Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states it is a "manual intraosseous device" and focuses on mechanical features like the handle and stepped-needle design. There is no mention of AI, ML, or any computational processing of data.

Therapeutic

No
The device is described as an intraosseous device intended to provide vascular access for fluid and drug infusion, not to treat a disease or condition itself. Its function is primarily diagnostic or supportive, enabling the delivery of therapeutic agents.

Diagnostic

No

The device is an intraosseous infusion device intended to provide vascular access for administering fluids and drugs, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, manual intraosseous device with a handle, needle, trocar, and cannula, indicating it is a hardware medical device, not software-only.

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 vascular access in the proximal tibia of infants for emergency IV access. This is a procedure performed directly on the patient's body to deliver fluids and drugs.
Device Description: The description details a manual device for inserting a needle into bone to access the vascular system. It does not involve testing samples of bodily fluids or tissues outside of the body.
Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The NIO-I is a therapeutic/access device, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

FMI, MHC

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.

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

infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.

Intended User / Care Setting

Emergency Care for infant patients (birth to 29 days with minimal limit of gestational age of 36 weeks and weight of 5lb [2.3Kg]).
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)

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. Biocompatibility tests included, sensitization, hemolysis, pyrogenicity, cytotoxicity, acute system toxicity and intracutaneous reactivity.
Additionally, 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. These tests included:

Force required for needle cover removal
Visual inspection for corrosion, per ISO 9626
Force required for needle insertion
Minimal force for insertion of the needle
Force for detachment of the needle housing from the needle gripper
Maximum force for trocar removal after insertion to the platform
Cannula effective length, per ISO 9626 and ISO 7864
Maximum force for cannula removal after insertion
Usability study, per IEC 62366-1
Shelf life, per ISO 11607-1 and ASTM F1980-16
Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72
Limits for acidity or alkalinity, per ISO 7864
Conical fitting, per ISO 594-1 and ISO 594-2.

The test results demonstrated that the proposed device complies with the listed standards and all tests' results support Einstein Works LLC labeling claims in order to establish substantial equivalency.

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

Not Found

Predicate Device(s)

K190538

Reference Device(s)

Not Found

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/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)

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.

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

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.

6. Indications for Use Statement

Characteristics	Subject Device	Predicate Device
	Einstein Works LLC NIO-I	Waismed Ltd NIO-I
K190538
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 Only
or Over the
counter	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-I
K190538
Target
Population	Emergency Care for infant
patients (birth to 29 days
with minimal limit of
gestational age of 36
weeks and weight of 5lb
[2.3Kg]).	Emergency Care for infant
patients (birth to 29 days
with minimal limit of
gestational age of 36
weeks and weight of 5lb
[2.3Kg]).	Equivalent
Anatomical Sites	Proximal Tibia.	Proximal Tibia.	Equivalent
Environment
Used	Hospital, Clinic,
Emergency Care.	Hospital, Clinic,
Emergency Care.	Equivalent
Design	Consists of: handle, needle
gripper, needle housing,
trocar needle (trocar +
cannula) and needle cover,
allowing intraosseous
access for the delivery of
drugs and fluids.	Consists of: handle, needle
gripper, needle housing,
trocar needle (trocar +
cannula) and needle cover,
allowing intraosseous
access for the delivery of
drugs and fluids.	Equivalent
Mechanism of
Action	Manually in three stages:
(1) The NIO-I needle is
manually inserted through
the cortex of the bone until
change is resistance is felt,
indicating the needle
penetrated the bone
marrow cavity.
(2) The insertion handle is
then disconnected from the
needle and, (3) the trocar
is removed by pulling it
upwards.	Manually in three stages:
(1) The NIO-I needle is
manually inserted through
the cortex of the bone until
change is resistance is felt,
indicating the needle
penetrated the bone
marrow cavity.
(2) The insertion handle is
then disconnected from the
needle and, (3) the trocar
is removed by pulling it
upwards.	Equivalent
Over-
Penetration	Stepped-needle Exists to
provide sensory feedback	Stepped-needle Exists to
provide sensory feedback	Equivalent
Item	Subject Device	Predicate Device	Comment
	Einstein Works LLC NIO-I	Waismed Ltd NIO-I K190538
Safety Mechanisms	upon cortex penetration to
prevent over-penetration.	upon cortex penetration to
prevent over-penetration.
Insertion Site	In proximal tibia	In proximal tibia	Equivalent
Insertion Site Identification	Extending the patient's leg
at the tibia site, the
insertion site is located
approximately 1cm medial
to the tibial tuberosity, or
just below the patella
(approximately 1cm or one
finger width) and slightly
medial (approximately
1cm or one finger width),
along the flat aspect of the
tibia. Then insertion takes
place.	Extending the patient's leg
at the tibia site, the
insertion site is located
approximately 1cm medial
to the tibial tuberosity, or
just below the patella
(approximately 1cm or one
finger width) and slightly
medial (approximately
1cm or one finger width),
along the flat aspect of the
tibia. Then insertion takes
place.	Equivalent
Materials	Needle:
Stainless steel 302
(Trocar), stainless steel
316L (Cannula)

Plastic components:
Polycarbonate Makrolon
Rx2530 and ABS PA757
(Handle only, no body
contact with the patient). | Needle:
Stainless steel 302
(Trocar), stainless steel
316L (Cannula)

Plastic components:
Polycarbonate Makrolon
Rx2530 and ABS PA757
(Handle only, no body
contact with the patient). | Equivalent |
| Biocompatibility | Biocompatible. Complies
with ISO 10993-1 | Biocompatible. Complies
with ISO 10993-1 | Equivalent |
| Needle dwelling time | 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.