(351 days)
The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) cross-contamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.
The Operational Rescue Containment Apparatus (ORCATM) Patient Isolation Unit, Model ORCA-2016CN, is a tubular, flexible, Patient Isolation Unit (PIU) for use during transport and evacuation of chemical and particulate (biological and radiological) contaminated patients who have been medically stabilized. Each unit employs clear windows to allow visual monitoring of the patient. The unit incorporates multiple glove arms for minimal medical intervention. The PIU's have a reinforced base mat with integrated carry straps and tethers to enable lifting and attachment to a Stokes litter for hoisting operations or a North Atlantic Treaty Organization (NATO) litter for alternative transportation. Chamber airflow through the isolator and across the patient is provided by the blower from a Powered Air-Purifying Respirator (PAPR). Internal contaminated air in the PIU is vented out the exhaust ports which are fitted with two Chemical, Biological, Radiological, Nuclear (CBRN) filter cartridges, thus protecting the external environment from a contaminated patient.
The provided text describes the ISOVAC Products, LLC ORCA™ - Operational Rescue Containment Apparatus (K163223), a patient isolation unit. However, the document does not contain information relevant to all parts of the request. Specifically, it does not detail a study involving an algorithm or artificial intelligence, a common scenario for multi-reader multi-case (MRMC) comparative effectiveness studies. Therefore, some sections of your request cannot be fully addressed from the provided text.
Here's an analysis of the acceptance criteria and performance data available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each performance test in a formal table format with numerical targets. Instead, it describes tests performed and their successful outcomes, implying that successful completion of these tests serves as the acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Operational Testing (Hoisting and Transport): Device must withstand hoisting and transport in extreme conditions (e.g., helicopter rotor wash). | Successfully conducted by the U.S. Coast Guard (USCG) on an MH-60 helicopter. Hoisted multiple times at various altitudes (25/50/75/100 ft.) with a trail line to stabilize the Stokes litter. The MH-60 generates 90+ knots of downward rotor wash. USCG deemed this sufficient testing to validate the "proof of concept." |
| Chemical Agent Permeation: Exceed objective requirement for containment efficiency (%) for aerosols at a maximum 0.3 micron particle size against HD (distilled mustard) and GD (soman). | PIU system permeation testing performed in principle to IEST-RP-CC001.3 and MIL-STD-282 Method 102.9.1. Demonstrated a containment efficiency (%) for both aerosols at a maximum 0.3 micron particle size that exceeded the objective requirement. |
| Liquid Penetration / Pathogen Passage: No detectable bacteriophage (0 PFU/mL) in assay titer. | Testing performed using ASTM F1671/F1671M-13 (Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration). No detectable bacteriophage in the assay titer (i.e., 0 PFU/mL) was considered passing. The Bag Seam, Sleeve Seam, and Window Seam materials passed liquid penetration testing. |
| Human Use Comfort: Participant's vital signs stable, and no significant problems reported during extended use in varying environments. | A test participant (TP) was contained in the PIU for four hours across six temperature and RH% environments (65-90°F and 40-90% at 4 mph wind speed). Internal PIU temperature, RH%, CO2, O2 levels, patient vitals, and comfort levels were monitored. TP's vital signs were stable with no indication of heat stress or health issue. TP reported no significant problems. |
| Weight Lift Capacity: Handles and strapping must hold a maximum specified test load. | Tested under ISOVAC standard protocol procedure. Demonstrated the PIU handle strapping can hold the maximum test load of 480lb or a load of 137% of the stated maximum. |
2. Sample Size Used for the Test Set and Data Provenance
- Operational Testing: The document mentions "multiple times" for hoisting. It doesn't specify a numerical sample size for the tests on the PIU during helicopter operations.
- Data Provenance: Conducted by the U.S. Coast Guard, suggesting a domestic (USA) origin. The nature of the test (actual helicopter operations) implies prospective testing for the specific device, though it's evaluating a physical product's performance rather than data analysis.
- Chemical Agent Permeation, Liquid Penetration / Pathogen Passage, Human Use Comfort, Weight Lift Testing: These were performed by a "third-party testing party under contract with the USGC." No specific numerical sample sizes are given for the number of units tested or the number of samples for materials.
- Data Provenance: The location of the third-party testing party is not specified, but the USGC contract suggests it's likely within the US. These tests are prospective.
- Human Use Comfort: "a test participant (TP)" was used, indicating a sample size of 1 for the comfort study.
- Data Provenance: Not explicitly stated, but likely domestic (USA) given the context. Prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the document describes performance testing of a physical medical device (Patient Isolation Unit), not an AI or algorithm-based device that would require expert consensus for establishing ground truth data. The "ground truth" for these tests is based on objective measurements (e.g., lack of permeation, stable vitals, weight holding capacity) and successful operational use as determined by the USCG.
4. Adjudication Method for the Test Set
This is not applicable for the type of device and testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical data by multiple experts to establish a "true" label, which is not the nature of the tests conducted for this physical device. The USCG "deemed...sufficient testing" for the operational tests, indicating their internal expert judgment as an adjudicator, but not in the sense of a medical image or diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical cases with and without AI assistance. The ORCA™ is a physical containment apparatus.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The ORCA™ is a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is primarily based on:
- Objective performance measurements: For chemical permeation, liquid penetration, vital signs, and weight capacity. These are quantifiable outcomes.
- Operational success/validation: For hoisting and transport, determined by the U.S. Coast Guard's assessment of suitability for use in their aircraft.
8. The Sample Size for the Training Set
Not Applicable. The ORCA™ is a physical medical device, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As mentioned above, there is no AI or algorithm with a training set for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 2, 2017
ISOVAC Products, LLC % Jeffery Jones Consultant JL Jones Group, Inc 1213 Kevington Drive Antioch, Illinois 60002
Re: K163223
Trade/Device Name: ORCA™ - Operational Rescue Containment Apparatus Regulation Number: 21 CFR 880.5450 Regulation Name: Patient Care Reverse Isolation Chamber Regulatory Class: Class II Product Code: LGN Dated: September 29, 2017 Received: October 4, 2017
Dear Jeffery Jones:
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163223
Device Name
ORCA (tm) - Operational Rescue Containment Apparatus
Indications for Use (Describe)
The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) cross-contamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.
| 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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Image /page/3/Picture/1 description: The image shows the logo for ISOVAC Products LLC. The logo consists of the company name in green text. To the left of the company name is a circular graphic with the letters ISOVAC inside.
1306 Enterprise Drive, Unit C • Romeoville, IL 60446 • 630-679-1740
510(k) Summary
Submitter's Name: ISOVAC Products, LLC 1306 Enterprise Drive, Unit C Romeoville, IL 60446 Telephone: (630) 679-1740 Fax: (630) 679-1750 E-mail: pjenkner@isovacproducts.com
Contact person: Mr. Jeffery Jones, Consultant
Date of Summary: October 31, 2017
Device Names:
Trade Name: ORCA™ - Operational Rescue Containment Apparatus Common Name: Patient Isolation Unit (PIU) Regulation Name: Patient care reverse isolation chamber Classification Name: Class II (21 CFR 880.5450) Product Code: LGN
Predicate Device:
The legally marketed predicate device is the CAPSULS Patient Isolation Unit (K052798) manufactured by ISOVAC Products. -
Device Description:
The Operational Rescue Containment Apparatus (ORCATM) Patient Isolation Unit, Model ORCA-2016CN, is a tubular, flexible, Patient Isolation Unit (PIU) for use during transport and evacuation of chemical and particulate (biological and radiological) contaminated patients who have been medically stabilized. Each unit employs clear windows to allow visual monitoring of the patient. The unit incorporates multiple glove arms for minimal medical intervention.
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Image /page/4/Picture/1 description: The image shows the logo for ISOVAC Products LLC. The logo consists of the company name in green text, with the word "ISOVAC" in a bold, sans-serif font and "Products LLC" in a smaller font below it. To the left of the name is a circular graphic with the letters "ISOVAC" inside.
1306 Enterprise Drive, Unit C • • Romeoville, IL 60446 • • 630-679-1740
The PIU's have a reinforced base mat with integrated carry straps and tethers to enable lifting and attachment to a Stokes litter for hoisting operations or a North Atlantic Treaty Organization (NATO) litter for alternative transportation. Chamber airflow through the isolator and across the patient is provided by the blower from a Powered Air-Purifying Respirator (PAPR). Internal contaminated air in the PIU is vented out the exhaust ports which are fitted with two Chemical, Biological, Radiological, Nuclear (CBRN) filter cartridges, thus protecting the external environment from a contaminated patient.
The device is used by trained medical personnel, who may or may not be licensed physicians or surgeons, and who may or may not be operating the device under the supervision of such licensed medical professionals. For this reason, ISOVAC Products intends that the ORCA™ be cleared for over-the-counter use.
Indications for Use:
The Model ORCA-2016CN is a portable and ambulatory Patient Isolation Unit (PIU) designed to prevent chemical and particulate (biological and radiological) crosscontamination between an enclosed contaminated patient and the external environment during evacuation and transport activities.
Descriptive Summary of Technological Characteristics:
The indications for use and principles of operation of the ORCA™ Patient Isolation Unit are essentially identical to those of the predicate device (CAPSULS™); however, the ORCATM device will additionally protect the external environment from a chemically contaminated patient. The unit is lighter in weight, and provides first responders with hoisting capability. Differences between the devices result primarily from technological advances, such as those in materials technology, which have occurred since the CAPSULS™ device was introduced in 2005.
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Image /page/5/Picture/1 description: The image shows the logo for ISOVAC Products LLC. The logo is divided into two parts, with the left side featuring the word "ISOVAC" in bold, black letters, with the words "PRODUCTS LLC" in smaller letters below. The letters are surrounded by a green circle. The right side of the logo displays the words "ISOVAC Products LLC" in a larger, green font.
1306 Enterprise Drive, Unit C • 630-679-1740
| Differences between the predicate and proposed devices are shown in BOLD type. | ||
|---|---|---|
| PARAMETERS | PREDICATE DEVICE | PROPOSED DEVICE |
| INTENDED USE | The CAPSULS (Containment andProtection System Utilizing LifeSupport) is a portable PatientIsolation Unit (PIU)It is intended for the transport ofpatients while preventingparticulate (biological andradiological) cross-contaminationbetween the patient and theexternal environment.PIU is designed with features thatenable medical intervention. | The Model ORCA-2016CN(Operational Rescue ContainmentApparatus) is a portable andambulatory Patient Isolation Unit(PIU)The Model ORCA-2016CN is aportable and ambulatory PatientIsolation Unit (PIU) designed toprevent chemical and particulate(biological and radiological)cross-contamination between anenclosed contaminated patientand the external environmentduring evacuation and transportactivities. |
| FRAMEWORK | Plastic resin stanchions andintegral ribs | Plastic rib structure |
| ENVELOPE | Zippered transparent flexiblePVC or Polyurethane (PUR)welded transparent film enclosure | Zippered GORE® CHEMPAK®SPM Fabric enveloped withclear PVC viewing windows |
| LIFTING ANDTRANSPORT SUPPORT | The CAPSULS is intended formounting on a standardmedical litter that can also belifted by a (PVC or PUR)coated fabric mesh base mat | The ORCA is intended formounting on a standard medicallitter or on a Stokes litter (notsupplied) during hoistingoperations that be lifted by a |
| 1306 Enterprise Drive, Unit C • Romeoville, IL 60446 • 630-679-1740 | ||
| with carry straps integral tothe product. | fabric mesh base mat withcarry straps integral to theproduct. | |
| AIR SUPPLY BLOWER | C420, battery operated,military issue, commercial(Powered Air PurifyingRespirator) blower | C420, battery operated,military issue, commercial(Powered Air PurifyingRespirator) blower. |
| BLOWER POWERSUPPLY ANDCONTROLS | One replaceable orrechargeable, 10-hour, 6VDCbattery.Blower incorporatesON/OFF switchLow battery alarm | 6VDC battery options:#1: D-Cell battery pack(standard)#2: AA-Cell battery pack#3: Rechargeable NiMH battery#4: BA5800/U LiSO2Blower incorporatesON/OFF switchLow battery alarm |
| AIR FILTRATION | Two (2) M95, P100/HEPA(High Efficiency ParticulateAir) rated filter cartridges | Two (2) M96, P100/HEPA(High Efficiency ParticulateAir) rated filter cartridges |
| ROUGHING FILTERS | Integral with the M95 cartridgesdescribed above. | Integral with the M96 cartridgesdescribed above. |
| AIR FLOW CONTROL | Airflow from patient head to footis set by the blower manufacturerat 4 CFM. Air backflow isprevented by check valves. | Airflow enters at the rightsside of patient head and isexhausted to the left of patienthead. Airflow rate is set by theblower manufacturer at 4CFM. Air backflow isprevented by a check valve. |
| PATIENT ANCILLARYOXYGEN | Tubing ports compatible withoxygen tubing and mask (notsupplied) | No Tubing Ports |
| LIFTING HANDLES | CAPSULS™ is designed to bemounted on and lifted with thehandles of a standard medicallitter. In the absence of a litter,CAPSULS may be lifted with the | ORCA is designed to bemounted on and lifted with thehandles of a standard medicallitter or NATO or Stokes litter.In the absence of a litter,ORCA may be lifted with the |
| 1306 Enterprise Drive, Unit C •Romeoville, IL 60446 •630-679-1740 | ||
| four integral carrying straps oneach side of the unit. | four integral carrying straps oneach side of the unit. | |
| ABSORBENT PAD | No Absorbent Pad | Internal Absorbent Pad |
| AIR CHANGES | 15-20 air changes per hour undernormal use conditions. | 20-38 air changes per hourunder normal use conditions. |
| DIMENSIONS | ||
| (with handles retracted) | ||
| Length | 78" envelope, 88" overall lengthwith blower and stanchions | 81" overall length |
| Width | 24 inches | 26 inches |
| Height | 18 inches | 20 inches |
| Storage Height | 15 inches | 10 inches |
| Storage Volume | Approximately 3 cubic feet | Approximately 4.2 cubic feet |
| Weight | 25 lbs. (polyurethane), 35 lbs.(PVC) | 21 lbs. |
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Image /page/6/Picture/1 description: The image shows the logo for ISOVAC Products LLC. The logo features the company name in bold, black letters, with the "V" in "ISOVAC" stylized as an inverted triangle. A green circle surrounds the "ISO" portion of the name. Below the "VAC" portion, the words "PRODUCTS LLC" are written in a smaller, sans-serif font.
ISOVAC Products LLC
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Image /page/7/Picture/1 description: The image contains the logo for ISOVAC Products LLC. On the left side of the image is the ISOVAC logo, which consists of the company name in bold black letters surrounded by a green circle. To the right of the logo, the company name is written out in green letters.
Performance Data:
Operation system testing was successfully conducted on the ORCA™ PIU by the U.S. Coast Guard. This operational testing included hoisting and transport of the PIU with the test platform being a MH-60 helicopter. The PIU was hoisted multiple times at various altitudes (25/50/75/100 ft.) using a trail line to stabilize the stokes litter (video documentation is on file with the USCG). The results from this performance testing, to the satisfaction of the USCG, validated the "proof of concept" for using the PIU in USCG aircraft. The MH-60 generates 90 plus knots of downward rotor wash during a hover and this was deemed by the
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Image /page/8/Picture/1 description: The image shows the logo for ISOVAC Products LLC. The logo consists of the text "ISOVAC" in black, with the words "PRODUCTS LLC" in smaller green font below it, all enclosed in a green circle. To the right of the logo is the text "ISOVAC Products LLC" in a larger green font.
1306 Enterprise Drive, Unit C • • Romeoville, IL 60446 • 630-679-1740
USCG as sufficient testing as the PIU is intended to be a one time use piece of equipment. USCG Tactics, Techniques and Procedures (TTP) for operational use of the PIU clearly articulates this requirement/limitation of the PIU. This includes the maximum flight duration allowed, DECON, training and maintenance. While a small boat could be used for transport of the PIU, the current CONOP uses a helicopter as this is the most extreme condition and most likely in the event we are transporting a contaminated patient.
The predicate device was not designed for hoisting.
Performance system testing was successfully conducted on the ORCA™ PIU by a third-party testing party under contract with the USGC. This performance testing included Chemical Agent Permeation (HD (distilled mustard) and GD (soman)), Liquid Penetration / Pathogen Passage, Human Use Comfort, and Weight Lift Testing.
PIU system permeation testing was performed in principle to those methods described in Institute of Environmental Sciences and Technology IEST- RP-CC001.3 (Ref 2) and MIL-STD-282 Method 102.9.1 (Ref 3) and demonstrated a containment efficiency (%) for both aerosols at a maximum 0.3 micron particle size exceeded the objective requirement. Liquid Penetration / Pathogen Passage testing was performed using methods described in ASTM F1671/F1671M-13: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System. No detectable bacteriophage in the assay titer (i.e., 0 PFU/mL) was considered passing. The Bag Seam, Sleeve Seam, and Window Seam three materials passed liquid penetration testing.
Human interface comfort testing was performed using a test participant (TP) while being contained in the PIU for four hours. The participant was exposed to a matrix of six (6) temperature and RH% environments ranging from 65-90°F and 40 - 90% in a wind speed of 4 mph. Internal PIU temperature, RH%, CO2 and O2 levels, as well patient vitals and comfort levels were monitored over the four-hour test duration. The TP's vital signs were stable for the duration of the test with no indication of any heat stress or health related issue. Additionally, the TP reported no significant problems throughout the duration of the test.
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Image /page/9/Picture/1 description: The image shows the logo of ISOVAC Products LLC. The logo consists of the company name in a green font. To the left of the company name is a circular graphic with the letters ISOVAC inside.
1306 Enterprise Drive, Unit C • 630-679-1740
The PIU weight lift capacity was tested under ISOVAC standard protocol procedure. The testing demonstrated the PIU handle strapping can hold the maximum test load of 480lb or a load of 137% of the stated maximum.
Conclusion:
The conclusions drawn from the nonclinical and clinical tests that 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).