(224 days)
Not Found
No
The device description focuses on mechanical components and manual operation for establishing intraosseous access, with no mention of AI or ML capabilities.
No.
The device facilitates the administration of drugs and fluids for resuscitation, but it does not directly treat a condition or restore health itself. It provides access for therapeutic agents.
No
This device is used to establish an intraosseous access route for administering drugs or fluids in emergency resuscitation, not for diagnosing a condition.
No
The device description clearly outlines physical components like an introducer handle, target foot, infusion tube bone portal, luer lock, strain relief hook, and protective dome. These are hardware components, not software.
Based on the provided information, the FASTx™ Sternal Intraosseous Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- FASTx™ Device Function: The FASTx™ Sternal Intraosseous Device is used to establish a physical access route into the bone marrow (intraosseous) for the direct administration of drugs and fluids into the circulatory system. It is a delivery system, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states it's for "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." This is a therapeutic/interventional use, not a diagnostic one.
- Device Description: The description details the physical components and how they are used to create the access point for infusion. There is no mention of analyzing any biological samples.
Therefore, the FASTx™ Sternal Intraosseous Device falls under the category of a therapeutic or interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sternal, manubrium, the upper (superior) portion of the sternum
Indicated Patient Age Range
Adult and adolescent patients (12 years of age and older)
Intended User / Care Setting
Paramedic/Doctor, Pre-hospital, ambulance, hospital, battlefield
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)
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.
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
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: 604.303.7964 Fax: 604.303.7987 Email: MButterfield@pynq.com
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.
1
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 | |
| Intraosseous Device | FAST1™ Intraosseous | |
| 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 | |
| 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. | 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. | ||
| 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, |
| hospital, battlefield | ||
| IO Insertion Location | Same as K080865 | Manubrium; superior part of |
| the sternum | ||
| Method of Insertion | Same as K080865 | Manual (user applied force) |
| insertion with automatic | ||
| release and automatic depth | ||
| 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 |
2
1EDICAL
| | Pyng Medical Corp.
| Pyng Medical Corp. |
|--------------------|----------------------------------------|------------------------------------------------------------------------------------------------------------|
| Product Name | FASTxTM Sternal
Intraosseous Device | FAST1TM Intraosseous
Infusion System |
| Removal | Same as K080865 | Grip infusion tubing near the
surface of the skin and pull to
disengage portal from cortical
bone |
| Duration of Use | Same as K080865 | Less then 24 hours. Until an
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
ISO10993 |
| Fluids infused | Same as K080865 | Emergency IV fluids |
| Fluids aspirated | Same as K080865 | Bone marrow - optional step
to check placement of
Infusion Tube |
| Materials | Molded plastics and stainless
steel | Molded plastics and stainless
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. .
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
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
Page 1 of /
510(k) Number: K180124