(22 days)
No
The device description focuses on material and dimensional changes to a mechanical needle and introducer system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for guidewire introduction during gastrointestinal procedures, which is a diagnostic or procedural aid, not a device that directly treats a disease or condition.
No
The device is described as a "Modified TFX Medical Safety Needle with Introducer" intended for "guidewire introduction during gastrointestinal procedures." Its function is to facilitate the placement of a guidewire, which is an interventional step, not a diagnostic one. There is no mention of it being used to gather information about a patient's condition.
No
The device description clearly outlines physical components (needle, sheath introducer) made of materials like Polypropylene, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "guidewire introduction during gastrointestinal procedures". This is a procedural device used in vivo (within the body) to facilitate another medical procedure.
- Device Description: The description details a needle and introducer sheath, components used for accessing a body cavity or vessel to insert a guidewire. This aligns with an in vivo procedural device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing blood, urine, tissue, or other bodily fluids.
Therefore, the Modified TFX Medical Safety Needle with Introducer is a medical device used for a surgical/procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
78 KNT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K021034, K851140, K895024, K000665
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 with
Introducer |
|----------------------|---------------------------------------------------------|
| Proprietary Name: | Modified TFX Medical Safety Needle with
Introducer |
| Classification Name: | Tube, Gastrointestinal and Accessories |
Indications for Use
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.
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1
November 16, 2004
K043258
Page 2 of 3
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.
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
2
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.
3
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.
4
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
5
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:
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.
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)
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