(56 days)
The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps.
The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump.
The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
The described device is an "Extension Set with Microbore Tubing" and variants. This 510(k) summary does not contain information typically found in an acceptance criteria table or a detailed study report for AI/ML-based medical devices. The submission concerns a standard medical device (tubing) and focuses on functional and biocompatibility testing rather than performance metrics related to AI or a "test set" in the context of an algorithm.
Therefore, I cannot provide the requested information for an AI/ML device. However, I can extract the relevant information about the functional testing performed for this traditional medical device.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not detail specific quantitative acceptance criteria or a performance table in the way one would for an AI/ML device. Instead, it states that "Functional testing performed on the sets to establish their operating parameters" and "The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification." No numerical results or specific pass/fail thresholds are provided in the summary.
2. Sample Size for the Test Set and Data Provenance
This information is not applicable. The submission refers to "functional testing" and "biocompatibility testing" of physical medical devices, not a 'test set' of data for an algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because data collection for AI/ML algorithms is not relevant here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. Ground truth, in the context of an AI/ML algorithm, involves expert labels or pathological findings. For this device, "ground truth" would be the engineering specifications and performance standards against which the functional tests were conducted. The experts would be the engineers and technicians performing the functional and biocompatibility tests, but their number and specific qualifications are not detailed in this summary.
4. Adjudication Method
This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve disagreements among experts when establishing ground truth for AI/ML training or test sets. This concept does not apply to functional and biocompatibility testing of a physical medical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is used to assess the impact of AI assistance on human reader performance. This device is not an AI/ML algorithm, so such a study was not performed or necessary.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical medical device (extension set), not an algorithm. Therefore, a standalone performance study for an algorithm was not done.
7. Type of Ground Truth Used
The "ground truth" for this device would be defined by engineering specifications and performance standards. The functional testing verified whether the device performed "according to specification." Biocompatibility testing verified that "the materials used in the sets are biocompatible."
8. Sample Size for the Training Set
This information is not applicable. Training sets are used for machine learning algorithms. The design and testing of this medical device did not involve machine learning, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no training set for an algorithm.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
DEC 1 7 1997
Extension Sets with Microbore Tubing
October 20, 1997
GENERAL INFORMATION L
| Applicant's Nameand Address: | SIMS Deltec, Inc.1265 Grey Fox RoadSt. Paul, MN 55112 |
|---|---|
| Contact Person: | Edward W. NumainvilleVice President, Regulatory Affairs and Quality SystemsTel. (612) 628-7166 |
| Common/Usual Name: | Extension Set |
| Proprietary Name: | Extension Set with Microbore Tubing |
| Equivalence DeviceComparison: | Extension Set with Anti-Siphon Valve(manufactured by SIMS Deltec, Inc.)Micro-Volume Extension Set with 0.22 µ Filter(manufactured by Baxter Healthcare Corp.) |
II. DEVICE DESCRIPTION
The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
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INTENDED USE OF DEVICE Ш.
The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for use with the CADD-Micro® pump.
The Extension Set with Anti-Siphon Valve must be used with the MEDICATION CASSETTE™ reservoir to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
| Extension Set withmicrobore tubing | Extension Set withmicrobore tubing and0.2 μ filter | Extension Set withmicrobore tubing, 0.2μ filter, and anti-siphon valve | Extension Set withanti-siphon valveK942046 | Micro-VolumeExtension Set with0.22 μ FilterK811463 | |
|---|---|---|---|---|---|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Baxter HealthcareCorporation |
| INTENDED USE | The Extension Set withmicrobore tubingattaches to the MicroMedication Reservoir foruse with the CADD-Micro® pump. | The Extension Set withmicrobore tubingattaches to the MicroMedication Reservoir foruse with the CADD-Micro® pump. | The Extension Set withAnti-Siphon Valve mustbe used with theMEDICA-TIONCASSETTE™ reservoirto protect againstunregulated gravityinfusion that can resultfrom an improperlyattached reservoir. | The Extension Set withAnti-Siphon Valve is anaccessory for fluiddelivery devices. It isdesign-ed to protectagainst unregulatedgravity infusion fromimproperly attachedadministration sets usedwith mechanical infusionpumps in vulnerablepatients. | |
| DIMENSIONS(Nominal) | |||||
| LENGTH | 45 inches | 60 inches | 60 inches | 4 inches or 60 inches | 60 inches |
| TUBING LD. | 0.020 inches | 0.020 inches | 0.020 inches | 0.040 inches | |
| TUBING O.D. | 0.088 inches | 0.088 inches | 0.088 inches | 0.105 inches | |
| FILTER | NO | YES | YES | NO | YES |
| ANTI-SIPHONVALVE | NO | NO | YES | YES | NO |
IV. DEVICE COMPARISON
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SUMMARY OF STUDIES V.
A. Functional Testing
Functional testing performed on the sets to establish their operating parameters.
Biocompatibility testing was conducted on the set components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the Extension Sets with Microbore Tubing due to their similarity in materials, design and function to current SIMS Deltec commercially available extension sets.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification and the materials used in the sets are biocompatible. Therefore, these sets are considered acceptable for human use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Mr. Edward W. Numainville Mr. Baward W. Ramatillatory Affairs and Quality Systems Sims Deltec, Incorporated 1265 Grey Fox Road 55112 St. Paul, Minnesota
K974013 Re : Extension Set with Microbore Tubing, Trade Name: Extension Set with Microbore Tubing and 0.2 µ Filter Requlatory Class: II Product Code: FPA Dated: October 20, 1997 Received: October 22, 1997
Dear Mr. Numainville:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Numainville
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 requlations.
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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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
premarket notification" (21 CFR 807.97). Other gener 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot hy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Extension Set with Microbore Tubing, 0.2 u Filter, and Anti-Siphon Valve
Indications for Use:
" The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps. "
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Litera Cucente
(Division Sign-Off) Division of Dental, Infection Control, and General Flospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
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. . . . . . . .
510(k) Number (if known):
Device Name: Extension Set with Microbore Tubing, or Extension Set with Microbore Tubing and 0.2 u Filter
Indications for Use:
"The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fabian Cusati
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital B r : ^/k) Number _
Prescription Use レ (Per 21 CFR 801.109)
OR
Over-The Counter Use -------
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.