Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical design improvements and safety features, with no mention of AI or ML algorithms for image processing, data analysis, or decision-making. The "detection of the proper injection point" and "adjustable needle penetration depth" are described as design features, not AI/ML functionalities.

Therapeutic

No
The device facilitates access for fluid and drug delivery but does not directly treat a disease or condition itself.

Diagnostic

No

The device is an intraosseous access device intended to provide an alternative to IV access for delivering fluids and drugs, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a trocar needle, spring, piston, and housing, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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 access in the proximal tibia for delivering fluids and drugs. This is a therapeutic and access device, not a diagnostic test performed on samples from the body.
Device Description: The description details a mechanical device for inserting a needle into bone. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to diagnose a condition.
Lack of IVD Characteristics: There is no mention of reagents, assays, sample collection, or any other elements typically associated with in vitro diagnostics.

The device is clearly intended for direct patient intervention to establish a route for administering substances, which falls outside the scope of in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

FMI

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.

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

pediatric patients between 3 and 12 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)

Provided performance data include the following validations and studies:

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K142086

Reference Device(s)

K022415

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
Over-The-Counter Use (21 CFR 801 Subpart C)

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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: +972-9- 9517444
	Fax: +972-9- 9517666
	E-mail: einat@persysmedical.com
Contact Person:
Official Correspondent:	Jonathan Kahan
Company Name:	Hogan Lovells US LLP
Address:	Columbia Square
	555 Thirteenth Street, NW
	Washington, DC 20004
	Tel: (202) 637 5794
	Fax: (202) 637 5910
	E-mail: Jonathan.Kahan@hoganlovells.com
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
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.
1. Adequate Spring Force and Bone Integrity Following Activation Validation.
1. Needle Stabilizer Validation.
1. Hub-Cannula/Hub-Needle Bond Strength Testing (According to ISO 7864).
1. 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
Ltd. Predicate
Device
(K142086) | BIG-P Waismed
Ltd. Reference
Device (K022415) | NIO-P Waismed
Ltd. (Modified
Device) |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Classification | Regulation number:
880.5570
Code: FMI,
Class: II | Same | Same |
| Indications for
Use | The NIO is intended to
provide intraosseous
access in the proximal
tibia, as an alternative to
IV access during
emergencies. The device
is for use in adult patients
only.

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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.