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.

The NIO is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO 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.

Device Description

The Adult NIO permits intraosseous access through the Proximal Tibia and the Humeral Head.

The NIO device is comprised of a trocar needle, spring, piston and housing and it resembles a syringe. When activated, a loaded spring is released, and the device injects the needle to a predetermined depth into the bone marrow cavity.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding an "Adult Intraosseous infusion device" (K182770). It explicitly states that no performance testing (clinical or non-clinical) was required or submitted to prove the device meets acceptance criteria.

The basis for substantial equivalence is that the Einstein Works, L.L.C. Adult Intraosseous infusion device (NIO) is identical to the legally marketed predicate device, WaisMed LTD NIO-A Intraosseous Infusion Device (K142086), in terms of intended use, technological characteristics, design, components, and safety mechanisms.

Therefore, your request for acceptance criteria and study details cannot be fully answered from the provided text, as such information was not part of this 510(k) submission.

Here's what can be extracted based on the document's content:

1. A table of acceptance criteria and the reported device performance

The document states:

"Performance data were not required to determine substantial equivalence."
"There are no clinical data submitted with this Notification."

Therefore, no acceptance criteria or reported device performance are provided in this document as they were not a requirement for this specific 510(k) clearance due to the device being identical to a previously cleared predicate. The "performance" in this context refers to the device being functionally identical to the predicate.

Acceptance Criteria Category	Acceptance Criteria (Not Explicitly Stated as Performance Criteria for This Submission)	Reported Device Performance (as stated for substantial equivalence)
Intended Use	Must match predicate device's intended use.	Matches predicate (NIO is intended to provide intraosseous access in the proximal tibia and humeral head, as an alternative to IV access during emergencies, for adult patients only).
Technological Characteristics	Must match predicate device's technological characteristics.	Matches predicate (Design, Mechanism of Action, Components, Dimensions, Weight, Safety Mechanisms). For instance, the penetration depth is $25 \pm 3$ mm, identical to the predicate.
Materials	Must match predicate device's materials.	Matches predicate (Stainless steel, Brass 360 nickel-plated, Makrolon® Rx2530 Polycarbonate).
Standards Met	Must meet the same recognized standards as the predicate.	Meets ISO 594, ISO 9626, ISO 7864, identical to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No test set data of this nature were submitted or required for this 510(k) notification. The substantial equivalence was based on direct comparison to an existing device rather than new performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No test set requiring expert ground truth was performed or submitted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was performed or submitted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (intraosseous infusion device), not an AI-assisted diagnostic tool. No MRMC studies were conducted or relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this 510(k), the "ground truth" for demonstrating substantial equivalence was the established characteristics and performance of the legally marketed predicate device (WaisMed LTD NIO-A Intraosseous Infusion Device, K142086). The applicant asserted and the FDA confirmed that their device was identical to this predicate.

8. The sample size for the training set

Not applicable. No training set was used as no new algorithm development or clinical performance testing was conducted.

9. How the ground truth for the training set was established

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized depiction of a human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font.

April 9, 2019

Linda Taylor Senior Vice-President Einstein Works, L.L.C. 5312 Elm Street Houston, TX 77081

Re: K182770

Trade/Device Name: Adult Intraosseous infusion device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 10, 2019 Received: March 13, 2019

Dear Linda Taylor :

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

Tina Kiang, Ph.D. Acting 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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510(K) SUMMARY: K182770

Date	April 9, 2019
SUBMITTER	Linda Taylor, Senior Vice-PresidentEinstein Works, L.L.C.5312 Elm StreetHouston, TX 77081
CONTACT PERSON	Linda Taylor, Senior Vice-PresidentEinstein Works, L.L.C.5312 Elm StreetHouston, TX 77081Tel: (888) 737-7978
DEVICE NAME
Classification	Class II
Trade Name	Adult Intraosseous Infusion Device
Classification Regulation	21 C.F.R. 880.5570 (Hypodermic single lumen needle)
Product Code	FMI
Review Panel	General Hospital
PREDICATE DEVICE:	WaisMed LTD NIO- A Intraosseous Infusion Device (K142086)
INTENDED USE:	The NIO is intended to provide intraosseous access in the proximaltibia, as an alternative to IV access during emergencies. The device isfor use in adult patients only.The NIO is indicated for use in providing intraosseous access as analternative to IV access during emergencies. Humeral head IO accessis indicated when rapid fluid or pharmacological resuscitation isrequired, and intravenous access is not possible. The device is for usein adult patients only.

DEVICE DESCRIPTION:

The Adult NIO permits intraosseous access through the Proximal Tibia and the Humeral Head.

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The device design is the same as the predicate and no changes have been made.

TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:

The following table provides more detailed information regarding the basis for the determination of substantial equivalence:

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PERFORMANCE TESTING - (NON-CLINICAL) BENCH

Performance data were not required to determine substantial equivalence. .

PERFORMANCE TESTING - CLINICAL

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There are no clinical data submitted with this Notification.

CONCLUSION:

The Einstein Works NIO Adult intraosseous infusion device is the same as the WaisMed NIO Intraosseous infusion device. It has the same intended use and the same technological characteristics. It is substantially equivalent.

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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).

TechnologicalCharacteristic	NIO DeviceWaismed Ltd.(K142086)	NIO DeviceEinstein Works, L.L.C.
Product Code, Class	FMI,Class II	FMI,Class II
Indications for Use	The NIO is intended to provideintraosseous access in the proximal tibia, asan alternative to IV access duringemergencies. The device is for use in adultpatients only.The NIO is indicated for use in providingintraosseous access as an alternative to IVaccess during emergencies. Humeral headIO access is indicated when rapid fluid orpharmacological resuscitation is requiredand intravenous access is not possible. Thedevice is for use in adult patients only.	The NIO is intended to provideintraosseous access in the proximal tibia, asan alternative to IV access duringemergencies. The device is for use in adultpatients only.The NIO is indicated for use in providingintraosseous access as an alternative to IVaccess during emergencies. Humeral headIO access is indicated when rapid fluid orpharmacological resuscitation is requiredand intravenous access is not possible. Thedevice is for use in adult patients only.
Target Population	Emergency Care Patients	Emergency Care Patients
Anatomical Sites	Proximal Tibia and Humeral Head	Proximal Tibia and Humeral Head
Environment Used	Hospital, Clinic, Emergency Care	Hospital, Clinic, Emergency Care
Energy Used /Delivered	No energy delivered	No energy delivered
Design:	The NIO consists of trocar needle, spring,piston and housing.	The NIO consists of trocar needle, spring,piston and housing.
Mechanism ofAction	The device resembles a syringe and whenactivated, a loaded spring is released, andthe device injects the needle to apenetration depth of $25 \pm 3$ mm into thebone marrow cavity.	The device resembles a syringe and whenactivated, a loaded spring is released, andthe device injects the needle to apenetration depth of $25 \pm 3$ mm into thebone marrow cavity.
TechnologicalCharacteristic	NIO DeviceWaismed Ltd.(K142086)	NIO DeviceEinstein Works, L.L.C.
- Components	The NIO device consists of the followingcomponents:- The trocar needle- The spring- The piston- The housing- The needle holder- The safety latch- The trigger- The needle stabilizer	The NIO device consists of the followingcomponents:- The trocar needle- The spring- The piston- The housing- The needle holder- The safety latch- The trigger- The needle stabilizer
- Dimensions(packaging)	Length 17.3cmWidth 8.8cmDepth 4.7cm	Length 17.3cmWidth 8.8cmDepth 4.7cm
- Weight (in package)	110gm (0.24lbs)	110gm (0.24lbs)
Safety Mechanisms	1. Rotational safety latch to preventaccidental activation2. Simultaneous pressing of device againstthe bone and pulling of trigger mechanismrequired to activate device.	1. Rotational safety latch to preventaccidental activation2. Simultaneous pressing of device againstthe bone and pulling of trigger mechanismrequired to activate device.
Standards Met	- ISO 594, Conical Fittings with a 6% (Luer)Taper for Syringes, Needles, and CertainOther Medical Equipment;- ISO 9626, Stainless Steel Needle Tubingfor Manufacture of Medical DevicesISO 7864, Sterile hypodermic needles forsingle use	- ISO 594, Conical Fittings with a 6% (Luer)Taper for Syringes, Needles, and CertainOther Medical Equipment;- ISO 9626, Stainless Steel Needle Tubingfor Manufacture of Medical DevicesISO 7864, Sterile hypodermic needles forsingle use
Materials	Stainless steel (trocar needle & cannula)Brass 360 nickel-plated (hub)Makrolon® Rx2530 Polycarbonate (Plasticparts with direct contact to skin)	Stainless steel (trocar needle & cannula)Brass 360 nickel-plated (hub)Makrolon® Rx2530 Polycarbonate (Plasticparts with direct contact to skin)
Hub Interface	The cannula hub is a standard metal hubLuer Lock appropriate for connecting toany standard infusion system.	The cannula hub is a standard metal hubLuer Lock appropriate for connecting toany standard infusion system.