K Number
K211968
Device Name
NIO+ Adult
Manufacturer
Date Cleared
2021-07-22

(28 days)

Product Code
Regulation Number
880.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NIO+ Adult is intended to provide intraosseous (IO) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent mecessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.
Device Description
The NIO+ Adult (NIO+) is intended to be used with the same patient population and same age range. The NIO+ utilizes the very same technology and has the same operation method. The main difference is that the NIO+ provides a more physically robust version of the NIO Adult (NIO-A) which was selected to serve as the primary predicate device for this submission. The NIO+ was designed to better serve in tactical settings, such as battlefields, as the device and its package are more durable. It should be noted that the NIO-A is currently in use for all segments and settings that the NIO+ is targeted for. The additional robustness of the NIO+ is achieved by utilizing raw materials that have higher mechanical properties. The sterile single unit packaging robustness was increased, by using a rigid-blister and rigid plastic cover to protect the Tyvek paper. In addition, the maximal storage temperature was increased to 50°C versus room temperature, in order to assure that the device can function such extreme temperatures. All NIO products are intended to be used by skilled, authorized medics, nurses, paramedics and doctors who are trained to use the device in military, emergency services and hospitals environments. The products are for single use and supplied sterile.
More Information

Not Found

No
The summary describes a mechanical intraosseous access device with no mention of AI or ML capabilities. The focus is on physical robustness and mechanical function.

No.
The device is described as an intraosseous access device intended to provide an alternative to emergency IV access for rapid fluid or pharmacological resuscitation, which is a supportive and access function, not a direct therapeutic treatment itself.

No
The device is described as an intraosseous access device intended for fluid and pharmacological resuscitation, not for diagnosing conditions.

No

The device description clearly details a physical, mechanical device intended for intraosseous access, focusing on its physical robustness and materials. There is no mention of software components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to provide intraosseous (IO) access for fluid or pharmacological resuscitation. This is a procedure performed directly on a patient's body to deliver substances into the bone marrow, not to test a sample taken from the body.
  • Device Description: The device is described as a tool for creating IO access, focusing on its mechanical properties and durability for use in emergency settings. There is no mention of it being used to analyze biological samples.
  • Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing blood, urine, tissue, or any other biological sample in vitro (outside the body).

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to provide a route for administering treatment into the body.

N/A

Intended Use / Indications for Use

The NIO+ Adult is intended to provide intraosseous (IO) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent mecessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.

Product codes

FMI

Device Description

The NIO+ Adult (NIO+) is intended to be used with the same patient population and same age range. The NIO+ utilizes the very same technology and has the same operation method. The main difference is that the NIO+ provides a more physically robust version of the NIO Adult (NIO-A) which was selected to serve as the primary predicate device for this submission. The NIO+ was designed to better serve in tactical settings, such as battlefields, as the device and its package are more durable. It should be noted that the NIO-A is currently in use for all segments and settings that the NIO+ is targeted for. The additional robustness of the NIO+ is achieved by utilizing raw materials that have higher mechanical properties. The sterile single unit packaging robustness was increased, by using a rigid-blister and rigid plastic cover to protect the Tyvek paper. In addition, the maximal storage temperature was increased to 50°C versus room temperature, in order to assure that the device can function such extreme temperatures.

All NIO products are intended to be used by skilled, authorized medics, nurses, paramedics and doctors who are trained to use the device in military, emergency services and hospitals environments. The products are for single use and supplied sterile.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Proximal tibia and humeral head

Indicated Patient Age Range

Adults

Intended User / Care Setting

Skilled, authorized medics, nurses, paramedics and doctors who are trained to use the device in military, emergency services and hospitals environments.

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 evaluation according to ISO 10993-1. Tests performed for NIO-A and applicable to NIO+: sensitization, hemolysis, pyrogenicity, cytotoxicity, acute system toxicity and intracutaneous reactivity.
  • Reliability testing of trigger mechanism and penetration depth.
  • Compressed spring force.
  • Trigger safety mechanisms.
  • Cannula effective length, per ISO 9626 and ISO 7864.
  • Environmental and transportation testing, per ASTM D4332-14 and ASTM D4169.
  • Shelf life, per ISO 11607-1 and ASTM F1980-16.
  • Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72.
  • 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)

K142086

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).

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July 22, 2021 WaisMed Ltd Shifra Hoch QA/RA Manager 10 Amal St. Afek Industrial Park Rosh Ha'Ayin, 4809234 Israel

Re: K211968

Trade/Device Name: NIO+ Adult Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: June 21, 2021 Received: June 24, 2021

Dear Shifra Hoch:

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 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

1

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 mediation-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) K211968

Device Name NIO+ Adult

Indications for Use (Describe)

The NIO+ Adult is intended to provide intraosseous (IO) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent mecessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.

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 letters, with the "Wais" in blue and the "Med" in red. A registered trademark symbol is located to the right of the word "WaisMed". Below the company name, the text "A PerSys Medical Company" is written in a smaller font size.

K211968

Special 510(k) Summary

NIO+ Adult

510(k) Summarv:

1. Submitter Information

Name:WaisMed Ltd
Address:10 Amal St.
Rosh Ha'Ayin, Israel
Contact Person:Shifra Hoch
Phone:+972-9-951-7444
E mail:shifra@persysmedical.com

2. Date of Preparation

22 June 2021

3. Subject Device

Trade Name:NIO+ Adult
Common Name:Intraosseous infusion device
Regulation Number:21 CFR 880.5570
Regulation Name:Hypodermic Single Lumen Needle
Product Code:FMI

4. Predicate Device

NIO Adult (WaisMed Ltd., K142086).

5. Device Description

The NIO+ Adult (NIO+) is intended to be used with the same patient population and same age range. The NIO+ utilizes the very same technology and has the same operation method. The main difference is that the NIO+ provides a more physically robust version of the NIO Adult (NIO-A) which was selected to serve as the primary predicate device for this submission. The NIO+ was designed to better serve in tactical settings, such as battlefields, as the device and its package are more durable. It should be noted that the NIO-A is currently in use for all segments and settings that the NIO+ is targeted for. The additional robustness of the NIO+ is achieved by utilizing raw

4

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 letters, with the "Wais" in blue and the "Med" in red. To the right of the word "WaisMed" is a circled R, indicating that the name is a registered trademark. Below the name is the text "A PerSys Medical Company".

materials that have higher mechanical properties. The sterile single unit packaging robustness was increased, by using a rigid-blister and rigid plastic cover to protect the Tyvek paper. In addition, the maximal storage temperature was increased to 50°C versus room temperature, in order to assure that the device can function such extreme temperatures.

All NIO products are intended to be used by skilled, authorized medics, nurses, paramedics and doctors who are trained to use the device in military, emergency services and hospitals environments. The products are for single use and supplied sterile.

Characteristics Subiect Modified Device Predicate Device WaisMed NIO+ WaisMed NIO-A K142086 Indications for The NIO+ Adult is intended to The NIO Adult is intended to Use provide intraosseous (IO) access in provide intraosseous access in the the proximal tibia and the humeral proximal tibia, as an alternative to head as an alternative to emergency IV access during emergencies. IV access. Per urgent medical The device is for use in adult necessity, humeral head IO access patients only. may be used when rapid fluid or The NIO is indicated for use in pharmacological resuscitation is providing intraosseous access as required. The device is intended for an alternative to IV access during use in adult patients only. emergencies. Humeral head access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only. Prescription only or Over the Prescription Prescription counter

6. Indications for Use Statement

Discussion of Differences in Indications for Use statement:

The NIO+ and the NIO-A have the same intended use, indications and clinical purpose. The only difference between both devices is the shelf life and storage conditions which are more suitable for military situations in extreme conditions.

Therefore, in terms of indications for use statement, the NIO+ is substantially equivalent to the selected predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for WaisMed, a PerSys Medical Company. The word "WaisMed" is written in a combination of blue and maroon colors, with the "Wais" part in blue and the "Med" part in maroon. To the right of the logo is a registered trademark symbol. Below the logo, the text "A PerSys Medical Company" is written in a smaller font size.

7. Summary of Technological Characteristics

ItemSubject Modified DevicePredicate DeviceComment
WaisMed NIO+WaisMed NIO-A
K142086
Target
PopulationAdultsAdultsEquivalent
Anatomical
SitesProximal tibia and humeral headProximal tibia and humeral headEquivalent
Environment
UsedHospital, clinic, emergency care.
Additionally, may be used under
extreme temperature conditions (50°c).Hospital, clinic, emergency care,
stored and used in
room
temperature.Equivalent
DesignAutomatic single-use device, including
a pre-loaded spring that releases the
needle to a predetermined IO depth.Automatic single-use device,
including a pre-loaded spring that
releases the needle
to a predetermined
IO depth.Equivalent
Mechanism of
ActionThe device resembles a syringe and
when activated, a loaded spring is
released and the device injects the
needle to a penetration depth of
25±3mm into the bone marrow cavity.The device
resembles a
syringe and when
activated, a loaded
spring is released
and the device
injects the needle
to a penetration
depth of 25±3mm
into the bone
marrow cavity.Equivalent
Safety
Mechanisms1. Rotational cap to prevent accidental
activation;
  1. Simultaneous pressing of device
    against the bone and pulling of the
    trigger mechanism required to
    activate the device. | 1. Rotational cap
    to prevent
    accidental
    activation;
  2. Simultaneous
    pressing of
    device against
    the bone and | Equivalent |
    | Item | Subject Modified Device | Predicate Device | Comment |
    | | WaisMed NIO+ | WaisMed NIO-A | |
    | | | K142086 | |
    | | | pulling of the
    trigger
    mechanism
    required to
    activate the
    device. | |
    | Insertion depth | Proximal tibia/humeral head: 2.5(cm) | Proximal
    tibia/humeral
    head: 2.5(cm) | Equivalent |
    | Insertion Site
    Identification | Proximal tibia: Approximately 1 inch
    or 2 cm medially and 1/2 inch or 1 cm
    proximally to the Tibial tuberosity.
    Humeral head: greater tubercle next to
    the head of the humerus. | Proximal tibia:
    Approximately 1
    inch or 2 cm
    medially and 1/2
    inch or 1 cm
    proximally to the
    Tibial tuberosity.
    Humeral head:
    greater tubercle
    next to the head
    of the humerus. | Equivalent |
    | Materials | 1. Stainless steel (trocar and cannula
    needle)
  3. Brass nickel-plated
  4. Plastic parts: Polycarbonate
  5. Body: Ultem
  6. Spring: Stainless Steel | 1. Stainless steel
    (trocar and
    cannula
    needle)
  7. Brass nickel-
    plated
  8. Plastic parts
    not including
    Body:
    Polycarbonate
  9. Body:
    Polycarbonat
  10. Spring: Music
    wire | Difference in
    materials.
    This change does
    not lead to new
    questions of safety
    and effectiveness. |
    | Biocompatibility | Biocompatible. Complies with ISO
    10993-1 | Biocompatible.
    Complies with
    ISO 10993-1 | Equivalent |
    | Item | Subject Modified
    Device | Predicate Device | Comment |
    | | WaisMed NIO+ | WaisMed NIO-A
    K142086 | |
    | Needle dwelling
    time |