(89 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and pressure monitoring technology, with no mention of AI/ML capabilities.
No
The device is described as a "Pressure Monitoring Kit" used for "monitoring intravascular blood pressure, intracranial pressure, and intrauterine pressure." Its function is to display pressure data, not to directly treat a condition. While monitoring is often a part of therapy, the device itself is for diagnostic/monitoring purposes, not therapeutic intervention.
Yes
The device is a pressure monitoring kit, which collects data (pressure readings) from inside the patient's body for monitoring and display, facilitating diagnosis and treatment decisions by healthcare professionals.
No
The device description explicitly states it is a "sterile, single-use kit" that includes a "disposable sterile cable" and a "TruWave Disposable Pressure Transducer," indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for monitoring pressure within the body (intravascular, intracranial, or intrauterine). This involves direct measurement of physiological parameters in a living patient.
- Device Description: The device is a pressure monitoring kit with a transducer that interfaces with a patient monitor. It measures pressure directly from the patient's body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. This device does not process or analyze such specimens.
The device is a medical device used for in vivo monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Product codes (comma separated list FDA assigned to the subject device)
DXO
Device Description
The Edwards Lifesciences Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors intravascular blood pressure, intracranial pressure, and intrauterine pressure. The disposable sterile cable (available in 12-inch/30 cm and 48-inch/120 cm lengths) interfaces exclusively with an Edwards Lifesciences cable that is specifically wired for the patient monitor used to display the pressure data. The TruWave Disposable Pressure Transducer has a straight, flow-through design, where the fluid is passed across the pressure sensor. The DPT is available either with or without an integral flush device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intravascular, intracranial, or intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and other appropriate clinical environments.
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)
Material biocompatibility testing in compliance with applicable ISO 10993 requirements, and performance testing was conducted to compare the proposed device to the predicate device. The results of the testing indicate that the fundamental scientific technology of the proposed device is unchanged from the legally marketed device (predicate). The proposed change to the TruWave disposable pressure transducer has been shown to be safe, effective, and substantially equivalent to the predicate device (Phoenix [TruWave] disposable pressure transducer) for its intended use in hospitals and other appropriate clinical environments.
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).
Not Found
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human face in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
September 3, 2014
Edwards Lifesciences, LLC. Mr. Andrew S. Mazurkiewicz, Jr., MBA/MKT Senior Associate, Regulatory Affairs Critical Care One Edwards Way, CA 92614
Re: K141495
Trade/Device Names: Pressure Monitoring Kit with TruWave Disposable Pressure Transducers, with list of 577 models attached Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXO Dated: August 22, 2014 Received: August 25, 2014
Dear Mr. Mazurkiewicz:
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. 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.
1
Page 2 – Mr. Andrew S. Mazurkiewicz, Jr.
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT 1
SUPPLEMENT TO TABLE 11-2: TRUWAVE MODELS
(Total of 577 models)
3
| Supplement to Table 11-2: TruWave™ Models | ||||
|---|---|---|---|---|
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PX284AN | 1 | 3 | 210 | N/A |
| PXMK1940 | 1 | 3 | 183 | N/A |
| PX2X2284C | 2 | 3 | 211 | N/A |
| PXMK2002 | 1 | 3 | 91 | N/A |
| PXMK478 | 1 | 3 | 150 | N/A |
| T494C00B | 2 | 3 | 180 | N/A |
| PXVMP260 | 1 | 3 | 150 | 5 |
| PXVP0861 | 2 | 3 | 170 | 12 |
| T001650A | 2 | 3 | 150 | N/A |
| VMP426PX | 1 | 3 | 66 | 3 |
| PXMK2041 | 1 | 3 | 183 | N/A |
| PXVP2284 | 1 | 3 | 210 | 12 |
| T001709A | 2 | 3 | 210 | N/A |
| T432105A | 1 | 30 | 130 | N/A |
| T322242B | 2 | 3 | 210 | N/A |
| T531401A | 2 | 3 | 0 | N/A |
| T434303A | 2 | 3 | 210 | 5 |
| T001759A | 2 | 3 | 171 | 12 |
| T001737A | 2 | 3 | 180 | 5 |
| PX12N | 1 | 30 | 30 | N/A |
| T001657A | 2 | 3 | 210 | N/A |
| T001775A | 1 | 3 | 195 | N/A |
| T433803A | 1 | 3 | 200 | N/A |
| PX200 | 1 | 3 | 0 | N/A |
| PX1X2 | 1 | 3 | 150 | N/A |
| PXVMP2X31 | 2 | 3 | 160 | 5 |
| PX6001 | 1 | 3 | 0 | N/A |
| PXMK1849 | 1 | 3 | 193 | N/A |
| T001633A | 1 | 3 | 150 | N/A |
| T001624A | 1 | 3 | 150 | N/A |
| T321571A | 2 | 3 | 165 | N/A |
| PXMK0666 | 2 | 3 | 208 | N/A |
| T001658A | 2 | 3 | 180 | N/A |
| PX2X2YB | 2 | 3 | 180 | N/A |
| T391T00A | 2 | 3 | 221 | 12 |
| T001712A | 2 | 3 | 195 | N/A |
| T441T01C | 1 | 3 | 225 | N/A |
| T491Y01B | 1 | 3 | 185 | N/A |
| T581203B | 1 | 3 | 210 | N/A |
| Supplement to Table 11-2: TruWave™ Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| T530217B | 1 | 3 | 180 | N/A |
| VMP448PX | 1 | 3 | 122 | 3 |
| PXVP2284DZ | 1 | 3 | 210 | 12 |
| T001660A | 3 | 3 | 150 | N/A |
| T100202A | 1 | 3 | 105 | N/A |
| T001741A | 2 | 3 | 180 | 12 |
| PXVP0549 | 3 | 3 | 221 | 12 |
| PX3X3284C | 3 | 3 | 211 | N/A |
| PX2X3 | 2 | 3 | 150 | N/A |
| T005002A | 1 | 3 | 180 | N/A |
| T001745A | 1 | 3 | 180 | 12 |
| PX3X3 | 3 | 3 | 150 | N/A |
| PXVK0458 | 3 | 3 | 236 | 5 |
| PXVMP3X31 | 3 | 3 | 160 | 5 |
| PX600F | 1 | 3 | 0 | N/A |
| T005025A | 1 | 3 | 180 | N/A |
| PX4X4 | 4 | 3 | 211 | N/A |
| PX3X3AN | 3 | 3 | 211 | N/A |
| PXMK2011 | 1 | 3 | 196 | N/A |
| PXMK9146 | 2 | 3 | 178 | N/A |
| T001789B | 1 | 3 | 150 | N/A |
| T325202A | 1 | 3 | 150 | N/A |
| PX3X3272 | 3 | 3 | 178 | N/A |
| PXVMP172 | 1 | 3 | 180 | 5 |
| PX600F30 | 1 | 30 | 0 | N/A |
| PXMK053 | 1 | 3 | 210 | N/A |
| PXMK2008 | 1 | 3 | 180 | N/A |
| PXVP2284AT3 | 1 | 3 | 210 | 12 |
| PXVP23X3AT3 | 3 | 3 | 231 | 12 |
| PXVP2X2AT3 | 2 | 3 | 213 | 12 |
| PXVK0388 | 3 | 3 | 188 | N/A |
| PXCMK590 | 2 | 3 | 208 | N/A |
| PXVK0387 | 2 | 3 | 188 | N/A |
| PX266C | 1 | 3 | 168 | N/A |
| PXMK1479 | 1 | 3 | 148 | N/A |
| PXVP2272 | 1 | 3 | 180 | 12 |
| PX600 | 1 | 3 | 0 | N/A |
| PXMK0695 | 1 | 3 | 130 | N/A |
| PX284 | 1 | 3 | 210 | N/A |
4
5
| Supplement to Table 11-2: TruWave™ Models | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Model # | # of | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Transducers | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (P/N 500479) | Transducer | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Flow Rate | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (mL/hr) | Tubing Length | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (cm) | Blood Sampling | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reservoir Size (cc) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| VAMP (K896819) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK2043 | 3 | 3 | 183 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PX212 | 1 | 3 | 30 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK0976 | 2 | 3 | 147 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVK0398 | 2 | 3 | 188 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVMP160 | 1 | 3 | 150 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PX284R | 1 | 3 | 210 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK0688 | 1 | 30 | 119 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PX260 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| (Representative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Model) | 1 | 3 | 150 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PX272 | 1 | 3 | 180 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PX2X2 | 2 | 3 | 150 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVMP120 | 1 | 3 | 50 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVP0897 | 3 | 3 | 193 | 12 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVP23X3 | 3 | 3 | 170 | 12 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVMP184 | 1 | 3 | 210 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVMP272 | 1 | 3 | 180 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVMP284 | 1 | 3 | 210 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXVP2260 | 1 | 3 | 150 | 12 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| T001631A | 1 | 3 | 150 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| T001645A | 1 | 3 | 165 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| T001670A | 1 | 3 | 150 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| T001671A | 1 | 3 | 180 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| T001673A | 2 | 3 | 150 | 5 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PX3X3MT | 3 | 3 | 211 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK1876 | 3 | 3 | 213 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK1805 | 3 | 3 | 211 | N/A | PXMK2012 | 4 | 3 | 196 | N/A | T100209A | 1 | 3 | 150 | N/A | PXAK1568 | 1 | 3 | 0 | N/A | PXAK2066 | 3 | 3 | 0 | N/A | PXAK2296 | 4 | 3 | 0 | N/A | PXMK0933 | 1 | 3 | 208 | N/A | PXMK1300 | 3 | 3 | 274 | N/A | PXMK1737 | 2 | 3 | 208 | N/A | PXMK1863 | 4 | 3 | 178 | N/A | PXMK2143 | 3 | 3 | 198 | N/A | PXMK2144 | 3 | 3 | 211 | N/A | PXMK2258 | 4 | 3 | 183 | N/A | PXMK2270 | 5 | 3 | 0 | N/A | PXMK560 | 2 | 3 | 30 | N/A |
| PXMK1805 | 3 | 3 | 211 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK2012 | 4 | 3 | 196 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| T100209A | 1 | 3 | 150 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXAK1568 | 1 | 3 | 0 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXAK2066 | 3 | 3 | 0 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXAK2296 | 4 | 3 | 0 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK0933 | 1 | 3 | 208 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK1300 | 3 | 3 | 274 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK1737 | 2 | 3 | 208 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK1863 | 4 | 3 | 178 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK2143 | 3 | 3 | 198 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK2144 | 3 | 3 | 211 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK2258 | 4 | 3 | 183 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK2270 | 5 | 3 | 0 | N/A | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| PXMK560 | 2 | 3 | 30 | N/A |
6
| Supplement to Table 11-2: TruWave™ Models | ||||
|---|---|---|---|---|
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXVK0363 | 3 | 3 | 241 | 5 |
| PXVK0438 | 4 | 3 | 163 | 5 |
| PXVK0738 | 4 | 3 | 244 | 5 |
| PXVK0755 | 3 | 3 | 244 | 5 |
| PXVK0797 | 3 | 3 | 224 | 5 |
| PXVK0965 | 3 | 3 | 173 | 5 |
| PXVK1001 | 3 | 3 | 206 | 5 |
| PXVK1003 | 4 | 3 | 173 | 5 |
| PXVK1086 | 3 | 3 | 99 | 5 |
| PXVK268 | 3 | 3 | 203 | 5 |
| PXVP0686 | 2 | 3 | 220 | 12 |
| PXVP0812 | 3 | 3 | 155 | 12 |
| PXVP0880 | 3 | 3 | 231 | 12 |
| PXVP0902 | 3 | 3 | 206 | 12 |
| PXVP0966 | 3 | 3 | 231 | 12 |
| PXVP1066 | 3 | 3 | 177 | 12 |
| PXVP1087 | 4 | 3 | 199 | 12 |
| T493Y02B | 3 | 3 | 195 | N/A |
| T001619A | 1 | 3 | 30 | N/A |
| T310195A | 1 | 30 | 150 | N/A |
| T001691A | 1 | 3 | 171 | 12 |
| T100214A | 1 | 3 | 180 | N/A |
| T100215A | 1 | 3 | 210 | N/A |
| T430023B | 2 | 3 | 215 | 12 |
| T001702A | 2 | 3 | 135 | N/A |
| T001724A | 1 | 3 | 210 | N/A |
| T001758A | 1 | 3 | 0 | N/A |
| T001760A | 2 | 3 | 171 | 12 |
| T001786A | 2 | 3 | 195 | N/A |
| T005004A | 1 | 3 | 150 | N/A |
| T005052A | 1 | 3 | 210 | N/A |
| T005074A | 2 | 3 | 175 | 12 |
| T005080A | 1 | 3 | 180 | N/A |
| T100212A | 1 | 3 | 150 | N/A |
| T100500A | 1 | 3 | 60 | 5 |
| T100504A | 1 | 3 | 190 | 5 |
| T100671B | 3 | 3 | 171 | 12 |
| T330639B | 2 | 3 | 150 | N/A |
| T330831A | 1 | 3 | 210 | N/A |
| Supplement to Table 11-2: TruWaveTM Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| T330918A | 2 | 3 | 200 | N/A |
| T330919A | 1 | 3 | 200 | N/A |
| T330V11A | 3 | 3 | 200 | N/A |
| T331E02A | 1 | 3 | 0 | N/A |
| T331F06B | 1 | 3 | 90 | N/A |
| T331S05B | 2 | 3 | 200 | N/A |
| T332J01A | 1 | 3 | 150 | N/A |
| T333529A | 2 | 3 | 150 | N/A |
| T333709B | 2 | 3 | 0 | N/A |
| T333710C | 2 | 3 | 0 | N/A |
| T333918A | 2 | 3 | 210 | N/A |
| T333919A | 1 | 3 | 150 | N/A |
| T333C00A | 1 | 3 | 180 | N/A |
| T333D00A | 1 | 3 | 150 | N/A |
| T333F00A | 1 | 3 | 210 | N/A |
| T334041A | 2 | 3 | 180 | N/A |
| T334402A | 2 | 3 | 180 | N/A |
| T334708C | 1 | 3 | 0 | N/A |
| T336546B | 2 | 3 | 197 | 12 |
| T336547B | 3 | 3 | 197 | 12 |
| T336548B | 1 | 3 | 197 | 12 |
| T337003A | 1 | 3 | 150 | N/A |
| T337119B | 2 | 3 | 200 | N/A |
| T337305B | 3 | 3 | 240 | N/A |
| T391T01A | 3 | 3 | 221 | 12 |
| T441809C | 2 | 3 | 150 | N/A |
| T450552C | 1 | 30 | 156 | 3 |
| T491U01B | 1 | 3 | 180 | N/A |
| T492011A | 3 | 3 | 135 | N/A |
| T493Y03B | 1 | 30 | 156 | N/A |
| T495009A | 3 | 3 | 175 | N/A |
| T321570A | 1 | 3 | 120 | N/A |
| T321572A | 3 | 3 | 150 | N/A |
| T321573A | 1 | 3 | 165 | N/A |
| T321575A | 1 | 3 | 105 | N/A |
| T449103B | 2 | 3 | 160 | 5 |
| T100209A | 1 | 3 | 150 | N/A |
| T391314A | 3 | 3 | 210 | N/A |
| T770000A | 1 | 3 | 210 | 5 |
| Supplement to Table 11-2: TruWave™ Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| T005086A | 1 | 3 | 210 | N/A |
| T440B26B | 2 | 3 | 200 | 5 |
| T321811A | 1 | 3 | 162 | 5 |
| T321811Z | 1 | 3 | 162 | 5 |
| T443422A | 2 | 3 | 210 | N/A |
| T391312A | 1 | 3 | 210 | N/A |
| T320161B | 1 | 3 | 150 | N/A |
| T460061A | 1 | 3 | 195 | N/A |
| T341211A | 1 | 3 | 0 | N/A |
| T433202B | 1 | 3 | 210 | N/A |
| T460225D | 3 | 3 | 205 | N/A |
| T395705A | 1 | 3 | 180 | N/A |
| T322241A | 1 | 3 | 150 | N/A |
| T325615A | 1 | 3 | 195 | N/A |
| T398807D | 1 | 3 | 58 | 12 |
| T531900A | 1 | 3 | 55 | N/A |
| T341210A | 1 | 3 | 150 | N/A |
| T397705B | 2 | 3 | 180 | N/A |
| T433802A | 1 | 3 | 220 | 5 |
| T320943A | 2 | 3 | 120 | N/A |
| T320940B | 3 | 3 | 120 | N/A |
| PXVJ0441 | 1 | 30 | 168 | 3 |
| T005094A | 1 | 3 | 150 | N/A |
| T430181A | 1 | 3 | 221 | 5 |
| PX601 | 1 | 3 | 0 | N/A |
| T395606B | 3 | 3 | 180 | N/A |
| T451703A | 3 | 3 | 215 | 12 |
| T451703A | 3 | 3 | 215 | 12 |
| T433806A | 2 | 3 | 220 | 5 |
| T310682A | 3 | 3 | 150 | N/A |
| T432703A | 2 | 3 | 220 | 5 |
| T349302A | 1 | 30 | 150 | N/A |
| T530317A | 1 | 3 | 30 | N/A |
| T413405A | 1 | 3 | 150 | N/A |
| T431305A | 3 | 3 | 190 | 5 |
| T320162C | 2 | 3 | 60 | N/A |
| T349301B | 1 | 3 | 180 | N/A |
| T328500A | 1 | 3 | 180 | N/A |
| PXMK0010 | 1 | 3 | 230 | N/A |
| Supplement to Table 11-2: TruWave™ Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXMK0011 | 2 | 3 | 230 | N/A |
| PXMK0012 | 3 | 3 | 230 | N/A |
| PXMK0013 | 1 | 3 | 0 | N/A |
| PXMK0014 | 1 | 3 | 150 | N/A |
| T610002A | 1 | 3 | 30 | N/A |
| PXMK2329 | 2 | 3 | 89 | N/A |
| PXMK2330 | 3 | 3 | 119 | N/A |
| T413675A | 2 | 3 | 225 | N/A |
| T397704A | 1 | 3 | 180 | N/A |
| T001725A | 1 | 3 | 150 | N/A |
| T322238A | 1 | 3 | 190 | N/A |
| T322515A | చి | చి | 180 | N/A |
| T398603A | 2 | 3 | 220 | 5 |
| T001744A | 1 | 3 | 220 | 5 |
| T323922D | 2 | 3 | 180 | N/A |
| T434304A | 1 | 3 | 190 | 5 |
| T433204B | 1 | 3 | 210 | N/A |
| PX24N | 1 | 30 | 60 | N/A |
| T323923A | 1 | 3 | 30 | N/A |
| T433801A | 1 | 3 | 200 | N/A |
| T430142A | 4 | 3 | 150 | N/A |
| T312306A | 1 | 3 | 15 | N/A |
| T005048B | 1 | 3 | 200 | 5 |
| T320563A | 1 | 3 | 200 | N/A |
| T530310A | 1 | 3 | 150 | N/A |
| T391313A | 2 | 3 | 210 | N/A |
| T323924C | 1 | 3 | 210 | N/A |
| T341212A | 1 | 3 | 90 | N/A |
| T320137D | 3 | 3 | 150 | N/A |
| T443952B | 2 | 3 | 136 | 3 |
| T325306B | 1 | 3 | 210 | N/A |
| T413670A | 1 | 3 | 180 | N/A |
| T413406A | 1 | 3 | 150 | N/A |
| T410001Z | 1 | 3 | 165 | N/A |
| T432104B | 2 | 3 | 250 | 5 |
| T450217A | 2 | 3 | 190 | N/A |
| T450217A | 2 | 3 | 190 | N/A |
| T440B28A | 1 | 3 | 200 | 5 |
| T320544A | 1 | 3 | 0 | N/A |
| Supplement to Table 11-2: TruWave™ Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| T440B21A | 2 | 3 | 30 | N/A |
| T434500B | 1 | 3 | 225 | 5 |
| T001767A | 1 | 3 | 150 | N/A |
| T323932C | 2 | 3 | 180 | N/A |
| T323931C | 3 | 3 | 180 | N/A |
| T005050B | 3 | 3 | 200 | 5 |
| T433201A | 2 | 3 | 150 | N/A |
| T328201A | 1 | 3 | 180 | N/A |
| T530116B | 3 | 3 | 0 | N/A |
| T322256A | 3 | 3 | 240 | N/A |
| T398105B | 2 | 3 | 180 | N/A |
| T397708A | 1 | 3 | 191 | 12 |
| T322247A | 1 | 3 | 150 | N/A |
| T310761C | 1 | 3 | 0 | N/A |
| T320941A | 1 | 3 | 120 | N/A |
| T433804Z | 1 | 3 | 210 | 5 |
| T450553A | 3 | 3 | 186 | 3 |
| T451702A | 2 | 3 | 215 | 12 |
| T001743A | 1 | 3 | 160 | 5 |
| T430609A | 3 | 30 | 150 | N/A |
| T001765A | 1 | 3 | 186 | 12 |
| T322244A | 1 | 3 | 60 | N/A |
| T432618G | 1 | 3 | 215 | 12 |
| T005049B | 2 | 3 | 200 | 5 |
| T530219D | 2 | 3 | 165 | 12 |
| T310762A | 1 | 3 | 90 | N/A |
| T447907A | 2 | 3 | 150 | N/A |
| T581201F | 3 | 3 | 200 | N/A |
| T320564A | 1 | 30 | 180 | N/A |
| T320947B | 1 | 3 | 0 | N/A |
| T310197A | 1 | 30 | 150 | N/A |
| T398808A | 1 | 3 | 231 | 12 |
| T430169A | 1 | 3 | 180 | 3 |
| T410115C | 3 | 3 | 150 | N/A |
| T005005A | 1 | 3 | 180 | N/A |
| T430139A | 1 | 3 | 150 | N/A |
| T441L01A | 2 | 3 | 300 | N/A |
| T450545A | 3 | 3 | 190 | 5 |
| T530219A | 2 | 3 | 180 | N/A |
| Supplement to Table 11-2: TruWave™ Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| T430180A | 2 | 3 | 220 | 5 |
| T410114B | 2 | 3 | 150 | N/A |
| T001797B | 1 | 3 | 150 | N/A |
| T431514C | 2 | 3 | 210 | N/A |
| T413403C | 1 | 3 | 150 | N/A |
| T430179A | 3 | 3 | 220 | 5 |
| T450544A | 2 | 3 | 190 | 5 |
| T431108A | 1 | 3 | 265 | 12 |
| T001746A | 3 | 3 | 190 | 5 |
| T440B20B | 2 | 3 | 200 | N/A |
| T326207B | 1 | 3 | 171 | 12 |
| T430178B | 3 | 3 | 190 | 5 |
| T430168A | 1 | 30 | 180 | 3 |
| T434501B | 2 | 3 | 225 | 5 |
| T460237A | 2 | 3 | 195 | N/A |
| T413642B | 1 | 3 | 150 | N/A |
| T430177B | 1 | 3 | 30 | N/A |
| T001713A | 2 | 3 | 180 | N/A |
| T770003A | 3 | 3 | 200 | 5 |
| T460243A | 3 | 3 | 175 | 12 |
| T430140A | 3 | 3 | 190 | 5 |
| T322251A | 2 | 3 | 150 | N/A |
| T320139D | 1 | 30 | 0 | N/A |
| T530223A | 1 | 3 | 165 | 12 |
| T391608B | 1 | 3 | 30 | N/A |
| T770001A | 4 | 3 | 220 | 5 |
| T770002A | 2 | 3 | 200 | 5 |
| T470411B | 1 | 30 | 25 | 3 |
| T323930D | 2 | 3 | 150 | N/A |
| T461803B | 1 | 3 | 160 | N/A |
| T434502B | 3 | 3 | 225 | 5 |
| T460250A | 1 | 30 | 140 | N/A |
| T005093A | 2 | 3 | 150 | N/A |
| T460235A | 1 | 3 | 135 | N/A |
| PXMK2294 | 1 | 3 | 211 | N/A |
| T460249A | 1 | 30 | 140 | N/A |
| T492F02B | 1 | 3 | 160 | 5 |
| T492F02Z | 1 | 3 | 160 | 5 |
| PXVK282 | 3 | 3 | 193 | 5 |
| Supplement to Table 11-2: TruWave™ Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXMK1392 | 1 | 30 | 120 | N/A |
| T270003B | 2 | 3 | 0 | N/A |
| PXMK2217 | 3 | 3 | 211 | N/A |
| VMP406PX | 1 | 3 | 15 | 3 |
| PXMK1267 | 2 | 3 | 0 | N/A |
| PXMK1589 | 1 | 3 | 0 | N/A |
| PXMK2274 | 1 | 3 | 30 | N/A |
| T001691M | 1 | 3 | 215 | 12 |
| T001741M | 2 | 3 | 235 | 5 |
| T001744M | 1 | 3 | 235 | 5 |
| T005025M | 1 | 3 | 180 | N/A |
| T005050M | 3 | 3 | 235 | 5 |
| T100671M | 3 | 3 | 215 | 12 |
| T430023M | 2 | 3 | 215 | 12 |
| T470411M | 1 | 30 | 32 | 3 |
| T270004B | 2 | 3 | 0 | N/A |
| T270900A | 2 | 3 | 210 | N/A |
| PXVJ356 | 1 | 3 | 120 | 3 |
| PXMK2210 | 3 | 3 | 211 | N/A |
| PXMK188 | 1 | 30 | 60 | N/A |
| PXMK2122 | 1 | 30 | 60 | N/A |
| VMP306PX | 1 | 30 | 15 | 3 |
| PXAVMP3 | 2 | 3 | 173 | 5 |
| PX604 | 1 | 3 | 0 | N/A |
| PXMK2277 | 1 | 3 | 0 | N/A |
| PXVMP2X21 | 2 | 3 | 160 | 5 |
| PXMK2016 | 1 | 3 | 168 | N/A |
| PXMK1077 | 1 | 3 | 150 | N/A |
| PX36N | 1 | 30 | 90 | N/A |
| PXMK2056 | 1 | 3 | 240 | N/A |
| PXMK2137 | 3 | 3 | 211 | N/A |
| PXMK1780 | 1 | 3 | 30 | N/A |
| PXMK1140 | 3 | 3 | 208 | N/A |
| PXMK2042 | 2 | 3 | 180 | N/A |
| PXMK1691 | 1 | 3 | 210 | N/A |
| PXVK0670 | 1 | 3 | 191 | 5 |
| PXMK1476 | 2 | 3 | 178 | N/A |
| PXMK0692 | 1 | 30 | 15 | N/A |
| PXMK0774 | 1 | 30 | 60 | N/A |
| Supplement to Table 11-2: TruWave™ Models | ||||
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXMK1915 | 1 | 30 | 90 | N/A |
| PXMK1393 | 3 | 3 | 180 | N/A |
| PXMK1997 | 1 | 30 | 173 | N/A |
| PXMK1714 | 4 | 3 | 241 | N/A |
| PXMK1716 | 2 | 3 | 211 | N/A |
| PXMK2009 | 1 | 3 | 180 | N/A |
| PXMK2010 | 1 | 3 | 180 | N/A |
| PXMK1299 | 1 | 3 | 269 | N/A |
| PXMK1360 | 3 | 3 | 147 | N/A |
| PXVK0437 | 3 | 3 | 218 | N/A |
| PXVK0478 | 1 | 3 | 147 | N/A |
| PXMK2108 | 2 | 3 | 213 | N/A |
| PXMK1749 | 3 | 3 | 213 | N/A |
| PXMK1750 | 4 | 3 | 213 | N/A |
| PXMK1696 | 2 | 3 | 0 | N/A |
| T001718A | 2 | 3 | 210 | N/A |
| T440907B | 3 | 3 | 210 | N/A |
| PXMK1977 | 1 | 3 | 150 | N/A |
| PXMK2036 | 2 | 3 | 211 | N/A |
| PXVJ0690 | 1 | 3 | 254 | 3 |
| PXVK1079 | 3 | 3 | 203 | 5 |
| T001724A | 1 | 3 | 210 | N/A |
| T005004A | 1 | 3 | 150 | N/A |
| PXMK2279 | 3 | 3 | 208 | N/A |
| PXMK2284 | 1 | 3 | 60 | N/A |
| PXMK2298 | 2 | 3 | 178 | N/A |
| PXMK2302 | 1 | 3 | 150 | N/A |
| PXMK2306 | 1 | 3 | 210 | N/A |
| PXMK2307 | 2 | 3 | 208 | N/A |
| PXMK2308 | 2 | 3 | 150 | N/A |
| PXMK2316 | 1 | 3 | 0 | N/A |
| PXMK2321 | 1 | 3 | 120 | N/A |
| PXMK2327 | 1 | 3 | 30 | N/A |
| PXMK2047 | 1 | 30 | 15 | N/A |
| PXMK7729 | 1 | 30 | 30 | N/A |
| PXMK2331 | 4 | 3 | 30 | N/A |
| PXMK273 | 1 | 3 | 150 | N/A |
| PXMK287 | 1 | 3 | 150 | N/A |
| PXMK318 | 3 | 3 | 206 | N/A |
7
8
9
10
11
12
13
14
| Supplement to Table 11-2: TruWave™ Models | ||||
|---|---|---|---|---|
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXMK332 | 1 | 3 | 76 | N/A |
| PXMK500 | 1 | 3 | 210 | N/A |
| PXMK573 | 1 | 3 | 180 | N/A |
| PXMK575 | 3 | 3 | 274 | N/A |
| PXMK582 | 1 | 3 | 150 | N/A |
| PXVJ0705 | 1 | 3 | 18 | 3 |
| PXVK0364 | 1 | 3 | 241 | 5 |
| PXVK0386 | 1 | 3 | 188 | N/A |
| PXVK0412 | 1 | 3 | 198 | 5 |
| PXVK0467 | 1 | 3 | 224 | 5 |
| PXVK0481 | 4 | 3 | 190 | 5 |
| PXVK064 | 1 | 3 | 190 | 5 |
| PXVK0789 | 1 | 3 | 210 | N/A |
| PXVK0796 | 1 | 3 | 224 | 5 |
| PXVK0802 | 1 | 3 | 213 | 5 |
| PXVK0853 | 3 | 3 | 193 | 5 |
| PXVK093 | 1 | 3 | 206 | 5 |
| PXVK0996 | 1 | 3 | 174 | 5 |
| PXVK1041 | 3 | 3 | 254 | 5 |
| PXVK1075 | 1 | 3 | 193 | N/A |
| PXVK1076 | 2 | 3 | 218 | N/A |
| PXVK1084 | 3 | 3 | 193 | 5 |
| PXVK1085 | 3 | 3 | 203 | 5 |
| PXVK1091 | 4 | 3 | 210 | N/A |
| PXVK1099 | 1 | 3 | 157 | N/A |
| PXVK1102 | 1 | 3 | 132 | N/A |
| PXVK1103 | 3 | 3 | 203 | 5 |
| PXVK220 | 2 | 3 | 170 | 5 |
| PXVK225 | 2 | 3 | 175 | 5 |
| PXVK275 | 2 | 3 | 168 | 5 |
| PXVJ0711 | 1 | 30 | 132 | 3 |
| PXVK2W4IV | 2 | 3 | 198 | 5 |
| PXVMP172AT3 | 1 | 3 | 224 | 5 |
| PXVMP2X22 | 2 | 3 | 160 | 5 |
| PXVMP3X32 | 3 | 3 | 193 | 5 |
| PXVP0550 | 3 | 3 | 231 | 12 |
| PXVP0566 | 1 | 3 | 208 | 12 |
| PXVP0765 | 2 | 3 | 193 | 12 |
| PXVP0778 | 1 | 3 | 230 | 12 |
15
| Supplement to Table 11-2: TruWave™ Models | ||||
|---|---|---|---|---|
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXVP0843 | 2 | 3 | 201 | 12 |
| PXVP1071 | 3 | 3 | 221 | 12 |
| PXVP1072 | 2 | 3 | 221 | 12 |
| PXVP1073 | 1 | 3 | 221 | 12 |
| PXVP1089 | 2 | 3 | 170 | 12 |
| PXVP1097 | 3 | 3 | 170 | 12 |
| PXVP1098 | 1 | 3 | 170 | 12 |
| PXVP1107 | 2 | 3 | 231 | 12 |
| PXVP3X3DZ | 3 | 3 | 170 | 12 |
| PXMK0940 | 1 | 30 | 30 | N/A |
| PX278C | 1 | 3 | 198 | N/A |
| PX602 | 1 | 3 | 0 | N/A |
| PX6041 | 1 | 3 | 0 | N/A |
| PX604INS | 1 | 3 | NA | N/A |
| PXAK0712 | 1 | 3 | 0 | N/A |
| PXAK0910 | 1 | 3 | 0 | N/A |
| PXAK1022 | 1 | 3 | 0 | N/A |
| PXAK1639 | 1 | 3 | 76 | N/A |
| PXAK1898 | 1 | 3 | 0 | N/A |
| PXAK2253 | 1 | 3 | 0 | N/A |
| PXAK2422 | 1 | 3 | 0 | N/A |
| PXAVMP | 1 | 3 | 172 | 5 |
| PXCMK315 | 1 | 3 | 148 | N/A |
| PXMK0619 | 1 | 3 | 180 | N/A |
| PXMK0657 | 2 | 3 | 150 | N/A |
| PXMK0658 | 1 | 3 | 150 | N/A |
| PXMK0769 | 1 | 3 | 46 | N/A |
| PXMK077 | 1 | 3 | 120 | N/A |
| PXMK0854 | 1 | 3 | 150 | N/A |
| PXMK0882 | 1 | 3 | 180 | N/A |
| PXMK0973 | 1 | 3 | 178 | N/A |
| PXMK099 | 1 | 3 | 0 | N/A |
| PXMK1063 | 1 | 3 | 240 | N/A |
| PXMK1065 | 3 | 3 | 239 | N/A |
| PXMK1070 | 1 | 3 | 120 | N/A |
| PXMK1071 | 2 | 3 | 119 | N/A |
| PXMK1074 | 2 | 3 | 180 | N/A |
| PXMK1085 | 1 | 3 | 180 | N/A |
| PXMK1132 | 4 | 3 | 206 | N/A |
16
| Supplement to Table 11-2: TruWave TM Models | ||||
|---|---|---|---|---|
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXMK1159 | 1 | 3 | 0 | N/A |
| PXMK1161 | 1 | 3 | 208 | N/A |
| PXMK1183 | 1 | 3 | 180 | N/A |
| PXMK1256NS | 1 | 3 | NA | N/A |
| PXMK1289 | 1 | 3 | 0 | N/A |
| PXMK1302 | 1 | 3 | 120 | N/A |
| PXMK1326 | 1 | 3 | 30 | N/A |
| PXMK1350 | 1 | 3 | 210 | N/A |
| PXMK1389 | 2 | 3 | 150 | N/A |
| PXMK1390 | 3 | 3 | 150 | N/A |
| PXMK142 | 1 | 3 | 90 | N/A |
| PXMK1505 | 1 | 3 | 0 | N/A |
| PXMK1506 | 1 | 3 | 0 | N/A |
| PXMK1545 | 1 | 3 | 119 | N/A |
| PXMK1577 | 1 | 3 | 23 | N/A |
| PXMK1640 | 4 | 3 | 274 | N/A |
| PXMK1717 | 2 | 3 | 58 | N/A |
| PXMK1724 | 4 | 3 | 0 | N/A |
| PXMK1736 | 2 | 3 | 234 | N/A |
| PXMK1752 | 1 | 3 | 120 | N/A |
| PXMK1761 | 3 | 3 | 119 | N/A |
| PXMK1861 | 1 | 3 | 180 | N/A |
| PXMK1882 | 1 | 3 | 30 | N/A |
| PXMK1903 | 1 | 3 | 89 | N/A |
| PXMK1927 | 4 | 3 | 119 | N/A |
| PXMK1935 | 1 | 3 | 90 | N/A |
| PXMK1939 | 1 | 3 | 150 | N/A |
| PXMK1967 | 4 | 3 | 196 | N/A |
| PXMK1970 | 3 | 3 | 150 | N/A |
| PXMK1978 | 2 | 3 | 150 | N/A |
| PXMK2005 | 1 | 3 | 15 | N/A |
| PXMK2024 | 1 | 3 | 198 | N/A |
| PXMK2064 | 1 | 3 | 180 | N/A |
| PXMK2065 | 3 | 3 | 183 | N/A |
| PXMK2082 | 3 | 3 | 203 | N/A |
| PXMK2112 | 1 | 3 | 210 | N/A |
| PXMK2127 | 3 | 3 | 180 | N/A |
| PXMK2138 | 1 | 3 | 30 | N/A |
| PXMK2147 | 1 | 3 | 0 | N/A |
17
| Supplement to Table 11-2: TruWave™ Models | ||||
|---|---|---|---|---|
| Model # | # of | |||
| Transducers | ||||
| (P/N 500479) | Transducer | |||
| Flow Rate | ||||
| (mL/hr) | Tubing Length | |||
| (cm) | Blood Sampling | |||
| Reservoir Size (cc) | ||||
| VAMP (K896819) | ||||
| PXMK2043 | 3 | 3 | 183 | N/A |
| PXMK2153 | 2 | 3 | 183 | N/A |
| PXMK2160 | 1 | 3 | 0 | N/A |
| PXMK2164 | 3 | 3 | 150 | N/A |
| PXMK2221 | 1 | 3 | 150 | N/A |
| PXMK2222 | 1 | 3 | 210 | N/A |
| PXMK2242 | 1 | 3 | 30 | N/A |
| PXMK2255 | 1 | 3 | 150 | N/A |
| PXMK2256 | 1 | 3 | 183 | N/A |
| PXMK2259 | 1 | 3 | 150 | N/A |
| PXMK2260 | 1 | 3 | 150 | N/A |
| PXMK2267 | 1 | 3 | 180 | N/A |
| PXMK2273 | 1 | 3 | 120 | N/A |
| PXMK2225 | 2 | 3 | 180 | N/A |
| PXMK1964 | 1 | 3 | 163 | N/A |
| PXMK1965 | 1 | 3 | 132 | N/A |
| PXMK1976 | 2 | 3 | 210 | N/A |
| T310845A | 1 | 30 | 171 | 3 |
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SECTION 4 - INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K141495
TruWave™ Disposable Pressure Transducer Device Name:
Indications For Use:
The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
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SECTION 5 – 510(k) SUMMARY
| TruWave™ Disposable Pressure Transducer 510(k) | |
|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC |
| Contact Person | Andrew S. Mazurkiewicz, Jr., MBA/MKT |
| Edwards Lifesciences | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Tel: (949) 250-5167 | |
| Date Prepared | June 5, 2014 |
| Trade Name | TruWave™ |
| Common Name | Disposable Pressure Transducer |
| Classification | |
| Name | Transducer, pressure, catheter tip |
| Regulation | |
| Class/Product | |
| Code | 21 CFR 870.2870 |
| Class II | |
| DXO | |
| Predicate Device(s) | K925638 - Phoenix Disposable Pressure Transducer #73-600 (Cleared 10/18/1993) |
| Device Description | The Edwards Lifesciences Pressure Monitoring Kit with TruWave |
| disposable pressure transducer is a sterile, single-use kit that monitors | |
| intravascular blood pressure, intracranial pressure, and intrauterine | |
| pressure. The disposable sterile cable (available in 12-inch/30 cm and | |
| 48-inch/120 cm lengths) interfaces exclusively with an Edwards | |
| Lifesciences cable that is specifically wired for the patient monitor used | |
| to display the pressure data. | |
| The TruWave Disposable Pressure Transducer has a straight, flow- | |
| through design, where the fluid is passed across the pressure sensor. | |
| The DPT is available either with or without an integral flush device. | |
| Indications for | |
| Use/Intended Use | The Pressure Monitoring Kit with TruWave Disposable Pressure |
| Transducer is for use on patients requiring intravascular, intracranial, or | |
| intrauterine pressure monitoring. | |
| Comparative | |
| Analysis | Material biocompatibility testing in compliance with applicable ISO 10993 |
| requirements, and performance testing was conducted to compare the | |
| proposed device to the predicate device. The results of the testing | |
| indicate that the fundamental scientific technology of the proposed | |
| device is unchanged from the legally marketed device (predicate). | |
| The proposed change to the TruWave disposable pressure transducer | |
| has been shown to be safe, effective, and substantially equivalent to the | |
| predicate device (Phoenix [TruWave] disposable pressure transducer) | |
| for its intended use in hospitals and other appropriate clinical | |
| environments. | |
| Functional/ Safety | |
| Testing | The TruWave disposable pressure transducer has successfully passed |
| functional- performance testing and biocompatibility testing, in | |
| accordance with applicable consensus standards. | |
| Conclusion | The TruWave disposable pressure transducers has been shown to be |
| safe, effective, and substantially equivalent to the predicate device | |
| (Phoenix [TruWave] disposable pressure transducer) for its intended use | |
| in hospitals and other appropriate clinical environments. |
20