(92 days)
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 between 3 and 12 years of age.
The NIO product family (Adult and Pediatric) is an upgrade in terms of design and structure to the company's B.I.G. Bone Injection Gun product family. The NIO product family has already one cleared model, for the adult population NIO Adult (K142086). Both product families NIO and BIG are composed of a trocar needle, spring, piston, and housing that contains safety mechanisms to prevent accidental device activation. Both devices are positioned onto the appropriate insertion site. Both product families have the same principle of operation. The device resembles a syringe and, when activated, a loaded spring is released and the device injects a needle to a predetermined depth into the bone marrow cavity. The user then pulls out the trocar needle, leaving the cannula inside the bone marrow cavity. Through the cannula, fluids and drugs can be delivered to the vascular system via the bone marrow cavity. The NIO-P device is designed to detect the proper injection point. In addition, the NIO-P is also equipped with a unique, adjustable needle penetration depth according to the age group, as part of the stabilizer. Both features are designed to improve accuracy in detecting the insertion point and needle penetration depth.
This document describes a 510(k) premarket notification for the NIO-P device, a hypodermic single lumen needle intended for pediatric intraosseous access. The submission aims to demonstrate substantial equivalence to existing predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it lists several validations and studies performed to demonstrate the device's performance characteristics. The "Reported Device Performance" is implied through the successful completion of these validations and bench testing, confirming the device functions as intended and meets safety and effectiveness requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Proper Insertion Point Detection | Validated by Insertion Point and Penetration Depth Validation |
| Accurate Needle Penetration Depth (adjustable for age group) | Validated by Insertion Point and Penetration Depth Validation |
| Adequate Spring Force for Bone Penetration | Validated by Adequate Spring Force and Bone Integrity Following Activation Validation |
| Preservation of Bone Integrity after Activation | Validated by Adequate Spring Force and Bone Integrity Following Activation Validation |
| Needle Stabilizer Effectiveness | Validated by Needle Stabilizer Validation |
| Hub-Cannula/Hub-Needle Bond Strength | Tested in Hub-Cannula/Hub-Needle Bond Strength Testing (According to ISO 7864) |
| Structural Integrity during use | Tested in Structural Deformation and Needle Integrity Test |
| Substantial Equivalence to predicate/reference devices | Demonstrated through performance testing and comparison to NIO-A and BIG-P, confirming that modifications do not raise new safety/effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes bench testing and validation studies. It does not specify sample sizes for these tests. The data provenance is implied to be from the manufacturer's internal testing (Waismed Ltd.). There is no mention of country of origin for test data, nor whether it is retrospective or prospective, as it pertains to engineering and product validation rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies listed are bench tests evaluating physical properties and functionalities of the device (e.g., spring force, bond strength, structural deformation). These types of tests typically rely on engineering specifications and laboratory measurements rather than expert human assessment for ground truth.
4. Adjudication Method for the Test Set
Given that the studies are bench tests of physical characteristics, an adjudication method in the context of expert consensus or disagreement is not applicable and therefore not mentioned. The "ground truth" for these tests would be defined by the pre-established engineering specifications and validated measurement techniques.
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. The submission focuses on demonstrating substantial equivalence through bench testing of the device's physical and functional characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a mechanical hypodermic needle for intraosseous access. It is not an algorithm-based device or software, so the concept of "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its mechanical function, albeit with features designed to aid the human user (e.g., detecting proper injection point, adjustable penetration depth).
7. The Type of Ground Truth Used
The ground truth used for the performance studies is based on:
- Engineering specifications and design requirements: For aspects like proper insertion point, penetration depth, spring force, bone integrity, bond strength, and structural deformation.
- Established standards: E.g., ISO 7864 for Hub-Cannula/Hub-Needle Bond Strength Testing.
- Comparison to predicate device characteristics: To demonstrate that the modified device's characteristics are consistent with or improved upon the predicate and reference devices, without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
This information is not applicable. The NIO-P is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and validation are based on engineering principles and physical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set for a mechanical device.
{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 stylized depiction of an eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 23, 2016
WaisMed Ltd. % Mr. Jonathan Kahan Partner Hogan Lovells US, LLP Columbia Square, 555 Thirteenth St Washington, DC 20004
Re: K160805
Trade/Device Name: NIO-P Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 29, 2016 Received: April 29, 2016
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}------------------------------------------------
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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,
Tina Kiang
-s
for 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) K160805
Device Name NIO-P
Indications for Use (Describe)
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 between 3 and 12 years of age.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY K160805
Applicant Name:
| Applicant Name: | |
|---|---|
| Company Name: | WaisMed Ltd. |
| Address: | 10 Amal St., Afek Industrial Park |
| Rosh Ha'ayin, ISRAEL 4809234 | |
| 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: | June 17, 2016 |
| Trade Name: | NIO-P |
| Classification Name: | 880.5570 Hypodermic single lumen needle, (Product code FMI) |
| Classification: | Class II |
| Predicate Devices: |
| Manufacturer / Owner | 510(k) No. | ||
|---|---|---|---|
| Predicate Device | NIO Adult | WaisMed Ltd. | K142086 |
| Reference Device | B.I.G Bone Injection forPediatrics | WaisMed Ltd. | K022415 |
{4}------------------------------------------------
Device Description:
The NIO product family (Adult and Pediatric) is an upgrade in terms of design and structure to the company's B.I.G. Bone Injection Gun product family. The NIO product family has already one cleared model, for the adult population NIO Adult (K142086).
Both product families NIO and BIG are composed of a trocar needle, spring, piston, and housing that contains safety mechanisms to prevent accidental device activation. Both devices are positioned onto the appropriate insertion site.
Both product families have the same principle of operation. The device resembles a syringe and, when activated, a loaded spring is released and the device injects a needle to a predetermined depth into the bone marrow cavity. The user then pulls out the trocar needle, leaving the cannula inside the bone marrow cavity. Through the cannula, fluids and drugs can be delivered to the vascular system via the bone marrow cavity.
The NIO-P device is designed to detect the proper injection point. In addition, the NIO-P is also equipped with a unique, adjustable needle penetration depth according to the age group, as part of the stabilizer. Both features are designed to improve accuracy in detecting the insertion point and needle penetration depth.
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 between 3 and 12 years of age.
Performance Data:
Provided performance data include the following validations and studies:
-
- Insertion Point and Penetration Depth Validation.
-
- Adequate Spring Force and Bone Integrity Following Activation Validation.
-
- Needle Stabilizer Validation.
-
- Hub-Cannula/Hub-Needle Bond Strength Testing (According to ISO 7864).
-
- Structural Deformation and Needle Integrity Test.
Substantial Equivalence:
The indications of the NIO-P are identical to those of the reference device, the BIG-P (K022415), except that the NIO-P is specifically indicated for pediatric patients between 3 and 12 years of age. The technological characteristics of the modified NIO-P device, as compared to
{5}------------------------------------------------
the predicate NIO-A device (K142086) are identical except for the modification of the needle stabilizer to allow detection of the accurate insertion point and the adjustable needle depth penetration. This modification has been validated by bench testing, and does not raise new types of safety or effectiveness questions. A comparison table between the subject and predicate devices is provided below.
| NIO-A WaismedLtd. PredicateDevice(K142086) | BIG-P WaismedLtd. ReferenceDevice (K022415) | NIO-P WaismedLtd. (ModifiedDevice) | |
|---|---|---|---|
| ProductClassification | Regulation number:880.5570Code: FMI,Class: II | Same | Same |
| Indications forUse | The NIO is intended toprovide intraosseousaccess in the proximaltibia, as an alternative toIV access duringemergencies. The deviceis for use in adult patientsonly.The NIO is indicated foruse in providingintraosseous access as analternative to IV accessduring emergencies.Humeral head IO access isindicated when rapid fluidor pharmacologicalresuscitation is requiredand intravenous access isnot possible. The deviceis for use in adult patientsonly. | The Bone Injection Gun(B.I.G.) for pediatric isintended to provideintraosseous access in theproximal tibia, as analternative to IV accessduring emergencies. Thedevice is for use inpediatric patients up to 12years of age. | The NIO-P for pediatrics isintended to provideintraosseous access in theproximal tibia, as analternative to IV accessduring emergencies. Thedevice is for use in pediatricpatients between 3 and 12years of age. |
| EnvironmentUsed | Hospital, Clinic,Emergency Care | Same | Same |
| Design: | Consists of trocar needle,spring, piston andhousing. | Same | Same |
| Dimensions(packaging) | Length 17.5cmWidth 8.8cmDepth 4.7cm | Length 16.5cmWidth 7.4cmDepth 2.8cm | Length 17.5cmWidth 8.8cmDepth 4.7cm |
| Weight (inpackage) | 113.8gm (0.25lbs) | 80gm (0.18lbs) | 107.6gm (0.24lbf) |
| NIO-AWaismed Ltd.Predicate Device(K142086) | BIG-PWaismed Ltd.Reference Device(K022415) | NIO-PWaismed Ltd.(Modified Device) | |
| Materials | Stainless steel (trocarneedle & cannula)Brass 360 nickel-plated(hub)Makrolon® Rx2530polycarbonate (Plasticparts with direct contact toskin) | Same | Same |
| Hub Interface | The cannula hub is astandard metal hub LuerLock appropriate forconnecting to any standardinfusion system. | Same | Same |
| Needle length | 42.0mm (1.65") | 23.6mm (1.31") | 38.1mm (1.5") |
| Needle gauge | 15G | 18G | 18G |
| Sterilization | Single use, sterile | Same | Same |
| Sterilizationmethod | Gamma sterilization | Same | Same |
{6}------------------------------------------------
Conclusions:
Based on the performance testing and comparison to the predicate and reference devices, the modified NIO-P is substantially equivalent to the NIO-A.
§ 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).