(120 days)
No
The device description and summary of performance studies focus on mechanical function and physical placement, with no mention of AI/ML terms, data sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is used to establish an access route for administering drugs or fluids, which are the therapeutic agents. The device itself is an access tool, not a therapeutic agent.
No
The device is designed to establish an intraosseous access route for administering drugs or fluids, which is a therapeutic rather than a diagnostic function.
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, indicating it is a hardware device.
Based on the provided information, the FASTResponder™ Sternal Intraosseous 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 directly into the bone marrow for emergency resuscitation. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a tool for creating a physical access point into the bone. It facilitates the delivery of substances, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
In summary, the FASTResponder™ Sternal Intraosseous Device is a medical device used for direct patient treatment (drug/fluid delivery), not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
FMI
Device Description
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 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
manubrium; superior part 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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: 604.303.7964 Fax: 604.303.7987 Email: mtyler@pyng.com
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
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
support multiple needles | Candidate Device |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------|-----------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------|----------------|------------------------------|--------------------------------|---------------------|-----------------------------------------------------------------|-------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------|---------------------------------------------------------------------|
| Company | Pyng Medical Corp. | Pyng Medical Corp. | Pyng Medical Corp. | Pyng Medical Corp.
FASTX™ Sternal Intraosseous
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.
FASTX™ Sternal Intraosseous
Device | Pyng Medical Corp.
FAST1® Intraosseous
Infusion System | Pyng Medical Corp.
FASTResponder™ Sternal
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
| 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
Candidate Device | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | support multiple needles | | |
| Compa | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Medical Corp.
Dung | l Pyng Medical Corp. | Pyng Medical Corp. | |
| Product Na | FASTx™ Sternal Intraosseous | FAST1® Intraosseou | FASTResponder™ Sterna | |
| | Device | Infusion System
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Intraosseous Device | |
| Contraindicatio | None known | Equivalent to Primar | Equivalent to Prima | |
| | | Predicate | Predicate | |
| Company
Product Name | Cautions/Warnings | Primary Predicate | Secondary Predicate to
support multiple needles | Candidate Device |
| Pyng Medical Corp.
FASTX™ Sternal Intraosseous
Device | PRECAUTIONS:
• The FASTX ™ Sternal is
designed to penetrate 6mm
into the manubrium.
| | Pyng Medical Corp.
FAST1® Intraosseous
Infusion System
• The FAST1 ™
Intraosseous Infusion
System is designed to
penetrate 6 mm into the
manubrium.
• Adult and adolescent*
patients are expected to
have a manubrium
thickness greater than 6
mm. Qualified
professionals should
determine any appropriate
or necessary exceptions,
either inclusions or
exclusions, to the criterion
"For use with adult and
adolescent* patients"
- (12 years of age and
over). | Pyng Medical Corp.
FASTResponder™ Sternal
Intraosseous Device
Equivalent to Primary
Predicate |
| | • Compromised skin over the
insertion site such as
trauma, infection or burns
• Fracture of the sternum or
vascular injury which may
compromise the integrity of
the manubrium or its
vascularization
• Midline sternotomy scars | | • Severe skin compromise
such as trauma, infection or
burns over the infusion site
may interfere with use of
the device.
• Check for fracture of the
sternum or vascular injury
which may compromise the
integrity of the manubrium
or its vascularization. | |
| Company
Product Name | Cautions/Warnings
(continued) | Primary Predicate | Secondary Predicate to
support multiple needles | Candidate Device |
| Pyng Medical Corp.
FASTX™ Sternal Intraosseous
Device | WARNINGS:
• Safety in patients with very
severe osteoporosis has not
been proven
• Insertion in sites other than
the manubrium may result
in ineffective infusion
and/or serious injury to the
patient. | Pyng Medical Corp.
FAST1® Intraosseous
Infusion System | Pyng Medical Corp.
FASTResponder™ Sternal
Intraosseous Device
Equivalent to Primary
Predicate | |
| | | • Check for midline
sternotomy scars - the
device may be less effective
in patients with a previous
midline sternotomy.
• Safety of the FAST1™ in
patients with very severe
osteoporosis has not been
proven.
• Insertion of the FAST1™
in sites other than the
manubrium may result in
ineffective infusion and may
result in over-penetration of
the infusion tube with
consequent serious injury
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 _ . :
. . . . . . .