(93 days)
K11101
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a non-coring needle, with no mention of AI or ML technology.
No.
The device is a non-coring needle intended for accessing vascular access ports to administer fluids and blood products, which are part of a therapy regimen, but the needle itself does not provide therapy.
No
The device is described as a needle intended for accessing vascular access ports to administer or withdraw fluids, blood products, and drugs as part of a therapy regimen. Its purpose is for therapeutic intervention, not for diagnosis.
No
The device description clearly details physical components made of stainless steel, K-Resin, and LDPE, and describes manufacturing processes like molding and sterilization, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for accessing vascular access ports to administer or withdraw fluids and blood as part of a therapy regimen. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a needle used for physical access to a port. It doesn't mention any components or functions related to analyzing samples in vitro (outside the body).
- Lack of Diagnostic Elements: There is no mention of analyzing blood, fluids, or any other biological samples for diagnostic purposes. The device's function is purely for access and delivery/withdrawal.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Tidal High-Flow Non-coring Needle is intended for the access of totally implantable vascular access ports (VAPs) to administer I.V. fluids, infusions drugs, and other fluids, and for the administration of blood products, and/or withdrawal of blood as part of the therapy regimen.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The 16Ga and 18Ga Tidal High-Flow Non-coring Needles are an extension of our 19, 20, and 22 gauge non-coring (Huber) Needle line used to access our line of totally implantable access devices. These large gauge non-coring needles incorporate a stylet to render them non-coring. The needle is made from 304 series stainless steel and the hubs are molded from K-Resin and LDPE. All materials are certified USP Class VI and are the exact same materials used to manufacture the products approved under K863721 and K111101. The needles are a disposable product that will be packaged sterile and non-pyrogenic in a single use peel pouch. ETO sterilization will be used. The sterilization will be done in-house using a validated sterilization procedure that is identical to the sterilization method used in previous 510(k) clearances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
The following bench tests were performed to evaluate the performance of the Tidal High-Flow Non-coring Needles:
- Septum puncture / Port Leak to failure with the 16Ga high-flow, noncoring needles needles (worst case scenario) using a representative sample of ports found in the marketplace
2 Septum Puncture / Port Leak to failure with a 19Ga Huber point needle following 25 punctures with the 16Ga high-flow needle using a representative sample of ports found in the marketplace
The data collected from the non-clinical tests demonstrated that the functionality and performance characteristics of the Tidal High-Flow Non-coring Needles are comparable to the currently marketed needles based on available literature.
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.
K11101
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).
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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2015
Norfolk Medical Mr. Natan Pheil Product Development Manager 7350 N. Ridgeway Avenue Skokie, Illinois 60076
Re: K151341
Trade/Device Name: Tidal High-Flow Non-coring Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 13, 2015 Received: May 19, 2015
Dear Mr. Pheil:
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. Natan Pheil
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 (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 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
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) K151341
Device Name
Tidal High-Flow Non-coring Needle
Indications for Use (Describe)
The Tidal High-Flow Non-coring Needle is intended for the access of totally implantable vascular access ports (VAPs) to administer I.V. fluids, infusions drugs, and other fluids, and for the administration of blood products, and/or withdrawal of blood as part of the therapy regimen
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the words "Norfolk" and "Medical" in a serif font, with a red heart-shaped graphic in between. Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA •" followed by the phone number "847-674-7075".
Section 5
510(k) Summary
Tidal High-Flow Non-Coring Needle
510(k) Summary 21 CFR 807.92
Part I General Information
5.1 Submitter/Sponsor Information
5.2
5.3
| Submitter Name:
| FDA Establishment | Norfolk Medical Products, Inc. |
|---|---|
| Registration Number: | 1450392 |
| Address: | 7350 N. Ridgeway |
| Skokie, IL 60076 | |
| Telephone Number: | (847) 674-7075 |
| Fax Number: | (847) 674-7066 |
| Contact Person: | Natan Pheil, Product Development Manager |
| Device Name | |
| Trade Name: | Tidal High-Flow Non-coring Needle |
| Common Name: | Straight Non-coring Needle |
| Classification Panel: | 80 General Hospital |
| Classification: | 21 CFR 880.5570 |
| Class: | Class II |
| Product Code: | FMI - Needle, Hypodermic Single Lumen, |
| Predicate Device Name | |
| Device Name: | Arrow Non-coring Needle |
| Premarket Notification: | K961088 |
| Device Name: | Norfolk Medical Posi-Grip Needle |
| Premarket Notification: | K863721 |
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Image /page/4/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the word "Norfolk" in a serif font, followed by a red heart-shaped symbol, and then the word "Medical" in a serif font. Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075".
5.4 Reference Device Name
Device Name:
Premarket Notification:
Lucent Non-coring Needle Infusion Set (reference device) K11101
ર્સ્ટ Device Description
The 16Ga and 18Ga Tidal High-Flow Non-coring Needles are an extension of our 19, 20, and 22 gauge non-coring (Huber) Needle line used to access our line of totally implantable access devices. These large gauge non-coring needles incorporate a stylet to render them non-coring. The needle is made from 304 series stainless steel and the hubs are molded from K-Resin and LDPE. All materials are certified USP Class VI and are the exact same materials used to manufacture the products approved under K863721 and K111101. The needles are a disposable product that will be packaged sterile and non-pyrogenic in a single use peel pouch. ETO sterilization will be used. The sterilization will be done in-house using a validated sterilization procedure that is identical to the sterilization method used in previous 510(k) clearances.
ર્સ્વ Indications for Use Statement
The Tidal High-Flow Non-coring Needles are intended for the access of totally implantable vascular access ports (VAPs) to administer I.V. fluids, infusions drugs, and other fluids, and for the administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
5.7 Technological Characteristics and Substantial Equivalence
The proposed devices are equivalent to Arrow International's current legally marketed device cleared under 510(k) premarket notification K961088 (cleared on July 2nd, 1996). The difference consists of a different needle size. Whereas K961088 sought clearance for 14G and 16G needles, this application seeks clearance for 16G and 18G needles. The intended use, the basic design, and the function for the proposed devices are equivalent to the predicate device. They differ from the other predicate device, K863721 and the reference device, K111101, in that these large gauge non-coring needles incorporate a stylet rather than a deflected tip to render them non-coring. These non-coring devices (K863621 and K111101) are included, as we believe this application is an extension of K863721. The materials used are identical, and the tests performed on these devices can readily be referenced.
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Image /page/5/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the word "Norfolk" in a serif font, followed by a red heart-shaped graphic, and then the word "Medical" in a serif font. Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075".
ని.8 Discussion of Non-clinical Tests
Norfolk Medical develops product specifications based on design input and risk analysis activities related to the intended use of the product. These product specifications are used to create appropriate design verification tests with reference/guidance to established standards (listed below). For this application, the tests conducted were based on the following standards, specifically in reference to septum puncture / port leak information:
- FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990
- ISO 10555-6:2015 - Intravascular catheters -- Sterile and single-use catheters -- Part 6: Subcutaneous implanted ports
Performance Data:
The following bench tests were performed to evaluate the performance of the Tidal High-Flow Non-coring Needles:
-
- Septum puncture / Port Leak to failure with the 16Ga high-flow, noncoring needles needles (worst case scenario) using a representative sample of ports found in the marketplace
- 2 Septum Puncture / Port Leak to failure with a 19Ga Huber point needle following 25 punctures with the 16Ga high-flow needle using a representative sample of ports found in the marketplace
The data collected from the non-clinical tests demonstrated that the functionality and performance characteristics of the Tidal High-Flow Non-coring Needles are comparable to the currently marketed needles based on available literature.
Biocompatibility:
The materials used in the Tidal High-Flow Non-coring Needles are regularly used in the medical device industry. These materials have been well characterized chemically and physically in the published literature and have a long history of safe use.
The raw materials that make up device are as follows: 304 Stainless Steel, K-Resin and Low-density Polyethylene (LDPE). These materials comply with biocompatible requirements ISO 10993 and Pharmacopeia E.P/F.U.I/USP.
Referencing the FDA General Program Memorandum-#G95-1, "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," we have been able to assess the biocompatibility
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Image /page/6/Picture/0 description: The image shows the logo for Norfolk Medical. The logo consists of the word "Norfolk" in large, bold, black font, followed by a red heart-shaped symbol, and then the word "Medical" in the same font as "Norfolk". Below the logo is the address "7350 N. Ridgeway • Skokie, IL, USA • 847-674-7075".
requirements of the Tidal High-Flow Non-coring Needle.
According to the Blue Book Memorandum-#G95-1, attachment C, "Biocompatibility Flow Chart for the Selection of Toxicity Tests for 510(k)'s", the Tidal High-Flow Needle has met the biocompatibility requirements.
5.9 Conclusion
The Tidal High-Flow Non-coring Needles have met all predetermined acceptance criteria of design verification evaluations through testing examination. Based on the FDA's decision tree, it is logically concluded through evidence that the Tidal High-Flow Non-coring Needles are substantially equivalent to the predicate devices listed above in Section 5.3.