Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20

Q: Who is the manufacturer of Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20?

Flexicare Medical Limited. filed the 510(k) submission for Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 (K181583).

Q: What is the FDA product code for Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20?

BTM. It is classified under 21 CFR 868.5915 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20?

Ambu SPUR II Adult Single Patient Use Resuscitator (K042682); Ambu SPUR II Pediatric Single Patient Use Resuscitator (K042843); Ambu SPUR II Infant Single Patient Use Resuscitator (K042843).

Q: Who can help prepare an FDA 510(k) submission like Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K181583 · Flexicare Medical Limited. · BTM · Dec 7, 2018 · Anesthesiology

Device Facts

Record ID	K181583
Device Name	Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
Applicant	Flexicare Medical Limited.
Product Code	BTM · Anesthesiology
Decision Date	Dec 7, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5915
Device Class	Class 2
Attributes	Therapeutic, Pediatric, 3rd-Party Reviewed

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 CPR-trained 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.

Device Story

Manual pulmonary resuscitator; provides emergency respiratory support via manual compression of a bag. Input: ambient air or supplemental oxygen. Operation: user squeezes compression bag; one-way duck bill valve delivers gas to patient; one-way valve at distal end draws in fresh gas upon release; pressure relief valve limits airway pressure. Output: delivered tidal volume to patient lungs via face mask or airway tube. Used in hospital/pre-hospital settings by CPR-trained personnel. Benefits: provides short-term ventilation for patients with inadequate or no breathing. Includes medication port and CO2 monitoring luer lock. Features adjustable hand strap for grip security.

Clinical Evidence

Bench testing only. Performance verified against pre-determined acceptance criteria and FDA-recognized standards (ISO 10651-4, ISO 5356-1, ISO 10993, BS EN 13544-2, BS ISO 18562-2). Tests included valve function, drop testing, oxygen concentration, inspiratory/expiratory resistance, tidal volume, pressure relief, and biocompatibility (cytotoxicity, irritation, sensitization). All tests passed.

Technological Characteristics

Manual resuscitator; non-sterile, single-use. Materials: TPE (compression bag), ABS (connectors), Silicone (valves), PVC (tubing/mask/reservoir), Stainless Steel (valve spring). Connectivity: None. Standards: ISO 10651-4:2009, ISO 5356-1:2004, ISO 10993, BS EN 13544-2:2002+A1:2009, BS ISO 18562-2 2017. Features pressure relief valve (40/60 cmH2O or plain).

Indications for Use

Indicated for manual pulmonary resuscitation and emergency respiratory support. Adult: >30kg. Pediatric: 10-30kg. Infant: <10kg. For use by CPR-trained personnel in hospital or pre-hospital settings.

Regulatory Classification

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.

Predicate Devices

Ambu SPUR II Adult Single Patient Use Resuscitator (K042682)
Ambu SPUR II Pediatric Single Patient Use Resuscitator (K042843)
Ambu SPUR II Infant Single Patient Use Resuscitator (K042843)

Related Devices

K963848 — MANUAL RESUSCITATOR · Owens-Brigam Medical Co. · Jul 7, 1997
K021390 — PMX COMPACT RESUCITATOR · Cheen Houng Ent. Co. , Ltd. · Oct 4, 2002
K102824 — AMBU OVAL SILICONE RESUSCITATOR, ADULT AND PEDIATRIC · Ambu A/S · Jan 28, 2011
K031434 — BAWMED E-Z BAG RESUSCITATOR · Bawmed UK · Feb 6, 2004
K970756 — MERCURY MEDICAL REUSABLE CPR BAG · Mercury Medical · Oct 31, 1997

Submission Summary (Full Text)

{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) | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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. | Characteristic compared | Flexicare's Adult Single Use Resuscitator Bag | Ambu SPUR II Adult Single Patient Use Resuscitator | | |-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 510K | K: Unknown | K:042682 | | | 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 CPR-trained personnel only within hospital and/ pre-hospital environments. | The Ambu SPUR II Adult Single Patient Use Resuscitator is intended for pulmonary resuscitation and emergency respiratory support of adult patients with a body weight more than 66lbs (30kg). Source: K042682 SE letter from FDA | | | Target population | Adult >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 <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) | 635ml | 635ml | | | 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) | 40cmH2O | 40cmH2O | | | Available ports at patient end | • Medication port– Standard luer slip • Manometer • CO2 monitoring – Standard luer lock…