REAVILLMED PRESSURE MONITORING SYSTEM AND PICC

K101189 · Reavillmed · DRS · Dec 22, 2010 · Cardiovascular

Device Facts

• Record ID: K101189
• Device Name: REAVILLMED PRESSURE MONITORING SYSTEM AND PICC
• Applicant: Reavillmed
• Product Code: DRS · Cardiovascular
• Decision Date: Dec 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2850
• Device Class: Class 2

Intended Use

The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.

Device Story

ReavillMED Pressure Monitoring System is a combination device comprising a blood pressure monitoring line, disposable pressure transducer, and single-lumen polyurethane reverse taper PICC. Device facilitates continuous measurement of blood or physiological pressures while providing short-term peripheral access to the central venous system. Used in clinical settings by healthcare professionals. Transducer converts physiological pressure signals into electrical signals for monitoring equipment. System includes catheter hub with suture wing tabs and slip tip cap. Sterile, single-use, non-pyrogenic design ensures patient safety during venous access and pressure monitoring procedures.

Clinical Evidence

Bench testing only. Testing performed per ANSI/AAMI BP-22 (1994) for sensor performance (operating range -50 to +300 mmHg, sensitivity 5µV/V/mmHg, leakage current <2µA, natural frequency >20 Hz). Biocompatibility testing conducted per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility, implantation, genotoxicity). Mechanical testing performed per ISO 594-1 (luer fittings) and ISO 10555 (tensile strength). All results met acceptance criteria.

Technological Characteristics

Combination device: single-lumen polyurethane reverse taper catheter and disposable pressure transducer. Materials meet ISO 10993-1 biocompatibility standards. Sensing principle: pressure transducer (ANSI/AAMI BP-22). Connectivity: standard pressure monitoring line interface. Sterilization: Ethylene Oxide (EtO) per ANSI/AAMI/ISO 11135-1. Mechanical specs: ISO 594-1 luer fittings, ISO 10555 tensile requirements.

Indications for Use

Indicated for patients requiring continuous blood or physiological pressure monitoring and short-term peripheral access to the central venous system.

Regulatory Classification

Identification

An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

Predicate Devices

• Utah Pressure Monitoring Device (K842352)
• Utah Disposable Pressure Transducer (K841788)
• POLY RADPICC (K031129)
• UMBILI-CATH-P (K940871)

Submission Summary (Full Text)

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## Attachment 1

DEC 2 2 2010

#### న్. 510(k) Summary

(10118 Trade Name: ReavillMED Pressure Monitoring System Common Name: Blood Pressure Monitoring/Transducer Peripheral Inserted Central Catheter Intravascular Catheter Classification Name: Extravascular blood pressure transducer 21 CFR 870.2850. This device is categorized as DRS and is regulated as Class II. . Percutaneous, implanted, long-term intravascular catheter 21 CFR 880.5970. This device is categorized as LJS and is regulated as Class II. Intravascular catheter 21 CFR 880.5200. This device is categorized as LJS and is regulated as Class II. ー ReavillMED LLC Submitter Information: 888 E. Belvidere Rd., Suite 212 Grayslake, IL 60030 USA Tel: [phone] Fax: [phone] Michele Vovolka Summary Prepared By: President, Vantage Consulting International, Ltd. Date Prepared: December 1, 2010 Predicate Devices: Utah Pressure Monitoring Device (K842352) Utah Disposable Pressure Transducer (K841788) Bard POLY PER-Q-CATH PICC CATHETERS: POLY RADPICC (K031129) UMBILI-CATH-P (K940871)

### Device Description:

The ReavillMED pressure monitoring device is a combination product consisting of the following components within a single device:

- . Blood pressure monitoring line and end cap
- . Disposable pressure transducer
- Single lumen polyurethane reverse taper catheter .
- . Catheter hub with suture wing tabs and slip tip cap

The single lumen catheter is packaged within a pressure monitoring line to maintain a sterile environment. A transducer is attached to the distal end of the monitoring line.

The product is sold sterile, single use, and non-pyrogenic.

#### Indications for Use:

The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.

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# Attachment 1

## Technological Characteristics:

The technological characteristics of the ReavillMED device are compatible to those of the following predicate devices.

# Utah Medical Disposable Pressure Transducer (K841788):

| • Intended use | • Unbalance | • Phase shift |
|--------------------------------------------------|----------------------------------|-----------------------------------|
| • Sensor materials | • Overpressure protection | • Output impedance |
| • Wire connector material | • Operating temperature | • Input impedance |
| • Housing assembly materials | • Excitation voltage & frequency | • Sterility |
| • Operating pressure range | • Operating life | • Leakage current |
| • Sensitivity | • Storage temperature | • Natural frequency |
| • Zero drift with time | • Defibrillation withstand | |
| Utah Medical Pressure Monitoring Line (K842352): | | |
| • Intended use | • Dimensions | • Sterility |
| • Tubing connectors material | • Hardness | • Performance |
| • Pressure tubing material | | |
| Poly RADPICC (K031129): | | |
| • Intended Use | • Sterility | • Dimensional diameter and length |
| • ISO 10553 Parts 1 and 3 | | |
| UMBILI-CATH-P (K940871): | | |
| • Intended Use | • Sterility | • Contact duration |

- · Material
- · Sterility
- · ISO 10553 Parts 1 and 3

# Non Clinical Data Summary:

The following testing was performed on the ReavillMED Blood Pressure Monitoring Device

| Testing Performed | Standard | Acceptance Criteria | Results |
|----------------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Sensor Testing | ANSI/AAMI BP-22, 1994 | Operating Pressure Range: -50<br>mmHg to +300 mmHg<br>Sensitivity: 5µV/V/mmHg, +/- 2%<br>(typically < +/- 1%)<br>Zero Drift with Time: +1.0 mmHg/8<br>hours after 10 minute warm up to<br>operating temperature<br>Leakage Current: < 2µA @ 115 VAC<br>RMS and 60 Hz<br>Unbalance: +75 mmHg | Meets Requirements |
| Sensor Testing (continued) | ANSI/AAMI BP-22, 1994 | Overpressure Protection: -400<br>mmHg to +4000 mmHg<br>Operating Temperature: 15 C to 40 C<br>Excitation Voltage and Frequency: 2<br>to 10 VDC or VAC RMS to 50kHz<br>Operating Life: >500 hours<br>Storage Temperature: -25 C to +65 C<br>Defibrillation Withstand: 5<br>discharges/5 minutes of 360 joules @<br>50 Ω load)<br>Natural Frequency: > 20 Hz in saline<br>Phase Shift: < 5 degrees at 5 Hz<br>Output Impedance: 270 Ω to 400 Ω<br>Input Impedance: 270 Ω to 400 Ω | Meets Requirements |

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#### Attachment 1

| Testing Performed | Standard | Acceptance Criteria | Results |
|-----------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Luer taper and lock fittings | ISO 594-1 | • Concial fitting and 6% luer taper<br>• Liquid leakage from fitting assembly under pressure<br>• Air leakage into fitting assembly during aspiration<br>• Separation force of fitting assembly<br>• Unscrew torque of fitting assembly<br>• Ease of assembly<br>• Resistance to overriding | Meets Requirements |
| Tensile Testing | ISO 10555 Parts 1 and 3 | • Minimum break force of 4N (or 0.89923 lbs of force) | Meets requirements |
| Biocompatibility testing<br>(Monitoring Line) | ISO 10993-1 | • Cytotoxicity<br>• Sensitization<br>• Irritation/Intracutanious Reactivity<br>• Systematic Toxicity<br>• Hemocompatibility | Meets requirements |
| Biocompatibility testing<br>(Catheter) | ISO 10993-1 | • Cytotoxicity<br>• Sensitization<br>• Irritation Reactivity<br>• Systematic Toxicity<br>• Hemolysis<br>• Implantation<br>• Genotoxicity | Meets requirements |
| Risk Analysis | ISO 14971 | • No unacceptable risks | Acceptable |
| EtO sterilization validation | ANSI/AAMI/ISO 11135-1 | • No growth of the test organism from any of the processed indicators for ethylene oxide sterilization<br>• following incubation | To be performed prior<br>to product release |
| EtO residual testing | ISO 10993-7 | • EO = 60mg/30days | To be performed prior<br>to product release |

#### Non Clinical Data Summary (continued):

#### Conclusions:

The indications for use are consistent with the previously indicated predicate devices and in the applicable FDA classification regulation. Differences in technological characteristics from those of the cited predicate devices do not raise new issues of safety or effectiveness and are addressed in the submission. The product meets the following standards:

- · ANSI/AAMI BP-22, 1994
- . ISO 594-1
- ISO 10555 Parts 1 and 3 .
- . ISO 10993-1
- . ISO 14971
- ANSI-AAMI/ISO 11135-1 .
- ISO 10993-7 .

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.

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

Ms. Michele Vovolka Vice President, Quality Operations ReavillMED 888 East Belvidere Road. Suite 212 Grayslake, Illinois 60030

DEC 2 2 2000

Re: K101189

Trade/Device Name: ReavillMED Blood Pressure Monitoring System Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: II Product Code: DRS, LJS Dated: November 18, 2010 Received: November 19, 2010

Dear Ms. Vovolka:

.

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.

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Page 2 - Ms. Vovolka

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

James J. Solstad

for

Anthony Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

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#### Indications for Use 4.

DEC 2 2 2010

510(k) Number (if known): K101189

Device Name: __ ReavillMED Blood Pressure Monitoring System

Indications for Use:

The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nld C. Alr 12/2/10

(Division Biga-Off)
Division of Anesthesiology, Gunna Magte
Infection Control and Dental Devings
\$100)

K1 01189

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