(183 days)
The NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various clinical procedures as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.
The NeedleVISE™ Large-Bore Sharps Securing Device is a single patient procedure use, disposable device used for securing needles. The healthcare professional using only one hand can render the sharps harmless. The purpose of the NeedleVISE™ Large-Bore Sharps Securing Device is to provide a means to make contaminated sharps immediately unavailable for all instances in which introduction of contaminated sharps containers is not acceptable.
The provided text describes a 510(k) submission for the Atrion NeedleVISE™ Large-Bore Sharps Securing Device, focusing on establishing substantial equivalence to a predicate device. The information primarily concerns mechanical testing and an ease-of-use field trial rather than a complex AI-driven diagnostic or analytical device. As such, many of the requested criteria related to AI performance, expert review, and ground truth establishment for AI models are not directly applicable or explicitly stated in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device comparison) | Reported Device Performance (Atrion NeedleVISE™) |
|---|---|
| Mechanical Properties: | Showed "substantially equivalent" results to the predicate device. |
| - Impact resistance | Tested and found substantially equivalent. |
| - Puncture resistance | Tested and found substantially equivalent. |
| - Pull-out force | Tested and found substantially equivalent. |
| Ease of Use: | "Evaluated in field trials designed to assess ease of use." The results showed the device was "substantially equivalent" to the predicate device. |
| Material Composition: Similar to predicate device. | "Similar materials as the predicate device." |
| Sharps-locking Mechanism: Locks used sharps into a metal retaining clip within a plastic housing. | "Locks the used sharps into a metal retaining clip contained within a plastic housing" (same as predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "field trials designed to assess ease of use" and "Summary of Testing" for mechanical properties. However, it does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. The "field trials" would likely have involved healthcare professionals, but their number, specific qualifications, or their role in establishing "ground truth" (beyond assessing ease of use) are not detailed. For mechanical tests, the ground truth would be objectively measured physical properties, not expert opinion.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. Given the nature of the device (a mechanical sharps securing device), adjudication methods commonly used for subjective diagnostic images are not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
An MRMC study was not done as this is a mechanical medical device, not an AI-assisted diagnostic tool. Therefore, there is no information about the effect size of human readers improving with AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance Study was Done
A standalone algorithm performance study was not done as this device is a mechanical product and does not involve any AI algorithms.
7. The Type of Ground Truth Used
For the mechanical tests (impact, puncture resistance, pull-out force), the ground truth would be objective physical measurements obtained through standardized testing procedures.
For the ease-of-use evaluation, the ground truth would be based on observational data and feedback from healthcare professionals during the field trials, likely assessing factors like intuitive design, efficient operation, and secure needle retention.
This is not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.
8. The Sample Size for the Training Set
This question is not applicable as there is no mention of a training set for an AI model.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there is no mention of a training set for an AI model.
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MAY 2 5 2005
Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel 256 586 1580 Fax 256 586 8529
Image /page/0/Picture/3 description: The image shows the logo for Atrion Medical. The logo is black and white and features the word "Atrion" in a bold, sans-serif font. A stylized graphic element, resembling a swoosh or a stylized "A", is placed to the left of the word "Atrion". Below the word "Atrion" is the word "Medical" in a smaller, less bold font.
11. 510(k) SUMMARY
| Date of Preparation: | April 30, 2005 |
|---|---|
| Device Names: | Atrion NeedleVISE™ Large-Bore Sharps Securing Device |
| Common Name: | Accessory to a Needle, Hypodermic, Single Lumen |
| Classification Name: | Accessory to single lumen hypodermic needle21 CFR 880.5570, ProCode 80 FMI |
| Manufacturer: | Atrion Medical Products, Inc.1426 Curt Francis RoadArab, AL 35016 |
| Contact: | Mr. Dan Clark,Atrion Medical Products, Inc.1426 Curt Francis RoadArab, AL 35016Telephone: (256) 586-1580, Fax: (256) 586-8529 |
| Predicates: | Devon Industries, Inc. Point-Lok® Needle Protection Device(K946289) |
Device Description:
The NeedleVISE™ Large-Bore Sharps Securing Device is a single patient procedure use, disposable device used for securing needles.
The healthcare professional using only one hand can render the sharps harmless. The purpose The neathedie profoseional asing Securing Device is to provide a means to make of the Needle TOL - Eargo Boro ion available for all instances in which introduction of contaminated sharps containers is not acceptable.
Intended Use:
The Atrion NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various The Attrion Necule Froz - as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.
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KC.43249
Atrion Medical Products, Inc. 1426 Curt Francis Road Post Office Box 564 Arab, AL 35016 Tel 256 586 1580 Fax 256 586 8529
Image /page/1/Picture/2 description: The image shows the logo for Atrion Medical. The word "Atrion" is in a bold, sans-serif font, with a stylized swoosh extending from the left side of the "A". Below "Atrion" and slightly to the right, the word "Medical" is written in a smaller, sans-serif font.
Technological Characteristics:
The NeedleVISE™ Large-Bore Sharps Securing Device has similar materials as the predicate The NeculeVTOL - Earge Berb States tics are unchanged from the predicate device, as they both lock the used sharps into a metal retaining clip contained within a plastic housing.
Summary of Testing:
The NeedleVISE™ Large-Bore Sharps Securing Device tests included mechanical property The Nedalovice - Earge puncture resistance and pull out force. The results showed the testing to assoco impact, panears Securing Device to be substantially equivalent to the Needicate device. Earge Belleted in field trials designed to assess ease of use.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular pattern around the symbol. The caduceus symbol is composed of three curved lines that resemble the wings of a bird or the leaves of a plant. The text is in a simple, sans-serif font.
Public Health Service
MAY 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan Clark Vice President Atrion Medical Products, Incorporated 1426 Curt Francis Road P.O. Box 564 Arab, Alabama 35016
Re: K043249
18045247
Trade/Device Name: Atrion NeedleVISE™ Large-Bore Sharps Securing Device Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: April 30, 2005 Received: May 2, 2005
.
Dear Mr. Clark:
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 approvisions 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 such additional controls. Existing major regulations affecting (1 wr 1) is a 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.
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Page 2 - Mr. Clark
Please be advised that FDA's issuance of a substantial equivalence determination does not r lease be act for a made a determination that your device complies with other requirements mount that I DIT has made statutes and regulations administered by other Federal agencies. or the Fet of any 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 and ibsing (= = = set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as as electronic product radiation control provisions 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) rins reter 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), 11 you debite bythe of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inter 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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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12. INDICATIONS FOR USE STATEMENTS
b. NeedleVISE Large-Bore Sharps Securing Device
Indications for Use
510(k) Number (if known): KONGORAS
Device Names: Atrion NeedleVISE™ Large-Bore Sharps Securing Device
Indications For Use:
The NeedleVISE™ Large-Bore Sharps Securing Device is intended for use in various clinical The NeedleVISE™ Large-Bore Shaps Gecuring Device is increase to:
procedures as a sharps securing device for contaminated needles that do not have integral engineered sharps safety systems.
Prescription Use × (Per 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 PAGEIFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
Susan Evans
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices
510(k) Number:
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).