(44 days)
Not Found
No
The device description and performance testing focus on the physical components and basic physiological monitoring (O2 delivery, CO2 sampling). There is no mention of AI/ML algorithms for data analysis, interpretation, or decision support.
No.
The device facilitates oxygen delivery and CO2 monitoring, which are supportive functions during and after endoscopy. It does not actively treat a disease or condition itself.
No
Explanation: The device is primarily for delivering oxygen and sampling CO2 during endoscopy procedures and recovery. While it monitors CO2, which provides physiological data, its main function is supportive (oxygen delivery) and monitoring, not diagnosing a specific condition or disease. The CO2 monitoring is for procedural safety and recovery, not diagnostic purposes.
No
The device description clearly outlines physical components like a bite block, cannula, tubing, and straps, indicating it is a hardware device.
Based on the provided information, the DualGuard™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for delivering supplemental oxygen and monitoring CO2 during and after endoscopy procedures in adult patients. This is a direct interaction with the patient's respiratory system for monitoring and support, not for analyzing samples outside the body.
- Device Description: The description details a bite block with integrated oxygen delivery and CO2 sampling lines that are placed in the patient's nose and mouth. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) in vitro (in a test tube or lab setting) to provide diagnostic information. The CO2 monitoring is a real-time measurement of a physiological parameter.
In summary, DualGuard™ is a medical device used for patient support and monitoring during a medical procedure, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
DualGuard™ is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring during endoscopy procedures and recovery.
The complete device with bite block is to be used during endoscopy procedures. The DualGuard™ Bite Block is to be removed after endoscopy, leaving the O2 delivering/CO2 sampling cannula in place for patient recovery period.
Product codes (comma separated list FDA assigned to the subject device)
CCK, MNK, CAT
Device Description
DualGuard™ is an endoscopic bite block which is designed to fit into the nose and mouth of the patient during an endoscopy procedure.
DualGuard™ consists of a bite block with a removable oxygen delivering/CO2 monitoring cannula, which when attached located under the patient nose. The bite block also has an Oral CO2 monitoring line attached at the mouth opening. DualGuard™ is able to deliver oxygen via the nose, whilst sampling CO2 from the nose and mouth.
When the Endoscopy is complete the bite block of DualGuard™ can be removed whilst leaving the cannula in place on patient, delivering oxygen and monitoring CO2.
DualGuard™ has a soft TPE over molded Bite block to reduce the risk of damage to teeth, a tube slide for securing, and an adjustable head strap for a secure comfortable fit.
The CO2 line from the DualGuard™ has a self sealing "luersafe" luer port which allows the oral CO2 line to be removed with the bite block without any leaking of CO2 or ingress of air that may cause an inaccurate reading.
DualGuard™ is available in adult size only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
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)
DualGuard™ has been evaluated in accordance with standards listed in table:
| Test | Standard / Pre-Determined Acceptance Criteria | Outcome |
|---|---|---|
| Visual inspection | Pre-Determined Acceptance Criteria | All Samples pass |
| Tubing flow resistance | All Samples pass | |
| O2 Connector to tubing tensile strength | BS EN13544-2: 2002 +A1:2009. | All Samples pass |
| O2 Connector to nipple tensile strength | All Samples pass | |
| Tube resistance to kinking | All Samples pass | |
| Dimensional inspection of luer conical | ISO 594-1 / BS EN 20594-1:1994. | All Samples pass |
| Dead Space | Pre-Determined Acceptance Criteria | DualGuard Dead space is less than marketed predicate. |
| Dimensional inspection of luer conical | All Samples pass | |
| Gauging tests on luer | All Samples pass | |
| Liquid leakage from luer | All Samples pass | |
| Air leakage from luer | All Samples pass | |
| Luer separation force | All Samples pass | |
| Luer unscrewing torque | ISO 594-2 (BS EN 1707:1997) | All Samples pass |
| Luer ease of assembly | All Samples pass | |
| Luer resistance to overriding | All Samples pass | |
| Luer testing for stress cracking | All Samples pass | |
| Leak testing of all bonded components | Pre-Determined Acceptance Criteria | All Samples pass |
| Co2 monitoring function test | Pre-Determined Acceptance Criteria | All Samples pass |
| Tensile testing - CO2 & O2 lines to connector and/or cannula prongs | Pre-Determined Acceptance Criteria | All Samples pass |
| Dimensional characteristics | Pre-Determined Acceptance Criteria | All Samples pass |
| Accelerated age testing | ASTM F1980 | All Samples pass |
| Cytotoxicity, Irritation, sensitization | BS EN ISO 10993-10:2010 BS EN ISO 10993-5:2009 | All Samples pass |
All Samples passed the performance testing when tested against methods and criteria from pre-determined acceptance criteria In-House test methods and relevant BS EN, ISO & ASTM FDA recognized standards.
The results of this testing show that DualGuard™ passes all performance tests and performs at least as well as the marketed predicate device "TwinGuard" by Trawax.
The conclusions drawn from the nonclinical performance comparison testing demonstrate that DualGuard™ is as safe, as effective, and performs as well as or better than the legally marketed Predicate device "TwinGuard" by Trawax.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).
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Cynon Valley Business Park, Mountain Mid Glamorgan. CF45 4ER UK. Tel: +44 (0) 1443 474647 APR 1 0 2014 Fax: +44 (0) 1443 474222 Customer Services: +44 (0) | 443 471580 Purchasing Fax: +44 (0) 1443 476332
· K140473
Email: enquiries@flexicare.com www.flexicare.com
510(k) Summary
510(k) Sponsor, Contact Person and Date Summary Prepared:
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, Mid. Glamorgan CF45 4ER. United Kingdom
Christopher Watkins Quality Regulatory & Technical Director Telephone: 00 44 1443 471 593 Fax: 00 44 1443 474 222
Summary prepared on: 10th April 2014
Device Name:
Trade Name: DualGuard™ Common/Usual Name: Endoscopic bite block and nasal oxygen cannula with CO2 monitoring accessory
Classification Name: Primary Classification: Carbon dioxide analyzer 21 CFR 868.1400 Primary Product Code: CCK Secondary Product Codes: Endoscopic bite block (MNK), Nasal oxygen cannula (CAT)
Legally Marketed Equivalent Device:
The DualGuard™ is substantially equivalent to Trawax's TwinGuard® cleared under 510(k) K080527.
Device Description:
DualGuard™ is an endoscopic bite block which is designed to fit into the nose and mouth of the patient during an endoscopy procedure.
DualGuard™ consists of a bite block with a removable oxygen delivering/ CO2 monitoring cannula, which when attached located under the patient nose. The bite block also has an Oral CO2 monitoring line attached at the mouth opening. DualGuard™ is able to deliver oxygen via the nose, whilst sampling CO2 from the nose and mouth.
When the Endoscopy is complete the bite block of DualGuard™ can be removed whilst leaving the cannula in place on patient, delivering oxygen and monitoring CO2.
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Image /page/1/Picture/2 description: The image shows the logo for "Flexicare". The logo is in black and white and features a stylized "F" followed by the word "lexicare" in a bold, sans-serif font. Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
DualGuard™ has a soft TPE over molded Bite block to reduce the risk of damage to teeth, a tube slide for securing, and an adjustable head strap for a secure comfortable fit.
The CO2 line from the DualGuard™ has a self sealing "luersafe" luer port which allows the oral CO2 line to be removed with the bite block without any leaking of CO2 or ingress of air that may cause an inaccurate reading.
DualGuard™ is available in adult size only.
Intended Use:
DualGuard™ is intended for use in Adult patients who require supplemental oxygen delivery and CO2 monitoring during endoscopy procedures and recovery.
The complete device with bite block is to be used during endoscopy procedures. The DualGuard™ Bite Block is to be removed after endoscopy, leaving the O2 delivering/CO2 sampling cannula in place for patient recovery period.
Substantial Equivalence:
DualGuard™ has the same intended use as the predicate device.
Both the DualGuard and TwinGuard are single patient use devices. Supplied in Adult size onlv.
Neither device is life supporting or life sustaining.
Patient Contact -Bite block - Invasive - Mucosal membrane - Limited duration (>24hrs) Cannula & tubing - skin contact (intact) and externally communicating - Limited duration (>24hrs)
Neither the DualGuard nor the TwinGuard uses software/ neither are electronically driven. Both devices are supplied non-sterile in individual poly bags.
Both devices are able to be used with industry standard devices such as oxygen cylinders/connectors and Capnograph machines.
Both the DualGuard and TwinGuard devices are designed for the same intended use in the same intended conditions.
Both designs consist of 10+ components made from injection molded & extruded plastics.
From comparison testing it was determined that the only invasive components of the two devices were the bite blocks.
The DualGuard bite blocks are manufactured from Polypropylene with a soft TPE section over molded.
TwinGuard bite blocks are also manufactured from Polypropylene but do not have an over molded section.
The Oxygen tubing, cannula, CO2 line and oxygen connector of both the DualGuard and TwinGuard devices are manufactured from PVC.
The Trawax "TwinGuard" bite block is Green in color with clear tubing. The Flexicare Duale, Luard TM in Dlun 9 aranan in antar uith aloar fuhina Thia diffaran
2
Image /page/2/Picture/2 description: The image shows the logo for "Flexicare". The logo has a stylized "F" on the left, followed by the text "lexicare" in a serif font. Below the name is the text "TOTAL QUALITY - TOTAL CARE" in a smaller, sans-serif font.
manufacturer's choice/ branding, and is not related to sizing, intended use, gender of patient or performance of device.
Both the DualGuard and Predicate devices have 2M oxygen & CO2 lines.
| Flexicare DualGuard™ | Trawax "TwinGuard" | |
|---|---|---|
| K: Unknown | K080527 | |
| Components | O2 tube | O2 tube |
| O2 connector | O2 connector | |
| CO2 line | CO2 line | |
| CO2 luer | CO2 luer | |
| Bite block | Bite block | |
| TPE over mold | Nasal cannula | |
| Nasal cannula | Head strap | |
| Head strap | Tube slide | |
| Tube slide | Oral CO2 tube link | |
| Oral CO2 tube link | ||
| Self sealing CO2 Y-piece | ||
| Oral CO2 luer | ||
| 0.45µm Hydrophobic filter | ||
| Medical grade PVC | ||
| Materials | Medical grade PVC | |
| Medical grade Polypropylene | Medical grade Polypropylene | |
| Medical grade ABS | Medical grade ABS | |
| Medical grade TPE | ||
| Medical grade ABS/Nylon (filter) | ||
| Target | Adult | Adult |
| population | ||
| Home use | No | No |
| Emergency use | Yes | Yes |
| Assembly | Bonded - Solvent adhesive | Bonded - Solvent adhesive |
| method | ||
| Connectable to | Yes | Yes |
| Capnograph? | ||
| Monitors CO2? | Yes | Yes |
| Nasal CO2 | Yes | Yes |
| monitoring? | ||
| Oral CO2 | Yes | Yes |
| monitoring? | ||
| Use | Single use | Single use |
| Supplied sterile | No | No |
| Soft molded bite | Yes | No |
| area? | ||
| Indications for | ||
| use | DualGuard™ is intended for use in Adult | |
| patients who require supplemental oxygen | ||
| delivery and CO2 monitoring during | ||
| endoscopy procedures and recovery. |
The complete device with bite block is to be
used during endoscopy procedures.
The DualGuard™ Bite Block is to be removed
after endoscopy, leaving the 02
delivering/CO2 sampling cannula in place for
patient recovery period. | TwinGuard®, a bite block with a nasal oxygen
cannula, is used during endoscopy
procedures to administer continuous oxygen
to the nose and mouth.
After endoscopy the bite block is removed,
leaving the cannula in place during recovery,
to continue delivering oxygen to the nose
and mouth.
In addition, the TwinGuard® contains an
optional accessory which collects samples of
the patient's breathing at the nose and
mouth to measure CO2 with a capnograph
during endoscopy procedures. It is intended
for adult patients. |
| Prescription Use? | Yes | Yes |
| Processes carried
out | Injection moulding
Tube extrusion
Solvent bonding
Packaging | Injection moulding
Tube extrusion
Solvent bonding
Packaging |
| Component
interactions | O2 & CO2 Tube - non-Invasive, skin contact
(intact) and Externally communicating.
Limited use (