(147 days)
Not Found
No
The device description details a purely mechanical manometer that uses a spring and seal to indicate pressure. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device provides a visual indication of airway pressure during ventilation, which is a diagnostic or monitoring function, not a direct therapeutic intervention. It helps in managing ventilation but does not directly treat a condition.
Yes
This device provides a visual indication of a patient's airway pressure, which can be used to assess and monitor a physiological state (airway pressure) during ventilation. While it doesn't diagnose a disease, it provides data that aids in clinical assessment and decision-making for patient care.
No
The device description explicitly details physical components (end cap, clear housing, concertina seal, slider, stainless steel spring) and mechanical operation (spring compression, seal raising) to provide pressure indication. This is a hardware device, not software.
Based on the provided information, the Flexicare Single Use Manometer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Flexicare Single Use Manometer is used to measure pressure within the patient's airway during ventilation, which is a direct measurement of a physiological parameter, not an analysis of a biological sample.
- The intended use clearly states it provides "visual indication of the patient's airway pressure during ventilation." This is a monitoring function, not a diagnostic test performed on a sample.
- The device description details mechanical components and pressure measurement. There is no mention of reagents, assays, or any process involving the analysis of biological specimens.
Therefore, the Flexicare Single Use Manometer falls under the category of a medical device used for monitoring or treatment, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CAP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult, Pediatric, Infant
Intended User / Care Setting
trained personnel only within a hospital and/or pre-hospital environment.
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 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 Particulate Emission. Testing demonstrated that the relevant features, design and performance of each manufacturer's device are substantially equivalent.
Summary of Performance Testing: Flexicare's Single Use Manometer has been evaluated in accordance with standards listed in table:
- Visual Inspection: Pass
- Degree of Accuracy: Pass
- Repeatability: Pass
- Leak testing: Comparable performance outcome between Flexicare's device and the predicate devices
- Drop testing (ISO 10651-4: 2009): Pass
- Drop testing (ISO 10993-10:2010): Pass
- Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Extractables & Leachables (ISO 10993-5:2009, ISO 10993-11:2009, ISO 10993-17:2009): Pass
- Particulate emissions (gas pathway) (EN ISO 18562-2:2017): Pass
- Accelerated Ageing (ASTM F1980): Pass
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ± 1 cm H2O at 20, 40, 60cm H2O
Leak testing:
§ 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).
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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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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