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 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.

AI/ML Overview

The ReavillMED Pressure Monitoring System is a combination product consisting of a blood pressure monitoring line with an end cap, a disposable pressure transducer, a single lumen polyurethane reverse taper catheter, and a catheter hub with suture wing tabs and a slip tip cap. It is intended for continuous measurement of blood pressure or other physiological pressures, and the catheter is for short-term peripheral access to the central venous system.

1. Table of acceptance criteria and the reported device performance

Testing Performed	Standard	Acceptance Criteria	Reported Device Performance
Sensor Testing	ANSI/AAMI BP-22, 1994	Operating Pressure Range: -50 mmHg to +300 mmHg	Meets Requirements
		Sensitivity: 5µV/V/mmHg, +/- 2% (typically < +/- 1%)	Meets Requirements
		Zero Drift with Time: +1.0 mmHg/8 hours after 10 minute warm up to operating temperature	Meets Requirements
		Leakage Current: < 2µA @ 115 VAC RMS and 60 Hz	Meets Requirements
		Unbalance: +75 mmHg	Meets Requirements
		Overpressure Protection: -400 mmHg to +4000 mmHg	Meets Requirements
		Operating Temperature: 15 C to 40 C	Meets Requirements
		Excitation Voltage and Frequency: 2 to 10 VDC or VAC RMS to 50kHz	Meets Requirements
		Operating Life: >500 hours	Meets Requirements
		Storage Temperature: -25 C to +65 C	Meets Requirements
		Defibrillation Withstand: 5 discharges/5 minutes of 360 joules @ 50 Ω load	Meets Requirements
		Natural Frequency: > 20 Hz in saline	Meets Requirements
		Phase Shift: < 5 degrees at 5 Hz	Meets Requirements
		Output Impedance: 270 Ω to 400 Ω	Meets Requirements
		Input Impedance: 270 Ω to 400 Ω	Meets Requirements
Luer taper and lock fittings	ISO 594-1	Conical fitting and 6% luer taper, Liquid leakage from fitting assembly under pressure, Air leakage into fitting assembly during aspiration, Separation force of fitting assembly, Unscrew torque of fitting assembly, Ease of assembly, 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 (Monitoring Line)	ISO 10993-1	Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemocompatibility	Meets requirements
Biocompatibility testing (Catheter)	ISO 10993-1	Cytotoxicity, Sensitization, Irritation Reactivity, Systemic Toxicity, Hemolysis, Implantation, 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 following incubation	To be performed prior to product release
EtO residual testing	ISO 10993-7	EO = 60mg/30days	To be performed prior to product release

The study details provided here are for the ReavillMED Pressure Monitoring System. The “Results” column in the table above indicates "Meets Requirements" or "Acceptable" for all tests performed and reported. For EtO sterilization validation and EtO residual testing, the results were "To be performed prior to product release", implying these were pending and not part of the initial submission for assessment.

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

The document does not specify the sample size used for the test set for any of the non-clinical tests. Furthermore, it does not provide information about the data provenance (country of origin), nor if the data was retrospective or prospective.

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 tests performed are primarily non-clinical, laboratory-based functional and safety tests, rather than studies requiring expert interpretation of clinical data.

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

This information is not applicable and is not provided in the document, as the tests are non-clinical, not requiring a human adjudication method for interpretation.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission is for a medical device (a pressure monitoring system and catheter), not an AI-powered diagnostic tool.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

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

The ground truth for the non-clinical tests was established by predefined objective acceptance criteria based on recognized international and national standards (e.g., ANSI/AAMI BP-22, ISO 594-1, ISO 10555 Parts 1 and 3, ISO 10993-1, ISO 14971, ANSI-AAMI/ISO 11135-1, ISO 10993-7). The "ground truth" here refers to the quantitative and qualitative pass/fail thresholds defined by these standards.

8. The sample size for the training set

This information is not applicable. The development of this medical device does not involve a "training set" in the context of machine learning or AI. The product undergoes design, manufacturing, and testing according to engineering and quality standards, not algorithm training.

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

This information is not applicable, as there is no "training set" as understood in machine learning contexts for this device.

Summary

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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: 847-856-0355 Fax: 847-856-0355 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:

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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: -50mmHg to +300 mmHgSensitivity: 5µV/V/mmHg, +/- 2%(typically < +/- 1%)Zero Drift with Time: +1.0 mmHg/8hours after 10 minute warm up tooperating temperatureLeakage Current: < 2µA @ 115 VACRMS and 60 HzUnbalance: +75 mmHg	Meets Requirements
Sensor Testing (continued)	ANSI/AAMI BP-22, 1994	Overpressure Protection: -400mmHg to +4000 mmHgOperating Temperature: 15 C to 40 CExcitation Voltage and Frequency: 2to 10 VDC or VAC RMS to 50kHzOperating Life: >500 hoursStorage Temperature: -25 C to +65 CDefibrillation Withstand: 5discharges/5 minutes of 360 joules @50 Ω load)Natural Frequency: > 20 Hz in salinePhase Shift: < 5 degrees at 5 HzOutput Impedance: 270 Ω to 400 ΩInput 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• Liquid leakage from fitting assembly under pressure• Air leakage into fitting assembly during aspiration• Separation force of fitting assembly• Unscrew torque of fitting assembly• Ease of assembly• 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(Monitoring Line)	ISO 10993-1	• Cytotoxicity• Sensitization• Irritation/Intracutanious Reactivity• Systematic Toxicity• Hemocompatibility	Meets requirements
Biocompatibility testing(Catheter)	ISO 10993-1	• Cytotoxicity• Sensitization• Irritation Reactivity• Systematic Toxicity• Hemolysis• Implantation• 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• following incubation	To be performed priorto product release
EtO residual testing	ISO 10993-7	• EO = 60mg/30days	To be performed priorto 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 (800) 638-2041 or (301) 796-7100 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:

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

Page 1 of 1

Regulation Number and Section

§ 870.2850 Extravascular blood pressure transducer.

(a)
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.(b)
Classification. Class II (performance standards).