(288 days)
The Advantis ASC is intended to be used for intravascular administration of drugs, fluids, blood and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.
The Advantis™ ASC (Alternate Site Care) is a multi-mode large volume infusion pump suitable for general and homecare applications. The instrument is a microprocessorcontrolled device designed to use a standard, single use, administration set (dedicated and non-dedicated). The large volume infusion pump provides control of infusion rates (0.1 ml/hr to 999 m/hr) due to the positive displacement action of the linear peristaltic mechanism. The instrument's features include multi programs (standard, micro, primary, secondary modes), TPN and 10-P delivery, free flow protection, user selectable occlusion pressures, automatic priming, and an anti-bolus system. This instrument incorporates both audible and visual alarms for Air-in-line, Upstream and Downstream Occlusion, Low Battery, Electrical or Mechanical Failure, Open Door and Incorrect IV Administration Set.
The provided text is related to a 510(k) premarket notification for an infusion pump, which is a medical device. This type of document is for regulatory clearance and does not typically include information about "acceptance criteria" and "studies" in the context of AI/ML device performance, as outlined in your request.
The questions you are asking (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are specific to the evaluation and validation of Artificial Intelligence/Machine Learning (AI/ML) medical devices, particularly those involving diagnostic or prognostic algorithms.
The document discusses:
- Device Name: Advantis™ ASC Infusion System
- Intended Use: Intravascular administration of drugs, fluids, blood, and blood products; also indicated for epidural applications.
- Technological Characteristics: Similar to predicate devices (Sabratek 3030 Volumetric Infusion Pump and Baxter Flo-Gard 6201 Infusion Pump), using similar technologies, software, materials, electronics, energy sources, and mechanical components, including standard PVC administration sets.
- Regulatory Clearance: A 510(k) premarket notification indicating substantial equivalence to predicate devices.
Since the Advantis ASC Infusion Pump is a traditional electromechanical medical device and not an AI/ML diagnostic or prognostic device, the information you've requested regarding AI/ML-specific acceptance criteria and validation studies (like those involving ground truth, expert consensus, MRMC studies, training/test sets) is not applicable to this document.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about AI/ML study design, as the provided text does not contain that kind of information.
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AUG 1 2000
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Advantis™ ASC Infusion Pump System 510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS
- SUBMITTER'S NAME: ALARIS Medical Systems, Inc. 10221 Wateridge Circle San Diego, CA 92121-2733 (619) 458-7563 (619) 458-6223 FAX
CONTACT PERSON:
Renée L. Fluet Sr. Regulatory Affairs Specialist
DATE PREPARED:
PREDICATE DEVICES:
-
DEVICE NAME:
Proprietary Name: Advantis ASC Infusion System
October 15, 1999
Common Name: Infusion Pump and Administration Set
Classification Name: Infusion Pump and Intravascular Administration Set
Sabratek Corporation Sabratek 3030 Infusion Pump K914589
Baxter Healthcare Corporation Flo-Gard 6201 Infusion Pump K915522
Baxter (under Travenol Laboratories) Continu-Flo Admin Set, Code 2C/200 K792538
DEVICE DESCRIPTION: 4.
The Advantis™ ASC (Alternate Site Care) is a multi-mode large volume infusion pump suitable for general and homecare applications. The instrument is a microprocessorcontrolled device designed to use a standard, single use, administration set (dedicated and non-dedicated).
Advantis ASC 510(k) Premarket Notification Summary of Safety and Effectiveness
0004
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Advantis ASC Infusion Pump 510(k) Premarket Notification
SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)
4. DEVICE DESCRIPTION (Continued):
The large volume infusion pump provides control of infusion rates (0.1 ml/hr to 999 m/hr) due to the positive displacement action of the linear peristaltic mechanism. The instrument's features include multi programs (standard, micro, primary, secondary modes), TPN and 10-P delivery, free flow protection, user selectable occlusion pressures, automatic priming, and an anti-bolus system.
This instrument incorporates both audible and visual alarms for Air-in-line, Upstream and Downstream Occlusion, Low Battery, Electrical or Mechanical Failure, Open Door and Incorrect IV Administration Set.
5. INTENDED USE:
The Advantis ASC is intended to be used for intravascular administration of drugs, fluids, blood and blood products and epidural applications.
ર. TECHNOLOGICAL CHARACTERISTICS:
The Advantis ASC is similar to the Sabratek 3030 Volumetric Infusion Pump (Sabratek Corporation, K914589) and the Baxter Flo-Gard 6201 Infusion Pump (Baxter Healthcare Corporation, K915522). All devices have the same general design and incorporate similar technologies, software, materials, electronics, energy sources, and mechanical components.
The Advantis ASC administration sets are the same as the IV sets utilized by both the Sabratek and Baxter devices: Baxter administration sets (cleared under Travenol Laboratories) as "Continu-Flo Admin Sets, 2C/200", K792538. These sets are standard PVC sets with no proprietary pumping segment. In addition, Baxter added blood and epidural use with K900699, "Flo-Gard 6300 Blood Pumping Indication" (blood use) and K913895, "Flo-Gard 6200, 6300 & 8000" (epidural use). The sets have similar intended use, technological characteristics, materials, components, and labeling.
0005
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2000 AUG
Ms. Renee L. Fluet Senior Regulatory Affairs Specialist Alaris Medical Systems, Incorporated Corporate Office 10221 Wateridge Circle San Diego, California 92121-2733
Re : K993524
Advantis ASC Infusion Pump and Administation Trade Name: Sets Requlatory Class: II Product Code: FRN May 12, 2000 Dated: Received: May 15, 2000
Dear Ms. Fluet:
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 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). 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.
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 Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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 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.
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Page 2 - Ms. Fluet
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 leqally 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".
Sincerely yours,
Timothy 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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Advantis™ ASC Infusion System 510(k) Premarket Notification
INDICATIONS FOR USE
510(k) Number (if known): _
Device Name: Advantis ASC Infusion System
Indications for Use: The Advantis ASC is intended to be used for intravascular administration of drugs, fluids, blood and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.
ALARIS Medical's policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent with this policy, we would contraindicate drugs and/or fluids as appropriate for the Advantis ASC. No such contraindications have been identified.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Use (Per 21 CFR 801.109)
Patricia Crescent
Over-The Counter
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
0007
§ 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).