MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

K020985 · Tfx Medical, Inc. · KNT · Jun 25, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020985
• Device Name: MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
• Applicant: Tfx Medical, Inc.
• Product Code: KNT · Gastroenterology, Urology
• Decision Date: Jun 25, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5980
• Device Class: Class 2

Intended Use

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

Device Story

Device consists of safety needle with passive sharps protection and peelable splitable introducer. Used for guidewire introduction during endoscopic gastrointestinal procedures (e.g., PEG, PEJ). Operated by physicians in clinical settings. Needle features blunter technology for sharps injury prevention upon withdrawal from introducer hub. Available in 2F-6F sizes with 2.50"-4.0" lengths to accommodate varying patient body types and procedure requirements. Facilitates placement of 0.015"-0.052" guidewires. Provides clinician protection from needle sticks during procedure.

Clinical Evidence

Bench testing only. Verification of sharps injury protection function performed per FDA guidance document 'Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features'.

Technological Characteristics

Device comprises a safety needle with passive sharps protection and a peelable splitable introducer. Needle sizes 2F-6F; lengths 2.50"-4.0". Accommodates guidewires 0.015"-0.052". Safety mechanism utilizes blunter technology. Manufactured under QSR Design Control requirements.

Indications for Use

Indicated for patients undergoing endoscopic gastrointestinal procedures, including PEG or PEJ, requiring guidewire placement. No specific age or gender restrictions provided.

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.

Predicate Devices

• TFX Medical Introducer Needle (K851140)
• PUNCTUR-GUARD Blood Collection Needle (K895034)
• COOK OB/GYN Russell Gastrostomy Tray (K912047)
• TFX Medical, Inc. Over-the-Needle Splitable Catheter Assembly, Type I (K920908)
• TFX Medical Safety Needle with Introducer (K000665)

Reference Devices

• COOK Gastric Port System
• COOK Edelman Gastrostomy Tray

Submission Summary (Full Text)

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JUN 2 5 2002

all Pines Park affrev. NH 03452 603) 532-7706 AX [phone] or 6108

510 (k) Summary

- Submitter Name, Address, and Date of Submission: 1.
Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park Jaffrey, NH 03452

| Telephone: | [phone] |
|------------|-----------------|
| Fax: | [phone] |
| E-Mail: | [e-mail] |

Same as above Contact:

- 2. Name of the Device, Common, Proprietary (if known), and Classification:

| Classification Name: | Tube, Gastrointestinal and<br>Accessories |
|----------------------|---------------------------------------------------------|
| Common Name: | Guidewire Introduction Safety<br>Needle with Introducer |
| Proprietary Name: | Modified TFX Medical Safety<br>Needle with Introducer |

- 3. 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:

- The TFX Medical Introducer Needle K851140 ●
- The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc, for the activation mechanism - K895034
- The COOK® OB/GYN Russell Gastrostomy Tray K912047 ●
- TFX Medical, Inc. Over-the-Needle Splitable Catheter Assembly, Type I - K920908

10+ 3

1020985

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## Page 2

- The TFX Medical Safety Needle with Introducer K000665 ●
- The COOK® Gastric Port System 510(k) Unknown ●
- The COOK® Edelman Gastrostomy Tray 510(k) Unknown ●

#### Description of the Device: 4 .

This device, with the exception of length, is identical to the TFX Medical Safety Needle with Introducer cleared by the FDA in K000665. The working length of the needle has been increased, due to the intended gastrointestinal use, and will be available in 2F - 6F sizes with lengths ranging between 2.50″ - 4.0″. The Modified TFX Medical Safety Needle with Introducer will allow placement of guidewires ranging from 0.015″ - 0.052″. The variance in sizes and lengths is due to specific procedure, physician preference and patient body type.

This product consists of two components:

- 1. Safety Needle (Needle with Passive Sharps Protection)-The Safety Needle, which has the same blunter technology Bio-Plexus, Punctur-Guard® Blood Collection a s the needle, is manufactured under the QSR Design Control The quidance document, "Supplementarv requirements. Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices with Sharps Injury Protection Features", was used in the design and verification of the function of the Safety Needle.
- 2. Peelable Splitable Introducer- This introducer is identical to the existing introducer sold by TFX Medical, which was cleared under K920908.

#### 5. Intended Use of the Device:

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

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# Page 3

#### Summary of Technological Characteristics: 6.

The Modified TFX Medical Safety Needle with Introducer adds a safety feature to the needle for the prevention of needle sticks, after the needle is withdrawn from the hub of the introducer.

The device is equivalent technologically to the devices mentioned on paqes 1-2. The anti-stick safety feature, which forms an integral part of this device, is the reason for this submission.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2002

Mr. Rick Lykins Group RA Manager - US Rüsch International Tall Pines Park JAFFREY NH 03452

Re: K020985

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: March 26, 2002 Received: March 27, 2002

Dear Mr. Lykins:

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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Page 2

This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] 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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# 510(k) Number (if known):

Modified TFX Medical Safety Needle with Device Name: Introdfucer

## Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)