(228 days)
To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.
The PYLANT MONITOR is used by personnel trained in pulmonary resuscitation and airway management (ex. anesthesiologists, RN, respiratory therapists, EMT, paramedics) used to measure the trachael cuff pressure of an endotrachael tube or tracheotomy tube by measuring the external pilot line port of the tube. The Pylant Monitor (PM) is a medical device intended to indicate changes inside an endotracheal tube (ETT) cuff. One end of the PM is fabricated to fit into the "pilot balloon" (international standard for all types of intra-tracheal tubes with a cuff) of the ETT cuff. The other end is fabricated to accept a medical syringe (international standard for all intravenous syringes) for adding or removing air from inside the ETT cuff and altering the volume of air and therefore the pressure inside the ETT cuff. The syringe end of the PM has a one way air tight valve that is open when the syringe is connected. When the syringe is not connected the valve is closed and air is trapped within the ETT cuff and the PM creating the seal between the trachea and cuff. In between the two ends of the PM is a silicone diaphragm that expands and contacts with pressure. As pressure rises the more the diaphragm expands and as pressure falls the diaphragm contracts. Attached to the center of the diaphragm is and indicator arrow/needle. The diaphragm and arrow/needle is housed inside a designed case. The case acts as a protector of the silicone diaphragm arrow needle assembly and is labeled, color coded and calibrated to indicate pressure ranges from 20 cm H2O to 30 cm H2O. The PM is designed to remain connected to the ETT pilot balloon and continuously monitor the pressure or monitor pressure intermittently. Pressure changes within the ETT when connected to the PM are indicated by expansion or contraction of the silicone diaphragm causing calibrated movement of the arrow/needle and indicated on the color coded label.
Acceptance Criteria and Device Performance for PYLANT MONITOR
The provided documentation describes the Pylant Monitor, a device intended to provide a visual indication of pressure within an inflatable tracheal tube cuff. The acceptance criteria for this device and its performance are detailed below, along with information about the study conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy | +/- 4 cm H2O (Identical to predicate device) |
| Register within "safe zone" | All 120 tested Pylant Monitors registered within the 20-30 cm H2O "safe zone" when pressurized to 25 cm H2O, specifically hitting the "mid-point" on the scale. |
| Correct ETT cuff pressure | The Pylant Monitor successfully registered the correct ETT cuff pressure. When pressurized to 25 cm H2O, 120 units indicated the "mid point" on the scale. The document also states that the PYLANT MONITOR pressures were substantially equivalent when compared to the FDA cleared predicate device (PressureEasy K833327). |
| Visual "green" area/indication for acceptable pressure range (20-30 cm H2O) | The device has a visual "green" area on the monitor for the acceptable pressure range (20-30 cm H2O). The "set point" of approximately 25 cm H2O is the small black line centered in this 20-30 mark. |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 120 randomly selected production Pylant Monitors were used for the bench testing.
- Data Provenance: The study was a bench test conducted by the manufacturer (Kal-Med, LLC). The document does not specify the country of origin of the data beyond the manufacturer being in the United States. It is an in-vitro (bench) study and therefore neither retrospective nor prospective in the clinical sense.
3. Number of Experts and their Qualifications for Ground Truth
- Number of Experts: Not applicable. The ground truth for the test set was established using a calibrated instrument rather than expert human interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "ground truth" was determined by a calibrated PYTON regulator, which provided a known pressure of 25 cm H2O. The device's reading was then compared against this known value.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The study was a bench test evaluating the physical performance of the device against a known pressure.
- Effect Size: Not applicable as no MRMC study was conducted.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance study (algorithm only without human-in-the-loop performance) was conducted. The Pylant Monitor's ability to accurately indicate pressure was tested directly against a calibrated pressure source (PYTON regulator). The device's visual indication was the sole output evaluated.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was established by a calibrated instrument. Specifically, a calibrated PYTON regulator was used to pressurize the ETT cuff to a known 25 cm H2O.
8. Sample Size for the Training Set
- Sample Size: Not applicable. The Pylant Monitor is a mechanical device that indicates pressure changes. It does not employ an algorithm or AI that would require a "training set" in the conventional sense of machine learning. Its design and calibration are based on established physical principles.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of mechanical device. The device's calibration is inherent in its design and manufacturing to visually represent specific pressure ranges.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Kal-Med LLC Sandra Greenwood Office Manager 570 Percival Avenue Kensington, Connecticut 06037
Re: K191858
Trade/Device Name: Pylant Monitor Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: July 27, 2019 Received: August 16, 2019
Dear Sandra Greenwood:
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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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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 medical devices and radiation-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,
Todd Courtney Assistant Director 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) K191858
Device Name PYLANT MONITOR
Indications for Use (Describe)
To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.
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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Section 5
510(k) Summary
(per 21 CFR 807.92(c))
1. Applicant
Kal-Med, LLC 570 Percival Avenue Kensington, CT 06037 United States of America
| Contact Person: | Sandra Greenwood |
|---|---|
| Phone: | (585) 633-4225 |
| E-mail: | Sandra@Kalmed.net |
| Date Prepared: | July 4, 2019 |
2. Device Name
| Trade Name: | PYLANT MONITOR |
|---|---|
| Common/ Usual Name: | Endotracheal tube (ET) cuff pressure monitor |
| Classification Name: | Inflatable tracheal tube cuff |
| Regulation Number: | 868.5750 |
| Product Code: | BSK |
| Device Classification: | II |
| Review Panel: | Anesthesiology |
3. Predicate Devices
The PYLANT MONITOR is substantially equivalent to:
| Subject Device | PredicateDevice | ||
|---|---|---|---|
| Name | Company | 510(k)Number | |
| PYLANT Monitor | PressureEasy | SmithsMedical | K833327 |
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| Kal-Med | Smiths Medical | |
|---|---|---|
| Product Name | PYLANT Monitor | PressureEasy |
| Product Code | BSK | BSK |
| Regulation No. | 868.5750 | 868.5750 |
| Class | II | II |
Table 1: Substantial Equivalence Table for PYLANT MONITOR
| Company | Kal-Med | Smiths Medical |
|---|---|---|
| Product Name | PYLANT MONITOR | PressureEasy |
| Intended Use | To provide visualindication of the pressurewithin an inflatabletracheal tube cuff, whichis a device, used toprovide an airtight sealbetween a tracheal tubeand a patient's trachea. | To provide visualindication of the pressurewithin an inflatabletracheal tube cuff, whichis a device, used toprovide an airtight sealbetween a tracheal tubeand a patient's trachea. |
| Basic Principle of Operation | Deflection of an indicatorcaused by changes in airpressure. This devise hasa visual "green" area onthe monitor foracceptable pressure range(20-30 cm H2O) | Deflection of an indicatorcaused by changes in airpressure. This devise has avisual green lineappearing for acceptablepressure range (20-30 cmH2O) |
| Connection type | Connects directly toETT cuff filling tube.Inflate with syringe. | Connects directly toETT cuff filling tube.Inflate with syringe. |
| User Interface | Green accept area onscale | Green dash in windowfor accept |
| Accuracy | $+/- 4 cm H_2O$ | $+/- 4 cm H_2O$ |
| Materials | Polypropylene | Polypropylene |
| Intended population | Any patient requiringendotracheal tube cuffpressure measurement | Any patient requiringendotracheal tube cuffpressure measurement |
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4. Intended Use
To provide visual indication of the pressure within an inflatable tracheal tube cuff, which is a device, used to provide an airtight seal between a tracheal tube and a patient's trachea.
5. Description of the Devices
The PYLANT MONITOR is used by personnel trained in pulmonary resuscitation and airway management (ex. anesthesiologists, RN, respiratory therapists, EMT, paramedics) used to measure the trachael cuff pressure of an endotrachael tube or tracheotomy tube by measuring the external pilot line port of the tube.
The Pylant Monitor (PM) is a medical device intended to indicate changes inside an endotracheal tube (ETT) cuff. One end of the PM is fabricated to fit into the "pilot balloon" (international standard for all types of intra-tracheal tubes with a cuff) of the ETT cuff. The other end is fabricated to accept a medical syringe (international standard for all intravenous syringes) for adding or removing air from inside the ETT cuff and altering the volume of air and therefore the pressure inside the ETT cuff. The syringe end of the PM has a one way air tight valve that is open when the syringe is connected. When the syringe is not connected the valve is closed and air is trapped within the ETT cuff and the PM creating the seal between the trachea and cuff. In between the two ends of the PM is a silicone diaphragm that expands and contacts with pressure. As pressure rises the more the diaphragm expands and as pressure falls the diaphragm contracts. Attached to the center of the diaphragm is and indicator arrow/needle. The diaphragm and arrow/needle is housed inside a designed case. The case acts as a protector of the silicone diaphragm arrow needle assembly and is labeled, color coded and calibrated to indicate pressure ranges from 20 cm H20 to 30 cm H20. The PM is designed to remain connected to the ETT pilot balloon and continuously monitor the pressure or monitor pressure intermittently.
Pressure changes within the ETT when connected to the PM are indicated by expansion or contraction of the silicone diaphragm causing calibrated movement of the arrow/needle and indicated on the color coded label.
6. Summary of Performance Data
Bench tests of the PYLANT MONITOR were conducted comparing PYLANT MONITOR to an FDA cleared pressure monitor; the PressureEasy K833327. The PYLANT MONITOR pressures were substantially equivalent when compared to the PressureEasy Device.
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Description of Performance Test
The objective of the testing is to determine if the Pylant Monitor will register the correct ETT cuff pressure. The scale on the monitor has a "set point" which is approximately 25 CM H20 pressure. The "set point" is the small black line centered in the 20 - 30 mark on the scale. Each Monitor will be pressurized with the PYTON regulator to 25 CM H20 pressure and will register the pressure from the ETT cuff.
The test consisted of 120 randomly selected production Pylant Monitors. The bench testing included the use of a calibrated Pyton regulator used to pressurize the ETT cuff. which is attached to the Monitor through the inlet tube. Each Monitor was attached to the PYTON pressure regular at the check valve.
In order for the Pylant Monitors to pass, the units must register in the 20 - 30 CM H20 "safe zone". When the Monitors were pressurized to 25 CM H20 pressure all 120 units passed the test by hitting the "mid point" on the scale.
The Pressure Easy devices were tested using the same set-up and test
criteria. This comparative study has been included in Section 18.
7. Safety & Effectiveness
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
Both devices are intended to monitor the pressure inside an ETT cuff. Both devices use a silicone diaphragm that expands and contacts with changes in pressure inside the ETT cuff.
Both devices use a color coded label to indicate pressure changes inside the ETT cuff. Both devices connect to the pilot balloon of an ETT tube and both use a syringe to change volume inside the ETT cuff. Both devices can be left on the pilot balloon for continuous monitoring. The predicate device uses a "plunger" up and down type movement to indicated changes in pressure. The Pylant Monitor uses a "sweep" side to side type movement to indicate changes in pressure. The devices are shaped differently.
lt has been shown in this 510(k) submission that the differences between the Pylant Monitor devices and the predicate devices do not raise any questions regarding their safety and effectiveness, and therefore have been determined to be substantially equivalent to the referenced predicate device.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).