FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE

K130487 · Pyng Medical Corp. · FMI · Jun 25, 2013 · General Hospital

Device Facts

• Record ID: K130487
• Device Name: FASTRESPONDER STERNAL INTRAOSSEOUS DEVICE
• Applicant: Pyng Medical Corp.
• Product Code: FMI · General Hospital
• Decision Date: Jun 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

The FASTResponder™ Sternal Intraosseous Device provides an alternative to intravenous access for emergency resuscitation. It is a single-use, manual device operated by clinicians (paramedics/doctors) in pre-hospital, ambulance, or hospital settings. The device consists of an introducer handle with a target foot used to position an infusion tube into the manubrium. The user applies manual force to insert the tube; the handle is then withdrawn, leaving the portal in the bone. The target foot remains adhered to the skin for protection, and a protective dome is placed over the site. The infusion tube luer lock connects to standard IV lines or syringes. By establishing intraosseous access, the device enables rapid delivery of life-saving fluids and drugs to the circulatory system, benefiting patients when intravenous access is difficult or impossible to achieve.

Clinical Evidence

Bench testing only. Evidence includes functional testing, validation studies, risk analysis per ISO 14971:2012, biocompatibility testing per ISO 10993-1, sterilization validation per ISO 11137, pyrogen testing per USP guidelines, and packaging validation per ISO 11607.

Technological Characteristics

Manual intraosseous infusion device. Materials: molded plastics and stainless steel. Insertion: manual force with target foot for site alignment. Dimensions: designed for manubrium insertion. Sterilization: radiation (ISO 11137). Connectivity: none (mechanical).

Indications for Use

Indicated for adult and adolescent patients (12 years and older) requiring vascular access for emergency drug or fluid administration via the manubrium. Contraindicated in patients with compromised skin over the insertion site (trauma, infection, burns), sternal fracture, vascular injury, or midline sternotomy scars. Safety in severe osteoporosis not established.

Regulatory Classification

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.

Predicate Devices

• FASTx™ Sternal Intraosseous Device (K100124)
• FAST1® Intraosseous Infusion System (K080865)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "K1304.87". The characters are handwritten and appear to be part of a label or identifier. The writing style is simple and legible, with each character clearly distinguishable.

## 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: [phone] Fax: [phone] Email: [e-mail]

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

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

{1}------------------------------------------------

## 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.

{2}------------------------------------------------

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

| | Primary Predicate | Secondary Predicate to support multiple needles | Candidate Device | Company<br>Product 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 to<br>support multiple needles | Candidate Device |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------|------------------------------|--------------------------------|---------------------|-----------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------|
| Company | Pyng Medical Corp. | Pyng Medical Corp. | Pyng Medical Corp. | Pyng Medical Corp.<br>FASTX™ Sternal Intraosseous<br>Device | 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.<br>FASTX™ Sternal Intraosseous<br>Device | Pyng Medical Corp.<br>FAST1® Intraosseous<br>Infusion System | Pyng Medical Corp.<br>FASTResponder™ Sternal<br>Intraosseous 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 | | | | | | | | | | | | | | | |

Page 5-3

{3}------------------------------------------------

Page 5-4

{4}------------------------------------------------

| | Primary Predicate<br> | Secondary Predicate | Comments of the comments of the first of the first of the first of the first of the first of the first for<br>Candidate Device | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | support multiple needles | | |
| Compa | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Medical Corp.<br>Dung | l Pyng Medical Corp. | Pyng Medical Corp. | |
| Product Na | FASTx™ Sternal Intraosseous | FAST1® Intraosseou | FASTResponder™ Sterna | |
| | Device | Infusion System<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Intraosseous Device | |
| Contraindicatio | None known | Equivalent to Primar | Equivalent to Prima | |
| | | Predicate | Predicate | |
| Company<br>Product Name | Cautions/Warnings | Primary Predicate | Secondary Predicate to<br>support multiple needles | Candidate Device |
| Pyng Medical Corp.<br>FASTX™ Sternal Intraosseous<br>Device | PRECAUTIONS:<br>• The FASTX ™ Sternal is<br>designed to penetrate 6mm<br>into the manubrium.<br> | | Pyng Medical Corp.<br>FAST1® Intraosseous<br>Infusion System<br>• The FAST1 ™<br>Intraosseous Infusion<br>System is designed to<br>penetrate 6 mm into the<br>manubrium.<br>• Adult and adolescent*<br>patients are expected to<br>have a manubrium<br>thickness greater than 6<br>mm. Qualified<br>professionals should<br>determine any appropriate<br>or necessary exceptions,<br>either inclusions or<br>exclusions, to the criterion<br>"For use with adult and<br>adolescent* patients"<br>* (12 years of age and<br>over). | Pyng Medical Corp.<br>FASTResponder™ Sternal<br>Intraosseous Device<br>Equivalent to Primary<br>Predicate |
| | • Compromised skin over the<br>insertion site such as<br>trauma, infection or burns<br>• Fracture of the sternum or<br>vascular injury which may<br>compromise the integrity of<br>the manubrium or its<br>vascularization<br>• Midline sternotomy scars | | • Severe skin compromise<br>such as trauma, infection or<br>burns over the infusion site<br>may interfere with use of<br>the device.<br>• Check for fracture of the<br>sternum or vascular injury<br>which may compromise the<br>integrity of the manubrium<br>or its vascularization. | |
| Company<br>Product Name | Cautions/Warnings<br>(continued) | Primary Predicate | Secondary Predicate to<br>support multiple needles | Candidate Device |
| Pyng Medical Corp.<br>FASTX™ Sternal Intraosseous<br>Device | WARNINGS:<br>• Safety in patients with very<br>severe osteoporosis has not<br>been proven<br>• Insertion in sites other than<br>the manubrium may result<br>in ineffective infusion<br>and/or serious injury to the<br>patient. | Pyng Medical Corp.<br>FAST1® Intraosseous<br>Infusion System | Pyng Medical Corp.<br>FASTResponder™ Sternal<br>Intraosseous Device<br>Equivalent to Primary<br>Predicate | |
| | | • Check for midline<br>sternotomy scars - the<br>device may be less effective<br>in patients with a previous<br>midline sternotomy.<br>• Safety of the FAST1™ in<br>patients with very severe<br>osteoporosis has not been<br>proven.<br>• Insertion of the FAST1™<br>in sites other than the<br>manubrium may result in<br>ineffective infusion and may<br>result in over-penetration of<br>the infusion tube with<br>consequent serious injury<br>to the patient | | |

{5}------------------------------------------------

Page 5-6

{6}------------------------------------------------

{7}------------------------------------------------

## 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.

{8}------------------------------------------------

## 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,

{9}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{10}------------------------------------------------

## 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 _ . :

. . . . . . .