(117 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a physical needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to facilitate the infusion of drugs and fluids, but it is not a drug or fluid itself, nor does it directly treat a disease. It is a delivery mechanism.
No
Explanation: The device is used for infusing resuscitative drugs or fluids, not for diagnosing a condition or disease.
No
The device description clearly outlines physical components made of stainless steel, brass, and polycarbonate, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "effective infusion of resuscitative drugs or fluids" directly into the bone (intraosseous access). This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a needle and cannula assembly designed for physical insertion into bone to create a pathway for fluid delivery. This is a medical device for direct patient treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to perform tests in vitro (outside the body) to diagnose, monitor, or screen for diseases or conditions.
This device is a therapeutic medical device used for delivering substances directly into the patient's body.
N/A
Intended Use / Indications for Use
Cook Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Intraosseous Infusion Needles consist of a two-part assembly with a needle and a cannula. The device is pre-assembled with the hub of the cannula attached to the needle by a luer-lock connection. The cannula shaft is made of stainless steel and is available in 14, 16, or 18 Gauge, with shaft lengths of 2.5, 3.0, or 4.0 cm. The hub and base plate of the cannula are constructed of either nickel-plated brass or polycarbonate. The stylet of the needle is constructed of stainless steel. For placement, the needle assembly is inserted into the bone with firm, downward pressure using a clockwise rotation, with the needle tip directed away from the joint space and epiphyseal plate; the needle orientation should always be maintained in line with the long axis of the bone. The stylet of the needle can then be removed by stabilizing the base plate of the cannula and turning the knob of the needle counterclockwise to disengage the needle from the cannula. Once access to the intramedullary space is confirmed, infusion of drugs and fluids can be initiated through the cannula. Five different versions of Cook Intraosseous Infusion Needles, with the same basic design, will be made available:
- Dieckmann Intraosseous Infusion Needle High Density Hub/Brass Design
- Dieckmann Intraosseous Infusion Needle Standard Hub/Polycarbonate Design
- Intraosseous Infusion Needles Standard Tip Design
- Intraosseous Infusion Needle with Adjustable Flange
- Sussmane-Raszynski Intraosseous Infusion Needle
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
pediatric
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)
Modifications to the subject Intraosseous Infusion Needles were evaluated per ISO 14971. The following tests have been conducted to ensure reliable design and performance under the specified design requirements based on these modifications:
- Biocompatibility was evaluated per ISO 10993-1. Testing included cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity (acute), hemolysis, and rabbit pyrogen testing.
- Tensile Strength testing was performed per BS EN ISO 11070. Liquid Leakage testing was performed per BS EN ISO 10555
- Tensile Strength testing was performed per BS EN ISO 11070. Unscrewing Torque testing was performed per ISO 594-2
- Resistance to Overriding testing was performed per ISO 594-2
The results of all tests met their predetermined acceptance criteria.
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 features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of the department's name, which is written in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
Cook Incorporated Ms. Julia Ferguson Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K160887
Trade/Device Name: Cook Intraosseous Infusion Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 27, 2016 Received: June 28, 2016
Dear Ms. Ferguson:
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
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
Indications for Use
510(k) Number (if known) K160887
Device Name
Cook Intraosseous Infusion Needles
Indications for Use (Describe)
Cook Intraosseous Infusion Needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is white text on a red background. The word "COOK" is in large, bold letters at the top. Below that, in smaller letters, is the word "MEDICAL".
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
510(k) SUMMARY
Intraosseous Infusion Needles 21 CFR §880.5570 Date Prepared: 27 June 2016
| Submitted By: | |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Steven Lawrie |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x104518 |
| Contact Fax Number: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Cook Intraosseous Infusion Needles |
| Common Name: | Intraosseous Infusion Needles |
| Classification Name: | Needle, Hypodermic, Single Lumen |
| Regulation: | 21 CFR §880.5570 |
| Product Code | FMI - Needle, Hypodermic, Single Lumen |
Predicate Device:
- o K913258 - Disposable Intraosseous Infusion Needles
Device Description:
The Intraosseous Infusion Needles consist of a two-part assembly with a needle and a cannula. The device is pre-assembled with the hub of the cannula attached to the needle by a luer-lock connection. The cannula shaft is made of stainless steel and is available in 14, 16, or 18 Gauge, with shaft lengths of 2.5, 3.0, or 4.0 cm. The hub and base plate of the cannula are constructed of either nickel-plated brass or polycarbonate. The stylet of the needle is constructed of stainless steel. For placement, the needle assembly is inserted into the bone with firm, downward pressure using a clockwise rotation, with the needle tip directed away from the joint space and epiphyseal plate; the needle orientation should always be maintained in line with the long axis of the bone. The stylet of the needle can then be removed by stabilizing the base plate of the cannula and turning the knob of the needle counterclockwise to disengage the needle from the cannula. Once access to the intramedullary space is confirmed, infusion of drugs and fluids can be initiated through the cannula. Five different versions of Cook Intraosseous Infusion Needles, with the same basic design, will be made available:
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is in white text on a red background. The word "COOK" is in large, bold letters at the top of the logo. Below the word "COOK" is the word "MEDICAL" in smaller letters.
- · Dieckmann Intraosseous Infusion Needle High Density Hub/Brass Design
- · Dieckmann Intraosseous Infusion Needle Standard Hub/Polycarbonate Design
- · Intraosseous Infusion Needles Standard Tip Design
- · Intraosseous Infusion Needle with Adjustable Flange
- · Sussmane-Raszynski Intraosseous Infusion Needle
Intended Use:
Intraosseous infusion needles are sterile, disposable devices used primarily during pediatric emergencies as an alternative to unsuccessful intravenous access to allow for effective infusion of resuscitative drugs or fluids.
Comparison to Predicates:
The Intraosseous Infusion Needles are substantially equivalent to the predicate device, the Disposable Intraosseous Infusion Needles (K913258) in that these devices have similar designs, methods of construction and operation, and indications for use. The differences from the predicate include material changes (i.e., the hub and base plate material have been modified to be either nickel-plated brass or polycarbonate and the stylet luer-lock material has been modified to be either nickel-plated brass or polypropylene) and the addition of a device variant (i.e., the Intraosseous Infusion Needle with Adjustable Flange). A detailed comparison to the predicate is provided in Table 1.
| Table 1. Substantial equivalence comparison | ||||
|---|---|---|---|---|
| Predicate Device | Subject Device | |||
| Disposable Intraosseous Infusion | ||||
| Needles | ||||
| (K913258) | Intraosseous Infusion Needles | |||
| Regulation | 880.5570 | 880.5570 | ||
| Product Code | FMI | FMI | ||
| Classification | II | II | ||
| Intended | ||||
| Use | From Device | |||
| Description in | ||||
| 510(k) | ||||
| (K913258) | Intraosseous infusion needles are | |||
| sterile, disposable devices used | ||||
| primarily during pediatric | ||||
| emergencies as an alternative to | ||||
| unsuccessful intravenous access to | ||||
| allow for effective infusion of | ||||
| resuscitative drugs or fluids. | Intraosseous infusion needles are | |||
| sterile, disposable devices used | ||||
| primarily during pediatric | ||||
| emergencies as an alternative to | ||||
| unsuccessful intravenous access to | ||||
| allow for effective infusion of | ||||
| resuscitative drugs or fluids. | ||||
| Cannula | Hub Material | Brass | Nickel Plated Brass or | |
| Polycarbonate | ||||
| Base Plate | ||||
| Material | Stainless Steel | Nickel Plated Brass or | ||
| Polycarbonate | ||||
| Solder | ||||
| Material | All State 430 | Identical |
| Table 1: Substantial equivalence comparison | |||
|---|---|---|---|
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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The word "COOK" is in large, bold, white letters at the top of the image. Below that, the word "MEDICAL" is in smaller, white letters. The background is a solid red color.
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Disposable Intraosseous Infusion | |||
| Needles | |||
| (K913258) | Intraosseous Infusion Needles | ||
| Cannula | Weld Material | Silweld 1618 | Identical |
| Cannula Shaft | |||
| Material | Stainless Steel | Identical | |
| Cannula Shaft | |||
| Diameter (gauge) | 12, 14, 15.5, 16, 18 | 14, 15.5, 16, 18 | |
| Cannula Shaft Length | |||
| (cm) | 1.8, 2.3, 2.5, 3.0, 4.0 | 2.5, 3.0, 4.0 | |
| Knob Material | Nylon 6 (Black) | Nylon 6 (Grey) | |
| Needle | Stylet Luer-lock Material | Brass | Nickel Plated Brass or |
| Polypropylene | |||
| Adhesive Material | Thermoset DC140 | RenCast 140 | |
| Solder Material | Allstate #430 | Identical | |
| Beveled Stylet | |||
| Material | Stainless Steel | Identical | |
| Stylet Length | |||
| (cm) | 1.8, 2.3, 5.1, 5.5, 5.6, 6.1, 6.6 | 4.2, 4.6, 4.65, 4.7, 5.51, 5.6, 5.65, | |
| 5.7, 6.8, 7.0 | |||
| Packaging | PETG Tray/Tyvek | Identical | |
| Sterilization | EtO | Identical | |
| SAL | 10-6 | Identical |
Table 1: Substantial equivalence comparison (continued)
Technological Characteristics:
Modifications to the subject Intraosseous Infusion Needles were evaluated per ISO 14971. The following tests have been conducted to ensure reliable design and performance under the specified design requirements based on these modifications:
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Image /page/6/Picture/0 description: The image shows a close-up of the Cook Medical logo. The word "COOK" is written in large, white, sans-serif letters against a red background. Below the word "COOK", the words "MEDICAL" are written in smaller, white letters. The logo is simple and clean, with a focus on the company name.
Table 2: Design Control Activities
| Modification | Risk Addressed | Design Control Activity |
|---|---|---|
| Modification to hub and | ||
| base plate material | Modified device is not | |
| biocompatible | Biocompatibility was evaluated per | |
| ISO 10993-1. Testing included | ||
| cytotoxicity, sensitization, | ||
| intracutaneous reactivity, systemic | ||
| toxicity (acute), hemolysis, and | ||
| rabbit pyrogen testing. | ||
| Failure of hub to shaft bond | Tensile Strength testing was | |
| performed per BS EN ISO 11070. | ||
| Liquid Leakage testing was | ||
| performed per BS EN ISO 10555 | ||
| Modification to stylet | ||
| luer-lock material | Failure of knob to stylet bond | Tensile Strength testing was |
| performed per BS EN ISO 11070. | ||
| Unscrewing Torque testing was | ||
| performed per ISO | ||
| 594-2 | ||
| Overriding of luer lock during | ||
| torqueing | Resistance to Overriding testing was | |
| performed per ISO 594-2 |
The results of all tests met their predetermined acceptance criteria.
Conclusion:
The results of performance tests support a conclusion that the proposed Intraosseous Infusion Needles have met the design input requirements based on the intended use and support the conclusion that these devices perform in a substantial equivalent manner as compared to the predicate.