(193 days)
Not Found
No
The device description and intended use focus on a mechanical mechanism for intraosseous access and do not mention any AI/ML components or functions.
No
The device is used to provide intraosseous access for fluid or pharmacological resuscitation during emergencies, which is a supportive intervention rather than a direct treatment for a disease or condition.
No
The device is used to provide intraosseous access for drug or fluid delivery, indicating a therapeutic or interventional purpose rather than diagnosis.
No
The device description clearly states it is comprised of physical components like a trocar needle, spring, piston, and housing, indicating it is a hardware device, not software-only.
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 intraosseous access for fluid and pharmacological resuscitation during emergencies, as an alternative to IV access. This is a procedure performed directly on the patient's body to deliver substances, not to analyze samples taken from the body.
- Device Description: The device is described as a needle and spring mechanism for injecting into bone marrow. This is a medical device for direct patient intervention, not for testing or analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely different.
N/A
Intended Use / 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.
Product codes
FMI
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.
The device design is the same as the predicate and no changes have been made.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal Tibia and Humeral Head
Indicated Patient Age Range
adult patients only
Intended User / Care Setting
Not Found
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)
PERFORMANCE TESTING - (NON-CLINICAL) BENCH
- Performance data were not required to determine substantial equivalence. .
PERFORMANCE TESTING - CLINICAL
There are no clinical data submitted with this Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WaisMed LTD NIO- A Intraosseous Infusion Device (K142086)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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
- Simultaneous pressing of device against
the bone and pulling of trigger mechanism
required to activate device. | 1. Rotational safety latch to prevent
accidental activation - 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.
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