(342 days)
The Anodyne TM CC Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
The HEYER America® Anodyne™ CC Anesthesia System is a standalone anesthesia device. The device is a reusable, non-sterile, life-supporting anesthesia machine for prescription use in hospitals, clinics and surgery centers. The device is software driven. Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device. The device is electrically operated.
The provided text describes the Heyer America® Anodyne™ CC Anesthesia System and its comparison to predicate devices for 510(k) clearance. However, it does not contain a study specifically designed to establish acceptance criteria or prove device performance through clinical trials with human subjects, statistical analysis, or defined ground truth establishment methods.
Instead, the document focuses on a performance comparison with predicate devices based on technical specifications and functional capabilities. The core argument for safety and effectiveness relies on substantial equivalence to existing, legally marketed anesthesia systems.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study (e.g., target sensitivity/specificity). Instead, it presents a comparison of the Anodyne™ CC's technical specifications and performance parameters against two predicate devices (Narkomed® 2C and Modulus® II Plus). The implied "acceptance criterion" is that the Anodyne™ CC's performance should be comparable to or within the established ranges of these predicate devices.
| Parameter | Anodyne™ CC Reported Performance | Predicate Device 1 (Narkomed® 2C) Performance | Predicate Device 2 (Modulus® II Plus) Performance |
|---|---|---|---|
| Ventilator Performance | |||
| Tidal volume range (Total) | 50 - 1,400 ml | 50 - 1,500 ml | 50 - 1,500 ml |
| Tidal volume range (Pediatric) | 50 - 400 ml | 50 - 300 ml | 50 - 300 ml |
| Tidal volume range (Adult) | 300 - 1,400 ml | 300 - 1,500 ml | 300 - 1,500 ml |
| Frequency range (Total) | 2 - 99 BPM | 1 - 99 BPM | 2 - 100 BPM |
| Frequency range (Pediatric) | 20 - 99 BPM | 1 - 99 BPM | 2 - 100 BPM |
| Frequency range (Adult) | 2 - 30 BPM | 1 - 99 BPM | 2 - 100 BPM |
| I:E Ratio range | 1:3, 1:2, 1:1.5, 1:1, 2:1, 3:1 | 1:4.5, 1:4, 1:3.5, 1:3, 1:2.5, 1:2, 1:1.5, 1:1 | dependent variable |
| Insp. Flow Range | dependent variable | 10 - 33 l/min | 10 - 100 l/min |
| Insp. Pause | 20%, 30% | - | 25% |
| Sigh | 1 of 100, 1.5 * Vt | - | - |
| Pressure limit range | 10 - 100 cmH2O | 15 - 120 cmH2O | 20 - 100 cmH2O |
| Airway Pressure Monitor | |||
| Pressure range | -10 - 100 cmH2O | -10 - 70 cmH2O | -20 - 120 cmH2O |
| High Alarm limits | 10 - 100 cmH2O | 10 - 70 cmH2O | 20 - 100 cmH2O |
| Sustain Alarm limits | 2 - 30 cmH2O | 10 - 30 cmH2O | 10 - 30 cmH2O |
| Spirometer / Volume Monitor | |||
| Tidal volume range | 20 - 9,999 ml | 70 - 9,999 ml | 0 - 9,999 ml |
| Breath rate range | 0 - 99 BPM | 3 - 50 BPM | 0 - 99 BPM |
| Minute Volume range | 0.1 - 999.9 l/min | 0 - 999.9 l/min | 0 - 999.9 l/min |
| Tidal v. Low Alarm limits | 20 - 1,400 ml | 70 - 1,500 ml | - |
| Minute v. Low Alarm limits | 0.5 - 5 L/min | 0.5 - 10 L/min | 0 - 9.9 L/min |
| Low rate Alarm limits | 2 - 30 BPM | - | - |
| High rate Alarm limits | 10 - 99 BPM | - | - |
| Oxygen Monitor Performance | |||
| Concentration range | 0 - 100 Vol% | 0 - 100 Vol% | 0 - 105 Vol% |
| Response time T90 | 15 sec | 20 sec | 15 sec |
| Sensor Life | 12 months | 12 months | 12 months |
| Low Fio2 Alarm limits | 18 - 99 Vol% | 18 - 99 Vol% | 18 - 99 Vol% |
| High Fio2 Alarm limits | 30 - 99 Vol% | 18 - 99 Vol% | 18 - 99 Vol% |
| Gas Management Performance | |||
| Pipeline operating range | 45 - 55 psig | 50 - 55 psig | 50 psig |
| O2 supply failure alarm starts at | 27 psig | 27 psig | 27 psig |
| N2O shut off at | 24 psig | 20 psig | 20 psig |
| O2 flush | 50 ± 10 lpm | 55 ± 10 lpm | 60 ± 15 lpm |
| Minimum O2 flow | 250 ± 50 ml/min | 250 ± 50 ml/min | 200 ml/min |
| Hypoxic guard | 25 Vol% O2 | 25 Vol% O2 | 25 Vol% O2 |
| Rebreathing Circuit | |||
| APL range | 2 - 50 cm H2O | 2 - 100 cm H2O | 1 - 75 cm H2O |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The document describes a comparison based on product specifications and predicate device performance, not a clinical trial with a defined test set of patients or data points. The "performance comparison" tables list operational ranges and features, implying engineering validation against design specifications rather than a test on a specific dataset.
- Data Provenance: Not applicable in the context of a "test set." The comparison references the specifications of the Anodyne™ CC and two predicate devices (OHMEDA® Modulus® II Plus and North American Dräger® Narkomed® 2C). The document also mentions that the Anodyne™ CC is based on products legally marketed in Europe (HEYER Anesthesia DOGMA® and ACCESS®), implying their successful use in Europe contributes to the provenance of the underlying technology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No "ground truth" for a test set was established by experts in the context of a clinical study or evaluation of diagnostic accuracy.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There was no clinical test set requiring adjudication.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is an anesthesia system, not an AI or imaging diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable as the device is an anesthesia machine. While it contains software and electronic controls, its performance is assessed as a complete system, and it is intended for use by medical professionals (human-in-the-loop). The document states, "Adequate software testing with respect to the new IEC 601-1-4 has been conducted on the device." This implies engineering and software validation, but not a "standalone performance" study in the AI sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable. The comparisons are based on the published technical specifications, operational envelopes, and functional descriptions of the devices. For example, "Tidal volume range 50 - 1,400 ml" would be validated against calibrated measuring equipment consistent with engineering and manufacturing standards, not medical ground truth like pathology. The "Clinical discussion" refers to the long-standing safe and effective use of similar devices in Europe as a basis for substantial equivalence, which could be considered a form of "outcomes data" at a high level, but not a formal ground truth for a specific test set.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document is for a 510(k) premarket notification for an anesthesia system, not an AI/machine learning device that would require training sets. The "software-driven" nature only indicates it has controlling software, not learning algorithms.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
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K 963481
510(K) SUMMARY (as required by 807.92(c))
| AUG 1 1997 | |
|---|---|
| ------------ | -- |
| Submitter of 510(k): | Regulatory & Marketing Services, Inc. (RMS)40178 U.S. 19 NorthTarpon Springs, FL 34689 | ||
|---|---|---|---|
| Phone:Fax: | 813-942-3908813-942-3828 | ||
| Contact Person: | Ed Ransom | ||
| Date of Summary: | August | ||
| Trade Name: | Heyer America® Anodyne™ CC | ||
| Classification Name: | Gas Machine for Anesthesia, 21CFR section 868.5160 | ||
| Predicate Device: | K882484K930351 | Modulus II PlusNarkomed 2C | OhmedaNorth American Drager |
| Device Description/Comparison: | The HEYER America® Anodyne™ CC Anesthesia System isa standalone anesthesia device. The device is a reusable,non-sterile, life-supporting anesthesia machine forprescription use in hospitals, clinics and surgery centers.The device is software driven. Adequate software testingwith respect to the new IEC 601-1-4 has been conducted onthe device. The device is electrically operated | ||
| Intended Use: | The Anodyne™ CC Anesthesia System is a device used toadminister to a patient, continuously or intermittently, ageneral inhalation anesthetic and to maintain a patient'sventilation |
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RMS
Answer to question #2 about the technology of the product.
page 1 of 20
Technology comparison
The HEYER America® Anodyne™ CC anesthesia system is a device that is used for the administration of anesthetic agents and gases, ventilatory patient monitoring and controlled respiratory ventilation.
The HEYER America® Anodyne™CC anesthesia system uses similar or identical technology and methods of operation as the legally marketed devices.
| OHMEDA® | Modulus® II Plus | K 882489 |
|---|---|---|
| North American Dräger® | Narkomed® 2C | K 930351 |
A defailed comparison of the technology used in the Anodyne CC anesthesia system and in the predicate devices follows for the different functions and features, including a comparison of non-clinical performance data.
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Table of content
| Chapter | Page | |
|---|---|---|
| Technological comparison in | ||
| Gas management | 3 | |
| Hypoxic guard | 4 | |
| Flowcontrol | 4 | |
| Flowmetering | 5 | |
| Vaporization | 5 | |
| Ventilator | 6 | |
| Bellows | 7 | |
| Absorber | 7 | |
| Rebreathing circuit | 8 | |
| Spirometry measurement | 9 | |
| Pressure measurement | 9 | |
| Oxygen measurement | 10 | |
| Performance comparison for | ||
| Ventilator performance | 11 | |
| Airway pressure monitor performance | 12 | |
| Spirometry monitor performance | 13 | |
| Oxygen monitor performance | 14 | |
| Alarm management performance | 15 | |
| Data management performance | 15 | |
| Gas management performance | 16 | |
| Flowmetering performance | 17 | |
| Vaporizer performance | 18 | |
| Rebreathing circuit performance | 19 | |
| Clinical discussion | 20 | |
| Conclusion | 20 |
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page 3 of 20
Technology comparison
Gas management
Similarities between the product and the predicate devices.
Cylinder yokes for PIN index E-cylinders allow the attachment of two O2, one N2O and 1 Air cylinder. The cylinder supply management contains filters at the cylinder gas inlet, check valves for the two O2 cylinder inlets to prevent bleeding of one cylinder, if the other yoke is not used, pressure regulators to reduce cylinder pressure downto the normal operating pressure and Bourdon type cylinder pressure gauges for each cylinder gas supply line. Pipeline inlets with DISS connectors for O2, N2O, Air, Vac and Evac allow the attachment of central gas supply. Bourdon type pressure gauges indicate the pipeline pressure to the operator. A check valve arrangement for each gas provides the separation of cylinder and pipeline supply line.
The 02 supply line is checked for sufficient pressure level. When the 02 supply pressure drops below the specified minimum pressure level the O2 fail alarm device alarms the operator to the low O2 pressure.
In case the O2 supply pressure drops below the specified N2O-shut-off-O2pressure-level, the N2O supply is shut off.
A main switch activates the device's gas supply.
Differences between the product and the predicate devices.
In the Anodyne CC patient and device is protected by water traps and particulate filters. In the predicate devices there are no built-in water traps. These are added as accessories.
In the Anodyne CC the O2 fail alarm operates pneumatically, using a pneumatic whistle. In the predicate devices the O2 fail alarm operates with an electrical alarm device delivering an alarm tone.
In the Anodyne CC the gas mix selector enables the operator to select one of four different Freshgas selections.
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In a predicate device this selection is one of three.
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Hypoxic guard
Similarities between the product and the predicate devices.
The 02/N2O mixture delivered in the Freshgas is generated from a hypoxic guard system providing a specified minimum percentage of oxygen. The operator is not able to adjust a mixture below this minimum 02 concentration. A minimum O2 flow is supplied to the Freshgas line, in case gas selections with N2O are made.
The combination of a specified minimum O2 flow and a hypoxic guard system provides an oxygen concentration dependent on the total Freshgas flow. Between mid and high flows the O2 concentration stays at the minimum level as specified. For lower flowrates the O2 concentration increases upto 100 % when the minimum O2 flow is reached.
Differences between the product and the predicate devices.
The Anodyne CC uses a mechanical hypoxic guard system. So does the OHMEDA device. The NAD unit uses a pneumatic system.
Flowcontrol
Similarities between the product and the predicate devices.
The flowcontrol enables the operator to dose the gas flow precisely by changing the orifice of a valve. The flowcontrol for each gas is mounted correspondent to the flowmeters.
An independent O2 flush allows a fast delivery of oxygen to the patient.
Differences between the product and the predicate devices.
None.
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Flowmetering
Similarities between the product and the predicate devices.
The flowmeter set consist of two flowmeters for each gas with a fine and a coarse tube. The tubes are cascaded. Due to the overflow from fine to coarse the fine tube shows the specified values for the fine range and the coarse tube, beginning with the end of the fine tube range, shows the coarse range. The flowmeter tube operate with the taper-cone-float system.
Differences between the product and the predicate devices.
None.
Vaporization
Similarities between the product and the predicate devices.
The vaporizer assembly is able to carry three vaporizers at a time with a safety function to enable only one vaporizer to work at a time.
The NAD device uses Dräger back entry type vaporizers. These back entry type vaporizers are mounted fixed to the vaporizer assembly and are not detachable. An exclusion system enables only one vaporizer to be operated at a time.
The OHMEDA device has a mounting system to carry detachable vaporizers of the Selectatec type. These vaporizers have a standardized mounting system for the gas connectors and the locking mechanism.
The mounting system on the device allows only vaporizers to adapt, that have an interlocking mechanism providing only one vaporizer to operate at a time.
The Anodyne CC can be equipped with either system, mentioned above.
Differences between the product and the predicate devices.
None.
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Ventilator
Similarities between the product and the predicate devices.
The ventilator allows manual and controlled mandatory ventilation mode.
The ventilator is a time-cycled-flow-controlled type with pneumatic gas supply and electronic control.
The ventilator allows ventilation of pediatric and adult patients.
The ventilator has an adjustable pressure limiting function and a separate safety . pressure limiting valve.
The ventilator provides PEEP capabilities.
The ventilator activity is transferred to the patient gas circuit by a bellows assembly, contained within a cannister with clear plastic housing to view the bellows movement
Differences between the product and the predicate devices.
The NAD device allows the adjustment of I:E ratio, rate and flow. With these settings the ventilator creates a specific tidal volume as a resulting parameter.
The OHMEDA device allows the adjustment of rate, flow, an tidal volume. The I:E ratio is a dependent variable.
The Anodyne CC combines both systems in a way, that adjustments for I:E ratio, rate and tidal volume are allowed and the flow is a dependent variable.
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Bellows
Similarities between the product and the predicate devices.
The bellows operates in a so called "bag in bottle" principle. A gas flow created by the ventilator powers the bellows housing and pressurizes the bellows inside.
The bellows transfers this activity onto the patient gas circuit, separating the two gas circuits by its membrane.
Differences between the product and the predicate devices.
The OHMEDA device uses bellows with two different sizes to match the different tidal volume ranges for pediatric and adult ventilation.
The NAD device uses only one bellows for both ventilation ranges. So does the Anodyne CC.
NAD and OHMEDA use a separate ascending bellows assembly. The Anodyne CC uses a descending one integrated inside the rebreathing circuit.
Absorber
Similarities between the product and the predicate devices.
An absorber system retaining the patients exhaled CO2 is installed, prepared for two prefill absorber container. The absorber canister allows the CO2 flow to move downstream.
The absorber canister is of transparent material to allow the operator to watch a color indicator inside the absorber material.
Differences between the product and the predicate devices.
The predicate devices have the absorber mounted as a separate component from the basic machine.
On the Anodyne CC the absorber is integrated inside the rebreathing system.
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Rebreathing circuit / Patient module
Similarities between the product and the predicate devices.
The rebreathing circuit is a system to handle the gas going to and coming from the patient, representing the interface between basic gas machine and patient.
Inside the circuit directional valves control inspiratory and expiratory gas flow.
The rebreathing circuit allows the freshgas to flow to the patient with a blender type function between freshgas and rebreathing gas. Rebreathed gas flows to the CO2 absorber to retain the CO2 before it is blended with Freshgas.
A bag is connected to the rebreathing circuit to allow manual mode ventilation with an adjustable pressure limiting valve (APL) enabling the adjustment of the maximum airway pressure.
Differences between the product and the predicate devices.
The predicate devices have the absorber mounted as a separate component to the basic machine. Several connections to the basic machine for bellows, Freshgas and pressure measurement are necessary.
The predicate devices have the ventilator's bellows assembly mounted as a separate component to the basic machine. A connection between rebreathing / absorber system and bellows assembly is necessary.
On the Anodyne CC the absorber and the bellows assembly are integrated inside the rebreathing system. All connections to the basic machine are made inside the rebreathing system's docking station.
To prevent subatmospheric pressure effecting the patient the Anodyne CC allows room air to supply the rebreathing system in case a subatmospheric pressure is detected throug an "emergency air intake" valve.
To provide a fast pressure release in case of an accidental overpressure inside the rebreathing circuit the Anodyne CC provides an integrated Pop-off valve function.
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Spirometry measurement
Similarities between the product and the predicate devices.
Flow measurement is performed to get information about the patient's expiratory tidal volume, minute volume and rate. The measured data are displayed to the operator to allow on-line control of ventilation efficiency.
Minimum alarm limits are adjustable to monitor the patient's tidal volume and/or minute volume activities.
Differences between the product and the predicate devices.
The NAD device displays the spirometry information in a separate monitoring display.
The OHMEDA device displays the spirometry data inside the ventilators display. So does the Anodyne CC.
The predicate devices use separate stand alone spirometry sensors, that need to be mounted either onto the rebreathing circuit (NAD) or inside the expiratory line (OHMEDA).
The Anodyne CC carries the spirometry sensor inside its rebreathing circuit.
Pressure measurement
Similarities between the product and the predicate devices.
Airway pressure measurement is performed to get information about the patient's airway pressure. Peak and PEEP pressure information is displayed numerically. A Bourdon type pressure gauge allows the operator to watch the pressure-time characteristic of the ventilation. Maximum and minimum pressure limits are adjustable to monitor the patient's airway pressure.
Differences between the product and the predicate devices.
The predicate devices also displays the pressure information in a separate monitoring display.
The Anodyne CC also displays the pressure data inside the ventilators display.
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page 10 of 20
Oxygen measurement
Similarities between the product and the predicate devices.
Inspiratory oxygen concentration measurement is performed by a fuel cell type sensor mounted inside the inspiratory pathway. The information is displayed numerically. Maximum and minimum oxygen concentration limits are adjustable to monitor the patient's inspiratory concentration.
Differences between the product and the predicate devices.
The NAD device displays the oxygen concentration information in a separate monitoring display.
The OHMEDA device displays the oxygen concentration data inside the ventilators display.
So does the Anodyne CC.
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page 11 of 20
Performance comparison
Ventilator Performance
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
|---|---|---|---|
| Tidal volume range | |||
| Total | 50 - 1,400 ml | 50 - 1,500 ml | 50 - 1,500 ml |
| Pediatric | 50 - 400 ml | 50 - 300 ml | 50 - 300 ml |
| Adult | 300 - 1,400 ml | 300 - 1,500 ml | 300 - 1,500 ml |
| Frequency range | |||
| Total | 2 - 99 BPM | 1 - 99 BPM | 2 - 100 BPM |
| Pediatric | 20 - 99 BPM | 1 - 99 BPM | 2 - 100 BPM |
| Adult | 2 - 30 BPM | 1 - 99 BPM | 2 - 100 BPM |
| I:E Ratio range | 1:3, 1:2, 1:1.51:1, 2:1, 3:1 | 1:4.5, 1:4, 1:3.51:3, 1:2.5, 1:21:1.5, 1:1 | dependent variable |
| Insp. Flow Range | dependent variable | 10 - 33 l/min | 10 - 100 l/min |
| Insp. Pause | 20%, 30% | - | 25% |
| Sigh | 1 of 100, $1.5 * Vt$ | - | - |
| Pressure limit range | 10 - 100 cmH2O | 15 - 120 cmH2O | 20 - 100 cmH2O |
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page 12 of 20
Airway Pressure Monitor Performance
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
|---|---|---|---|
| Pressure range | -10 - 100 cmH2O | -10 - 70 cmH2O | -20 - 120 cmH2O |
| Real Time Graphics | Yes | Yes | No |
| Numerical values | PPEEP | PPEEP | PPEEP |
| PMEAN | - | - | |
| PPEAK | PPEAK | PPEAK | |
| PPLATEAU | - | - | |
| Alarm Messages | High | High | High |
| Sustain | Sustain | Sustain | |
| Sub. | Sub. | Sub. | |
| Apnea | Apnea | Apnea | |
| Alarm limits | - | - | - |
| High | 10 - 100 cmH2O | 10 - 70 cmH2O | 20 - 100 cmH2O |
| Sustain | 2 - 30 cmH2O | 10 - 30 cmH2O | 10 - 30 cmH2O |
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page 13 of 20
Spirometer / Volume Monitor Performance
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
|---|---|---|---|
| Tidal volume range | 20 - 9,999 ml | 70 - 9,999 ml | 0 - 9,999 ml |
| Breath rate range | 0 - 99 BPM | 3 - 50 BPM | 0 - 99 BPM |
| Minute Volume range | 0.1 - 999.9 l/min | 0 - 999.9 l/min | 0 - 999.9 l/min |
| Real Time Graphics | Yes | Yes | No |
| Numeric Values | Tidal volume | Tidal volume | Tidal Volume |
| Minute volume | Minute volume | Minute volume | |
| Breath rate | Breath rate | Breath rate | |
| Alarm messages | Tidal volume low | Tidal volume low | - |
| Minute volume low | Minute volume low | Minute volume low | |
| Low rate | - | - | |
| High rate | - | - | |
| Alarm limits | Tidal v. Low 20 - 1,400 ml | 70 - 1500 ml | - |
| Minute v.Low 0.5 - 5 L/min | 0.5 - 10 L/min | 0 - 9.9 L/min | |
| Low rate 2 - 30 BPM | - | - | |
| High rate 10 - 99 BPM | - | - |
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Oxygen Monitor Performance
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
|---|---|---|---|
| Concentration range | 0 - 100 Vol% | 0 - 100 Vol% | 0 - 105 Vol% |
| Numeric value Fio2 | Fio2 | Fio2 | Fio2 |
| Response time T90 | 15 sec | 20 sec | 15 sec |
| Sensor Life | 12 months | 12 months | 12 months |
| Alarm messages | Low Fio2 | Low Fio2 | Low Fio2 |
| High Fio2 | High Fio2 | High Fio2 | |
| Alarm limits | |||
| Low Fio2 | 18 - 99 Vol% | 18 - 99 Vol% | 18 - 99 Vol% |
| High Fio2 | 30 - 99 Vol% | 18 - 99 Vol% | 18 - 99 Vol% |
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Alarm Management Performance
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
|---|---|---|---|
| Central alarm panel | Yes | Yes | No |
| Central alarm silencer | Yes | Yes | No |
| Alarm silencer | 60, 120 sec | 60, 120 sec | individual |
| O2 fail alarm | audible | audible | audible |
Data management Performance
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
|---|---|---|---|
| Type of interface | optical | galvanic | galvanic |
| Hardware protocol | IRDA | - | - |
| RS 232 C | RS 232 C | RS 232 | |
| Bidirectional block | Yes | Yes | No |
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
| Pressure gauges | |||
| Pipeline | 0 - 100 psig | 0 - 100 psig | 0 - 100 psig |
| Cylinder 02 | 0 - 3,000 psig | 0 - 3,000 psig | 0 - 3,000 psig |
| Cylinder Air | 0 - 3,000 psig | 0 - 3,000 psig | 0 - 3,000 psig |
| Cylinder N2O | 0 - 1,500 psig | 0 - 1,500 psig | 0 - 3,000 psig |
| High pressure regulators | |||
| For each gas | Yes | Yes | Yes |
| Max. Input pressure | 100 psig | 100 psig | 100 psig |
| Inlet connectors | DISS | DISS | DISS |
| Dual gas supply | manual | manual | manual |
| automatic (option ) | - | - | |
| Pipeline operating range | 45 - 55 psig | 50 - 55 psig | 50 psig |
| O2 supply failure alarm starts at | 27 psig | 27 psig | 27 psig |
| N2O shut off at | 24 psig | 20 psig | 20 psig |
| O2 flush | $50 \pm 10$ lpm | $55 \pm 10$ lpm | $60 \pm 15$ lpm |
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
| O2 double tube | 0 - 1,000 ml/min | 100 - 1,000 ml/min | 200 - 650 ml/min |
| 1.0 - 10 l/min | 1.0 - 10 l/min | 0.7 - 12 l/min | |
| N2O double tube | 0 - 1,000 ml/min | 100 - 1,000 ml/min | 20 - 650 ml/min |
| 1.0 - 10 l/min | 1.0 - 10 l/min | 0.7 - 12 l/min | |
| AIR tube | double | double | single |
| 0 - 1,000 ml/min | 100 - 1,000 ml/min | 1 - 15 l/min | |
| 1.0 - 10 l/min | 1.0 - 10 l/min | - | |
| Minimum O2 flow | 250 +- 50 ml/min | 250 +- 50 ml/min | 200 ml/min |
| Hypoxic guard | 25 Vol% O2 | 25 Vol% O2 | 25 Vol% O2 |
| Backlight | Yes | Yes | ( Option ) |
| O2 knob | Touch code | Touch code | Touch code |
| Knob guard | Yes | Yes | Yes |
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
| Maximum number of vaporizers to mount | 3 | 3 | 3 |
| Mounting system I. | Selectatec® | - | Selectatec® |
| Vaporizers to mount | OHMEDA®TEC® 4TEC® 5TEC® 6Penlon®PPV Elite®Blease®Datum®MIE®Vapamaster® | - | OHMEDA®TEC® 4TEC® 5TEC® 6Penlon®PPV Elite®Blease®Datum®MIE®Vapamaster® |
| Interlock system | Yes | - | Yes |
| Mounting system II. | Back entry | Back entry | - |
| Vaporizers to mount | DRÄGER®Vapor® 19.1Desvapor® | DRÄGER®Vapor® 19.1Desvapor® | - |
| Parameter | Anodyne™ CC | Narkomed® 2C | Modulus® II Plus |
| Mounting type | integrated | stand alone | stand alone |
| APL valve | Yes | Yes | Yes |
| APL range | 2 - 50 cm H2O | 2 - 100 cm H2O | 1 - 75 cm H2O |
| Canister capacity | 3 lbs | 3 lbs | 3 lbs |
| Pre fill type | US | US | US |
| Exhalation port | 22 mm taper | 22 mm taper | 22 mm taper |
| Inhalation port | 22 mm taper | 22 mm taper | 22 mm taper |
| Bag nipple | 22 mm taper | 22 mm taper | 22 mm taper |
| Excess gas outlet | 19 mm OD | 19 mm OD | 19 mm OD |
| Ventilator connection | integrated | 22 mm OD | 22 mm OD |
| Circuit pressure sensing port | integrated | 8 mm ID | 8 mm ID |
| Common gas inlet | integrated | 11 mm ID | 11 mm ID |
| Oxygen sensor place | Inspiration valve | Inspiration valve | Inspiration valve |
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Gas management Performance
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Flowmeter assembly Performance
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Vaporizer Performance
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Rebreathing Circuit Performance
HEYER America Inc., Anodyne CC, 510(k), 1. response, 12/18/1996 T.K.
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page 20 of 20
Clinical discussion
The HEYER America Anodyne CC anesthesia system is also based on the technology of a product series legally marketed in Europe and manufacturered by HEYER Anesthesia, such as:
| Manufacturer | Model | Approval No. | Approval Date |
|---|---|---|---|
| HEYER Anesthesia | DOGMA® | 09/M-015/94 | 05/11/1994 |
| HEYER Anesthesia | ACCESS® | 09/M-019/95 | 10/25/1995 |
Numerous units of these types are in clinics and hospitals inside Europe being used as anesthetic gas delivery machines.
Compared to the predicate devices these devices have proven over the years to have the same level of safety and efficiency in Europe where the predicate deives are also sold.
Conclusion
Basing on the technology comparison, the performance comparison and the clinical discussion we can confirm the HEYER America Anodyne CC to be as safe as and as effective as the predicate compared devices.
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Image /page/22/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Ed Ransom Heyer American, Inc. C/O Regulatory & Marketing Services, Inc. 40178 U.S. 19 North Tarpon Springs, Florida 34689
Re: K963481 Heyer America® Anodyne™ CC Anesthesia System Regulatory Class: II (two) Product Code: 74 BSZ March 16, 1997 Dated: Received: May 19, 1997
Dear Mr. Ransom:
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 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (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 requlatory 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.
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Page 2 - Mr. Ed Ransom
This letter will allow you to begin 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 requlation (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/dsmamain.html".
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
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| 510(k) Number (if known): | K963481 |
|---|---|
| --------------------------- | --------- |
Heyer America® Anodyne™ CC Anesthesia System Device Name:
Indications For Use:
The Anodyne TM CC Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K963481 |
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).