WINGED NEEDLE HOLDER

K974327 · Phx Technologies Corp. · FHQ · Jan 9, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974327
• Device Name: WINGED NEEDLE HOLDER
• Applicant: Phx Technologies Corp.
• Product Code: FHQ · Gastroenterology, Urology
• Decision Date: Jan 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4730
• Device Class: Class 1

Intended Use

This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.

Device Story

Winged needle holder fabricated from polyethylene; designed to secure and position hypodermic needles during peribulbar nerve block procedures. Device features curved wing shape to facilitate handling. Intended for single-use (disposable) and provided sterile. Operated by clinicians during ophthalmic anesthesia procedures to stabilize needle placement.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Material: Polyethylene. Form factor: Curved wing design. Function: Needle hub holder. Sterility: Sterile. Reuse: Disposable.

Indications for Use

Indicated for securing and positioning hypodermic needles during peribulbar nerve block administration.

Regulatory Classification

Identification

A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.

Predicate Devices

• Removable winged needle holder (Becton Dickinson and Company)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the letters PHX in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black and the background is white.

**Technologies**
Corporation

JAN - 9 1998

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1032 Shady Oaks Drive, Bldg. 100 Denton, Texas 76205 TEL [phone] FAX [phone]

K974327

# 510(K) Summary

Date: 12 November 1997

Trade Name: Removable wings

Common Name: Winged needle holder

Classification Name: Unknown

Device Description: The winged needle holder is fabricated from polyethylene.

Intended Use: This winged needle holder indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.

Substantial Equivalence: This winged needle holder submitted device is substantially equivalent to the removable winged needle holder predicate device currently being sold in the United States by Becton Dickinson and Company, Franklin Lakes, New Jersey 07417. To the best of my knowledge, this predicate devices is being "legally" marketed.

## Comparison to Predicate Device:

## Attribute

### Predicate Device

Material of construction Wing shape Needle fit Reuseability Sterility

Submitter's Name Submitter's Address: Submitter's Phone #: Submitter's FAX: Submitter's Contact Person:

Polyethylene Butterfly Needle hub through holder Disposable Sterile

## Submitted Device

Polyethylene Curved Needle hub through holder Disposable Sterile

PHX Technologies Corporation 1032 Shady Oaks Drive, No. 100, Denton, TX 76205 [phone] [phone] James F. Chapel

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

James F. Chapel, Ph.D. President PHX Technologies Corporation 1032 Shady Oaks Drive, No.100 Denton, Texas 76205

JAN - 9 1998

K974327 Re: Trade Name: Winged Needle Holder Regulatory Class: I Product Code: FHQ Dated: November 12, 1997 Received: November 18, 1997

Dear Dr. Chapel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Dr. Chapel

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K974327

Device Name: WINGED NEEDLE HOLDER

Indications For Use:

Indications For Use: This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

OR