(52 days)
This winged needle holder is indicated for use in securing and positioning a hypodermic needle during the administration of a peribulbar nerve block.
The winged needle holder is fabricated from polyethylene.
This document describes a 510(k) submission for a "Removable Wings" device, also referred to as a "Winged needle holder." The submission focuses on demonstrating substantial equivalence to a predicate device already on the market. Consequently, the study described does not involve performance criteria and a study to prove they are met in the manner of a typical medical device with measurable outcomes (e.g., accuracy, sensitivity, specificity for a diagnostic device, or efficacy for a therapeutic device).
Instead, the "acceptance criteria" here are based on the comparison of attributes to a legally marketed predicate device. The "study" is a comparison table rather than a clinical trial or performance study.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Attribute for Substantial Equivalence) | Reported Device Performance (Submitted Device) |
|---|---|
| Material of construction | Polyethylene |
| Wing shape | Curved |
| Needle fit | Needle hub through holder |
| Reusability | Disposable |
| Sterility | Sterile |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable in the traditional sense for this type of submission. There is no "test set" of patient data or clinical samples. The "test" is a direct comparison of physical and functional attributes of the submitted device against a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The "ground truth" for this substantial equivalence submission is the attributes of the legally marketed predicate device. No expert consensus on a test set was required.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, nor is it a diagnostic imaging device that would typically undergo an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" used for this submission is the characteristics and functionality of a legally marketed predicate device (Becton Dickinson and Company's removable winged needle holder). This is a regulatory "ground truth" for substantial equivalence rather than a clinical one.
8. The Sample Size for the Training Set
Not applicable. There is no training set as this is not an algorithm or AI-powered device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set. The "ground truth" for the comparison was established by the existence and characteristics of the predicate device, presumably through manufacturer specifications and its established market use.
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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
್ನು
1032 Shady Oaks Drive, Bldg. 100 Denton, Texas 76205 TEL (940)387-5696 FAX (940)382-0577
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 (940) 387-5696 (940) 382-0577 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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) . ..
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
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.