The NIO-P for pediatric 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 in age 3-12 years of age.

Device Description

The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device 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. The NIO device also features the same safety latch and trigger mechanism which is found with the predicate device.

AI/ML Overview

The provided document is a 510(k) summary for the Einstein Works NIO Pediatric (NIO-P) Intraosseous Infusion Device. It's a regulatory submission to the FDA, not a research paper detailing a study that proves a device meets specific acceptance criteria. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against new, explicit acceptance criteria through a dedicated study.

Therefore, much of the requested information regarding "acceptance criteria," "study," "sample size," "experts," "adjudication," "MRMC study," "stand-alone performance," and "ground truth" establishment for a medical device software or AI solution is not applicable to this document.

The document explicitly states:

"No additional performance testing was performed to support the proposed changes because the device is identical."
"Changes to labeling did not require bench testing to support substantial equivalence."
"There are no clinical data submitted with this Notification."

The "acceptance criteria" here are implicit in the FDA's substantial equivalence pathway: demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "study" proving this largely relies on comparison of design, materials, and intended use to the predicate.

Given this context, I will address what can be extracted from the document related to the requested points, and explicitly state when information is not present or not applicable.

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

As this submission is for substantial equivalence of an identical device with labeling changes, there are no new "acceptance criteria" or measured "device performance" in the traditional sense of a new performance study. The acceptance is based on its identity to the predicate.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as demonstrated by equivalence to predicate)
Identical design to predicate device	Reported: Yes, "The proposed device and the predicate device are the same device."
Identical materials to predicate device	Reported: Yes, "The proposed device and the predicate device are the same device."
Identical principle of operation to predicate device	Reported: Yes, "Same." (Mechanism of Action)
Identical indications for use to predicate device	Reported: Yes, "Same," and "There are no differences in indications for use."
Identical technological characteristics to predicate device	Reported: Yes, "Same" for all characteristics listed (Sponsor, Target Population, Anatomical Sites, Environment Used, Design, Mechanism of Action, Components, Dimensions, Weight, Safety Mechanisms, Materials, Hub Interface, Needle Fixation).
Performance demonstrated as safe and effective as predicate	Reported: "Based on the results of non-clinical testing [meaning the comparison to predicate], the Einstein Works intraosseous infusion device performs safely, as intended, and the comparative discussion of intended use, principle of operation, and technological characteristics, it is determined that the Einstein Works intraosseous infusion device is substantially equivalent to the predicate device..."

2. Sample size used for the test set and the data provenance

Sample size: Not applicable. No test set was used for a performance study. The submission relies on demonstrating identity to the predicate.
Data provenance: Not applicable. No new data was generated from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No test set was created or ground truth established for a performance study.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication was used.

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 device is an intraosseous infusion device, a physical medical device, not an AI/software product that would involve human readers or AI assistance.

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 or AI.

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

Not applicable. No ground truth for a performance study was established as no new performance study was conducted. The "truth" in this submission relies on the established safety and efficacy of the predicate device.

8. The sample size for the training set

Not applicable. This refers to a dataset for training AI/machine learning models. This document is for a physical medical device and does not involve AI development.

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

Not applicable. As above, this document does not involve AI or machine learning models that would require a training set with ground truth.

Summary

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October 23, 2019 Einstein Works, L.L.C. % David Makanani CEO OMEDtech, L.L.C. 1725 Signal Ridge Drive, Suite 150 Edmond, Oklahoma 73013

Re: K191258

Trade/Device Name: Intraosseous infusion device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 13, 2019 Received: September 17, 2019

Dear David Makanani:

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

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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 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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K191258

Device Name Intraosseous Infusion Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) SUMMARY

The 510(k) Summary is included following this page.

510(K) SUMMARY: K191258

Date	October 16, 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 77081
DEVICE NAMEClassificationTrade NameCommon NameRegulation NameClassification RegulationProduct Code	Class IIIntraosseous Infusion DeviceNeedle, Hypodermic, Single LumenHypodermic single lumen needle21 C.F.R. 880.5570FMI
PREDICATE DEVICE:	Primary Predicate:WaisMed LTD, NIO- P (Pediatric) Intraosseous Infusion Device(K160805)Secondary Predicate:Einstein Works, L.L.C. NIO- A (Adult) Intraosseous Infusion Device(K182770)

DEVICE DESCRIPTION:

The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device permits intraosseous access through the Proximal Tibia and the Humeral Head.

Einstein Works, L.L.C. · Houston, TX 77081

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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.

The NIO device also features the same safety latch and trigger mechanism which is found with the predicate device.

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 in age 3- 12 years old.

Differences in Indications There are no differences in indications for use.

TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:

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

TechnologicalCharacteristic	NIO-PEinstein Works, L.L.C.	NIO-PWaismed Ltd.(Primary Predicate )(KI60805)	Comparison
Sponsor	Einstein Works, LLC	Waismed Ltd	Same device with US companydistributing
Indications for Use	The NIO-P for pediatrics isintended to provideintraosseous access in theproximal tibia, as analternative to IV accessduring emergencies. Thedevice is for use in pediatricpatients in age 3- 12 yearsof age.	The NIO-P for pediatrics isintended to provideintraosseous access in theproximal tibia, as analternative to IV access duringemergencies. The device is foruse in pediatric patients in age3- 12 years of age.	Same
Target Population	Emergency Care Patients	Emergency Care Patients	Same
Anatomical Sites	Proximal Tibia	Proximal Tibia	Same
Environment Used	Hospital, Clinic, EmergencyCare	Hospital, Clinic, EmergencyCare	Same
Design:	Consists of trocar needle,spring, piston and housing.	Consists of trocar needle,spring, piston and housing.	Same
TechnologicalCharacteristic	NIO-PEinstein Works, L.L.C.	NIO-PWaismed Ltd.(Primary Predicate )(K160805)	Comparison
Mechanism of Action	The device resembles asyringe and when activated,a loaded spring is released,and the device injects theneedle to a predetermineddepth into the bone marrowcavity according to thepatient age.	The device resembles asyringe and when activated, aloaded spring is released, andthe device injects the needleto a predetermined depth intothe bone marrow cavityaccording to the patient age.	Same
Components	- The trocar needle- The spring- The piston- The housing- The needle holder- The safety latch- The trigger- The needle stabilizer withthe location arrow	- The trocar needle- The spring- The piston- The housing- The needle holder- The safety latch- The trigger- The needle stabilizer withthe location arrow	Same
Dimensions (packaging)	Length 17.5cmWidth 8.8cmDepth 4.7cm	Length 17.5cmWidth 8.8cmDepth 4.7cm	Same
Weight (in package)	107.6gm (0.24lbf)	107.6gm (0.24lbf)	Same
Safety Mechanisms	1. Rotational safety latch toprevent accidentalactivation2. Simultaneous pressing ofdevice against the bone andpulling of triggermechanism required toactivate device.	1. Rotational safety latch toprevent accidental activation2. Simultaneous pressing ofdevice against the bone andpulling of trigger mechanismrequired to activate device.	Same
Materials	Stainless steel (trocarneedle & cannula)Brass 360 nickel-plated(hub)Makrolon® Rx2530polycarbonate (Plastic partswith direct contact to skin)	Stainless steel (trocar needle& cannula)Brass 360 nickel-plated (hub)Makrolon® Rx2530polycarbonate (Plastic partswith direct contact to skin)	Same
TechnologicalCharacteristic	NIO-PEinstein Works, L.L.C.	NIO-PWaismed Ltd.(Primary Predicate )(K160805)	Comparison
Hub Interface	The cannula hub is astandard metal hub LuerLock appropriate forconnecting to any standardinfusion system.	The cannula hub is a standardmetal hub Luer Lockappropriate for connecting toany standard infusion system.	Same
Needle Fixation	Pediatric needle stabilizer	Pediatric needle stabilizer	Same
Labeling	Einstein Works labeling isthe same basic labeling asthe Waismed but clarity wasadded for needlepenetration andappropriateness of thetarget population	Same basic labeling asWaismed labeling.	Same basic labeling withclarifications added to the"Instruction for Use".

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This 510 (K) submission represents changes in labeling (Sponsor and instructions for use). There are no changes in the materials and design of proposed device, because the proposed device and the predicate device are the same device.

PERFORMANCE TESTING - (NON-CLINICAL) BENCH

No additional performance testing was performed to support the proposed changes because the device is identical. Changes to labeling did not require bench testing to support substantial equivalence.

PERFORMANCE TESTING - CLINICAL

There are no clinical data submitted with this Notification.

CONCLUSION:

Based on the results of non-clinical testing, the Einstein Works intraosseous infusion device performs safely, as intended, and the comparative discussion of intended use, principle of operation, and technological characteristics, it is determined that the Einstein Works intraosseous infusion device is substantially equivalent to the predicate device, WaisMed NIO Intraosseous infusion device.

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).