(28 days)
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.
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.
This is a 510(k) premarket notification for a medical device called "NIO Adult," a hypodermic single lumen needle intended for intraosseous access. The document does not describe a study that uses acceptance criteria and reports device performance in the way a clinical trial or a machine learning algorithm validation would. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (B.I.G. Adult Bone Injection Gun) through a series of engineering and performance tests.
Therefore, many of the requested categories for acceptance criteria and study design are not applicable in the context of this 510(k) submission.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several performance tests, but it does not explicitly state quantitative acceptance criteria or detailed numerical performance results for each test in a table format. It generally states that the device "functions as intended" and "inserts the needle to the same penetration depth as the predicate device."
| Test Name | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Trigger Safety Mechanism Test | Device safety mechanism functions correctly. | Functions correctly, improves device safety. |
| Needle Stabilizer (Mechanical Stopper) Performance Test | Stabilizer performs as intended. | Performs as intended. |
| Needle Penetration Depth Test | Penetration depth is consistent with the predicate device. | Inserts the needle to the same penetration depth as the predicate device. |
| Compressed Spring Force Test | Spring force is within specified limits for proper needle insertion. | Functions as intended. |
| Bone Fracture Test | Device does not cause undue bone fracture during use. | Functions as intended. |
| Biocompatibility Testing (ISO 10993-5, -10, -11) | Materials are biocompatible (non-cytotoxic, non-irritating, non-sensitizing). | Meets ISO 10993 standards. |
| Hub-Cannula/Hub-Needle Bond Strength Testing (ISO 7864) | Bond strength meets ISO 7864 requirements to prevent separation. | Meets ISO 7864 standards. |
| Structural Deformation and Needle Integrity Test | Device structure and needle maintain integrity during use. | Maintains integrity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify general "sample sizes" in the way a clinical study would (e.g., number of patients or cases). The tests described are engineering and bench tests, likely performed on a small number of device units or components.
- Sample Size: Not specified for each test. Typically, these types of tests involve a limited number of devices or components to demonstrate consistency and compliance.
- Data Provenance: The tests were conducted to demonstrate substantial equivalence to the predicate device, also manufactured by Waismed Ltd. The document does not specify a country of origin for the testing data itself, but the applicant company (Waismed Ltd.) is located in Herzliya, Israel. The data is retrospective in the sense that it's comparing against an existing predicate, but the testing itself would have been conducted more recently.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert human interpretation or diagnosis. The "ground truth" for these engineering tests is established by objective measurements against predefined specifications or comparison to the predicate device's characteristics.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described, as the tests are objective engineering measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the subject of this medical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The NIO Adult is a physical medical device (a needle system), not an algorithm or software-based device.
7. The type of ground truth used
The "ground truth" for the performance tests is based on:
- Engineering Specifications: Designed performance characteristics for components (e.g., spring force, depth of penetration).
- International Standards: Compliance with standards like ISO 10993 (biocompatibility) and ISO 7864 (bond strength).
- Predicate Device Performance: Direct comparison to the established performance characteristics of the B.I.G. Adult Bone Injection Gun in areas like needle penetration depth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
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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.
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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
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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
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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
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(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.
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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.
§ 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).