The Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Pressure Monitoring Kit with TruWave Disposable Pressure Transducers" (K141495). This is a submission to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets acceptance criteria in the context of a new diagnostic algorithm or AI system.

Therefore, the information typically requested in your query regarding acceptance criteria and performance studies of AI/diagnostic algorithms (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, ground truth establishment) is not present in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through material biocompatibility and performance testing, without the need for the types of clinical performance studies you're asking about for AI/diagnostic algorithms.

However, I can extract the information relevant to what is present, which is comparative analysis and functional/safety testing, rather than an AI algorithm's performance.

Here's an interpretation based on the given information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Reported Device Performance
Material Biocompatibility	Successfully passed in compliance with applicable ISO 10993 requirements.
Performance Testing	Successfully passed performance testing.
Substantial Equivalence	Demonstrated to be safe, effective, and substantially equivalent to the predicate device (Phoenix [TruWave] disposable pressure transducer) for its intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document states that "performance testing was conducted", but no details about the sample size (number of devices, test conditions, etc.) or data provenance are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The evaluation of this medical device is based on "performance testing" and "biocompatibility testing," not on establishing ground truth for a diagnostic algorithm with expert review.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are typically relevant for diagnostic studies involving human interpretation or subjective assessments, which is not the nature of the testing described for this pressure transducer.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable as the device is a disposable pressure transducer, not an AI or diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device would be its physical and functional specifications. The performance testing would have compared the device's output (e.g., pressure readings) against a known standard or established measurement. The document states that testing was done to "compare the proposed device to the predicate device", implying the predicate device's established performance serves as a comparative benchmark.

8. The sample size for the training set

This is not applicable as the device is a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

This is not applicable as the device is a physical medical device, not an AI algorithm.

Summary

{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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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(RepresentativeModel)	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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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 #	# ofTransducers(P/N 500479)	TransducerFlow Rate(mL/hr)	Tubing Length(cm)	Blood SamplingReservoir 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

{18}------------------------------------------------

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)

{19}------------------------------------------------

SECTION 5 – 510(k) SUMMARY

TruWave™ Disposable Pressure Transducer 510(k)
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Andrew S. Mazurkiewicz, Jr., MBA/MKTEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250-5167
Date Prepared	June 5, 2014
Trade Name	TruWave™
Common Name	Disposable Pressure Transducer
ClassificationName	Transducer, pressure, catheter tip
RegulationClass/ProductCode	21 CFR 870.2870Class IIDXO
Predicate Device(s)	K925638 - Phoenix Disposable Pressure Transducer #73-600 (Cleared 10/18/1993)
Device Description	The Edwards Lifesciences Pressure Monitoring Kit with TruWavedisposable pressure transducer is a sterile, single-use kit that monitorsintravascular blood pressure, intracranial pressure, and intrauterinepressure. The disposable sterile cable (available in 12-inch/30 cm and48-inch/120 cm lengths) interfaces exclusively with an EdwardsLifesciences cable that is specifically wired for the patient monitor usedto 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 forUse/Intended Use	The Pressure Monitoring Kit with TruWave Disposable PressureTransducer is for use on patients requiring intravascular, intracranial, orintrauterine pressure monitoring.
ComparativeAnalysis	Material biocompatibility testing in compliance with applicable ISO 10993requirements, and performance testing was conducted to compare theproposed device to the predicate device. The results of the testingindicate that the fundamental scientific technology of the proposeddevice is unchanged from the legally marketed device (predicate).The proposed change to the TruWave disposable pressure transducerhas been shown to be safe, effective, and substantially equivalent to thepredicate device (Phoenix [TruWave] disposable pressure transducer)for its intended use in hospitals and other appropriate clinicalenvironments.
Functional/ SafetyTesting	The TruWave disposable pressure transducer has successfully passedfunctional- performance testing and biocompatibility testing, inaccordance with applicable consensus standards.
Conclusion	The TruWave disposable pressure transducers has been shown to besafe, effective, and substantially equivalent to the predicate device(Phoenix [TruWave] disposable pressure transducer) for its intended usein hospitals and other appropriate clinical environments.

{20}------------------------------------------------

Regulation Number and Section

§ 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).