FASTResponder™ 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

FASTRESPONDER™ 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 FASTRESPONDER™ 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 text describes a 510(k) summary for the FASTResponder™ Sternal Intraosseous Device. It outlines the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain any information about acceptance criteria, device performance, a specific study proving acceptance, sample sizes for test or training sets, ground truth establishment, expert involvement, adjudication methods, or MRMC studies.

The section "Safety & Effectiveness VII." mentions that "Bench tests, functional testing, and validation studies were conducted," and refers to compliance with various ISO standards and USP guidelines for specific aspects like risk analysis, biocompatibility, sterilization, and pyrogen studies. However, it does not provide details on the actual results of these studies or specific performance metrics that would be considered acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria, as this information is not present in the provided document.

Summary

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510(k) Summary

(per 21 CFR 807.92)

JUN 2 5 2013

I. Applicant

Pyng Medical Corp. 13480 Crestwood Place Unit 210 Richmond, BC, Canada, V6V 2J9

Contact Person: Michele Tyler Ouality Assurance & Requlatory Affairs Vice President Tel: 604.303.7964 Fax: 604.303.7987 Email: mtyler@pyng.com

Date Prepared: June 24, 2013

II. Device Name

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

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

III. Predicate Devices

FASTRESPONDER™ STERNAL INTRAOSSEOUS DEVICE is substantially equivalent to the FASTx™ Sternal Intraosseous Device cleared under K100124 and FAST1® Intraosseous Infusion System cleared under K080865.

IV. Indications for Use of the Device

Indications for Use:

FASTRESPONDER™ 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.

V. Description of the Device

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MEDICAL

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.

Summary of the Technical Characteristics VI.

FASTRESPONDER™ Sternal Intraosseous Device has the similar technological characteristics as the FAST1® Intraosseous Infusion System that received FDA 510{k) clearance under K080865 and FASTx™ Sternal Intraosseous Device that received FDA 510(k) clearance under K100124.

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Substantial Equivalence Table giving the similarities and differences between FASTResponder™ and the Predicate

	Primary Predicate	Secondary Predicate to support multiple needles	Candidate Device	CompanyProduct Name	Where Used	IO Insertion Location	Method of Insertion	Removal	Duration of Use	Number of Uses	Sterility	Biocompatibility	Fluids infused	Fluids aspirated	Materials	Primary Predicate	Secondary Predicate tosupport multiple needles	Candidate Device
Company	Pyng Medical Corp.	Pyng Medical Corp.	Pyng Medical Corp.	Pyng Medical Corp.FASTX™ Sternal IntraosseousDevice	Pre-hospital, ambulance, hospital, battlefield	Manubrium; superior part of the sternum	Manual (user applied force) insertion with automatic release and automatic depth control	Grip infusion tubing near the surface of the skin and pull to disengage portal from cortical bone	Less than 24 hours. Until an alternative access is achieved	Single use	Delivered in sterile package	Meets requirements of ISO10993	Emergency IV fluids	Bone marrow - optional step to check placement of Infusion Tube	Molded plastics and stainless steel	Pyng Medical Corp.FASTX™ Sternal IntraosseousDevice	Pyng Medical Corp.FAST1® IntraosseousInfusion System	Pyng Medical Corp.FASTResponder™ SternalIntraosseous Device
Product Name	FASTX™ Sternal Intraosseous Device	FAST1® Intraosseous Infusion System	FASTResponder™ Sternal Intraosseous Device													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
Product Status	Cleared but recalled	Cleared, On market	Pending clearance													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
510(k) Number	K100124	K080865	K130487													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
Product Code(s)	FMI	Equivalent to Primary Predicate	Equivalent to Primary Predicate													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
Regulation #	880.5570	Equivalent to Primary Predicate	Equivalent to Primary Predicate													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
Class	II	Equivalent to Primary Predicate	Equivalent to Primary Predicate													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
Intended Use	The 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.	Equivalent to Primary Predicate	Equivalent to both the Primary and Secondary Predicates													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
Intended User	Paramedic/Doctor	Equivalent to Primary Predicate	Equivalent to Primary Predicate													Equivalent to Primary Predicate	Equivalent to Primary Predicate	Equivalent to Primary Predicate
Target Population	Patients 12 years and older	Equivalent to Primary Predicate	Equivalent to Primary Predicate

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	Primary Predicate	Secondary Predicate	Comments of the comments of the first of the first of the first of the first of the first of the first forCandidate Device
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------		support multiple needles
Compa	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Medical Corp.Dung	l Pyng Medical Corp.	Pyng Medical Corp.
Product Na	FASTx™ Sternal Intraosseous	FAST1® Intraosseou	FASTResponder™ Sterna
	Device	Infusion System------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Intraosseous Device
Contraindicatio	None known	Equivalent to Primar	Equivalent to Prima
		Predicate	Predicate
CompanyProduct Name	Cautions/Warnings	Primary Predicate	Secondary Predicate tosupport multiple needles	Candidate Device
Pyng Medical Corp.FASTX™ Sternal IntraosseousDevice	PRECAUTIONS:• The FASTX ™ Sternal isdesigned to penetrate 6mminto the manubrium.		Pyng Medical Corp.FAST1® IntraosseousInfusion System• The FAST1 ™Intraosseous InfusionSystem is designed topenetrate 6 mm into themanubrium.• Adult and adolescentpatients are expected tohave a manubriumthickness greater than 6mm. Qualifiedprofessionals shoulddetermine any appropriateor necessary exceptions,either inclusions orexclusions, to the criterion"For use with adult andadolescent patients"* (12 years of age andover).	Pyng Medical Corp.FASTResponder™ SternalIntraosseous DeviceEquivalent to PrimaryPredicate
	• Compromised skin over theinsertion site such astrauma, infection or burns• Fracture of the sternum orvascular injury which maycompromise the integrity ofthe manubrium or itsvascularization• Midline sternotomy scars		• Severe skin compromisesuch as trauma, infection orburns over the infusion sitemay interfere with use ofthe device.• Check for fracture of thesternum or vascular injurywhich may compromise theintegrity of the manubriumor its vascularization.
CompanyProduct Name	Cautions/Warnings(continued)	Primary Predicate	Secondary Predicate tosupport multiple needles	Candidate Device
Pyng Medical Corp.FASTX™ Sternal IntraosseousDevice	WARNINGS:• Safety in patients with verysevere osteoporosis has notbeen proven• Insertion in sites other thanthe manubrium may resultin ineffective infusionand/or serious injury to thepatient.	Pyng Medical Corp.FAST1® IntraosseousInfusion System	Pyng Medical Corp.FASTResponder™ SternalIntraosseous DeviceEquivalent to PrimaryPredicate
		• Check for midlinesternotomy scars - thedevice may be less effectivein patients with a previousmidline sternotomy.• Safety of the FAST1™ inpatients with very severeosteoporosis has not beenproven.• Insertion of the FAST1™in sites other than themanubrium may result inineffective infusion and mayresult in over-penetration ofthe infusion tube withconsequent serious injuryto the patient

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Safety & Effectiveness VII.

FASTRESPONDER™ 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 devices do not raise issues of safety and effectiveness of the FASTRESPONDER™ Sternal Intraosseous Device.

Bench tests, functional testing, and validation studies were conducted. ●
The infusion needle tubing and portal tip of the FASTRESPONDER™ Sternal . Intraosseous Device are comparable to the predicate device.
The risk analysis was conducted according to ISO 14971:2012. .
· 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

Public Health Service

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

June 25, 2013

Pyng Medical Corporation Ms. Michele Tyler Quality Assurance and Regulatory Affairs Vice President 13480 Crestwood Place Unit 210 Richmond BC Canada V6V 2J9

Re: K130487

Trade/Device Name: FASTResponder™ Sternal Intraosseous Device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: March 29, 2013 Received: April 1, 2013

Dear Ms. Tyler:

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. 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. Tyler

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Saliety/ReportalProblem/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 yours,

Susan Runner DDS, MA.
Mary S.
Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology. General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ICAL

4. Indication for Use Statement

510(k) Number (if known): K130487

FASTResponder™ Sternal Intraosseous Device Device Name:

Indications for Use:

FASTResponder™ 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.

Prescription Use _X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE) Date: 2013.06.24 16:47:23 -04'00' DivIsion Sign-Off) ivision of Anestheslology, General Hospital .fection Control, Dental Devices K130487 510(k) Number: Page 1 of _ . :

. . . . . . .

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).