Carecube Negative Pressure Isolation Chamber

K231256 · Carecubes, Inc. · LGM · Jan 3, 2024 · General Hospital

Device Facts

• Record ID: K231256
• Device Name: Carecube Negative Pressure Isolation Chamber
• Applicant: Carecubes, Inc.
• Product Code: LGM · General Hospital
• Decision Date: Jan 3, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5450
• Device Class: Class 2

Indications for 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).

Device Story

Carecube is a modular, negative pressure patient isolation unit (PIU) for hospital use. It encloses a patient to prevent airborne particulate cross-contamination between the patient and healthcare practitioners. The device features a thermoplastic polyurethane (TPU) canopy and a powder-coated steel frame. It includes glove arms, trunk ports, conduit ports, and lean-in windows to allow clinicians to perform low-to-moderate complexity interventions (e.g., blood draws, medication administration, cardiac auscultation) while the patient remains isolated. The system uses a fan and H13 HEPA filter to maintain negative pressure and airflow (35 air changes per hour). It is designed for stationary use in hospitals for up to 24 hours. The output is a contained environment that protects staff from infectious disease particulates. It benefits patients by allowing necessary medical care while maintaining strict isolation, reducing the risk of hospital-acquired infections or environmental contamination.

Clinical Evidence

Prospective, single-center, non-blinded study with 10 healthy volunteers (ages 21-47). Evaluated patient safety and comfort during 3 hours of containment. Endpoints included vital signs (BP, temp, pulse, O2 saturation), anxiety levels (STAID), and environmental monitoring (temp, humidity, CO2, O2). Results showed the device is safe for patient and provider use. Bench testing included biocompatibility (ISO 10993), electrical safety (IEC 60601), and functional performance (HEPA filtration, viral penetration per ASTM F1671).

Technological Characteristics

Modular negative pressure isolation chamber. Materials: Thermoplastic Polyurethane (TPU) envelope, powder-coated steel frame. Filtration: H13 HEPA (99.97% at 0.3μ). Airflow: 35 air changes per hour (ACH). Dimensions: 118"L x 54"W x 82"H. Power: Electrical fan/blower. Connectivity: None. Sterilization: Reusable components validated via cleaning/disinfection protocols (AAMI TIR30/ST98).

Indications for Use

Indicated for temporary isolation of patients in hospital settings to prevent particulate (biological) cross-contamination between user and patient, while enclosing the patient from the external environment. Intended for temporary housing prior to transfer to a permanent hospital setting. Enables low-moderate complexity medical interventions including blood draw, medication administration, abdominal palpation, cardiac auscultation, and connection to IV/monitoring cables. Contraindicated for morbidly obese patients and patients weighing less than 45 lbs.

Regulatory Classification

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.

Predicate Devices

• CAPSULS™ Patient Isolation Unit (K052798)

Reference Devices

• ORCA™ Operational Rescue Containment Apparatus (K163223)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: | [phone] |
| Email: | [e-mail] |
| 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 Rescue<br>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.

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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 | PROPOSED<br>DEVICE | PREDICATE<br>DEVICE | COMPARISON |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Carecube Negative<br>Pressure Isolation<br>Chamber | CAPSULS™ Patient<br>Isolation Unit | |
| Manufacturer | Carecubes, Inc. | ISOVAC | |
| 510(k) | K231256 | K052798 | |
| Product<br>Classification | II | II | Same |
| Product Code | LGM | LGN | Equivalent Carecube<br>(LGM) is not used<br>for transport (LGN) |
| Regulation<br>Number | 880.5450 | 880.5450 | Same |
| Regulation<br>Name | Chamber, Patient<br>Isolation | Chamber, Patient<br>Isolation | Same |
| Intended Use | Negative Pressure<br>Isolation Chamber | Negative Pressure<br>Isolation Chamber | Same |
| Indications for<br>Use | The Carecube is a patient<br>isolation unit (PIU)<br>designed for the<br>temporary isolation of<br>patients within a hospital<br>setting to prevent<br>particulate (biological)<br>cross-contamination<br>between user and patient,<br>while enclosing the<br>contaminated patient from<br>the external environment.<br>Device should only be<br>used in a hospital setting.<br>This is for temporary<br>housing of a patient prior<br>to transfer to an<br>appropriate hospital<br>destination. Transfer to a<br>more permanent hospital<br>setting should occur as<br>soon as possible. The<br>Carecube is designed with<br>features that enable low-<br>moderate complexity<br>medical interventions.<br>This includes the<br>following procedures:<br>blood draw, medication<br>administration, palpating<br>abdomen, cardiac<br>auscultation, and<br>connection to IV<br>line/monitoring cables. | The CAPSULS<br>(Containment and<br>Protection System Utilizing<br>Life Support) is a portable<br>Patient Isolation Unit<br>(PIU), which prevents<br>particulate (biological and<br>radiological) cross-<br>contamination between the<br>patient and the external<br>environment; and with<br>features that enable medical<br>intervention to the patient<br>via end-user supplied<br>medical equipment. The<br>CAPSULS is intended to<br>be used for:<br>• The transport and<br>isolation of<br>patients on<br>aircraft,<br>ambulances, ships<br>and any vehicle<br>capable of safely<br>transporting a<br>patient on a<br>standard litter.<br>• The temporary<br>isolation, with or<br>without transport,<br>of patients within<br>hospitals or<br>medical facilities. | Same except the<br>Carecube<br>indications are a<br>subset of the<br>predicate device<br>because the former<br>is not used for<br>transport. |
| Provided<br>Sterile | No | No | Same |
| Reusable | Yes | No | Different<br>Reprocessing<br>validation was<br>performed to ensure<br>safe reuse |
| Contra-<br>indications | • Morbidly<br>obese patients<br>• Patients<br>weighing less<br>than 45 lbs. or<br>less<br>• Oxygen-rich | Unknown | |
| OTC Use | Yes | Yes | Same |
| Materials of<br>Construction | Thermoplastic Polyurethane (TPU) envelope Powder-coated steel frame | Clear polyurethane (PUR) or polyvinylchlori de (PVC) envelope Plastic resin stanchions and integral ribs | Different<br>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<br>54" width<br>82" height | 81" overall length<br>26" width<br>20" | Different<br>The Carecube is longer to accommodate stationary use and a medical bed for patient isolation up to 24 hours.<br>Clinical testing demonstrates no new questions of safety or effectiveness. |
| Weight | 120 lbs. | 21 lbs. | Different<br>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<br>Both devices have an inline outbound filter, with differences in model type and size.<br>Performance testing demonstrates that, despite the differences, the Carecube is effective in air filtration. |
| Air Flow | Airflow for patient<br>head to foot is<br>controlled by the fan<br>and HEPA filter<br>blower manufacturer<br>at 150 CFM. | Airflow rate is set by<br>the blower<br>manufacturer at 4<br>CFM. | Different<br>Air flow capabilities<br>are larger due to the<br>larger room and<br>containment area.<br>Safety and<br>effectiveness is<br>demonstrated in<br>patient comfort and<br>in performance<br>testing. |
| Pressure | Negative Pressure<br>(NP) | Negative Pressure<br>(NP)<br>Positive Pressure (PP) | Different<br>The CAPSULS™<br>PIU allows the use<br>of PP or NP which<br>is not necessary for<br>the Carecube's<br>intended use. Both<br>devices utilize NP to<br>isolate a patient and<br>prevent the patient<br>from infecting<br>others. The<br>Carecube negative<br>pressure<br>performance was<br>validated. |
| Air Changes | 35 air changes per<br>hour (ACH) | 20-38 air changes per<br>hour (ACH) | Different<br>(The Carecube ACH<br>is within the ACH<br>range for the<br>predicate device.) |
| Glove Arms | Multiple Glove Arms | Multiple Glove Arms | Same |
| Other Access<br>Ports | Trunk Ports<br>Conduit Ports<br>Lean-In Windows | Access Ports<br>Conduit Port | Different<br>The Carecube offers<br>additional access<br>ports to facilitate<br>stationary use for<br>patient isolation.<br>The additional ports<br>do not raise different<br>questions of safety or<br>effectiveness and<br>performance was<br>demonstrated. |

### 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/Test<br>Method | Proposed Device<br>Result | Predicate Result |
|---------------------------------------------------|-----------------------------------------------|---------------------------|--------------------------|
| Biocompatibility | | | |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic | Not available |
| Sensitization | ISO 10993-10 | Non-sensitizing | Not available |
| Intracutaneous<br>Reactivity | ISO 10993-23 | Non-irritant | Not available |
| Acute Systemic<br>Toxicity | ISO 10993-11 | Non-toxic | Not available |
| Volatile<br>Organic<br>Compounds;<br>Particulates | Toxicological Risk<br>Assessment | Non-toxic | Not available |
| EMC and Electrical<br>Safety | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6 | Pass | Not available |
| Usability /Human<br>Factors | IEC 62366-1 | Pass | Not available |
| Packaging Testing | ASTM D4169<br>ASTM D4332 | Pass | Pressure/Leak<br>testing |
| Shelf-life Testing | ASTM F1980 | 12 months | Not available |
| Functional Performance Testing | | | |
| Canopy Robustness | Internal | Pass | Not available |
| Airflow and Smoke<br>Testing | Internal | Pass | Not available |
| Differential Pressure | Internal | Pass | Not available |
| Tagged particle<br>Clearance | Internal | Pass | Not available |
| Tagged particle<br>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<br>AAMI ST98 | Pass | Not available |
| Disinfection Validation | AAMI TIR30<br>AAMI ST98 | Pass | Not available |
| Flammability | 16 CFR Part<br>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.

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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/Test<br>Method | Result | Comparison to<br>Predicate |
|----------------------|-------------------------|--------|----------------------------|
| Human Use<br>Comfort | 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.