The moorVMS-PRES pressure cuff controller is a device for cuff inflation and deflation control and pressure measurement. It is intended to allow non-invasive measurement of skin perfusion pressure, pulse volume, systolic blood pressure and ankle/toe brachial pressure index when used with a laser Doppler monitor either manually by the operator or automatically by separate dedicated PC software.

Device Description

The moorVMS-PRES vascular assessment pressure cuff controller is a device for cuff inflation and deflation control and pressure measurement. It allows connection of a range of standard pressure cuffs, ranging in size from small digit cuffs. It incorporates an air pump for cuff inflation and a proportional valve for controlled deflation. The moorVMS-PRES provides measurement of cuff gauge pressure which can be displayed on the front panel, and also the AC component of the cuff pressure (referred to as pulse volume) which can be outputted as analogue signals via a BNC connector or as digital data via the USB port.

The moorVMS-PRES is capable of performing timed inflation/deflation sequences when used alone and also be capable of remote control when connected to a PC via USB.

The moorVMS-PRES is intended to form part of a modular vascular monitoring system when used in conjunction with the moorVMS-LDF laser Doppler perfusion and temperature monitors. When used in this way the instruments will be controlled and monitored via USB using PC software to perform vascular assessment such as Skin Perfusion Pressure (SPP), Limb Blood Pressure or Toe Blood Pressure (LBP/TBP), Pulse Volume (PV), and Post Occlusive Reactive Hyperemia (PORH) analyses.

AI/ML Overview

The moorVMS-PRES Pressure Cuff Controller, a device for cuff inflation, deflation control, and pressure measurement, addresses its acceptance criteria and supporting study within the provided document through a comparison to a predicate device and compliance with established performance standards.

The document primarily focuses on establishing substantial equivalence to a predicate device, the Perimed PF 5050 Pressure Unit (K011899), rather than presenting a de novo clinical study with specific performance metrics and dedicated test sets.

Here's a breakdown based on the provided text:

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

The document does not provide a table of acceptance criteria with specific numerical targets and corresponding device performance values. Instead, it relies on a qualitative comparison to the predicate device and compliance with general safety and performance standards.

The key acceptance criteria and reported performance are implicitly stated through the comparison to the predicate device:

Acceptance Criteria (Implicit)	Reported Device Performance (as stated in the document)
Accuracy (of cuff pressure and PV pressure oscillations)	"The performance of the moorVMS-PRES is equivalent to or greater than that of the predicate device [PF 5050] in terms of accuracy..."
Inflation Control	"The performance of the moorVMS-PRES is equivalent to or greater than that of the predicate device in terms of... inflation."
Deflation Control	"The performance of the moorVMS-PRES is equivalent to or greater than that of the predicate device in terms of... deflation."
Biocompatibility	"The moorVMS-PRES has the same levels of biocompatibility... as the predicate device PF 5050 Pressure Unit."
Sterilization (if applicable for external contact parts)	"The moorVMS-PRES has the same levels of... sterilization... as the predicate device PF 5050 Pressure Unit."
Electrical Safety	"The moorVMS-PRES has the same levels of... electrical safety as the predicate device PF 5050 Pressure Unit."
Pressure Safety	"The moorVMS-PRES pressure safety is equivalent to or greater than that of the predicate device."
General Safety and Essential Performance	Compliance with IEC 60601-1:2005 and its corrigendum.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2:2007.
Usability	Compliance with IEC 60601-1-6:2006.
Biological Evaluation of Medical Devices	Compliance with ISO 10993-1:2003.
Functionality (e.g., inflation/deflation sequences, remote control, PC software integration for SPP, LBP/TBP, PV, PORH analyses)	The device is described as capable of performing these functions, and these are deemed equivalent to or enhanced compared to the predicate. For example, it automatically controls inflation/deflation, whereas the predicate used a manual pump for inflation.

2. Sample size used for the test set and the data provenance

The document does not explicitly mention a sample size for a dedicated test set for evaluating the moorVMS-PRES's performance. The basis for proving acceptance criteria is primarily through:

Comparison to a predicate device: This implies that the predicate device's established performance serves as the benchmark.
Compliance with international standards: This typically involves laboratory testing against specified requirements, but the document does not detail the specific tests conducted, the number of units tested, or the data provenance for these compliance tests.

Therefore, no specific sample size, country of origin, or information on whether the data was retrospective or prospective is provided for a test set in the context of a clinical performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document as there is no mention of a clinical test set requiring expert ground truth establishment.

4. Adjudication method for the test set

This information is not provided in the document, as no clinical test set requiring adjudication is described.

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

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or described in this document. The device is a "Pressure Cuff Controller" and is not an AI-assisted diagnostic tool in the sense of image interpretation where MRMC studies are common.

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

The device itself is a piece of hardware that performs physical actions (cuff inflation/deflation) and measurements. Its performance is inherent to its design and calibration, not a standalone algorithm in the typical sense of AI/image processing. The document focuses on its inherent performance characteristics and its capability to integrate with PC software for analyses. Therefore, this question doesn't directly apply, but the "standalone" performance is implicitly covered by the accuracy and safety standards listed.

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

For the direct comparison and performance claims, the "ground truth" is established by:

Predicate device performance: The established and accepted performance of the Perimed PF 5050 Pressure Unit serves as the benchmark.
International standards: Compliance with standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and ISO 10993-1 means the device has met predefined technical and safety specifications, which act as the "ground truth" for those specific aspects.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for a clinical validation or performance study.

8. The sample size for the training set

This information is not applicable/provided. The moorVMS-PRES is a physical medical device, not a machine learning model that requires a "training set" in the context of AI.

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

This information is not applicable/provided, for the same reasons as point 8.

Summary

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102433

moorVMS-PRES Pressure Cuff Controller 510(k) Summary

Submitter:	Moor Instruments Ltd		NOV 18 2010
Address:	MillweyAxminster, DevonEX13 5HU, United Kingdom
Telephone:	(+44) 1297 35715
Fax:	(+44) 1297 35716
Contact:	Xiabing Huang
Contact title:	Technical Manager
E-mail:	xhuang@moor.co.uk
Date:	August 25th, 2010
Model Name:	moorVMS-PRES Pressure Cuff Controller
Model Number:	moorVMS-PRES
Common Name:	Pressure Cuff Controller
Classification Name:	Air Plethysmograph / Pulse Volume Recorder, DPW, 21 CFR
Regulatory Status:	Class II
Establishment Reg No:	8043564
Type of 510(k):	Traditional
Reason for submission:	New device
Predicate Device:	PF 5050 Pressure Unit, Perimed AB, 510(k) Number K011899

Moor Instruments Ltd Millwey Axminster Devon EX13 5HU UK tel +44 (0)1297 35715 fax +44 (0)1297 35716 ' email sales@moor.co.uk website www.moor.co.uk Company Registered in England No. 2200367 VAT Registration No. GB490667906

Image /page/0/Picture/5 description: The image contains two logos. The logo on the left has a check mark inside of a circle with the text "SGS" below it and the text "13.03.2003" at the bottom. The logo on the right has a crown above a check mark with the text "UKAS QUALITY MANAGEMENT" below it and the number "005" at the bottom.

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Description of the Device

The moorVMS-PRES is capable of performing timed inflation/deflation sequences when used alone and also be capable of remote control when connected to a PC via USB.

Intended Use

Comparison to Predicate Device

Technological Characteristics

Both moorVMS-PRES and the predicate device PF 5050 control cuff pressure and measure cuff pressure and PV pressure oscillations. Both are intended for use with PC software for PV analysis and also for PORH, SPP and LDP/TBP analyses when a laser Doppler blood flow monitor is connected.

Both devices rely on the same principles of operation, i.e. a piezoelectric pressure sensor for both pressure and AC pulse volume measurement. The moorVMS-PRES and the predicate device both control cuff pressure. The difference is that the predicate device uses a manual pump for inflation while the moorVMS-PRES controls both cuff inflation and cuff deflation automatically. The performance of the moorVMS-PRES is equivalent to or greater than that of the predicate device in terms of accuracy, inflation and deflation.

The moorVMS-PRES has the same levels of biocompatibility, sterilization and electrical safety as the predicate device PF 5050 Pressure Unit. The moorVMS-PRES pressure safety is equivalent to or greater than that of the predicate device.

Both devices have pressure control protocols for PV, PORH, SPP and LBP/TBP analyses performed by the PC program. The moorVMS-PRES also allows users to build pressure control protocols from the stages used in the analyses. Further more the moorVMS PC software provides Ankle Brachial Pressure Index (ABPI) and Toe Brachial Pressure Index (TBPI) calculation based on the limb and toe systolic blood pressure measured.

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Performance Standards

The moorVMS-PRES has been designed and tested for compliance with the following standards:

IEC 60601-1:2005 Medical Electrical Equipment General Requirements for basic safety and ■ essential performance including corrigendum 1 Dec 2006.
. IEC 60601-1-2:2007 Medical electrical equipment. Collateral standard. Electromagnetic compatibility. Requirements and tests
이 IEC 60601-1-6:2006 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
. ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing

Conclusions

From the description of the technological characteristics and the performance standards above, it can be concluded that the moorVMS-PRES is substantially equivalent to the Perimed PF5050 predicate device, in terms of effectiveness and safety.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Moor Instruments LTD c/o Mr. Xiabing Huang Millwey Axminster, Devon EX13 SHU UNITED KINGDOM

NOV 1 8 2010

Re: K102433

Trade/Device Name: moorVMS-PRES Pressure Cuff Controller Regulatory Number: 21 CFR 870.2100 Regulation Name: Cardiovascular Blood Flowmeter Regulatory Class: II (two) Product Code: DPW Dated: August 24, 2010 Received: August 26, 2010

Dear Mr. Huang:

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 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

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Page 2 - Mr. Xiabing Huang

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Indications for Use Statement 5

NOV 1 8 2010

510(k) Number: K102433

moorVMS-PRES Pressure Cuff Controller Device name:

Indications for use:

Prescription Use: Yes

(Part 21 CFR 801 SubpartD)	(21 CFR 807 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)

ascular Devices

AND/OR

510(k) Numb

loti

Over-The-Counter Use: No

Regulation Number and Section

§ 870.2100 Cardiovascular blood flowmeter.

(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).