The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

Device Description

This Intended Use of the Modified Safety Needle with Introducer device is identical to the Modified TFX Medical Safety Needle with Introducer cleared by the FDA in K021034. In order to provide a more robust design, the material of construction has been changed from High Density Polyethylene to Polypropylene. An increase in the outer diameter has also been implemented to add additional rigidity to the cannula sheath.

The Modified TFX Medical Safety Needle with Introducer will continue to allow placement of guidewires ranging from 0.015" - 0.052". The variance in sizes and lengths is due to the specific procedure, physician preference and patient body type.

This product consists of the following two components:

Safety Needle (Needle with Passive Sharps Protection)- The Safety Needle, has the 1. same blunter technology as the Bio-Plexus, Punctur-Guard Blood Collection needle (K895024).
Sheath Introducer- The functionality of the peelable, splitable introducer is identical 2. to the existing introducer sold by TFX Medical, which was initially cleared under K920908 and subsequently cleared under K021034 to be used for guidewire introduction during gastrointestinal procedures.

The sheath will also be made available in a non-peelable configuration.

AI/ML Overview

The provided text describes a 510(k) submission for a Modified TFX Medical Safety Needle with Introducer. This submission is for a medical device and not an AI/ML algorithm, therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

The submission relies on substantial equivalence to predicate devices, rather than establishing new performance criteria through clinical studies with acceptance criteria. The acceptance criteria for the material and design changes are inferred to be successful performance in the identified performance testing and conformance with voluntary performance standards.

Acceptance Criteria Category	Reported Device Performance
Material Equivalence	The new material, Polypropylene, is in the same family (Olefins) as the previous High Density Polyethylene, indicating similar behavior under processing conditions (molding, sterilization, aging).
Design Equivalence (Sheath)	The non-peelable sheath configuration is identical to the peelable version, except for the lack of a skiving operation.
Performance Testing	Performance testing was conducted to support substantial equivalence. (Specific results are not detailed in this summary).
Conformance with Voluntary Standards	Conformance with ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices.
Intended Use	Identical to the Modified TFX Medical Safety Needle with Introducer cleared under K021034.
Guidewire Compatibility	Continues to allow placement of guidewires ranging from 0.015" - 0.052".

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

The document does not mention the specific sample size used for performance testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective).

2. 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)

This is not applicable as the submission is for a physical medical device, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from a test set. Substantial equivalence is based on engineering and material characteristics, and conformance to standards.

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

This is not applicable for a physical medical device submission of this nature.

4. 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

This is not applicable. The device is a safety needle and introducer, not an imaging analysis or diagnostic AI tool.

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

This is not applicable. The submission is for a physical medical device.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the material and design changes, the "ground truth" is based on established engineering principles, material science properties, and adherence to recognized performance standards (e.g., ISO 10993-1 for biocompatibility). The performance testing would have compared the device's characteristics against these established benchmarks or against the predicate device's measured performance. No clinical "outcomes data" or "expert consensus" for diagnostic accuracy are mentioned beyond the device's intended function.

7. The sample size for the training set

This is not applicable. The submission does not involve an AI/ML algorithm or a "training set" in that context.

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

This is not applicable.

Summary

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TFX Medical Special 510(k) Submission: Modified TFX Medical Safety Needle with Introducer

DEC 1 6 2004

November 16, 2004

K043258
Page 1 of 3

Attachment 4 510(k) Summary

Substantial Equivalence

In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule "... 510(k) Summaries and 510(k) Statements ..." and can be used to provide equivalence summary to anyone requesting it from the Agency.

Teleflex Medical Inc. Manufacturer 50 Plantation Drive Tall Pines Park Jaffrey, NH 03452

Contact Person Susan Kagan Regulatory Affairs Specialist Phone: (508) 677-6675 (888) 273-6897 Fax: e-mail: skagan@teleflexmedical.com
November 16, 2004 Date Prepared

Device Information

Common Name:	Guidewire Introduction Safety Needle withIntroducer
Proprietary Name:	Modified TFX Medical Safety Needle withIntroducer
Classification Name:	Tube, Gastrointestinal and Accessories

Indications for Use

Confidential

Page 26

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November 16, 2004

K043258
Page 2 of 3

Device Description

This product consists of the following two components:

Safety Needle (Needle with Passive Sharps Protection)- The Safety Needle, has the 1. same blunter technology as the Bio-Plexus, Punctur-Guard Blood Collection needle (K895024).
Sheath Introducer- The functionality of the peelable, splitable introducer is identical 2. to the existing introducer sold by TFX Medical, which was initially cleared under K920908 and subsequently cleared under K021034 to be used for guidewire introduction during gastrointestinal procedures.

The sheath will also be made available in a non-peelable configuration.

Substantial Equivalence

The device is similar in intended use, design, and performance characteristics to the currently cleared Modified TFX Medical Safety Needle with Introducer cleared under K021034.

The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with voluntary performance standards, e.g. ANSI/AAMI/ISO 10993-1 Biological Evaluation of Medical Devices.

1. Identification of the legally marketed device to which the submitter claims equivalence:

The Modified TFX Medical Safety Needle with Introducer is substantially equivalent in design and materials to:

Confidential

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K643258
Page 3 of 3

The TFX Medical Introducer Needle -- K851140 .
The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc, for the . activation mechanism - K895024
The TFX Medical Safety Needle with Introducer K000665 .
The Modified TFX Medical Safety Needle with Introducer-K021034 .

Summary of Technological Characteristics: 2.

The device is equivalent technologically to the devices mentioned on pages 2. The change in sheath material from High Density Polyethylene to Polypropylene, plus the inclusion of a non-peelable sheath configuration is the reason for this submission.

The new material for the cannula, Polypropylene, is in the same family, Olefins, as the current material of the cannula, High Density Polyethylene. Therefore they behave very similarly under processing conditions such as molding, sterilization and aging.

The only difference between the peelable and non-peelabe introducers is that the skiving operation, which allows for the splitting of the sheath, is not performed during manufacturing. Otherwise all characteristics are identical.

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2004

Ms. Susan Kagan Regulatory Affairs Specialist Teleflex Medical 50 Plantation Drive Tall Pines Park JAFFREY NH 03452

Re: K043258

Trade/Device Name: Modified TFX Medical Safety Needle with Introducer Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: November 16, 2004 Received: November 24, 2004

Dear Ms. Kagan:

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.

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.

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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation . Center for Devices and Radiological Health

Enclosure

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November 16, 2004

TFX Medical Special 510(k) Submission: Modified TFX Medical Safety Needle with Introducer

Indications for Use

510(k) Number (if known): K_043258 Device Name: Modified TFX Medical Safety Needle with Introducer

Indications for Use :

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

. AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

In Magazz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Page 1 of 1 (Posted November 13, 2003)

Confidential

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.