(45 days)
Not Found
No
The device description details a purely mechanical and electrical system for pressure measurement and transmission. There is no mention of any computational analysis, learning, or adaptive algorithms. The testing focuses on physical and electrical performance, not algorithmic accuracy.
No.
The device is indicated for physiological, invasive pressure measurement, and is used for monitoring, not therapy.
Yes
The device is described as an "Invasive Pressure Monitoring Kit" used for "physiological, invasive pressure measurement" and "continuously monitoring changes in blood pressure". This collection and transmission of physiological data for display on a monitor clearly falls under the definition of a diagnostic purpose.
No
The device description explicitly lists multiple hardware components including tubing, stopcocks, a transducer, a continuous flow flush device, and an IV set.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "physiological, invasive pressure measurement" and "intravascular pressure monitoring." This involves measuring a physiological parameter directly within the body (intravascular pressure).
- Device Description: The device functions by transmitting pressure waves from the patient's vascular system to a transducer, which then generates an electrical signal for display on a monitor. This is a direct measurement of a physiological process.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not analyze samples taken from the body.
The device is designed to directly monitor a physiological parameter within the patient's body, which falls under the category of a medical device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Sentra's 'TruePulse' Invasive Pressure Monitoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requiring intravascular pressure monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DRS
Device Description
Sentra's 'TruePulse' Invasive Pressure Monitoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requiring intravascular pressure monitoring.
The True Pulse Disposable Blood Pressure Kit from Sentra medical devices LLC consists of a Arterial extension line (available in various standard lengths) is attached via a luer connection to the catheter that is inserted into the patient, (the male portion of the lumen is a part of the kit and the female portion of the lumen is a part of the catheter is not a part of this device) a stopcock, a monitoring line, to another stopcock, a transducer, a continuous flow flush device, and an IV set all connected by standard luer connections.
The device functions by continuously monitoring changes in blood pressure from the function of the heart. The pressure waves generated in the heart are transmitted through the vacult of system, to the catheter and then through the saline fluid - filled tubing to a transducer. Up on reaching the transducer, pressure waves from the fluid pathway depress a diaphragm, changing the resistance to the flow of current through a circuit. The change in resistance produces an electrical event that creates a signal that is then transmitted to a monitor through a cable and displaying pressure reading and a wave form on a monitor. (The cather and monitor are not parts of this kit).
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
Not Found
Intended User / Care Setting
In Hospitals, by trained health care personnel
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)
The two kits were found to be substantially equivalent based on the following functional tests performed on 4 samples each of the two devices.
- . Luer inspection per ISO 594
- . De-bubbling and leak
- Output flow .
- Transducer Zero setting
- Square wave response .
- Prolonged exposure dwell with 300 mmHg saline pressure, and pressure accuracy during . and after prolonged exposure
- . Volume of kit CC
This bench testing of the Sentra Kits as compared to the Edward's Kits showed that the Sentra Kit served the same functions with the same degree of safety as the Edward's Kits.
The Sentra Kit has passed sterilization tests, bio-compatibility requirements, and product performance standards set forth by Sentra as proven in bench tests. International standards have been adopted in several areas, deemed important. The tests conducted, flow, procedures, acceptance criteria and results are discussed elsewhere in the 510(k).
All tests were designed in a test flow, with detailed test procedures and tests were executed in 2 legs, one was for functional verification of the kits and second for proof of substantial equivalence.
The transducer complies with the industry consensus standard AAMI BP22: 1995 R 2001 tested by our transducer supplier. Results are provided in the 510(k) Exhibit 1.
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).
Sentra will market standard variants of the base design. The variation is only in the presence or absence of some of the components, variations in lengths of the tubes, while utilizing the same materials and base design verified in testing. A matrix showing these variants is discussed in the 510(k).
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).
0
K062342
p1/4
| ು ಸಿನಿಯ | ||
|---|---|---|
SENTRA
Sentra Medical Devices LLC 2831 Woodmont Dr., Canton, M1 43158
Section 6 -510(k) SUMMARY 510(k) Summary As Required by 21 CFR 807.92 (c) Owner: Sentra Medical Devices LLC 2831 Woodmont Dr. W. Canton, MI 48188 Contact Person: Karthik Narayan Phone/Email: 734 502-9729 / karthik_sentra@wowway.com Date of Summary: 04-30-2006 Device Information
Trade Name True Pulse Invasive Blood Pressure Monitoring Kit Common Name Invasive Blood Pressure Monitoring Kits Classification Name Transducer, Blood -pressure, Extravascular C F R Section 870.2850 Product Code DRS
Predicate Device
Edwards Lifesciences Pressure Monitoring Kit with TruWave Disposable Pressure Transducer has been chosen as the predicate device for this pre -market application.
The filing of the 510(k) associated with this pre dicate device is K832907, filed by American Pharmaseal, a Baxter Edwards company, for a blood pressure transducer including a continuous flush device, marketed by Edwards Life sciences .
Description of the Device
Sentra's 'TruePulse' Invasive Pressure Mon itoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requir ing intravascular pressure monitoring.
The True Pulse Disposable Blood Pressure Kit from Sentra medical d evices LLC consists of a Arterial extension line (available in various standard lengths) is attached via a luer connection to the catheter that is inserted into the patient, (the male portion of the lumen is a part of the kit and the female portion of the lumen is a part of the catheter is not a part of this device) a stopcock, a monitoring line, to another stopcock, a transducer, a continuous flow flush device, and an IV set all connected by standard luer connections.
The device functions by continuously monitoring changes in blood pressure from the function of the heart. The pressure waves generated in the heart are transmitted through the vacult of system, to the catheter and then through the saline fluid - filled tubing to a transducer. Up on reaching the transducer, pressure waves from the fluid pathway depress a diaphragm, changing the resistance to the flow of current through a circuit. The change in resistance produces an electrical event that creates a signal that is then transmitted t o a monitor through a cable and displaying pressure reading and a wave form on a monitor. (The cather and monitor are not parts of this kit).
SEP 2 5 2006
Page 6.1
1
062342
Intended Use
Usually patients who require this type of monitoring have one of two major common factors. failure of the heart to pump effectively or a major disturbance of the circulatory system. The heart failure can be the result of several diseases such as acute myocardial infarction, long-standing valve disease, and cardio-myopathy. Major disturbances of the circulatory system may be major blood loss due to trauma, major surgery, or excessive fluid shifts within the body.
Comparison of the True Pulse Disposable Blood Pressure Kit to the predicate device.
The True Pulse Disposable Blood Pressure Kit is being compared to the Edwards Life sciences Pressure Monitoring Kit with TruWave Disposable Pressure Transducer ( Ref: PX260). Components of each kit are described in the table below.
Usage comparison
| ltem | Sentra's True Pulse | Edwards TruWave | Comments |
|---|---|---|---|
| Basic description | Single use transducer | ||
| kit | Single use transducer | ||
| kit | Similar | ||
| Target usage | Patients | ||
| requiring | |||
| invasive | |||
| pressure | |||
| measurement | |||
| and | |||
| monitoring | Patients | ||
| requiring | |||
| invasive | |||
| pressure | |||
| measurement | |||
| and | |||
| monitoring | Similar usage | ||
| Where used | In Hospitals, by trained | ||
| health care personnel | In Hospitals, by trained | ||
| health care personnel | Similar | ||
| Sterilization | ETO sterile | ETO sterile | Similar |
| type | |||
| of | |||
| sterilization | |||
| Packaging | Coiled and taped tubes | ||
| in a Tyvek and Mylar | |||
| pack, heat sealed peel- | |||
| open package | Coiled and taped tubes | ||
| in a Tyvek and Mylar | |||
| pack, heat sealed peel- | |||
| open package | Similar | ||
| type | |||
| of | |||
| packaging |
Technological Characteristics comparison
| Kit Components | Sentra's True Pulse | Edwards TruWave | Comments |
|---|---|---|---|
| Arterial | |||
| Extension Line | Extruded PVC tube | ||
| bonded to Luers at both | |||
| ends | Extruded PVC tube | ||
| bonded to Luers at both ends | Similar design & | ||
| construction, similar | |||
| functions | |||
| Stopcock for | |||
| fluids collection | Molded housing with | ||
| handle rotating a core, | |||
| Luer ends, cap | Molded housing with | ||
| handle rotating a core, | |||
| Luer ends, cap | Similar design & | ||
| construction, similar | |||
| functions | |||
| Monitoring Line | Extruded PVC tube | ||
| bonded to Luers at both | |||
| ends | Extruded PVC tube | ||
| bonded to Luers at both | |||
| ends | Similar design & | ||
| construction, similar | |||
| functions | |||
| Stopcock for | |||
| zeroing | Molded housing with | ||
| handle rotating a core, | |||
| one Luer end, non- | |||
| vented cap | Molded housing with | ||
| handle rotating a core, | |||
| Luer ends, vented cap | Similar design & | ||
| construction, similar | |||
| functions | |||
| Pressure | |||
| Transducer. | |||
| (Industry | |||
| consensus | |||
| Standard met) | Meets AAMI: BP22 | ||
| 1995, R2001. Which | |||
| combines AAMI BP22 | |||
| 1986 Blood pressure | |||
| transducers and AAMI | |||
| BP23: | Meets AAMI BP23: | ||
| 1986.Interchangeability | |||
| and performance of | |||
| resistive bridge type | |||
| blood pressure | |||
| transducers. (Per IFU) | Minor differences in | ||
| over all construction, | |||
| similar functions. | |||
| Transducer used in | |||
| Sentra kit meets or | |||
| exceeds the |
2
Image /page/2/Picture/0 description: The image is a black and white image that appears to be a scatter plot. There are several points scattered across the image. The points are not clustered together, but are spread out randomly.
SENTRA
Sentra Medical Devices LI.C 2432 Woodmont On, Camon 14748188
| | 1986. Interchangeability
and performance of
resistive bridge type
blood
transducers.
Stand alone transducer,
injection
housing, Pole or patient
arm mounted, wheat
Stone bridge connector,
sensor element isolated
by gel, Luer ends. | Stand
alone
transducer, injection
molded housing, Pole
or patient arm
mounted, wheat
Stone
bridge
connector, sensor
element isolated by
gel, Luer ends. | standards that
Edwards transducer
meets, as outlined in
the comparison
column. |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
| Flush Device | Injection molded
housing, Squeeze
handle changes flow
rate, Luer connections,
stand alone flush device | Injection molded
housing, pulling tab
changes flow rate,
integrated in
transducer housing | Differences in over all
construction, similar
function |
| IV Set | Molded spike, drip
chamber, tube bonded to
Luer, roller clamps | Molded spike, drip
chamber, tube
bonded to Luer, roller
clamp | Similar construction,
function |
Edwards TruWave transducer housing has integrated in it, a stop-cock and flush device while in Sentra's design these items are stand-alone. The reason for integration in Edwards design is cost savings and the two kits were found to be substantially equivalent in function.
The two kits were found to be substantially equivalent based on the following functional tests performed on 4 samples each of the two devices.
- . Luer inspection per ISO 594
- . De-bubbling and leak
- Output flow .
- Transducer Zero setting
- Square wave response .
- Prolonged exposure dwell with 300 mmHg saline pressure, and pressure accuracy during . and after prolonged exposure
- . Volume of kit CC
This bench testing of the Sentra Kits as compared to the Edward's Kits showed that the Sentra Kit served the same functions with the same degree of safety as the Edward's Kits.
Design
Specifications for components and packaging including materials used, functions required were developed. Kits were built and sterilized with production intent methods and processes. These kits were then used for functional and predicate device comparison testing.
Sentra has utilized Failure Modes and Effects Analysis to estimate and mitigate risks.
Materials for the kits components were chosen with careful analysis of material properties. Detailed material properties, and the list of materials used are discussed in the Sentra's 510(k) sections and exhibits.
Drawings of the components, assembly have been provided in the 510(k).
3
Image /page/3/Picture/0 description: The image shows four sets of numbers. The first set contains the number 2, the second set contains the number 2, the third set contains the number 6, and the fourth set contains the number 7. The numbers are arranged horizontally in a row. The numbers are small and faint.
SENTRA
K062342 74/4
Sentra will market standard variants of the base design. The variation is only in the presence or absence of some of the components, variations in lengths of the tubes, while utilizing the same materials and base design verified in testing. A matrix showing these variants is discussed in the 510(k).
Testing and verification
The Sentra Kit has passed sterilization tests, bio-compatibility requirements, and product performance standards set forth by Sentra as proven in bench tests. International standards have been adopted in several areas, deemed important. The tests conducted, flow, procedures, acceptance criteria and results are discussed elsewhere in the 510(k).
All tests were designed in a test flow, with detailed test procedures and tests were executed in 2 legs, one was for functional verification of the kits and second for proof of substantial equivalence.
The transducer complies with the industry consensus standard AAMI BP22: 1995 R 2001 tested by our transducer supplier. Results are provided in the 510(k) Exhibit 1.
Detailed discussion and results on all of these topics are available in Sentra's 510(k) sections and exhibits.
4
Image /page/4/Picture/0 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The eagle is composed of three curved lines that suggest feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP % 5 2006
Sentra Medical Devices, LLC c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC -1394 25th Street NW Buffalo, MN 55313
Re: K062342
Trade Name: Sentra True Pulse Invasive Pressure Monitoring Kit Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II (two) Product Code: DRS Dated: September 9, 2006 Received: September 11, 2006
Dear Mr. Job:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
Page 2 - Mr. Mark Job
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bfimmerman for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Section - 5
Indications for Use
510(k) Number (if known): Not issued yet.
Device Name: Sentra True Pulse Invasive Pressure Monitoring Kit
Indications For Use:
Sentra's 'TruePulse' Invasive Pressure Monitoring Kits are indicated for use in physiological, invasive pressure measurement, and are for use with patients requiring intravascular pressure monitoring.
Prescription Use : Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use: No (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bttmman
Page 5.1