SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S

K022099 · Hdc Corp. · FOZ · Sep 20, 2002 · General Hospital

Device Facts

• Record ID: K022099
• Device Name: SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'S
• Applicant: Hdc Corp.
• Product Code: FOZ · General Hospital
• Decision Date: Sep 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2

Intended Use

The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

Device Story

Safe-T-Peel® Safety Needle/Introducer is a single-patient, single-use device designed to facilitate the placement of peripherally inserted intravenous catheters. The device consists of a stainless steel needle and a splittable plastic sheath. It functions as an introducer to gain venous access; the sheath is designed to be split for removal after catheter placement. The device incorporates a sharps injury prevention mechanism to reduce the risk of accidental needle sticks during or after use. It is intended for use by healthcare professionals in clinical settings. The device is substantially equivalent to existing introducers with integrated safety features.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stainless steel needle; splittable plastic sheath. Single-use, sterile. Sharps injury prevention mechanism integrated into the needle/introducer assembly.

Indications for Use

Indicated for patients requiring placement of a peripherally inserted intravenous catheter. Used to facilitate catheter insertion and reduce risk of accidental needle stick.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• INTROSYTE Autoguard Shielded Introducer (K013304)
• TFX Medical Introducer Assembly (K993191)
• TFX Medical Safety Needle with Introducer (K000665)

Submission Summary (Full Text)

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SEP 2 0 2002

Ko 22099

# HDC Corporation's Safe-T-Peel® Safety Needle/Introducer 510(k) Summary

| Name of Device | Safe-T-Peel® Safety Needle/Introducer |
|----------------------|----------------------------------------------------------------------------------------------|
| Common or Usual Name | Safety Needle/Introducer |
| Classification Names | Catheter, Intravascular (Therapeutic,<br>Short-term less than 30 days) - 21 C.F.R. §880.5200 |
| Product Codes | FOZ |

## Submitter

HDC Corporation 628 Gibraltar Court Milpitas, CA 95035

Phone: [phone] Facsimile: [phone] Contact Person: Earl Smart Date Prepared: June 27, 2002June 26, 2002

## Predicate Devices

| Becton Dickinson<br>Infusion Therapy<br>Systems, Inc. | TFX Corporation | TFX Corporation |
|-------------------------------------------------------|---------------------------------------|-------------------------------------------------|
| INTROSYTE<br>Autoguard<br>Shielded<br>Introducer | TFX Medical<br>Introducer<br>Assembly | TFX Medical<br>Safety Needle with<br>Introducer |
| (K013304) | (K993191) | (K000665) |

# Intended Use

The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

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# Substantial Equivalence

All predicate devices presented for comparison with the Safe-T-Peel® Safety Needle/Introducer are single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).

The Safe-T-Peel® Safety Needle/Introducer is substantially equivalent to the previously cleared predicate device (K013304) with sharps injury prevention features because it has the same intended uses, similar principles of operation, similar technological characteristics and similar performance test results. The primary intended use is nearly identical to the primary intended use of Becton Dickinson's INTROSYTE Autoguard Shiclded Introducer (K013304), TFX Corporation's TFX Medical Introducer Assembly (K993191), and TFX Corporation's TFX Modical Safety Needle with Introducer (K000665). The secondary intended use (protection against needle stick injury) is nearly identical to that of both theK013304 and K000665 predicate devices. The sharps injury prevention mechanism is essentially identical to the mechanism used in Becton Dickinson's INTROSYTE Autoguard Shielded Introducer (K013304).

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2002

HDC Corporation C/O Mr. Jonathan S. Kahan Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington. D.C. 20004-1109

Re: K022099

Trade/Device Name: Safe-T-Peel® Safety Needle Introducer Regulation Number: 880.5200 and 870.1340 Regulation Name: Intravascular Catheter and Catheter Introducer Regulatory Class: II Product Code: FOZ and DYB Dated: June 27, 2002 Received: June 27, 2002

Dear Mr. Kahan:

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 cither class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 – Mr. Kahan

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618 . 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" (21CFR Part 807.97). Other general information on your 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 vours,

Suren Ramo

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

| 510(k) Number | K |
|---------------|--------------------------------------|
| Device Name | Safe-T-Peel Safety Needle Introducer |

Indications for Use The Safety T Reel Safety Needle Introducer is used to facilitateThe Safety-T-Peel Safety Needle Introducer is used to facilitate Indications for Use placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

Tallessa Vincenti

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022677