(183 days)
Not Found
No
The description focuses on a mechanical device for securing needles and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is described as a "sharps securing device for contaminated needles" and its purpose is "to make contaminated sharps immediately unavailable." It does not provide any diagnostic, therapeutic, or rehabilitative benefit to a patient, but rather manages medical waste and prevents accidental needlesticks.
No
The device is described as a "sharps securing device for contaminated needles" and its purpose is to "make contaminated sharps immediately unavailable." It focuses on safety and disposal of sharps, not on detecting, monitoring, or diagnosing a medical condition.
No
The device description clearly states it is a "disposable device used for securing needles" and mentions "mechanical property testing," indicating it is a physical hardware device, not software.
Based on the provided information, the NeedleVISE™ Large-Bore Sharps Securing Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure contaminated needles, preventing sharps injuries. This is a physical action performed on a medical device (the needle) and not a test performed on a biological sample to diagnose a condition.
- Device Description: The description focuses on the physical mechanism of securing a needle and making it harmless. It doesn't mention any analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The NeedleVISE™ is a device designed for sharps safety and injury prevention, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Atrion 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.
Product codes (comma separated list FDA assigned to the subject device)
80 FMI
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 of the NeedleVISE™ Large-Bore Sharps Securing Device is to provide a means to make contaminated sharps unavailable for all instances in which introduction of contaminated sharps containers is not acceptable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The NeedleVISE™ Large-Bore Sharps Securing Device tests included mechanical property testing to assess impact, puncture resistance and pull out force. The results showed the NeedleVISE™ Large-Bore Sharps Securing Device to be substantially equivalent to the predicate device. The device was also evaluated in field trials designed to assess ease of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 needle |
| 21 CFR 880.5570, ProCode 80 FMI | |
| Manufacturer: | Atrion Medical Products, Inc. |
| 1426 Curt Francis Road | |
| Arab, AL 35016 | |
| Contact: | Mr. Dan Clark, |
| Atrion Medical Products, Inc. | |
| 1426 Curt Francis Road | |
| Arab, AL 35016 | |
| Telephone: (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.
1
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.
2
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.
3
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
4
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: