NIO+ Adult

K211968 · Waismed, Ltd. · FMI · Jul 22, 2021 · General Hospital

Device Facts

• Record ID: K211968
• Device Name: NIO+ Adult
• Applicant: Waismed, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Jul 22, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

NIO+ Adult is an automatic, single-use, spring-loaded intraosseous (IO) infusion device. It functions like a syringe; upon activation, a pre-loaded spring drives a 15G needle to a fixed depth of 25±3mm into the bone marrow cavity. Designed for use by trained medics, nurses, paramedics, and physicians in military, emergency, and hospital settings. The device features a rotational safety cap and requires simultaneous pressure against the bone and trigger activation to prevent accidental deployment. The device provides a standard Luer hub for connection to infusion systems. The NIO+ is a more robust version of the predicate NIO-A, utilizing higher-strength materials (Ultem body, stainless steel spring) and rigid-blister packaging to withstand extreme tactical environments and storage temperatures up to 50°C. It enables rapid vascular access in critical situations where IV access is difficult or impossible, potentially improving patient outcomes through timely fluid or drug delivery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including reliability of trigger/penetration depth, spring force, environmental/transportation testing (ASTM D4332-14, ASTM D4169), shelf-life validation (ASTM F1980-16), and sterilization validation (ISO 11137). Biocompatibility was established via reference to predicate data and compliance with ISO 10993 standards.

Technological Characteristics

Automatic spring-loaded IO device. Materials: Stainless steel (needle/spring), nickel-plated brass, polycarbonate, Ultem (body). Dimensions: 15G needle, 42mm length, 25±3mm penetration depth. Connectivity: Standard Luer hub. Sterilization: Gamma irradiation. Standards: ISO 10993 (biocompatibility), ISO 594-1/2 (Luer), ISO 9626/7864 (needles), ISO 11607-1 (packaging), ASTM D4332/D4169 (environmental).

Indications for Use

Indicated for adult patients requiring intraosseous access in the proximal tibia or humeral head as an alternative to emergency IV access, particularly when rapid fluid or pharmacological resuscitation is necessary.

Regulatory Classification

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.

Predicate Devices

• NIO Adult (K142086)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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.<br>Rosh Ha'Ayin, Israel |
| Contact Person: | Shifra Hoch |
| Phone: | [phone] |
| E mail: | [e-mail] |

#### 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

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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 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

| Item | Subject Modified Device | Predicate Device | Comment |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| | WaisMed NIO+ | WaisMed NIO-A<br>K142086 | |
| Target<br>Population | Adults | Adults | Equivalent |
| Anatomical<br>Sites | Proximal tibia and humeral head | Proximal tibia and humeral head | Equivalent |
| Environment<br>Used | Hospital, clinic, emergency care.<br>Additionally, may be used under<br>extreme temperature conditions (50°c). | Hospital, clinic, emergency care,<br>stored and used in<br>room<br>temperature. | Equivalent |
| Design | Automatic single-use device, including<br>a pre-loaded spring that releases the<br>needle to a predetermined IO depth. | Automatic single-use device,<br>including a pre-loaded spring that<br>releases the needle<br>to a predetermined<br>IO depth. | Equivalent |
| Mechanism of<br>Action | The device resembles a syringe and<br>when activated, a loaded spring is<br>released and the device injects the<br>needle to a penetration depth of<br>25±3mm into the bone marrow cavity. | The device<br>resembles a<br>syringe and when<br>activated, a loaded<br>spring is released<br>and the device<br>injects the needle<br>to a penetration<br>depth of 25±3mm<br>into the bone<br>marrow cavity. | Equivalent |
| Safety<br>Mechanisms | 1. Rotational cap to prevent accidental<br>activation;<br>2. Simultaneous pressing of device<br>against the bone and pulling of the<br>trigger mechanism required to<br>activate the device. | 1. Rotational cap<br>to prevent<br>accidental<br>activation;<br>2. Simultaneous<br>pressing of<br>device against<br>the bone and | Equivalent |
| Item | Subject Modified Device | Predicate Device | Comment |
| | WaisMed NIO+ | WaisMed NIO-A | |
| | | K142086 | |
| | | pulling of the<br>trigger<br>mechanism<br>required to<br>activate the<br>device. | |
| Insertion depth | Proximal tibia/humeral head: 2.5(cm) | Proximal<br>tibia/humeral<br>head: 2.5(cm) | Equivalent |
| Insertion Site<br>Identification | Proximal tibia: Approximately 1 inch<br>or 2 cm medially and 1/2 inch or 1 cm<br>proximally to the Tibial tuberosity.<br>Humeral head: greater tubercle next to<br>the head of the humerus. | Proximal tibia:<br>Approximately 1<br>inch or 2 cm<br>medially and 1/2<br>inch or 1 cm<br>proximally to the<br>Tibial tuberosity.<br>Humeral head:<br>greater tubercle<br>next to the head<br>of the humerus. | Equivalent |
| Materials | 1. Stainless steel (trocar and cannula<br>needle)<br>2. Brass nickel-plated<br>3. Plastic parts: Polycarbonate<br>4. Body: Ultem<br>5. Spring: Stainless Steel | 1. Stainless steel<br>(trocar and<br>cannula<br>needle)<br>2. Brass nickel-<br>plated<br>3. Plastic parts<br>not including<br>Body:<br>Polycarbonate<br>4. Body:<br>Polycarbonat<br>5. Spring: Music<br>wire | Difference in<br>materials.<br>This change does<br>not lead to new<br>questions of safety<br>and effectiveness. |
| Biocompatibility | Biocompatible. Complies with ISO<br>10993-1 | Biocompatible.<br>Complies with<br>ISO 10993-1 | Equivalent |
| Item | Subject Modified<br>Device | Predicate Device | Comment |
| | WaisMed NIO+ | WaisMed NIO-A<br>K142086 | |
| Needle dwelling<br>time | <24 Hours | <24 Hours | Equivalent |
| Hub Interface | The cannula hub is a standard hub<br>Luerappropriate for connecting to any<br>standard infusion system. | The cannula hub<br>is a standard hub<br>Luer appropriate<br>for connecting to<br>any standard<br>infusion system. | Equivalent |
| Needle length | 42mm | 42mm | Equivalent |
| Needle gauge | 15G | 15G | Equivalent |
| Single use | Single use | Single use | Equivalent |
| Sterilization | Sterile | Sterile | Equivalent |
| Sterilization<br>method | Gamma irradiation | Gamma<br>irradiation | Equivalent |
| Sterile<br>Packaging | PETG injected sealed with Tyvek | PET-A sealed<br>with Tyvek | Difference in<br>materials.<br>This change does<br>not lead to new<br>questions of safety<br>and effectiveness. |
| Storage<br>Conditions | 5 years at room temperature<br>5 years at 50°C | 5 years at<br>room<br>temperature | Difference in<br>storage<br>conditions.<br>This change does<br>not lead to new<br>questions of safety<br>and effectiveness. |

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### Discussion of Technological Characteristics

The following differences do not raise different question of safety and effectiveness.

The change in raw materials of the non-contacting components (body and spring) and of the packaging, contributes to the robustness of the NIO+ device in comparison to the NIO-A, which enables its use under tactical settings, especially for extreme conditions and temperatures, as supported by the additional storage conditions of 5 years at 50°C. These differences were assessed by performance testing, and there were no new questions of safety or effectiveness.

## 8. Non-Clinical Performance Testing

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Body contact materials were evaluated for biocompatibility in accordance with FDA's Guidance for Use of ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", dated June 16, 2016 and ISO 10993 international standards series as detailed below.

The NIO-A and NIO+ are being manufactured using the same needles and the same raw materials for body contacting components. Therefore, no additional tests were necessary to evaluate the safety of the NIO+. Biocompatibility tests that were performed for the NIO-A, and apply for the NIO+ included, sensitization, hemolysis, pyrogenicity, cytotoxicity, acute system toxicity and intracutaneous reactivity.

The biocompatibility tests were conducted to verify that the proposed device will not adversely affect human tissue based on the following standards:

- . 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.
- 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', 'b', 'c' below are based on WaisMed V&V tests plan.

Tests identified under subsections 'd', 'e', 'f, 'g', 'h' are in compliance with applicable standards as follows:

- a) Reliability testing of trigger mechanism and penetration depth;
- b) Compressed spring force;
- Trigger safety mechanisms; c)
- d) Cannula effective length, per ISO 9626 and ISO 7864;
- e) Environmental and transportation testing, per ASTM D4332-14 and ASTM D4169;
- Shelf life, per ISO 11607-1 and ASTM F1980-16; f)
- Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI g) ST72;
- h) 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 .

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Image /page/9/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 red colors, with the "Wais" part in blue and the "Med" part in red. The registered trademark symbol is next to the word "Med". Below the company name is the text "A PerSys Medical Company".

certain other medical equipment - Part 1: General requirements.

- 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.
- ISO 11137-2:2013 Sterilization of Health Care Products Radiation Part 2: ● Establishing the Sterilization Dose.
- ISO 13004:2013 Sterilization of health care products Radiation Substantiation ● of selected sterilization dose: Method VDmax SD.
- ANSI AAMI ST72:2011/(R)2016 Bacterial endotoxins –Test methods, routine . monitoring, and alternatives to batch testing.
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier . Systems for Medical Devices.
- ASTM D4332-14 - Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping ● Containers and Systems
- . ISO 11607-1:2016 - 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.
- 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.

#### 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.