(175 days)
Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required.
Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve.
Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.
The provided text describes the acceptance criteria and a study demonstrating the Flexicare Single Use Resuscitator Bags meet these criteria by showing substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting recognized standards and performance characteristics comparable to the predicate devices. The "Outcome" column in the table below indicates that the Flexicare device "Passed" each test, implying that it met the respective criteria.
| Test / Characteristic compared | Acceptance Criteria (or Standard Met) | Reported Device Performance (Outcome) |
|---|---|---|
| Visual inspection | Comparison test | Substantially equivalent |
| Valve Function after contamination with vomitus | BS EN ISO 10651-4:2009 | Pass |
| Mechanical shock - Drop testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Immersion in Water | - (Implied to meet performance of predicate / safety standards) | Pass |
| Supplementary Oxygen & Delivered Oxygen Concentration | - (Implied to meet performance of predicate / safety standards) | Pass |
| Expiratory Resistance | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required resistance range) | Pass |
| Inspiratory Resistance | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required resistance range) | Pass |
| Patient Valve Malfunction | - (Implied to meet performance of predicate / safety standards) | Pass |
| Tidal Volume - Minimum Delivered Volume | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required volume range) | Pass |
| Pressure Limitation - Pressure Relief Blow off | - (Implied to meet performance of predicate / safety standards. Specific values provided in comparison tables indicate a required pressure) | Pass |
| Conical Connector compliance | ISO 5356-1:2004 | Pass |
| Leak testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Drop testing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Cytotoxicity, Irritation, Sensitization, Systemic Toxicity, Extractables & Leachables | ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2009, ISO 10993-17:2009 | Pass |
| Tubing resistance to gas flow | BS EN 13544-2:2002+A1:2009 | Pass |
| Tensile strength – connector to tubing | - (Implied to meet performance of predicate / safety standards) | Pass |
| Tensile strength – connector to O2 spout | - (Implied to meet performance of predicate / safety standards) | Pass |
| Resistance to kinking | - (Implied to meet performance of predicate / safety standards) | Pass |
| Accelerated Ageing | ASTM F1980 | Pass |
| Particulate Emissions | BS ISO 18562-2 2017 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of devices) used for each specific test in the "test set". However, it mentions "Verification tests were performed to establish the safety and efficacy of Flexicare's Adult Single Use Resuscitator Bag." and similarly for Pediatric and Infant versions. The tests would likely involve a statistically relevant number of devices to ensure reliability.
The data provenance is from Flexicare Medical Limited, United Kingdom. The study is retrospective in the sense that it compares the newly developed Flexicare device against existing, legally marketed predicate devices (Ambu SPUR II Adult, Pediatric, and Infant Single Patient Use Resuscitators) that have already been cleared by the FDA. The performance testing itself would be prospective for the Flexicare device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance testing. Instead, the ground truth is established by objective measurements against recognized international standards and direct comparison of performance characteristics with legally marketed predicate devices.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method involving human reviewers for the test set. The validation relies on objective laboratory testing against predefined criteria and standards, and direct comparison of measured characteristics with those of predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI/CAD systems for image interpretation, which is not applicable to a manual resuscitator bag. The study is a non-clinical performance and biocompatibility evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone (algorithm-only) study was not done. This device is a manual medical device and does not involve any algorithms or AI for its operation.
7. The Type of Ground Truth Used
The ground truth used for this device's validation is based on:
- Recognized International Standards: Compliance with standards such as BS EN ISO 10651-4:2009, ISO 10993 series, ISO 5356-1:2004, BS EN 13544-2:2002+A1:2009, BS ISO 18562-2 2017, and ASTM F1980.
- Performance Specifications of Legally Marketed Predicate Devices: The performance characteristics (e.g., volume, resistance, force, dead space, stroke volume, pressure relief) of the Flexicare devices are compared directly to those of the Ambu SPUR II predicate devices. The goal is to demonstrate "substantial equivalence," meaning the new device performs as safely and effectively as the predicate.
- Objective Laboratory Measurements: The "Non-clinical Test Results" section explicitly states that "Verification tests were performed to establish the safety and efficacy" including visual inspection, dimensional inspection, internal volume, valve function, drop testing, immersion in water, oxygen concentration, resistances, valve malfunction, tidal volume calculation, O2 tube testing, conical connector compliance, biocompatibility, and particulate emission testing.
8. The Sample Size for the Training Set
There is no training set as this is a physical medical device, not an AI or machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name, "U.S. Food & Drug Administration," is in blue text.
December 7, 2018
Flexicare Medical Limited % Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K181583
Trade/Device Name: Flexicare Single Use Resuscitator Bags Regulation Number: 21 CFR 868.5915 Regulation Name: Manual emergency ventilator Regulatory Class: Class II Product Code: BTM Dated: November 20, 2018 Received: November 21, 2018
Dear Dave Yungvirt:
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. 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 located 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.
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
{1}------------------------------------------------
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K181583
Device Name Flexicare Single Use Resuscitator Bags
Indications for Use (Describe)
Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66bs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22bs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital environments.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for Flexicare. The logo is in blue and features a stylized "f" followed by the word "lexicare". Below the word "lexicare" is the tagline "TOTAL QUALITY - TOTAL CARE".
510(k) Sponsor, Contact Person and Date Summary Prepared:
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash. CF45 4ER. United Kingdom
Joel Biddle Senior Compliance Engineer Telephone: 00 44 1443 474 647 Fax: 00 44 1443 474 222
Summary prepared on: November 14th, 2018
Device Name:
Trade Name: Flexicare Single Use Resuscitator Bags
Common/Usual Name: Resuscitator Bag
Classification Name: Ventilator, Emergency, Manual (Resuscitator): 21 CFR 868.5915
Product Codes: BTM (Manual emergency ventilator)
Legally Marketed Equivalent Device:
Flexicare's Adult Single Use Resuscitator Bag is substantially equivalent to Ambu's SPUR II Adult Single Patient Use Resuscitator cleared under K042682.
Flexicare's Pediatric Single Use Resuscitator Bag is substantially equivalent to Ambu's SPUR II Pediatric Single Patient Use Resuscitator cleared under K042843.
Flexicare's Infant Single Use Resuscitator Bag is substantially equivalent to Ambu's SPUR II Infant Single Patient Use Resuscitator cleared under K042843.
Device Description:
Flexicare's Single Use Resuscitator Bags are Single Use devices For manual ventilation of a patient by trained operators in emergency/critical situations where short term ventilation is demanded by the patient's medical condition (e.g. inadequate or no breathing). Manual squeezing of the resuscitator bag forces air or air /O2 mixture into the patient's lungs via a face mask or pre-positioned airway tube with a 15mm male connection. A reservoir bag is present at the distal end of the device which fills with supplementary O2 (if using). This can be squeezed into the resuscitator for administration if required.
Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image is a logo for "flexicare". The logo is blue and features a stylized "f" with three curved lines above the word "flexicare". Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller letters. The logo is simple and modern, and the blue color gives it a clean and professional look.
Flexicare's Single Use Resuscitator Bags feature a one-way duck bill valve at the patient end to deliver fresh gas to the patient whilst preventing ingress of exhaled air and potential rebreathing. A one-way valve is also present at the distal end of the device, ensuring that upon squeezing the Resuscitator bag air only travels toward the patient, and upon release of a squeezed bag fresh ambient air with/without supplementary O2 is drawn in. Flexicare's Single Use Resuscitator Bags incorporate a pressure relief valve. This valve limits the pressure within the resuscitator and patient lungs to 60cmHzO (Adult) or 40cmHzO (Adult, Pediatric, Infant). One variant of Flexicare's Adult Single Use Resuscitator Bags does not feature a pressure relief valve.
Flexicare's Single Use Resuscitator Bags are comprised of disposable components including a compression bag, valves, tubing and connectors. The Single Use Resuscitator Bags are intended for Adult. Pediatric and Infant patients, are supplied non sterile and are for use by CPR-trained personnel only within a hospital and/ pre-hospital environments.
Intended Use:
Flexicare's Adult Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients with a body weight of more than 66lbs (30kg). For use with ambient air and supplemental oxygen if required. For use by CPRtrained personnel only within hospital and/ pre-hospital environments.
Flexicare's Pediatric Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of infants and children with a body weight of 22lbs to 66lbs (10-30kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital and/ pre-hospital environments.
Flexicare's Infant Single Use Resuscitator Bag is intended for manual pulmonary resuscitation and emergency respiratory support of neonates and infants with a body weight of up to 22lbs (10kg). For use with ambient air and supplemental oxygen if required. For use by CPR-trained personnel only within hospital and/ pre-hospital environments.
Substantial Equivalence:
Flexicare's Single Use Resuscitator Bags have the same intended use as the predicate devices.
Flexicare's Single Use Resuscitator Bags and the predicate devices are Single Use nonreusable devices. Supplied in Adult, Pediatric and Infant sizes.
Flexicare's Single Use Resuscitator Bags, along with their marketed predicate devices belong to FDA code BTM, and are classified as lifesaving or sustaining devices.
Patient Contact - Skin Contact & Externally Communicating - Limited duration <24hrs (less than 1hr actual use).
Neither Flexicare's Single Use Resuscitator Bags nor the predicate devices by Ambu require software to operate/function.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Flexicare. The logo is in blue and features a stylized "f" followed by the word "lexicare". Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" also in blue.
Both manufacturers' devices are able to be used with industry standard devices such as monitoring lines, face masks. ET tubes and catheter mounts.
Both Flexicare's Single Use Resuscitator Bags and the predicate devices by Ambu are designed for the same intended use in the same intended conditions.
Both manufacturers' devices consist of components made from injection molded, injection blow molded & extruded polymers.
During comparison testing it was determined that there were no invasive components in either of the manufacturer's devices.
The compression bag of Flexicare's devices is a soft TPE, whilst the compression bag of Ambu's devices is noted as SEBS. However, SEBS is a Thermoplastic Elastomer (TPE) and no substantial differences between bag performance were noted during performance testing. O2 delivering tubing of both the Flexicare and predicate devices is manufactured from PVC. Both manufacturers' device's feature a main compression bag along with a supplementary oxygen reservoir bag. Both manufacturers' device's also feature a Medication port and luer lock CO2 monitoring port at the patient end.
All conical connectors and luer lock connectors on both Flexicare and Predicate devices are compliant with ISO 5356-1:2004 and BS EN 1707:1997 respectively.
The compression bag of Flexicare's Single Use Resuscitator Bags is blue, with remaining components being blue or colorless/transparent. All caps and valves are blue in color. The compression bag of Ambu's Resuscitator bags is colorless/translucent, whilst remaining components such as connectors, valves and caps are either clear/transparent, red or white.
Any differences in color between the Flexicare devices and the predicate devices is by manufacturer's aesthetics choice/ branding, and is not related to sizing, intended use, gender of patient or performance of device.
Both manufacturer's devices are supplied with oxygen tubing, a face mask and an O₂ reservoir baq.
Both Flexicare's Single Use Resuscitator Bags and the predicate devices' O2 tubes terminate with a connector for securing to an oxygen source.
Both Flexicare's Single Use Resuscitator Bags and the predicate devices by Ambu have gripping/ securing aids, texture and branding molded into the compression bag.
Both Flexicare's Single Use Resuscitator Bags and the predicate devices by Ambu have hand straps to provide additional grip security to the user whilst in operation. The Ambu Devices have a hand strap molded as part of the compression bag, whilst the Flexicare devices feature a removable hand strap that can be adjusted to suit user.
Both devices feature a medication port at their patient end connector sealed by a soft polymer cap, through which drugs can be introduced using a needle and syringe if required. Both devices have been tested with Epinephrine, Lidocaine and Atropine.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image is a logo for Flexicare. The logo is blue and features a stylized "f" with two lines extending from the top. The word "flexicare" is written in a sans-serif font to the right of the "f" symbol. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
Substantial equivalence comparison table – Adult Resuscitator Bags
Flexicare's Adult Single Use Resuscitator Bag is substantially equivalent to SPUR II Adult Single Patient Use Resuscitator manufactured by Ambu (510(k) K042682).
The Table below shows the similarities and differences between the Flexicare's Adult Single Use Resuscitator Bags and the Adult predicate device manufactured by Ambu.
| Characteristiccompared | Flexicare's Adult Single Use ResuscitatorBag | Ambu SPUR II Adult Single Patient UseResuscitator | |
|---|---|---|---|
| 510K | K: Unknown | K:042682 | |
| Intended use | Flexicare's Adult Single Use Resuscitator Bagis intended for manual pulmonaryresuscitation and emergency respiratorysupport of adult patients with a body weightof more than 66lbs (30kg). For use withambient air and supplemental oxygen ifrequired. For use by CPR-trained personnelonly within hospital and/ pre-hospitalenvironments. | The Ambu SPUR II Adult Single Patient UseResuscitator is intended for pulmonaryresuscitation and emergency respiratorysupport of adult patients with a body weightmore than 66lbs (30kg).Source: K042682 SE letter from FDA | |
| Targetpopulation | Adult >30kg | Adult >30kg | |
| Patientconnection | Face Mask, ET tube | Face Mask, ET tube | |
| Indications foruse | Instruction leaflet | Instruction leaflet | |
| Environmentused | Hospital, Pre-hospital | Hospital, Pre-hospital | |
| Product labelling | Single Use Resuscitator Bag | Single Patient Use Resuscitator | |
| Volume (ml) | 1490ml | 1475ml | |
| O2 TubeDimensions | OD: 5.0mmID: 3.9mmLENGTH: 3.0M | OD: 5.0mmID: 3.9mmLENGTH: 2.0M | |
| Componentmaterials | Compression bag - TPEConnectors - ABSValves - SiliconeO2 Tubing - PVCReservoir bag - PVCFace mask - PVCValve spring - Stainless Steel | Compression bag - SEBS (TPE)Connectors - ABSValves - SiliconeO2 Tubing - PVCReservoir bag - PVCFace mask - PVCValve spring - Stainless Steel | |
| Maximumpressure relief(cmH2O) | Available in:60cmH2O40cmH2OPlain (no pressure relief valve) | Available in:Plain (no pressure relief valve) | |
| Available ports atpatient end | Medication port- Standard luer slip Manometer CO2 monitoring – Standard luer lock | Mediport (Medication port) – Standard luer slip Manometer CO2 monitoring – Standard luer lock | |
| Option for PEEP | Yes - 30mm Male (ISO) | Yes - 30mm Male (ISO) | |
| valve attachment | |||
| Criticaldimensions (mm) | Compression bag length: 180mmCompression bag diameter: 127mmDevice assembly length: 640.3mm | Compression bag length: 190mmCompression bag diameter: 118mmDevice assembly length: 530mm | |
| InspiratoryResistance(cmH2O) | 1.5cmH2O @ 50L/min | 2.6 cmH2O @ 50L/min | |
| ExpiratoryResistance(cmH2O) | 1.7cmH2O @ 50L/min | 3.0cmH2O @ 50L/min | |
| Force tocompress bag | 11.3N | 13N | |
| Deadspace (ml) | 4.27ml | 5.08ml | |
| Stroke Volume -One Hand (ml) | 700ml | 640ml | |
| Stroke Volume -Two Hands (ml) | 850ml | 890ml | |
| Supplied Masksize | Adult - size 5 | "Medium" | |
| Compatibilitywith theenvironment andother devices. | Compatible with ISO 5356-1:2004 and BS EN1707:1997 compliant connectors | Compatible with ISO 5356-1:2004 and BS EN1707:1997 compliant connectors | |
| Energy used andor delivered | No energy is delivered to patient. Ambientair or ambient air with supplemental O2 issupplied to the patient by manuallycompressing the device. | No energy is delivered to patient. Ambient airor ambient air with supplemental O2 issupplied to the patient by manuallycompressing the device. | |
| Sterility | Non-Sterile | Non-Sterile | |
| Standards Met | BS EN ISO 10651-4:2009ISO 10993ISO 5356-1:2004BS EN 13544-2:2002+A1:2009BS ISO 18562-2 2017 | BS EN ISO 10651-4:2002ASTM F 920-93 | |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | |
| Non-clinicalTest Results | Verification tests were performed to establish the safety and efficacy of Flexicare's AdultSingle Use Resuscitator Bag. These Non-clinical tests included Visual inspection/comparison,Dimensional inspection, Internal Volume, Valve function, Drop testing, immersion in water,oxygen concentration, expiratory resistance, inspiratory resistance, valve malfunction, tidalvolume calculation, O2 tube tensile testing, O2 tube resistance to flow, O2 tube resistance tokinking, conical connector compliance, Biocompatibility testing and Particulate emissiontesting.Testing demonstrated that the relevant features, design and performance of eachmanufacturer's device are substantially equivalent. | ||
| Conclusion | Flexicare's Adult Single Use Resuscitator Bag is considered to be substantially equivalent tothe Ambu SPUR II Adult Single Patient Use Resuscitator. The comparison of features,performance, materials and intended use demonstrate that Flexicare's Adult Single UseBesuscitator Bag is as safe and effective as the predicate device for its intended purpose. | ||
| Characteristiccompared | Flexicare's Pediatric Single Use ResuscitatorBag | Ambu SPUR II Pediatric Single Patient UseResuscitator | |
| 510K | K: Unknown | K:042843 | |
| Intended use | Flexicare's Pediatric Single Use ResuscitatorBag is intended for manual pulmonaryresuscitation and emergency respiratorysupport of infants and children with a bodyweight of 22lbs to 66lbs (10-30kg). For usewith ambient air and supplemental oxygen ifrequired. For use by CPR-trained personnelonly within hospital and/ pre-hospitalenvironments. | The Ambu SPUR II Pediatric Single Patient UseResuscitator is intended for pulmonaryresuscitation and emergency respiratorysupport of infants and children with a bodyweight up to 66lbs (30kg), approx. 9 years ofage.Source: K042843 SE letter from FDA | |
| Targetpopulation | Pediatric 10-30kg | Pediatric <30kg | |
| Patientconnection | Face Mask, ET tube | Face Mask, ET tube | |
| Indications foruse | Instruction leaflet | Instruction leaflet | |
| Environmentused | Hospital, Pre-hospital | Hospital, Pre-hospital | |
| Productlabelling | Single Use Resuscitator Bag | Single Patient Use Resuscitator | |
| Volume (ml) | 635ml | 635ml | |
| O2 TubeDimensions | OD: 5.0mmID: 3.9mmLENGTH: 3.0M | OD: 5.0mmID: 3.9mmLENGTH: 2.0M | |
| Componentmaterials | Compression bag - TPEConnectors - ABSValves - SiliconeO2 Tubing - PVCReservoir bag - PVCFace mask - PVCValve spring - Stainless Steel | Compression bag - SEBS (TPE)Connectors - ABSValves - SiliconeO2 Tubing - PVCReservoir bag - PVCFace mask - PVCValve spring - Stainless Steel | |
| Maximumpressure relief(cmH2O) | 40cmH2O | 40cmH2O | |
| Available portsat patient end | • Medication port– Standard luer slip• Manometer• CO2 monitoring – Standard luer lock | • Mediport (Medication port) –Standard luer slip• Manometer• CO2 monitoring – Standard luer lock | |
| Option for PEEPvalve | Yes - 30mm Male (ISO) | Yes – 30mm Male (ISO) | |
| attachment | |||
| Criticaldimensions(mm) | Compression bag length: 130mmCompression bag diameter: 101mmDevice assembly length: 590.3mm | Compression bag length: 130mmCompression bag diameter: 90mmDevice assembly length: 439mm | |
| InspiratoryResistance(cmH2O) | $1.5 cmH_2O$ @ 50L/min | $2.2 cmH_2O$ @ 50L/min | |
| ExpiratoryResistance(cmH2O) | $1.7cmH_2O$ @ 50L/min | $3.0cmH_2O$ @ 50L/min | |
| Force tocompress bag | 10N | 12N | |
| Deadspace (ml) | 5.01ml | 5.64ml | |
| Stroke Volume -One Hand (ml) | 450ml | 390ml | |
| Stroke Volume -Two Hands (ml) | N/A | N/A | |
| Supplied Masksize | Pediatric - size 2 | "Toddler" | |
| Compatibilitywith theenvironmentand otherdevices. | Compatible with ISO 5356-1:2004 and BS EN1707:1997 compliant connectors | Compatible with ISO 5356-1:2004 and BS EN1707:1997 compliant connectors | |
| Energy usedand ordelivered | No energy is delivered to patient. Ambient airor ambient air with supplemental O2 issupplied to the patient by manuallycompressing the device. | No energy is delivered to patient. Ambient airor ambient air with supplemental O2 issupplied to the patient by manuallycompressing the device. | |
| Sterility | Non-Sterile | Non-Sterile | |
| Standards Met | BS EN ISO 10651-4:2009ISO 10993ISO 5356-1:2004BS EN 13544-2:2002+A1:2009BS ISO 18562-2 2017 | BS EN ISO 10651-4:2002ASTM F 920-93 | |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | |
| Non-clinicalTest Results | Verification tests were performed to establish the safety and efficacy of Flexicare's Adult SingleUse Resuscitator Bag. These Non-clinical tests included Visual inspection/comparison,Dimensional inspection, Internal Volume, Valve function, Drop testing, immersion in water,oxygen concentration, expiratory resistance, inspiratory resistance, valve malfunction, tidalvolume calculation, O2 tube tensile testing, O2 tube resistance to flow, O2 tube resistance tokinking, conical connector compliance, Biocompatibility testing and Particulate emissiontesting.Testing demonstrated that the relevant features, design and performance of eachmanufacturer's device are substantially equivalent. | ||
| Conclusion | Flexicare's Pediatric Single Use Resuscitator Bag is considered to be substantially equivalent tothe Ambu SPUR II Pediatric Single Patient Use Resuscitator. The comparison of features,performance, materials and intended use demonstrate that Flexicare's Pediatric Single UseResuscitator Bag is as safe and effective as the predicate device for its intended purpose. | ||
| Characteristiccompared | Flexicare's Infant Single Use Resuscitator Bag | Ambu SPUR II Infant Single Patient UseResuscitator | |
| 510K | K: Unknown | K:042843 | |
| Intended use | Flexicare's Infant Single Use Resuscitator Bagis intended for manual pulmonaryresuscitation and emergency respiratorysupport of neonates and infants with a bodyweight of up to 22lbs (10kg). For use withambient air and supplemental oxygen ifrequired. For use by CPR-trained personnelonly within hospital and/ pre-hospitalenvironments. | The Ambu SPUR II Infant Single Patient UseResuscitator is intended for pulmonaryresuscitation and emergency respiratorysupport of neonates and infants with a bodyweight up to 22lbs (10kg)Source: K042843 SE letter from FDA | |
| Targetpopulation | Infant <10kg | Infant <10kg | |
| Patientconnection | Face Mask, ET tube | Face Mask, ET tube | |
| Indications foruse | Instruction leaflet | Instruction leaflet | |
| Environmentused | Hospital, Pre-hospital | Hospital, Pre-hospital | |
| Productlabelling | Single Use Resuscitator Bag | Single Patient Use Resuscitator | |
| Volume (ml) | 370ml | 220ml | |
| O₂ TubeDimensions | OD: 5.0mmID: 3.9mmLENGTH: 3.0M | OD: 5.0mmID: 3.9mmLENGTH: 2.0M | |
| Componentmaterials | Compression bag - TPEConnectors - ABSValves - SiliconeO₂ Tubing - PVCReservoir bag - PVCFace mask - PVCValve spring - Stainless Steel | Compression bag - SEBS (TPE)Connectors - ABSValves - SiliconeO₂ Tubing - PVCReservoir bag - PVCFace mask - PVCValve spring - Stainless Steel | |
| Maximumpressure relief(cmH₂O) | 40cmH2O | 40cmH2O | |
| Available portsat patient end | ● Medication port- Standard luer slip● Manometer● CO₂ monitoring – Standard luer lock | ● Mediport (Medication port) –Standard luer slip● Manometer● CO₂ monitoring - Standard luer lock | |
| Option for PEEPvalve | Yes - 30mm Male (ISO) | Yes - 30mm Male (ISO) | |
| attachment | |||
| Criticaldimensions(mm) | Compression bag length: 100mmCompression bag diameter: 87.7mmDevice assembly length: 444.3mm | Compression bag length: 75mmCompression bag diameter: 67mmDevice assembly length: 417mm | |
| InspiratoryResistance(cmH2O) | 0.4 cmH2O @ 5L/min | 0.5 cmH2O @ 5L/min | |
| ExpiratoryResistance(cmH2O) | 0.9cmH2O @ 5L/min | 1.6cmH2O @ 5L/min | |
| Force tocompress bag | 10N | 12N | |
| Deadspace (ml) | 4.46ml | 5.64ml | |
| Stroke Volume -One Hand (ml) | 170ml | 110ml | |
| Stroke Volume -Two Hands (ml) | N/A | N/A | |
| Supplied Masksize | Infant - size 0 | "Neonate" | |
| Compatibilitywith theenvironmentand otherdevices. | Compatible with ISO 5356-1:2004 and BS EN1707:1997 compliant connectors | Compatible with ISO 5356-1:2004 and BS EN1707:1997 compliant connectors | |
| Energy usedand ordelivered | No energy is delivered to patient. Ambient airor ambient air with supplemental O2 issupplied to the patient by manuallycompressing the device. | No energy is delivered to patient. Ambient airor ambient air with supplemental O2 issupplied to the patient by manuallycompressing the device. | |
| Sterility | Non-Sterile | Non-Sterile | |
| Standards Met | BS EN ISO 10651-4:2009ISO 10993ISO 5356-1:2004BS EN 13544-2:2002+A1:2009BS ISO 18562-2 2017 | BS EN ISO 10651-4:2002ASTM F 920-93 | |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | |
| Non-clinicalTest Results | Verification tests were performed to establish the safety and efficacy of Flexicare's Adult SingleUse Resuscitator Bag. These Non-clinical tests included Visual inspection/comparison,Dimensional inspection, Internal Volume, Valve function, Drop testing, immersion in water,oxygen concentration, expiratory resistance, inspiratory resistance, valve malfunction, tidalvolume calculation, O2 tube tensile testing, O2 tube resistance to flow, O2 tube resistance tokinking, conical connector compliance, Biocompatibility testing and Particulate emissiontesting.Testing demonstrated that the relevant features, design and performance of eachmanufacturer's device are substantially equivalent.Flexicare's Infant Single Use Resuscitator Bag is considered to be substantially equivalent to theAmbu SPUR II infant Single Patient Use Resuscitator. The comparison of features, performance,materials and intended use demonstrate that Flexicare's Infant Single Use Resuscitator Bag is assafe and effective as the predicate device for its intended purpose. |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image is a logo for Flexicare. The logo is blue and features a stylized "f" with three curved lines. Below the logo is the text "TOTAL QUALITY - TOTAL CARE".
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image is a logo for Flexicare. The logo is blue and features a stylized "f" with two lines extending from the top. The word "flexicare" is written in a sans-serif font to the right of the "f" symbol. Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
Substantial equivalence comparison table – Pediatric Resuscitator Bags
Flexicare's Pediatric Single Use Resuscitator Bag is substantially equivalent to SPUR II Pediatric Single Patient Use Resuscitator manufactured by Ambu (510(k) K042843).
The Table below shows the similarities and differences between the Flexicare's Pediatric Single Use Resuscitator Bags and the Pediatric predicate device manufactured by Ambu.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image is a logo for "Flexicare". The logo is blue and features a stylized "F" symbol on the left side. Below the word "Flexicare" is the text "TOTAL QUALITY - TOTAL CARE".
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image is a logo for Flexicare. The logo is blue and features a stylized "f" followed by the word "lexicare". Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
Substantial equivalence comparison table – Infant Resuscitator Bags
Flexicare's Infant Single Use Resuscitator Bag is substantially equivalent to SPUR II Infant Single Patient Use Resuscitator manufactured by Ambu (510(k) K042843).
The Table below shows the similarities and differences between the Flexicare's Infant Single Use Resuscitator Bags and the Infant predicate device manufactured by Ambu.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image is a logo for "Flexicare". The logo is blue and features a stylized "f" symbol made of three curved lines. Below the logo is the text "TOTAL QUALITY - TOTAL CARE" in a smaller font, also in blue. The logo is clean and modern, and the text emphasizes the company's commitment to quality and care.
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "f" followed by the word "lexicare". Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font. The logo is clean and modern, and the blue color gives it a sense of trustworthiness and reliability.
Summary of performance Testing: Flexicare's Single Use Resuscitator Bags have been evaluated in accordance with standards listed in table:
| Test | Standard / Pre-DeterminedAcceptance Criteria | Outcome |
|---|---|---|
| Visual inspection | Comparison test | Substantiallyequivalent |
| Valve Function after contamination with vomitus | BS EN ISO 10651-4:2009 | Pass |
| Mechanical shock - Drop testing | ||
| Immersion in Water | ||
| Supplementary Oxygen & Delivered OxygenConcentration | ||
| Expiratory Resistance | ||
| Inspiratory Resistance | ||
| Patient Valve Malfunction | ||
| Tidal Volume - Minimum Delivered Volume | ||
| Pressure Limitation - Pressure Relief Blow off | ||
| Conical Connector compliance | ISO 5356-1:2004 | Pass |
| Leak testing | ||
| Drop testing | ||
| Cytotoxicity, Irritation, Sensitization, SystemicToxicity, Extractables & Leachables. | ISO 10993-10:2010ISO 10993-5:2009ISO 10993-11:2009ISO 10993-17:2009 | Pass |
| Tubing resistance to gas flow | BS EN 13544-2:2002+A1:2009 | Pass |
| Tensile strength – connector to tubing | ||
| Tensile strength – connector to O2 spout | ||
| Resistance to kinking | ||
| Accelerated Ageing | ASTM F1980 | Pass |
| Particulate Emissions | BS ISO 18562-2 2017 | Pass |
Flexicare's Single Use Resuscitator Bags passed the performance testing when tested against methods and criteria from both pre-determined acceptance criteria methods and relevant FDA Recognized standards. The results of this testing show that Flexicare's Single Use Resuscitator Bags pass all performance tests and perform substantially equivalent to the marketed predicate devices.
Consensus Standards
ISO 10651-4 and ISO 5356-1 are recognized consensus standards for devices classified through FDA product code BTM.
The Flexicare Single Use Resuscitator Bags passed the performance testing when tested against methods and criteria from relevant FDA Recognized standards. The results of this testing show that The Flexicare Single Use Resuscitator Bags passes all performance & safety tests and perform substantially equivalent to the marketed predicate devices.
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "f" symbol made of three curved lines. To the right of the symbol is the word "lexicare" in a sans-serif font. Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Although very similar in design and function there are some differences, as described below, between the Flexicare's Single Use Resuscitator Bags and the predicate devices from Ambu.
Differences:
- The Flexicare Single Use Resuscitator Bags feature an adjustable hand strap to aid in ● securing the device to user's hands of varying sizes. The Ambu Single Use Resuscitators feature a 1-piece molded strap that is integral to the compression bag.
- . The Flexicare Single Use Resuscitator Bags consist of clear/colorless and blue components whereas the Ambu devices consist of clear/colorless, white and red components. However, this difference in color is due to manufacturer branding and in no way reflects sizing, intended use, gender of patient or performance of device.
- Both manufacturer's offer devices with lockable pressure relief valves. However, The . Flexicare Single Use Resuscitator Bags feature a compress & twist action to lock the valve whereas the Ambu devices use a pivoted lever to lock the valve in closed position.
- . Both manufacturer's devices feature inlet connectors for supplementary oxygen. However, the Ambu devices feature their oxygen inlet connectors at a 90° angle to the horizontal plane of the device. Flexicare's Single Use Resuscitator Bags oxygen inlet connectors are in line with the horizontal plane of the device.
- . The Flexicare Single Use Resuscitator Bags feature a 3M O2 line whilst the Ambu Single Use Resuscitators feature a 2M O2 line. This difference does not contribute towards device performance. However, the extra 1M length could be seen as a usability advantage to Flexicare's devices.
Conclusion: The overall conclusion from the comparison testing is that Flexicare Single Use Resuscitator Bags are considered to be substantially equivalent to those of the predicate devices manufactured by Ambu, and that Flexicare's Single Use Resuscitator Bags perform substantially equivalent to the marketed predicate devices.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).