(217 days)
Not Found
No
The device description and performance studies focus on mechanical and manual operation, with no mention of AI or ML.
Yes.
The device facilitates the infusion of fluids and drugs into the vascular system, which implies a therapeutic intervention.
No
Explanation: The device is an intraosseous access device intended to provide vascular access for fluid and drug infusion, not to diagnose a condition or disease.
No
The device description clearly outlines a physical, manual intraosseous device with a handle, needle, trocar, and cannula, indicating it is a hardware device.
Based on the provided information, the NIO-I is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- NIO-I Function: The NIO-I is a device used to gain direct access to the vascular system within the bone marrow (intraosseous access) for the purpose of infusing fluids and drugs into the body. It is a therapeutic/access device, not a diagnostic one that analyzes samples.
The description clearly states its purpose is to provide vascular access as an alternative to emergency IV access and to allow for the infusion of fluids and drugs. This is an in-vivo (within the living body) procedure, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
The NIO-I is an Intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
Product codes
FMI
Device Description
The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 0 and 3 years of age. The NIO-I provides haptic feedback via the stepped-needle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal Tibia
Indicated Patient Age Range
The NIO-I is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
Intended User / Care Setting
Hospital, Clinic, Emergency Care
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)
Non-Clinical Performance Testing:
Biocompatibility tests: sensitization, hemolysis, material-mediated pyrogenicity, cytotoxicity, acute system toxicity and intracutaneous reactivity. These tests were conducted based on ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11.
Other non-clinical tests conducted:
- Force required for needle cover removal
- Visual inspection for corrosion, per ISO 9626
- Force required for needle insertion
- Minimal force for insertion of the needle
- Force for detachment of the needle housing from the needle gripper
- Maximum force for trocar removal after insertion to the platform
- Cannula effective length, per ISO 9626 and ISO 7864
- Maximum force for cannula removal after insertion
- Usability study, per IEC 62366-1
- Shelf life, per ISO 11607-1 and ASTM F1980-16
- Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72
- Limits for acidity or alkalinity, per ISO 7864
- Conical fitting, per ISO 594-1 and ISO 594-2
Key results: All tests' results support WaisMed's labeling claims in order to establish substantial equivalency.
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
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October 7, 2019
WaisMed Ltd % Tali Hazan Consultant Talmed Ltd Ramot Naftali, 1383000 Il
Re: K190538
Trade/Device Name: NIO-I Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 27, 2019 Received: September 5, 2019
Dear Tali Hazan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190538
Device Name NIO-I
Indications for Use (Describe)
The NIO-I is an Intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red colors, with "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. There is a gray swoosh design element on the bottom left of the logo.
510(k)Summary: K190538
1. Submitter Information
WaisMed Ltd 10 Amal St. Rosh Haayin, Israel Phone: +972-72-2234585 Fax: +972-9-9517666 E mail: maya@persysmedical.com
Contact person name: Ms. Tali Hazan - RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il
2. Date of Preparation
4th October, 2019
3. Identification of Predicate
a. Primary Predicate
VidaCare Corporation's PD-IO, Disposable Intraosseous Infusion Needle and Handle cleared under 510(k) number K043490 on February 18, 2005.
b. Secondary Predicate
VidaCare Corporation's EZ-MIO Manual Driver cleared under 510(k) number K052195 on November 2, 2005.
4. Identification of Subject Device
- a. Regulatory Information Regulation Name: Hypodermic single lumen needle Regulation Number: 880.5570 Product Code: FMI Common Name: Needle, Hypodermic, Single Lumen Proprietary/Trade name: NIO-I
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Image /page/4/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red colors. The first part, "Wais," is in blue, while the second part, "Med," is in red. Below the name, in smaller, gray font, is the text "A PerSys Medical Company."
5. Device Description
The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 0 and 3 years of age. The NIO-I provides haptic feedback via the stepped-needle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.
| Characteristics | Subject Device
Waismed NIO-I
K190538 | Primary Predicate
VidaCare Corp.
K043490 | Secondary Predicate
EZ-MIO Intraosseous
Infusion System
K052195 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The NIO-I is an
intraosseous device
intended to provide
vascular access in the
proximal tibia of
infants as an
alternative to
emergency IV access.
It is indicated for use
in infants between
gestational age of 36
weeks and weight of
at least 5 pounds (2.3
Kg) and up to 3 years
of age. | The PD-IO
Disposable
Intraosseous Infusion
Needle and Handle
provides intraosseous
access in the proximal
tibia, as an alternative
to IV access during
emergencies. The
device is for use in
pediatric patients. | For pediatric use: The
PD-IO™ infusion
system provides
intraosseous access in
proximal tibia, as an
alternative to IV access
during emergencies to
pediatric patients, from
birth to 21 years of age
(approximate weight
range: 3 kg - 39 kg).
For adult use: The EZ-
IOTM Infusion System
provides intraosseous
access in the proximal
tibia, as an alternative to
IV access during
emergencies to adult
patients (22 years of age
or older, > 40 kg)
*Note: the adult use
part of the indications
for use is not included in
this submission. |
6. Indications for Use Statement
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Image /page/5/Picture/0 description: The image contains the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red colors, with "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. The logo is simple and professional, likely representing a medical or healthcare-related business.
| Characteristics | Subject Device
Waismed NIO-I
K190538 | Primary Predicate
VidaCare Corp.
K043490 | Secondary Predicate
EZ-MIO Intraosseous
Infusion System
K052195 |
|---------------------------------------------|--------------------------------------------|------------------------------------------------|--------------------------------------------------------------------------|
| Prescription Only
or Over the
counter | Prescription | Prescription | Prescription |
Discussion of Differences in Indications for Use statement:
The NIO-I and the EZ-MIO have the same intended use, indications and clinical purpose. Slight differences in the age range of each device dose not raise new questions of safety and effectiveness since the NIO-I is intended to narrower age population and.
Therefore, in terms of indications for use statement, the NIO-I is substantially equivalent to the selected predicate devices.
7. Summary of Technological Characteristics
| Item | Subject Device
Waismed NIO-I
K190538 | Primary
Predicate
VidaCare Corp.
K043490 | Secondary
Predicate
EZ-MIO
Intraosseous
Infusion System
K052195 | Comment |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Target
Population | Emergency Care
for infant
patients (0-3
years of age) | Emergency Care
for pediatric
patients (0-21
years of age) | Emergency Care
for pediatric and
adult patients | See comment #1 |
| Anatomical
Sites | Proximal Tibia | Proximal Tibia | Proximal Tibia | Same |
| Environment
Used | Hospital, Clinic,
Emergency Care | Hospital, Clinic,
Emergency Care | Hospital, Clinic,
Emergency Care | Same |
| Design | Consists of
trocar needle,
stylet and | Consists of trocar
needle, stylet and
catheter, needle | Consists of a
pentagon shaft
permanently | Same |
| Item | Subject Device
Waismed NIO-I
K190538 | Primary
Predicate
VidaCare Corp.
K043490 | Secondary
Predicate
EZ-MIO
Intraosseous
Infusion System
K052195 | Comment |
| | catheter, needle
cover and a
handle. | cover and a
handle. | attached to a
handle and
connected to the
PD-IO (for
pediatrics) | |
| Mechanism of
Action | Manually in
three stages:
(1) The NIO-I
needle is
manually
inserted through
the cortex of the
bone until
change is
resistance is felt,
indicating the
needle penetrated
the bone marrow
cavity.
(2) The insertion
handle is then
disconnected
from the needle
and, (3) the
trocar is removed
by pulling it
upwards. | Manually in three
stages:
(1) The PD-IO
needle is
manually inserted
through the
cortex of the
bone to a desired
depth within the
bone marrow. (2)
The insertion
handle with
trocar is then
separated from
the catheter hub
by turning the
handle counter
clockwise and
then, (3) being
removed, leaving
the a standard
luer lock catheter
securely seated in
the bone. | Manual needle
insertion using
stylet and
catheter into the
bone cortex to a
desired depth
within the bone
marrow.
After insertion of
the needle set the
manual driver is
detached from
the needle set
leaving the stylet
and cannula
firmly seated in
the bone. The
stylet is then
separated and
removed from
the catheter by
turning the stylet
hub counter
clockwise,
leaving a
standard luer
lock catheter | Same |
| Item | Subject Device
Waismed NIO-I
K190538 | Primary
Predicate
VidaCare Corp.
K043490 | Secondary
Predicate
EZ-MIO
Intraosseous
Infusion System
K052195 | Comment |
| | | | securely seated in
the bone. | |
| Over-
Penetration
Safety
Mechanisms | Stepped-needle
exists to provide
sensory feedback
upon cortex
penetration to
prevent over-
penetration. | No over-
penetration safety
mechanism
exists. | No over-
penetration safety
mechanism
exists. | See comment #2 |
| Insertion Site | In proximal tibia | In the proximal
tibia | In proximal tibia | Same |
| Insertion Site
Identification | Extending the
patient's leg at
the tibia site, the
insertion site is
located
approximately
1cm medial to
the tibial
tuberosity, or just
below the patella
(approximately
1cm or one
finger width) and
slightly medial
(approximately
1cm or one
finger width),
along the flat
aspect of the
tibia. Then
insertion takes
place. | After extending
the patient's leg
at the tibia site,
the insertion site
is located
approximately 1
cm medial to the
tibial tuberosity,
or (if the tibial
tuberosity cannot
be palpated),
approximately 1
cm medial to the
tibial tuberosity,
or just below the
inferior border of
the patella
(approximately 1
cm) and slightly
medial
(approximately 1
cm) along the flat
aspect of the | Insertion site
identification is
defined using the
PD-IO when
connected to the
MIO driver. | Same |
| | | | | |
| Item | Subject Device
Waismed NIO-I
K190538 | Primary
Predicate
VidaCare Corp.
K043490 | Secondary
Predicate
EZ-MIO
Intraosseous
Infusion System
K052195 | Comment |
| | | tibia. Pinching
the tibia between
caregiver fingers
to identify the
medial and
lateral borders,
and insert the
needle in the
center of the
bone. | | |
| Materials | Needle:
Stainless steel
302 (Trocar),
stainless steel
316L (Cannula)
Plastic
components:
Polycarbonate
Makrolon
Rx2530 and
ABS PA757
(Handle only,
no body contact
with the
patient). | Needle (Trocar +
catheter):
Stainless steel
304
Hub and Handle:
Polycarbonate | Needle (Trocar +
catheter):
Stainless steel
304
Hub:
Polycarbonate
*The needle and
Hub refer to the
PD-IO used
along with the
MIO driver
Handle: Plastic | See comment #3 |
| Biocompatibility | Biocompatible.
Complies with
ISO 10993-1 | Biocompatible.
Complies with
ISO 10993-1 | Biocompatible.
Complies with
ISO 10993-1. | Same |
| Needle dwelling
time | $≤$ 24
Hours | $≤$ 24 Hours | Used along with
the
PD-IO needle | Same |
| Item | Subject Device
Waismed NIO-I
K190538 | Primary
Predicate
VidaCare Corp.
K043490 | Secondary
Predicate
EZ-MIO
Intraosseous
Infusion System
K052195 | Comment |
| | | | therefore ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
-
ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
-
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
- A ISO 10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity.
Other non-clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicates. The tests are as follows. Tests identified under subsections 'a', 'c', 'e', 'f', 'h' below are based on Waismed V&V tests plan.
Tests identified under subsections 'b', 'g', 'i', 'j', 'k', 'l', 'm' are in compliance with applicable standards as follows:
- a) Force required for needle cover removal;
- b) Visual inspection for corrosion, per ISO 9626;
- c) Force required for needle insertion;
- d) Minimal force for insertion of the needle;
- e) Force for detachment of the needle housing from the needle gripper;
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Image /page/12/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "Wais" is in blue, and the word "Med" is in red. Underneath the company name, the text "A PerSys Medical Company" is written in a smaller, gray font.
- Maximum force for trocar removal after insertion to the platform; f)
- g) Cannula effective length, per ISO 9626 and ISO 7864;
- h) Maximum force for cannula removal after insertion;
- Usability study, per IEC 62366-1; i)
- Shelf life, per ISO 11607-1 and ASTM F1980-16; i)
- k) Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72;
- l) Limits for acidity or alkalinity, per ISO 7864;
- m) Conical fitting, per ISO 594-1 and ISO 594-2.
The test results demonstrated that the proposed device complies with the following standards:
-
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements.
- A ISO 594-2:1998 - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings.
-
ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- A ISO 11137-2:2013 - Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose.
- A ISO 13004:2013 - Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD.
-
ANSI AAMI ST72:2011/(R)2016 Bacterial endotoxins Test methods, routine monitoring, and alternatives to batch testing.
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to A medical devices.
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- A ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
-
ISO 7153-1:1999 Surgical instruments Metallic materials Part 1: Stainless steel.
-
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods.
- A ISO 7864:2016 - Sterile hypodermic needles for single use - Requirements and test methods.
All tests' results support WaisMed's labeling claims in order to establish substantial equivalency.
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Image /page/13/Picture/0 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and red letters, with "Wais" in blue and "Med" in red. Below the company name, the text "A PerSys Medical Company" is written in a smaller, gray font. A partial gray arc is visible on the left side of the logo.
9. Clinical Test Conclusion
No clinical Study is included in this submission.
10. Substantially Equivalent (SE) Conclusion
The evaluation of the subject device performance demonstrates that it is as safe and as effective as the legally marketed predicate devices.
...............
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