(175 days)
Not Found
No
The device description and performance studies focus on mechanical components and standard performance metrics for manual resuscitators, with no mention of AI or ML.
Yes
The device is intended for manual pulmonary resuscitation and emergency respiratory support, which involves providing a therapeutic intervention for patients with inadequate or no breathing.
No
The device is a resuscitator bag used for manual pulmonary resuscitation, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components like a compression bag, valves, tubing, and connectors, and the performance studies focus on physical characteristics and functionality, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Flexicare Single Use Resuscitator Bag is a mechanical device used for manual ventilation, directly assisting a patient's breathing. It does not analyze any biological samples.
- Intended Use: The intended use clearly states "manual pulmonary resuscitation and emergency respiratory support," which is a direct intervention on the patient's respiratory system, not an in vitro test.
Therefore, the Flexicare Single Use Resuscitator Bag falls under the category of a medical device used for direct patient care, not an IVD.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
BTM
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary
Indicated Patient Age Range
Adult: more than 66lbs (30kg)
Infants and children: 22lbs to 66lbs (10-30kg)
Neonates and infants: up to 22lbs (10kg)
Intended User / Care Setting
CPR-trained personnel only within hospital environments.
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)
Verification tests were performed to establish the safety and efficacy of Flexicare's Adult Single 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, tidal volume calculation, O2 tube tensile testing, O2 tube resistance to flow, O2 tube resistance to kinking, conical connector compliance, Biocompatibility testing and Particulate emission testing.
Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent.
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.
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
§ 868.5915 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).
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) |
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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 30kg | Adult >30kg | |
| Patient
connection | Face Mask, ET tube | Face Mask, ET tube | |
| Indications for
use | Instruction leaflet | Instruction leaflet | |
| Environment
used | Hospital, Pre-hospital | Hospital, Pre-hospital | |
| Product labelling | Single Use Resuscitator Bag | Single Patient Use Resuscitator | |
| Volume (ml) | 1490ml | 1475ml | |
| O2 Tube
Dimensions | OD: 5.0mm
ID: 3.9mm
LENGTH: 3.0M | OD: 5.0mm
ID: 3.9mm
LENGTH: 2.0M | |
| Component
materials | Compression bag - TPE
Connectors - ABS
Valves - Silicone
O2 Tubing - PVC
Reservoir bag - PVC
Face mask - PVC
Valve spring - Stainless Steel | Compression bag - SEBS (TPE)
Connectors - ABS
Valves - Silicone
O2 Tubing - PVC
Reservoir bag - PVC
Face mask - PVC
Valve spring - Stainless Steel | |
| Maximum
pressure relief
(cmH2O) | Available in:
60cmH2O
40cmH2O
Plain (no pressure relief valve) | Available in:
Plain (no pressure relief valve) | |
| Available ports at
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 PEEP | Yes - 30mm Male (ISO) | Yes - 30mm Male (ISO) | |
| valve attachment | | | |
| Critical
dimensions (mm) | Compression bag length: 180mm
Compression bag diameter: 127mm
Device assembly length: 640.3mm | Compression bag length: 190mm
Compression bag diameter: 118mm
Device assembly length: 530mm | |
| Inspiratory
Resistance
(cmH2O) | 1.5cmH2O @ 50L/min | 2.6 cmH2O @ 50L/min | |
| Expiratory
Resistance
(cmH2O) | 1.7cmH2O @ 50L/min | 3.0cmH2O @ 50L/min | |
| Force to
compress 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 Mask
size | Adult - size 5 | "Medium" | |
| Compatibility
with the
environment and
other devices. | Compatible with ISO 5356-1:2004 and BS EN
1707:1997 compliant connectors | Compatible with ISO 5356-1:2004 and BS EN
1707:1997 compliant connectors | |
| Energy used and
or delivered | No energy is delivered to patient. Ambient
air or ambient air with supplemental O2 is
supplied to the patient by manually
compressing the device. | No energy is delivered to patient. Ambient air
or ambient air with supplemental O2 is
supplied to the patient by manually
compressing the device. | |
| Sterility | Non-Sterile | Non-Sterile | |
| Standards Met | BS EN ISO 10651-4:2009
ISO 10993
ISO 5356-1:2004
BS EN 13544-2:2002+A1:2009
BS ISO 18562-2 2017 | BS EN ISO 10651-4:2002
ASTM F 920-93 | |
| Biocompatibility | ISO 10993 compliant | ISO 10993 compliant | |
| Non-clinical
Test Results | Verification tests were performed to establish the safety and efficacy of Flexicare's Adult
Single 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, tidal
volume calculation, O2 tube tensile testing, O2 tube resistance to flow, O2 tube resistance to
kinking, conical connector compliance, Biocompatibility testing and Particulate emission
testing.
Testing demonstrated that the relevant features, design and performance of each
manufacturer's device are substantially equivalent. | | |
| Conclusion | Flexicare's Adult Single Use Resuscitator Bag is considered to be substantially equivalent to
the Ambu SPUR II Adult Single Patient Use Resuscitator. The comparison of features,
performance, materials and intended use demonstrate that Flexicare's Adult Single Use
Besuscitator Bag is as safe and effective as the predicate device for its intended purpose. | | |
| Characteristic
compared | Flexicare's Pediatric Single Use Resuscitator
Bag | Ambu SPUR II Pediatric Single Patient Use
Resuscitator | |
| 510K | K: Unknown | K:042843 | |
| Intended use | 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. | The Ambu SPUR II Pediatric Single Patient Use
Resuscitator is intended for pulmonary
resuscitation and emergency respiratory
support of infants and children with a body
weight up to 66lbs (30kg), approx. 9 years of
age.
Source: K042843 SE letter from FDA | |
| Target
population | Pediatric 10-30kg | Pediatric