NIO-P

K160805 · Waismed, Ltd. · FMI · Jun 23, 2016 · General Hospital

Device Facts

• Record ID: K160805
• Device Name: NIO-P
• Applicant: Waismed, Ltd.
• Product Code: FMI · General Hospital
• Decision Date: Jun 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The NIO-P for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients between 3 and 12 years of age.

Device Story

NIO-P is a spring-loaded, single-use, sterile intraosseous (IO) access device. It consists of a trocar needle, spring, piston, and housing. The device is positioned on the proximal tibia; upon activation, the spring-loaded mechanism drives the needle to a predetermined depth into the bone marrow cavity. The user removes the trocar, leaving a cannula in place for fluid or drug delivery. It features an adjustable needle penetration depth and a stabilizer to assist in insertion point detection. Used in hospitals, clinics, and emergency care settings by healthcare providers. It provides rapid vascular access when IV access is difficult or impossible, facilitating life-saving resuscitation.

Clinical Evidence

Bench testing only. Validations included insertion point and penetration depth accuracy, spring force, bone integrity post-activation, needle stabilizer performance, hub-cannula/hub-needle bond strength (ISO 7864), and structural/needle integrity.

Technological Characteristics

Materials: Stainless steel (trocar/cannula), nickel-plated Brass 360 (hub), Makrolon® Rx2530 polycarbonate (skin-contact parts). Principle: Spring-loaded mechanical insertion. Dimensions: 17.5cm x 8.8cm x 4.7cm. Connectivity: None. Sterilization: Gamma radiation. Single-use.

Indications for Use

Indicated for pediatric patients aged 3 to 12 years requiring intraosseous access in the proximal tibia as an alternative to IV access during emergencies.

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)

Reference Devices

• B.I.G Bone Injection for Pediatrics (K022415)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 23, 2016

WaisMed Ltd. % Mr. Jonathan Kahan Partner Hogan Lovells US, LLP Columbia Square, 555 Thirteenth St Washington, DC 20004

Re: K160805

Trade/Device Name: NIO-P Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 29, 2016 Received: April 29, 2016

Dear Mr. Kahan:

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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang
-s

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160805

Device Name NIO-P

Indications for Use (Describe)

The NIO-P for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients between 3 and 12 years of age.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> </div> |
|----------------------------------------------|--------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |

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# 510(k) SUMMARY K160805

# Applicant Name:

| Applicant Name: | |
|-------------------------|-------------------------------------------------------------|
| Company Name: | WaisMed Ltd. |
| Address: | 10 Amal St., Afek Industrial Park |
| | Rosh Ha'ayin, ISRAEL 4809234 |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Contact Person: | |
| Official Correspondent: | Jonathan Kahan |
| Company Name: | Hogan Lovells US LLP |
| Address: | Columbia Square |
| | 555 Thirteenth Street, NW |
| | Washington, DC 20004 |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Date Prepared: | June 17, 2016 |
| Trade Name: | NIO-P |
| Classification Name: | 880.5570 Hypodermic single lumen needle, (Product code FMI) |
| Classification: | Class II |
| Predicate Devices: | |

| | Manufacturer / Owner | 510(k) No. | |
|------------------|----------------------------------------|--------------|---------|
| Predicate Device | NIO Adult | WaisMed Ltd. | K142086 |
| Reference Device | B.I.G Bone Injection for<br>Pediatrics | WaisMed Ltd. | K022415 |

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### Device Description:

The NIO product family (Adult and Pediatric) is an upgrade in terms of design and structure to the company's B.I.G. Bone Injection Gun product family. The NIO product family has already one cleared model, for the adult population NIO Adult (K142086).

Both product families NIO and BIG are composed of a trocar needle, spring, piston, and housing that contains safety mechanisms to prevent accidental device activation. Both devices are positioned onto the appropriate insertion site.

Both product families have the same principle of operation. The device resembles a syringe and, when activated, a loaded spring is released and the device injects a needle to a predetermined depth into the bone marrow cavity. The user then pulls out the trocar needle, leaving the cannula inside the bone marrow cavity. Through the cannula, fluids and drugs can be delivered to the vascular system via the bone marrow cavity.

The NIO-P device is designed to detect the proper injection point. In addition, the NIO-P is also equipped with a unique, adjustable needle penetration depth according to the age group, as part of the stabilizer. Both features are designed to improve accuracy in detecting the insertion point and needle penetration depth.

#### Indications for Use:

The NIO-P for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients between 3 and 12 years of age.

#### Performance Data:

Provided performance data include the following validations and studies:

- 1) Insertion Point and Penetration Depth Validation.
- 2) Adequate Spring Force and Bone Integrity Following Activation Validation.
- 3) Needle Stabilizer Validation.
- 4) Hub-Cannula/Hub-Needle Bond Strength Testing (According to ISO 7864).
- 5) Structural Deformation and Needle Integrity Test.

#### Substantial Equivalence:

The indications of the NIO-P are identical to those of the reference device, the BIG-P (K022415), except that the NIO-P is specifically indicated for pediatric patients between 3 and 12 years of age. The technological characteristics of the modified NIO-P device, as compared to

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the predicate NIO-A device (K142086) are identical except for the modification of the needle stabilizer to allow detection of the accurate insertion point and the adjustable needle depth penetration. This modification has been validated by bench testing, and does not raise new types of safety or effectiveness questions. A comparison table between the subject and predicate devices is provided below.

| | NIO-A Waismed<br>Ltd. Predicate<br>Device<br>(K142086) | BIG-P Waismed<br>Ltd. Reference<br>Device (K022415) | NIO-P Waismed<br>Ltd. (Modified<br>Device) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Classification | Regulation number:<br>880.5570<br>Code: FMI,<br>Class: II | Same | Same |
| Indications for<br>Use | The NIO is intended to<br>provide intraosseous<br>access in the proximal<br>tibia, as an alternative to<br>IV access during<br>emergencies. The device<br>is for use in adult patients<br>only.<br><br>The NIO is indicated for<br>use in providing<br>intraosseous access as an<br>alternative to IV access<br>during emergencies.<br>Humeral head IO access is<br>indicated when rapid fluid<br>or pharmacological<br>resuscitation is required<br>and intravenous access is<br>not possible. The device<br>is for use in adult patients<br>only. | The Bone Injection Gun<br>(B.I.G.) for pediatric is<br>intended to provide<br>intraosseous access in the<br>proximal tibia, as an<br>alternative to IV access<br>during emergencies. The<br>device is for use in<br>pediatric patients up to 12<br>years of age. | The NIO-P for pediatrics is<br>intended to provide<br>intraosseous access in the<br>proximal tibia, as an<br>alternative to IV access<br>during emergencies. The<br>device is for use in pediatric<br>patients between 3 and 12<br>years of age. |
| Environment<br>Used | Hospital, Clinic,<br>Emergency Care | Same | Same |
| Design: | Consists of trocar needle,<br>spring, piston and<br>housing. | Same | Same |
| Dimensions<br>(packaging) | Length 17.5cm<br>Width 8.8cm<br>Depth 4.7cm | Length 16.5cm<br>Width 7.4cm<br>Depth 2.8cm | Length 17.5cm<br>Width 8.8cm<br>Depth 4.7cm |
| Weight (in<br>package) | 113.8gm (0.25lbs) | 80gm (0.18lbs) | 107.6gm (0.24lbf) |
| | NIO-A<br>Waismed Ltd.<br>Predicate Device<br>(K142086) | BIG-P<br>Waismed Ltd.<br>Reference Device<br>(K022415) | NIO-P<br>Waismed Ltd.<br>(Modified Device) |
| Materials | Stainless steel (trocar<br>needle & cannula)<br>Brass 360 nickel-plated<br>(hub)<br>Makrolon® Rx2530<br>polycarbonate (Plastic<br>parts with direct contact to<br>skin) | Same | Same |
| Hub Interface | The cannula hub is a<br>standard metal hub Luer<br>Lock appropriate for<br>connecting to any standard<br>infusion system. | Same | Same |
| Needle length | 42.0mm (1.65") | 23.6mm (1.31") | 38.1mm (1.5") |
| Needle gauge | 15G | 18G | 18G |
| Sterilization | Single use, sterile | Same | Same |
| Sterilization<br>method | Gamma sterilization | Same | Same |

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# Conclusions:

Based on the performance testing and comparison to the predicate and reference devices, the modified NIO-P is substantially equivalent to the NIO-A.