(81 days)
Not Found
No
The description focuses on mechanical components and manual procedures for intraosseous infusion, with no mention of AI or ML technologies.
Yes.
The device facilitates emergency resuscitation through the use of drugs and fluids, which are therapeutic interventions.
No
The device is described as an "Intraosseous Infusion System" intended for "intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids." Its purpose is to administer substances, not to diagnose conditions.
No
The device description explicitly details physical components like an infusion tube, introducer, target/strain-relief patch, protector dome, and removal tool, indicating it is a hardware-based medical device.
Based on the provided information, the F.A.S.T. 1™ Intraosseous Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids." This describes a procedure performed directly on a patient's body for therapeutic purposes (administering fluids and drugs), not for examining specimens outside the body to diagnose or monitor a condition.
- Device Description: The description details a system for physically accessing the bone marrow space (sternum) to deliver substances. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information about a patient's health status.
- Using reagents or assays.
Therefore, the F.A.S.T. 1™ Intraosseous Infusion System is a medical device used for a therapeutic procedure, not an IVD.
N/A
Intended Use / Indications for Use
The F.A.S.T. 1™ Intraosseous Infusion System is intended for intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids.
Product codes
FMI
Device Description
The F.A.S.T. 1™ Intraosseous Infusion System has been designed to provide a means, as an alternative to intravenous infusion, for facilitating emergency resuscitation of adults through the administration of fluids and drugs. The F.A.S.T. 1™ Intraosseous Infusion System has been designed for use on the adult sternum. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the skin into the sternum of the patient, the target / strain-relief patch, and a protector dome. There is also an infusion tube removal tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
adult sternum
Indicated Patient Age Range
adults
Intended User / Care Setting
relatively untrained and unpractised users; civilian and military paramedics
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
Data has been obtained from tests conducted by or for Pyng Medical Corp., and from published literature. These tests relate to the safety and effectiveness of the new technological characteristics, and of technological characteristics shared with the predicate devices. The data include material on biocompatibility, material relating to technological characteristics shared with the predicate devices, and material relating to new technological characteristics.
Non-clinical data, simulated clinical trials, simulations and simulators general description:
The data include the results of common non-clinical engineering tests masses, forces, strengths, etc. In addition, much data was acquired during testing with excised human sternums, with human cadavers, and with live human subjects in a variety of simulations and simulated clinical trials.
In order to appropriately evaluate and develop the F.A.S.T. 1™ Intraosseous Infusion System. Pyng developed two different mechanical devices as simulators - a simulated Intraosseous Infusion System, and a simulated sternum. These devices allowed the developers, and potential users, to experience the use of the system on live human volunteers without injury to the volunteers, and to experience insertion and placement of infusion portals at the correct depth through overlying layers of tissue and skin. Using these devices, simulated clinical trials were conducted by civilian and military paramedics.
Further data on the performance of the complete F.A.S.T. 1™ Intraosseous Infusion System were gathered from testing with human cadavers and excised sternums.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
ുമ്പന്മാരും
അവലംബം
പ്രാ
11.0 510(K) SUMMARY
510(K) SUMMARY APR 25 1997
This summary of safety and effectiveness was prepared on January 31, 1997 and is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92
Submitted by:
Pyng Medical Corp. 2660 Oak Street, Vancouver, B.C. V6H 3Z6 Canada.
Phone: (604) 875 4526 Fax: (604) 875 5390
David L. Johnson, Ph.D., Contact person: Vice-President, Research and Development
Names of Device:
Trade Name: F.A.S.T. 1™ Intraosseous Infusion System Common Name: Intraosseous Infusion System (Hypodermic Needle) Classification Name: Hypodermic Single Lumen Needle (880.5570) Class: Il Panel: 80 Procode: FMI - Hypodermic Single Lumen Needle
Predicate Devices:
The legally marketed devices (predicate devices) upon which substantial equivalence to the F.A.S.T. 1™ Intraosseous Infusion System is based are:
-
- "SHERWOOD ILLINOIS needle". Sherwood Medical Co. Monoject® 16 gage Illinois Sternal / Iliac Aspiration Needle, reorder number 8881-245164. The 510(k) number for this product is K883014.
1
Description of Device:
The F.A.S.T. 1™ Intraosseous Infusion System has been designed to provide a means, as an alternative to intravenous infusion, for facilitating emergency resuscitation of adults through the administration of fluids and drugs. The F.A.S.T. 1™ Intraosseous Infusion System has been designed for use on the adult sternum. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the skin into the sternum of the patient, the target / strain-relief patch, and a protector dome. There is also an infusion tube removal tool.
Function. concepts. performance characteristics:
The concept of the device is that it will allow relatively untrained and unpractised users to safely and effectively insert a flexible infusion needle into the adult sternum.
The F.A.S.T. 1™ Intraosseous Infusion System is a hand-held, manually operated passive device. (it has no internal energy source). The infusion needle has a sharp stainless steel tip, a flexible shaft and a standard Luer connector. The user grasps an introducer handle attached to the infusion needle, and pushes the needle tip through the skin and overlying tissue into the stemum of the subject. Fluids or drugs are delivered through the needle to the marrow space of the sternum, and flow out the emissary veins of the sternum into the central circulation.
When the user has pushed the infusion needle to the correct penetration depth in the stemum, a mechanism inside the introducer handle disconnects the handle from the infusion needle, preventing the user from pushing the needle any further. The mechanism is fast acting - the user can push the needle in. have it released at the correct depth, and remove the introducer handle, all in the space of 1-2 seconds. The principle of the mechanism is that it detects the position of the anterior surface of the cortical bone of the sternum, and relates the position of the tip of the infusion needle to the surface of the cortical bone.
Another feature of the device is an adhesive patch which is applied to the top of the patient's chest. During application the user aligns the patch with the suprasternal notch. The position of the recommended insertion site is marked on the patch to aid in landmarking. Also, the patch and an associated cover provide protection and strain-relief to the site and the installed infusion needle.
The materials used in the F.A.S.T. 1™ Intraosseous Infusion System are materials commonly used in other infusion devices; stainless steels, medical
2
grade polyurethane and PVC, radiation sterilizable medical grade plastic (polyetherimide), and patch and adhesive materials commonly used in mounting transdermal drug delivery devices to human skin for extended periods.
Intended Use of the Device:
The F.A.S.T. 1™ Intraosseous Infusion System is intended for intraosseous infusion as an alternative to intravenous access to facilitate emergency resuscitation through the use of drugs and fluids.
Technological Characteristics compared with Predicate Devices:
The F.A.S.T. 1™ Intraosseous Infusion System and the COOK needles and the SHERWOOD needle have common technological characteristics in that they:
- are passive, hollow entry ports for the delivery of fluids to a marrow . space:
- have a stainless steel tip which penetrates through skin and overlying . tissue into a marrow space;
- are manually inserted using forces applied by the practitioner to a plastic . handle, at least part of which is removable;
- penetrate the cortical bone by the user pushing on the stainless steel tip, . either without twisting (Pyng) or with twisting (Cook, Sherwood);
- have a lumen which may be blocked with a removable stylet during . insertion:
- have a lumen which conveys drugs or fluids to a tip positioned in a marrow space:
- . include a distal connector which is a Luer taper connector and which connects to the source of drugs or fluids;
- are supplied as biocompatible, sterile, single-use products; .
- insert a needle or portal which is removed by attaching a remover and/or ● twisting and pulling out.
Each of the F.A.S.T. 1™ Intraosseous Infusion System, the COOK needles and the SHERWOOD needle consists of an apparatus and method for placing, into the marrow space of a bone, a hollow tube with a Luer connector on the distal end, for the purpose of delivering drugs and fluids. Each is manually operated. Each is made of common biocompatible steels and plastics.
Not all the technological characteristics of the F.A.S.T. 1™ Intraosseous Infusion System are the same as the predicate devices. The new technological characteristics of the F.A.S.T. 1™ Intraosseous Infusion System all arise from
3
the fundamental design objective of producing a system which is fully compatible with the environment in which it will be used. The F.A.S.T. 1™ Intraosseous Infusion System has several new technological characteristics.
Tests conducted:
Data have been obtained from tests conducted by or for Pyng Medical Corp., and from published literature. These tests relate to the safety and effectiveness of the new technological characteristics, and of technological characteristics shared with the predicate devices. The data include material on biocompatibility, material relating to technological characteristics shared with the predicate devices, and material relating to new technological characteristics.
These data support the assertion that the F.A.S.T. 1™ Intraosseous Infusion System is as safe and as effective as the predicate devices.
Non-clinical data, simulated clinical trials, simulations and simulators general description:
The data include the results of common non-clinical engineering tests masses, forces, strengths, etc. In addition, much data was acquired during testing with excised human sternums, with human cadavers, and with live human subjects in a variety of simulations and simulated clinical trials.
In order to appropriately evaluate and develop the F.A.S.T. 1™ Intraosseous Infusion System. Pyng developed two different mechanical devices as simulators - a simulated Intraosseous Infusion System, and a simulated sternum. These devices allowed the developers, and potential users, to experience the use of the system on live human volunteers without injury to the volunteers, and to experience insertion and placement of infusion portals at the correct depth through overlying layers of tissue and skin. Using these devices, simulated clinical trials were conducted by civilian and military paramedics.
Further data on the performance of the complete F.A.S.T. 1™ Intraosseous Infusion System were gathered from testing with human cadavers and excised sternums.
How the test results support substantial equivalence:
The F.A.S.T. 1™ Intraosseous Infusion System and predicate devices meet the relevant voluntary and mandatory standards including those for biocompatibility
4
(ISO 10993-1 as modified in FDA General Program memorandum #G95-1), sterilization (ANSI/ISO 11137 (R2-94)), and mechanical performance of Luer connectors (ISO 594).
The F.A.S.T. 1™ Intraosseous Infusion System has passed evaluation of all the internal specifications developed by Pyng Medical Corp. to ensure that the infusion system meets or exceeds the performance of the predicate devices, and meets or exceeds the safety and effectiveness requirements for a successful adult emergency intraosseous infusion system. The F.A.S.T. 1™ Intraosseous Infusion System has been evaluated by both civilian and military paramedics, and given highly positive ratings. To achieve this level of performance certain technological features not common to the predicate devices had to be developed and incorporated.
Safety. The quick push-pull insertion method, the protector dome, and the strainrelief and target functions of the target patch ensure that safe use of the system requires only the skills possessed by the intended user. The protector dome keeps the infusion site clean, and allows the user to see the site during infusion. The depth control mechanism. the bone probe and the target function of the patch avoid excess penetration. The flexible needle and subcutaneous portal. and the strain relief function of the patch minimize leakage. Data included in the submission support these assertions and the conclusion that the F.A.S.T. 1™ Intraosseous Infusion System is as safe as the predicate devices.
Effectiveness. The target function of the patch facilitates correct placement at the recommended insertion site. The depth control mechanism and the bone probe ensure that the system penetrates into the marrow space. These features together with the push-pull insertion method ensure that the system meets user criteria for vascular access time and success rate. The strain-relief function of the patch resists pull-out resulting from tension on the infusion line. The flexible needle and subcutaneous portal, and the protector dome, ensure that the system will be unaffected by large external forces and be compatible with other procedures performed on the patient. Data included in the submission support these assertions and the conclusion that the F.A.S.T. 1™ Intraosseous Infusion System is as effective as the predicate devices.
Conclusions:
The F.A.S.T. 1™ Intraosseous Infusion System and the predicate devices are all indicated for use in intraosseous infusion.
The F.A.S.T. 1™ Intraosseous Infusion System and one or both of its predicate devices are similar in that they are passive, needle-like devices intended for
5
emergency intraosseous infusion. They have a handle, at least part of which is removable, which the care-giver uses to place a steel tip through overlying tissue into the marrow space of a bone, using pushing and/or twisting motions. They have a lumen with a distal Luer taper connector which connects to a source of drugs or fluids to be infused. They are removed by attaching a remover and/or twisting and pulling out. They are supplied as biocompatible, sterile, single use products.
The above data and conclusions demonstrate that the F.A.S.T. 1™ Intraosseous Infusion System is as safe and effective as the predicate devices.