(509 days)
No reference devices were used in this submission.
No
The document mentions "automated ventilation with Adaptive Support Ventilation (ASV)", which is a control strategy, but does not explicitly mention or describe the use of AI or ML algorithms for this or any other function. The focus of the submission is on adding neonatal capabilities, SpO2 monitoring, and battery/environmental range improvements.
Yes
Explanation: The device, a ventilator, is intended to provide positive pressure ventilatory support, which is a direct therapeutic intervention to assist patients with breathing.
No
Explanation: The devices are ventilators, providing positive pressure ventilatory support, which is a treatment, not a diagnostic function. While they can monitor SpO2, this monitoring is for managing ventilation, not for diagnosing a condition.
No
The device description clearly states that the HAMILTON-T1 and HAMILTON-C1 are ventilators, which are hardware devices that provide positive pressure ventilatory support. The submission describes adding new features to these existing hardware devices.
Based on the provided text, the HAMILTON-T1 and HAMILTON-C1 ventilators are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use clearly states that the devices are for providing "positive pressure ventilatory support" to patients. This is a life support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical function of providing ventilation and monitoring physiological parameters like SpO2 and pulse rate. It does not mention analyzing biological samples (blood, urine, tissue, etc.) to diagnose diseases or conditions.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as reagents, calibrators, controls, or the analysis of biological specimens.
Therefore, these devices fall under the category of therapeutic medical devices, specifically ventilators, rather than In Vitro Diagnostics.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
CBK, DOA
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.
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
Adults, pediatrics, and optionally infants and neonates.
Intended User / Care Setting
Qualified, trained personnel under the direction of a physician.
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.
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
Bench testing of the device demonstrated that the HAMILTON-T1 and the HAMILTON-C1 operate as intended.
Testing demonstrated that the HAMILTON-T1 and HAMILTON-C1 are compliant with various guidelines and standards (listed under "Summary of Performance Studies").
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."
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.
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.
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
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.
Key results: 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.
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.
HAMILTON-T1 (K120670), HAMILTON-C1 (K120574), HAMILTON-C2 (K121225), HAMILTON-G5 (K131774), MAQUET Servo-i (K073179), Dräger Oxylog 3000 (K062267)
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.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/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
1
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
2
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
3
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
4
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 the | |
| neonatal modes. | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
| HAMILTON-G5 (K131774) for the | |
| Masimo SpO2 board and sensors | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK, (incl. Class II DQA) |
| MAQUET Servo-i (K073179) for the | |
| nCPAP and nCPAP-PC modes. | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
| Dräger Oxylog 3000 (K062267) for | |
| O2 consumption | 21 CFR 868.5895 Continuous Ventilator, Class II, CBK |
No reference devices were used in this submission.
5
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
6
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.
7
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 of
HAMILTON-T1 | Application device:
HAMILTON-T1 | Difference Status |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The HAMILTON-T1
ventilator is
intended to provide
positive pressure
ventilatory support
to adults and
pediatrics.
Intended areas of
use: | The HAMILTON-T1
ventilator is
intended to provide
positive pressure
ventilatory support
to adults, pediatrics,
and optionally
infants and
neonates. | The patient group
infants and
neonates is new.
The substantial
equivalence has
been proven to the
HAMILTON-C2
(K121225). |
| | Predicate device:
previous version of
HAMILTON-T1 | Application device:
HAMILTON-T1 | Difference Status |
| | • 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. | 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-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 | |
| Product
Classification Code | CBK | CBK | Identical |
| CFR Citation | 21 CFR 868.5895 | 21 CFR 868.5895 | Identical |
| Principal Operator | Qualified, trained
personnel under | Qualified, trained
personnel under the | Identical |
| | Predicate device:
previous version of
HAMILTON-T1 | Application device:
HAMILTON-T1 | Difference Status |
| | the direction of a
physician | direction of a
physician | |
| 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 |
| Environmental
conditions | 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 cmH2O
Neo: 3-25 cmH2O | Identical |
| Alarms and Monitoring | Yes | Yes | Identical |
| | Predicate device:
previous version of
HAMILTON-T1 | Application device:
HAMILTON-T1 | Difference Status |
| Adjustable
Inspiration Time
total range | 0.1-40 sec | 0.1-40 sec | Identical |
| Supply Gas | Oxygen, ambient
Air | Oxygen, ambient Air | Identical |
| Method of supply
gas pressurization | Internal turbine for
Air
Compressed Source
for O2 | Internal turbine for
Air
Compressed Source
for O2 | Identical |
| MR Unsafe symbol | No | Yes | The proposed
device now carries
the "MR Unsafe"
symbol according to
ASTM F2503 |
| O2 consumption
monitoring | No | Yes | Substantial
equivalence has
been proven to the
Dräger 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 of
HAMILTON-C1 | Application device:
HAMILTON-C1 | Difference Status |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The HAMILTON-C1
ventilator is
intended to provide
positive pressure
ventilatory support
to adults and
pediatrics.
Intended areas of
use:
• In the intensive
care ward or in
the recovery
room.
• During transfer | 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 | The patient group
infants and
neonates is new.
The substantially
equivalency has
been proven to the
HAMILTON-C2
(K121225). |
| | Predicate device:
previous version of
HAMILTON-C1 | Application device:
HAMILTON-C1 | Difference Status |
| | 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. | 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. | |
| Product
Classification Code | CBK | CBK | Identical |
| CFR Citation | 21 CFR 868.5895 | 21 CFR 868.5895 | Identical |
| Principal Operator | Qualified, trained
personnel under
the direction of a
physician | Qualified, trained
personnel under the
direction of a
physician | Identical |
| Environment of Use | • In the
intensive care
ward or in the
recovery
room.
• During
transport
within and
outside the
hospital. | 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 | Environment is
identical, was only
better specified |
| Environmental | 5 to 40 °C (41 to | 5 to 40 °C (41 to | Identical |
| | Predicate device:
previous version of
HAMILTON-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) or
non-invasively (via
mask) | Delivered invasively
(via ET tube) or non-
invasively (via mask) | Identical |
| Power Source | AC and Battery
powered with one,
can be run while
battery is charging
with a maximal run
time of 2 hrs | AC and Battery
powered with one
battery, can be run
while battery is
charging with a
maximal run time of
4.30 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 are
substantially
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 | 10.8 lb | 10.8 lb | Identical |
| Volume Setting
Range | 20-2000 ml | 2-2000 ml | Volume can be set
down to 2 ml for
neonatal
application: |
| | Predicate device:
previous version of
HAMILTON-C1 | Application device:
HAMILTON-C1 | Difference Status |
| | | | substantial
equivalent to
HAMILTON-C2
(K121225) |
| PEEP setting | 0-35 cmH2O | 0-35 cmH2O
Neo: 3-25 cmH2O | Identical |
| Alarms and
Monitoring | Yes | Yes | Identical |
| Adjustable
Inspiration Time
total range | 0.1-40 sec | 0.1-40 sec | Identical |
| Supply Gas | Oxygen, ambient
Air | Oxygen, ambient Air | Identical |
| Method of supply
gas pressurization | Internal turbine for
Air
Compressed Source
for 02 | Internal turbine for
Air
Compressed Source
for 02 | Identical |
| MR Unsafe symbol | No | Yes | The proposed
device now carries
the "MR Unsafe"
symbol according to
ASTM 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.