The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation

Device Description

The modified FASTI™ Intraosseous Infusion System is very similar to the FAST1™ Intraosseous Infusion System previously cleared under 510(k) K970380. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the sternum of the patient, the target/strain-relief patch, protector dome and sharps plug. The minor difference is that the infusion tube of the modified FAST1™ Intraosseous Infusion System can be removed from the patient's sternum by directly pulling on the infusion tubing, whereas the predicate device utilizes a remover tool to remove the infusion tube from the patient's sternum.

Both products are single use, hand-held, manually operated passive devices, (it has no internal energy source). Both products have an infusion tube with a sharp stainless steel tip, a flexible shaft and a standard Luer connector. For both products the user grasps an introducer handle attached to the infusion needle, and pushes the needle tip through the skin and overlying tissue into the sternum 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 venous circulation.

Both devices use the same pusher handle and method to insert the infusion needle to the correct penetration depth in the sternum; a mechanism inside the introducer handle disconnects the handle from the infusion needle, preventing the user from pushing the needle any further. The principal of the mechanism is identical for both devices in 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.

Both devices utilize the same adhesive patch which is applied to the top of the patient's chest which the user aligns with the supra-sternal notch of the patient. The position of the recommended insertion site is the same for both devices and is marked on the patch to aid in land marking. Also, the same patch and an associated cover for both devices provide protection and strain-relief to the site and the installed Infusion Tube.

AI/ML Overview

The provided text is a 510(k) summary for the FAST1™ Intraosseous Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device, specifically highlighting a minor modification related to the removal mechanism of the infusion tube. It does not contain specific acceptance criteria, a detailed study description with performance metrics, or information related to AI or ground truth establishment in the context of medical device performance studies.

Therefore, many of the requested details cannot be extracted from the provided input. The document is primarily a regulatory submission for a device modification, not a standalone performance study report.

Here's a breakdown of what can be inferred and what is missing, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated. The document focuses on demonstrating substantial equivalence to a predicate device, which implies the modified device should perform at least as safely and effectively as the predicate.
Reported Device Performance: Not quantified. The study conclusion states "The verification and validation conducted and conclusions demonstrate that the modified FAST1™ Intraosseous Infusion System is as safe and effective as the predicate device K970380." This is a qualitative statement of equivalence, not a report of specific performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not mentioned.
Data Provenance: Not mentioned.
Retrospective/Prospective: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided. The study is a comparison of a modified mechanical device to a predicate device, not an assessment of diagnostic performance requiring expert interpretation or ground truth establishment in that typical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable and not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No, an MRMC study was not done. The device is a direct-use medical device, not a diagnostic or AI-assisted tool involving human readers.
AI Improvement Effect Size: Not applicable, as the device does not involve AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the typical sense. The "ground truth" for this device's performance would likely involve mechanical testing, simulated insertion/removal tests, and potentially human factors assessments to confirm the modified removal mechanism's efficacy and safety. These details are not provided.

8. The sample size for the training set

Not applicable, as this device does not use machine learning or AI that would require a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K072487

3.0 510(k) SUMMARY

This summary of safety and effectiveness was prepared on 31* August 2007 and is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitted by:

Name:	Pyng Medical Corporation
Address:	7 - 13511 Crestwood PlaceRichmond, British Columbia, V6V 2E9
Country:	Canada
Establishment Registration:	9615387	FEB 13 2008
Tel:	+1 604 303-7964
Fax:	+1 604 303-7987
E-mail:	info@pyng.com
Contact Person:	Dr. Maya Butterfield
Title:	Quality Assurance & Regulatory Affairs Manager

Name of Device:

Trade Name:	FAST1™ Intraosseous Infusion System
Common Name:	Intraosseous Infusion System
Classification Name:	Hypodermic Single Lumen Needle
Regulation Number:	880.5570
Product Code:	FMI
Class:	Class II
Panel:	80

Predicate Device:

The legally marketed device (predicate device) upon which substantial equivalence to the modified FASTI™ Intraosseous Infusion System is based is:

FAST1 ™ Intraosseous Infusion System

The 510(k) number for this product is K970380.

Indications for Use:

Description of the Device:

		IT IN INSTITUTION COLLECTION COLLECTION CONSTITUTION CONSTITUTION OF CONSULTION CONSULTION CONSULTION COLLECTION COLLECTION COLLECTION COLLECTION CONSULTION CONSULTION CONSUL
Date: August 31. 2007	DO NOT COPY	CONFIDENTIAL	Page #: 3 - 1
		МИНИЕ Г. Г. Г. Г. РИСТИНИВАНИЯ ПРИСТЕРИНИ ПРИСЕРИНИ ПРИСЕРИНИ ПРИСЕРИНИ ПРИСЕРИИ ПРИСЕРИИ ПРИССИИ ПОДРЕДНИКА ПО Г. С ПРИСИНИЕ НА ПРИСТИВНИКА ПО ГОДИНИ ПРИСТИВ ПОДИНИ ПРИСТИВ

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MEDICAL

Summary of the Technological Characteristics compared with Predicate Device:

The modified FAST1™ Intraosseous Infusion System and the predicate device are both indicated for use in intraosseous infusion.

The modified FAST1™ Intraosseous Infusion System and its predicate device are similar in that they are passive, hand-held, manually operated devices intended for emergency intraosseous infusion. They both have a handle, at least part of which is removable, which the care-giver uses to place a stainless steel portal tip through overlying tissue into the marrow space of the Manubrium, using only manual force. The Infusion Tubes of both devices have sharp stainless steel tips, a flexible shaft and a standard Luer connector. Both are supplied as biocompatible, sterile, single use products. The revised device does not require a remover tool in order to remove the Infusion Tube. The predicate device does require a remover tool in order to remove the Infusion Tube. Otherwise both devices are similar, and where it is used is identical.

The verification and validation conducted and conclusions demonstrate that the modified FAST1™ Intraosseous Infusion System is as safe and effective as the predicate device K970380.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three curved lines or ribbons flowing from the figure.

FEB 13 2008

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Mava Butterfield Quality Assurance & Regulatory Affairs Manager PYNG Medical Corporation #7-13511 Crestwood Place Richmond, B.C., V6V 2E9 CANADA

Re: K072487

Trade/Device Name: FAST1™ Intraosseous Infusion System Regulation Number: 880.5570 Regulation Name: Hypodermic Single lumen Needle Regulatory Class: II Product Code: FMI Dated: February 5, 2008 Received: February 6, 2008

Dear Dr. Butterfield:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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. Page 2 – Dr. Butterfield

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0 INDICATION FOR USE STATEMENT

Indication for Use Statement

510(k) Number (if known):

Device Name:

FAST1 ™ Intraosseous Infusion System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Centen O.m

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Date: August 31, 2007 DO NOT COPY CONFIDENTIAL

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Regulation Number and Section

§ 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).