(342 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on traditional anesthesia system components and functions.
Yes.
The device is used to administer anesthesia and maintain ventilation in patients, which are therapeutic interventions.
No
The device's intended use is to administer anesthesia and maintain ventilation, not to diagnose a condition.
No
The device description explicitly states it is a "standalone anesthesia device" and an "anesthesia machine," which are hardware components. While it is "software driven," it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation." This describes a device used on a patient for treatment and life support, not a device used to examine specimens from a patient to provide diagnostic information.
- Device Description: The description reinforces this by calling it a "standalone anesthesia device" and a "life-supporting anesthesia machine."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing diagnostic information about a patient's condition
In summary, the Anodyne TM CC Anesthesia System is a therapeutic and life-support device used directly on a patient, not a diagnostic device used to analyze specimens.
N/A
Intended Use / 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.
Product codes
74 BSZ
Device Description
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.
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
pediatric and adult patients
Intended User / Care Setting
prescription use in hospitals, clinics and surgery centers.
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)
The document provides a performance comparison of the Anodyne CC with predicate devices for Ventilator, Airway Pressure Monitor, Spirometer / Volume Monitor, Oxygen Monitor, Alarm Management, Data Management, Gas Management, Flowmeter assembly, Vaporizer, and Rebreathing Circuit. Key results are presented in tabular format contrasting various parameters, ranges, and features.
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
§ 868.5160 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).
0
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 North
Tarpon Springs, FL 34689 | | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|---------------------------------|
| | Phone:
Fax: | 813-942-3908
813-942-3828 | |
| 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: | K882484
K930351 | Modulus II Plus
Narkomed 2C | Ohmeda
North American Drager |
| Device Description/Comparison: | 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 | | |
| Intended Use: | The Anodyne™ 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 | | |
1
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.
2
page 2 of 20
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 |
3
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.
4
In a predicate device this selection is one of three.
5
page 4 of 20
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.
6
page 5 of 20
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.
7
page 6 of 20
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.
8
page 7 of 20
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.
9
page 8 of 20
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.
10
page 9 of 20
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.
11
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.
12
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, 1:1.5 | ||
| 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 |
13
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 |
14
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 | - | - |
15
page 14 of 20
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% |
16
page 15 of 20
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® 4 | |||
| TEC® 5 | |||
| TEC® 6 | |||
| Penlon® | |||
| PPV Elite® | |||
| Blease® | |||
| Datum® | |||
| MIE® | |||
| Vapamaster® | - | OHMEDA® | |
| TEC® 4 | |||
| TEC® 5 | |||
| TEC® 6 | |||
| Penlon® | |||
| PPV Elite® | |||
| Blease® | |||
| Datum® | |||
| MIE® | |||
| Vapamaster® | |||
| Interlock system | Yes | - | Yes |
| Mounting system II. | Back entry | Back entry | - |
| Vaporizers to mount | DRÄGER® | ||
| Vapor® 19.1 | |||
| Desvapor® | DRÄGER® | ||
| Vapor® 19.1 | |||
| Desvapor® | - | ||
| 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 |
17
page 16 of 20
Gas management Performance
18
page 17 of 20
Flowmeter assembly Performance
19
page 18 of 20
Vaporizer Performance
20
page 19 of 20
Rebreathing Circuit Performance
HEYER America Inc., Anodyne CC, 510(k), 1. response, 12/18/1996 T.K.
21
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.
22
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.
23
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
24
| 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)