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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.

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 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.

This document is a 510(k) summary for the SIGMA International General Medical Apparatus, LLC Spectrum with or without Master Drug Library infusion pump, submitted in 2004. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed performance studies with acceptance criteria, sample sizes, expert involvement, or comparison to human readers.

Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance or other detailed study descriptions.

Explanation for missing information:

• Acceptance Criteria & Reported Performance: The document states that "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." However, the specific acceptance criteria (e.g., volumetric accuracy thresholds, flow rate uniformity) and the numerical results against these criteria are not included in this summary.
• Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): This summary focuses on establishing substantial equivalence through a comparison of technological characteristics and intended use to predicate devices, rather than presenting a standalone performance study with detailed methodologies as would be standard for AI/imaging device submissions. The "non-clinical performance data" mentioned refers to engineering tests to ensure the device meets its own specifications, not clinical performance studies comparing it to humans or a gold standard.
• Training Set Information: This is an infusion pump, not an AI/ML device that requires a training set in the typical sense (i.e., for model training with labeled data). The "Master Drug Library" is a software package with programmed delivery profiles and limits, not a machine learning model developed through training data.

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The "Sigma Syringe Delivery System" is designed for the controlled intermittent administration of small volume intravenous fluid medications for the treatment of human or animal subjects. Its specific design characteristics limit the device's use to slow, non-rate critical, small volume parenteral applications, identical to the predicate devices.

The SIGMA Syringe Deliver Systems are syringe infusion pumps that operate using two principles for delivery - a spring and resistive tubing. The mechanical principle is produced by relaxing spring force. The devices are strictly mechanical in operation and do not require the execution of software. This type of infusion pump is used to pump fluids into a patient in a controlled manner. The models are designed specifically for the controlled, parenteral infusion of non-rate critical drugs and medications. The SIGMA infusers are best identified and described in Title 21, Part 880.5725, of the Code of Federal Regulations, as classification Class II, Infusion Pump.

The "SIGMA Syringe Infusion System" is a combination of three components : 1) an Infuser, 2) Rate-Control Extension Set and 3) syringes(supplied by the user). All three components act together as a system. The infuser acts as the energy force that pushes fluid from the syringe, the fluid reservoir, through a Rate-Control IV Extension Administration Set, that controls the rate of the fluid delivery to the patient.

The provided document outlines the safety and effectiveness of the SIGMA Syringe Delivery System based on non-clinical bench testing. It details acceptance criteria for infusion time and accuracy, and the studies conducted to demonstrate compliance.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents infusion time and accuracy specifications for different syringe types used with the SIGMA Syringe Delivery System.

• B-D™ 60cc: Typical 35 mins, Range 25-45 mins (Average Flow Rate 18 ml/hr)
• Monoject™ 60cc: Typical 30 mins, Range 22-37 mins (Average Flow Rate 21 ml/hr)

Single-Doser R. I-10: Typical 25 minutes, Range 18-32 minutes
Single-Doser R. I-20: Typical 55 minutes, Range 40-70 minutes

Impact of factors on 60cc Multi-Doser Rev. I:

• Spring Force: Low force increased infusion time by 4% (Monoject) and 28% (B-D); High force decreased infusion time by 11% (Monoject) and increased by 2% (B-D). All still within specified range.
• High Temperature (82°F): Decreased infusion time by 12% (Monoject) and 15% (B-D). Averages: Monoject 25.3 mins, B-D 29.8 mins. Still within safe/effective range.
• Low Temperature (62°F): Increased infusion time by 20% (Monoject), decreased by 4% (B-D). Averages: Monoject 34.6 mins, B-D 33.5 mins. Still within safe/effective range.
• Negative Head Height (+24 inches): Decreased infusion time by 13% (Monoject & B-D). Averages: Monoject 24.9 mins, B-D 30.4 mins. Still within safe/effective range.
• Positive Head Height (-24 inches): Increased infusion time by 8% (Monoject) and 12% (B-D). Averages: Monoject 30.9 mins, B-D 39.1 mins. Still within safe/effective range. |
  | Infusion Time Accuracy | Not explicitly stated as a separate acceptance criterion, but determined and reported for 95% confidence interval. | Multi-Doser Rev. I (60cc syringes):
• B-D™ 60cc: ± 28.5%
• Monoject™ 60cc: ± 23% |
  | Uncontrolled Flow | System meets ANSI/AAMI D26-1996 for uncontrolled flow protection; no free flow. | Test 1 (plunger removed, 5ft head height, 0 venous pressure): Flow rate significantly lower (at least 25% of nominal, e.g., 4 ml/hr for Monoject nominal 21 ml/hr).
  Test 2 (Monoject/B-D 60cc, 4ft head height, 0 venous pressure, 10cc sterile water): One Monoject syringe showed very slow flow (4cc over 3 hours, 1.3 ml/hr).
  Test 3 (syringes at 2ft level, 10cc sterile water): Zero flow in a 24-hour period. Conclusion: Uncontrolled flow could not occur with venous pressure and syringe friction. Even if it did occur (as in Test 1), the slow rate would not harm the patient. |
  | Drop Test | Device remains fully functional after drop. | Dropped six times from six feet onto a hard tile/concrete floor; fully functional afterward. |
  | Environmental Test | Device remains fully functional after liquid spill. | One liter of 5% Dextrose spilled on infuser and dried for 72 hours; fully functional afterward, no effect on performance. |
  | Pull Test | Rate-Control Microbore Sets meet 4 lbs. of force. | Rate-Control Microbore Sets met the required 4 lbs. of force. |

2. Sample Size Used for the Test Set and the Data Provenance

The primary test set for the performance studies (Infusion Time, Accuracy, Uncontrolled Flow) involved:

• 18 Infusers for the "Effect of Spring Force" bench test (3 with low, 3 with nominal, 3 with high spring force for both Monoject 60cc and B-D 60cc syringes).
• Six Infusers for each temperature variation test (high and low temperatures).
• Six Infusers for each head height variation test (+24 inches and -24 inches).
• For the "Uncontrolled Flow" tests, specific details are given (e.g., "a 60cc syringe," "both 60cc Monoject™ and 60cc B-D™ syringes"). The exact number of syringes per test is not specified beyond "a" or "both."
• For the Drop Test: "Device" (singular implied, but typically multiple units would be tested for such a claim).
• For the Environmental Test: "One liter of solution...was spilled on the infuser" (singular implied).
• For the Pull Test: "The Rate-Control Microbore Sets are pull tested" (plural implies multiple sets, but specific number not given).

The data provenance is retrospective bench data, generated by the manufacturer (SIGMA) in a controlled laboratory setting. The location is not explicitly stated by country, but the context implies it is a US-based submission to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This document describes non-clinical bench testing of a mechanical medical device (syringe infusion pump), not studies involving image analysis or diagnostic tasks requiring expert clinical labeling of data. The ground truth for performance metrics like infusion time, flow rate, and accuracy was established through direct measurement using sterile water under controlled laboratory conditions, not through expert consensus.

4. Adjudication Method

Not applicable. As the studies are bench tests of mechanical performance, there is no need for expert adjudication of results. Measurements were taken and recorded directly.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC comparative effectiveness study. The studies described are non-clinical bench tests of the device's mechanical performance in a standalone setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, all the described studies are standalone bench tests focusing on the device's intrinsic mechanical performance. The studies assessed the device's ability to maintain specified infusion times and accuracy under various conditions (spring force, temperature, head height), its resistance to uncontrolled flow, and its durability (drop test, environmental test, pull test). There is no "human-in-the-loop" component in the reported performance metrics.

7. The Type of Ground Truth Used

The ground truth used was direct physical measurement of:

• Infusion Time: Measured duration of fluid delivery.
• Infusion Volume/Rate: Calculated based on the volume delivered over time.
• Accuracy: Calculated as a percentage deviation from a target or expected value.
• Flow Rate: Measured volume over time.
• Uncontrolled Flow: Observation and measurement of fluid flow under simulated incorrect usage.
• Functionality: Assessment of continued operation after stress tests (drop, environmental).
• Force: Measurement of force required for pull tests.

The fluid used for these measurements was primarily sterile water, chosen because it represents the fastest flow variable, ensuring that drugs with higher viscosity would not infuse faster than the established minimum infusion time (20 minutes).

8. The Sample Size for the Training Set

Not applicable. The SIGMA Syringe Delivery System is a mechanical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design is based on mechanical principles and engineering, not data-driven training.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device and studies.

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