended use | Supplying compressed air for medical ventilators. | Supply gas for critical care ventilator. | No differences |
| 2 | Indications for use | Clean, oil-free pressurized air for medical ventilators. | Dry filtered and compressed air to a Medical Ventilator. | No differences |
| 3 | Environment of Use | Medical Care Facilities | Medical Care Facilities | No Differences |
| 4 | Principle of operation | Compression, cooling, drying, filtering of oil-free air. | Compression, cooling, drying, filtering of oil-free air. | No Differences |
| 5 | Output flow/pressure | 40 l/min at 51 psig | 40 l/min at 50 psig | No Differences |
| 6 | Peak Flow | 200 lpm for 2 sec | 180 Lpm for 0.6 sec | No Differences (The slight difference in peak flow duration is considered non-significant for substantial equivalence). |
| 7 | Power | 120V/60 Hz | 115V/60 Hz | AC Mains line voltage varies from 103VAC to 127VAC. Both systems are within the range. |
| 8 | Power consumption | 5.6 A | Nominal current (amps) <600VA | Oricare device consumes slightly less power, meaning it is slightly more efficient. |
| 10 | Air filtration | 5 micron | 5 micron | No Difference |
| 11 | Pressure dew point | @ 40 Lpm 20°C - 5°C below ambient temperature | @ 40 Lpm 3°C below ambient temperature | No real discernible difference. |
| 12 | Outlet connection | DISS | 1- DISS | No Difference |
| 13 | Sound level | < 51 dB(A) | < 52 dB(A) | No real discernible difference. An increase in the dB(A) provides an advantage to the user for alarm annunciation. |
| 14 | Mode of operation | Continuous - SI | Continuous - SI | No Difference |
| 15 | Separation of condensed water | Automatic | Automatic | No Difference |
| 16 | Operating pressure of safety valve | 116 psig | 65 psig | Device regulates pressure at 40 psig. The lower safety valve pressure is still well above the operating pressure. |
| 17 | Adjustment of pressure | Pressure regulator | Pressure regulator | No Difference |
| 18 | Alarm for cooling failure / high temp | Acoustic and optical if increase in internal temp > 80°C | Acoustic and optical if increase in internal temp > 80°C | No Difference |
| 19 | Automatic turn-on pressure | When central distribution pressure < 40.6 psig | When central distribution pressure < 40.6 psig | No Difference |
| 20 | Output pressure | Pressure gauge | Pressure gauge | No Difference |
| 21 | Alarm - loss of power | No, but instructions require connection to equipment with this alarm | Yes | Advantage for Oricare product safety. |
| 22 | Additional Visual Indicators | Not included | "AC Power" light, "Ready" light, "Air Source - Wall" light | Safety Advantage for determining AC Mains Power is connected. |
| 23 | Indication of drying | Pressure gauge | None | Design includes chiller and external water trap to remove excess moisture, thus an explicit drying indication is not deemed necessary. |
| 24 | Alarm for low pressure | None, instructions require connection to equipment with this alarm | Yes, triggers when output pressure <25.4 psig | Oricare device does not rely on 3rd party device to be connected, providing an advantage. |
| 25 | Material in gas pathway | Aluminum, brass, nickel plated brass, polyurethane and silicon tubing, copper tubing, Plastic (PA, PET, POM, PBT, PC, Acetyl, Polyester), polyurethane foam, NBR rubber, Stainless steel, die cast zinc | Aluminum, brass, nickel plated brass, polyurethane and silicon tubing, copper tubing, Plastic (PA, PET, POM, PBT, PC, Acetyl, Polyester), polyurethane foam, NBR rubber, Stainless steel, die cast zinc | No Difference |
| 26 | Air tank capacity | 5L | 2L | Excess capacity not needed to supply sufficient peak flow. Predicate device is larger because extra capacity requires additional weight and physical size, making the Oricare's smaller capacity an advantage. |
| 27 | Compressor Type | Oil free piston and ring- positive | Oil free wobble type rocker piston- positive | No Difference |
| 28 | Type of lubrication | Oil-less | Oil-less | No Difference |
| 29 | Ambient Environment | 41 to 104 degrees F; up to 95% RH | 50 to 104 degrees F; 15 – 90% RH | Oricare device range is typical of many ventilators. The narrower humidity range is not considered an adverse difference. |
| 30 | Dimensions | 19(L)x20(W)x33(H) in | 16.22 (L)x17.4(W)x15.75(H) in | Oricare device is smaller. This is an advantage. |
| 31 | Weight | 101 lbs | 66 lbs | Oricare device is lighter. This is an advantage. |
| 32 | Electrical Safety | EN 60601-1 | IEC 60601-1:1988, +A1:1991, +A2:1995 | No difference, both comply (IEC 60601-1 is the international standard from which EN 60601-1 is derived). |
| 33 | Mechanical Safety | EN 60601-1 | IEC 60601-1:1988, +A1:1991, +A2:1995 | No difference, both comply. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes a "Substantial Equivalence Summary" based on a comparison to a predicate device and compliance with recognized standards. This is not a study in the typical sense of testing a specific sample size of the device to collect performance data from the field. Instead, it's a design and engineering comparison.
- Test Set Sample Size: The document does not specify a "test set" in the context of a clinical trial or a large-scale performance study with a numerical sample size. The testing appears to be functional and safety testing as part of design verification, likely performed on a limited number of engineering or production units.
- Data Provenance: The data primarily comes from device testing described as having been done "in accordance with various recognized standards, including ISO 10993-1:1999, AAMI BI79:1995 and IEC 60601-2-2:2007." Additionally, Air Purity Testing was conducted. This indicates the testing was likely done in a prospective manner during the device development and verification phase by Oricare, Inc. or its designated testing facilities, presumably in the USA (where Oricare, Inc. is based and the 510(k) was submitted). The "comparison to predicate device" serves as the primary "data" for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (510(k) for a medical air compressor) typically does not involve a "ground truth" derived from expert consensus in the same way a diagnostic AI algorithm would. The "ground truth" for a device like this would be established through engineering specifications, regulatory standards, and objective physical measurements.
- Number of Experts: Not applicable in the context of expert human review for ground truth
- Qualifications of Experts: N/A for this type of device submission
4. Adjudication Method for the Test Set
Again, this is not applicable for a device of this nature where objective engineering and performance specifications are the "truth." There is no mention of "adjudication" in the context of resolving differing expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. The Oricare C4500 is an air compressor, not a diagnostic device, and does not involve human interpretation or AI assistance in a diagnostic capacity.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is an air compressor, not an algorithm, and therefore doesn't have "standalone" algorithm performance to be assessed. Its performance is measured directly by its physical output and adherence to specifications.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on:
- Objective Engineering Specifications: The technical requirements and design parameters of the device (e.g., flow rate, pressure, power consumption, filtration).
- Compliance with Recognized Standards: Verification that the device meets relevant national and international medical device performance and safety standards (e.g., ISO 10993-1, AAMI BI79, IEC 60601-1).
- Bench Testing and Performance Data: Direct measurements of the device's output and characteristics (e.g., air purity through air testing, sound level, temperature performance).
- Predicate Device Specifications: The established performance and safety characteristics of the legally marketed EKOM DK50 D Medical Compressor, which serves as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
- Not applicable. This device is an air compressor and does not involve AI or machine learning that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. Since there is no training set, there is no ground truth established for one.
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(128 days)
The Independence™ Medical Air Compressor is indicated for use as a Medical Air Compressor providing compressed air to ventilators.
The Independence™ Medical Air Compressor is a Class II device, "Portable Air Compressor'', per 21 CFR Part 868.6250. This device is designated a Class I. Type B equipment per IEC 60601-1.
The Independence™ Medical Air Compressor is an air compressor for use in intensive care units or the recovery rooms of clinics, hospitals and hospital-type facilities which delivers filtered, oil-free and dehumidified compressed air to ventilators. Using the integrated backup function, the Independence™ Medical Air Compressor can be connected between an existing air supply network and a ventilator. If the compressed air from the air supply network fails, the Independence™ Medical Air Compressor automatically starts and supplies compressed air to the ventilator.
The provided text describes a Medical Air Compressor and its regulatory clearance, not an AI/ML device. Therefore, many of the requested criteria related to AI/ML device evaluation (such as expert adjudication, MRMC studies, standalone performance, and training/test set details) are not applicable to this document.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a quantitative "acceptance criteria" table in the way one might expect for an AI/ML device that generates specific performance metrics (e.g., sensitivity, specificity). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and compliance with voluntary and international standards.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| 1. Substantial Equivalence to Predicate Device (Drager Inc. Medical Air Compressor, Model 98, K982789) | - Intended Use: "The intended use of the Independence™ Medical Air Compressor is the same as that for standard, currently marketed medical air compressors." - Materials and Design: "The materials and design of this device are similar to those of the predicate device (Drager Inc. Medical Air Compressor, Model 98, K982789)." - Technical Characteristics: "The technical characteristics of the Independence™ Medical Air Compressor do not introduce new questions regarding safety or effectiveness." - Labeling: "the labeling associated with the Independence™ Medical Air Compressor provides similar information as the predicate device." |
| 2. Safety and Effectiveness | - Performance Testing: "Performance testing was conducted per internal, company requirements." - Environmental and EMC Testing: "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)." - Compliance with Standards: "The Independence™ Compressor device is also compliant with various voluntary and international standards including: IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive." - Overall Conclusion: "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." and "In summary eVent Medical Ltd. has demonstrated the Independence™ Medical Air Compressor to be safe and effective." |
| 3. Regulatory Classification | - Classification: Class II per 21 CFR 868.6250, Portable Air Compressor. (Matches predicate and regulatory requirements). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a medical air compressor, "test set" would likely refer to engineering validation and verification tests, not a clinical data set.
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)
This is not applicable as the device is a medical air compressor, not an AI/ML diagnostic tool requiring expert ground truth in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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. The device is an air compressor, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a medical air compressor, "ground truth" would be related to engineering specifications and performance metrics. The document states:
- "Performance testing was conducted per internal, company requirements."
- "environmental and electromagnetic compatibility testing has been successfully completed in accordance with the requirements of the FDA's draft Reviewer Guidance for PreMarket Notification Submissions document (Nov '93)."
- Compliance with "IEC 60601-1:1990, IEC 60601-1-2:1993 and 93/42/EEC Medical Device Directive."
Therefore, the "ground truth" or reference standards are the engineering specifications, regulatory guidance documents, and international voluntary standards.
8. The sample size for the training set
This is not applicable as the device is not an AI/ML product that learns from training data.
9. How the ground truth for the training set was established
This is not applicable as the device is not an AI/ML product.
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(80 days)
Air compressor supplying compressed air for medical ventilators.
The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.
This K982789 submission is for a Medical Air Compressor "Model 98", not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, and standalone performance, are not applicable.
The submission focuses on establishing substantial equivalence to a legally marketed predicate device, the Dräger Medical Air Compressor (K951126), through a comparison of specifications and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the "Medical Air Compressor Model 98" were based on demonstrating substantial equivalence to its predicate device, the "Medical Air Compressor (K 951126)". The reported performance for the new device matches the criteria set by the predicate.
| Specification | Acceptance Criteria (from Predicate Device K951126) | Reported Device Performance (Medical Air Compressor Model 98) |
|---|---|---|
| Intended Use | Air compressor supplying compressed air for medical respirators | Air compressor supplying compressed air for medical respirators |
| Safety: | ||
| High temperature alarm? | Yes | Yes |
| Audible alarm? | Yes | Yes |
| Visible alarm? | Yes | Yes |
| Main Fuses? | Yes | Yes |
| Performance Characteristics: | ||
| Dew point depression: below room temperature? | Yes | Yes |
| Air quality: Dust and oil free? | Yes | Yes |
| Installed filter? | Yes | Yes |
| Standby-Mode? | Yes | Yes |
| Operating Characteristics | Substantially equivalent to predicate | All operating characteristics of both devices are substantially equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a conventional medical device without AI/ML components. The evaluation method relies on direct comparison of specifications and functionality rather than data-driven performance metrics on a test set.
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. This is a conventional medical device. Ground truth as typically defined for AI/ML devices is not relevant here. The evaluation is based on engineering specifications and adherence to existing medical device standards.
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 a conventional medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a conventional medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this conventional device, the "ground truth" for demonstrating substantial equivalence is the established specifications, performance characteristics, and safety features of the predicate device (Dräger Medical Air Compressor K951126), as well as relevant medical device standards. The "Model 98" is deemed acceptable if it meets or matches these established benchmarks.
8. The sample size for the training set
Not applicable. This is a conventional medical device.
9. How the ground truth for the training set was established
Not applicable. This is a conventional medical device.
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