(317 days)
Medline Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
Medline Sharps Containers are two-piece conventional, disposable sharps containers. The base container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1g and 2g containers in locking and non-locking variations. The device is intended to be used by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
The provided text describes the acceptance criteria and performance of Medline Sharps Containers, which are medical devices for disposing of contaminated sharps. The document is a 510(k) premarket notification to the FDA. As such, it details physical device compliance rather than software or AI performance. Therefore, many of the requested elements (e.g., sample size for test set, data provenance, ground truth experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device and document.
Here's a breakdown of the requested information based on the provided text, focusing on the device's physical performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Objective | Acceptance Criteria (from BS EN ISO 23907 or ASTM F 2132) | Reported Device Performance |
|---|---|---|
| Container Stability | BS EN ISO 23907 Requirements: "Specimens were placed on a surface with an inclination of 15° in the most adverse position for toppling with no more than 0 failures per container." | Meets ISO 23907 Requirements - Specimens were placed on a surface with an inclination of 15° in the most adverse position for toppling with no more than 0 failures per container. |
| Handle Strength | BS EN ISO 23907 Requirements: The standard implies that the handles should withstand a specified load for a period without failure. (Specific numerical criteria for load/duration not explicitly stated in this summary, but the context implies compliance with the standard's full requirements.) | Meets ISO 23907 Requirements - The sharps containers were filled to 50% of the fill line with de-ionized water and were then suspended by the handles for a period of at least 60 minutes; no failures were observed. |
| Puncture Resistance | ASTM F 2132 Requirements: "Per the acceptance criteria the average force was required to be greater 3.4 lbf (15 N), and no single value from any region was allowed to be below 2.8 lbf." | Meets ASTM F 2132 Requirements - The puncture force was recorded, and the results met the specified criteria (average force > 3.4 lbf (15 N) and no single value below 2.8 lbf). |
| Resistance to Damage (Drop/Impact Test) | BS EN ISO 23907 Requirements: Drop tested at a height of 1m. Acceptance criterion: "no evidence of leakage or damage resulting in a breach of the sharps containment area." Additional testing for OSHS safe lifting limits: "The test allowed only a single failure per test condition" (for five containers used for each test orientation). | Meets ISO 23907 Requirements – Drop tested at height of 1m per test standard. Testing resulted in no evidence of leakage or damage resulting in a breach of the sharps containment area. All Medline products met the acceptance criteria for resistance to damage from a vertical drop. Additional 1m drop testing with 40 lb. or capacity load: The containers passed this test. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Test Set:
- Container Stability: Not explicitly stated, but "Specimens" were used. The wording "no more than 0 failures per container" suggests individual containers were tested.
- Handle Strength: Not explicitly stated, but "The sharps containers" were tested.
- Puncture Resistance: Not explicitly stated, but tests were performed on the container secured to an apparatus.
- Resistance to Damage (Drop/Impact Test): "Five containers were used for each test orientation for each tested model."
- Data Provenance: Not specified, but given the submission is to the U.S. FDA, the testing was likely conducted in facilities compliant with relevant standards (e.g., ISO accredited labs), potentially in the U.S. or by a manufacturer supplying the U.S. market. It is retrospective in the sense that the testing was completed before this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a physical device subject to engineering performance testing against established standards, not a diagnostic or AI device requiring expert ground truth in the clinical sense.
4. Adjudication Method for the Test Set
Not applicable. Physical performance tests are judged against objective, measurable criteria defined in the standards (e.g., specific force, leakage, breach of containment).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established engineering and safety standards (BS EN ISO 23907 for "Sharps injury protection – Requirements and test methods – Sharps containers" and ASTM F 2132 for "Standard Test Method for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps"). These standards define objective, measurable criteria for a sharps container's performance regarding stability, handle strength, puncture resistance, and impact resistance.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not an AI model.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2015
Medline Industries, Inc. Matt Clausen Sr. Regulatory Affairs Specialist One Medline Place Mundlelein, IL 60060
Re: K143693
Trade/Device Name: Medline Sharps Containers Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: November 2, 2015 Received: November 5, 2015
Dear Mr. Clausen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143693
Device Name Medline Sharps Containers
Indications for Use (Describe)
Medline Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
| Medline ModelNo. | Capacity | LidConfiguration | Dimensions ofLid Opening(aperture) | Weight ofFinishedGood (lbs) | Dimensions ofFinished Good(L x W x H) | Color |
|---|---|---|---|---|---|---|
| MDS701201 | 1 GALLON | Sliding | 5.5" x 2.25" | 0.681 | 6.88"x 10.06"x 4.5" | Red |
| MDS701201F** | 1 GALLON | Counter-Balanced | 8.75" x 1.75" | 0.752 | 6.88"x 10.06"x 6.25" | Red |
| MDS705201 | 1 GALLON | Sliding | 5.5" x 2.25" | 0.676 | 6.88"x 10.06"x 4.5" | Red |
| MDS705201F** | 1 GALLON | Counter-Balanced | 8.75" x 1.75" | 0.747 | 6.88"x 10.06"x 6.25" | Red |
| MDS701202 | 2 GALLONS | Sliding | 5.5" x 2.25" | 1.014 | 6.88"x 10.06"x 9.5" | Red |
| MDS701202F** | 2 GALLONS | Counter-Balanced | 8.75" x 1.75" | 1.085 | 6.88"x 10.06"x 11.25" | Red |
| MDS705202 | 2 GALLONS | Sliding | 5.5" x 2.25" | 1.002 | 6.88"x 10.06"x 9.5" | Red |
| MDS705202F** | 2 GALLONS | Counter-Balanced | 8.75" x 1.75" | 1.073 | 6.88"x 10.06"x 11.25" | Red |
| MDS705208HN | 8 GALLONS | Hinged | 16.5" x 5.75" | 2.491 | 12.5"x 18.25"x 11" | Red |
| MDS705208SL | 8 GALLONS | Sliding | 9" x 8.5" | 2.884 | 12.5"x 18.25"x 11.5" | Red |
| MDS705208ST | 8 GALLONS | Star | 1.75" x 1.75" | 2.551 | 12.5"x 18.25"x 12.38" | Red |
| MDS705210HN | 10 GALLONS | Hinged | 16.5" x 5.75" | 2.813 | 12.5"x 18.25"x 14" | Red |
| MDS705210SL | 10 GALLONS | Sliding | 9" x 8.5" | 3.206 | 12.5"x 18.25"x 14.5" | Red |
| MDS705210ST | 10 GALLONS | Star | 1.75" x 1.75" | 2.873 | 12.5"x 18.25"x 15.38" | Red |
| MDS705212HN | 12 GALLONS | Hinged | 16.5" x 5.75" | 3.311 | 12.5"x 18.25"x 17" | Red |
| MDS705212SL | 12 GALLONS | Sliding | 9" x 8.5" | 3.704 | 12.5"x 18.25"x 17.5" | Red |
| MDS705212ST | 12 GALLONS | Star | 1.75" x 1.75" | 3.371 | 12.5"x 18.25"x 18.38" | Red |
| MDS705218HN | 18 GALLONS | Hinged | 16.5" x 5.75" | 4.269 | 12.5"x 18.25"x 28" | Red |
| MDS705218SL | 18 GALLONS | Sliding | 9" x 8.5" | 4.662 | 12.5"x 18.25"x 28.5" | Red |
| MDS705218ST | 18 GALLONS | Star | 1.75" x 1.75" | 4.329 | 12.5"x 18.25"x 29.38" | Red |
- Intended for areas with no unsupervised patient access for the container models that do not have features to prevent hand and finger access to the sharps waste.
** Intended for use with mounting accessories.
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| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|
| -- | ---------------------------------------------- | --------------------------------------------- |
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Image /page/4/Picture/0 description: The image shows the Medline logo. The word "MEDLINE" is written in blue, with the letters slightly slanted upwards from left to right. Below the text is a blue star-like symbol with four points. The logo is simple and clean, using only the color blue.
510(k) Summary (as required per 21 CFR 807.92)
Summary Preparation Date
November 6, 2015
Submitter / 510(k) Sponsor
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
Contact Person
Matt Clausen Sr. Regulatory Affairs specialist Phone: 847-643-4785 Fax: 847-643-4482
Device Name / Classification
Device Name: Medline Sharps Containers Proprietary Name: Medline Sharps Containers Common Name: Sharps Container Classification Name: Hypodermic single lumen needle (21 CRF 880.5570, product code - MMK, Class II)
Predicate Device
Medline Sharps Container, K132767
Comparison of Subject and Predicates
| Characteristic | Proposed Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) | K143693 | K132767 | n/a |
| Product Code | MMK | M | Same |
| Regulation No. | 21 CRF 880.5570 | 21 CRF 880.5570 | Same |
| Class | II | II | Same |
| Indications For Use | Medline Sharps Containers areintended to provide a receptaclefor used, contaminated medicalsharps and act as an enclosureduring transport to ultimatedisposal. | Medline Sharps Containers areintended to provide areceptacle for used,contaminated medical sharpsand act as an enclosureduring transport to ultimatedisposal. | Same |
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Image /page/5/Picture/0 description: The image shows the logo for Medline. The logo is blue and consists of the word "MEDLINE" in a bold, sans-serif font. To the right of the word is a stylized star shape. The star has four points and a curved base.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486
| Size | 1G / 2G / 8G / 10G / 12G / 18G | 1Qt / 5Qt | Sizesaredifferent |
|---|---|---|---|
| Dimensions (mm) | 177 x 259 x 123 /177 x 259 x 265 /322 x 470 x 332 /322 x 470 x 409 /322 x 470 x 489 /322 x 470 x 765 | 95 x 95 x 153 /265 x 113 x 233 | Different |
| Weight range (grams) | 303 - 2388 | 107 - 360 | Different |
| No. of Pieces | 2-3 | 2-3 | Same |
| Material | Poly-propylene | Poly-propylene | Same |
| Base Color | Red | Re | Same |
| Clarity | Opaque/translucent | Opaque/translucent | Same |
| Method ofManufacture | Injection Molded | Injection Molded | Same |
| Performance testing(puncture, impact,drop, stability,integrity) | Pass | Pass | Same |
| Technicalcharacteristics | Refer to statement in Summary ofTechnological Characteristics section | Refer to statement in Summary ofTechnological Characteristics section | Same |
| Lid configurations /aperturedimensions | Refer to table below in Indication For Usesection | Container capacities are different;dimensions are different | Different |
| Accessories | Mounting accessories(brackets) are available for usewith 1g and 2g containers inlocking and non-lockingvariations. | None | Different |
Device Description
Medline Sharps Containers are two-piece conventional, disposable sharps containers. The base container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1g and 2g containers in locking and non-locking variations. The device is intended to be used by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
Indications for Use
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Image /page/6/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in blue, with a stylized star symbol to the right of the text. The star symbol is also blue and has a unique shape, with one point extending upwards and two curved shapes forming the lower part of the star.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060-4486
Medline Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
| Medline Model No. | Capacity | Lid Configuration | Dimensions of Lid Opening (aperture) | Weight of Finished Good (lbs) | Dimensions of Finished Good (L x W x H) | Color |
|---|---|---|---|---|---|---|
| MDS701201 | 1 G | Sliding | 5.5" x 2.25" | 0.681 | 6.88"x 10.06"x 4.5" | Red |
| MDS701201F * / ** | 1 G | Counter-Balanced | 8.75" x 1.75" | 0.752 | 6.88"x 10.06"x 6.25" | Red |
| MDS705201 * / ** | 1 G | Sliding | 5.5" x 2.25" | 0.676 | 6.88"x 10.06"x 4.5" | Red |
| MDS705201F * / ** | 1 G | Counter-Balanced | 8.75" x 1.75" | 0.747 | 6.88"x 10.06"x 6.25" | Red |
| MDS701202 * / ** | 2 G | Sliding | 5.5" x 2.25" | 1.014 | 6.88"x 10.06"x 9.5" | Red |
| MDS701202F * / ** | 2 G | Counter-Balanced | 8.75" x 1.75" | 1.085 | 6.88"x 10.06"x11.25" | Red |
| MDS705202 * / ** | 2 G | Sliding | 5.5" x 2.25" | 1.002 | 6.88"x 10.06"x 9.5" | Red |
| MDS705202F * / ** | 2 G | Counter-Balanced | 8.75" x 1.75" | 1.073 | 6.88"x 10.06"x11.25" | Red |
| MDS705208HN | 8 G | Hinged | 16.5" x 5.75" | 2.491 | 12.5"x 18.25"x 11" | Red |
| MDS705208SL | 8 G | Sliding | 9" x 8.5" | 2.884 | 12.5"x 18.25"x 11.5" | Red |
| MDS705208ST | 8 G | Star | 1.75" x 1.75" | 2.551 | 12.5"x 18.25"x12.38" | Red |
| MDS705210HN | 10 G | Hinged | 16.5" x 5.75" | 2.813 | 12.5"x 18.25"x 14" | Red |
| MDS705210SL | 10 G | Sliding | 9" x 8.5" | 3.206 | 12.5"x 18.25"x 14.5" | Red |
| MDS705210ST | 10 G | Star | 1.75" x 1.75" | 2.873 | 12.5"x 18.25"x15.38" | Red |
| MDS705212HN | 12 G | Hinged | 16.5" x 5.75" | 3.311 | 12.5"x 18.25"x 17" | Red |
| MDS705212SL | 12 G | Sliding | 9" x 8.5" | 3.704 | 12.5"x 18.25"x 17.5" | Red |
| MDS705212ST | 12 G | Star | 1.75" x 1.75" | 3.371 | 12.5"x 18.25"x18.38" | Red |
| MDS705218HN | 18 G | Hinged | 16.5" x 5.75" | 4.269 | 12.5"x 18.25"x 28" | Red |
| MDS705218SL | 18 G | Sliding | 9" x 8.5" | 4.662 | 12.5"x 18.25"x 28.5" | Red |
| MDS705218ST | 18 G | Star | 1.75" x 1.75" | 4.329 | 12.5"x 18.25"x29.38" | Red |
- Intended for areas with no unsupervised patient access for the container models that do not have features to prevent hand and finger access to the sharps waste.
** Intended for use with mounting accessories.
Summary of Technological Characteristics
The subject device and predicate device differ in container dimensions; sharps aperture features; use of mounting accessories and container capacities. The differences in design are intended to address specific site and user needs. Any risks resulting from design differences from the predicate device have been adequately mitigated with the performance testing, site-of-use labeling, and use with appropriate mounting accessories. The differences in technological characteristics do not impair the subject device models from their intended functions of disposal and storage of sharps waste.
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Summary of Non-Clinical Testing
The safety and effectiveness of the Medline Sharps Containers are adequately supported by the substantial equivalence information, materials information, and Design Control activities referenced within this Premarket Notification.
Summary of Performance Testing
| Test Objective | Testing Standards | Performance Results |
|---|---|---|
| Container Stability | BS EN ISO 23907 | Meets ISO 23907 Requirements -Specimens were placed on a surface with an inclination of 15° in the most adverse position for toppling with no more than 0 failures per container. |
| Handle Strength | BS EN ISO 23907 | Meets ISO 23907 Requirements -The sharps containers were filled to 50% of the fill line with de-ionized water and were then suspended by the handles for a period of at least 60 minutes; no failures were observed. |
| Puncture Resistance | ASTM F 2132 | Meets ASTM F 2132 Requirements -Container was secured to the test apparatus using a specimen support plate with a 6mm diameter hole. The inside surface of the container was facing towards and perpendicular to the 21 gauge, 1 inch long needle. The needle was lowered vertically towards the test specimen at a rate of 100 mm/min, and was allowed to penetrate the test specimen; the puncture force was recorded. Per the acceptance criteria the average force was required to be greater3.4 lbf (15 N), and no single value from any region was allowed to be below 2.8 lbf. |
| Resistance to Damage(Drop/Impact Test) | BS EN ISO 23907 | Meets ISO 23907 Requirements –Drop tested at height of 1m per test standard. Testing resulted in no evidence of leakage or damage resulting in a breach of the sharps containment area. As such, all Medline products were found to meet the acceptance criteria for resistance to damage from a vertical drop. Additional 1m drop testing was conducted using subject containers with a 40 lb. load or capacity load (23 lbs for smaller |
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| sharps container), intended to |
|---|
| simulate OSHA safe lifting limits. |
| Five containers were used for each |
| test orientation for each tested |
| model. The test allowed only a |
| single failure per test condition. The |
| containers passed this test. |
Summary of Clinical Testing
Not applicable.
Conclusion
Medline Industries, Inc. concludes that the Medline Sharps Containers are substantially equivalent to the predicate device [Medline Sharps Container (K132767)] as described herein.
§ 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).