(166 days)
No
The device description and performance studies focus on mechanical function and safety, with no mention of AI or ML capabilities.
No
The device is described as an "Intraosseous Infusion Device" which provides "Intraosseous access." Its purpose is to gain access to the bone marrow cavity for infusion, not to directly treat a disease or condition. While it is used in emergency situations to facilitate treatment, it is an access device, not a therapeutic device itself.
No
The device is described as an "Intraosseous Infusion Device" which provides "Intraosseous access in the proximal tibia, as an alternative to IV access during emergencies." This indicates it is used for delivering substances into the bone marrow, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a trocar needle, spring, piston, and housing, indicating it is a hardware device.
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 in the proximal tibia as an alternative to IV access during emergencies. This is a procedure performed directly on the patient's body to gain access to the bone marrow cavity for fluid or medication administration.
- Device Description: The device is described as an "Intraosseous Infusion Device" that injects a needle into the bone marrow cavity. This is a mechanical device used for a medical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed for testing samples in vitro. This device is designed for a direct medical intervention in vivo (within the body).
N/A
Intended Use / Indications for 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.
Product codes
FMI
Device Description
The Einstein Works NIO Pediatric (NIO- P) Intraosseous Infusion Device 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 NIO device also features the same safety latch and trigger mechanism which is found with the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Proximal Tibia, Humeral Head
Indicated Patient Age Range
3-12 years of age.
Intended User / Care Setting
Emergency Care Patients in 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)
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.
There are no clinical data submitted with this Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
WaisMed LTD, NIO- P (Pediatric) Intraosseous Infusion Device (K160805), Einstein Works, L.L.C. NIO- A (Adult) Intraosseous Infusion Device (K182770)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
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
1
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 (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) 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 |
| 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 | |
| DEVICE NAME | |
| Classification | |
| Trade Name | |
| Common Name | |
| Regulation Name | |
| Classification Regulation | |
| Product Code | Class II |
| Intraosseous Infusion Device | |
| Needle, Hypodermic, Single Lumen | |
| Hypodermic single lumen needle | |
| 21 C.F.R. 880.5570 | |
| FMI | |
| PREDICATE DEVICE: | Primary Predicate: |
| WaisMed LTD, NIO- P (Pediatric) Intraosseous Infusion Device | |
| (K160805) | |
| Secondary Predicate: | |
| Einstein Works, L.L.C. NIO- A (Adult) Intraosseous Infusion Device | |
| (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
Characteristic | NIO-P
Einstein Works, L.L.C. | NIO-P
Waismed Ltd.
(Primary Predicate )
(KI60805) | Comparison |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Sponsor | Einstein Works, LLC | Waismed Ltd | Same device with US company
distributing |
| 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
of age. | 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 of age. | Same |
| Target Population | Emergency Care Patients | Emergency Care Patients | Same |
| Anatomical Sites | Proximal Tibia | Proximal Tibia | Same |
| Environment Used | Hospital, Clinic, Emergency
Care | Hospital, Clinic, Emergency
Care | Same |
| Design: | Consists of trocar needle,
spring, piston and housing. | Consists of trocar needle,
spring, piston and housing. | Same |
| Technological
Characteristic | NIO-P
Einstein Works, L.L.C. | NIO-P
Waismed Ltd.
(Primary Predicate )
(K160805) | Comparison |
| Mechanism of Action | The device resembles a
syringe and when activated,
a loaded spring is released,
and the device injects the
needle to a predetermined
depth into the bone marrow
cavity according to the
patient age. | The device resembles a
syringe and when activated, a
loaded spring is released, and
the device injects the needle
to a predetermined depth into
the bone marrow cavity
according to the patient age. | Same |
| Components | - The trocar needle
- The spring
- The piston
- The housing
- The needle holder
- The safety latch
- The trigger
- The needle stabilizer with
the location arrow | - The trocar needle - The spring
- The piston
- The housing
- The needle holder
- The safety latch
- The trigger
- The needle stabilizer with
the location arrow | Same |
| Dimensions (packaging) | Length 17.5cm
Width 8.8cm
Depth 4.7cm | Length 17.5cm
Width 8.8cm
Depth 4.7cm | Same |
| Weight (in package) | 107.6gm (0.24lbf) | 107.6gm (0.24lbf) | Same |
| 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. | Same |
| 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) | Same |
| Technological
Characteristic | NIO-P
Einstein Works, L.L.C. | NIO-P
Waismed Ltd.
(Primary Predicate )
(K160805) | Comparison |
| 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. | Same |
| Needle Fixation | Pediatric needle stabilizer | Pediatric needle stabilizer | Same |
| Labeling | Einstein Works labeling is
the same basic labeling as
the Waismed but clarity was
added for needle
penetration and
appropriateness of the
target population | Same basic labeling as
Waismed labeling. | Same basic labeling with
clarifications added to the
"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.