Who is the manufacturer of Adult Intraosseous Infusion Device?

Einstein Works, LLC filed the 510(k) submission for Adult Intraosseous Infusion Device (K182770).

What is the FDA product code for Adult Intraosseous Infusion Device?

FMI. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Adult Intraosseous Infusion Device?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Adult Intraosseous Infusion Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Adult Intraosseous Infusion Device

Q: What are the predicate devices for Adult Intraosseous Infusion Device?

WaisMed LTD NIO- A Intraosseous Infusion Device (K142086).

K182770 · Einstein Works, LLC · FMI · Apr 9, 2019 · General Hospital

Device Facts

Record ID	K182770
Device Name	Adult Intraosseous Infusion Device
Applicant	Einstein Works, LLC
Product Code	FMI · General Hospital
Decision Date	Apr 9, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5570
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Adult Intraosseous (IO) infusion device; provides emergency vascular access via proximal tibia or humeral head. Device resembles syringe; contains trocar needle, spring, piston, and housing. Operation: user presses device against bone and pulls trigger; spring-loaded mechanism drives needle to 25mm depth into bone marrow cavity. Used in hospital, clinic, or emergency care settings by healthcare providers. Output: established IO access point with standard Luer Lock hub for connection to infusion systems. Benefits: enables rapid fluid or drug delivery when IV access is impossible.

Clinical Evidence

No clinical data submitted. Substantial equivalence determined via bench-level comparison of design and technological characteristics.

Technological Characteristics

Materials: Stainless steel (trocar needle/cannula), nickel-plated Brass 360 (hub), Makrolon® Rx2530 Polycarbonate (skin-contact parts). Mechanism: Spring-actuated needle insertion to 25±3 mm depth. Interface: Standard Luer Lock. Standards: ISO 594 (conical fittings), ISO 9626 (stainless steel tubing), ISO 7864 (sterile hypodermic needles). Safety: Rotational safety latch and dual-action trigger (simultaneous pressure and trigger pull).

Indications for Use

Indicated for adult patients requiring intraosseous access in the proximal tibia or humeral head as an alternative to IV access during emergencies, specifically when rapid fluid or pharmacological resuscitation is required and IV access is not possible.

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- A Intraosseous Infusion Device (K142086)

Related Devices

K191258 — Intraosseous infusion device · Einstein Works, LLC · Oct 23, 2019
K091140 — EZ-MIO DISTAL TIBIA, EZ-IO DISTAL TIBIA, VIDAPORT INTRAOSSEOUS INFUSION SYSTEM, EZ-IO · Vidacare Corporation · Oct 14, 2009
K970380 — F.A.S.T. 1 INTRAOSSEOUS INFUSION SYSTEM · Pyng Medical Corp. · Apr 25, 1997
K101026 — POWERED PD-IO INFUSION SYSTEM, EZ-IO HUMERAL HEAD, POWERED PH-IO · Vidacare Corporation · Jul 27, 2010
K203193 — BD Intraosseous Infusion System · Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd] · Mar 4, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 510(K) SUMMARY: K182770 | Date | April 9, 2019 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SUBMITTER | Linda Taylor, Senior Vice-President Einstein Works, L.L.C. 5312 Elm Street Houston, TX 77081 | | CONTACT PERSON | Linda Taylor, Senior Vice-President Einstein Works, L.L.C. 5312 Elm Street Houston, TX 77081 Tel: (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 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. {3}------------------------------------------------ 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: | Technological Characteristic | NIO Device Waismed Ltd. (K142086) | NIO Device Einstein Works, L.L.C. | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code, Class | FMI, Class II | FMI, Class II | | Indications for Use | 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. | 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. | | 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 of Action | The device resembles a syringe and when activated, a loaded spring is released, and the device injects the needle to a penetration depth of $25 \pm 3$ mm into the bone marrow cavity. | The device resembles a syringe and when activated, a loaded spring is released, and the device injects the needle to a penetration depth of $25 \pm 3$ mm into the bone marrow cavity. | | Technological Characteristic | NIO Device Waismed Ltd. (K142086) | NIO Device Einstein Works, L.L.C. | | - Components | The NIO device consists of the following components: - 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 following components: - The trocar needle - The spring - The piston - The housing - The needle holder - The safety latch - The trigger - The needle stabilizer | | - Dimensions (packaging) | Length 17.3cm Width 8.8cm Depth 4.7cm | Length 17.3cm Width 8.8cm Depth 4.7cm | | - Weight (in package) | 110gm (0.24lbs) | 110gm (0.24lbs) | | Safety Mechanisms | 1. Rotational safety latch to prevent accidental activation 2. Simultaneous pressing of device against the bone and pulling of trigger mechanism required to activate device. | 1. Rotational safety latch to prevent accidental activation 2. Simultaneous pressing of device against the bone and pulling of trigger mechanism required to activate device. | | Standards Met | - ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment; - ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices ISO 7864, Sterile hypodermic needles for single use | - ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment; - ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices ISO 7864, Sterile hypodermic needles for single use | | Materials | Stainless steel (trocar needle & cannula) Brass 360 nickel-plated (hub) Makrolon® Rx2530 Polycarbonate (Plastic parts with direct contact to skin) | Stainless steel (trocar needle & cannula) Brass 360 nickel-plated (hub) Makrolon® Rx2530 Polycarbonate (Plastic parts with direct contact to skin) | | Hub Interface | The cannula hub is a standard metal hub Luer Lock appropriate for connecting to any standard infusion system. | The cannula hub is a standard metal hub Luer Lock appropriate for connecting to any standard infusion system. | {4}------------------------------------------------ ### PERFORMANCE TESTING - (NON-CLINICAL) BENCH - Performance data were not required to determine substantial equivalence. . ## PERFORMANCE TESTING - CLINICAL {5}------------------------------------------------ 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. {6}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.