(89 days)
Not Found
No
The description focuses on the mechanical delivery of predetermined volumes and order of solutions based on bag configuration, with no mention of adaptive learning, pattern recognition, or any AI/ML-specific terms or functionalities.
Yes
The device is described as an "Infusion system" intended for sequential infusion of intravenous solutions, which typically deliver substances to treat or manage a patient's condition. While it focuses on the delivery of solutions like saline and heparin, these are used as part of a therapeutic regimen (e.g., SASH protocol) to facilitate the administration of other medications, indicating its role in patient treatment.
No
The device is described as an "Infusion System" intended for sequential infusion of intravenous solutions, which is a therapeutic function, not a diagnostic one. It does not mention any capabilities for detecting, analyzing, or identifying a medical condition or disease.
No
The device description clearly describes a physical system ("disposable bag", "AutoDose Bag", "AutoDose Restrictor Set") designed to infuse IV solutions, indicating it is a hardware device with potentially integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "sequential infusion of predetermined volumes of intravenous solutions." This describes a system for delivering fluids into a patient's body, not for testing samples from a patient's body.
- Device Description: The description details a system for infusing IV solutions in a specific order and volume. It focuses on the mechanical delivery of fluids.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on testing these samples.
The device is clearly intended for therapeutic delivery of medications and solutions to a patient, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions.
Product codes (comma separated list FDA assigned to the subject device)
MEB
Device Description
The AutoDose Infusion System was designed to infuse Intravenous solutions of predetermined volumes in a predetermined order based on the configuration of the disposable bag. The system is capable of infusing Intravenous (IV) solutions of the following volumes in this order: Chamber 1: $\leq$ 10 mls., Chamber 2: $\sim$ 25 – 120 mls, Chamber 3: $\leq$ 10 mls. A Pharmacist may decide to use the AutoDose Infusion System with an AutoDose Bag filled with 0.9% Sodium Chloride Injection and Heparin Lock Flush Solutions, USP in conjunction with an Administration IV fluid. In this configuration, the AutoDose would deliver the IV fluids using the deliver regimen, commonly known as SASH: (Saline, Administration, Saline, Heparin) and eliminate the need to use needles, syringes and access the IVAD (Intravenous Access Device) multiple times. When the Pharmacist chooses to use the AutoDose Infusion system in this manner, an empty AutoDose Bag is filled with Saline and Heparin solutions drawn and prepared from the Pharmacy stores. After the prescription is filled with the main medication (i.e. Administration solution), the solutions are administered to the patient using the AutoDose Infusion System following the Directions for Use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pharmacist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device and Solution Compatibility and Stability: The AutoDose™ Infusion System was tested to verify that both 0.9% Sodium Chloride, Injection and Heparin Lock Flush Solutions, USP are both compatible and stable. The AutoDose Bag and AutoDose Restrictor Set were filled with these solutions and tests were performed on the solutions per the applicable USP 24/NF 19 monographs. The results confirmed that the solutions meet all requirements over the storage periods and conditions.
Solution Infusion: The AutoDose System infuses IV fluids at consistent rates and pressures. Performance testing of the AutoDose Infusion System verified that the Saline and Heparin fluids would be consistently delivered in predetermined order and volumes, and generated infusion pressures no greater than 25 psi.
Biocompatibility: Safety testing performed on the AutoDose Bag and AutoDose Restrictor Set materials in fluid contact demonstrate they are biocompatible.
Hazards Analysis: A Product Hazards Analysis was performed on the AutoDose Infusion System used with Sodium Chloride and Heparin solutions. The compatibility and stability of the solutions were tested and verified. No new or increased risk factors were identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows handwritten text. The top line reads "K993832". The bottom line reads "1 cf 3" with each character underlined.
9 2000 FEB
SECTION 15: SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR807.92
15.1 SUBMITTER INFORMATION
- Company Name: Tandem Medical, Inc. a. 15910 Bernardo Center Dr. b. Company Address: Company Phone: (858) 673-3900 C. Company Facsimile (858) 673-3566 d. Contact Person: Albert Misajon Director, Regulatory Affairs And Quality Assurance Date Summary Prepared: November 10, 1999 e. DEVICE IDENTIFICATION 15.2 AutoDose™ Infusion System - For Trade/Proprietary Name: a.
- Classification Name: b.
AutoDose Infusion System
- For use with
S.A.S.H.
Infusion Pump 21 CFR 880.5725
IDENTIFICATION OF PREDICATE DEVICES 15.3
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Tandem | |||
| Medical | |||
| Inc. | AutoDose™ Infusion System | K990889 | June 3, 1999 |
15.4 DEVICE DESCRIPTION
The AutoDose Infusion System was designed to infuse Intravenous solutions of predetermined volumes in a predetermined order based on the configuration of the disposable bag. The system is capable of infusing Intravenous (IV) solutions of the following volumes in this order:
| Chamber | Volume |
|---|---|
| 1 | $\leq$ 10 mls. |
| 2 | $\sim$ 25 – 120 mls |
| 3 | $\leq$ 10 mls. |
1
4 AutoDose TM Infusion System - For Use With S.A.S.H. |
| Indications for Use: | The AutoDose Infusion system is intended for sequential infusion of predetermined volumes of intravenous solutions including 0.9% Sodium Chloride Injection, (NaCl), and Heparin Lock Flush Solution, USP solutions. |
(PLEASE DO NOT WRITE BELOW TILIS LINE - CONTINUE ON ANOTHER PAGF. II: NEUDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patrice Cuscente
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use V
— ————— —
Over-The-Counter Use