(76 days)
No
The summary describes a mechanical elastomeric infusion pump and associated components, with no mention of AI or ML capabilities.
Yes
The device is intended to provide continuous infusion of a local anesthetic for regional anesthesia and pain management, which directly addresses medical conditions and symptoms.
No
This device is an infusion kit designed for continuous delivery of local anesthetics, which is a therapeutic function for pain management, not a diagnostic one.
No
The device description explicitly lists multiple hardware components, including an elastomeric infusion pump, catheter, needle, syringe, dressing, tape, gauze, hemostasis valve assembly, and hookup wire. It is a kit comprised of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management. This is a therapeutic application, delivering a substance to the body for treatment.
- Device Description: The device is an infusion kit comprised of a pump and various components for delivering medication. This aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples (like blood, urine, tissue) to diagnose diseases, monitor health, or determine compatibility. This device's function is to deliver medication, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The Nerve Block Infusion Kit is intended to provide continuous infusion of a local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative general and orthopedic surgery. Additional routes of infusion include percutaneous, subcutaneous, epidural and into intraoperative sites.
Product codes (comma separated list FDA assigned to the subject device)
MEB
Device Description
The Nerve Block Infusion Kit is nearly identical to the I-Flow PainBuster Infusion Kit with the exception of a new intended use, the addition of three new pump models and the addition of three new kit components (insulated Tuohy needle, hemostasis valve assembly and hookup wire). The kit is comprised of an elastomeric infusion pump (K944692) and various components such as catheter, needle, syringe, dressing, tape, gauze, hemostasis valve assembly, hookup wire and accessories such as carry case, power ring and clothing attachment clip (E-Clip). The PainBuster kit contains all the above components except for the insulated Tuohy needle, hemostasis valve assembly and hookup wire.
The Nerve Block pump is a disposable device intended for single patient use.
The Nerve Block pump is suitable for use as an ambulatory device and is intended for use in the hospital, home environment or alternative care sites.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Near a nerve, intraoperative (soft tissue / body cavity) site, synovial cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital, home environment or alternative care sites.
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)
Flow Rate Performance Data: Testing occurred at standard operating conditions. Testing occurred at nominal fill volumes for each model. All models produced an average flow rate within the ±15% accuracy claim.
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.
I-Flow PainBuster Infusion Kit (K980558, K982946), Sqarlato Pain Control Infusion Pump (PCIP) (K896422), I-Flow Homepump C-Series (K944692), B. Braun Continuous Nerve Block Set, McKinley Outbound Syringe Infuser (K982256)
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
3/4/99
Premarket Notification - 510(k) Summary of Safety and Effectiveness Nerve Block Infusion Kit Page 2 of 4
GENERAL INFORMATION 1.0
Purpose of Submission 1.1
- This submission is intended to notify the Federal Food and Drug 1.1.1 Administration that I-Flow Corporation intends to market a new product line to be called the Nerve Block Infusion Kit.
- Trade Name: Nerve Block Infusion Kit 1.1.2
- Common Name: Elastomeric Infusion Pump Kit 1.1.3
- 1.1.4 Classification Name: Pump, Infusion, Elastomeric
- Classification Panel: General Hospital and Personal Use Device 1.1.5
1.2 Statement of Equivalence
- The Nerve Block Infusion Kit is substantially equivalent in total or in part to the 1.2.1 following: the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sqarlato Pain Control Infusion Pump (PCIP) (K896422), the I-Flow Homepump C-Series (K944692), the B. Braun Continuous Nerve Block Set (pre-amendment device) and the McKinley Outbound Syringe Infuser (K982256).
- The Nerve Block Infusion Kit includes components that are legally marketed 1.2.2 (either pre-amendment devices or devices that have been granted permission to market via premarket notification regulation).
- The pumps used in the Nerve Block Infusion Kit are identical in design and 1.2.3 materials to the pumps used in the PainBuster Infusion Kit.
- 1.3 Definitions (from Taber's Cyclopedic Medical Dictionary, 1997)
- Nerve Block: The induction of regional anesthesia by preventing sensory 1.3.1 nerve impulses from reaching the centers of consciousness. This is usually done on a temporary basis, by using chemical or electrical means. In the former case. it is accomplished by injecting an anesthetic solution, such as procaine, around the nerve but at some distance, or by anesthetizing nerve endings in the region itself (infiltration).
PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.0
2.1 Description of the Nerve Block Infusion Kit
- The Nerve Block Infusion Kit is nearly identical to the I-Flow PainBuster 2.1.1 Infusion Kit with the exception of a new intended use, the addition of three new pump models and the addition of three new kit components (insulated Tuohy needle, hemostasis valve assembly and hookup wire).
- 2.1.2 The kit is comprised of an elastomeric infusion pump (K944692) and various components such as catheter, needle, syringe, dressing, tape, gauze, hemostasis valve assembly, hookup wire and accessories such as carry case, power ring and clothing attachment clip (E-Clip).
- 2.1.2.1 The PainBuster kit contains all the above components except for the insulated Tuohy needle, hemostasis valve assembly and hookup wire.
1
- The Nerve Block Infusion Kit is intended to provide continuous infusion of a 2.1.3 local anesthetic near a nerve for regional anesthesia and pain management for pre-operative, perioperative and postoperative general and orthopedic surgery. Additional routes of administration include percutaneous, subcutaneous, epidural and into the intraoperative (soft tissue / body cavity) site and synovial cavity.
- The Nerve Block pump is a disposable device intended for single patient use. 2.1.4
- The Nerve Block pump is suitable for use as an ambulatory device and is 2.1.5 intended for use in the hospital, home environment or alternative care sites.
2.2 Product Configuration
- The Nerve Block kit models are available in fill volumes from 50 to 500 ml and 2.2.1 flow rates from 0.5 to 10 ml/hr.
- Each model consists of a kit with a Nerve Block pump and the following 2.2.2 optional components/accessories:
- Catheter, needle, hemostasis valve assemlby, hookup wire, 2.2.2.1 syringe, dressing, carry case, E-clip, antiseptic skin swabs, tape, gauze and power ring.
2.3 Components and Materials
All fluid path components of the Nerve Block pump are identical to the fluid path components of the PainBuster pump.
2.4 Pumping Mechanism
- The pressure that pumps the fluid comes from the strain energy of the 2.4.1 elastomeric membranes which are forced to expand when the pump is filled.
- The administration set consists of fixed diameter flow control tubing or glass 2.4.2 orifice.
2.5 Power Requirements
- 2.5.1 The Nerve Block pump is a mechanical pump that utilizes elastomeric membranes for power. No additional external power source is required.
OPERATIONAL SPECIFICATIONS AND DESCRIPTIONS 3.0
Standard Operating Conditions: 3.1
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