(203 days)
K140939 – Hamilton T-1
No
The summary describes a microprocessor-controlled ventilator with various standard ventilation modes. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The TV-100 is a ventilator that provides ventilatory support to patients. Ventilatory support is a therapeutic intervention that directly treats respiratory conditions.
No
The TV-100 is a ventilator designed to provide ventilatory support to patients. Its function is to assist with breathing, not to diagnose a medical condition.
No
The device description clearly states it is a microprocessor-controlled ventilator with an internal compressor, touchscreen LCD, internal batteries, and an external power supply. This indicates it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the TV-100 is for providing ventilatory support to patients. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details a ventilator, a device used to assist breathing. It does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.) which is the core of IVD devices.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of substances in the body.
- Providing information for diagnosis, monitoring, or screening.
The TV-100 is a medical device, specifically a ventilator, used for patient care and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both invasive and non-invasive ventilation modes. The TV-100 is intended for use in hospital including intrahospital transport, pre-hospital, and air transport settings.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The TV-100 is designed to be a compact, lightweight, microprocessor controlled ventilator which allows for precise ventilatory control. The TV-100 features an internal compressor which allows the TV-100 to operate without the need for external pressurized gas supplies; however an external oxygen supply may be connected to blend with the air from the internal compressor. To further simplify use there are minimal ventilation controls. The TV-100 user interface (UI) is a touchscreen color LCD with full VGA resolution.
The TV-100 ventilator is a DC powered device operating on internal lithium ion batteries and powered by an external IEC 60601-1 compliant power supply. The external supply also charges the batteries.
Ventilation Modes include: A/C Mode (Assist/Control) CPAP Mode (Continuous Positive Airway Pressure) NIV Bilevel Mode (Non-invasive Ventilation) SIMV Mode (Synchronized Intermittent Mandatory Ventilation) PRVC Mode (Pressure Regulated Volume Control) Constant Flow Apnea Detection Standby Mode
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
neonatal, pediatric, and adult patients.
Intended User / Care Setting
qualified medical personnel; hospital including intra-hospital transport, pre-hospital, and air transport settings.
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 Performance Testing Summary:
Biocompatibility / Materials - The materials which are in the gas pathway have been evaluated via Gas emission VOC. Inorganic gases (CO, CO2, Ozone), and PM25 testing with a risk based assessment. No materials are in a humidified gas pathway. Discussion - The materials were found to be biocompatible for the intended use, intended population and type of patient contact.
Performance Testing - The device has been tested to insure that all requirements have been met, this includes:
-Testing for compliance with ISO 80601-2-12
-Gas Compatibility Requirement o
-Alarm, Power Supply Failure o
-Alarm, Internal Power Supply o
-Volume Control Accuracy o
-Pressure Control Accuracy o
-O Oxygen Response Time
-Alarm, Oxygen o
-Accuracy, Airway Pressure o
-Alarm, Low Volume Conditions o
-O Alarm, VTE LTE 50 ml
-Maximum Pressure Limiting o
-Alarm, High Pressure o
-Alarm, PEEP High Limit o
-Alarm, Obstruction Condition o
-Alarm, Partial Occlusion o
-Single Fault Conditions o
-Failure, One Gas Supply o
-Single Fault Tolerance o
-Delivered Oxygen Concentration o
-O Accessory Compliance Testing
-Gas Mixer per 11195 o
-Leakage, Unintended o
-Breathing, Loss of Power Supply o
-Signal IO Disruption o
-Expiratory Pause o
-Inspiratory Pause o
-Global Alarm Off Prevention o
-O Alarm Condition, Audio Paused
-Trigger sensitivity o
-Testing in accordance with ASTM F1100-90 ●
-Usability testing ●
-Endurance Testing
-Comparative Waveform Testing ●
-Shock and Vibration Testing ●
-DO-160 testing ●
-RFID following AIM standard ●
-Drop, vibration and environmental temperature and humidity, and altitude for the ● applicable environments of use
In addition the device has also been tested to the requirements of the following standards:
-. AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment - part 1: general requirements for basic safety and essential performance
-IEC 60601-1-2: 2007 Collateral standard: Electromagnetic Compatibility - Requirements and Tests
-IEC 60601-1-8: 2012 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-ISO 80601-2-12: 2011 Particular requirements for the safety of lung ventilators Critical ● care ventilators
-. ASTM F1100: 2004 Standard Specification for Ventilators Intended for Use in Critical Care
Discussion - The results of the testing demonstrated that the TV-100 comply with the applicable requirement of both standards as well as performed within it performance specifications that are substantially equivalent to the predicates – Bio-Med Devices - CrossVent 4 - K942938 and Hamilton T-1 – K140939.
Usability - We performed a usability study with 16 qualified users. Discussion - The usability demonstrated that the TV-100 can be used by the intended users as intended.
No clinical testing was performed.
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.
K942938 – Bio-Med Devices CrossVent-4
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.
K140939 – Hamilton T-1
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(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 square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2018
Bio-Med Devices, Inc. % Paul Dryden Consultant ProMedic. LLC 61 Soundview Road Guilford, Connecticut 06437
Re: K173973
Trade/Device Name: Tv-100 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: June 20, 2018 Received: June 21, 2018
Dear Paul Dryden:
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. 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 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); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
TV-100
Indications for Use (Describe)
The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both invasive and non-invasive ventilation modes. The TV-100 is intended for use in hospital including intrahospital transport, pre-hospital, and air transport settings.
Type of Use (Select one or both, as applicable) XX Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (7/17)
Page 1 of 1
3
510(k) Summary Page 1 of 7 7/19/2018
| Bio-Med Devices
61 Soundview Road
| Guilford, CT 06437 | Tel (203) 458-0202 |
|---|---|
| Official Contact: | Kenneth Close – Regulatory Affairs Manager |
| Proprietary or Trade Name: | TV-100 |
| Common/Usual Name: | Ventilator, continuous, facility use |
| Classification Name/Code: | CBK - ventilator, continuous, facility use |
| 21CFR 868.5895 | |
| Class II | |
| Device Name: | TV-100 |
| Predicate Device: | |
| Reference Device: | K942938 – Bio-Med Devices CrossVent-4 |
| K140939 – Hamilton T-1 |
Device Description:
The TV-100 is designed to be a compact, lightweight, microprocessor controlled ventilator which allows for precise ventilatory control. The TV-100 features an internal compressor which allows the TV-100 to operate without the need for external pressurized gas supplies; however an external oxygen supply may be connected to blend with the air from the internal compressor. To further simplify use there are minimal ventilation controls. The TV-100 user interface (UI) is a touchscreen color LCD with full VGA resolution.
The TV-100 ventilator is a DC powered device operating on internal lithium ion batteries and powered by an external IEC 60601-1 compliant power supply. The external supply also charges the batteries.
Ventilation Modes include: A/C Mode (Assist/Control) CPAP Mode (Continuous Positive Airway Pressure) NIV Bilevel Mode (Non-invasive Ventilation) SIMV Mode (Synchronized Intermittent Mandatory Ventilation) PRVC Mode (Pressure Regulated Volume Control) Constant Flow Apnea Detection Standby Mode
Indications for Use:
The TV-100 is intended for use by qualified medical personnel to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. The TV-100 is intended for use in both invasive and non-invasive ventilation modes. The TV-100 is intended for use in hospital including intra-hospital transport, pre-hospital, and air transport settings.
4
Patient Population
Neonates, pediatrics, and adults.
Environment of Use:
Hospital including intra-hospital transport, Pre-hospital, and Air Transport settings.
Predicate and Reference Device Comparison:
We compared the Bio-Med Devices TV-100 to the predicate device: Bio-Med Devices -CrossVent 4 - K942938 and the reference device Hamilton T-1 - K140939.
Substantial Equivalence Discussion of Comparison to Predicate and Reference
The Bio-Med Devices TV-100 is viewed as substantially equivalent to the predicate and reference devices because:
Indications -
Indications for use are to provide intermittent to continuous ventilatory support to neonatal, pediatric, and adult patients. For use in both invasive and non-invasive ventilation modes. Discussion - These are similar indications for use of the predicate - Bio-Med Devices -Cross Vent 4 - K942938, except for non-invasive ventilation. These are similar indications for use to the reference - Hamilton T-1 - K140939.
Technology -
The technology of a turbine based portable ventilator is similar to the predicate. Discussion - The technology and principle of operation for the proposed device is similar to the predicate - Bio-Med Devices - Cross Vent 4 - K942938 and reference Hamilton T-1 -K140939.
Environment of Use -
The environment of use - hospital and intra-hospital transport, pre-hospital and aircraft transport setting are similar to the predicate and reference.
Discussion - The environments of use are similar to the reference - Hamilton T-1 -K140939.
Patient Population -
The patient population of neonates to adults is similar to both the predicate and reference. Discussion - The patient population is identical to the predicate - Bio-Med Devices -CrossVent 4 - K942938 and reference Hamilton T-1 - K140939.
Modes of Ventilation and Specifications -
The modes of ventilation are similar to both the predicate and reference. In addition, a comparison of the specifications and operating ranges are similar as well. Discussion - All ventilation modes, except NIV, are similar to the predicate - Bio-Med Devices - Cross Vent 4 - K942938. For NIV mode the reference - Hamilton T-1 - K140939 has this mode as well as all the modes of ventilation of the proposed device.
5
Non-Clinical Performance Testing Summary
Biocompatibility / Materials -
The materials which are in the gas pathway have been evaluated via Gas emission VOC. Inorganic gases (CO, CO2, Ozone), and PM25 testing with a risk based assessment. No materials are in a humidified gas pathway.
Discussion - The materials were found to be biocompatible for the intended use, intended population and type of patient contact.
Performance Testing -
.
The device has been tested to insure that all requirements have been met, this includes:
- Testing for compliance with ISO 80601-2-12
- Gas Compatibility Requirement o
- Alarm, Power Supply Failure O
- Alarm, Internal Power Supply o
- Volume Control Accuracy O
- Pressure Control Accuracy O
- O Oxygen Response Time
- Alarm, Oxygen o
- Accuracy, Airway Pressure O
- Alarm, Low Volume Conditions O
- O Alarm, VTE LTE 50 ml
- Maximum Pressure Limiting O
- Alarm, High Pressure O
- Alarm, PEEP High Limit O
- Alarm, Obstruction Condition O
- Alarm, Partial Occlusion O
- Single Fault Conditions O
- Failure, One Gas Supply O
- Single Fault Tolerance o
- Delivered Oxygen Concentration O
- O Accessory Compliance Testing
- Gas Mixer per 11195 O
- Leakage, Unintended o
- Breathing, Loss of Power Supply O
- Signal IO Disruption O
- Expiratory Pause O
- Inspiratory Pause O
- Global Alarm Off Prevention O
- O Alarm Condition, Audio Paused
- Trigger sensitivity o
- Testing in accordance with ASTM F1100-90 ●
- Usability testing ●
- Endurance Testing
- Comparative Waveform Testing ●
- Shock and Vibration Testing ●
- DO-160 testing ●
- RFID following AIM standard ●
6
510(k) Summary Page 4 of 7 7/19/2018
-
Drop, vibration and environmental temperature and humidity, and altitude for the ● applicable environments of use
In addition the device has also been tested to the requirements of the following standards: -
. AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment - part 1: general requirements for basic safety and essential performance
-
IEC 60601-1-2: 2007 Collateral standard: Electromagnetic Compatibility - Requirements and Tests
-
IEC 60601-1-8: 2012 Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
-
ISO 80601-2-12: 2011 Particular requirements for the safety of lung ventilators Critical ● care ventilators
-
. ASTM F1100: 2004 Standard Specification for Ventilators Intended for Use in Critical Care
Discussion - The results of the testing demonstrated that the TV-100 comply with the applicable requirement of both standards as well as performed within it performance specifications that are substantially equivalent to the predicates – Bio-Med Devices - CrossVent 4 - K942938 and Hamilton T-1 – K140939.
Usability -
We performed a usability study with 16 qualified users.
Discussion - The usability demonstrated that the TV-100 can be used by the intended users as intended.
Discussion of Differences
The basic design, indications for use, patient population, and environments of use, technological characteristics, ventilation modes, alarms, performance specifications and features of the TV-100 are similar to both the predicate and reference – Bio-Med Devices - CrossVent 4 - K942938 and Hamilton T-1 – K140939.
There are no notable differences in the performance range which would raise any new risks or safety concerns.
7
K173973
510(k) Summary Page 5 of 7
7/19/2018
Device Comparison
| Attribute | Proposed
TV-100 | Primary Predicate
Bio-Med Devices - CrossVent -4
K942938 | Reference
Hamilton -T-1
K140939 |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | CBK | CBK | CBK |
| Intended Use | The TV-100 is intended for use by qualified
medical personnel to provide intermittent to
continuous ventilatory support to neonatal,
pediatric, and adult patients. The TV-100 is
intended for use in both invasive and non-
invasive ventilation modes. The TV-100 is
intended for use in hospital including intra-
hospital transport, pre-hospital, and air
transport settings. | The CV4 is intended for use by qualified
medical personnel to provide intermittent to
continuous ventilatory support to neonatal,
pediatric, and adult patients. The TV-100 is
intended for use in both invasive and non-
invasive ventilation modes. The CV4 is
intended for use in hospital, intra-hospital
transport and pre-hospital transport settings.
Note there was not a FDA published IFU
statement. | The HAMILTON-T1 ventilator is intended
to provide positive pressure ventilatory
support to adults and pediatrics, and
optionally infants and neonates. |
| Patient population | Neonate, pediatric, adults | Neonate, pediatric, adults | Neonate, infant, pediatric, adults |
| Environment of use | Hospital, intra-hospital transport
Pre-hospital
Air transport settings | Hospital, intra-hospital transport
Pre-hospital | Hospital, intra-hospital transport
Pre-hospital
Air transport settings |
| Modes of Operations | | | |
| Assist / Control | Yes | Yes | Yes |
| SIMV | Yes | Yes | Yes |
| CPAP | Yes | Yes | Yes |
| Pressure support | Yes | Yes | Yes |
| Sigh | Yes | Yes | Yes |
| Continuous Flow | Yes | Yes | Yes |
| Pressure Limit | Yes | Yes | Yes |
| NIV Bi-Level | Yes | No | Yes |
| Delivered Parameter Ranges | | | |
| Peak Pressure | 3-100 cmH2O | 0-120 cmH2O | 60 cm H2O |
| PEEP Pressure | 0-35 cmH2O | 0-35 cmH2O | 0-35 cmH2O |
| Pressure Support | 1-60 cmH2O | 0-50 cmH2O | 0-60 cmH2O |
| Oxygen % | 21-100% | 21-100% | 21-100% |
| Breath Rate (bpm) | 5-150 BPM | 5-150 BPM | 5-150 BPM |
| Tidal Volume | 2-2500 mL | 5-2500 mL | 2-2000 mL |
| Attribute | Proposed
TV-100 | Primary Predicate
Bio-Med Devices - CrossVent -4 | Reference
Hamilton -T-1 |
| | | K942938 | K140939 |
| Inspiratory Time | 0.10-3.0 sec | 0.10-3.0 sec | 0.1-12.0 sec |
| I/E Ratio | 3:1 to 1:99 | 3:1 to 1:99 | 1:9 to 4:1 |
| Flow Rate | 0.1-180 LPM | 1-120 LPM | up to 260 l/min |
| Pressure Trigger | -0.2 to -10 cmH2O | -0.2 to -10 cmH2O | N/A |
| SIMV Rate | 0.6-50 BPM | 0.6-50 BPM | 5 to 80 b/min |
| SIGH | Up to 130% of set volume or +10 cm H2O | 0-2500 mL | Every 50 breaths at +10 cm H2O |
| Alarms | | | |
| Peak Pressure | YES | YES | YES |
| Rate | YES | YES | YES |
| Oxygen | YES | YES | YES |
| PEEP / CPAP | YES | YES | YES |
| Mean Pressure | YES | YES | YES |
| Low Battery | YES | YES | YES |
| Low Supply Pressure | YES | YES | YES |
| Exhaled Tidal Volume | YES | YES | YES |
| Exhaled Minute Volume | YES | YES | YES |
| Technology | | | |
| Software driven | Yes | Yes | Yes |
| Gas source | Turbine | Turbine | Turbine |
| Physical Specifications | | | |
| Dimensions | 12.8" x 11.9" x 7.9" | 10" x 11" x 5.5" | 9.4" x 8.3" x 12.2" |
| Weight | 7 kg | 4.8 kg | 14.3 kg with battery |
| Operating Temperatures | 0 to 40°C | 0 to 40°C | -15 to 50°C |
| Storage Temperatures | 0 to 50°C | 0 to 50°C | -20 to 60°C |
| Electrical Power Source | 90 to 264 V AC
Back-up battery | 100 to 240 V AC
Back-up battery | 100 to 240 V AC
Back-up battery |
| Battery time | 7 hr | 6 hr | 8 hr |
| Maximum Safety Pressure | 81-119 cm H2O adult
49-71 cm H2O neonatal | 98 to 142 cm H2O | 70 cm H2O |
| Pneumatic Power Source | Air / Oxygen | Air / Oxygen | Air / Oxygen |
| Audible Alarm characteristics | 83 dB min @ 10cm | 83 dB min @ 10cm | Not specified |
8
510(k) Summary Page 6 of 7
7/19/2018
9
Clinical Testing Summary:
No clinical testing was performed
Substantial Equivalence Conclusion
The Bio-Med Devices TV-100 ventilator is substantially equivalent to the above listed predicate and we have determined that there are no significant differences which would affect safety and efficacy for the patient population. This has been demonstrated through performance testing, design, and features, and non-clinical testing.