(162 days)
Not Found
No
The device description explicitly states it is a "single use, hand-held, manually operated passive device, (it has no internal energy source)" and describes purely mechanical mechanisms for insertion depth control and removal. There is no mention of any computational or data-driven components.
Yes.
Explanation: The device is used to establish an intraosseous access route for administering drugs or fluids for emergency resuscitation, which directly contributes to patient treatment and health restoration.
No
This device is used to establish an access route for administering drugs or fluids for resuscitation, not for diagnosing a medical condition.
No
The device description clearly outlines physical components like an infusion tube, introducer, patch, protector dome, and sharps plug, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to establish a sternal intraosseous access route for administering drugs or fluids for emergency resuscitation. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a system for physically inserting a needle into the sternum to deliver substances. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information about a patient's condition
The device is clearly designed for direct patient intervention and treatment, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The modified FASTI™ Intraosseous Infusion System is very similar to the FAST1™ Intraosseous Infusion System previously cleared under 510(k) K970380. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the sternum of the patient, the target/strain-relief patch, protector dome and sharps plug. The minor difference is that the infusion tube of the modified FAST1™ Intraosseous Infusion System can be removed from the patient's sternum by directly pulling on the infusion tubing, whereas the predicate device utilizes a remover tool to remove the infusion tube from the patient's sternum.
Both products are single use, hand-held, manually operated passive devices, (it has no internal energy source). Both products have an infusion tube with a sharp stainless steel tip, a flexible shaft and a standard Luer connector. For both products the user grasps an introducer handle attached to the infusion needle, and pushes the needle tip through the skin and overlying tissue into the sternum of the subject. Fluids or drugs are delivered through the needle to the marrow space of the sternum, and flow out the emissary veins of the sternum into the venous circulation.
Both devices use the same pusher handle and method to insert the infusion needle to the correct penetration depth in the sternum; a mechanism inside the introducer handle disconnects the handle from the infusion needle, preventing the user from pushing the needle any further. The principal of the mechanism is identical for both devices in that it detects the position of the anterior surface of the cortical bone of the sternum, and relates the position of the tip of the infusion needle to the surface of the cortical bone.
Both devices utilize the same adhesive patch which is applied to the top of the patient's chest which the user aligns with the supra-sternal notch of the patient. The position of the recommended insertion site is the same for both devices and is marked on the patch to aid in land marking. Also, the same patch and an associated cover for both devices provide protection and strain-relief to the site and the installed Infusion Tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternal intraosseous
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The verification and validation conducted and conclusions demonstrate that the modified FAST1™ Intraosseous Infusion System is as safe and effective as the predicate device K970380.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
3.0 510(k) SUMMARY
This summary of safety and effectiveness was prepared on 31* August 2007 and is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitted by:
| Name: | Pyng Medical Corporation | |
|---|---|---|
| Address: | 7 - 13511 Crestwood Place | |
| Richmond, British Columbia, V6V 2E9 | ||
| Country: | Canada | |
| Establishment Registration: | 9615387 | FEB 13 2008 |
| Tel: | +1 604 303-7964 | |
| Fax: | +1 604 303-7987 | |
| E-mail: | info@pyng.com | |
| Contact Person: | Dr. Maya Butterfield | |
| Title: | Quality Assurance & Regulatory Affairs Manager |
Name of Device:
| Trade Name: | FAST1™ Intraosseous Infusion System |
|---|---|
| Common Name: | Intraosseous Infusion System |
| Classification Name: | Hypodermic Single Lumen Needle |
| Regulation Number: | 880.5570 |
| Product Code: | FMI |
| Class: | Class II |
| Panel: | 80 |
Predicate Device:
The legally marketed device (predicate device) upon which substantial equivalence to the modified FASTI™ Intraosseous Infusion System is based is:
FAST1 ™ Intraosseous Infusion System
The 510(k) number for this product is K970380.
Indications for Use:
The FAST1™ Intraosseous Infusion System is indicated for use in establishing a sternal intraosseous access route in adult patients requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
Description of the Device:
The modified FASTI™ Intraosseous Infusion System is very similar to the FAST1™ Intraosseous Infusion System previously cleared under 510(k) K970380. It consists of a primary component - the infusion tube, and secondary components - the introducer for placing it through the sternum of the patient, the target/strain-relief patch, protector dome and sharps plug. The minor difference is that the infusion tube of the modified FAST1™ Intraosseous Infusion System can be removed from the patient's sternum by directly pulling on the infusion tubing, whereas the predicate device utilizes a remover tool to remove the infusion tube from the patient's sternum.
| IT IN INSTITUTION COLLECTION COLLECTION CONSTITUTION CONSTITUTION OF CONSULTION CONSULTION CONSULTION COLLECTION COLLECTION COLLECTION COLLECTION CONSULTION CONSULTION CONSUL | |||
|---|---|---|---|
| Date: August 31. 2007 | DO NOT COPY | CONFIDENTIAL | Page #: 3 - 1 |
| МИНИЕ Г. Г. Г. Г. РИСТИНИВАНИЯ ПРИСТЕРИНИ ПРИСЕРИНИ ПРИСЕРИНИ ПРИСЕРИНИ ПРИСЕРИИ ПРИСЕРИИ ПРИССИИ ПОДРЕДНИКА ПО Г. С ПРИСИНИЕ НА ПРИСТИВНИКА ПО ГОДИНИ ПРИСТИВ ПОДИНИ ПРИСТИВ |
1
MEDICAL
Both products are single use, hand-held, manually operated passive devices, (it has no internal energy source). Both products have an infusion tube with a sharp stainless steel tip, a flexible shaft and a standard Luer connector. For both products the user grasps an introducer handle attached to the infusion needle, and pushes the needle tip through the skin and overlying tissue into the sternum of the subject. Fluids or drugs are delivered through the needle to the marrow space of the sternum, and flow out the emissary veins of the sternum into the venous circulation.
Both devices use the same pusher handle and method to insert the infusion needle to the correct penetration depth in the sternum; a mechanism inside the introducer handle disconnects the handle from the infusion needle, preventing the user from pushing the needle any further. The principal of the mechanism is identical for both devices in that it detects the position of the anterior surface of the cortical bone of the sternum, and relates the position of the tip of the infusion needle to the surface of the cortical bone.
Both devices utilize the same adhesive patch which is applied to the top of the patient's chest which the user aligns with the supra-sternal notch of the patient. The position of the recommended insertion site is the same for both devices and is marked on the patch to aid in land marking. Also, the same patch and an associated cover for both devices provide protection and strain-relief to the site and the installed Infusion Tube.
Summary of the Technological Characteristics compared with Predicate Device:
The modified FAST1™ Intraosseous Infusion System and the predicate device are both indicated for use in intraosseous infusion.
The modified FAST1™ Intraosseous Infusion System and its predicate device are similar in that they are passive, hand-held, manually operated devices intended for emergency intraosseous infusion. They both have a handle, at least part of which is removable, which the care-giver uses to place a stainless steel portal tip through overlying tissue into the marrow space of the Manubrium, using only manual force. The Infusion Tubes of both devices have sharp stainless steel tips, a flexible shaft and a standard Luer connector. Both are supplied as biocompatible, sterile, single use products. The revised device does not require a remover tool in order to remove the Infusion Tube. The predicate device does require a remover tool in order to remove the Infusion Tube. Otherwise both devices are similar, and where it is used is identical.
The verification and validation conducted and conclusions demonstrate that the modified FAST1™ Intraosseous Infusion System is as safe and effective as the predicate device K970380.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three curved lines or ribbons flowing from the figure.
FEB 13 2008
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Mava Butterfield Quality Assurance & Regulatory Affairs Manager PYNG Medical Corporation #7-13511 Crestwood Place Richmond, B.C., V6V 2E9 CANADA
Re: K072487
Trade/Device Name: FAST1™ Intraosseous Infusion System Regulation Number: 880.5570 Regulation Name: Hypodermic Single lumen Needle Regulatory Class: II Product Code: FMI Dated: February 5, 2008 Received: February 6, 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.
3
. 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 vour 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
4
2.0 INDICATION FOR USE STATEMENT
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 patients 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)
Centen O.m
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________
Page 1 of 1
Date: August 31, 2007 DO NOT COPY CONFIDENTIAL
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