(154 days)
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport. The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃. The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission. The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack. The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V). The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.
Here's an analysis of the provided text regarding the Atom Transcapsule V-707, focusing on acceptance criteria and the study proving it meets these criteria:
Device: Atom Transcapsule V-707 (Neonatal Transport Incubator)
The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria for a novel device. Therefore, much of the requested information (like sample sizes for test sets, expert qualifications, MRMC studies, standalone performance with specific thresholds, and ground truth for training data) is not present. The "acceptance criteria" discussed are primarily related to meeting recognized performance standards and comparing features to a predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) Summary, the "acceptance criteria" are implied by the standards the device complies with and its performance characteristics as compared to the predicate. The "reported device performance" is a statement of compliance or the specified operating range/accuracy.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Performance Standards Compliance: | |
| IEC 60601-1 (1988) - Medical Electrical Equipment - Part 1: General Requirements for Safety+A1+A2Amendment 2 | Complied and passed all testing criteria. |
| IEC 60601-1-2 : 2007 - Medical Electrical Equipment - Part 1-2: General requirements for Safety - Collateral standard: Electromagnetic compatibility Requirements and tests (Edition 3) | Complied and passed all testing criteria. |
| IEC 60061-2-20 (1996) - Amendment 1 - Medical Electrical Equipment - Part 2: Particular Requirements for the Basic Safety and Essential Performance of Infant Transport Incubators | Complied and passed all testing criteria. |
| Temperature Control: | |
| Incubator air temperature setting range: Adequate for neonates | 23.0 to 38.0℃ in 0.1℃ increments |
| Measured air temperature display range | 20.0-42.0℃ in 0.1℃ increments |
| Accuracy of measured air temperature | +/-1.0°C |
| Skin temperature measurement display range | 30.0-42.0°C in 0.1°C increments |
| Accuracy of skin temperature measurement | +/-0.3℃ |
| Warm-up time: Efficient operation | Approximately 40 min @ 25℃ |
| Alarms: Sufficient for safety monitoring | High temperature, Set point, Power failure, Fan, System failure, Silence, Skin temperature probe, Low voltage |
| Environmental Control: | |
| CO2 concentration in the hood: Safe levels | < 0.5% 10cm above center of mattress at 750 ml/min |
| Oxygen supply: Adequate | ≥ 60% @ 10 Lpm |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The document refers to "Performance testing has been performed per the following standards" and "The proposed device met and passed all testing criteria" (Page 3). This usually implies lab-based engineering verification and validation testing, not clinical trials with patient populations or specific test sets for algorithms.
- Data Provenance: Not applicable in the context of the provided document. The testing described is non-clinical, likely conducted by the manufacturer (Atom Medical Corporation in Japan).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is an incubator, and its performance is evaluated against engineering and safety standards, not against expert human interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. The testing described is against engineering specifications and international standards, not involving human interpretation or adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-analysis AI devices where human performance is part of the comparison. The Atom Transcapsule V-707 is a medical device for infant transport, and its evaluation focuses on mechanical, electrical, and thermal performance according to recognized standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its physical and electronic components.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering specifications, international medical device standards (IEC 60601 series), and physical measurements. For example, the accuracy of temperature measurement (e.g., +/-1.0°C for air temperature) is a direct performance characteristic measured against calibrated reference instruments, not an expert consensus or pathology result.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML system that requires a training set or ground truth for training.
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123937
MAY 2 3 2013
510(k) Summary Page 1 of 4 つつ、あるの ...
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| Atom Medical Corporation | |
|---|---|
| 3-18-15, Hongo, Bunkyo-ku | Tel - 011-81-3-3815-3632 |
| Tokyo, Japan 113-0033 | Fax - 011-81-3-3812-3199 |
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Atom Transcapsule V-707 |
| Common/Usual Name: | Neonatal Transport Incubator |
| Classification Name/Code: | FPL - neonatal transport incubatorCFR 880.5410 |
| Device: | Atom Transcapsule V-707 |
| Predicate Devices: | Air-Shields (Draeger) TI500 Isolette - K941106 |
Device Description:
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is intended to be used in hospitals, delivery suites, NICU, and transport.
The Transcapsule V-707 controls temperature based on air temperature within the incubator. The front panel shows set temperature and the actual temperature. The heat source is electrically powered and can be set between 23.0 to 38.0℃ in 0.1℃ increments. The measured temperature within the incubator has a range of 20.0-42.0℃ in 0.1℃ increments with an accuracy of +/-1.0°C. It can also show skin temperature of the infant between 30.0 and 42.0°C in 0.1°C increments with an accuracy of +/-0.3℃.
The Transcapsule V-707 can be mounted in a variety of mechanical configurations, the HL Stand for transport and Cabinet Stand for internal hospital use are typical examples, see Section 11 for further details. The HL Stand for transport and the Cabinet Stand for internal hospital use (and oxygen gas cylinder) are not included in this submission.
The Transcapsule V-707 consists of a hood, a main body, a control panel and an external power pack which provides DC power to the incubator. The external power pack also contains batteries to allow for operation when external power is lost. The battery is automatically kept charged when there is an external source of power provided to the device. Battery status (charging and capacity) is indicated on the power pack.
The device provides audible and visual alarms for: High temperature, set point, power failure, fan, system failure, silence, skin temperature probe, low voltage (when the voltage from the battery or the external DC power source falls to approx. 10.5V).
The device complies with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-20.
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510(k) Summary Page 2 of 4 23-May-13
Indications for Use:
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.
Environment of Use: Hospitals, delivery suites, NICU, and transport
Comparison to Predicate
| ProposedTranscapsule V-707 | PredicateK941106Air-Shields (Draeger) T1500 IsoletteInfant Incubator | |
|---|---|---|
| Indications for Use | The Atom Transcapsule V-707 is aclosed-type transport incubator forneonatal and premature infants intendedto transport low birth weight infants andneonates. | Specific indications as submitted to theFDA are unknown. Intended use isequivalent |
| Environment of use | Hospitals, delivery suites, NICU, andtransport | Hospital, NICU |
| Patient Population | Infant and neonates | Premature infants |
| Technology | Electrically heated and controlled on airtemperature | Electrically heated and controlled on airtemperature |
| Features and Performance Characteristics | ||
| Overall dimensions | Main Body:95(W) X 44(D) X 42(H) cmPower Pack:29(W) X 17.5(D) X 25(H) cmAlternate Power Pack:35(W) X 20(D) X 33(H) cmMattress - 55(W) x 28(D) x 2.5(H) cm | 52.7(W) X 95.9(L) X 50.8(H)Mattress - 74(W) x 36(D) x 2(T) cm |
| Weight | Main Body and Power Packapproximately 32kg | 49kg |
| Major components | HoodMain bodyPower Pack | HoodMain body |
| Power | 100-240 VAC47-63 Hz or 47-440Hz220 or 280VA max11.0- 14V DC 10A | 110/120 V, 50/60/400 Hz - 220/240 V,50/60/400 Hz11-13/26-30 VDC 200W |
| Operating conditions | Temperature: 10-30 °CRH - 30-75% | Temperature: Not specifiedRH - 0-95% |
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510(k) Summary
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| ProposedTranscapsule V-707 | PredicateK941106Air-Shields (Draeger) T1500 IsoletteInfant Incubator | |
|---|---|---|
| Maximum load capacity | IV Pole ~ 3 kg | Not specified |
| Features and Performance Characteristics (continued) | ||
| Accessories / optionalcomponents | Skin Temperature ProbeAccess port coversInfant Fixing BandIV Pole | Skin Temperature ProbeAccessory ShelfIV PoleInfant restraint strapsHigh Hood, Pressure Regulator andflowmeterHumidity Pad |
| Control modes | Automatic based on incubator airtemperature | Automatic based on incubator airtemperature |
| Skin TemperatureMeasurement Range | 30.0 and 42.0℃ in 0.1℃ incrementswith an accuracy of +/-0.3°C | Not specified |
| Incubator air temperaturesetting range | 23.0 to 38.0℃ in 0.1℃ increments | 22 - 38°C |
| Display range | Skin - 30.0 - 42 °C in 0.1°C increments,Accuracy - ± 0.3 °CAir - 20.0 - 42.0 °CAccuracy - ± 1.0 °C | Skin - Not specifiedAir - Not specified |
| Heater output | 0 - 100% in 10 increments | Not specified |
| Warm-up time | Approximately 40 min @ 25℃ | ≤ 60 min @ 25°C |
| Alarms | High temperatureSet pointSkin Temperature Probe Fault | High temperatureHeater temperatureSkin temperature probe fault |
| Humidity | N/A | Passive |
| Oxygen supply | ≥ 60% @ 10 Lpm | 21% to 58% minimum |
| Environment CO₂concentration in the hood | < 0.5% 10cm above center of mattressat 750 ml/min | Not specified |
| Other alarms | FanSystem failurePower failureLow voltage | FanSystem failurePower failure |
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510(k) Summary Page 4 of 4 23-May-13
| ProposedTranscapsule V-707 | PredicateK941106Air-Shields (Draeger) T1500 IsoletteInfant Incubator | |
|---|---|---|
| Safety and Performance testing | ||
| Performance testing has beenperformed per the followingstandards | IEC 60601-1 (1988) - MedicalElectrical Equipment - Part 1: GeneralRequirements for Safety+Al+A2Amendment 2IEC 60601-1-2 : 2007- MedicalElectrical Equipment - Part 1-2:General requirements for Safety-Collateral standard: Electromagneticcompatibility Requirements and tests(Edition 3)IEC 60061-2-20 (1996) - Amendment1 - Medical Electrical Equipment - Part2: Particular Requirements for theBasic Safety and Essential Performanceof Infant Transport Incubators | Not specified |
Substantial Equivalence Rationale
The Atom Transcapsule V-707 is viewed as substantially equivalent to the predicate device because:
Indications -
- Based on marketing literature equivalent .
Technology -
- Identical technology and design .
Materials -
- . The materials in patient contact are identical to previously cleared Atom Medical Devices
Environment of Use -
- Similar to predicate ~ Air-Shields (Draeger) T1500 Isolette K941106 .
Nonclinical Performance Testing -
Performance testing has been performed to verify requirements have been met and in accordance . with FDA recognized standards. The proposed device met and passed all testing criteria.
Substantial Equivalence Conclusion -
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 23, 2013
Atom Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive BONITA SPRINGS, FL 34134
Re: K123937
Trade/Device Name: Atom Medical Transcapsule V-707 Regulation Number: 21 CFR 880.5410 Regulation Name: Neonatal Transport Incubator Regulatory Class: II Product Code: FPL Dated: April 15, 2013 Received: April 16, 2013
Dear Mr. Dryden:
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.
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Page 2 – Mr. Dryden
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours.
DAGRID
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director
FOR
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Statement
Page 1 of 1
510(k) Number:
K123937 :
Device Name:
Atom Medical Transcapsule V-707
Indications for Use:
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates.
Environment of use -- Hospitals, delivery suites, NICU, and transport
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sajjad H Syed
Digitally signed by Sajjad H. Syed DN: c=US, o=U.S. Government, ou=HH5, ou=FDA, ou=People, cn=Sajjad H. Syed, 0.9.2342.19200300.100.1.1=2000601 742 Date: 2013.05.23 09:32:23 -04'00'
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K123957
§ 880.5410 Neonatal transport incubator.
(a)
Identification. A neonatal transport incubator is a device consisting of a portable rigid boxlike enclosure with insulated walls in which an infant may be kept in a controlled environment while being transported for medical care. The device may include straps to secure the infant, a battery-operated heater, an AC-powered battery charger, a fan to circulate the warmed air, a container for water to add humidity, and provision for a portable oxygen bottle.(b)
Classification. Class II (performance standards).