Intraosseous infusion device

K191258 · Einstein Works, LLC · FMI · Oct 23, 2019 · General Hospital

Device Facts

• Record ID: K191258
• Device Name: Intraosseous infusion device
• Applicant: Einstein Works, LLC
• Product Code: FMI · General Hospital
• Decision Date: Oct 23, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Intraosseous infusion device; syringe-like form factor; contains trocar needle, spring, piston, housing, safety latch, and trigger. Operated by clinician in hospital, clinic, or emergency care settings. Mechanism: spring-loaded activation drives needle to predetermined depth into bone marrow cavity. Provides vascular access when IV access is difficult or unavailable. Features rotational safety latch and dual-action trigger (simultaneous pressure against bone and trigger pull) to prevent accidental activation. Cannula hub uses standard Luer Lock for connection to infusion systems. Benefits patient by enabling rapid fluid/medication delivery in emergency scenarios.

Clinical Evidence

No clinical data submitted. Bench testing not required as the device is identical to the predicate.

Technological Characteristics

Materials: Stainless steel (trocar needle/cannula), nickel-plated Brass 360 (hub), Makrolon® Rx2530 polycarbonate (skin-contact parts). Mechanism: Spring-loaded mechanical needle insertion. Dimensions: 17.5cm x 8.8cm x 4.7cm. Connectivity: Standard Luer Lock hub. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for pediatric patients aged 3-12 years requiring intraosseous access in the proximal tibia as an alternative to IV access during emergencies.

Regulatory Classification

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.

Predicate Devices

• WaisMed LTD, NIO- P (Pediatric) Intraosseous Infusion Device (K160805)
• Einstein Works, L.L.C. NIO- A (Adult) Intraosseous Infusion Device (K182770)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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-President<br>Einstein Works, L.L.C.<br>5312 Elm Street<br>Houston, TX 77081 |
| CONTACT PERSON | Linda Taylor, Senior Vice-President<br>Einstein Works, L.L.C.<br>5312 Elm Street<br>Houston, TX 77081 |
| DEVICE NAME<br>Classification<br>Trade Name<br>Common Name<br>Regulation Name<br>Classification Regulation<br>Product Code | Class II<br>Intraosseous Infusion Device<br>Needle, Hypodermic, Single Lumen<br>Hypodermic single lumen needle<br>21 C.F.R. 880.5570<br>FMI |
| PREDICATE DEVICE: | Primary Predicate:<br>WaisMed LTD, NIO- P (Pediatric) Intraosseous Infusion Device<br>(K160805)<br>Secondary Predicate:<br>Einstein Works, L.L.C. NIO- A (Adult) Intraosseous Infusion Device<br>(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:

| Technological<br>Characteristic | NIO-P<br>Einstein Works, L.L.C. | NIO-P<br>Waismed Ltd.<br>(Primary Predicate )<br>(KI60805) | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Sponsor | Einstein Works, LLC | Waismed Ltd | Same device with US company<br>distributing |
| Indications for Use | The NIO-P for pediatrics is<br>intended to provide<br>intraosseous access in the<br>proximal tibia, as an<br>alternative to IV access<br>during emergencies. The<br>device is for use in pediatric<br>patients in age 3- 12 years<br>of age. | The NIO-P for pediatrics is<br>intended to provide<br>intraosseous access in the<br>proximal tibia, as an<br>alternative to IV access during<br>emergencies. The device is for<br>use in pediatric patients in age<br>3- 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, Emergency<br>Care | Hospital, Clinic, Emergency<br>Care | Same |
| Design: | Consists of trocar needle,<br>spring, piston and housing. | Consists of trocar needle,<br>spring, piston and housing. | Same |
| Technological<br>Characteristic | NIO-P<br>Einstein Works, L.L.C. | NIO-P<br>Waismed Ltd.<br>(Primary Predicate )<br>(K160805) | Comparison |
| Mechanism of Action | The device resembles a<br>syringe and when activated,<br>a loaded spring is released,<br>and the device injects the<br>needle to a predetermined<br>depth into the bone marrow<br>cavity according to the<br>patient age. | The device resembles a<br>syringe and when activated, a<br>loaded spring is released, and<br>the device injects the needle<br>to a predetermined depth into<br>the bone marrow cavity<br>according to the patient age. | Same |
| Components | - The trocar needle<br>- The spring<br>- The piston<br>- The housing<br>- The needle holder<br>- The safety latch<br>- The trigger<br>- The needle stabilizer with<br>the location arrow | - The trocar needle<br>- The spring<br>- The piston<br>- The housing<br>- The needle holder<br>- The safety latch<br>- The trigger<br>- The needle stabilizer with<br>the location arrow | Same |
| Dimensions (packaging) | Length 17.5cm<br>Width 8.8cm<br>Depth 4.7cm | Length 17.5cm<br>Width 8.8cm<br>Depth 4.7cm | Same |
| Weight (in package) | 107.6gm (0.24lbf) | 107.6gm (0.24lbf) | Same |
| Safety Mechanisms | 1. Rotational safety latch to<br>prevent accidental<br>activation<br>2. Simultaneous pressing of<br>device against the bone and<br>pulling of trigger<br>mechanism required to<br>activate device. | 1. Rotational safety latch to<br>prevent accidental activation<br>2. Simultaneous pressing of<br>device against the bone and<br>pulling of trigger mechanism<br>required to activate device. | Same |
| Materials | Stainless steel (trocar<br>needle & cannula)<br>Brass 360 nickel-plated<br>(hub)<br>Makrolon® Rx2530<br>polycarbonate (Plastic parts<br>with direct contact to skin) | Stainless steel (trocar needle<br>& cannula)<br>Brass 360 nickel-plated (hub)<br>Makrolon® Rx2530<br>polycarbonate (Plastic parts<br>with direct contact to skin) | Same |
| Technological<br>Characteristic | NIO-P<br>Einstein Works, L.L.C. | NIO-P<br>Waismed Ltd.<br>(Primary Predicate )<br>(K160805) | Comparison |
| Hub Interface | The cannula hub is a<br>standard metal hub Luer<br>Lock appropriate for<br>connecting to any standard<br>infusion system. | The cannula hub is a standard<br>metal hub Luer Lock<br>appropriate for connecting to<br>any standard infusion system. | Same |
| Needle Fixation | Pediatric needle stabilizer | Pediatric needle stabilizer | Same |
| Labeling | Einstein Works labeling is<br>the same basic labeling as<br>the Waismed but clarity was<br>added for needle<br>penetration and<br>appropriateness of the<br>target population | Same basic labeling as<br>Waismed labeling. | Same basic labeling with<br>clarifications added to the<br>"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.