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

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.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the Tidal High-Flow Non-coring Needle. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria in the manner that an AI/ML device would be evaluated.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of regulatory submission and device.

However, I can extract information related to the closest equivalents to "acceptance criteria" and "performance data" as presented in this document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically seen for AI/ML device evaluations. Instead, it states that "The Tidal High-Flow Non-coring Needles have met all predetermined acceptance criteria of design verification evaluations through testing examination." The tests performed are listed as:

Acceptance Criteria (Implied)	Reported Device Performance
Performance with 16Ga high-flow, noncoring needles for septum puncture / port leak to failure (worst case scenario) 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.
Performance following 25 punctures with the 16Ga high-flow needle for septum puncture / port leak to failure with a 19Ga Huber point 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. (This is a general statement. Specific numerical results are not provided in this summary.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: The document mentions "a representative sample of ports found in the marketplace" was used for the septum puncture/port leak tests. No specific number is provided.
Data provenance: Not explicitly stated, however, the testing was conducted by Norfolk Medical, a US-based company, and the FDA guidance referenced is US-based. It is implied to be prospective bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical device being evaluated via bench testing for mechanical properties and biocompatibility, not an AI/ML device requiring expert consensus for ground truth. The "ground truth" here is the physical performance as observed in the tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an image review or interpretative task requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (needle), not an AI/ML diagnostic or assistive device for human readers.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is a physical medical device. The "standalone" performance refers to the device's inherent mechanical and material properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluation in this context is based on bench testing results (septum puncture/port leak to failure) and material characterization against established standards (e.g., ISO, USP Class VI for biocompatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. There is no training set for this type of device.

Summary

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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

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Indications for Use

510(k) Number (if known) K151341

Device Name

Tidal High-Flow Non-coring Needle

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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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. RidgewaySkokie, 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

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:

1. 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.

Regulation Number and Section

§ 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).