(247 days)
No
The document describes a physical isolation unit and its intended use and performance studies, with no mention of AI or ML technology.
No
The device is described as a patient isolation unit designed to prevent cross-contamination and provide temporary isolation, not to treat a specific medical condition or disease. It enables some medical interventions but is not a therapeutic device itself.
No
The Carecube is described as a patient isolation unit designed for temporary isolation, not for diagnosing medical conditions. Its purpose is to prevent cross-contamination and house patients prior to transfer, and while it allows for low-moderate complexity medical interventions, these are for care and monitoring, not diagnosis. The performance studies focus on patient comfort and environmental safety within the unit, not diagnostic accuracy.
No
The device description clearly states it is a "modular, negative pressure, isolation patient care system with both reusable and disposable components," indicating it is a physical device with hardware.
Based on the provided text, the Carecube device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that 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." This describes a physical barrier and containment system for patients.
- Device Description: The description reinforces this, calling it a "modular, negative pressure, isolation patient care system."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are typically reagents, instruments, or systems used for these purposes.
- Focus on Physical Isolation and Patient Care: The text focuses on the physical isolation function, the negative pressure system, and the ability to perform low-moderate complexity medical interventions on the patient within the unit.
In summary, the Carecube is a medical device designed for patient isolation and containment, not for performing diagnostic tests on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LGM
Device Description
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.
Mentions image processing
No
Mentions AI, DNN, or ML
No
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The clinical study consisted of a minimum of ten (10) Subjects and came from a cross-section of males and females, ages 21-47 years old.
Intended User / Care Setting
Used indoors, in a hospital setting. Intended to prevent Healthcare Practitioners (HCP) exposure to pathogenic biological airborne particulates.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 oxygen 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. Result: Pass for Human Use Comfort.
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.
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.
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
The Carecube Negative Pressure Isolation Chamber is 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 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.
§ 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).
0
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"
1
(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
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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4
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 |
5
III. Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| CAPSULS™ Patient Isolation Unit | K052798 | ISOVAC Products, LLC |
| Reference Device | ||
| ORCA™ Operational Rescue | ||
| Containment 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.
6
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 | PROPOSED
DEVICE | PREDICATE
DEVICE | COMPARISON |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Carecube Negative
Pressure Isolation
Chamber | CAPSULS™ Patient
Isolation Unit | |
| Manufacturer | Carecubes, Inc. | ISOVAC | |
| 510(k) | K231256 | K052798 | |
| Product
Classification | II | II | Same |
| Product Code | LGM | LGN | Equivalent Carecube
(LGM) is not used
for transport (LGN) |
| Regulation
Number | 880.5450 | 880.5450 | Same |
| Regulation
Name | Chamber, Patient
Isolation | Chamber, Patient
Isolation | Same |
| Intended Use | Negative Pressure
Isolation Chamber | Negative Pressure
Isolation Chamber | Same |
| 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. | The CAPSULS
(Containment and
Protection System Utilizing
Life Support) is a portable
Patient Isolation Unit
(PIU), which prevents
particulate (biological and
radiological) cross-
contamination between the
patient and the external
environment; and with
features that enable medical
intervention to the patient
via end-user supplied
medical equipment. The
CAPSULS is intended to
be used for:
• The transport and
isolation of
patients on
aircraft,
ambulances, ships
and any vehicle
capable of safely
transporting a
patient on a
standard litter.
• The temporary
isolation, with or
without transport,
of patients within
hospitals or
medical facilities. | Same except the
Carecube
indications are a
subset of the
predicate device
because the former
is not used for
transport. |
| Provided
Sterile | No | No | Same |
| Reusable | Yes | No | Different
Reprocessing
validation was
performed to ensure
safe reuse |
| Contra-
indications | • Morbidly
obese patients
• Patients
weighing less
than 45 lbs. or
less
• Oxygen-rich | Unknown | |
| OTC Use | Yes | Yes | Same |
| Materials of
Construction | Thermoplastic Polyurethane (TPU) envelope Powder-coated steel frame | Clear polyurethane (PUR) or polyvinylchlori de (PVC) envelope Plastic resin stanchions and integral ribs | Different
Materials 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 length
54" width
82" height | 81" overall length
26" width
20" | Different
The 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. | Different
Carecube 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 | Different
Both 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 patient
head to foot is
controlled by the fan
and HEPA filter
blower manufacturer
at 150 CFM. | Airflow rate is set by
the blower
manufacturer at 4
CFM. | Different
Air flow capabilities
are larger due to the
larger room and
containment area.
Safety and
effectiveness is
demonstrated in
patient comfort and
in performance
testing. |
| Pressure | Negative Pressure
(NP) | Negative Pressure
(NP)
Positive Pressure (PP) | Different
The CAPSULS™
PIU allows the use
of PP or NP which
is not necessary for
the Carecube's
intended use. Both
devices utilize NP to
isolate a patient and
prevent the patient
from infecting
others. The
Carecube negative
pressure
performance was
validated. |
| Air Changes | 35 air changes per
hour (ACH) | 20-38 air changes per
hour (ACH) | Different
(The Carecube ACH
is within the ACH
range for the
predicate device.) |
| Glove Arms | Multiple Glove Arms | Multiple Glove Arms | Same |
| Other Access
Ports | Trunk Ports
Conduit Ports
Lean-In Windows | Access Ports
Conduit Port | Different
The Carecube offers
additional access
ports to facilitate
stationary use for
patient isolation.
The additional ports
do not raise different
questions of safety or
effectiveness and
performance was
demonstrated. |
Table 5-1. General Technological Characteristics Comparison
7
8
9
!The Carecube Negative Pressure Isolation Chamber is to be used by a single patient for up to 24 hours of
10
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 ●
11
| Performance | Standard/Test
Method | Proposed Device
Result | Predicate Result |
|---------------------------------------------------|-----------------------------------------------|---------------------------|--------------------------|
| Biocompatibility | | | |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Not available |
| Sensitization | ISO 10993-10 | Non-sensitizing | Not available |
| Intracutaneous
Reactivity | ISO 10993-23 | Non-irritant | Not available |
| Acute Systemic
Toxicity | ISO 10993-11 | Non-toxic | Not available |
| Volatile
Organic
Compounds;
Particulates | Toxicological Risk
Assessment | Non-toxic | Not available |
| EMC and Electrical
Safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6 | Pass | Not available |
| Usability /Human
Factors | IEC 62366-1 | Pass | Not available |
| Packaging Testing | ASTM D4169
ASTM D4332 | Pass | Pressure/Leak
testing |
| Shelf-life Testing | ASTM F1980 | 12 months | Not available |
| Functional Performance Testing | | | |
| Canopy Robustness | Internal | Pass | Not available |
| Airflow and Smoke
Testing | Internal | Pass | Not available |
| Differential Pressure | Internal | Pass | Not available |
| Tagged particle
Clearance | Internal | Pass | Not available |
| Tagged particle
Containment | 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 TIR30
AAMI ST98 | Pass | Not available |
| Disinfection Validation | AAMI TIR30
AAMI ST98 | Pass | Not available |
| Flammability | 16 CFR Part
1610.7 | 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.
12
13
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/Test
Method | Result | Comparison to
Predicate |
|----------------------|-------------------------|--------|----------------------------|
| Human Use
Comfort | Internal | Pass | Not available |
14
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.