(90 days)
Not Found
Not Found
No
The device description and intended use clearly describe a simple mechanical device made of paper board for holding needle caps. There is no mention of any computational or data-driven components.
No
The device is described as facilitating safe uncapping and recapping of needles, reducing accidental needle sticks, and promoting compliance with OSHA requirements. It does not directly treat or diagnose a disease or condition.
No
The device is described as a "Needle Sheath Prop" used for safely uncapping and recapping needles to prevent accidental needle sticks. It does not perform any diagnosis or analysis of physiological parameters or medical conditions.
No
The device description clearly indicates it is a physical, disposable device made of paper board, designed to hold a needle cap. There is no mention of software components.
Based on the provided information, the ProTector™ Needle Sheath Prop is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- ProTector™ Function: The ProTector™ Needle Sheath Prop is a physical device designed to facilitate the safe handling of needles by holding the needle cap. Its purpose is to prevent accidental needle sticks, which is a safety measure related to the use of needles, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any interaction with biological specimens, chemical reactions, or diagnostic analysis. Its function is purely mechanical and related to the physical manipulation of a medical device (the needle).
Therefore, the ProTector™ Needle Sheath Prop falls under the category of a general medical device used for safety and handling, not an IVD.
N/A
Intended Use / Indications for Use
ProTector™ Needle Sheath Prop is a disposable, non-sterile device that can be used to safely uncap and recap needles using a one-handed technique. ProTector™ Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray. The Prop is autoclavable for one-time sterile tray set-up. It holds the cap securely in the ready position.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The ProTector™ Needle Sheath Prop is a disposable, non-sterile, one-time use device that can be used to safely uncap and recap needles using a one-handed technique. The ProTector™ facilitates and meets OSHA's Bloodborne Pathogens requirement to promote reduction in accidental needle sticks. Use of the ProTector™ discourages leaving the needle unsheathed on an instrument trav. The device is specifically designed to capture the needle cover/cap and hold it in the ready position.
The ProTector™ is manufactured using a premium grade rectangular paper board card. The sheathed needle cap is inserted into the targeted hole up to the cover hub, securing the needle cover firmly in the ProTector™. The targeted hole is designed as a flexible press-fit to accommodate all sizes of needle protector cover up to 3/8" OD which accommodates most needle covers on the market.
After the needle and cover is inserted into the ProTector™, it is now in the ready position to be able to safely withdraw the needle. The rectangular shape of the ProTector™ allows the needle cover to be propped on the tray in a ready position for recapping using a onc-handed technique.
The ProTector™ has the same technological characteristics and material construction as the Hunter Research Bull's Eye Recapping Aid. Both products are constructed of paper board material with a variable press-fit target hole in the card. The Certol design is a rectangle which nllows the loaded needle cover to be propped on the dental or medical tray. The Bull's Eye is an octagon shape but the feature to prop the cover in the ready position is the same. Both units may be autoclaved by the user.
Mentions image processing
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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)
Not Found
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.
Not Found
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
K052725
1 of 2
DEC 2 8 2005
510(k) Summary
Certol Intl., LLC 6120 E. 580 Avenue Commerce City, CO 80022 303-799-9401 Phone 303-799-9408 Fax Contact: Steve Cassinis September 28, 2005
Trade Name: ProTector™ Needle Sheath Prop
Common Name: Disposable One-Handed Recapper
Classification: 21 CFR 880.5570
Product Code: FMI
This product is substantially equivalent to the legally marketed Bull's Eye Disposable Needle Recapping Aid manufactured by Hunter Research Laboratories, Inc., Denver, Colorado.
The ProTector™ Needle Sheath Prop is a disposable, non-sterile, one-time use device that can be used to safely uncap and recap needles using a one-handed technique. The ProTector™ facilitates and meets OSHA's Bloodborne Pathogens requirement to promote reduction in accidental needle sticks. Use of the ProTector™ discourages leaving the needle unsheathed on an instrument trav. The device is specifically designed to capture the needle cover/cap and hold it in the ready position.
The ProTector™ is manufactured using a premium grade rectangular paper board card. The sheathed needle cap is inserted into the targeted hole up to the cover hub, securing the needle cover firmly in the ProTector™. The targeted hole is designed as a flexible press-fit to accommodate all sizes of needle protector cover up to 3/8" OD which accommodates most needle covers on the market.
After the needle and cover is inserted into the ProTector™, it is now in the ready position to be able to safely withdraw the needle. The rectangular shape of the ProTector™ allows the needle cover to be propped on the tray in a ready position for recapping using a onc-handed technique.
Indications for Use:
ProTector™ Needle Sheath Prop is a disposable, non-sterile device that can be used to safely uncap and recap needles using a one-handed technique. ProTector™ Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray. The Prop is autoclavable for one-time sterile tray set-up. It holds the cap securely in the ready position.
1
Kora725
2 of 2
The ProTector™ has the same technological characteristics and material construction as the Hunter Research Bull's Eye Recapping Aid. Both products are constructed of paper board material with a variable press-fit target hole in the card. The Certol design is a rectangle which nllows the loaded needle cover to be propped on the dental or medical tray. The Bull's Eye is an octagon shape but the feature to prop the cover in the ready position is the same. Both units may be autoclaved by the user.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2005
Certol International, LLC C/O Mr. Lewis Ward President L.W. Ward and Associates, Incorporated 4655 Kirkwood Court Boulder, Colorado 80301
Re: K052725
Trade/Device Name: ProTector™Needle Sheath Prop, Disposable One-Handed Recapper Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: December 9, 2005 Received: December 15, 2005
Dear Mr. Ward:
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 either 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.
3
Page 2 - Mr. Ward
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. 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 (QS) 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), please contact the Office of Compliance at (240) 276-0115. 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 Division 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,
Shule H. Murphy, B. Holtz Jr. Cini.
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
( of )
INDICATIONS FOR USE
510(k)
Device Name: ProTector™ Needle Sheath Prop, Disposable One-Handed Recapper
Indications for Use:
ProTector™ Needle Sheath Prop is a disposable, non-sterile device that can be used to safely uncap and recap needles using a one-handed technique. ProTector™ Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray. The Prop is autoclavable for one-time sterile tray set-up. It holds the cap securely in the ready position.
Prescription Use X___ (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula H. Maughley, D.D.S. P. Watson 12/28/05
Cancell
K 052725