(28 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and safety mechanisms, with no mention of AI or ML.
No.
The device is intended to provide intraosseous access for drug and fluid administration during emergencies, not for therapeutic treatment itself.
No
Explanation: The device is intended to provide intraosseous access for fluid or pharmacological resuscitation during emergencies. It is a tool for treatment/intervention, not for diagnosis.
No
The device description explicitly states it is comprised of physical components (trocar needle, spring, piston, housing) and is a modification of a hardware device (Bone Injection Gun). The performance studies also focus on mechanical and material properties.
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 when IV access is not possible. This is a direct intervention on the patient's body for therapeutic purposes.
- Device Description: The device is a mechanical tool designed to physically insert a needle into bone marrow. It does not involve the analysis of biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples, detecting biomarkers, or providing diagnostic results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) for therapeutic access.
N/A
Intended Use / Indications for Use
The NIO Adult 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 Adult 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 (comma separated list FDA assigned to the subject device)
FMI
Device Description
The NIO Adult device is a modification to the company's cleared Adult B.I.G - Bone Injection Gun (K981853 and K062940) to permit intraosseous access through the Proximal Tibia and the Humeral Head.
Like the cleared Adult B.I.G., the NIO Adult device is comprised of a trocar needle, spring, piston and housing. Likewise, both devices resemble 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.
The difference between the NIO Adult device and the cleared B.I.G. device is primarily the safety latch and trigger mechanism which is designed to provide a safer device and the minor design modifications to the plastic housing and needle dimensions in order to accommodate the modified safety mechanism.
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
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)
Provided performance data include a Trigger Safety Mechanism Test, Needle Stabilizer (Mechanical Stopper) Performance Test, Needle Penetration Depth Test, Compressed Spring Force Test, Bone Fracture Test. Biocompatibility Testing (per ISO 10993-5 -10. and -11), Hub-Cannula/Hub-Needle Bond Strength Testing (According to ISO 7864), and Structural Deformation and Needle Integrity Test.
Device testing demonstrates that the device functions as intended and inserts the needle to the same penetration depth as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The profiles are black against a white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2014
Hogan Lovells US LLP Jonathan Kahan Columbia Square 555 Thirteen Street NW Washington, DC 20004
Re: K142086
Trade/Device Name: NIO Adult Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 31, 2014 Received: July 31, 2014
Dear Mr. Kahan:
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. 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.
1
Page 2 – Mr. Kahan
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142086
Device Name
NIO Adult
Indications for Use (Describe)
The NIO Adult 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 Adult is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head 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.
Type of Use (Select one or both, as applicable)
쓰 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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3
510(k) SUMMARY
K142086
(Premarket Notification [510(k)] Number)
Applicant Name:
| Company Name: | Waismed Ltd. |
|---|---|
| Address: | 11 Galgalei HaPlada Str. (P.O.B 12135) |
| Herzliya, ISRAEL 4672211 | |
| Tel: | +972-9- 9517444 |
| Fax: | +972-9- 9517666 |
| E-mail: | einat@persysmedical.com |
Contact Person:
| Official Correspondent: Jonathan Kahan | |
|---|---|
| Company Name: | Hogan Lovells US LLP |
| Address: | Columbia Square |
| 555 Thirteenth Street, NW | |
| Washington, DC 20004 | |
| Tel: (202) 637 5794 | |
| Fax: (202) 637 5910 | |
| E-mail: Jonathan.Kahan@hoganlovells.com |
Date Prepared: July 31, 2014
Trade Name: NIO Adult
Classification Name: CFR Classification section 880.5570 (Product code FMI)
Classification: Class II Medical Device
Predicate Device: B.I.G. Adult Bone Injection Gun
The modified NIO Adult device is substantially equivalent to the previously cleared, B.I.G. Adult (Bone Injection Gun), also manufactured by Waismed Ltd.:
| Device | Manufacturer | 510(k) No. |
|---|---|---|
| B.I.G. (Bone Injection Gun) | Waismed Ltd. | K981853, K062940 |
Device Description:
The NIO Adult device is a modification to the company's cleared Adult B.I.G - Bone Injection Gun
4
(K981853 and K062940) to permit intraosseous access through the Proximal Tibia and the Humeral Head.
Like the cleared Adult B.I.G., the NIO Adult device is comprised of a trocar needle, spring, piston and housing. Likewise, both devices resemble 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.
The difference between the NIO Adult device and the cleared B.I.G. device is primarily the safety latch and trigger mechanism which is designed to provide a safer device and the minor design modifications to the plastic housing and needle dimensions in order to accommodate the modified safety mechanism.
Intended Use/Indication for Use:
The NIO Adult 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 Adult 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.
Performance Data:
Provided performance data include a Trigger Safety Mechanism Test, Needle Stabilizer (Mechanical Stopper) Performance Test, Needle Penetration Depth Test, Compressed Spring Force Test, Bone Fracture Test. Biocompatibility Testing (per ISO 10993-5 -10. and -11), Hub-Cannula/Hub-Needle Bond Strength Testing (According to ISO 7864), and Structural Deformation and Needle Integrity Test.
Substantial Equivalence:
The intended use and technological characteristics of the modified NIO Adult device are substantially equivalent to the intended use and technological characteristics of the original B.I.G. Adult device.
5
The addition of a second safety mechanism only improves device safety and does not raise new types of safety or effectiveness questions. Device testing demonstrates that the device functions as intended and inserts the needle to the same penetration depth as the predicate device.
Conclusions:
Based on the performance testing and comparison to the predicate device, the modified NIO Adult device is substantially equivalent to the B.I.G. Adult predicate device.