MOORVMS-PRES PRESSURE CUFF CONTROLLER

K102433 · Moor Instruments, Ltd. · DPW · Nov 18, 2010 · Cardiovascular

Device Facts

• Record ID: K102433
• Device Name: MOORVMS-PRES PRESSURE CUFF CONTROLLER
• Applicant: Moor Instruments, Ltd.
• Product Code: DPW · Cardiovascular
• Decision Date: Nov 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2100
• Device Class: Class 2

Intended Use

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 Story

The moorVMS-PRES is a pressure cuff controller for vascular assessment. It connects to standard pressure cuffs, using an internal air pump for inflation and a proportional valve for controlled deflation. It measures cuff gauge pressure and the AC component of cuff pressure (pulse volume). The device operates either as a standalone unit for timed inflation/deflation or via USB remote control from a PC. When integrated with moorVMS-LDF laser Doppler monitors, it facilitates clinical analyses including Skin Perfusion Pressure (SPP), Limb/Toe Blood Pressure (LBP/TBP), Pulse Volume (PV), and Post Occlusive Reactive Hyperemia (PORH). PC software calculates Ankle/Toe Brachial Pressure Indices (ABPI/TBPI). Clinicians use the output to assess vascular health and perfusion status. The device is intended for clinical settings where vascular monitoring is required.

Clinical Evidence

Bench testing only. The device was tested for compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), and ISO 10993-1 (biocompatibility). No clinical trial data was required or provided for this 510(k) submission.

Technological Characteristics

Piezoelectric pressure sensor for pressure and AC pulse volume measurement. Features internal air pump and proportional valve for automated inflation/deflation. Connectivity via USB for PC control and BNC for analog signal output. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and ISO 10993-1 standards.

Indications for Use

Indicated for non-invasive measurement of skin perfusion pressure, pulse volume, systolic blood pressure, and ankle/toe brachial pressure index in patients requiring vascular assessment, when used in conjunction with a laser Doppler monitor.

Regulatory Classification

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.

Predicate Devices

• PF 5050 Pressure Unit, Perimed AB (K011899)

Reference Devices

• moorVMS-LDF laser Doppler perfusion and temperature monitor (K083082)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo for Moor Instruments. The logo consists of a circular graphic with radiating lines on the left, followed by the text "moor instruments" in a simple, sans-serif font. Below the company name, there is a tagline that reads "laser Doppler blood flow assessment" in a smaller font size.

102433

# moorVMS-PRES Pressure Cuff Controller 510(k) Summary

| Submitter: | Moor Instruments Ltd | | NOV 18 2010 |
|------------------------|----------------------------------------------------------|--|-------------|
| Address: | Millwey<br>Axminster, Devon<br>EX13 5HU, United Kingdom | | |
| Telephone: | ([phone] | | |
| Fax: | ([phone] | | |
| Contact: | Xiabing Huang | | |
| Contact title: | Technical Manager | | |
| E-mail: | [e-mail] | | |
| 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 [phone] fax [phone] ' email [e-mail] website www.moor.co.uk Company Registered in England No. 2200367 VAT Registration No. GB490667906

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### Description of the Device

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. The moorVMS-LDF laser Doppler perfusion and temperature monitor has FDA 510(k) approval K083082.

#### Intended Use

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.

#### 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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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 [phone] or [phone] 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

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.

| (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

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Over-The-Counter Use: No