(143 days)
Sabratek 6060 Homerun, Abbott Aim
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the device's function as an infusion pump.
Yes
The device is an ambulatory infusion pump designed to administer intravenous fluids, which directly contributes to patient treatment.
No
Explanation: The device is an ambulatory infusion pump, which is used for delivering fluids to a patient, not for diagnosing conditions.
No
The device description explicitly states it is an "ambulatory infusion pump" and mentions "dedicated disposables and related accessories," indicating it is a hardware device with associated components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "manage a wide variety of intravenous fluid profiles." This describes a device that delivers fluids directly into a patient's body, which is an in-vivo (within the living organism) function, not an in-vitro (outside the living organism) diagnostic test.
- Device Description: The description reinforces this by calling it an "ambulatory infusion pump" and mentioning "dedicated disposables and related accessories," which are typical components of infusion systems used for administering substances to patients.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to administer fluids, not to perform such diagnostic tests.
N/A
Intended Use / Indications for Use
The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.
Product codes
Not Found
Device Description
The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories.
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
hospital, clinic and home care use.
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)
Not Found
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.
Sabratek 6060 Homerun, Abbott Aim
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
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
AUG 2 3 1996
APPENDIX F
Image /page/0/Figure/3 description: The image shows a document with the title "Patient Solutions Inc." at the top. Below the title, the text "MODEL 1200" is displayed in a larger font. At the bottom of the document, the text "510(k) Summary" is present.
ZLAI
1
Image /page/1/Picture/0 description: The image shows a logo for Patient Solutions Inc. The logo features a stylized letter "P" formed by interconnected loops, with the company name "Patient Solutions Inc." printed to the right of the letter. A dotted line extends from the right side of the "P" to the right edge of the image.
13220 Evening Creek Dr. So. Suite #114 San Diego, CA 92128 619-679-3840 FAX 619-679-3844
510(k) SUMMARY
| Submitter's Name: | Patient Solutions Inc. (PSI) |
|---|---|
| Address: | 13220 Evening Creek Dr. So. |
| Suite #114 | |
| San Diego, California 92128 | |
| Phone: | (619) 679-3840 |
| Contact: | Tom Kane |
| Date of Summary: | April 1, 1996 |
| Name of Device: | Model 1200 Ambulatory Infusion Pump |
Legally Marketed Device to Which Substantially Equivalency Is Claimed:
Sabratek 6060 Homerun and Abbott Aim
Description of Device:
The PSI Model 1200 is a small portable ambulatory infusion pump intended for hospital, clinic and home care use. It uses dedicated disposables and related accessories.
Intended Use:
The PSI Model 1200 ambulatory infusion pump is a multifunction pump designed to manage a wide variety of intravenous fluid profiles.
Technological Characteristics
The PSI, Sabratek and Abbott ambulatory infusion pumps all have the same general design and incorporate similar technologies, materials, and components.
The primary function of the PSI Model 1200 is the same as the Sabratek 6060 and Abbott Aim, to administer fluids to a patient. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. PSI concludes that the PSI Model 1200 is substantially equivalent to the Sabratek 6060 and Abbott Aim in providing infusion fluid therapy for the same clinical purposes that require the use of an ambulatory infusion pump.