SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY

K042121 · Sigma Intl. · FRN · Aug 26, 2004 · General Hospital

Device Facts

• Record ID: K042121
• Device Name: SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
• Applicant: Sigma Intl.
• Product Code: FRN · General Hospital
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Spectrum and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The spectrum is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. The Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician's directive.

Device Story

Spectrum is a lightweight, ambulatory-capable infusion pump using linear peristaltic mechanism for volumetric fluid delivery. User loads IV set; pump controller/processor manages motor speed via feedback loop to ensure flow uniformity. Master Drug Library (MDL) is a software package allowing creation/management of drug delivery profiles and safety limits. MDL data can be loaded directly or via external devices (PC, PDA, 'smart' C-pen) using wired/wireless communication. C-pen allows scanning patient/prescription info for download. Device features password protection and redundancy checks. Used in hospitals, homecare, and ambulatory settings by trained clinicians. MDL reduces medication errors by enforcing programmed limits for drug selection, dose rates, and concentrations. Healthcare providers use the interface to confirm parameters against physician directives, improving safety through automated programming and error prevention.

Clinical Evidence

Bench testing only. Testing conducted in accordance with recognized performance standards for infusion pumps and validation of design requirements. No clinical data provided.

Technological Characteristics

Linear peristaltic infusion pump; microcomputer-controlled motor with feedback loop. Features printed circuit board layout, corrosion-resistant pumping mechanism, and software-based control. Supports wired/wireless communication with external peripherals (PC, PDA, C-pen). User interface includes alarm sensing and display technology. Operates on Windows-based platform for MDL software.

Indications for Use

Indicated for controlled administration of IV fluids, including pharmaceutical drugs, blood, blood products, and therapy mixtures. Suitable for patients requiring intravenous, arterial, subcutaneous, intrathecal, epidural, or fluid space irrigation. Intended for use in hospitals, outpatient, homecare, and ambulatory settings by trained healthcare professionals.

Regulatory Classification

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.

Predicate Devices

• Medley™ System with Medication Management System (K030459)
• Horizon Outlook™ with DoseCom™ (K011975)
• SIGMA Model 8000 and 8002 Infusion Pumps (K950766)
• Colleague® CX Volumetric Infusion Pump (K002211)

Submission Summary (Full Text)

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Premarket Notification 510(k) K44212 Summary of Safety and Effectiveness

AUG 2 6 2004

Image /page/0/Picture/2 description: The image shows the logo for Sigma International. The word "SIGMA" is written in large, bold, sans-serif letters, with the "I" slightly taller than the other letters. Below "SIGMA", the word "International" is written in a smaller, sans-serif font. The logo is simple and modern, with a focus on the company name.

711 Park Avenue • Medina, New York 14103-0756 • 585-798-3901 • Fax: [phone]

SIGMA International General Medical Apparatus, LLC. Spectrum with or without Master Drug Library

## 510(k) Summary

### Submitter Information

Company Name & Address: SIGMA International General Medical Apparatus, LLC. 711 Park Avenue Medina, NY 14103-0756

Contact Name: Charles Martina Test Engineer SIGMA International [phone] [phone] Fax

Date Summary Prepared: April 12, 2003

### Device Information

Generic Name: Infusion Pump

Trade or Proprietary Name: Spectrum with or without Drug Library Work Station

Classification Designation: Class II, 80FRN Infusion Pump

## Device Description Information

The Spectrum with Master Drug Library (device) is an infusion pump having a basic The Spectrum with Master Brag Libra, P(2018) Section 5725. The Spectrum infusion desomplon as loonimou nicuitry and mechanical mechanisms that are integrated into pump consists of clouronio sirounly and mechanical operations are software a lightweight plastic ontroller and processor technology. The motor control / controlled dolly disorte merces in the linear peristaltic design using inlet and exit recoback partiping moontrol. Infusion therapy fluids and selected intravenous (IV) sets The Spectrum infusion pump is specifically are supplied by the device user. are Supplied by the cated for the application of standard gravity infusion sets of a manufacturer's brand, as indicated by the Spectrum's labeling. The IV set is loaded into

> 510(k) Submission Page 1508 of 1514

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#### K442121 Premarket Notification 510(k) Summary of Safety and Effectiveness 10.2 of 3,

# 510(k) Summary (continuation)

the Spectrum infusion pump. After acceptance of program parameters, the pump is the Upontain 'infactor' palled by the rhythmic action of the pumping mechanism against started and is properies a fine in tubing. The pump is controlled to create smooth fluid the outbide carace on volumetric accuracy, and uniformity of flow rate profile. The Spectrum infusion pump is small in comparison to the traditional "Large Volume" infusions pumps currently on the market. However, it is designed to be used in a infosions pampe carren IV pole mounted configuration or carried by the user in an ambulatory manner.

The Master Drug Library (MDL) capability is a software package that allows the rno nation and management of a patented downloadable drug library into to a target infusion pump. The library may be loaded directly into the infusion pump or uploaded into another computer, Personal Assistants (PDA's), or other transfer apparatus (I.e. "smart" C-pen) for wired or wireless communication to the infusion pump. The MDL software reduces the risk of medication errors by providing programmed delivery profiles and limits for a corresponding drug that is intend for a specific use classification. The MDL software will operate on a popular software systems platform (I.e. Windows) and have the capability (using external peripherals) of printing text / barcode labels that may be used to label and identify drug therapy bags and or patient identification labels. Through the application of the C-pen equipment, scanned patient and IV prescription information can be downloaded into the Spectrum infusion pump. The Spectrum infusion pump has the capability of communicating with a hospital information management system. The Spectrum infusion pump uses coded passwords and redundancy checks to mitigate the acceptance of improper information.

### Predicate Device Information

The Spectrum with Master Drug Library is considered to be substantially equivalent (as defined by U.S. FDA regulatory information) to other infusion pumps with software managing systems. The safety and effectiveness related to the predicate devices is comparable to the Spectrum with Master Drug Library. Examples of devices within the same requlatory classification as the Spectrum with Master Drug Library are identified as follows:

| Premarket<br>Notification,<br>Number | 510(k) | Device Name | Applicant |
|--------------------------------------|--------|-----------------------------------------------------|------------------------------|
| K030459 | | Medley™ System with Medication<br>Management System | ALARIS Medical Systems, Inc. |
| K011975 | | Horizon Outlook™ with<br>DoseCom™ | B. Braun Medical Inc. |

The Spectrum infusion pump may also be used without the Master Drug Library. Predicate devices within the same regulatory classification as the Spectrum are identified as follows:

> 510(k) Submission Page 1509 of 1514

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### Premarket Notification 510(k) Summary of Safety and Effectiveness P.30831

# 510(k) Summary (continuation)

| Premarket<br>Notification,<br>Number | 510(k) | Device Name | Applicant |
|--------------------------------------|--------|---------------------------------------------|--------------------------------------------------------|
| K950766 | | SIGMA Model 8000 and 8002<br>Infusion Pumps | SIGMA International General<br>Medical Apparatus, LLC. |
| K002211 | | Colleague® CX Volumetric<br>Infusion Pump | Baxter Healthcare<br>Corporation |

# Intended Use information for Subject Device

The Spectrum infusion pump is intended to be used for the controlled administration of intravenous fluids. These fluids may include blood, blood products or mixtures of inharmaceutical drugs for required patient therapy. The spectrum is used in conjunction with legally marked intravenous administration sets and medications provided by the user The Master Drug Library is a software package that will add additional features to The Master Drug Library will permit electronic the Spectrum infusion pump. the Opential "Mith the Spectrum pump and other external peripheral devices. The intended use of the Spectrum pump includes common drug error prevention, through the stand alone settings features of the pump. This includes drug parameter limits and associated drug name identification. With the Master Drug Library, the intended use is to reduce user errors associated with drug selection, drug dose rates, drug dose concentrations, and patient identification associated with the prescribed drug.

## Technological Characteristic Information

The technological characteristics of the Spectrum infusion pump are similar in many respects to the predicate devices. The Spectrum and predicated devices share mechanical and electrical assembly design complexity similarities. Their respective designs contain "state-of-the-art" printed circuit board layout system, proven reliable corrosion resistant pumping mechanisms and microcomputer software control intelligence. The functional characteristics including the user interface, alarm sensing systems, and display technology are of similar technological form. The Master Drug Library features and communication interaction with the Spectrum or other peripherals is also technologically similar in nature to the predicate devices. The technological characteristics of the Spectrum and Spectrum with Master Drug Library are substantially equivalent to the predicate device for intended use. Technological differences between the Spectrum and Spectrum with Master Drug Library do not raise new issues of safety and effectiveness.

### Non-Clinical Performance Data Information

The determination of substantial equivalency is also based on non-clinical performance data. The testing conducted on the Spectrum infusion pump was in accordance with recognized performance standards for infusion pumps. In addition, non-clinical testing based on the validation of design requirements has been conducted and is provided as support data for this 510(k) submission. The performance data indicate that the Spectrum and Spectrum with Master Drug Library meets specification requirements and is substantially equivalent to the predicate devices.

> 510(k) Submission Page 1510 of 1514

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines forming its body and wings. The eagle is facing to the right.

AUG 2 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SIGMA International General Medical Apparatus, LLC C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 70 Codman Hill Road Boxborough, Massachusetts 01779

Re: K042121

Trade/Device Name: Spectrum and Spectrum with Master Drug Library Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 18, 2004 Received: August 19, 2004

Dear Mr. Reuber:

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 approvisions 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 such additional controls. Existing major regulations affecting (1 Wr ), it hay of budging in the Code of Federal Regulations, Title 21. Parts 800 to 898. In your device announcements concernents concerning your device in the Federal Register.

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## Page 2 - Mr. Reuber

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. or the rive of any with all the Act's requirements, including, but not limited to: registration r ou intel comply was a 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in J . The FDA finding of substantial equivalence of your device to a premainter letting and in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you debite the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K042121

Device Name: Spectrum, Spectrum with Master Drug Library

## Indications for Use

The Spectrum and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically acceptable routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The spectrum is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user.

The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services.

The Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician's directive.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton Kent

of Anesthesiology, General Houpital. ontrol. Dental

510(k) Number

510(k) Submission Page 132 of 1514 REVISED DATE 7/06/04