FASTx™ Sternal Intraosseous Device is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.

Device Description

FASTx™ Sternal Intraosseous Device has been designed to provide an alternative to intravenous infusion access of the circulatory system. It utilizes intraosseous infusion in order to facilitate emergency resuscitation through the use of fluids and drugs. The device has been designed for use on the manubrium, the upper (superior) portion of the sternum. The FASTx™ Sternal Intraosseous Device consists of an introducer handle with target foot which allows the user to target the recommended insertion site and place the infusion tube bone portal into the manubrium. On withdrawing the introducer handle, the infusion tube bone portal is left firmly placed in the manubrium, the infusion tube luer lock can be connected to a source such as an IV line or standard syringe for infusion of emergency drugs or fluids. The target foot separated from the handle is adhered to the skin over the insertion site providing protection; the infusion tube strain relief hook is clipped to the target foot for strain relief. The protective dome is placed over the target foot insertion site providing additional protection from external forces.

AI/ML Overview

The provided document is a 510(k) summary for the FASTx™ Sternal Intraosseous Device, seeking substantial equivalence to a predicate device (FAST1® Intraosseous Infusion System cleared under K080865). This type of submission focuses on demonstrating equivalence rather than proving novel effectiveness through clinical studies with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria for a new device, a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The document states that the FASTx™ Sternal Intraosseous Device has "the same intended use and similar technological characteristics as the predicate devices." It outlines the safety and effectiveness review based on:

Bench tests, functional testing, and validation studies.
The infusion needle tubing and portal tip being the same as the predicate device.
Risk analysis conducted according to ISO 14971:2007.
Biocompatibility testing according to ISO 10993-1.
Sterilization validation study according to ISO 11137.
Pyrogen study according to USP guidelines.
Packaging validation according to ISO 11607.

These are standard regulatory assessments for demonstrating safety and performance equivalence to a legally marketed predicate device, not a study designed to establish novel acceptance criteria or compare performance against a specific clinical benchmark for a new, non-predicate-based claim.

Summary

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MEDICAL

KI10124

510(k) Summary

(per 21 CFR 807.92)

AUG 3 1 2010

I. Applicant

Pyng Medical Corp. 7 - 13511 Crestwood Place Richmond, BC, Canada, V6V 2E9

Contact Person: Dr. Maya Butterfield Quality Assurance & Regulatory Affairs Manager Tel: 604.303.7964 Fax: 604.303.7987 Email: MButterfield@pynq.com

June 29, 2010 Date Prepared:

II. Device Name

Trade Name: Device Type: Classification Name: Regulation Number: Product Code: Class: Advisory Committee:

FASTx™ Sternal Intraosseous Device Intraosseous Infusion Device Hypodermic Single Lumen Needle 880.5570 FMI Class II General Hospital

III. Predicate Devices

FAST'Y™ STERNAL INTRAOSSEOUS DEVICE is substantially equivalent to the FAST1® Intraosseous Infusion System cleared under K080865.

IV. Indications for Use of the Device

Indications for Use:

Description of the Device V.

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YYNG MEDICAL

On withdrawing the introducer handle, the infusion tube bone portal is left firmly placed in the manubrium, the infusion tube luer lock can be connected to a source such as an IV line or standard syringe for infusion of emergency drugs or fluids.

The target foot separated from the handle is adhered to the skin over the insertion site providing protection; the infusion tube strain relief hook is clipped to the target foot for strain relief. The protective dome is placed over the target foot insertion site providing additional protection from external forces.

VI. Summary of the Technical Characteristics FASTx™ Sternal Intraosseous Device has the similar technological

characteristics as the FAST1® Intraosseous Infusion System that has received FDA 510(k) clearance under K080865.

	Pyng Medical Corp.	Pyng Medical Corp.
Product Name	FASTx™ SternalIntraosseous Device	FAST1™ IntraosseousInfusion System
510(k) Number	K100124	K080865
Product Code(s)	FMI	FMI
Regulation #	880.5570	880.5570
Class	II	II
Indications for Use	The FASTx™ SternalIntraosseous Device isindicated for use inestablishing a sternalintraosseous access route inadult and adolescent patients(12 years of age and older)requiring vascularadministration of drugs orfluids to facilitate emergencyresuscitation.	The FAST1™ IntraosseousInfusion System is indicatedfor use in establishing asternal intraosseous accessroute in adult and adolescentpatients (12 years of age andolder) requiring vascularadministration of drugs orfluids to facilitate emergencyresuscitation.
Intended User	Same as K080865	Paramedic/Doctor
Target Population	Same as K080865	Patients 12 years and older
Where Used	Same as K080865	Pre-hospital, ambulance,hospital, battlefield
IO Insertion Location	Same as K080865	Manubrium; superior part ofthe sternum
Method of Insertion	Same as K080865	Manual (user applied force)insertion with automaticrelease and automatic depthcontrol

Company of Children Call & Addition American American American Comments of Children Comments of Children Comments of Children Comments of Children Comments of Children Commen	Substantial Equivalence Table qiving the similarities and differences
	between FASTx™ Sternal and the Predicate Device K080865

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1EDICAL

	Pyng Medical Corp.	Pyng Medical Corp.
Product Name	FASTxTM SternalIntraosseous Device	FAST1TM IntraosseousInfusion System
Removal	Same as K080865	Grip infusion tubing near thesurface of the skin and pull todisengage portal from corticalbone
Duration of Use	Same as K080865	Less then 24 hours. Until analternative access is achieved
Number of Uses	Same as K080865	Single use
Sterility	Same as K080865	Delivered in sterile package
Biocompatibility	Same as K080865	Meets requirements ofISO10993
Fluids infused	Same as K080865	Emergency IV fluids
Fluids aspirated	Same as K080865	Bone marrow - optional stepto check placement ofInfusion Tube
Materials	Molded plastics and stainlesssteel	Molded plastics and stainlesssteel
Contra-indications	None known	None known

VII. Safety & Effectiveness

FASTx™ Sternal Intraosseous Device has the same intended use and similar technological characteristics as the predicate devices. The differences in technological characteristics between the new device and the predicate device do not raise issues of safety and effectiveness of the FASTx™ Sternal Intraosseous Device.

Bench tests, functional testing, and validation studies were conducted. ●
The infusion needle tubing and portal tip of the FASTx™ Sternal . Intraosseous Device are the same as the predicate device.
The risk analysis was conducted according to ISO 14971:2007. .
Applicable biocompatibility testing was in accordance to the requirements of . ISO 10993-1.
The sterilization validation study was conducted in accordance to ISO 11137 . "Sterilization of health care products - Radiation- Part2: Establishing the sterilization dose".
Pyrogen study was conducted in accordance to USP: "Guideline on Validation . of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices".
Packaging validation was completed in accordance with ISO 11607. .

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pying Medical Corporation C/O Ms. Paula Wilkerson Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

AUG 31 2010

Re: K100124

Trade/Device Name: FASTx™ Sternal Intraosseous Device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: August 9, 2010 Received: August 16, 2010

Dear Ms. Wilkerson:

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 (fixs 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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- Ms. Wilkerson

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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4. Indication for Use Statement

510(k) Number (if known):

Device Name: FASTx™ Sternal Intraosseous Device

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Ola C. Umpen 8/30/10
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of /

510(k) Number: K180124

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).