(83 days)
The S.P.A.R. " Sterile Ambulatory Reservoir is intended for use with the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 Ambulatory Infusion Pumps, manufactured and distributed by Sims Deltec Inc., St. Paul, Minnesota. The S.P.A.R. Ambulatory Reservoir is intended for use as an accessory to the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps by replacing the Deltec Medication Cassette ™, Model 2050 - 50 mL and 2100 - 100 mL with S.P.A.R. ™ Sterile Ambulatory Reservoir.
The S.P.A.R.TM Sterile Ambulatory Reservoir is a sterile, disposable, nonpyrogenic, tamper proof (evident), ambulatory, reservoir system designed for use with the SIMS Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps.
This document describes the 510(k) summary for the S.P.A.R.™ Sterile Ambulatory Reservoir. The primary purpose of the submission is to demonstrate the substantial equivalence of the S.P.A.R.™ reservoir to the predicate device (SIMS Deltec Medication Cassette™) when used with the SIMS Deltec CADD-Prizm® Model 6100 infusion pump.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. Instead, the study's goal was to demonstrate "equivalence" by showing that both reservoirs are affected by various factors in a "similar manner." The reported performance demonstrates this similarity in response.
| Acceptance Criteria (Inferred from Study Goal) | Reported Device Performance |
|---|---|
| Equivalence in response to temperature changes | Reducing temperature from 40℃ to 2℃ reduces stroke displacement in both S.P.A.R.™ and Deltec reservoirs. |
| Equivalence in response to fluid viscosity changes | Changing fluid viscosity from 0.9% Sodium Chloride Injection USP to 30% Dextrose Injection, USP does not affect stroke displacement in either reservoir. |
| Equivalence in response to back pressure changes | Increasing back pressure from -100 mmHg to 300 mmHg reduces stroke displacement in both reservoirs. |
| Equivalence in response to flow rate changes | Increasing flow rate from 0.1 ml/hr to 30 mL/hr increases stroke displacement in both reservoirs. |
| Overall equivalence in factors affecting stroke displacement | Measured stroke displacement data established the equivalence of the two reservoirs in that both are affected by the same factors in a similar manner. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document refers to "measured stroke displacement data" without detailing the number of test runs, reservoirs, or conditions.
- Data Provenance: The study was carried out by the manufacturer (Faulding Pharmaceutical Company) to compare their S.P.A.R.™ reservoir to the predicate SIMS Deltec Medication Cassette™. This suggests prospective, in-house laboratory testing rather than data from real-world patients or clinical settings. The country of origin for the data is implicitly the country where Faulding Pharmaceutical Company conducted its research, which appears to be the USA (Cranford, New Jersey is listed as the address).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an accessory to an infusion pump, and the study focuses on the physical performance characteristics (stroke displacement) of the reservoir under various conditions. The "ground truth" here is the physical measurement of stroke displacement, not a clinical diagnosis or interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the "ground truth" is measured physical performance. There's no human interpretation or adjudication involved in determining stroke displacement.
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
Not applicable. This is not an AI/imaging device, and no human reader study or MRMC comparative effectiveness study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a passive mechanical component (a reservoir) and does not involve algorithms or AI.
7. The Type of Ground Truth Used
The ground truth used was measured physical performance data: specifically, stroke displacement measurements under various controlled environmental and operational conditions (temperature, back pressure, fluid viscosity, flow rate).
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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510(k) SUMMARY
| 1. | Classification Name: | Infusion Pump, Accessory or Piston Syringe |
|---|---|---|
| 2. | Common Name: | Medication Reservoir |
| 3. | Proprietary Name: | S.P.A.R.TM Sterile Ambulatory Reservoir |
| 4. | Classification: | Class II |
| 5. | Predicate Device: | SIMS Deltec Medication CassetteTM (K843772 |
Description of the Device: 6.
The S.P.A.R.TM Sterile Ambulatory Reservoir is a sterile, disposable, nonpyrogenic, tamper proof (evident), ambulatory, reservoir system designed for use with the SIMS Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps.
Intended Use: 7.
The S.P.A.R.TM Ambulatory Reservoir is intended for use as an accessory to the SIMS Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps by replacing the Deltec Medication Cassette "10 Model 2050 - 50 mL and 2100 - 100 mL with S.P.A.R.TM Sterile Ambulatory Reservoir.
The use of the S.P.A.R.T™ Ambulatory Reservoir as an accessory to the SIMS Deltec CADD-PCA® Model 5800 infusion pump was previously studied and approved for marketing by the FDA on July 18, 1997 (510(k) -K962159). The current 510(k) - 990091, covers studies and information on the SIMS Deltec CADD-Prizm® Model 6100 infusion pump.
8. Technological Characteristics:
The S.P.A.R.TM Sterile Ambulatory Reservoir uses similar technology to that found in the SIMS Deltec Medication Cassette™. In both cases, the pump platform and tubing components are in communication with the pump in the same manner.
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9. Substantial Equivalence:
The SIMS Deltec CADD-Prizm® Model 6100 infusion pump operates when coupled with either its original SIMS Deltec reservoir, or the S.P.A.R.TM Sterile Ambulatory Reservoir. In both cases the pumping principle is the same. with flow occurring as a series of fixed volume pulses, where pulse frequency determines the nominal flow rate.
Pulse frequency is controlled electronically to a high level of accuracy. whereas, pulse volume, or stroke displacement, as it is more correctly termed, is subject to variation and is the major determinant of flow rate accuracy.
The study carried out, therefore, identified statistically significant factors affecting stroke displacement from both the original Deltec reservoir and the S.P.A.R.TM reservoir when coupled with the Deltec CADD-Prizm® Model 6100 infusion pump. The factors investigated were temperature, back pressure in the delivery line, fluid viscosity, magnitude of flow rate, and reservoir type.
10. Conclusion Based on Non-Clinical Test:
Measured stroke displacement data established the equivalence of the two reservoirs in that both are affected by the same factors in a similar manner. Reducing temperature from 40℃ to 2℃ reduces the stroke displacement in both S.P.A.R.TM and Deltec reservoirs. Changing fluid viscosity from 0.9% Sodium Chloride Injection USP to 30% Dextrose Injection, USP does not affect stroke displacement in either reservoir. Increasing back pressure from -100 mmHg to 300 mmHg reduces stroke displacement in both reservoirs. Increasing flow rate from 0.1 ml/hr to 30 mL/hr increases stroke displacement in both reservoirs. Thus, the S.P.A.R.TM reservoir can be considered substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 6 1999
Dr. Heike Maaser Faulding Pharmaceutical Company 11 Commerce Drive 07016 Cranford, New Jersey
K990091 Re : S.P.A.R Sterile Ambulatory Reservoir Trade Name: Regulatory Class: II Product Code: MRZ January 8, 1999 Dated: Received: January 11, 1999
Dear Dr. Maaser:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Dr. Maaser
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to one rogalation" (21 CFR 807.97) Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name: S.P.A.R.TM Sterile Ambulatory Reservoir
Indications For Use:
The S.P.A.R. " Sterile Ambulatory Reservoir is intended for use with the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 Ambulatory Infusion Pumps, manufactured and distributed by Sims Deltec Inc., St. Paul, Minnesota. The S.P.A.R. Ambulatory Reservoir is intended for use as an accessory to the Sims Deltec CADD-PCA® Model 5800 and CADD-Prizm® Model 6100 infusion pumps by replacing the Deltec Medication Cassette ™, Model 2050 - 50 mL and 2100 - 100 mL with S.P.A.R. ™ Sterile Ambulatory Reservoir.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter-Use
Patricia Cirincionite
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K990091
§ 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).