(509 days)
The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
- In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
- For emergency medical care
- During transport within and outside the hospital
- During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship
The HAMILTON-T1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
- In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
- During transfer of ventilated patients within the hospital
The HAMILTON-C1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
The HAMILTON-C1 and HAMILTON-T1 are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. Both ventilators cover a full range of clinical requirements: including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive ventilation.
The two previously cleared ventilators, the HAMILTON-T1 and the HAMILTON-C1, have been bundled together in this 510(k) submission, in order to add the following new features to both ventilators:
Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL. The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC; SpO2 monitoring with MASIMO PULSE OXIMETERS;
An increase in the battery duration from 5.5 hours on the HAMILTON-T1, to 9.25 hours (maximum) instead and an increased battery duration from 2 hours to 4.30 hours on the HAMILTON-C1.
Increased temperature range for the HAMILTON-T1 to 50°C [122°F] for adult and pediatric patients. Increased altitude operating condition for the HAMILTON-T1 from 15.091 ft to 25.000 ft for adult and pediatric patients.
This document is a 510(k) summary for the Hamilton-T1 and Hamilton-C1 ventilators, detailing their substantial equivalence to predicate devices and the performance data supporting this claim.
Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding reported device performance for specific features. However, it implies that the devices meet a set of performance and safety standards, and that their performance on new features (neonatal ventilation, improved battery life, increased temperature/altitude range, SpO2 monitoring, and new modes) has been demonstrated to be "substantially equivalent" to legally marketed predicate devices.
The "Difference Status" column in the comparison tables (Table 1 for HAMILTON-T1 and Table 2 for HAMILTON-C1) implicitly acts as a form of "acceptance criteria met" by referencing substantial equivalence to specific predicate devices for each new or changed feature.
| Feature | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Neonatal Ventilation (HAMILTON-T1 & C1) | Must be substantially equivalent to the HAMILTON-C2 (K121225) for neonatal patient group. Minimum weight 0.2 kg, minimum tidal volume 2 mL. | Demonstrated substantial equivalence to HAMILTON-C2 (K121225). |
| nCPAP and nCPAP-PC modes (HAMILTON-T1 & C1) | Must be substantially equivalent to MAQUET Servo-I (K073179). | Demonstrated substantial equivalence to MAQUET Servo-I (K073179). New ventilation modes were subjected to waveform performance testing, as described in ASTM F1100-90, and data was shown to be substantially equivalent to legally marketed devices. |
| SpO2 monitoring (HAMILTON-T1 & C1) | Must be substantially equivalent to the HAMILTON-G5 (K131774) and ensure SpO2 and pulse rate values are not corrupted during communication between OEM system and host device. | Demonstrated substantial equivalence to HAMILTON-G5 (K131774). Testing demonstrated that SpO2 and pulse rate values calculated by the OEM system are not corrupted during communication to the HAMILTON-T1 or HAMILTON-C1 host device. |
| Battery Duration (HAMILTON-T1) | Maximal run time of 9.25 hrs (increased from 5.5 hrs). | Achieved a maximal run time of 9.25 hrs. |
| Battery Duration (HAMILTON-C1) | Maximal run time of 4.30 hrs (increased from 2 hrs). | Achieved a maximal run time of 4.30 hrs. |
| Temperature Range (HAMILTON-T1) | 5 to 50°C (41 to 122°F) for adults/pediatrics (increased from 5 to 40°C). | Components can withstand 50°C (122°F) in the adult/pediatric mode. |
| Altitude Operating Condition (HAMILTON-T1) | 1013 to 376 hPa (25.000 ft) for adults/pediatrics (increased from 1013 to 600 hPa). | Performance in high altitude has been increased for adult/pediatric patients to 376 hPa (25.000 ft). |
| O2 consumption monitoring (HAMILTON-T1) | Must be substantially equivalent to the Dräger Oxylog 3000 (K062267). | Demonstrated substantial equivalence to the Dräger Oxylog 3000 (K062267). |
| VOC and Particulate Matter | Output gas from the device must meet requirements for allowable levels of particulate matter for the most vulnerable patient population. | Gas sample analysis comprising VOC and particular matter testing has demonstrated that the output gas from the device meets the requirements. |
| General Safety and Performance | Compliance with relevant FDA guidelines and international standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2, ISO 80601-2-12, IEC 60601-1-8, IEC 60601-1-6, IEC 62366, IEC 62304, ISO 80601-2-55). Software is a "major" level of concern. | Testing demonstrated compliance with all listed standards and guidelines. Software verification and validation testing were conducted as per FDA guidance for "major" level of concern software. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document extensively references "bench testing" and "waveform performance testing" for the new ventilation modes as described in ASTM F1100-90. It also mentions "gas sample analysis" for VOC and particulate matter.
- Sample Size: The document does not specify the sample size for the test sets used in these bench tests.
- Data Provenance: The data appears to be from bench testing conducted by the manufacturer, Hamilton Medical AG, located in Bonaduz, Grisons, Switzerland. The nature of these tests (laboratory-based performance evaluation) suggests they are prospective in relation to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The testing described (bench testing, waveform performance testing, gas sample analysis) is focused on technical performance metrics against specified standards and predicate devices, rather than clinical ground truth established by medical experts for a diagnostic or treatment outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document. The tests described are objective engineering and performance evaluations, not subjective assessments requiring adjudication of ground truth by multiple human reviewers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. This document is for a ventilator, not an AI-assisted diagnostic or therapeutic device requiring human interpretation of output. Therefore, information on differences in human reader improvement with or without AI assistance is not applicable and not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a ventilator, which is a therapeutic medical device, not an algorithm for diagnosis or interpretation. The document describes the performance of the integrated device and its new features. Therefore, the concept of "standalone (algorithm only)" performance as typically applied to AI/ML devices is not directly applicable here. The performance data presented refers to the functionality of the device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the technical performance evaluations, the "ground truth" implicitly refers to the established standards (e.g., ASTM F1100-90), technical specifications, and the performance characteristics of the identified predicate devices. For example, for waveform performance, the waveforms generated by the new modes would be compared against expected waveforms defined by the standard and/or predicate device performance. For VOC and particulate matter, the ground truth is the "requirements for allowable levels" of these substances. This is not clinical ground truth derived from human subjects or pathology.
8. The sample size for the training set
The document describes a mechanical ventilator with hardware and embedded software, not a machine learning or AI algorithm that typically has a "training set." Therefore, the concept of a "training set sample size" is not applicable and not provided. The software mentioned (considered "major" level of concern) undergoes verification and validation, but this is distinct from machine learning model training.
9. How the ground truth for the training set was established
As the concept of a "training set" for an AI/ML algorithm is not applicable to this device, the method for establishing its "ground truth" is also not relevant and not provided. The software verification and validation would follow established software engineering principles and regulatory guidance, ensuring the software performs its intended functions correctly and safely.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The profiles are black and create a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Hamilton Medical AG Ms. Frederike Brühschwein Senior Manager Regulatory Affairs Via Crusch 8 Bonaduz, Grisons, 7402 Switzerland
Re: K140939
Trade/Device Name: Hamilton-T1, Hamilton-C1 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, DOA Dated: July 28, 2015 Received: August 3, 2015
Dear Ms. Brühschwein:
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. 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
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Project-Name:
HAMILTON-T1/C1 510(k) Submission
1.0
Doc.-Title:
Part 4: Indications for use
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K140939 |
|---|---|
| Device Name: | HAMILTON-T1 |
| Indication for Use: | The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. |
| Intended areas of use: | In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery roomFor emergency medical careDuring transport within and outside the hospitalDuring transfer by rescue vehicles, fixed wing aircraft, helicopter or ship |
The HAMILTON-T1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
| Prescription Use(Part 21 CFR 801 Subpart D) | X AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|
| ------------------------------------------------- | ---------- | ------------------------------------------------ |
Concurrence of CDRH, Office of Device Evaluation (ODE)
CONFIDENTIAL
© Copyright by HAMILTON MEDICAL AG
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Part 4: Indications for use Doc.-Title:
Doc.-No.:
Doc.-Version:
1.0
INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K140939 |
|---|---|
| Device Name: | HAMILTON-C1 |
| Indication for Use: | The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates. |
Intended areas of use:
- In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
- During transfer of ventilated patients within the hospital
The HAMILTON-C1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
| Prescription Use X(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use ____(21 CFR 801 Subpart C) |
|---|---|---|
| ----------------------------------------------------- | -------- | ----------------------------------------------------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 4 - 3
CONFIDENTIAL
© Copyright by HAMILTON MEDICAL AG
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Image /page/4/Picture/0 description: The image shows the logo for Hamilton Medical. The logo consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other in a bold, blue font. To the right of the word "HAMILTON" is a stylized "H" symbol. Below the two words is the tagline "Intelligent Ventilation since 1983" in a smaller, lighter blue font.
Image /page/4/Picture/1 description: The image shows two logos, both in blue. The first logo reads "HAMILTON-T1", and the second logo reads "HAMILTON-C1". The font is bold and sans-serif, with rounded edges. The logos appear to be for a company or product named Hamilton, with T1 and C1 possibly indicating different versions or models.
510(k) SUMMA
- l. SUBMITTER
Hamilton Medical AG Via Crusch 8 Bonaduz, 7402 Switzerland
Phone: +41 58 610 1568 Cell: +41 79 551 1151 +41 58 610 0020 Fax:
| Contact Person: | Frederike Brühschwein, Senior Manager of Regulatory Affairs |
|---|---|
| Date Prepared: | 2015-07-24 |
- II. DEVICE
Name of Devices: HAMILTON-T1 and HAMILTON-C1 Common or Usual Name: Transport/ICU and +ICU ventilator Device Classification and Name: 21 CFR 868.5895 Continuous Ventilator Device Classification and Product Code: Class II CBK (incl. Class II DQA)
III. PREDICATE DEVICES
| HAMILTON-T1 (K120670) | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
|---|---|
| HAMILTON-C1 (K120574) | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
| HAMILTON-C2 (K121225) for theneonatal modes. | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
| HAMILTON-G5 (K131774) for theMasimo SpO2 board and sensors | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK, (incl. Class II DQA) |
| MAQUET Servo-i (K073179) for thenCPAP and nCPAP-PC modes. | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
| Dräger Oxylog 3000 (K062267) forO2 consumption | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
No reference devices were used in this submission.
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Image /page/5/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a symbol that looks like a stylized "H". Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/5/Picture/1 description: The image shows two logos in blue. The first logo reads "HAMILTON-T1" and the second logo reads "HAMILTON-C1". The logos are similar in style and font, with the only difference being the last two characters.
IV. DEVICE DESCRIPTION
The HAMILTON-C1 and HAMILTON-T1 are designed for adults, pediatrics, infants and neonatal patients requiring invasive or non-invasive ventilation support. Both ventilators cover a full range of clinical requirements: including invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV), and non-invasive ventilation.
The two previously cleared ventilators, the HAMILTON-T1 and the HAMILTON-C1, have been bundled together in this 510(k) submission, in order to add the following new features to both ventilators:
Neonatal patients with a minimum weight of 0.2 kg and a minimal tidal volume of 2 mL. The following two new modes for the neonatal patient group: nCPAP and nCPAP-PC; SpO2 monitoring with MASIMO PULSE OXIMETERS;
An increase in the battery duration from 5.5 hours on the HAMILTON-T1, to 9.25 hours (maximum) instead and an increased battery duration from 2 hours to 4.30 hours on the HAMILTON-C1.
Increased temperature range for the HAMILTON-T1 to 50°C [122°F] for adult and pediatric patients. Increased altitude operating condition for the HAMILTON-T1 from 15.091 ft to 25.000 ft for adult and pediatric patients.
V. INDICATIONS for USE for the HAMILTON-T1
The HAMILTON-T1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
- । In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
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Image /page/6/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the word "HAMILTON" in large, bold letters, with a stylized "H" symbol next to it. Below "HAMILTON" is the word "MEDICAL" in a smaller, but still bold, font. Underneath the logo is the text "Intelligent Ventilation since 1983" in a smaller, lighter font.
Image /page/6/Picture/1 description: The image shows two logos, one above the other. The top logo reads "HAMILTON.T1" in a bold, rounded sans-serif font, with a dot separating "HAMILTON" and "T1". The bottom logo reads "HAMILTON.C1", also in a bold, rounded sans-serif font with a dot separator. Both logos are in the same shade of blue.
- -For emergency medical care
- -During transport within and outside the hospital
- -During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship
The HAMILTON-T1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
- VI. INDICATIONS for USE for the HAMILTON-C1
The HAMILTON-C1 ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics, and optionally infants and neonates.
Intended areas of use:
- । In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room
- -During transfer of ventilated patients within the hospital
The HAMILTON-C1 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.
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Image /page/7/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on top of the word "MEDICAL". To the right of the word "HAMILTON" is a blue circle with a white "H" inside. Below the words "HAMILTON MEDICAL" is the phrase "Intelligent Ventilation since 1983".
Image /page/7/Picture/1 description: The image shows two logos, one above the other. The top logo reads "HAMILTON-T1" in a bold, sans-serif font, with a dot between "HAMILTON" and "T1". The bottom logo reads "HAMILTON-C1", also in a bold, sans-serif font with a dot between "HAMILTON" and "C1". Both logos are in the same shade of blue.
VII. COMPARISON OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
The HAMILTON-T1 and HAMILTON-C1 are substantially equivalent to the technology, and performance of the previous adult/pediatric version of the devices (HAMILTON-T1 with K120670 and HAMILTON-C1 with K120574).
The HAMILTON-T1 and HAMILTON-C1 are substantially equivalent to the intended use (including neonatal ventilation) of the HAMILTON-C2 (K121225).
The HAMILTON-T1 and HAMILTON-C1 are substantially equivalent to the SpO2 technology and to the use of SpO2 with the HAMILTON-G5 (K131774).
The HAMILTON-T1 and HAMILTON-C1 are substantially equivalent to the modes nCPAP-PC and nCPAP of the MAQUET Servo-I (K073179).
The HAMILTON-T1 is substantially equivalent to the O2 consumption monitoring and calculation of the Dräger Oxylog 3000 (K062267).
| Predicate device:previous version ofHAMILTON-T1 | Application device:HAMILTON-T1 | Difference Status | |
|---|---|---|---|
| Indications for Use | The HAMILTON-T1ventilator isintended to providepositive pressureventilatory supportto adults andpediatrics.Intended areas ofuse: | The HAMILTON-T1ventilator isintended to providepositive pressureventilatory supportto adults, pediatrics,and optionallyinfants andneonates. | The patient groupinfants andneonates is new.The substantialequivalence hasbeen proven to theHAMILTON-C2(K121225). |
| Predicate device:previous version ofHAMILTON-T1 | Application device:HAMILTON-T1 | Difference Status | |
| • In theintensive careward or in therecoveryroom.• For emergencymedical careor primarycare.• Duringtransportwithin andoutside thehospital.• Duringtransfer byrescuevehicles, jet orhelicopter. | Intended areas ofuse:• In the intensivecare ward,intermediatecare ward,emergencyward, long termacute carehospital or inthe recoveryroom• For emergencymedical care• During transportwithin andoutside thehospital• During transferby rescuevehicles, fixedwing aircraft,helicopter orship. | ||
| The HAMILTON-T1ventilator is amedical deviceintended for use byqualified, trainedpersonnel underthe direction of aphysician andwithin the limits ofits stated technicalspecifications. | The HAMILTON-T1ventilator is amedical deviceintended for use byqualified, trainedpersonnel under thedirection of aphysician and withinthe limits of itsstated technicalspecifications | ||
| ProductClassification Code | CBK | CBK | Identical |
| CFR Citation | 21 CFR 868.5895 | 21 CFR 868.5895 | Identical |
| Principal Operator | Qualified, trainedpersonnel under | Qualified, trainedpersonnel under the | Identical |
| Predicate device:previous version ofHAMILTON-T1 | Application device:HAMILTON-T1 | Difference Status | |
| the direction of aphysician | direction of aphysician | ||
| Environment of Use | In the intensive care ward or in the recovery room. For emergency medical care or primary care. During transport within and outside the hospital. During transfer by rescue vehicles, jet or helicopter. | In the intensive care ward, intermediate care ward, emergency ward, long term acute care hospital or in the recovery room For emergency medical care During transport within and outside the hospital During transfer by rescue vehicles, fixed wing aircraft, helicopter or ship | Environment is identical, was only better specified |
| Environmentalconditions | 5 to 40 °C (41 to 104°F) 10 to 95%, non-condensing 1013 to 600 hPa (13.120 ft) | 5 to 50°C (41 to 122°F) for adults/pediatrics 5 to 40°C (41 to 104°F) for neonates 10 to 95%, non-condensing 1013 to 376 hPa (25.000 ft) for adults/pediatrics 1013 to 600 hPa (13.120 ft) for neonates | The components of the proposed device can withstand 50°C (122°F) in the adult/pediatric mode.The performance in high altitude has been increased for adult/pediatric patients to 376 hPa (25.000 ft) |
| Patient Interface | Delivered invasively (via ET tube) or non-invasively (via mask) | Delivered invasively (via ET tube) or non-invasively (via mask) | Identical |
| Predicate device: previous version of HAMILTON-T1 | Application device: HAMILTON-T1 | Difference Status | |
| Power Source | AC and DC; Battery powered with two batteries, can be run while battery is charging with a maximal run time of 5.5 hrs | AC and DC; Battery powered with two batteries, can be run while battery is charging with a maximal run time of 9.25 hrs | Identical, battery time has been improved |
| Operational Modes | • ASV• (S)CMV+• SIMV+• PCV+• PSIMV+• SPONT• DuoPAP• APRV• NIV• NIV-ST | • ASV• (S)CMV+• SIMV+• PCV+• PSIMV+• SPONT• DuoPAP• APRV• NIV• NIV-ST• nCPAP• nCPAP-PC | New modes nCPAP and nCPAP-PC substantialy equivalent to MAQUET Servo-l (K073179). |
| SpO2 monitoring | No SpO2 monitoring | SpO2 monitoring available | Substantial equivalence has been proven to the HAMILTON-G5 (K131774) |
| Active Exhalation Valve? | Yes, pneumatic | Yes, pneumatic | Identical |
| Size WxLxH (in) | 8.3 x 12.2 x 9.4 | 8.3 x 12.2 x 9.4 | Identical |
| Weight | 14.3 lb | 14.3 lb | Identical |
| Volume Setting Range | 20-2000 ml | 2-2000 ml | Volume can be set down to 2 ml for neonatal application; substantial equivalent to HAMILTON-C2 (K121225) |
| PEEP setting | 0-35 cmH2O | 0-35 cmH2ONeo: 3-25 cmH2O | Identical |
| Alarms and Monitoring | Yes | Yes | Identical |
| Predicate device:previous version ofHAMILTON-T1 | Application device:HAMILTON-T1 | Difference Status | |
| AdjustableInspiration Timetotal range | 0.1-40 sec | 0.1-40 sec | Identical |
| Supply Gas | Oxygen, ambientAir | Oxygen, ambient Air | Identical |
| Method of supplygas pressurization | Internal turbine forAirCompressed Sourcefor O2 | Internal turbine forAirCompressed Sourcefor O2 | Identical |
| MR Unsafe symbol | No | Yes | The proposeddevice now carriesthe "MR Unsafe"symbol according toASTM F2503 |
| O2 consumptionmonitoring | No | Yes | Substantialequivalence hasbeen proven to theDräger Oxylog 3000(K062267) |
Table 1: Comparison of HAMILTON-T1 with predicates
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Image /page/8/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" on top of the word "MEDICAL". There is a symbol to the right of the word "HAMILTON". Below the word "MEDICAL" is the phrase "Intelligent Ventilation since 1983".
JU ગાંતી જેવી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા IAMILTON.CI
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Image /page/9/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the word "HAMILTON" in large, bold letters, with a stylized "H" symbol next to it. Below "HAMILTON" is the word "MEDICAL" in a similar font. Underneath that, the text "Intelligent Ventilation since 1983" is written in a smaller, lighter font.
HAMI 1 21 IAMILTON.CI
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Image /page/10/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. Below the logo is the text "Intelligent Ventilation since 1983". The logo is simple and professional, and it conveys the company's focus on medical technology and ventilation.
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Image /page/11/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. There is a small symbol to the right of the word "HAMILTON". Below the logo is the text "Intelligent Ventilation since 1983".
Table 2: Comparison table of the HAMILTON-C1 with predicates
| Predicate device:previous version ofHAMILTON-C1 | Application device:HAMILTON-C1 | Difference Status | |
|---|---|---|---|
| Indications for Use | The HAMILTON-C1ventilator isintended to providepositive pressureventilatory supportto adults andpediatrics.Intended areas ofuse:• In the intensivecare ward or inthe recoveryroom.• During transfer | The HAMILTON-C1ventilator isintended to providepositive pressureventilatory supportto adults andpediatrics, andoptionally infantsand neonates.Intended areas ofuse:• In the intensivecare ward,intermediate careward, emergency | The patient groupinfants andneonates is new.The substantiallyequivalency hasbeen proven to theHAMILTON-C2(K121225). |
| Predicate device:previous version ofHAMILTON-C1 | Application device:HAMILTON-C1 | Difference Status | |
| of ventilatedpatients withinthe hospital.The HAMILTON-C1ventilator is amedical deviceintended for use byqualified, trainedpersonnel underthe direction of aphysician andwithin the limits ofits stated technicalspecifications. | ward, long termacute care hospital,or in the recoveryroom• During transfer ofventilated patientswithin the hospitalThe HAMILTON-C1ventilator is amedical deviceintended for use byqualified, trainedpersonnel under thedirection of aphysician and withinthe limits of itsstated technicalspecifications. | ||
| ProductClassification Code | CBK | CBK | Identical |
| CFR Citation | 21 CFR 868.5895 | 21 CFR 868.5895 | Identical |
| Principal Operator | Qualified, trainedpersonnel underthe direction of aphysician | Qualified, trainedpersonnel under thedirection of aphysician | Identical |
| Environment of Use | • In theintensive careward or in therecoveryroom.• Duringtransportwithin andoutside thehospital. | Intended areas ofuse:• In the intensivecare ward,intermediate careward, emergencyward, long termacute care hospital,or in the recoveryroom• During transfer ofventilated patientswithin the hospital | Environment isidentical, was onlybetter specified |
| Environmental | 5 to 40 °C (41 to | 5 to 40 °C (41 to | Identical |
| Predicate device:previous version ofHAMILTON-C1 | Application device:HAMILTON-C1 | Difference Status | |
| conditions | 104 °F)• 10 to 95%, non-condensing• 1013 to 600 hPa | 104 °F)• 10 to 95%, non-condensing• 1013 to 600 hPa | |
| Patient Interface | Delivered invasively(via ET tube) ornon-invasively (viamask) | Delivered invasively(via ET tube) or non-invasively (via mask) | Identical |
| Power Source | AC and Batterypowered with one,can be run whilebattery is chargingwith a maximal runtime of 2 hrs | AC and Batterypowered with onebattery, can be runwhile battery ischarging with amaximal run time of4.30 hrs | Identical, batterytime has beenimproved |
| Operational Modes | • ASV• (S)CMV+• SIMV+• PCV+• PSIMV+• SPONT• DuoPAP• APRV• NIV• NIV-ST | • ASV• (S)CMV+• SIMV+• PCV+• PSIMV+• SPONT• DuoPAP• APRV• NIV• NIV-ST• nCPAP• nCPAP-PC | New modes nCPAPand nCPAP-PC aresubstantiallyequivalent toMAQUET Servo-l(K073179). |
| SpO2 monitoring | No SpO2monitoring | SpO2 monitoringavailable | Substantialequivalence hasbeen proven to theHAMILTON-G5(K131774) |
| Active ExhalationValve? | Yes, pneumatic | Yes, pneumatic | Identical |
| SizeWxLxH (in) | 8.3 x 12.2 x 9.4 | 8.3 x 12.2 x 9.4 | Identical |
| Weight | 10.8 lb | 10.8 lb | Identical |
| Volume SettingRange | 20-2000 ml | 2-2000 ml | Volume can be setdown to 2 ml forneonatalapplication: |
| Predicate device:previous version ofHAMILTON-C1 | Application device:HAMILTON-C1 | Difference Status | |
| substantialequivalent toHAMILTON-C2(K121225) | |||
| PEEP setting | 0-35 cmH2O | 0-35 cmH2ONeo: 3-25 cmH2O | Identical |
| Alarms andMonitoring | Yes | Yes | Identical |
| AdjustableInspiration Timetotal range | 0.1-40 sec | 0.1-40 sec | Identical |
| Supply Gas | Oxygen, ambientAir | Oxygen, ambient Air | Identical |
| Method of supplygas pressurization | Internal turbine forAirCompressed Sourcefor 02 | Internal turbine forAirCompressed Sourcefor 02 | Identical |
| MR Unsafe symbol | No | Yes | The proposeddevice now carriesthe "MR Unsafe"symbol according toASTM F2503 |
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Image /page/12/Picture/0 description: The image contains the logo for Hamilton Medical. The logo is blue and consists of the word "HAMILTON" on the top line, with a stylized "H" in the "O". The word "MEDICAL" is on the second line, and the phrase "Intelligent Ventilation since 1983" is on the third line.
HAMI T IAMILTON.CT
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Image /page/13/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. There is a small icon to the right of the word "HAMILTON". Below the logo is the text "Intelligent Ventilation since 1983".
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Image /page/14/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON" and "MEDICAL" stacked on top of each other. There is a symbol to the right of the word "HAMILTON". Below the logo is the text "Intelligent Ventilation since 1983".
Image /page/14/Picture/1 description: The image shows two logos, one above the other. The top logo reads "HAMILTON-T1" in a bold, sans-serif font, with a dot between "HAMILTON" and "T1". The bottom logo reads "HAMILTON-C1", also in a bold, sans-serif font with a dot between "HAMILTON" and "C1". Both logos are in the same shade of blue.
Hamilton Medical has demonstrated the modified HAMILTON-T1 and HAMILTON-C1 ventilators to be substantially equivalent to currently marketed predicate devices that have been previously cleared by FDA.
PERFORMANCE DATA VIII.
The following performance and non-clinical data were provided in support of the substantial equivalence determination.
The Software Design and Validation process along with the bench testing of the device demonstrated that the HAMILTON-T1 and the HAMILTON-C1 operate as intended.
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Image /page/15/Picture/0 description: The image shows the logo for Hamilton Medical. The logo is in blue and consists of the words "HAMILTON MEDICAL" stacked on top of each other. To the right of the word "HAMILTON" is a stylized letter "H". Below the logo is the text "Intelligent Ventilation since 1983".
In particular, testing demonstrated that the HAMILTON-T1 and HAMILTON-C1 are compliant with the following guidelines and standards:
- FDA Draft Reviewer Guide for Ventilators (July 1995) ।
- -ANSI/AAMI ES60601-1 (2005/ (R) 2012): Medical electrical equipment – General Requirements for Safety
- -IEC 60601-1-2 (2007): Medical electrical equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
- -ISO 80601-2-12 (2011): Medical electrical equipment – Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- -IEC 60601-1-8 (2006 + Am.1: 2012): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- -IEC 60601-1-6 (2010 + A1 :2013): Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- -IEC 62366 (2008)+A1(2014): Medical devices - Application of usability engineering to medical devices
- -IEC 62304 (2006): Medical device software - Software life-cycle processes
- -ISO 80601-2-55 (2011): Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
Additional Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
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Image /page/16/Picture/1 description: The image shows two logos, one above the other. Both logos say "HAMILTON" followed by a dot and then two characters. The top logo says "HAMILTON.T1" and the bottom logo says "HAMILTON.C1". The logos are in a sans-serif font and are blue in color.
Testing of the modified HAMILTON-C1 and HAMILTON-T1, with the new features, was conducted. The new ventilation modes were subjected to waveform performance testing, as described in the standard ASTM F1100-90. The data provided from these tests was shown to be substantially equivalent to the legally marketed devices.
Testing demonstrated that SpO2 and pulse rate values calculated by the OEM system are not corrupted during communication to the HAMILTON-T1 or HAMILTON-C1 host device. No modifications were made to the previously cleared pulse-oximeter systems.
The following additional testing was carried out to demonstrate substantial equivalence: Additional VOC and particular matters testing for the most vulnerable patient population: A gas sample analysis comprising VOC and particular matter testing has demonstrated that the output gas from the device meets the requirements for allowable levels of particulate matter.
IX. CONCLUSION
The results of verification, validation, and testing activities demonstrate that the modified HAMILTON-T1 and HAMILTON-C1 ventilators are as safe and as effective as the legally marketed devices identified above.
§ 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).