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510(k) Data Aggregation
(187 days)
Sharps collectors are intended to be used for the disposal of contaminated medical sharps in health care facilities.
The BD Recykleen™ Sharps Collector is a single use device designed for the safe disposal of regulated medical waste such as contaminated sharps waste. All materials, including sides, bottom, and top are manufactured with polypropylene or polyolefin plastics. The basis of this new Traditional 510(k) submission is for a material change of the sharps collector. The material change, which will incorporate the use of a new resin grade of recycled plastic recovered from the hospital and healthcare facility medical sharps waste-stream. The use of post-hospital recycled resins in the manufacture of the BD Recykleen Sharps Collectors has been demonstrated to be safe and effective. BD has developed the BD ecoFinity™ Life Cycle Solution, which is a program for recycling clinically used hospital-generated medical sharps waste. The basics of this new recycling program are that plastics, recovered from recycling post-hopital sharps waste, are utilized to manufacture new sharps collectors rather than being treated and disposed in landfills or incinerated. After sanitization, the treated sharps waste is separated into metal, light plastics, and other materials. The light plastics are recovered, extruded and pellitized into a final resin pellet form. The recycled resin pellets are then injection molded into components that make up the finished BD Recykleen™ Sharps Collectors.
The provided text describes the BD Recykleen™ Sharps Collector, a single-use device designed for the safe disposal of regulated medical waste. The primary change in this 510(k) submission is the incorporation of a new resin grade of recycled plastic from the hospital and healthcare facility medical sharps waste-stream. The manufacturer, BD Medical Surgical Systems, asserts that the new device is substantially equivalent to the legally marketed BD Guardian™ Sharps Collector (K943134).
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Test Standard/Method | Pass/Fail Criteria | Reported Device Performance |
|---|---|---|---|
| Puncture Resistance | ASTM F2132-01 (2008), "Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps". | No single needle puncture force less than 2.8 lbf. Average puncture force of 3.4 lbf. | Met: Individual NPR regression analyses of wall thickness versus needle puncture force were completed for each of the following: 100% recycled resin grades (PH, PI, and PC); virgin and recycled resin blends. Each resin material is characterized to have a unique minimum wall thickness to meet ASTM F 2132-01 (page 6). |
| Impact Resistance | Drop test (39" from base onto hard surface floor) with a filled collector (assorted sharps/syringes or equivalent weight with resin beads). | No gross fractures (external wall of container open enough to allow escape of solid contents) or loss of contents. Stress fractures permitted. | Met: The results of product performance testing demonstrated equivalent performance to the predicate device performance (page 6). |
| Leak Resistance | OSHA Specification (29 CFR 1910.1030) - container filled with water to labeled fill line and left to stand for 1 hour. | No leaks observed with product standing in upright position. | Met: The results of product performance testing demonstrated equivalent performance to the predicate device performance (page 6). |
| Transit Damage Resistance | Shipping case with appropriate number of products dropped from 24" onto a hard surface floor in 10 different orientations. | Product free from any visible damage that may affect customer usage, safety, or satisfaction with a 90% pass rate. | Met: The results of product performance testing demonstrated equivalent performance to the predicate device performance (page 6). |
| Biocompatibility | ISO 10993 (Cell Toxicity, Murine Local Lymph Node Assay, Primary Dermal Irritation) | Passed | Passed: For both Principle Device (recycled resins) and Predicate Device (virgin PP) (Table 6, page 7). |
| Bioburden (Resin Pellets) | ISO 11737-1 | - | Met: (PI,PC,PH): <46 CFU/10g; Virgin PP: <4.8 CFU/10g (Table 6, page 7). |
| Bioburden (Sharps Collectors-Interior/Exterior) | - | - | Met: (PI,PC,PH): 1.5 CFU/2 swabs (interior), 10.8 CFU/100mL (exterior); Virgin PP: 3.7 CFU/2 swabs (interior), 3.1 CFU/100mL (exterior) (Table 6, page 7). |
| Chemical Analysis (Extractibles) | LC/DAD/MS | Same performance as predicate device. | Same: As predicate device (Table 6, page 7). |
| Chemical Analysis (Leachables) | GC/MS | No significant differences compared to predicate device. | No significant differences: Compared to predicate device (Table 6, page 7). |
| Heavy Metals | ICP/MS, XRF | Passed, TPCH <100ppm. | Passed: TPCH <100ppm for both principle and predicate devices (Table 6, page 7). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of samples or sample sizes used for each test performed on the BD Recykleen™ Sharps Collector. However, it indicates:
- Needle Penetration Resistance: "cutting 12 samples from needle containment areas of the sharps collector" (page 6).
- Data Provenance: The new device incorporates recycled plastic recovered from the hospital and healthcare facility medical sharps waste-stream (page 1). Testing was performed to demonstrate substantial equivalence to existing BD Sharps Collectors. The data is prospective, generated specifically for this 510(k) submission to demonstrate the performance of the new design. The country of origin for the data is not specified but is implicitly in line with U.S. regulatory standards (ASTM, OSHA, ISO).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is not applicable to this device and its testing. The device is a physical product (sharps collector), and its performance is evaluated through objective physical and chemical bench testing against established standards (e.g., ASTM, OSHA, ISO), not through expert interpretation or clinical assessment that would require ground truth established by medical experts.
4. Adjudication Method for the Test Set
Again, an adjudication method (like 2+1, 3+1 consensus) is not applicable to the testing for this device. The testing is based on objective, measurable physical and chemical properties and predefined pass/fail criteria, not on subjective assessments requiring expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that involve human interpretation of medical images or data. The BD Recykleen™ Sharps Collector is a physical medical waste containment device, and its safety and effectiveness are assessed through bench testing, not through human reader studies. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This type of study is also specific to AI/software as a medical device (SaMD). The BD Recykleen™ Sharps Collector is a physical device, and its performance is evaluated through bench testing.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the BD Recykleen™ Sharps Collector is established by objective performance standards and specifications. These include:
- ASTM F2132-01 (Reapproved 2008) e1: "Standard Specification for Puncture Resistance of Materials Used in Collectors for Discarded Medical Needles and Other Sharps."
- OSHA Regulation 29 CFR Part 1910.1030: Relevant for leak resistance.
- ISO 10993: For Biocompatibility testing.
- ISO 11737-1: For Bioburden testing.
- Internal BD specifications: For tests like Impact Resistance and Transit Damage Resistance, which have clearly defined pass/fail criteria.
- Chemical Analysis Methods: LC/DAD/MS, GC/MS, ICP/MS, XRF to assess material composition and potential contaminants.
These standards and methods define what constitutes acceptable performance for a sharps collector, serving as the objective ground truth against which the device's actual performance is measured.
8. The Sample Size for the Training Set
Not applicable. The BD Recykleen™ Sharps Collector is a physical medical device, not an AI algorithm or diagnostic tool. Therefore, a "training set" in the context of machine learning is not relevant here. The manufacturing process and material properties are developed and validated through engineering design, material science, and performance testing, not through iterative training on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The physical and chemical properties of the materials and the design of the device are developed and verified through established engineering and materials science principles, and tested against recognized industry and regulatory standards.
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