(247 days)
The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication administration, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.
The Carecube Negative Pressure Isolation Chamber is a modular, negative pressure, isolation patient care system with both reusable and disposable components that can rapidly augment capacity to care for airborne infectious diseases and other biological threats for common patient care protocols with features built into the unit to allow ease of execution. The device is intended to be used indoors, in a hospital setting, as a temporary isolation of patients with suspected or confirmed diagnosis of infectious disease to prevent Healthcare Practitioners (HCP) exposure to pathogenic biological airborne particulates and is designed with features that enable low-moderate complexity medical interventions.
This document describes the Carecube Negative Pressure Isolation Chamber, a patient isolation unit (PIU), and its assessment for substantial equivalence to a predicate device. This device is not an AI/ML powered device, so an analysis of acceptance criteria relative to an AI/ML device is not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device, the acceptance criteria are based on various performance and safety tests rather than metrics like sensitivity, specificity, or AUC. The document lists the following performance tests and their results:
| Performance Criterion | Standard/Test Method | Proposed Device Result |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-23 | Non-irritant |
| Acute Systemic Toxicity | ISO 10993-11 | Non-toxic |
| Volatile Organic Compounds; Particulates | Toxicological Risk Assessment | Non-toxic |
| EMC and Electrical Safety | ||
| IEC 60601-1 | Pass | |
| IEC 60601-1-2 | Pass | |
| IEC 60601-1-6 | Pass | |
| Usability / Human Factors | ||
| IEC 62366-1 | Pass | |
| Packaging Testing | ||
| ASTM D4169 | Pass | |
| ASTM D4332 | Pass | |
| Shelf-life Testing | ||
| ASTM F1980 | 12 months | |
| Functional Performance Testing | ||
| Canopy Robustness | Internal | Pass |
| Airflow and Smoke Testing | Internal | Pass |
| Differential Pressure | Internal | Pass |
| Tagged particle Clearance | Internal | Pass |
| Tagged particle Containment | Internal | Pass |
| Noise | Internal | Pass |
| Viral Penetration | ASTM F1671 | Pass |
| Cleaning Resiliency | Internal | Pass |
| Cleaning Validation | AAMI TIR30, AAMI ST98 | Pass |
| Disinfection Validation | AAMI TIR30, AAMI ST98 | Pass |
| Flammability | 16 CFR Part 1610.7 | Pass |
| Repeat Use Testing | Internal | Pass |
| Usage Life Testing | ||
| System Usage Life | Internal | Pass |
| Filter Usage Life | Internal | Pass |
| Clinical Testing | ||
| Human Use Comfort | Internal | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The clinical study conducted for the Carecube Negative Pressure Isolation Chamber was a prospective, single-center, non-blinded study.
- Sample Size: A minimum of ten (10) subjects were included.
- Data Provenance: The study used normal, healthy volunteers aged 21-47 years old, comprising a cross-section of males and females. This indicates prospective data collection from a single, unspecified center (presumably in the US given FDA submission).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is not an AI/ML device, the concept of "ground truth" as established by experts (e.g., radiologists) for a test set is not directly applicable. The clinical study focused on patient safety and comfort, assessed through routine monitoring of vital signs, STAID evaluation (for anxiety), and environmental monitoring (temperature, humidity, CO2, O2). The determination of "Pass" likely relies on established medical norms for vital signs and comfort levels, and environmental safety standards, interpreted by the study's clinical team, rather than a panel of independent expert adjudicators for a "ground truth" diagnosis.
4. Adjudication Method
Not applicable for this type of device and study. The study assessed physiological parameters and environmental conditions, not diagnostic outcomes requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI-powered device, and the study was designed to assess safety and comfort, not diagnostic performance with or without AI assistance.
6. Standalone Performance Study
Not applicable. This device is not an algorithm; it is a physical patient isolation unit. The performance studies detailed are for the physical device's characteristics and its interaction with a human patient (comfort, safety).
7. Type of Ground Truth Used
As mentioned above, the "ground truth" in the clinical study related to:
- Physiological measurements: Vital signs (blood pressure, body temperature, pulse, oxygen saturation), which have objective measurements.
- Patient-reported outcomes: Level of anxiety using the STAID evaluation, which is a standardized psychological assessment.
- Environmental measurements: Temperature, relative humidity, carbon dioxide (CO2), and atmospheric oxygen (O2) within the Carecube, which are objective measurements.
These measurements were used to determine if the device provided a safe and comfortable environment, not to establish a diagnostic ground truth.
8. Sample Size for the Training Set
Not applicable. This device does not use an AI/ML algorithm, so there is no training set as understood in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 3, 2024
Carecubes, Inc. Steve Bollinger Operational Lead 300 Oxford Drive Suite 330 Monroeville, Pennsylvania 15146
Re: K231256
Trade/Device Name: Carecube Negative Pressure Isolation Chamber Regulation Number: 21 CFR 880.5450 Regulation Name: Patient Care Reverse Isolation Chamber Regulatory Class: Class II Product Code: LGM Dated: April 27, 2023 Received: May 1, 2023
Dear Steve Bollinger:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231256
Device Name Carecube Negative Pressure Isolation Chamber
Indications for Use (Describe)
The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY K231256 Carecube Negative Pressure Isolation Chamber
I. Submitter Information
Carecubes, Inc. 3101 20th Street San Francisco, CA 94110
| Contact Person: | Steve Bollinger |
|---|---|
| Telephone Number: | (508) 942-6396 |
| Email: | steve@carecubes.com |
| Date Prepared: | January 03, 2023 |
II. Device
| Trade Name: | Carecube Negative Pressure Isolation Chamber |
|---|---|
| Common Name: | Patient Isolation Unit (PIU) |
| Classification Name: | Chamber, Patient Isolation |
| Produce Classification: | Class II |
| Regulation Number: | 21 CFR 880.5450 |
| Product Code: | LGM |
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III. Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| CAPSULS™ Patient Isolation Unit | K052798 | ISOVAC Products, LLC |
| Reference Device | ||
| ORCA™ Operational RescueContainment Apparatus | K163223 | ISOVAC Products, LLC |
IV. Description of Device:
The Carecube Negative Pressure Isolation Chamber is a modular, negative pressure, isolation patient care system with both reusable and disposable components that can rapidly augment capacity to care for airborne infectious diseases and other biological threats for common patient care protocols with features built into the unit to allow ease of execution. The device is intended to be used indoors, in a hospital setting, as a temporary isolation of patients with suspected or confirmed diagnosis of infectious disease to prevent Healthcare Practitioners (HCP) exposure to pathogenic biological airborne particulates and is designed with features that enable low-moderate complexity medical interventions.
V. Intended Use:
The Carecube Negative Pressure Isolation Chamber is a patient isolation unit (PIU) intended to be use in hospitals as a negative pressure isolation chamber. The Carecube is intended to be used by a single patient for up to 24 hours of continuous use. The Carecube Negative Pressure Isolation Chamber Canopy is intended for multi-patient use with a maximum of ten (10) patients. The Arm Access, Auxiliary Arm Access and Trunk ports of the Carecube Negative Pressure Isolation Chamber are intended for singlepatient use only. The unit is designed to be used with the required personal protective equipment (PPE).
VI. Indications for Use:
The Carecube is a patient isolation unit (PIU) designed for the temporary isolation of patients within a hospital setting to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. Device should only be used in a hospital setting. This is for temporary housing of a patient prior to transfer to an appropriate hospital destination. Transfer to a more permanent hospital setting should occur as soon as possible. The Carecube is designed with features that enable low-moderate complexity medical interventions. This includes the following procedures: blood draw, medication administration, palpating abdomen, cardiac auscultation, and connection to IV line/monitoring cables.
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VII. Comparison of Technological Characteristics with Predicate Devices
The indications for use and principle of operation of the Carecube Negative Pressure Isolation Chamber are equivalent to those of the predicate device, ISOVAC CAPSULS™ Patient Isolation Unit (K052798) and reference device, ISOVAC ORCA™ Operational Rescue Containment Apparatus (K163223). Differences between the devices result primarily from technological advances which have occurred since the ISOVAC CAPSULS™ device was introduced in 2005.
| PARAMETER | PROPOSEDDEVICE | PREDICATEDEVICE | COMPARISON |
|---|---|---|---|
| Trade Name | Carecube NegativePressure IsolationChamber | CAPSULS™ PatientIsolation Unit | |
| Manufacturer | Carecubes, Inc. | ISOVAC | |
| 510(k) | K231256 | K052798 | |
| ProductClassification | II | II | Same |
| Product Code | LGM | LGN | Equivalent Carecube(LGM) is not usedfor transport (LGN) |
| RegulationNumber | 880.5450 | 880.5450 | Same |
| RegulationName | Chamber, PatientIsolation | Chamber, PatientIsolation | Same |
| Intended Use | Negative PressureIsolation Chamber | Negative PressureIsolation Chamber | Same |
| Indications forUse | The Carecube is a patientisolation unit (PIU)designed for thetemporary isolation ofpatients within a hospitalsetting to preventparticulate (biological)cross-contaminationbetween user and patient,while enclosing thecontaminated patient fromthe external environment.Device should only beused in a hospital setting.This is for temporaryhousing of a patient priorto transfer to anappropriate hospitaldestination. Transfer to amore permanent hospitalsetting should occur assoon as possible. TheCarecube is designed withfeatures that enable low-moderate complexitymedical interventions.This includes thefollowing procedures:blood draw, medicationadministration, palpatingabdomen, cardiacauscultation, andconnection to IVline/monitoring cables. | The CAPSULS(Containment andProtection System UtilizingLife Support) is a portablePatient Isolation Unit(PIU), which preventsparticulate (biological andradiological) cross-contamination between thepatient and the externalenvironment; and withfeatures that enable medicalintervention to the patientvia end-user suppliedmedical equipment. TheCAPSULS is intended tobe used for:• The transport andisolation ofpatients onaircraft,ambulances, shipsand any vehiclecapable of safelytransporting apatient on astandard litter.• The temporaryisolation, with orwithout transport,of patients withinhospitals ormedical facilities. | Same except theCarecubeindications are asubset of thepredicate devicebecause the formeris not used fortransport. |
| ProvidedSterile | No | No | Same |
| Reusable | Yes | No | DifferentReprocessingvalidation wasperformed to ensuresafe reuse |
| Contra-indications | • Morbidlyobese patients• Patientsweighing lessthan 45 lbs. orless• Oxygen-rich | Unknown | |
| OTC Use | Yes | Yes | Same |
| Materials ofConstruction | Thermoplastic Polyurethane (TPU) envelope Powder-coated steel frame | Clear polyurethane (PUR) or polyvinylchlori de (PVC) envelope Plastic resin stanchions and integral ribs | DifferentMaterials used in both devices represent plastic materials commonly utilized in medical devices and do not raise new issues of safety or effectiveness |
| Dimensions | 118" overall assembled length54" width82" height | 81" overall length26" width20" | DifferentThe Carecube is longer to accommodate stationary use and a medical bed for patient isolation up to 24 hours.Clinical testing demonstrates no new questions of safety or effectiveness. |
| Weight | 120 lbs. | 21 lbs. | DifferentCarecube is heavier based on design for stationary use and does not raise new questions of safety or effectiveness. |
| Air Filtration | H13 HEPA (99.97% particulates @ 0.3μ) | M95, P100 (99.97% particulates @ 0.3μ) HEPA | DifferentBoth devices have an inline outbound filter, with differences in model type and size.Performance testing demonstrates that, despite the differences, the Carecube is effective in air filtration. |
| Air Flow | Airflow for patienthead to foot iscontrolled by the fanand HEPA filterblower manufacturerat 150 CFM. | Airflow rate is set bythe blowermanufacturer at 4CFM. | DifferentAir flow capabilitiesare larger due to thelarger room andcontainment area.Safety andeffectiveness isdemonstrated inpatient comfort andin performancetesting. |
| Pressure | Negative Pressure(NP) | Negative Pressure(NP)Positive Pressure (PP) | DifferentThe CAPSULS™PIU allows the useof PP or NP whichis not necessary forthe Carecube'sintended use. Bothdevices utilize NP toisolate a patient andprevent the patientfrom infectingothers. TheCarecube negativepressureperformance wasvalidated. |
| Air Changes | 35 air changes perhour (ACH) | 20-38 air changes perhour (ACH) | Different(The Carecube ACHis within the ACHrange for thepredicate device.) |
| Glove Arms | Multiple Glove Arms | Multiple Glove Arms | Same |
| Other AccessPorts | Trunk PortsConduit PortsLean-In Windows | Access PortsConduit Port | DifferentThe Carecube offersadditional accessports to facilitatestationary use forpatient isolation.The additional portsdo not raise differentquestions of safety oreffectiveness andperformance wasdemonstrated. |
Table 5-1. General Technological Characteristics Comparison
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!The Carecube Negative Pressure Isolation Chamber is to be used by a single patient for up to 24 hours of
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continuous use. The Carecube Negative Pressure Isolation Chamber canopy is intended for multi-patient re-use with a labeled maximum of ten (10) uses. The glove and trunk ports of the Carecube Negative Pressure Isolation Chamber are intended for single patient use only.
VIII. Performance Data
The following performance data was considered in support of the substantial equivalence determination.
Performance Testing - Bench
The following tests were performed to demonstrate that the proposed Carecube Negative Pressure Isolation Chamber met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards:
- Biocompatibility ●
- EMC and Electrical Safety
- Usability Testing
- Packaging Testing
- Shelf-Life Testing
- Canopy Robustness
- Functional Performance Testing ●
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| Performance | Standard/TestMethod | Proposed DeviceResult | Predicate Result |
|---|---|---|---|
| Biocompatibility | |||
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Not available |
| Sensitization | ISO 10993-10 | Non-sensitizing | Not available |
| IntracutaneousReactivity | ISO 10993-23 | Non-irritant | Not available |
| Acute SystemicToxicity | ISO 10993-11 | Non-toxic | Not available |
| VolatileOrganicCompounds;Particulates | Toxicological RiskAssessment | Non-toxic | Not available |
| EMC and ElectricalSafety | IEC 60601-1IEC 60601-1-2IEC 60601-1-6 | Pass | Not available |
| Usability /HumanFactors | IEC 62366-1 | Pass | Not available |
| Packaging Testing | ASTM D4169ASTM D4332 | Pass | Pressure/Leaktesting |
| Shelf-life Testing | ASTM F1980 | 12 months | Not available |
| Functional Performance Testing | |||
| Canopy Robustness | Internal | Pass | Not available |
| Airflow and SmokeTesting | Internal | Pass | Not available |
| Differential Pressure | Internal | Pass | Not available |
| Tagged particleClearance | Internal | Pass | Not available |
| Tagged particleContainment | Internal | Pass | Not available |
| Noise | Internal | Pass | Not available |
| Viral Penetration | ASTM F1671 | Pass | Not available |
| Cleaning Resiliency | Internal | Pass | Not available |
| Cleaning Validation | AAMI TIR30AAMI ST98 | Pass | Not available |
| Disinfection Validation | AAMI TIR30AAMI ST98 | Pass | Not available |
| Flammability | 16 CFR Part1610.7 | Pass | Not available |
| Repeat Use Testing | Internal | Pass | Not available |
| Usage Life Testing | |||
| System Usage Life | Internal | Pass | Not available |
| Filter usage Life | Internal | Pass | Not available |
Table 5-2. Summary of Performance Testing – Bench and Biocompatibility
Carecubes, Inc.
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Biocompatibility
Biocompatibility testing was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," September 4, 2020, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.
Based on the results of the biocompatibility testing performed on the Carecube Negative Pressure Isolation Chamber, the proposed device meets the requirements outlined in ISO 10993-1:2018.
Electrical Safety and Electromagnetic Compatibility (EMC)
EMC and Electrical Safety evaluation was conducted on the proposed Carecube Negative Pressure Isolation Chamber. Based on the results of the EMC testing, the Carecube Negative Pressure Isolation Chamber meets the requirements of IEC 60601-1.
Software Verification and Validation Testing
The proposed Carecube Negative Pressure Isolation Chamber does not contain software; therefore, the proposed device does not require software verification and validation testing.
Performance Testing - Animal
This submission does not include any animal performance testing. It was determined that no such testing was required to demonstrate substantial equivalence.
Performance Testing - Clinical
A non-significant risk (NSR) clinical study was conducted to evaluate patient comfort and environmental safety of the Carecube Negative Pressure Isolation Chamber. This study was intended to evaluate general patient safety and comfort within the Carecube (not associated with a specific disease state or condition), therefore allowing for the use of normal, healthy volunteers to achieve the study endpoints. This study was conducted as a prospective, single center, non-blinded study. The purpose of this study was to ensure patient safety and comfort during containment within the Carecube. Patient safety and comfort was assessed through routine monitoring of subject's vital signs (blood pressure, body temperature, pulse and oxvgen saturation), assessment of level of anxiety using the STAID evaluation, as well as monitoring of the Carecube environment (temperature, relative humidity, carbon dioxide (CO2) and atmospheric oxygen (O2) on an hourly basis. Subject data was recorded at baseline + 5 minutes and hourly, for a minimum of three (3) consecutive hours. This study consisted of a minimum of ten (10) Subjects and came from a cross-section of males and females, ages 21-47 years old.
| Table 5-3. Summary of Clinical Testing | ||
|---|---|---|
| ---------------------------------------- | -- | -- |
| Performance | Standard/TestMethod | Result | Comparison toPredicate |
|---|---|---|---|
| Human UseComfort | Internal | Pass | Not available |
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Based on the results of the study, it was determined that the Carecube Negative Pressure Isolation Chamber is safe for healthcare provider and patient use.
IX. CONCLUSION
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified as the CAPSUL Patient Isolation Unit, cleared under the 510(k) submission number K052798.
§ 880.5450 Patient care reverse isolation chamber.
(a)
Identification. A patient care reverse isolation chamber is a device consisting of a roomlike enclosure designed to prevent the entry of harmful airborne material. This device protects a patient who is undergoing treatment for burns or is lacking a normal immunosuppressive defense due to therapy or congenital abnormality. The device includes fans and air filters which maintain an atmosphere of clean air at a pressure greater than the air pressure outside the enclosure.(b)
Classification. Class II (performance standards).