(161 days)
The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
Environment of use - Hospitals, delivery suites, NICU
There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.
- Resuscitation Unit 105PV .
- . Resuscitation Unit 105EV
They have the same basic design. Table 1 outlines the basic features and differences of each model.
The Atom Medical Corporation Resuscitation Unit 105EV and 105PV are medical devices intended to remove secretions from neonatal/infant airways and to provide blended air and oxygen at a desired concentration (21-100%) to respiratory assist devices. The devices underwent performance testing to demonstrate substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from predicate devices) | Reported Device Performance (Resuscitation Unit 105EV/PV) |
|---|---|
| Air/O₂ blender:- Range: 21-100%- Accuracy: ±3%O₂ | Achieved 21-100% oxygen concentration with ±3%O₂ accuracy (implied by substantial equivalence to predicates like Bio-Med Devices BMD air/oxygen blender K925982 and Precision Medical Precision Blender K053232). |
| Airway pressure manometer:- Range: -20 to 80cmH₂O- Accuracy: ±1% of full scale | Achieved -20 to 80cmH₂O range with ±1% of full scale accuracy (implied by substantial equivalence to Atom V-505 Infant Warmer K060461, which features an airway pressure manometer). |
| Relieving valve:- Set to 5.9 kPa (60 cmH₂O) for preventing excessive airway pressure | The device has a relieving valve with a default setting of 5.9kPa (60cmH₂O), which is a feature not present in some predicates, indicating it meets or exceeds this safety aspect. |
| Gas sources input pressure:- Air/O₂: 206-517kPa | Achieved 300-500kPa (which falls within the predicate's range of 206-517kPa and implies compliance). |
| Gas flow rate range (blender):- ≥ 30 lpm (for certain predicates) | < 15 lpm for the blender module (Note: This is a point of difference with some predicates, but the filing argues that the overall performance and equivalence are maintained) |
| Suction bottle capacity:- Not specified (for some predicates) | Up to 1200 ml |
| Vacuum source:- Model 105PV: wall suction vacuum- Model 105EV: venturi method | Model 105PV - wall suction vacuumModel 105EV - venturi method |
| Vacuum range:- 0-200 mmHg (for Atom V-505 Infant Warmer)- 0-150 mmHg (for GE Giraffe and Panda) | 0-200 mmHg (for Model 105EV) |
| Vacuum Flow range:- 15 lpm (for GE Giraffe and Panda) | ~20 lpm |
| Compliance with standards:- ISO 10651-5 Gas powered resuscitators- ISO 10079-3 Suction equipment- ISO 11195 Alarm | Declared compliance with applicable sections of ISO 10651-5 and ISO 10079-3. Performed ISO 11195 Alarm testing. |
| Performance in specific tests:- Flow accuracy- Pressure gauge accuracy- ISO 10651-5 O2 concentration- ISO 10079-3: Suction, Overfill, Suction seal, Aspiration, Pressure, External gas source, suction equipment, Noise | Performed tests for Flow accuracy, Pressure gauge accuracy, ISO 10651-5 O2 concentration, and various sections of ISO 10079-3. All tests "met all pass/fail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates." |
2. Sample Size for Test Set and Data Provenance:
The document describes "bench tests" and general "performance testing" of the device. It does not specify a "test set" in terms of patient data or specific clinical cases, but rather refers to in-vitro or laboratory testing. Therefore, sample size and data provenance are not applicable in the traditional sense of a clinical study. The testing appears to be based on engineering and performance verification against specifications and standards.
3. Number of Experts and Qualifications for Ground Truth:
This information is not applicable as the study described is a bench test and performance verification, not a clinical study requiring expert-established ground truth for diagnostic accuracy or similar endpoints. The ground truth would be the established engineering specifications and international standards.
4. Adjudication Method:
This information is not applicable as the study described is a bench test and performance verification, not a clinical study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The submission focuses on device performance against engineering specifications and equivalence to predicate devices, not on direct human reader performance with or without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided or applicable.
6. Standalone (Algorithm Only) Performance:
This information is not applicable. The device is an air/oxygen blender with suction capabilities, a mechanical medical device, not an AI or algorithm-based system where "standalone performance" of an algorithm would be assessed.
7. Type of Ground Truth Used:
The ground truth used for this performance testing was device specifications, international standards (ISO 10651-5, ISO 10079-3, ISO 11195), and the performance characteristics of legally marketed predicate devices. The testing aimed to confirm that the Resuscitation Unit 105EV and 105PV met these predefined engineering and regulatory requirements.
8. Sample Size for Training Set:
This information is not applicable. The device is a mechanical medical device, not a machine learning model, so there is no "training set" in the context of AI/ML development.
9. How Ground Truth for Training Set was Established:
This information is not applicable for the same reasons as above (not an AI/ML device).
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510(k) Summary Page 1 of 8 5-Apr-11
APR 2 0 2011
| Atom Medical Corporation3-18-15, Hongo, Bunkyo-kuTokyo, Japan 113-0033 | Tel - 011-81-3-3815-3632Fax - 011-81-3-3812-3199 |
|---|---|
| Official Contact: | Tsuyoshi Sugino - Regulatory Affairs Manager |
| Proprietary or Trade Name: | Resuscitation Unit 105 |
| Common/Usual Name: | Air / oxygen blender |
| Classification Name/Code: | BZR - Breathing gas mixerCFR 868.5330 |
| Device: | Resuscitation Unit 105EVResuscitation Unit 105PV |
| Predicate Devices: | Bio-Med Devices_BMD_air/oxygen_blender_K925982Precision Medical - Precision Blender - K053232Atom Medical - V-505 Infant Warmer - K060461GE Giraffe and Panda system - K070210 |
Device Description:
There are two (2) models of the Resuscitation Unit 105 air / oxygen blender with suction.
- Resuscitation Unit 105PV .
- . Resuscitation Unit 105EV
They have the same basic design. Table 1 outlines the basic features and differences of each model.
Indications for Use:
The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are intended to remove secretions from the neonatal / infant airways and / or to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
Environment of Use: Hospitals, delivery suites, NICU
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510(k) Summary Page 2 of 8 5-Apr-11
Table 1 Resuscitation Models 105PV and 105EV
| Feature | Resuscitation Unit 105PV | Resuscitation Unit 105EV |
|---|---|---|
| Suction(Piping Type) | Yes | No |
| Suction(Venturi Type) | No | Yes |
| Oxygen / Air Blender | Yes | Yes |
| Inlet Gas Sources | Oxygen compressed gas | Oxygen compressed gas |
| Air compressed gas | Air compressed gas | |
| Suction compressed gas | ||
| Pressure Relief Valve | Yes | Yes |
| Pressure Gauge | Yes | Yes |
| Suction Pressure Gauge | Yes | Yes |
| Outlet | Double outlets(Outlet A/B) | Double outlets(Outlet A/B) |
| Outlet A / B is for delivery of the air/oxygen gas mixture to avariety of devices, i.e., oxygen tent, oxygen mask, nasal cannula,manual resuscitator or manual ventilator, in-line humidifier jar,etc. | ||
| Airway Pressure tube and adapter can be connected at the patientconnected to measure and monitor the airway pressure which isdisplayed on the integral pressure gauge as well as a pressureregulating valve |
As outlined in Table 1, the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are identical except for the source for vacuum. Model 105PV is from a wall vacuum source and Model 105EV is from an internal venturi.
Table 2 compares the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV to the predicates:
- Atom V-505 Infant warmer with optional oxygen / suction module (K060461) .
- . Bio-Med Devices – BMD air/oxygen blender (K925982) a blender which is incorporated into the proposed devices
- . Precision Medical – Precision Blender (K053232) which has the indications for use and product classification we are seeking.
Table 3 compares the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV to the predicates Atom V-505 Infant warmer with optional oxygen / suction module (K060461) and the GE Giraffe and Panda system (K070210) which incorporates suction function and features for the intended patient population and environment.
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510((k) Summary
S-Apr-11
able of the Similarities and Differences to the Predicates for Air / Oxygen Blender feature
| General Attributes | Resuscitation UnitUnit 105PVUnit 105EV | Atom V-505 InfantWarmer with oxygen /suction module K060461 | Bio-Med DevicesBMD air/oxygenblender K925982 | Precision MedicalPrecision BlenderK053232 | |
|---|---|---|---|---|---|
| Indications for Use | The Resuscitation Unit105 EV andResuscitation Unit 105PV are intended to removesecretions from theneonatal / infant airways orto provide blended air andoxygen at a desired oxygenconcentration in the rangeof 21-100% to a respiratoryassist device connected tothe patient such as aventilator (including amanually operated one)and an oxygen tent. | The blender and suctionmodules incorporated in theV-505 Infant Warmer areintended to removesecretions from the neonatal/ infant airways or toprovide blended air andoxygen at a desired oxygenconcentration in the range of21-100% to a respiratoryassist device connected tothe patient such as aventilator (including amanually operated one) andan oxygen tent. | There is no indicationsfor sue statement in theFDA database but theBMD air/oxygenblender is intended toprovide blended air andoxygen at a desiredoxygen concentration inthe range of 21-100% | Is intended to deliverblended air and oxygen ina hospital setting.Oxygen concentrationscan be dialed in from 21to 100%. The blender isnot intended as a lifesupporting device. | |
| Patient Population | Neonates and Infants | Neonates and Infants | Not specified | Not specified | |
| Environment of Use | Hospital, delivery suites,NICU | Hospital, delivery suites,NICU | Hospital, deliverysuites, NICU | Hospital setting | |
| Prescriptive | Yes | Yes | Yes | Yes | |
| Page 4 of 85-Apr-11 | |||||
| Resuscitation UnitUnit 105PVUnit 105EV | Atom V-505 InfantWarmer with oxygen /suction module K0604618 | Bio-Med DevicesBMD air/oxygenblender K925982 | Precision MedicalPrecision BlenderK053232 | ||
| General Attributes (continued) | Outlet connections to | Oxygen tentOxygen maskCannulaManual ventilatorManual resuscitator | Oxygen tentOxygen maskCannulaManual ventilatorManual resuscitator | Oxygen tentOxygen maskCannulaManual ventilatorManual resuscitatorNone supplied | Oxygen tentOxygen maskCannulaManual ventilatorManual resuscitatorNone supplied |
| Accessories/Components | Airway pressure tubeHoses and tubingHumidifier jarSuction jar | Hoses and tubingHumidifier jarSuction jar | |||
| Technical specifications | Oxygen / air supply module | ||||
| Gas sources | Air/O₂300-500kPa | Air/O₂206-517kPa | Air/O₂206-517kPa | Air/O₂206-517kPa | |
| input pressure | |||||
| Airway pressuremanometerRange Accuracy | -20 to 80cmH₂O±1% of full scale | N/A | N/A | N/A | |
| Air/O₂ blenderRangeAccuracy | 21-100%±3%O₂ | 21-100%±3%O₂ | 21-100%±3%O₂ | ||
| Alarm | Differential pressurebetween oxygen and airsupply | Differential pressurebetween oxygen and airsupply | Differential pressurebetween oxygen and airsupply | ||
| Bleed flow rate | 2.5-3.5 lpm | N/A | N/A | ||
| Gas flow rate range | < 15 lpm | < 15 lpm | ≥ 30 lpm | ≥ 30 lpm | |
| 510(k) Summary5 of 85-Apr-11 | |||||
| Resuscitation UnitUnit 105PVUnit 105EV | Atom V-505 InfantWarmer with oxygen /suction module K060461 | Bio-Med DevicesBMD air/oxygenblender K925982 | Precision MedicalPrecision BlenderK053232 | ||
| Technical specifications (continued) | |||||
| Relieving valve(for preventing excessiveairway pressure) | (Default setting : 5.9kPa(60cmH2O)) | N/A (no reliving valve) | N/A(no relieving valve) | N/A(no relieving valve) | |
| Flow outlet | Dual flow outlet to connect toa device requiring a gassupplyOxygen density of both is thesame. | Single flow outlet to connectto device requiring a gassupply | Flow outlet forconnecting to devicerequiring a gas supply | Flow outlet for connectingto device requiring a gassupply | |
| Standards | |||||
| ISO 10651-5 Gaspowered resuscitators | Yes, applicable sections | N/A | N/A | N/A | |
| ISO 10079-3 suctionequipment | Yes, applicable sections | N/A | N/A | N/A | |
| Section 514 | None | None | None | None |
Page 52
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510(k) Summary
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and the contraction of the comments of the control of
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510(k) Summary
able of the Similarities and Differences to the Predicates for Suction features
| General Attributes | ||||
|---|---|---|---|---|
| Indications for Use | Resuscitation UnitUnit 105PVUnit 105EV | Atom V-505 Infant Warmer withoxygen / suction moduleK060461 | GEGiraffe and PandaK070210 | |
| The Resuscitation Unit 105 EVand Resuscitation Unit 105 PV areintended to remove secretions fromthe neonatal / infant airways and toprovide blended air and oxygen at adesired oxygen concentration in therange of 21-100% to a respiratoryassist device connected to the patientsuch as a ventilator (including amanually operated one) and anoxygen tent. | The blender and suction modulesincorporated in the V-505 InfantWarmer are intended to removesecretions from the neonatal / infantairways and to provide blended airand oxygen at a desired oxygenconcentration in the range of 21-100% to a respiratory assist deviceconnected to the patient such as aventilator (including a manuallyoperated one) and an oxygen tent. | Provides the basic equipmentrequired for pulmonaryresuscitation of infants.Pulmonary resuscitation includespractices necessary to establish aclear airway and provide oxygenand air/oxygen mixtures and/ormanual ventilation to the infant.(Includes a suction function andfeature) | ||
| Patient Population | Neonates and Infants | Neonates and Infants | Infant | |
| Environment of Use | Hospital, delivery suites, NICU | Hospital, delivery suites, NICU | Hospital, delivery suites, NICU | |
| Prescriptive | Persons trained in infant / neonateresuscitation | Persons trained in infant / neonateresuscitation | Persons trained in infant / neonateresuscitation | |
| Technical specifications | ||||
| Suction bottle capacity | Up to 1200 ml | Not specified | Not specified other than varioussizes | |
| Dimensions | 200mm(W)x180 mm(D)x370mm (H) | Built-in to warmer, not standalone | 340mm(W)x250mm(D)x250mm(H) | |
| Weight | 7kg | 9 kg | ||
| Operating and Storagelimits | -20°C to 65°CUp to 97% RH | -20°C to 65°CUp to 97% RH | -20°C to 60°CUp to 95% RH | |
| 510(k) SummaryPage 7 of 85-Apr-11 | ||||
| Resuscitation UnitUnit 105PVUnit 105EV | Atom V-505 Infant Warmer withoxygen / suction module K060461 | GEGiraffe and Panda K070210 | ||
| Technical specifications (continued) | ||||
| Vacuum source | Model 105PV - wall suctionvacuum | Model 105PV - wall suctionvacuum | Wall suctionvacuum | |
| Vacuum range | Model 105EV - venturi method0-200 mmHg | 0-200 mmHg | 0-150 mmHg | |
| Vacuum Flow range | ~ 20 lpm | N/A | 15 lpm | |
| Standards | ||||
| ISO 10651-5 Gaspowered resuscitators | Yes, applicable sections | N/A | Yes, applicable sections | |
| ISO 10079-3 - Suctionequipment | Yes, applicable sections | N/A | Yes, applicable sections | |
| Section 514 | None | None | None | |
| Summary of substantial equivalence - Resuscitation Unit 105PV and Resuscitation Unit 105EV | ||||
| Indications for Use - The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV have equivalent indications for use to the predicates. Thatis as a breathing gas mixer (blender) with a suction feature. | ||||
| Patient Population -- The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV have the equivalent patient population, neonates andinfants, to the predicate V-505 Infant warmer module (K060461) and GE Giraffe and Panda system (K070210). | ||||
| Environment for use - The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV have the identical environments for use to the predicatesK060461, K053232, and K070210. | ||||
| Prescriptive - The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are prescriptive which is identical to the predicates K060641,K053232, and K070210. | ||||
| Page 56 |
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510(k) Summary Page 8 of 8 5-Apr-11
Design and Technology - The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are equivalent in design and features to the predicates and have the equivalent technology as the predicates.
Blender module is equivalent to V-505 Infant Warmer (K060461) and identical to Bio-Med Device (K925982).
Suction module is equivalent to V-505 Infant Warmer (K060461) and equivalent to GE Giraffe and Panda system (K070210).
Performance Specifications - The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV have equivalent specifications of performance to the predicate K060461.
Compliance with standards - Both devices declare compliance where applicable with the ISO 10651-5 for gas powered resuscitators and ISO 10079-3 for suction equipment.
Performance-Festing-
We have performed bench tests which included the list below and found that the Resuscitation Unit 105 EV and Resuscitation Unit 105 PV met all pass /f ail criteria, cited standards requirements or were found to be equivalent in comparison to the predicates.
We have performed the following performance testing. The results demonstrated that the device perform as intended. The tests are:
- Flow accuracy .
- Pressure gauge accuracy .
- ISO 10651-5 O2 concentration .
- ISO 10079-3 5.1.4 Suction, 3 6.1 Overfill, 6.3.1.1 Suction seal, 8.4.3 and 9.1 -. Aspiration, 6.5 - Pressure, 9.1 - External gas source, 8.1 - suction equipment, 6.11 -Noise
- ISO 11195 Alarm .
Conclusion
The Resuscitation Unit 105 EV and Resuscitation Unit 105 PV are substantially equivalent to the predicates Atom V-505 Infant warmer with oxygen / suction module (K060461) and the Bio-Med Devices - BMD air/oxygen blender (K925982) as the blender which is incorporated into the proposed devices and the Precision Medical – Precision Blender (K053232) in indications for use, patient population, and environment for use, and GE Giraffe and Panda systems for the suction feature (K070210). All of the predicates have equivalent technology characteristics, specifications / performance and compliance with international standards.
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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Atom Medical Corporation C/O Mr. Paul E. Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs. Florida 34134
APR 2 0 2011
Re: K103317
Trade/Device Name: Resuscitation Unit 105PV & Resuscitation Unit 105EV Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR Dated: April 8, 2011 Received: April 13, 2011
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh for
Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. 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:
Device Name:
Resuscitation Unit 105PV Resuscitation Unit 105 EV
Indications for Use:
The Resuscitation Unit 105 PV and Resuscitation Unit 105 EV are intended to remove secretions from the neonatal / infant airways and to provide blended air and oxygen at a desired oxygen concentration in the range of 21-100% to a respiratory assist device connected to the patient such as a ventilator (including a manually operated one) and an oxygen tent.
Environment of use - Hospitals, delivery suites, NICU
Prescription Use = XX ________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (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)
Z
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§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).