FAST1 INTRAOSSEOUS INFUSION SYSTEM

K080865 · Pyng Medical Corp. · FMI · Apr 24, 2008 · General Hospital

Device Facts

• Record ID: K080865
• Device Name: FAST1 INTRAOSSEOUS INFUSION SYSTEM
• Applicant: Pyng Medical Corp.
• Product Code: FMI · General Hospital
• Decision Date: Apr 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FAST1™ Intraosseous Infusion System 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

FAST1 Intraosseous Infusion System provides alternative circulatory access for emergency resuscitation. Device targets manubrium (upper sternum) for needle insertion. Enables rapid vascular administration of drugs/fluids when intravenous access is difficult. Used in emergency settings by healthcare providers. System facilitates infusion directly into bone marrow space, bypassing collapsed peripheral veins. Benefits include rapid, reliable access to systemic circulation during critical care scenarios.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use comparison to predicate devices.

Technological Characteristics

Hypodermic single lumen needle system for intraosseous access. Manual insertion mechanism targeting the manubrium. Class II device. No software or electronic components.

Indications for Use

Indicated for adult and adolescent patients (12 years and older) requiring vascular access for drug or fluid administration during emergency resuscitation via the sternal intraosseous route.

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 (K072487)
• EZ-MIO Intraosseous Infusion System (K052195)

Submission Summary (Full Text)

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K080865

APR 2 4 2008

# 510(k) Summary

FOICAL

(per 21 CFR 807.92)

### Applicant I.

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

Contact Person: Dr. Maya Butterfield Quality Assurance & Regulatory Affairs Manager Tel: [phone] Fax: [phone] Email: [e-mail]

March 26, 2008 Date Prepared:

### II. Device Name

Trade Name: Device Type: Classification Name: Regulation Number: Product Code: Class: Advisory Committee: FAST1 ™ Intraosseous Infusion System Intraosseous Infusion System Hypodermic Single Lumen Needle 880.5570 FMI Class II General Hospital

#### Predicate Devices III.

The FAST ™ Intraosseous Infusion System (expansion of intended use population) is substantially equivalent to the FAST1™ Intraosseous Infusion System cleared under K072487 and the EZ-MIO Intraosseous Infusion System from Vidacare Corporation cleared under K052195.

#### IV. Intended Use of the Device

The FAST1™ Intraosseous Infusion System 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

The FASTI™ Intraosseous Infusion System has been designed to provide alternative access of the circulatory system to intravenous infusion. 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.

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## Summary of the Technical Characteristics VI.

The FAST'1™ Intraosseous Infusion System (expansion of intended use population) has the same technological characteristics as the FAST1™ Intraosseous Infusion System that has received FDA 510(k) clearance under K072487.

### Safety & Effectiveness VII.

:

The FAST1 ™ Intraosseous Infusion System has the same intended use and the same or similar technological characteristics as the predicate devices. The differences in technological characteristics between the modified and the predicate devices do not raise issues with the safety and effectiveness of the modified FASTI™ Intraosseous Infusion System.

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APR 2 4 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K080865

Trade/Device Name: FAST1™ Intraosseous Infusion System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single lumen Needle Regulatory Class: II Product Code: FMI Dated: March 26, 2008 Received: March 28, 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 your 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte Y. Michu OMD.

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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Image /page/4/Picture/0 description: The image shows the words "PYNG MEDICAL" in a stylized font. The word "PYNG" is in a bold, sans-serif font, while the word "MEDICAL" is in a smaller, more delicate font. The letters in "PYNG" are connected, giving the word a sense of unity. The overall effect is modern and professional.

## 4. Indication for Use Statement

510(k) Number (if known):

Device Name:

FAST1™ Intraosseous Infusion System

## Indications for Use:

The FAST1™ Intraosseous Infusion System 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) 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)

Cinta Lomo

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

510(k) Number: Ky80865

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