(23 days)
Not Found
No
The device description explicitly states it uses a mechanical, elastomeric reservoir to provide infusion, and there is no mention of AI, ML, or any related concepts in the provided text.
Yes
The device is described as an "infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management." This indicates it is used for treatment (pain management) by delivering substances to the body, which aligns with the definition of a therapeutic device.
No
Explanation: The device is an infusion pump designed to deliver solutions at a preset rate for pain management, not to diagnose a medical condition.
No
The device description clearly outlines physical components like an elastomeric pump, catheter needle/introducer, and infusion catheter, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management." This describes a device used to deliver substances into the body, not to test samples from the body to diagnose or monitor a condition.
- Device Description: The description details a mechanical system for delivering fluid, not a system for analyzing biological samples. It explicitly states the device is "provided empty" and "no specific drug references are made."
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with in vitro diagnostics.
In summary, the device is an infusion pump, which is a therapeutic device used for drug delivery, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a preset rate for post-operative pain management.
Product codes
MEB, KGZ, BSO
Device Description
The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and accessories. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate.
The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
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
Infusion of liquids into a patient in the general hospital setting as well as at home is frequently required in medical treatment.
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
Not Found
Key Metrics
Accuracy: ± 15%
Predicate Device(s)
Reference Device(s)
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
JUL 1 9 2007
510(k) SUMMARY
Submitters Name: Michael James, Director of Quality Symbios Medical Products, LLC 7301 Georgetown Road, Suite 150 Indianapolis, IN 46268 Office: 317-225-4447 Mobile: 812-521-7074 Fax: 317-225-4451
Contact Person: Same as submitter. Facility Registration Number: 3005203102 Date Summary Prepared: May 1, 2007
IDENTIFICATION OF MODIFIED DEVICE
Trade Name: Disposable Infusion Pump Kit Common Name: Disposable Infusion Pump Kit Panel: General Hospital
Classification Name and Reference:
Pump
Pump, Infusion, Elastomeric, External (21 CFR 880.5725) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 80 Device Product Code: MEB
Catheter Needle/Introducer Catheter, Accessories (21 CFR 878.4200) Device Classification for the predicate devices: Class | Exempt Device Panel Code: 79 Device Product Code: KGZ
Infusion Catheter
Catheter, Conduction, Anesthetic (21 CFR 868.5120) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 73 Device Product Code: BSO
1
IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Trade Name: Disposable Infusion Pump Kit Common Name: Disposable Infusion Pump Kit 510(k) Number: K051474 Panel: General Hospital
Classification Name and Reference:
Pump
Pump, Infusion, Elastomeric, External (21 CFR 880.5725) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 80 Device Product Code: MEB
Catheter Needle/Introducer
Catheter, Accessories (21 CFR 878.4200) Device Classification for the predicate devices: Class I Exempt Device Panel Code: 79 Device Product Code: KGZ
Infusion Catheter
Catheter, Conduction, Anesthetic (21 CFR 868.5120) Device Classification for the subject and/or predicate devices: Class II Device Panel Code: 73 Device Product Code: BSO
DESCRIPTION OF THE DEVICE
Infusion of liquids into a patient in the general hospital setting as well as at home is frequently required in medical treatment. For example, in orthopedics a disposable device is often indicated after outpatient arthroscopic surgery in order to infuse local anesthetics for several days following the patient's return home. The infusion catheter is usually removed when the patient returns to the physician's office for a follow-up visit.
The Symbios Disposable Infusion Pump Kit is a convenience kit that includes the components necessary to provide temporary infusion of a liquid into a patient. The components of the system are an elastomeric pump, a catheter needle/introducer, an infusion catheter and accessories. The pump is a disposable, self-contained, infusion system utilizing an inflatable elastomeric reservoir to mechanically pressurize a fluid and drive it through tubing to a small restrictor to provide infusion at a pre-set rate.
The device is provided empty and no specific drug references are made in the labeling. The device is not intended for delivery of blood, blood products, lipids or fat emulsions.
2
INTENDED USE OF THE DEVICE
(Same for both the modified and unmodified predicate device)
The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management.
NEW DEVICE IN COMPARISON WITH PREDICATE DEVICE
Minor modifications have been made to the Disposable Infusion Pump Kit cleared in 510(k) Number K051474.
-
- The fill volume has been increased from 100 ml to 150 ml. The design (dimensions, materials, assembly methods) of the pump remains unchanged. Note - The design of the predicate device was capable of a 150 ml fill volume, but only tested and verified to 100 ml. Diagrams of the modified and predicate pump assemblies are shown in Attachment 2.
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- The catheter needle/introducer included in the kit has been extended to include needle/introducers that are as long as 10 inches in length, and up to 14 gauge (GA) in diameter. The increased size is needed for patients with larger bodies. The needle material remains stainless steel, while the introducer catheter material could be either Teflon or polyethylene.
| Modified Device | Predicate Device | |
|---|---|---|
| 510(k) Number | New | K051474 |
| Manufacturer | Symbios Medical Products, LLC | Symbios Medical Products, LLC |
| Type | Elastomeric Pump | Elastomeric Pump |
| Fluid Reservoir | Sold empty and capable of being | |
| filled via a fill port | Sold empty and capable of being | |
| filled via a fill port | ||
| Reservoir Material | Synthetic rubber, latex-free | |
| elastomeric membrane | Synthetic rubber, latex-free | |
| elastomeric membrane | ||
| Pressure Source | Strain energy of elastomeric | |
| membrane | Strain energy of elastomeric | |
| membrane | ||
| Fill Volume | 150 ml | 100 ml |
| Flow Rate | 2.0 ml/hr | 2.0 ml/hr |
| Flow Profile | Continuous | Continuous |
| Accuracy | ± 15% | ± 15% |
| Power Requirement | None | None |
| Tubing | Integrated | Integrated |
| Tubing Material | PVC | PVC |
| Flow Control | Consistent flow rate throughout the | |
| entire course of therapy is achieved | ||
| by orifice size (no change) | Consistent flow rate throughout the | |
| entire course of therapy is achieved | ||
| by orifice size | ||
| Safety Features | Fixed Flow rate tubing prevents fluid | |
| runaway conditions. Each | Fixed Flow rate tubing prevents fluid | |
| administration set is supplied with a | ||
| clamp to stop the infusion if | ||
| necessary. (no change) | runaway conditions. Each | |
| administration set is supplied with a | ||
| clamp to stop the infusion if | ||
| necessary. (no change) |
Pump
3
Catheter Needle/Introducer
| Modified Device | Predicate Device | |
|---|---|---|
| FDA Status | Exempt (878.4200) | Exempt (878.4200) |
| Sponsor/Manufacturer | Martech | Martech |
| Material - Needle | Stainless Steel | Stainless steel |
| Material - Introducer Catheter | Teflon or Polyethylene | Teflon |
| Needle Size | Up to 14 GA | 16 GA |
| Needle Length | Up to 10" | 2.75" |
STERILITY INFORMATION
EtO sterilization with the following parameters:
Sterility Assurance Level: 10-6
Sterility Validation Method: ANSI/AMMI/ISO 11135-1994
The maximum levels of residuals allowable:
| Ethylene Oxide (EtO) |