FASTX STERNAL INTRAOSSEOUS DEVICE

K100124 · Pyng Medical Corp. · FMI · Aug 31, 2010 · General Hospital

Device Facts

• Record ID: K100124
• Device Name: FASTX STERNAL INTRAOSSEOUS DEVICE
• Applicant: Pyng Medical Corp.
• Product Code: FMI · General Hospital
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

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 Story

Device provides alternative to intravenous access for emergency resuscitation. Input: manual user force applied to manubrium. Transformation: introducer handle with target foot guides infusion tube into manubrium; handle withdrawn, leaving infusion tube bone portal in place. Output: sternal intraosseous access point for drug/fluid administration. Used in pre-hospital, ambulance, hospital, or battlefield settings by paramedics or physicians. Healthcare providers connect IV line or syringe to luer lock for infusion. Benefits patient by providing rapid vascular access when IV access is difficult or impossible. Includes protective dome and strain relief hook for site protection.

Clinical Evidence

Bench testing only. Testing included functional testing, risk analysis per ISO 14971:2007, biocompatibility per ISO 10993-1, sterilization validation per ISO 11137, pyrogen testing per USP guidelines, and packaging validation per ISO 11607.

Technological Characteristics

Materials: molded plastics and stainless steel. Principle: manual intraosseous insertion into manubrium. Form factor: introducer handle, target foot, infusion tube, protective dome. Sterilization: radiation (ISO 11137). Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for adult and adolescent patients (12 years and older) requiring vascular administration of drugs or fluids for emergency resuscitation via sternal intraosseous access.

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

• FAST1® Intraosseous Infusion System (K080865)

Submission Summary (Full Text)

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

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:

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.

### Description of the Device V.

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.

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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™ Sternal<br>Intraosseous Device | FAST1™ Intraosseous<br>Infusion System |
| 510(k) Number | K100124 | K080865 |
| Product Code(s) | FMI | FMI |
| Regulation # | 880.5570 | 880.5570 |
| Class | II | II |
| Indications for Use | The FASTx™ Sternal<br>Intraosseous Device is<br>indicated for use in<br>establishing a sternal<br>intraosseous access route in<br>adult and adolescent patients<br>(12 years of age and older)<br>requiring vascular<br>administration of drugs or<br>fluids to facilitate emergency<br>resuscitation. | The FAST1™ Intraosseous<br>Infusion System is indicated<br>for use in establishing a<br>sternal intraosseous access<br>route in adult and adolescent<br>patients (12 years of age and<br>older) requiring vascular<br>administration of drugs or<br>fluids to facilitate emergency<br>resuscitation. |
| 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,<br>hospital, battlefield |
| IO Insertion Location | Same as K080865 | Manubrium; superior part of<br>the sternum |
| Method of Insertion | Same as K080865 | Manual (user applied force)<br>insertion with automatic<br>release and automatic depth<br>control |

| 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.<br> | Pyng Medical Corp. |
|--------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------|
| Product Name | FASTxTM Sternal<br>Intraosseous Device | FAST1TM Intraosseous<br>Infusion System |
| Removal | Same as K080865 | Grip infusion tubing near the<br>surface of the skin and pull to<br>disengage portal from cortical<br>bone |
| Duration of Use | Same as K080865 | Less then 24 hours. Until an<br>alternative 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 of<br>ISO10993 |
| Fluids infused | Same as K080865 | Emergency IV fluids |
| Fluids aspirated | Same as K080865 | Bone marrow - optional step<br>to check placement of<br>Infusion Tube |
| Materials | Molded plastics and stainless<br>steel | Molded plastics and stainless<br>steel |
| 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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

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 [phone] or [phone] 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:

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.

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

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510(k) Number: K180124