The NIO-I is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.

Device Description

The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age. The NIO-I provides haptic feedback via the steppedneedle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.

AI/ML Overview

The provided text is a 510(k) summary for the NIO-I intraosseous device, seeking substantial equivalence to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate, often without the need for new clinical trials if technological characteristics and indications for use are substantially similar.

The document explicitly states: "No clinical Study is included in this submission." This means that the information typically found in a clinical study report (such as sample size for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone algorithm performance) for a new device's performance against acceptance criteria in a clinical setting will not be present in this document.

Instead, the submission relies on:

Comparison to a predicate device: The core argument for substantial equivalence is that the NIO-I is technologically identical and shares the same indications for use as the previously cleared Waismed LTD's NIO-I (K190538).
Non-clinical performance testing: This includes biocompatibility testing, mechanical property tests, and compliance with various international standards. These tests demonstrate the device's physical and biological safety and performance characteristics, but not its clinical effectiveness in human subjects or its performance in an AI/imaging context.

Therefore, I cannot extract the requested information (acceptance criteria for clinical performance, details of a study proving device meets acceptance criteria, sample sizes, ground truth adjudication, MRMC studies, standalone performance, training set details) from this document because it explicitly states that no clinical study was performed or included in the submission.

The acceptance criteria described in this document are primarily for non-clinical performance and biocompatibility, demonstrating that the device meets engineering specifications and safety standards for the materials and design, aligning with the predicate device.

Here's the information that can be extracted from the provided text, primarily related to the device comparison and non-clinical testing:

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

Based on the document, the "acceptance criteria" are implied by compliance with specific standards and successful completion of internal V&V tests, aiming to demonstrate substantial equivalence to the predicate. No explicit numerical acceptance criteria (e.g., "accuracy > X%") for clinical performance are stated, as no clinical study was performed.

Criterion Type	Acceptance Criteria (Implied by Compliance)	Reported Device Performance
Indications for Use	Same as predicate (Waismed LTD's NIO-I K190538): vascular access in proximal tibia for infants (gestational age 36 wks to 3 yrs, >= 5lbs/2.3Kg).	Equivalent: Exact same indications for use as the predicate device.
Technological Characteristics	Structurally and functionally identical to predicate including target population, anatomical sites, environment, design, mechanism of action, over-penetration mechanism, insertion site, materials, biocompatibility, needle dwelling time, hub interface, needle length, needle gauge, single use, sterilization method, sterile packaging.	Equivalent: All listed technological characteristics are identical to the predicate. No differences raising safety/effectiveness questions.
Biocompatibility	Compliance with ISO 10993-1, -4, -5, -10, -11 (sensitization, hemolysis, pyrogenicity, cytotoxicity, acute systemic toxicity, intracutaneous reactivity).	Complies: All biocompatibility tests conducted per relevant ISO standards. Device found to be biocompatible.
Mechanical/Physical Performance	Compliance with internal V&V tests and specific ISO/ASTM standards for: needle cover removal force, visual inspection for corrosion, needle insertion force (min/max), needle housing detachment force, trocar removal force, cannula effective length, cannula removal force, conical fitting.	Complies: All conducted tests (a-h, l, m) supported Einstein Works LLC labeling claims and established substantial equivalence.
Usability	Compliance with IEC 62366-1.	Complies: Usability study conducted per IEC 62366-1.
Shelf Life	Compliance with ISO 11607-1 and ASTM F1980-16.	Complies: Shelf life study conducted per relevant standards.
Sterilization	Compliance with ISO 11137-1, -2, ISO 13004, ANSI AAMI ST72.	Complies: Sterilization validation conducted per relevant standards. Device is Sterile, Gamma irradiation method. Sterile barrier packaging.

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 for clinical data. The submission explicitly states, "No clinical Study is included in this submission."
For non-clinical tests (e.g., mechanical tests, biocompatibility), the document refers to "internal V&V tests plan" and compliance with standards, which would imply a number of samples tested per the specific standard requirements and validation protocols. However, the exact sample sizes for each non-clinical test are not specified in this summary. Data provenance for non-clinical tests is generally from the manufacturer's lab or contracted testing facilities.

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

Not applicable. No clinical study was performed or included where expert human review would be establishing ground truth for a test set. This device is not an AI/imaging device requiring expert interpretation.

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

Not applicable. No clinical study was performed or included.

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 needle), not an AI-assisted diagnostic imaging product. No MRMC study was conducted or is 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 clinical ground truth. For non-clinical performance, "ground truth" is defined by compliance with established engineering and biocompatibility standards (e.g., ISO, ASTM), and the device's characteristics being identical to the predicate.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.

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

Not applicable. This is a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

July 28, 2021 Einstein Works LLC Roy Bachrach Managing Director 5312 Elm St Houston, Texas 77081

Re: K211395

Trade/Device Name: NIO-I Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI, MHC Dated: April 28, 2021 Received: May 5, 2021

Dear Roy Bachrach:

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

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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 (OS) 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 (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) K211395

Device Name NIO-I

Indications for Use (Describe)

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

X Prescription Use (Part 21 CER 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Einstein Works, LLC. info@einsteinworksllc.com www.einsteinworksllc.com

Image /page/3/Picture/1 description: The image shows the logo for Einstein Works. On the left is a red graphic of a stylized letter 'e'. To the right of the graphic is the text 'EINSTEIN' on the top line and 'WORKS' on the bottom line. The text is in a dark blue font.

510(K) SUMMARY FOR EINSTEIN WORKS' NIO-I K211395

1. Submitter Information

Einstein Works LLC. 5312 Elm St. Houston, TX 77081 Phone: 001-713-7236000 E mail: roy@ps-med.com

Contact person name: Mr. Roy Bachrach - Managing Director Phone: 001-713-7236000 Email: roy@ps-med.com

2. Date of Preparation July 28, 2021

3. Identification of Predicate

Waismed LTD's NIO-I, Intraosseous infusion device cleared under 510(k) number K190538 on July 10, 2019.

4. Identification of Subject Device

a. Regulatory Information Regulation Name: Needle, Interosseous Regulation Number: 880.5570 Product Code: Primary: FMI Secondary: MHC Common Name: Intraosseous infusion device Proprietary/Trade name: NIO-I

..............................................................................................................................................................................

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Image /page/4/Picture/0 description: The image shows the logo for Einstein Works. The logo consists of a stylized letter 'e' in red, followed by the words 'EINSTEIN' and 'WORKS' stacked on top of each other in blue. The 'e' is formed by two curved lines that create an oval shape, and there is a thin red line underneath the entire logo.

5. Device Description

6. Indications for Use Statement

Characteristics	Subject Device	Predicate Device
	Einstein Works LLC NIO-I	Waismed Ltd NIO-IK190538
Indications for Use	The NIO-I is an intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.	The NIO-I is a intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
Prescription Onlyor Over thecounter	Prescription	Prescription

Discussion of Substantial Equivalence of in Indications for Use statement:

Both devices have the exact same intended use, indications and clinical purpose.

Therefore, in terms of indications for use statement, the NIO-I is substantially equivalent to the selected predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for Einstein Works. The logo consists of a stylized red oval shape on the left, followed by the words "EINSTEIN" and "WORKS" stacked on top of each other in blue. A thin red line is present at the bottom of the logo.

7. Summary of Technological Characteristics

Item	Subject Device	Predicate Device	Comment
	Einstein Works LLC NIO-I	Waismed Ltd NIO-IK190538
TargetPopulation	Emergency Care for infantpatients (birth to 29 dayswith minimal limit ofgestational age of 36weeks and weight of 5lb[2.3Kg]).	Emergency Care for infantpatients (birth to 29 dayswith minimal limit ofgestational age of 36weeks and weight of 5lb[2.3Kg]).	Equivalent
Anatomical Sites	Proximal Tibia.	Proximal Tibia.	Equivalent
EnvironmentUsed	Hospital, Clinic,Emergency Care.	Hospital, Clinic,Emergency Care.	Equivalent
Design	Consists of: handle, needlegripper, needle housing,trocar needle (trocar +cannula) and needle cover,allowing intraosseousaccess for the delivery ofdrugs and fluids.	Consists of: handle, needlegripper, needle housing,trocar needle (trocar +cannula) and needle cover,allowing intraosseousaccess for the delivery ofdrugs and fluids.	Equivalent
Mechanism ofAction	Manually in three stages:(1) The NIO-I needle ismanually inserted throughthe cortex of the bone untilchange is resistance is felt,indicating the needlepenetrated the bonemarrow cavity.(2) The insertion handle isthen disconnected from theneedle and, (3) the trocaris removed by pulling itupwards.	Manually in three stages:(1) The NIO-I needle ismanually inserted throughthe cortex of the bone untilchange is resistance is felt,indicating the needlepenetrated the bonemarrow cavity.(2) The insertion handle isthen disconnected from theneedle and, (3) the trocaris removed by pulling itupwards.	Equivalent
Over-Penetration	Stepped-needle Exists toprovide sensory feedback	Stepped-needle Exists toprovide sensory feedback	Equivalent
Item	Subject Device	Predicate Device	Comment
	Einstein Works LLC NIO-I	Waismed Ltd NIO-I K190538
Safety Mechanisms	upon cortex penetration toprevent over-penetration.	upon cortex penetration toprevent over-penetration.
Insertion Site	In proximal tibia	In proximal tibia	Equivalent
Insertion Site Identification	Extending the patient's legat the tibia site, theinsertion site is locatedapproximately 1cm medialto the tibial tuberosity, orjust below the patella(approximately 1cm or onefinger width) and slightlymedial (approximately1cm or one finger width),along the flat aspect of thetibia. Then insertion takesplace.	Extending the patient's legat the tibia site, theinsertion site is locatedapproximately 1cm medialto the tibial tuberosity, orjust below the patella(approximately 1cm or onefinger width) and slightlymedial (approximately1cm or one finger width),along the flat aspect of thetibia. Then insertion takesplace.	Equivalent
Materials	Needle:Stainless steel 302(Trocar), stainless steel316L (Cannula)Plastic components:Polycarbonate MakrolonRx2530 and ABS PA757(Handle only, no bodycontact with the patient).	Needle:Stainless steel 302(Trocar), stainless steel316L (Cannula)Plastic components:Polycarbonate MakrolonRx2530 and ABS PA757(Handle only, no bodycontact with the patient).	Equivalent
Biocompatibility	Biocompatible. Complieswith ISO 10993-1	Biocompatible. Complieswith ISO 10993-1	Equivalent
Needle dwelling time	<24 Hours	<24 Hours	Equivalent
Hub Interface	The cannula hub is astandard hub Luer Lock	The cannula hub is astandard hub Luer Lock	Equivalent
Item	Subject Device	Predicate Device	Comment
	Einstein Works LLC NIO-I	Waismed Ltd NIO-IK190538
	appropriate for connectingto any standard infusionsystem.	appropriate for connectingto any standard infusionsystem.
Needle length	15 mm (0.6") with steppedneedle for pediatric use.	15 mm (0.6") with steppedneedle for pediatric use.	Equivalent
Needle gauge	18G penetration(and 14G above the needlestep)	18G penetration(and 14G above the needlestep)	Equivalent
Single use	Single use	Single use	Equivalent
Sterilization	Sterile	Sterile	Equivalent
Sterilizationmethod	Gamma irradiation	Gamma irradiation	Equivalent
SterilePackaging	Sterile barrier	Sterile barrier	Equivalent

Table 1: Technological Comparison with the Predicates

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Image /page/6/Picture/0 description: The image shows the logo for Einstein Works. The logo consists of a red elliptical shape on the left and the words "EINSTEIN WORKS" in blue on the right. A thin red line is located underneath the logo.

Einstein Works, LLC. info@einsteinworksllc.com www.einsteinworksllc.com

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Image /page/7/Picture/0 description: The image shows the logo for Einstein Works. The logo consists of a stylized letter "e" in red on the left, followed by the words "EINSTEIN" and "WORKS" stacked on top of each other in blue. A thin red line is present below the text.

Einstein Works, LLC. info@einsteinworksllc.com www.einsteinworksllc.com

Discussion of Substantial Equivalence of in Technological Characteristics: Both devices have the exact same technological characteristics and principle of operation. Therefore, there are no differences raising any questions of safety and effectiveness.

8. Non-Clinical Performance Testing

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 September 04, 2020 and ISO 10993 international standards series as detailed below. Biocompatibility tests included, sensitization, hemolysis, pyrogenicity, cytotoxicity, acute system toxicity and intracutaneous reactivity.

The biocompatibility tests were conducted to verify that the proposed device is not adverse to human tissue based on the following standards:

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Image /page/8/Picture/1 description: The image shows the logo for Einstein Works. The logo consists of a stylized letter "e" in red, followed by the words "EINSTEIN" and "WORKS" stacked on top of each other in blue. The logo is simple and modern, and the colors are eye-catching.

ISO 10993-1:2018 Biological evaluation of medical devices Part 1: A 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 10993-11:2017 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 predicate device. Tests identified under subsections 'a', 'c', 'd', 'e', 'f', 'h' below are based on the company's internal V&V tests' plan, as following described.

Tests identified under subsections 'b', 'g', 'i', 'j', 'k', 'l', 'm' are in compliance with applicable standards as follows:

a) Force required for needle cover removal;
b) Visual inspection for corrosion, per ISO 9626;
c) Force required for needle insertion;
d) Minimal force for insertion of the needle;
e) Force for detachment of the needle housing from the needle gripper;
f) Maximum force for trocar removal after insertion to the platform;
g) Cannula effective length, per ISO 9626 and ISO 7864;
h) Maximum force for cannula removal after insertion;
Usability study, per IEC 62366-1; i)
Shelf life, per ISO 11607-1 and ASTM F1980-16; i)
k) Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72:
Limits for acidity or alkalinity, per ISO 7864; I)
m) 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 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.

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Image /page/9/Picture/0 description: The image shows the logo for Einstein Works. The logo consists of a stylized red orbit shape on the left and the words "EINSTEIN WORKS" in blue on the right. The word "EINSTEIN" is above the word "WORKS".

ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: A Requirements for development, validation and routine control of a sterilization process for medical devices.
A 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 -A Substantiation of selected sterilization dose: Method VDmaxSD.
ANSI AAMI ST72:2011/(R)2016 Bacterial endotoxins -Test methods, routine monitoring, and alternatives to batch testing.
IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical devices.
A ASTM F1980-16 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: A 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 Einstein Works LLC 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 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).