The Mespere LifeSciences Inc. Mespere Venus 1000 Central Venous Pressure System is used to indicate right heart pressure at the superior vena cava, which is clinically referred to as central venous pressure (CVP). The main components of the Mespere Venus 1000 System include: a handheld display unit, a pressure sensor cable unit, neck patch adhesive liners, an adhesive reference patch, and a docking station for calibration and charging. The handheld unit displays the CVP value at a refresh rate of one second and the plethysmographic waveform.

AI/ML Overview

The provided text describes two clinical studies: "Clinical Verification" and "Clinical Validation." The "Clinical Verification" study focused on usability, accuracy, and correlation of the device with CVP obtained by physicians, while the "Clinical Validation" study compared the device to the Edwards Swan-Ganz right heart catheter (RHC) for accuracy.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets (e.g., "accuracy must be X%"). Instead, the studies aim to demonstrate "claimed accuracy and appropriate usability" and "equivalence in performance."

Acceptance Criteria (Implicit)	Reported Device Performance
Usability of the device for measuring CVP	The clinical verification demonstrated "appropriate usability" of the Mespere Venus 1000 System.
Accuracy of the device for measuring CVP (compared to physical examination)	The clinical verification demonstrated the "claimed accuracy" of the Mespere Venus 1000 System. (No specific numerical accuracy is provided).
Accuracy of the device for measuring CVP (compared to RHC)	The clinical validation study demonstrated that the Mespere Venus 1000 System is "equivalent in performance" to the Edwards Lifesciences Swan-Ganz catheter with respect to measuring CVP. (No specific numerical equivalence metric is provided).
Safety (Adverse Events)	"No adverse events were reported" in both the clinical verification and clinical validation studies.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Verification:
- Sample Size: "a mix of healthy volunteers and patients." The exact number is not specified.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The text does not provide country of origin.
Clinical Validation:
- Sample Size: "acute and chronic heart failure patients already receiving RHC as part of their usual care." The exact number is not specified.
- Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The text does not provide country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Clinical Verification:
- Number of Experts: Unspecified, but ground truth was "CVP obtained by physicians." This implies multiple physicians, but the exact number isn't given.
- Qualifications: "physicians." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided.
Clinical Validation:
- Number of Experts: Not applicable, as the ground truth was the "Edwards Swan-Ganz right heart catheter (RHC)," which is a device, not human experts.

4. Adjudication Method for the Test Set

The text does not mention any adjudication method (e.g., 2+1, 3+1, none) for either the clinical verification or the clinical validation studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was explicitly described. The clinical validation study compared the device to a reference standard (RHC), but it did not involve human readers comparing the AI-assisted vs. non-AI assisted approaches. The "Clinical Verification" mentions "physicians" obtaining CVP, but doesn't describe a formal MRMC study design for improving human performance with AI.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

Yes, a standalone performance study was done. Both the "Clinical Verification" and "Clinical Validation" studies assessed the performance of the Mespere Venus 1000 System independently (i.e., the algorithm/device's output) against a reference standard or physician assessment. There is no mention of a "human-in-the-loop" component in these performance evaluations.

7. Type of Ground Truth Used

Clinical Verification: Expert consensus (implicitly, "CVP obtained by physicians" suggesting their clinical judgment)
Clinical Validation: Device-based reference standard ("Edwards Swan-Ganz right heart catheter (RHC)")

8. Sample Size for the Training Set

Not provided. The document focuses on the clinical verification and validation studies, which typically refer to the test set. Information about the training set size or how the algorithm was developed is not included.

9. How the Ground Truth for the Training Set Was Established

Not provided. As the training set information is absent, the method for establishing its ground truth is also not mentioned.

Summary

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Appendix 5-1

Image /page/0/Picture/2 description: The image shows the logo for Mespere Life Sciences. The logo is black and white and features the company name in a stylized font. The word "Mespere" is in a larger font than "Life Sciences", which is located below the company name.

180 Frobisher Drive, Suite 1C
Waterloo, ON N2V 2.42

t: 519-884-7575
£ 519-884-8810

ורוויווי.mespere.com

510(k) SUMMARY

Submitted by:	Mespere LifeSciences Inc.180 Frobisher Drive, Unit 1CWaterloo, Ontario, CanadaN2V 2A2Phone : (519) 884-7575Fax: (519) 884-8810
	AUG 2 2 2013
Company contact:	Helen Tan, Vice President, Regulatory Affairs and QualityAssurance
Date summary prepared:	04/05/2013
Trade name:	Central Venous Pressure System - Mespere Venus 1000
Common name:	CVP System
Classification name:	870.1140 (Product code PFA)
Classification:	Class II Medical Device
Predicate Device:	K014054EDWARDS LIFESCIENCES SWAN-GANZ MONITORINGCATHETER WITH OLIGON MATERIALProduct code: DQORegulation number: 870.1200K120773Nellcor Bedside SPO2 Patient Monitoring SystemProduct code: DQARegulation Number: 870.2700K102968Draeger Infinity CNAP SmartPodProduct Code: DXNRegulation Number: 870.1130

Page 1 of 4

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Image /page/1/Picture/1 description: The image shows the logo for "Mespere Life Sciences". The logo is in black and white and features a stylized font. The word "Mespere" is in a larger font than "Life Sciences", which is located underneath the first word.

180 Frobisher Drive, Suite 10 Waterloo, ON N2V 2A2

t: 519-884-7575 f: 519-384-8810

www.mespere.com

Device Description:

The main components of the Mespere Venus 1000 System include: a handheld display unit, a pressure sensor cable unit, neck patch adhesive liners, an adhesive reference patch, and a docking station for calibration and charging. The handheld unit displays the CVP value at a refresh rate of one second and the plethysmographic waveform.

The device is intended for use in hospital and clinical environments by healthcare professionals.

Intended Use/Indications For Use:

The Venus 1000 System is intended to be used by healthcare professionals for assessment of central venous blood pressure (CVP) of adult individuals.

Technology Characteristics:

The Venus 1000 System and the predicate device - Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon Material have the same intended use with respect to measuring right heart pressures. However, they have different technology characteristics. The Venus 1000 System is based on non-invasive near infrared spectroscopy (NIRS) technology. The Edwards Lifesciences Swan-Ganz Monitoring Catheter is based on invasive catheter and pressure transducer technology. The Venus 1000 System is safer and easier to use than catheters for right heart pressure measurement.

The Venus 1000 system and the predicate devices - Nellcor Bedside SPO2 Patient Monitoring System and the Draeger Infinity CNAP SmartPod have the similar technology. They all based on non-invasive near infrared spectroscopy (NIRS). The Venus 1000 System uses single-wavelength LEDs and photodetectors (PD) to detect changes in blood volume. The Nellcor Bedside SPO2 Patient Monitoring System uses multiple wavelength LEDs and photodetectors to detect ratio of light absorption between oxygenated and deoxygenated haemoglobin. The Draeger Infinity CNAP SmartPod uses photoplethysmograph sensors (LEDs and detectors) to detect changes in blood volume.

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Image /page/2/Picture/1 description: The image shows the logo for Mespere Life Sciences. The logo is in black and white and features the company name in a stylized font. The words "LIFE SCIENCES" are written in smaller letters below the company name. The logo is simple and modern.

180 Frobisher Drive, Suite 1C Waterloo, ON N2V 2A2

t: 519-884-7575 f: 519-884-8810

www.mespere.com

Complied Standards:

The design of the Mespere Venus 1000 device conforms to the following voluntary standards:

IEC 60601-1: 2005 edition 3.0 .
IEC 60601-1-2: 2007 edition 3.0 ●
IEC 60601-1-4: 2000 ●
IEC 60601-1-6: 2010 ●
IEC/ISO 62366:2007 �
. ISO 14971:2007
ISO 14155:2011 ●
IEC/EN 62304:2006 ●
EN 980:2008 .
. EN 1041:2008
ISO 15223-1:2012 �
ISO 13485:2003 ●
ISO 10993-1:2009 ●
ISO 2859-1:1999 .

Non-Clinical Tests:

The Venus 1000 System was subjected to extensive safety testing, performance testing, and verification tests of the Venus 1000 System included various performance tests and software tests, designed to ensure that the device met all its functional specifications. A bench test verified the performance of the device to meet the design requirements in an ideal non-clinical environment. All tests were performed to ensure the device complies with industry and safety standards.

Clinical Tests:

Clinical tests were performed to verify and validate the clinical performance of the Venus 1000 System and support the determination of substantial equivalence. The following clinical data was submitted:

Clinical verification: The primary objective of this study was to investigate the usability, accuracy and correlation of Mespere Venus 1000 System for measuring central venous pressure, by comparing it to physical examination of CVP obtained by physicians. The subjects recruited for this study were a mix of healthy volunteers and patients.

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Image /page/3/Picture/1 description: The image shows the logo for "Mespere Life Sciences". The logo features a stylized "M" with a vertical line to the left of it. Below the word "Mespere" are the words "LIFE SCIENCES" in a smaller font.

180 Frobisher Drive, Suite 10 Waterloo, ON N2V 2A2

t: 519-884-7575 f. 519-884-8810

ורויוי, mespere. com

Results: The clinical verification demonstrated the claimed accuracy and appropriate usability of the Mespere Venus 1000 System for measuring CVP.

No adverse events were reported.

Clinical Validation: The primary objective of this study was to validate the accuracy of central venous pressure (CVP) readings of the Venus 1000 System by comparison to the Edwards Swan-Ganz right heart catheter (RHC). The recruited subjects consisted of acute and chronic heart failure patients already receiving RHC as part of their usual care. RHC was performed in the standard fashion.

Results: The clinical validation study demonstrated that the Mespere Venus 1000 System is equivalent in performance to the Edwards Lifesciences Swan-Ganz catheter with respect to measuring CVP.

No adverse events were reported.

Substantial Equivalence of Performance:

The Venus 1000 device is substantially equivalent to the predicate devices in terms of the performance and the technology safety and effectiveness.

Conclusions:

The conclusions drawn from the above performance and clinical testing is that the Mespere Venus 1000 CVP System is substantially equivalent to the predicate devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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August 22, 2013

Mespere LifeSciences Inc C/O Helen Tan 180 Frobisher Dr. Unit 1C Waterloo, ON, CA N2V2A2

Re: K131085

Trade/Device Name: Central Venous Pressure System Regulation Number: 21 CFR 870.1140 Regulation Name: Venous Blood Pressure Regulatory Class: Class II Product Code: PFA Dated: June 28, 2013 Received: July 16, 2013

Dear Helen Tan:

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.

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.

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Page 2 - Helen Tan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact 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. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131085

Image /page/6/Picture/1 description: The image shows the text "Central Venous Pressure System - Traditional 510(k) Notification". The text is in black and is centered on the page. There is also a logo on the left side of the image. The logo is for a company called "Wescope Life Sciences".

SECTION 4 INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known):

Device Name: Central Venous Pressure System

Indications For Use: Mespere Venus 1000 is intended to be used by healthcare professionals for assessment of central venous blood pressure (CVP) of adult individuals.

Prescription Use _ Yes (Part 21 CFR 801 Subpart D)

UseYes
301 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)

Digitally signed by
Owen P. Faris -S
Date: 2013.08.22
15:40:41 -04'00'

Section 4

Regulation Number and Section

§ 870.1140 Venous blood pressure manometer.

(a)
Identification. A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.(b)
Classification. Class II (performance standards).