(70 days)
The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.
The M500-100 Sharps Container was compared to the below mentioned predicate containers in that it conforms to the same standards as its predicates. This container was made from polyethylene plastic with a polyethylene locking lid. This container was molded with no side or bottom seams. The predicate devices are also made of premotited polyethylene. The M500-100 has a lid, which locks when shut preventing any leakage or loss of its contents.
The M500-100 is designed to hold up to 30 used syringes of lec to 5cc in size. The syringes are placed into the container in a vertical position sharp side down. Other sharps may be disposed of by dropping them into the opening at the top.
The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table. This container can also be placed in a specially designed wall bracket.
There is a black line on this container to notify the user not to overfill .
The provided text describes a 510(k) submission for a medical device, specifically the M500-100 Sharps Container. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's effectiveness through a clinical study with detailed performance metrics like sensitivity/specificity or human reader improvement with AI.
Therefore, many of the typical acceptance criteria and study details requested (e.g., sample size for test sets, number of experts, MRMC studies, training set details) are not applicable to this type of device and submission. The "study" described is a series of tests to ensure the physical integrity and safety of the sharps container.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Description) | Reported Device Performance |
|---|---|
| No leakage when filled with water and allowed to stand | "showed no signs of leakage from the container." |
| Locked lid remains closed and prevents spillage/protrusion when dropped (3 feet) | "With the lid locked in place and the container filled with syringes the container was dropped from a suspended string 3 feet in the air onto a hard floor. The locked lid did not open up and there were no signs of the contents spilling out or protruding through the bottom." |
| Conformance to American Standards for Testing guidelines | "These test were conducted using the guidelines of the American Standards for Testing..." (Implies conformance) |
| Conformance to British Standards for Testing guidelines | "...and the British Standards of Testing." (Implies conformance) |
| Stability on a flat surface | "The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table." (Design feature, not a test with pass/fail) |
| Ability to hold 30 syringes (1cc to 5cc) | "The M500-100 is designed to hold up to 30 used syringes of 1cc to 5cc in size." (Design specification, not a test with pass/fail) |
| Notification of overfill | "There is a black line on this container to notify the user not to overfill." (Design feature, not a test with pass/fail) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. The text refers to "all tests" and "the M500-100 sharps container" implying that at least one unit of the device underwent each test. For a physical device like this, testing a small number (e.g., 1-5 units) to verify manufacturing quality and design integrity against standards is common practice.
- Data Provenance: The tests were conducted by Imagination Medical Inc. as part of their submission process. The text does not specify the country of origin of the data beyond the company's location in Jacksonville, Florida, USA. The tests appear to be prospective in nature, performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a physical device where "ground truth" for performance is established by objective physical tests (e.g., presence/absence of leakage, lid integrity after drop) against defined standards, not by expert consensus or interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. As the tests are objective physical measurements, there is no need for adjudication by multiple experts. The outcome is directly observable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for diagnostic or screening devices where human interpretation is involved and needs to be compared with or augmented by AI. A sharps container is a physical container, not a diagnostic tool requiring human-in-the-loop performance evaluation.
6. If a Standalone Study Was Done
- Yes, in spirit. The described tests are a standalone evaluation of the device's physical properties. However, "standalone" in the context of AI usually refers to the algorithm's performance without human intervention. For a physical device, the tests conducted (leakage, drop test) represent its standalone physical performance.
7. The Type of Ground Truth Used
- Objective Physical Standards/Measurements. The "ground truth" for the tests was based on direct observation of physical integrity (no leakage, no spillage/protrusion) and adherence to guidelines from the American Standards for Testing and the British Standards for Testing.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of a physical medical device like a sharps container. This is not an AI/algorithm-driven device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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MAR 1 3 1998
510(k) Summary
| Company: | Imagination Medical Inc.12855 Phillips HighwayJacksonville, Fl. 32256(904) 268-5531 |
|---|---|
| Contact: | Mr. Tim Weist |
| Device Name: | M500-100 Sharps Container |
| Common Name: | 1 QT Sharps Container |
| Classification: | 21 CFR 880 Type II |
The M500-100 Sharps Container was compared to the below mentioned predicate containers in that it conforms to the same standards as its predicates. This container was made from polyethylene plastic with a polyethylene locking lid. This container was molded with no side or bottom seams. The predicate devices are also made of premotited polyethylene. The M500-100 has a lid, which locks when shut preventing any leakage or loss of its contents.
The M500-100 is designed to hold up to 30 used syringes of lec to 5cc in size. The syringes are placed into the container in a vertical position sharp side down. Other sharps may be disposed of by dropping them into the opening at the top.
The M500-100 sharps container has a flat bottom, which makes it stable when sitting on a table. This container can also be placed in a specially designed wall bracket.
There is a black line on this container to notify the user not to overfill .
Predicate Devices:
- B.D. Home Sharps Container K943575 1
- 2 Sage Sharps Phiebotomy Confiner # 8900MW
Conclusions of Testing:
In all rest, the M500-100 sharps container met or exceeded the criteria set as pass. These test were conducted using the quidelines of the American Standards for Testing and the British Standards of Testing. This container when filled with water and allowed to stand
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showed no signs of leaksge from the container. With the lid locked in place and the container filled with syringes the container was dropped from a suspended string 3 feet in the air onto a hard floor. The locked lid did not open up and there were no signs of the contents spilling out or protruding through the bottom. Since syringes are placed into this container sharp side down always in a vertical position, it is unlikely that a sharp could of would protrude through the top.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 1998
Mr. Tim Weist Director of Safety and Compliance Imaqination Medical Incorporated 12855 Phillips Highway 32256 Jacksonville, Florida
K980003 Re: M500-100 Sharps Container Trade Name: Regulatory Class: II Product Code: FMI February 17, 1998 Dated: February 17, 1998 Received:
Dear Mr. Weist:
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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with -the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Weist
through 542 of the Act for devices under the Electronic enroagn Siz Or on Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA asboring 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) 594-4618. 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,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital 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): K980003
M500-100 Sharps Container DEVICE NAME:_________________________________________________________________________________________________________________________________________________________________
Indications for Use:
The M500-100 sharps container is designed to hold up to 30 syringes from 1 to 5 cc in size. This container is intended for use by trained medical personnel in a medical clinic setting for the safe disposal of hazardous sharps.
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental Infection Control
Division of Dental Infection Control, and General Hospital Devices
510(k) Number K980003
Prescription Use (Per 21 CFR 801.109) OR
Over the Counter Use
(Optional Format 1-2-96)
§ 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).