(147 days)
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation. Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O. Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.
The document provided is a 510(k) Premarket Notification for the Flexicare Single Use Manometer. It describes the device, its intended use, and compares it to a legally marketed predicate device (Ambu Disposable Pressure Manometer, K040991) to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Accuracy | ± 1 cm H₂O at 20, 40, 60 cm H₂O | Pass |
| Repeatability | Within accuracy tolerance (Graduation print and manometer slider overlap at each marked pressure graduation) | Pass |
| Leak Testing | No standard criteria available; Test for comparative use only (<1 ml/min stated in comparison table) | Comparable performance outcome between Flexicare's device and the predicate devices (Achieved <1 ml/min) |
| Drop Testing | ISO 10651-4: 2009 (within accuracy tolerance; mechanical integrity) | Pass |
| Visual Inspection | Samples free from any damage or defects (as per detailed methodology) | Pass |
| Cytotoxicity | ISO 10993-5:2009 | Pass |
| Irritation, Sensitization, Systemic toxicity, Extractables & Leachables | ISO 10993 compliant; ISO 10993-11:2009; ISO 10993-17:2009 | Pass |
| Particulate emissions (gas pathway) | EN ISO 18562-2:2017 | Pass |
| Accelerated Ageing | ASTM F1980 | Pass |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for each specific test in the test set. However, for "Visual Inspection," the methodology mentions "Inspect the packaging of each sample." For "Degree of Accuracy and Repeatability," it states, "Repeat step 1 - 7 a further 4 times at each pressure marking," implying multiple measurements on at least one device, or potentially multiple devices.
The data provenance is not specified in terms of country of origin, but the sponsor is Flexicare Medical Limited in the United Kingdom. The studies are retrospective as they are internal verification tests conducted by the manufacturer to demonstrate substantial equivalence to an existing device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device (a single-use manometer) does not typically involve expert review for establishing ground truth in performance testing. The "ground truth" for physical characteristics and performance (like accuracy, leak rate) is established through standardized physical measurements using calibrated equipment. Therefore, this information is not applicable to the context of this device and testing.
4. Adjudication method for the test set
Not applicable. As described above, the testing involves objective physical measurements against defined criteria and standards, not subjective assessments requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical medical device (manometer) for measuring airway pressure, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a purely mechanical device and does not involve any algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance tests for the manometer predominantly relied on reference measurements from calibrated equipment (e.g., digital pressure indicators, syringes for controlled pressure generation) and adherence to established national/international standards (e.g., ISO 10651-4, ISO 10993 series, EN ISO 18562-2, ASTM F1980). For tests without a specific standard (e.g., Leak Testing had no standard criteria available, used for comparative purposes), the ground truth for "pass" was determined by the manufacturer's pre-determined acceptance criteria and comparison to the predicate device's reported performance.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning or AI algorithm, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Flexicare Medical Limited Joel Biddle Regulatory Manager Cynon Valley Business Park Mountain Ash, cf45 4er United Kingdom
Re: K201666
Trade/Device Name: Single Use Manometer Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: Class II Product Code: CAP Dated: October 12, 2020 Received: October 15, 2020
Dear Joel Biddle:
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 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
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devices or post marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Brandon Blakely, PhD Assistant Director (Acting) DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201666
Device Name Single Use Manometer
Indications for Use (Describe)
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
| 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/0 description: The image is a logo for "flexicare". The logo is in blue and consists of a stylized "f" followed by the word "lexicare". Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE".
510(k) Summary
510(k) Sponsor, Contact Person and Date Summary Prepared:
Flexicare Medical Limited Cynon Valley Business Park Mountain Ash. CF45 4ER. United Kingdom
Joel Biddle Requlatory Manager Telephone: 00 44 1443 474 647 Fax: 00 44 1443 474 222
Summary prepared on: November 13th, 2020
Device Name:
Trade Name: Single Use Manometer
Common/Usual Name: Airway Pressure Monitor
Classification Name: Airway Pressure Monitor: 21 CFR. 868.2600
Product Codes: CAP (Airway Pressure Monitor)
Legally Marketed Equivalent Device:
Flexicare's Single Use Manometer is substantially equivalent to Ambu Disposable Pressure Manometer, cleared under K040991.
Device Description:
Flexicare's Single Use Manometer is a single use device that can be attached to the manometer port on resuscitation bags to provide visual indication of the patient's airway pressure during manual ventilation.
Flexicare's Single Use Manometer consists of end cap, clear housing with printed pressure scale, concertina seal, slider and stainless steel spring. When pressure rises, the spring is compressed raising the blue concertina seal and showing the pressure via markings on the manometer housing has calibrated marking at 20 cmH2O intervals between 0 through 60 cmH2O. The measured pressures are accurate to ± 1cmH2O.
Flexicare's Single Use Manometer is supplied non-sterile and are for use by CPR-trained personnel only within a hospital and/or pre-hospital environments.
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Image /page/4/Picture/0 description: The image is a logo for "flexicare". The logo is in 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 tagline "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Indications For Use:
Flexicare Single Use Manometer is attached to the manometer port on Flexicare resuscitation bags to provide visual indication of the patient's airway pressure during ventilation. The device is intended to be used by trained personnel only within a hospital and/or pre-hospital environment.
Substantial Equivalence:
Flexicare's Single Use Manometer has the same intended use as the predicate device.
Flexicare's Single Use Manometer and the predicate device are Single Use non-reusable devices.
Flexicare's Single Use Manometer, along with its marketed predicate device belongs to FDA code CAP and are not classified as a lifesaving or sustaining device.
Patient Contact – Externally Communicating – Limited duration <24hrs (less than 1hr actual use).
Neither Flexicare's Single Use Manometer nor the predicate device by Ambu require software to operate/function.
Neither Flexicare's Single Use Manometer nor the predicate device by Ambu require connection to an electronically powered device.
Both Flexicare's Single Use Manometer and the predicate device by Ambu are available nonsterile (in individually sealed polybags).
Both manufacturers' devices consist of components made from injection molded polymers and the housings of each are made from very similar amorphous polymers, providing a very hard, transparent shell.
During comparison inspections it was determined that there were no invasive components in either of the manufacturer's devices.
Neither manufacturer's devices are in vitro diagnostic devices.
The housing of Flexicare's Single Use Manometer is mostly opaque white, with the pressure markings panel being colorless. The end cap is blue color. The Ambu Disposable Pressure Manometer has white cap and color coded pressure markings (green, yellow and red).
Any differences in color between the Flexicare devices and the predicate device is by manufacturer's aesthetics choice/ branding, and is not related to standard criteria, sizing, intended use, gender of patient or performance of device.
Both manufacturer's devices are available non-sterile only.
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Image /page/5/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "f" with three curved lines above it. The word "flexicare" is written in lowercase letters to the right of the "f". Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller letters.
Substantial equivalence comparison table – Flexicare's Single Use Manometer
Flexicare's Single Use Manometer is substantially equivalent to the Ambu Disposable Pressure Manometer, manufactured by Ambu cleared under (510(k) K040991).
The table below shows the similarities and differences between the Flexicare's Single Use Manometer and the predicate device manufactured by Ambu.
| Flexicare's Single Use Manometer | Ambu Disposable Pressure Manometer | |
|---|---|---|
| 510(k) | K201666 | K040991 |
| Intended Use | Flexicare Single Use Manometer is attachedto the manometer port on Flexicareresuscitation bags to provide visualindication of the patient's airway pressureduring ventilation. The device is intended tobe used by trained personnel only within ahospital and/or pre-hospital environment. | Ambu Disposable Pressure Manometerwill be used to provide visual indication ofthe patient's airway pressure duringventilation. It may be attached to themanometer port on ventilation devicessuch as resuscitation bags, hyperinflationbags, CPAP mask or CPAP circuits.Source: K040991 510(k) summary |
| Target | Patient that the clinician desires to monitor | Unspecified |
| population | or measure pressure - Adult, Pediatric,Infant | |
| Product Labelling | Single Use Manometer for use with ManualResuscitator | Ambu ® Disposable Pressure Manometer |
| Patient Contact | External Communicating | External Communicating |
| Patientuse/Duration ofuse | Single use, disposable, <24hrs | Single use, disposable, <24hrs |
| Connects to a | It may be attached to the manometer port | It may be attached to the manometer port |
| sampling port ofany device | on Flexicare resuscitation bags. | on ventilation devices such asresuscitation bags, hyperinflation bags,CPAP mask or CPAP circuits. |
| Supplied sterile | Non-sterile | Non-sterile |
| Componentmaterials | End Cap - PVCConcertina Seal - SiliconeSlider - ABSSpring - Stainless SteelHousing - ABSOuter Shrink Sleeve - PVC | Connector - SEBSSpring - CuSnHousing - SBPiston - PPMembrane - Silicone(Source: Ambu Datasheet) |
| Connector sıze | ID 5.3mm | ID 3.7mm |
| Color coded | Not color coded | Color coded:● Green: 0 - 20 cmH2O● Yellow: 20 - 40 cmH2O● Red: 40 - 60 cmH2O |
| Pressure range | 0 - 60 cmH2O | 0 - 60 cmH2O |
| Displayincrement | 20, 40, 60 cmH2O | 5, 10, 15, 20, 30, 40, 60 cmH2O |
| Method oftranslating in-linepressure | Displacement of concertina seal againstspring (counter force) | Displacement of diaphragm against spring(counter force) |
| Indicatormovement | Linear, force pushes the center of concertinaseal and extends upward until lines up withpressure indicator label | Linear, force pushes the center ofdiaphragm, which extends upward untillines up with pressure indicator label |
| Pressure marking | Printed on outer shrink sleeve and wraparound housing | Pressure increment - tampo printedColor coding - sticker |
| Performancetesting | Accuracy• ± 1 cm H2O at 20, 40, 60cm H2O | Accuracy (source: Ambu IFU)• ± 2 cm H2O at 5, 10, 15, 20, 30 cm H2O• ± 3 cm H₂O at 40 cm H₂O• ± 5 cm H2O at 60 cm H2O |
| Leak testing | <1 ml/min | <2 ml/min |
| Repeatability | Passed - within accuracy tolerance | Passed - within accuracy tolerance |
| Environmentaltesting | Passed environmental testing at -40°C and+60°C according to ISO 10651-4:2009 | Tested at -40°C and +60°C according to ENISO 10651-4 (source: Ambu IFU) |
| Drop test | Passed - within accuracy toleranceMechanical integrity - passed | Passed – within accuracy toleranceMechanical integrity – one damaged |
| Shelf Life | 5 years | 5 years |
| Packaging | Polybag | Polybag |
| Standards met | ISO 10993-1ISO 18562-2ISO 10651-4 | 510(K) Summary does not specify |
| Biocompatibility | ISO 10993 compliantEN ISO 18562 compliant | Not stated |
| Non-clinicalTest Results | Verification tests were performed on Flexicare's Single Use Manometer. These Non-clinical tests included Visual Inspection/Comparison, Degree of Accuracy, Repeatability,Drop Testing, Leak Testing, Shelf Life Verification, Biocompatibility and ParticulateEmission. Testing demonstrated that the relevant features, design and performance ofeach manufacturer's device are substantially equivalent. | |
| Conclusion | Flexicare's Single Use Manometer is considered to be substantially equivalent to theAmbu Disposable Pressure Manometer. The comparison of each device's features,performance, materials, intended use and intended purpose demonstrate this |
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Image /page/6/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized letter "f" made of three curved lines. To the right of the "f" is the word "lexicare" in a sans-serif font, also in blue. Below the word "lexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in a smaller, sans-serif font.
Summary of Performance Testing: Flexicare's Single Use Manometer has been evaluated in accordance with standards listed in table:
| Test | Standard / Pre-Determined AcceptanceCriteria | Outcome |
|---|---|---|
| Visual Inspection | Pre-determined Acceptance Criteria* | Pass |
| Degree of Accuracy | Pre-determined Acceptance Criteria* | Pass |
| Repeatability | Pre-determined Acceptance Criteria* | Pass |
| Leak testing | Pre-determined Acceptance Criteria* | No pass criteria -Comparable performanceoutcome betweenFlexicare's device and thepredicate devices |
| Drop testing | ISO 10651-4: 2009 | Pass |
| Drop testing | ISO 10993-10:2010 | Pass |
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Image /page/7/Picture/0 description: The image shows the logo for Flexicare. The logo is blue and features a stylized "f" with three curved lines above it. The word "flexicare" is written in lowercase letters to the right of the "f". Below the word "flexicare" is the phrase "TOTAL QUALITY - TOTAL CARE" in smaller letters.
| Cytotoxicity, Irritation, Sensitization,Systemic toxicity, Extractables &Leachables. | ISO 10993-5:2009 | Pass |
|---|---|---|
| ISO 10993-11:2009 | Pass | |
| ISO 10993-17:2009 | Pass | |
| Particulate emissions (gas pathway) | EN ISO 18562-2:2017 | Pass |
| Accelerated Ageing | ASTM F1980 | Pass |
* Pre-determined Acceptance Criteria - Visual inspection
Criteria: Samples are free from any damage or defects.
Methodology: Inspect the packaging of each sample for any damage or defects present, including but not limited to punctures or tears, damaged or misprinted markings, contamination or foreign matter in bag material, dirty marks or foreign matter inside the bag and thinning of bag material. Remove the samples from their packaging and inspect for (but not limited to) missing components, incorrect or damaged print, incorrectly positioned sleeve, damaged or deformed spring, blockages inside body, excess molding flash on critical surfaces (e.g. inner wall of body. PVC connector), components not fitting together correctly, discoloration or print / components, correct color of parts (Refer to GA assembly drawing), foreign matter and unable to fit securely to a resus bag. Note any issues and record the result.
* Pre-determined Acceptance Criteria - Degree of Accuracy and Repeatability
Criteria: Graduation print and manometer slider overlap at each marked pressure graduation.
Methodology: Connect the digital pressure indicator and Syringe via a T-Piece. Set the Digital Pressure meter to mHzO. Zero the DPI at atmospheric pressure. Connect the T-Piece. Increase the pressure by depressing the syringe plunger to the required pressure graduations marked on the manometer body. At each pressure graduation inspect the manometer slider and check it aligns with the pressure graduation on the manometer housing. Release the pressure and check that the piston returns smoothly back to the original start position. Repeat step 1 - 7 a further 4 times at each pressure marking.
* Pre-determined Acceptance Criteria - Leak Testing
Criteria: There is no standard criteria available. Test is for comparative use only.
Methodology: Connect the digital pressure indicator and Syringe via a T-Piece. Set the Digital Pressure meter to mH2O. Zero the DPI at atmospheric pressure. Connect the T-Piece. Depress the syringe plunger to raise the internal pressure of the filter to 65cmH2O. Note the initial volume of the syringe and begin timing. Maintain the pressure at 65cmH2O for 1 minute, by adding air as necessary with the syringe. After one minute, note the new volume of the syringe. Calculate the leakage rate per minute: Leakage (ml/min) = Initial Volume (ml) = New Volume (ml)
Flexicare's Single Use Manometer 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 Manometer passes all performance tests and perform at least as well as the marketed predicate device.
Consensus Standards
There is no recognized consensus standard for devices classified through FDA product code CAP.
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Image /page/8/Picture/0 description: The image shows the logo for "flexicare". The logo is blue and features a stylized "f" with three curved lines above it. Below the word "flexicare" is the text "TOTAL QUALITY - TOTAL CARE" in a smaller font.
Device differences
Although very similar in design and function there are some differences, as described below, between the Flexicare's Single Use Manometer and the predicate device from Ambu.
Differences:
- . The housing of Flexicare's Single Use Manometer is mostly opaque white, with the pressure markings panel being colorless. The end cap is blue color. The Ambu Disposable Pressure Manometer has green, yellow and red color coded scale and white cap. However, this difference in color is due to manufacturer branding and in no way reflects standard criteria, sizing, intended use, gender of patient or performance of device. The color coded scale on Ambu Disposable Pressure Manometer is only for visual support. The correct ventilation pressure must be determined by the medical professional.
- . Flexicare's Single Use Manometer has calibrated marking at 20 cmH2O intervals, whereas Ambu Disposable Pressure Manometer has calibrated marking at 5, 10, 15, 20, 30, 40, 60 cmH2O.
- . Flexicare's Single Use Manometer has pressure marking printed on outer shrink sleeve and wrap around housing whereas the pressure increment on Ambu Disposable Pressure Manometer is tampo printed and the color coding is printed on a sticker.
- . The internal diameter of connector in Flexicare's Single Use Manometer is 5.3mm whilst Ambu Disposable Pressure Manometer features a connector with 3.7mm internal diameter. However, there is no standard requirement for the connector dimension of manometer. Flexicare's Single Use Manometer is only designed to be attached to the manometer port on Flexicare resuscitation bags. According to Ambu IFU. Ambu Disposable Pressure Manometer can be attached to the manometer port on ventilation devices such as resuscitation bags, hyperinflation bags, CPAP mask or CPAP circuits.
- . The size of Flexicare's Single Use Manometer (length 43.6mm, diameter 21mm) is slightly smaller than Ambu Disposable Pressure Manometer (length 55mm, diameter 22mm). However, there is no standard requirement for the specific length of manometer. This difference in dimension did not impact on devices ability to perform to a comparative level when conducting substantial equivalence testing within CTR-000006 test report.
Conclusion:
The overall conclusion from the comparison testing is that Flexicare's Single Use Manometer is considered to be substantially equivalent to the predicate device manufactured by Ambu. and that Flexicare's Single Use Manometer performs at least as well as the marketed predicate device.
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).