(315 days)
Not Found
No
The description details a microprocessor-controlled valve system for gas mixing based on user input, with safety features and alarms. There is no mention of AI or ML algorithms for decision-making, pattern recognition, or learning from data.
Yes
The device administers a mixture of Nitrous Oxide and Oxygen for analgesic purposes, directly treating pain and inducing sedation in patients.
No
The device is indicated for administering an adjustable mixture of nitrous oxide and oxygen for analgesia/sedation, not for diagnosing any medical condition.
No
The device description clearly details hardware components such as a microprocessor-controlled valve system, a Bag T, a breathing bag, and a double mask scavenger system, in addition to the software (firmware) component. The performance studies also include testing of hardware-related aspects like alarms, sealing, pressure ranges, and accessory compatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for administering a mixture of gases (Nitrous Oxide and Oxygen) to a patient for analgesia (pain relief). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a device that mixes and delivers gases for inhalation. It focuses on flow control, concentration adjustment, and safety features related to gas delivery. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for direct patient treatment through gas administration, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.
Product codes
BZR
Device Description
The device will be available in two models: FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %. 50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.
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
The intended patient population is adults and pediatrics.
Intended User / Care Setting
The operator, a doctor or a dentist. The intended operational environment is dental offices or clinics.
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)
Non-clinical testing: Laboratory testing confirmed compliance with the applicable portions of the following standards: IEC 60601-1, IEC 60601-1-2, ISO 11195, CGA V-5, CGA C-9, ISO 5356-1. Biocompatibility testing was performed according to ISO 18562-2 and ISO 18562-3. Cybersecurity measures were taken in compliance with FDA guidance. Additional successful bench testing performed: All alarms specified in the comparison table were tested and verified as operational, silicon sealing testing, performance ambient air valve, pressure differential, information signals + alarms durability of marking, normal operating conditions, reverse gas flow, ambient temperature range, accessory compatibility, on-demand flow, performance of the device at 2,260 meter above sea level (high altitude test), N2O room contamination, NIOSH O2 running empty test, N2O empty test.
Clinical testing: Not required to establish substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Below that is the word "ADMINISTRATION" in a smaller font.
July 28, 2023
Baldus Sedation GmbH & Co. KG % Daniel Kamm Principal Engineer Kamm & Assosciates 8870 Ravello Ct Naples, Florida 34114
Re: K222794
Trade/Device Name: FlowStar Touch Digital Mixer Flowmeter Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR Dated: July 26, 2023 Received: July 26, 2023
Dear Daniel Kamm:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James J. Lee -S
James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222794
Device Name FlowStar Touch Digital Mixer Flowmeter
Indications for Use (Describe)
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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510(k) Summary: 510(k) Number K222794
Image /page/3/Picture/1 description: The image shows the logo for Baldus Sedation. The logo features a blue circle on the left side of the word "Baldus", which is written in a bold, sans-serif font. Below the word "Baldus" is the word "Sedation", which is written in a smaller, lighter font. A thin blue line separates the two words.
Baldus Sedation GmbH & Co.KG In der Langfuhr 32 56170 Bendorf Germany www.baldus-sedation.de Phone: 0049 261 96 38 92666 Date Prepared: July 28, 2023 Prepared by: Lisa Baldus Head of Quality Management and Regulatory Affairs
-
- Identification of the Device: Trade/Device Name: FlowStar Touch Digital Mixer Flowmeter Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR
-
- Equivalent legally marketed device: K052335 Trade/Device Name: Accutron Digital Ultra Manufacturer: Accutron, Inc. Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR
-
- Indications for Use: Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient
4) Description of the Device:
The device will be available in two models: (Details below) FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %.
50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2)
4
percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.
The device contraindications (from the labeling) are:
- Hindered or restricted nasal breathing (rhinitis, sinusitis)
- impaired ability to communicate
- Severe psychological or behavioral and personality disorders ●
- Severe general diseases (MS, ileus) ●
- Status post eye operation with an intraocular gas bubble
- ASA >= 3
- Vitamin B12 and folic acid defiency or disorder
- First and second trimester of pregnancy
- Neither female employees in the dental practice nor patients in their first or second trimester of pregnancy.
- Hypersensitivity to the medication
- Head injuries with impaired consciousness
- Maxillofacial injuries
- Artificial, traumatic or spontaneous pneumothorax
- Air embolism
- Middle ear occlusion, ear infection
- Decompression sickness
- Abdominal distension / intestinal obstruction.
There are TWO product variants:
PRODUCT VARIANT 1:
FlowStar Touch Digital Mixer Flowmeter 70 %
Minimum O2 concentration: 30 %
Maximum O2 concentration: 100 %
Minimum N₂O concentration: 0 %
Maximum N₂O concentration: 70 %
PRODUCT VARIANT 2:
FlowStar Touch Digital Mixer Flowmeter 50 %
Minimum 02 concentration: 50 % Maximum O2 concentration: 100 %
5
The intended patient population is adults and pediatrics.
The intended operational environment is dental offices or clinics.
The patient contacting component is a face mask (not part of the mixer device described in this submission). The patient contact is with skin, and the duration is for the length of the patient wearing the mask. The face mask is FDA product code BSJ, 510(k) exempt. Other components are: Mask, Scavenging, product code KHA, 510(k) exempt, and Device Bag, Reservoir, product code BTC, 510(k) exempt. Color coded connectors are employed to prevent switching the oxygen and N₂O connections.
Constructional description: The device includes a microprocessor-controlled valve system that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes. The inputs of the touchpad influence the gas flow inside of the device. The firmware is considered to be of a moderate level of concern. The user interface is essentially identical to the predicate described in the detailed comparison table below.
| Characteristic | K052335, Accutron Digital Ultra, Accutron,
Inc. | FlowStar Touch Digital Mixer Flowmeter
(Two models: N2O max 70% or
N2O max 50%) |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use: | To be used in nitrous oxide-oxygen sedation
systems for delivering to a patient a mixture of
nitrous oxide and oxygen gases with a
maximum nitrous oxide concentration of 70%. | Indicated for administering an adjustable mixture
of Nitrous Oxide analgesic gas and Oxygen to a
conscious, spontaneously breathing patient.
(Functionally identical) |
| Range | Between 0 (100% O2) and 70 (30% O2)
percent N2O | Between 0 (100% O2) and 70 (30% O2) percent
N2O SAME |
| Power Source | 100-240 V AC, 50/60 Hz only. | 110-230 V 50-60 Hz (Essentially the same) |
| Controls | Touch Panel | SAME |
| Photo of Front | Image: Accutron Digital Ultra | Image: FlowStar Touch Digital Mixer Flowmeter |
| Population | Adults and Pediatrics | SAME |
| Gas Delivery | Oxygen Flush: Minimum 20 LPM
Oxygen Flow: 1.0 LPM-9.9 LPM
Oxygen %: 30%-100%
Oxygen Resuscitator Flow: Minimum 100 LPM
Nitrous Oxide Flow: 0-6.9 LPM
Nitrous Oxide %: 0-70%
Mixed Gas Flow: 1.0-9.9 LPM | Oxygen Flush 40-55 l/min
Oxygen Flow 1.0 - 18 l/min
Oxygen %: 30 % - 100 %
Oxygen Resuscitator Flow 100 - 250l/min
Nitrous Oxide Flow 0 - 12,6 l/min
Nitrous Oxide %: 0 -70 %
Mixed Gas Flow 3 – 18 l/min
SIMILAR |
| Characteristic | K052335, Accutron Digital Ultra, Accutron,
Inc. | FlowStar Touch Digital Mixer Flowmeter
(Two models: N₂O max 70% or
N₂O max 50%) |
| Safety
Standards | IEC 60601-1, "Medical Electrical Equipment -
Part 1: General Requirements for Safety"
IEC 60601-1-2, "Medical electrical equipment -
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests" | SAME |
| Alarms | O₂ Fail Safe System - Offers assurance that N₂O
ceases if the O₂ supply is interrupted or reduced.
Alarm will sound, FAILURE OXYGEN LEDs will light,
and N₂O flow will cease.
N₂O Supply Warning – Triggers an alarm if the
N₂O supply cannot keep up with user's needs.
Alarm will sound and FAILURE NITROUS LEDS will
light. Flow switches to 100% oxygen.
Mixed Gas Flow to Patient – Monitors pressure in
mixed gas line and triggers an alarm if flow to
patient is obstructed. Alarm will sound and
FAILURE NITROUS OXYGEN LEDS will light. | Check O₂: If no oxygen is being supplied, the unit
emits visual and acoustic information signals
Check N₂O: If no nitrous oxide is being supplied,
the unit emits visual and acoustic information signals.
This also happens if the pressure is too low or there is
a measurement section failure
O₂ minimum flow 3 l/min: Visual and acoustic signals:
The O₂ minimum flow is 3 l/min. The mixture
administered can never contain less than 1 litre of O₂.
Max. flow reached: Once the maximum total flow (18
l/min) is reached, this is signaled visually in the top
right and a signal tone sounds.
Flush flow low: This message appears if the flow rate
is less than the minimum value of 18 l/min when the
O₂ Flush button is pressed. The alarms are equivalent
to those of the predicate. |
| Dimensions/
weight | 7 1/2" x 7" x 8 3/4" 6.3 lbs | 5.3″ x 11.8″ x 4 ¾" (H x W x D) 5.5 lbs.
SIMILAR SIZE AND WEIGHT |
| Gas Inlet
Connectors | DISS connector (Diameter Index Safety
System) | DISS connector (Diameter Index Safety System)
SAME |
| External
interface
connector | Type DB-9 Serial Output for printer | USB Type A, accepts USB memory sticks for
storage of patient data entered via the front
panel. (MORE CONVENIENT THAN PRINTING) |
| Use
environment | Hospital, Dental Facility, Healthcare Facility | SAME |
5) Substantial Equivalence Chart
6
-
- The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new device is as safe and effective as the predicate device.
-
- Summary of non-clinical testing: Laboratory testing confirmed compliance with the applicable portions of the following standards:
IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance FDA Recognition Number: 19-4
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
7
disturbances - Requirements and tests FDA Recognition Number: 19-36
ISO 11195:2018 Gas mixers for medical use – Stand-alone gas mixers, no FDA Recognition Number
CGA V-5:2008 (Reaffirmed 2013), Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications), FDA Recognition Number: 1-81
CGA C-9: 2013 Standard Color Marking of Compressed Gas Containers for Medical Use STANDARD by Compressed Gas Association, FDA Recognition Number: 1-101
ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets FDA Recognition Number: 1-62
Biocompatibility testing: VOCs and particulate matter testing was performed according to: ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter, FDA recognition number 1-135, AND: ISO 18562-3 First edition 2017-03, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds, FDA recognition number 1-136.
Cybersecurity measures were taken in compliance with the FDA guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff. The problem is relatively simple to address because the unit has only one method of entry, the USB port.
Additional successful bench testing performed:
All alarms specified in the comparison table above were tested and verified as operational as intended. Silicon sealing testing. Performance ambient air valve Pressure differential Information signals + Alarms Durability of marking Normal operating conditions: Works as expected in the defined pressure ranges. Reverse gas flow Ambient temperature range Accessory compatibility On Demand Flow Performance of the device at 2,260 meter above the sea level (High altitude test) N2O Room Contamination NIOSH O2 Running Empty Test N2O Empty Test
-
- Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
-
- Conclusion: The comparison tables and the differences between the subject device and the predicate device shows that the subject device is substantially equivalent to the predicate/reference devices in terms of safety, efficacy, indications, and all the other technological
8
characteristics and do not introduce any potential risks. The subject device and the predicate device has the same intended use and the technological differences do not raise different questions of safety and effectiveness. So, the proposed device can be rated as substantially equivalent to the predicate.