(132 days)
No
The device description and intended use clearly describe a mechanical sharps container and re-capper, with no mention of software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical and sterilization efficacy.
No
The device is a sharps container and re-capper, intended for safe disposal and handling of needles to minimize injuries, not for treating a condition or disease.
No
The device description indicates it is a sharps container and needle recapper, both used for safe disposal and handling of needles rather than for diagnosing medical conditions.
No
The device description clearly describes physical, mechanical components (sharps container, re-capper with base, carrier plate, and activation plate) and performance studies involving mechanical testing, cleaning, and sterilization, indicating it is a hardware device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for the collection and disposal of contaminated wastes and sharps, and for minimizing needle stick injuries during needle disposal and re-capping procedures. This is a physical function related to safety and waste management, not the diagnosis of a disease or condition.
- Device Description: The descriptions detail mechanical devices designed for handling needles and sharps. There is no mention of analyzing biological samples or providing diagnostic information.
- 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 specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition.
The devices described are classified as medical devices, specifically accessories used in a dental setting for safety and waste management. They are not designed to perform diagnostic tests.
N/A
Intended Use / Indications for Use
The MIRAMATIC Box Sharps Container is intended for use in dental offices for collection and disposal of contaminated wastes and sharps. Indicated for use as an aid in minimizing needle stick injuries during needle disposal. For use with 25, 27 and 30 gauge long and short dental needles.
The Cap Trap Needle Re-capper is intended for use in dental offices during uncapping/recapping procedures. Indicated for use as an aid in minimizing needle stick injuries during re-capping and needle disposal.
Product codes
MMX, FMI
Device Description
The MIRAMATIC Box Sharps Container is designed for use with the MIRAMATIC cartridge syringe to enable single-handed disengagement, ejection and disposal of needles during dental procedures.
The Cap Trap Needle Re-capper is a mechanical re-capper designed to allow single-handed re-sheathing so that the needle is re-sheathed without directing it toward any part of the body. It consists of a base, carrier plate and activation plate
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
Dental offices
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
Testing activities were conducted to establish the performance and reliability characteristics of the accessories. Testing included mechanical testing, cleaning and sterilization efficacy and simulated use evaluation.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string is "KOG1933". The characters are written in a simple, slightly slanted style. The image is in black and white.
Section 5
.
510(k) Summary
| Submitted by: | Hager Worldwide, Inc.
13322 Byrd Drive
Odessa, FL 33556 | NOV 16 2006 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Prepared on: | October 25, 2006 | |
| Device name | The Hager MIRAMATIC Box Sharps Container
The Cap Trap Needle Re-capper | |
| Classification name | Sharps Container Accessory to Hypodermic Single Lumen Needle
Re-capper Accessory to Hypodermic Single Lumen Needle | |
| | The MIRAMATIC Box Sharps Container is classified as Class II, General
Hospital Panel (80), Pro Code MMX. The device is codified at 21 C.F.R. §
880.5570. | |
| | The Cap Trap Needle Re-capper is classified as Class II, General Hospital
Panel (80), Pro Code FMI. The device is codified at 21 C.F.R. § 880.5570 | |
| Predicate Devices | Sage Sharps Disposal Containers with Screw top K980490; and HypoGrip™
(needle re-capper) K924820 | |
| Intended Use | The MIRAMATIC Box Sharps Container is intended for use in dental offices for
collection and disposal of contaminated wastes and sharps. Indicated for use
as an aid in minimizing needle stick injuries during needle disposal. | |
| | The Cap Trap Needle Re-capper is intended for use in dental offices during
uncapping/recapping procedures. Indicated for use as an aid in minimizing
needle stick injuries during re-capping and needle disposal. | |
| Technological
Characteristics | The MIRAMATIC Box Sharps Container is designed for use with the
MIRAMATIC cartridge syringe to enable single-handed disengagement,
ejection and disposal of needles during dental procedures. | |
| | The Cap Trap Needle Re-capper is a mechanical re-capper designed to allow
single-handed re-sheathing so that the needle is re-sheathed without directing
it toward any part of the body. It consists of a base, carrier plate and
activation plate | |
| Testing | Testing activities were conducted to establish the performance and reliability
characteristics of the accessories. Testing included mechanical testing,
cleaning and sterilization efficacy and simulated use evaluation. | |
:
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hager Worldwide, Incorporated C/O Mr. James Delaney Consultant to Hager 4 Lincoln Street Andover, Massachusetts 01810
NOV 16 2006
Re: K061933
Trade/Device Name: Hager MIRAMATIC Box Sharps Container and Cap Trap Needle Re-Capper Regulation Number: 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: October 25, 2006 Received: October 27, 2006
Dear Mr. Delaney:
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.
2
Page 2 - Mr. Delaney
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,
Sydette Y. Michael M.D.
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
3
Section 4
Indications for Use Statement
Indications for Use
061933 510(k) Number (if known):
Device Name: Hagar MIRAMATIC Box Sharps Container
Indications for Use:
Intended for use in dental offices for collection and disposal of contaminated wastes and sharps.
Indicated for use as an aid in minimizing needle stick injuries during needle disposal.
For use with 25, 27 and 30 gauge long and short dental needles.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule A. Murphy Page_ of_
logy, General Hospi
(Posted November 13, 2003)
4
Indications for Use
510(k) Number (if known): _KO6 1933
Device Name: Cap Trap Needle Re-capper
Indications for Use:
Intended for use in dental offices during uncapping/recapping procedures.
Indicated for use as an aid in minimizing needle stick injuries during re-capping and needle disposal.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 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 PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shule Murphy MD
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices
ber. K061933
Page __ of ___
(Posted November 13, 2003)