MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
K043258 · Teleflex Medical · KNT · Dec 16, 2004 · Gastroenterology, Urology
Device Facts
Record ID
K043258
Device Name
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
Applicant
Teleflex Medical
Product Code
KNT · Gastroenterology, Urology
Decision Date
Dec 16, 2004
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.5980
Device Class
Class 2
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.
Device Story
Device consists of safety needle with passive sharps protection and sheath introducer; used for guidewire introduction during gastrointestinal procedures (e.g., PEG, PEJ). Needle incorporates blunter technology for sharps protection; sheath facilitates guidewire placement (0.015"-0.052"). Available in peelable and non-peelable configurations. Operated by clinicians in clinical settings. Material change from high-density polyethylene to polypropylene for cannula sheath; increased outer diameter for rigidity. Device provides mechanical access for guidewire placement; sharps protection mechanism reduces risk of needle-stick injuries to healthcare providers.
Clinical Evidence
Bench testing only. No clinical data presented.
Technological Characteristics
Cannula sheath material: Polypropylene (formerly high-density polyethylene). Passive sharps protection mechanism. Accommodates guidewires 0.015"-0.052". Configurations: peelable and non-peelable. Conformance to ANSI/AAMI/ISO 10993-1 for biological evaluation.
Indications for Use
Indicated for patients undergoing gastrointestinal procedures requiring guidewire placement, including PEG and PEJ procedures.
Regulatory Classification
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).
Special Controls
*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.
TFX Medical Safety Needle with Introducer (K000665)
Modified TFX Medical Safety Needle with Introducer (K021034)
Submission Summary (Full Text)
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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 with<br>Introducer |
|----------------------|---------------------------------------------------------|
| Proprietary Name: | Modified TFX Medical Safety Needle with<br>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.
Confidential
Page 26
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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
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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:
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)
Confidential
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
