The CADD®-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patientcontrolled analgesia.

Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.

Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.

Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.

Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion.

The CADD™ Solis Medication Safety Software – Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD -Solis VIP Ambulatory Infusion Pump, CADD -Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD™ Solis Medication Safety Software -- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software - Administrator to the CADD® Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

Device Description

The CADD®-Solis VIP Ambulatory Infusion Pump ("Solis VIP Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump (K072144) and CADD-Prizm® VIP Ambulatory Infusion Pump (K960826). The user activates the Solis VIP Pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The Solis VIP Pump consists of components, such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, on-board memory, and pump log. The Solis VIP Pump exterior surface components include the pump housing, LCD lens, labels, and keypad, and the materials of construction for these components are widely used in the medical industry. The Solis VIP Pump is designed to be used with an infusion disposable, such as medication cassette reservoir.

The Solis VIP Pump provides measured drug therapy to patients in the hospital, homecare, and outpatient settings. The Solis VIP Pump is intended for therapies that require a Continuous. Intermittent. Tapering, or Step rates of infusion, and Patient Controlled Analgesia (including Clinician Bolus).

The CADD™-Solis Medication Safety Software-Administrator ("Administrator") module allows the user to create, edit, and save therapy-based protocols and pump settings within user-defined protocol libraries. The system administrator user determines user access and library editing capabilities. Other Administrator module features include barcode printing, reports, and sending and receiving pump protocol information.

The CADD™-Solis Medication Safety Software-Point of Care ("POC") module allows the user to download therapy based protocols to the Solis Pump, and Prizm Pump (software revision H or higher) and send and receive pump settings via USB connection.

AI/ML Overview

The provided 510(k) summary for the CADD®-Solis VIP Ambulatory Infusion Pump and CADD™-Solis Medication Safety Software specifies performance testing and validation but does not describe an AI/algorithm-based device and therefore does not contain acceptance criteria related to AI performance, or detailed studies involving ground truth, expert consensus, or clinical outcomes that would typically be associated with AI/ML medical devices.

The document details performance testing typical for medical devices (electrical, mechanical safety, EMC, software validation, usability, biocompatibility) to demonstrate substantial equivalence to predicate devices, but lacks the specific types of studies requested in the prompt that are relevant to AI/ML device evaluation.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended." However, it does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. It lists categories of tests performed:

Test Category	Reported Device Performance
Electrical and mechanical safety tests	Met pre-established specifications; performed as intended.
Electromagnetic compatibility tests	Met pre-established specifications; performed as intended.
Solis VIP Pump software validation	Met pre-established specifications; performed as intended.
Administrator and POC software validation	Met pre-established specifications; performed as intended.
Usability/human factors validations	Met pre-established specifications; performed as intended.
Infusion disposable biocompatibility testing	Met pre-established specifications; performed as intended.

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

Sample Size: Not specified for any of the performance tests.
Data Provenance: Not specified. The tests appear to be internal Smiths Medical ASD, Inc. verification and validation tests.

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

This information is not applicable and not provided. The testing described is for device functionality, safety, and software validation, not for an AI/ML algorithm requiring expert ground truth for classification or prediction tasks.

4. Adjudication method for the test set

Not applicable and not provided.

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 MRMC or human-in-the-loop study involving AI is mentioned. The device is an infusion pump and associated software, not an AI diagnostic/analytic tool.

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

Not applicable in the context of AI/ML algorithms. Software validation was performed, but this refers to the functional correctness of the pump's embedded software and the medication safety software, not an AI algorithm.

7. The type of ground truth used

Not applicable for the types of tests described. The "ground truth" for these tests would be the functional requirements, safety standards (e.g., IEC 60601-1, IEC 60601-2-24), and software specifications.

8. The sample size for the training set

Not applicable. No AI/ML training set is mentioned.

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

Not applicable. No AI/ML training set is mentioned.

Summary:

This 510(k) summary describes a traditional medical device (infusion pump) and its associated software. The testing performed is standard for such devices, focusing on meeting pre-established engineering specifications, software validation, usability, and compliance with general and particular safety standards. It predates the widespread regulatory focus on AI/ML in medical devices, and therefore, the requested information regarding AI-specific criteria (ground truth, expert review, training/test sets, MRMC studies) is not present in the document.

Summary

{0}------------------------------------------------

KIII 275

510(k) Summary

FEB 0 1 2013

DATE PREPARED	January 29, 2013
I. GENERAL INFORMATION
Applicant's Name andAddress:	Smiths Medical ASD, Inc.1265 Grey Fox RoadSt. Paul, MN 55112
Contact Person:	Julie TapperSenior Regulatory Affairs Specialist
Common/Usual Name:	Ambulatory Infusion PumpPump Communications System
Proprietary Name:	CADD®-Solis VIP Ambulatory Infusion PumpCADD™-Solis Medication Safety Software
Predicate Devices:	K072144, CADD®-Solis Ambulatory Infusion PumpK960826, CADD-Prizm® VIP Ambulatory Infusion PumpK082783, CADD™-Solis Medication Safety Software-Point of CareK072144, CADD™-Solis Medication Safety Software-Administrator

II. DEVICE DESCRIPTION

CADD®-Solis VIP Ambulatory Infusion Pump

{1}------------------------------------------------

CADDTM-Solis Medication Safety Software-Administrator

CADD™-Solis Medication Safety Software-Point of Care

III. INTENDED USE OF THE DEVICE

CADD®-Solis VIP Ambulatory Infusion Pump

The CADD®-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patientcontrolled analgesia.

Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.

Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.

Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.

Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion.

CADD™-Solis Medication Safety Software-Administrator

The CADD™ Solis Medication Safety Software – Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD -Solis VIP Ambulatory Infusion Pump, CADD®-Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

CADD"-Solis Medication Safety Software-Point of Care:

The CADDIM Solis Medication Safety Software-Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software-Administrator to the CADD® Solis Ambulatory

{2}------------------------------------------------

Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

VI. SUMMARY OF STUDIES

Performance Testing

Smiths Medical performed extensive verification and validation testing on the Solis VIP Pump and Administrator and POC software.

Testing was completed in accordance with FDA's draft guidance, Total Product Life Cycle-Infusion Pump - Premarket Notification [510(k)] Submissions, issued on April 23, 2010; and the General Principles of Software Validation; Final Guidance for Industry and FDA Staff, issued on January 11, 2002.

Also, testing was completed in accordance with FDA consensus standards, IEC 60601-1:1988 Medical electrical equipment - Part 1: General reguirements for safety, plus Amendment 1:1991. Amendment 2:1995 and Amendment 2 Corrigendum: 2005, and IEC 60601-2-24:1998 - Medical electrical equipment - Part 2-24: Particular requirements for the safety of infusion pumps and controllers.

An overall summary of the performance testing was, as follows:

Electrical and mechanical safety tests	Electromagnetic compatibility tests
Solis VIP Pump software validation	Administrator and POC software validation
Usability/human factors validations forthe Solis VIP Pump and Administratorand POC Software	Infusion disposable biocompatibilitytesting, including extractables andleachables

Clinical Studies

Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Solis VIP Pump, and Administrator and POC software.

Testing Conclusion

All testing met pre-established specifications. and successfully demonstrated that the devices performed as intended. The testing results allowed for a conclusion to be made that the Solis VIP Pump, and Administrator and POC software were as safe and effective as the predicate devices.

VII. STATEMENT OF EQUIVALENCE

The Solis VIP Pump, and Administrator and POC software are substantially equivalent to the predicate devices, based on comparisons of the device classifications. intended use, and technological characteristics. Verification and validation tests confirmed the suitability of the devices for their intended uses. The test results did not raise new safety or performance questions, and confirmed that the Solis VIP Pump, and Administrator and POC software devices are substantially equivalent to the predicate devices.

{3}------------------------------------------------

ADD®-Solis VIP Ambulatory Infusion Pu
evice name	CADD®-	ADD®-Solis Ambulatory Infusio Pump	CADD-Prizm® VIP Ambulator Smiths Mesical ASS

		Smiths Medical ASD, K072144 (March 7, 2008)



Tanufacturer Notification numbr Substantial equivalence Substantial Eguivalence Subscription EDATURES Pump Lym FEAT UREST Display	- Linear Peristaltic display with 320 x 320 pixeColor	Linear Peristaltic olor display with 320 x 320 pixel	32Linear Peristalic Tonchromatics displayatriis Pixol, Dixplandisplanding Mariity Program Pixel, Mistrials EPS Portalian Provinsian Provinsia EPS Power Power Power Provinsian P

ower requiremen
	4AA Batteries AC Adapter echargeable Battery Pacd	4AA Batteries
	No	No	Yes
	No	No	No
rinting capabilities Remote communications capabilities USB port PROGRAMMING FUNCTIONS	Yes	Yes	No

Step	Yes	No	No
ntermitten	Yes	No	Yes
aper	Yes	No	Yes (TPN
	Yes	Y es	Yes
ontinuous infusion ontinuous infusion with bolus (PC)	Yes	ਿੰਡ ਨੇੜੇ ਵਿੱਚ ਮੈਡ	Yes
ecurity	Yes		Yes
	Yes	Y es	Y es
	Yes	Y es	Yes
	Yes	Yes	Yes
	Y es	Yes	Yes
	Yes	No	Yes
	ﺮ ،Yes	Yes	Yes
	Yes	Yes	Y es

	Yes	Yes	Yes
	Yes	Yes	Yes
	Yes	Yes	Yes

CADD®-Solis VIP Ambulatory Infusion Pump
Device name	CADD®-Solis VIP AmbulatoryInfusion Pump	CADD®-Solis Ambulatory InfusionPump	CADD-Prizm® VIP AmbulatoryInfusion Pump
No-battery alert	Yes	Yes	Yes
Pump in stop mode	Yes	Yes	Yes
High pressure	Yes	Yes	Yes
Power up fault	Yes	Yes	Yes
Low volume in medication reservoir	Yes	Yes	Yes
Cassette detachment	Yes	Yes	Yes
Upstream occlusion	Yes	Yes	Yes
Downstream occlusion	Yes	Yes	Yes
Air-in-line	Yes	Yes	Yes
Key stuck	Yes	Yes	Yes
INFUSION SPECIFICATIONS
Minimum continuous delivery rate	0 mL/hr	0 mL/hr	0 mL/hr
Maximum continuous delivery rate	100 mL/hr in PCA500 mL/hr in Continuous,Intermittent, Taper, Step	30 mL/hr	30 mL/hr in PCA350 mL/hr in Continuous,Intermittent, TPN
Maximum patient bolus	50 mL	20 mL	9.9 mL
Maximum clinician bolus	50 mL	20 mL	20 mL
Reservoir volume	1 to 9999 mL	1 to 9999 mL	1 to 9999 mL
Patient controlled access PCA (dosing)	Yes	Yes	Yes
Dose lockout time	Yes	Yes	Yes
Doses per hour limit	Yes	Yes	Yes
Delivery limit	Yes	Yes	Yes
Clinician bolus	Yes	Yes	Yes
Programmable maximum delivery rate(Continuous rate + bolus)	Yes	Yes	Yes

COMPARISION OF TECHNOLOGICAL CHARACTERISTICS v.

Page 4 of 6

K111275 510(k) Summar

Smiths Medical ASD, Inc

{4}------------------------------------------------

: :

: 上一篇:

K111275 510(k) Summary

Smiths Medical ASD, Inc.

Page 5 of 6

: 上一

{5}------------------------------------------------

CADD TM-Solis Medication SafetySoftware Administrator and POCDevice Name	CADDTM-Solis Medication SafetySoftware (software update)	CADDTM-Solis Medication SafetySoftware
Manufacturer	Smiths Medical ASD, Inc.	Smiths Medical ASD, Inc.
10(k) notification number(substantial equivalence date)	K111275(TBD)	K082783(December 17, 2008)	K072144(March 7, 2008)
COMPATIBILITY
Pump compatibility	CADD®-Solis VIP AmbulatoryInfusion Pump, CADD®-SolisAmbulatory Infusion Pump andCADD-Prizm® PCS II 6101 (rev Hand higher)	CADD®-Solis Ambulatory InfusionPump and CADD-Prizm® PCS II 6101(rev H and higher)	CADD®-Solis Ambulatory InfusionPump and CADD-Prizm® PCS II 6101(rev H and higher)
Accessory compatibility	USB cable for the CADD®-Solis VIPpump, and CADD®-Solis pump21-6144 Interface cable/null modemcable for CADD-Prizm® pump	USB cable for the CADD®-Solispump21-6144 Interface cable/null modemcable for CADD-Prizm® pump	USB cable for the CADD®-Solispump21-6144 Interface cable/null modemcable for CADD-Prizm® pump
PC software compatibilityComputer equipment	Windows 2000, XP, VISTARS232 serial port, USB, and CD-ROM	Windows 2000, XP, VISTARS232 serial port, USB, and CD-ROM	Windows 2000, XP, VISTARS232 serial port, USB, and CD-ROM

KI11275 510(k) Summary

Smiths Medical ASD, Inc

Page 6 of 6

. .

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Febauary 1, 2013

Ms. Julie Tapper Senior Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 1265 Grey Fox Road ST. PAUL, MN 55112

Re: K111275

Trade/Device Name: CADD® -Solis VIP Ambulatory Infusion Pump and CADD™-Solis Medication Safety Software Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 21, 2013 Received: January 22, 2013

Dear Ms. Tapper:

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.

{7}------------------------------------------------

Page 2 - Ms. Tapper

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours;

hor
Theth
Harshita.D.

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

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification

CADD®-Solis VIP Ambulatory Infusion Pump CADD"-Solis Medication Safety Software

Indications for Use --

510(k) Number: K 111275

TAB 5 - Page 1 of 2

1 389

Device Name: CADD®-Solis VIP Ambulatory Infusion Pump

Indications for Use:

"The CADD®-Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion.

PCA (patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patientcontrolled analgesia.

Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate.

Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval.

Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume.

Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman Date: 2013.02.01 13:20:30 -05'00'

(Division Sign-Off)

: vision of Anesthesiology, General Hespital rection Control, Dental Devices

510(k) Number:

{9}------------------------------------------------

SMITHS MEDICAL ASD, INC. 510(k) Premarket Notification CADD -Solis VIP Ambulatory Infusion Pump CADD™-Solis Medication Safety Software

Indications for Use --

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: CADD" Solis Medication Safety Software - Administrator

Indications for Use:

"The CADD" Solis Medication Safety Software - Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD -Solis VIP Ambulatory Infusion Pump, CADD -Solis Ambulatory Infusion Pump or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ OR Per 21 CFR 801.109

Device Name: CADD" Solis Medication Safety Software - Point of Care

Indications for Use:

"The CADD" Solis Medication Safety Software -- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD"-Solis Medication Safety Software - Administrator to the CADD® Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher)."

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ Per 21 CFR 801.109

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Richard C. Chapman Date: 2013.01.30 10:21:19 -05'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

TAB 5 - Page 2 of 2

1390

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).