(161 days)
Not Found
No
The device description and performance studies focus on mechanical and analog controls, safety features, and compliance with established standards for gas mixers. There is no mention of AI, ML, or any computational processing for decision-making or control.
Yes
The device is indicated for administering adjustable mixtures of Nitrous Oxide and Oxygen for patient sedation, which is a therapeutic purpose.
No.
This device administers a mixture of gases for sedation. It does not perform any diagnostic functions like detecting, monitoring, or analyzing a patient's condition or disease.
No
The device description clearly details physical components like rotary knobs, a Bag T, valves, and connections for gas supply and scavenging systems. The performance studies also mention testing of physical attributes like connectors, durability of marking, and climate chamber testing, indicating it is a hardware device with potential software control elements, but not software-only.
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 for sedation to a conscious, spontaneously breathing patient. This is a therapeutic/anesthetic use, not a diagnostic one.
- Device Description: The description details a device that mixes and delivers gases for patient sedation. It focuses on flow control, safety features related to gas mixing and supply, and patient breathing support. None of these functions are related to testing samples from the human body to diagnose conditions.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
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 (comma separated list FDA assigned to the subject device)
BZR
Device Description
The intended patient population is adults and pediatrics. The applicable pediatric subgroups are child and adolescent. The intended operational environments are: Hospital, Dental Facility, Healthcare Facility. There are no patient contacting components supplied with the device. Those are sold separately and are 510(k) exempt. The device will be available in two models: FLOWSTAR ANALOG MIXER FLOWMETER 50 %, and FLOWSTAR ANALOG MIXER FLOWMETER 70 %. 50% and 70% represent the maximum nitrous oxide concentration. This 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 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 FlowStar ® Analog Mixer 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. Two rotary knobs are used to select the desired total flow and N20/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® Analog Mixer device has an integrated O2 Flush knob which delivers at least over 40 l/min of pure oxygen if the user presses the knob to flush the N20 out of the patient circuit after the treatment or in the situation the patient is over sedated. The FlowStar Analog Mixer 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 FlowStar ® Analog Mixer has an integrated Bag T. The mixed gas to it. The Bag T is a device with one additional input and two outputs. The additional 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 by the mixing device when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the connected scavenger system and finally to the patient
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. The applicable pediatric subgroups are child and adolescent.
Intended User / Care Setting
Hospital, Dental Facility, Healthcare Facility. The operator, 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.
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)
Summary of non-clinical testing: Laboratory testing confirmed compliance with the applicable portions of the following standards: ISO 18562 Biocompatibility Evaluation of a medical device with a breathing gas pathway. The report is entitled: ISO 18562 Particulates and VOC GLP Report. The same test laboratory provided: Toxicological Risk Assessment: This toxicological risk assessment pertains to the particulates and volatile organic compounds (VOCs) emitted from the device underwent a particulates and VOC study per ISO 18562. We performed detailed Risk Analysis in accordance with: Medical devices - Application of risk management to medical devices (ISO 14971 Third Edition 2019-12), FDA Recognition Number: 5-125. Labeling was created in compliance with: ISO 15223-1 Fourth Edition 2021-07 Medical devices -Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements FDA Recognition Number: 5-134. Connectors were chosen in compliance with: CGA V-5:2008 (Reaffirmed 2013), Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications), FDA Recognition Number: 1-81. Testing was done to ISO 11195:2018 Gas mixers for medical use - Stand-alone gas mixers, no FDA Recognition Number: Alarm signal volume, Reverse gas flow, Ambient air valve, Leakage to atmosphere, Pressure differential, High pressure. Usability testing was done in accordance with: Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366- 1:2015 + COR1:2016), FDA Recognition Number: 5-114 All requirements were met, there are no inapplicable requirements or deviations. Additional successful bench testing performed: Climate chamber testing for worst case high temperature and humidity. Durability of marking. On demand air flow higher than 100 l/min. Accessory compatibility (510(k) exempt). Functional testing of aged components (to ASTM F1980).
Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
Key results: The comparison tables and the discussion of 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 characteristics and do not introduce any potential risks. So, the purposed device can be rated as substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 14, 2023
Baldus Sedation GmbH & Co. KG % Daniel Kamm Principal Engineer Kamm & Assosciates 8870 Ravello Ct Naples, Florida 34114
Re: K230987
Trade/Device Name: FlowStar Analog Mixer Flowmeter Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: Class II Product Code: BZR Dated: April 5, 2023 Received: April 6, 2023
Dear Daniel Kamm:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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/cfdocs/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
Bradley Q. Quinn -S
Bradley Quinn Assistant 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K23####
Device Name FlowStar Analog 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 K23###
Image /page/3/Picture/1 description: The image contains the word "Baldus" in a bold, sans-serif font. The word is white with a black outline, and it is positioned above the word "Sedation", which is written in a thinner, sans-serif font. To the left of the word "Baldus" is a blue circle.
Baldus Sedation GmbH & Co.KG In der Langfuhr 32 56170 Bendorf Germany www.baldus-sedation.de Phone: +49 261 96 38 92666 Date Prepared: April 5, 2023
Prepared by: Lisa Baldus Head of Quality Management and Regulatory Affairs
1) Identification of the Device:
Trade/Device Name: FlowStar Analog Mixer Flowmeter Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR
2) Equivalent legally marketed device: K970163
Trade/Device Name: ALPHA MX (20)/ULTRA PC (30) Manufacturer: TECHNICAL MEDICAL PRODUCTS, 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 intended patient population is adults and pediatrics. The applicable pediatric subgroups are child and adolescent. The intended operational environments are: Hospital, Dental Facility, Healthcare Facility. There are no patient contacting components supplied with the device. Those are sold separately and are 510(k) exempt. The device will be available in two models: (Details below)
FLOWSTAR ANALOG MIXER FLOWMETER 50 %, and
FLOWSTAR ANALOG MIXER FLOWMETER 70 %.
50% and 70% represent the maximum nitrous oxide concentration. This 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 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 FlowStar ® Analog Mixer 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.
Two rotary knobs are used to select the desired total flow and N20/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® Analog Mixer device has an integrated O2 Flush knob which delivers at
4
least over 40 l/min of pure oxygen if the user presses the knob to flush the N20 out of the patient circuit after the treatment or in the situation the patient is over sedated.
The FlowStar Analog Mixer 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 FlowStar ® Analog Mixer has an integrated Bag T. The mixed gas to it. The Bag T is a device with one additional input and two outputs. The additional 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 by the mixing device when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the connected scavenger system and finally to the patient
5) Contraindications.
- 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 Third trimester of pregnancy may be exposed to nitrous oxide. In Sweden, 90% of mothers are treated with nitrous oxide during the birth of their children
- · 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
Nitrous oxide diffuses into hollow spaces. Accordingly, it should not be inhaled following a middle ear infection, an intestinal obstruction, an eye operation with intraocular gas bubble, etc. In the last instance, for example, this could lead to loss of sight or, at least, an unpleasant feeling of pressure. Always take a medical history and observe the content conveyed in the advanced training course.
| | K970163
ALPHA MX (20)/ULTRA PC (30) | FlowStar Analog 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. EQUIVALENT |
| Range | Between 0 (100% O₂ and 70 (30% O₂) percent
N₂O (0-50% model available) | Between 0 (100% O₂) and 70 (30% O₂) percent
N₂O (0-50% model available) SAME |
| Power Source | Not required. | SAME |
| Population | Adults and Pediatrics | SAME |
| | K970163
ALPHA MX (20)/ULTRA PC (30) | FlowStar Analog Mixer Flowmeter
(Two models: N₂O max 70% or
N₂O max 50%) |
| Gas Delivery | Two knobs control the mixture. The left knob
controls the mixture percent (concentration)
and the center knob controls the flow. | Two knobs control the mixture: The left knob
controls the mixture percent (concentration)
and the right knob controls the flow.
EQUIVALENT |
| Gauges | N₂O flowmeter (left) and O₂ (right) | SAME |
| Safety
Features | O₂ Fail Safe System - Offers assurance that N₂O
ceases if the O₂ supply is interrupted or reduced. | 1 Safety shut-down in the event of a lack of
oxygen, Acoustic information signal in the
event of a lack of oxygen
2. If the pressure of the N₂O cylinder falls
below 0,7 bar, the device raises the O₂ flow to
the maximum |
| Controls | Rotary Knobs & a flush push button | SAME |
| Photo | Image: Accutron flowmeter | Image: Flowstar flowmeter |
| Standard met | Not specified | ISO 11195:2018 standard |
| Alarm | None cited in user manual | If the O2 cylinder runs empty and the pressure
is below 42 psi, a signal sounds until the
cylinder is completely empty |
| Dimensions/
weight | 330 x 127 x 203 mm 2.3 kg | 296 x 159 x 199 mm Weight: 3.3 kg
SIMILAR |
| Flow Meters | Two vertical cylindrical analog gauges, N₂ and O₂ | SAME |
| Gas Inlet
Connectors | DISS connector (Diameter Index Safety System) | DISS connector (Diameter Index Safety System)
SAME |
| Gas Supply
Pressure | 50-55 PSI | 50-72,5 psi SIMILAR |
| Gas Delivery | Oxygen Flush: Min 20 l/min
Oxygen Flow: 1 - 10 l/min
Emergency Mask Connection: Min 100 l/min
Nitrous Oxide %: 0-70% or 0-50% depending on
model. | Oxygen Flush: 40-55 l/min
Total Flow: 1-15 l/min
Emergency Mask Connection: 100- 250 l/min
Nitrous Oxide %: 0-70% or 0-50% depending on
model. SIMILAR |
| Use
environment | Hospital, Dental Facility, Healthcare Facility | SAME |
6) Substantial Equivalence Chart
5
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.
8) Summary of non-clinical testing:
Laboratory testing confirmed compliance with the applicable portions of the following standards:
ISO 18562 Biocompatibility Evaluation of a medical device with a breathing gas pathway. The report is entitled: ISO 18562 Particulates and VOC GLP Report. The same test laboratory provided: Toxicological Risk Assessment: This toxicological risk assessment pertains to the particulates and volatile organic compounds (VOCs) emitted from the device underwent a particulates and VOC study per ISO 18562
We performed detailed Risk Analysis in accordance with: Medical devices - Application of risk management to medical devices (ISO 14971 Third Edition 2019-12), FDA Recognition Number: 5-125
Labeling was created in compliance with: ISO 15223-1 Fourth Edition 2021-07 Medical devices -Symbols to be used with medical devices labels, labeling, and information to be supplied - Part 1: General requirements FDA Recognition Number: 5-134
Connectors were chosen in compliance with: CGA V-5:2008 (Reaffirmed 2013), Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications), FDA Recognition Number: 1-81
Testing was done to ISO 11195:2018 Gas mixers for medical use - Stand-alone gas mixers, no FDA Recognition Number: Alarm signal volume, Reverse gas flow, Ambient air valve, Leakage to atmosphere, Pressure differential, High pressure,
Usability testing was done in accordance with: Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366- 1:2015 + COR1:2016), FDA Recognition Number: 5-114 All requirements were met, there are no inapplicable requirements or deviations.
Additional successful bench testing performed:
- Climate chamber testing for worst case high temperature and humidity.
- Durability of marking. ●
- On demand air flow higher than 100 l/min
- Accessory compatibility (510(k) exempt)
- Functional testing of aged components (to ASTM F1980)
9) Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
-
- Conclusion: The comparison tables and the discussion of 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 characteristics and do not introduce any potential risks. So, the purposed device can be rated as substantially equivalent to the predicate.