(187 days)
Not Found
No
The summary describes a material change to a sharps collector, focusing on the use of recycled plastics. There is no mention of AI or ML technology.
No.
The device is a sharps collector used for the disposal of contaminated medical waste, not for treating a disease or condition.
No
The device is a sharps collector for waste disposal, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, single-use device made of plastic materials for the disposal of medical sharps. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "disposal of contaminated medical sharps." This is a waste management function, not a diagnostic test performed on a biological sample.
- Device Description: The device is a container designed for safe disposal. It does not involve any reagents, instruments, or procedures for analyzing biological specimens.
- Lack of Diagnostic Elements: There is no mention of analyzing blood, urine, tissue, or any other biological sample for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical integrity and safety of the container (impact resistance, needle penetration, leak resistance), not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This sharps collector does not fit that description.
N/A
Intended Use / Indications for Use
Sharps Collectors are intended to be used for disposal of contaminated medical sharps in health care facilities.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
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 same type of material used in current BD Sharps Collectors and BD Recykleen™ Sharps Collectors. The predicated devices were previously cleared under K943134.
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 technological and performance characterisitics of the BD Recykleen™ Sharps-Collectors (new-device) is similar-to-BD-Guardian Sharps-Collectors. (predicate device). There is no change to the intended use of the new or predicate Sharps Collectors, the collector design and technological and performance characteristics remain unchanged.
BD Sharps Collectors may be used with optional accessories, stabilizer and brackets, that provide the customer choices for further security and enhanced stability during usage. The 8Qt and 6 Gallon Product Instructions for Use list the compatible brackets and stabilizer accessories available.
Brackets are designed to secure the collector to a wall or cart. Some bracket accessories include additional security via a locking mechanism.
Stabilizers: Stabilizers are designed to stabilize collectors on a countertop or other flat surface.
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
health care facilities
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)
Performance Bench Testing of Device Modifications:
-
Performance Standards: No performance standards have been established under Section 514 for this product code. All recognized standards and other regulations and guidance documents that were used in this 510(k) have been listed in Section 20. The performance testing demonstrates compliance with the recognized consensus standard, ASTM F 2132-01 (Reapproved 2008) e1, "Standard Specification for Puncture Resistance of Materials Used in Collectors for Discarded Medical Needles and Other Sharps." In addition the relevant FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(K)] Submission for Sharps Collectors" dated October 1993, was used to identify applicable physical and mechanical features of the modified and predicate devices. All applicable standards have been used to show that the BD Recykleen Container family is substantially equivalent to the appropriately listed predicate devices. The performance testing summary demonstrates substantial equivalence between the modified device and the predicate devices. The new sharps collectors have been tested by appropriate methods with respect to relevant FDA guidance documents, FDA recognized ASTM standards F 2132-01 and OSHA regulations 29 CFR Part 1910:1030. No new issues of safety and effectiveness were raised with the testing performed, and the BD Recykleen Containers are considered substantially equivalent to its predicate device. This testing involved product_performance_testing_demonstrated_equivalent_performance_to_predicate_device performance and no new issues of concern-were raised.
-
Impact Resistance: The container is filled with assorted sharps or syringes with or without needles, or equivalent weight using resin beads and sealed as if ready for transport. The collector is dropped 39" from the base onto a hard surface floor.
- Pass/Fail Criteria: No gross fractures (external wall of container is open enough to allow escape of solid contents) or loss of contents are permitted. Stress fractures (crack in external wall where wall does not separate to release solid contents) are permitted.
-
Needle Penetration Resistance: Based on ASTM F2132-01, "Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps". for minimum and average needle penetration force. The test method involves cutting 12 samples from needle containment areas of the sharps collector. Each sample is tested using a motorized mechanical tester (Instron, ATS or equivalent) with a new 21 gauge x 1" needle, each penetration is tested at 4"/minute.
- Pass/Fail Criteria: No one needle puncture force can be less than 2.8 lbf and average puncture force of 3.4 lbf must be met to be acceptable.
-
Leak Resistance: Based on OSHA Specification (29 CFR 1910.1030). The container is filled with water to the labeled fill line and left to stand on its base 1 hour.
- Pass/Fail Criteria: No leaks are observed with product standing in upright position.
-
Transit Damage Resistance: Demonstrates the product is free from any visible damage that may affect customer usage, safety, or satisfaction when products are packaged in shipping cases and dropped. The appropriate number of products are packaged in the appropriate shipping case and sealed as if ready for shipment. The shipping case is dropped from 24" onto a hard surface floor in 10 different orientations.
- Pass/Fail Criteria: The product is free from any visible damage that may affect customer usage, safety, or satisfaction when products are packaged in the shipping case and dropped with a 90% pass rate.
-
Needle Penetration Resistance - Comparison of all Recycled Resin Grades and blend of resins in use: The critical performance characteristic for Sharps Collectors is Needle Penetration Resistance (NPR). 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. The NPR regression curves were completed for each virgin material, recycled resin blend formulation. Each resin material is characterized to have a unique minimum wall thickness to meet ASTM F 2132-01.
-
Safety Tests: To demonstrate that post hospital recycled resins are substantially equivalent to the PC and PI recycled resins and virgin resins used in the predicate Sharps Collectors. additional safety tests were conducted. These tests were selected to eliminate potential concerns of residual resin contamination after completion of the sanitization, separation, recycling and extrusion processes. Pellet samples or test plaques representing 100% PH, 100% PI, and 100% PC recycled and virgin resins were tested according to those listed in Table 6. All Safety Tests demonstrated equivalent performance between the principle and predicate Sharps Collectors and individual resins tests.
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.
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
MAR 2 8 2012
K112774 510k SUMMARY BD Recykleen™ Sharps Collector
Date: March 28, 2012
- Submitted By
BD Medical Surgical Systems Becton, Dickinson and Company 1 Becton Drive Franklin Lakes, New Jersey, 07417 USA
2. Contact Information
Primary Contact Eileen Hiller Director, Regulatory Affairs BD Medical Surgical Systems 1 Becton Drive Franklin Lakes. New Jersey 07417 USA 201-847-4570 Eileen Hiller@BD.com
Secondary Contact
Sergio Gadaleta Vice President, Regulatory Affairs BD Medical Surgical Systems 1 Becton Drive Franklin Lakes, New Jersey 07417 USA 201-847-4496 Sergio Gadaleta@BD.com
| 3 .- Device identification :- | |
|---|---|
| -Trade Name: | BD-Rec |
| Common Name: | Sharps |
| Classification: | MMK - |
| needles | |
| Allian William Harris, College, Comment | And Antiques and the manufacturer of the contribution of the contribution of the |
CFR Reference: Classification Panel:
cykleen TM-Sharps Container-Container Accessory to hypodermic single lumen 21CFR 880.5570 - Class II General Hospital
4. Predicate devices:
Substantial equivalence is being claimed to the following legally marketed devices:
Trade Name: BD Guardian™ Sharps Collector Common Name: Sharps Container Classification: MMK - Accessory to hypodermic single lumen needles Predicate 510k No K943134 Cleared 11/07/1994 21CFR 880.5570 - Class II CFR Reference:
1
Classification Panel:
General Hospital
5. Product Description:
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 same type of material used in current BD Sharps Collectors and BD Recykleen™ Sharps Collectors. The predicated devices were previously cleared under K943134.
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 technological and performance characterisitics of the BD Recykleen™ Sharps-Collectors (new-device) is similar-to-BD-Guardian Sharps-Collectors. (predicate device). There is no change to the intended use of the new or predicate Sharps Collectors, the collector design and technological and performance characteristics remain unchanged.
BD Sharps Collectors may be used with optional accessories, stabilizer and brackets, that provide the customer choices for further security and enhanced stability during usage. The 8Qt and 6 Gallon Product Instructions for Use list the compatible brackets and stabilizer accessories available.
Brackets are designed to secure the collector to a wall or cart. Some bracket accessories include additional security via a locking mechanism.
Stabilizers: Stabilizers are designed to stabilize collectors on a countertop or other flat surface.
2
6. Intended Use:
The BD Recykleen™ Sharps Collectors intended use:
Sharps Collectors are intended to be used for disposal of contaminated medical sharps in health care facilities
7. Comparison to Predicate Devices:
The sharps container is similar to the predicated in intended use, materials, measuring principle and performance.
| FEATURE | MODIFIED DEVICE
BD RECYKLEENTM
SHARPS COLLECTOR | PREDICATE DEVICE
BD GUARDIANTM SHARPS
COLLECTOR |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Closable | Same | Yes, Snap fit cap/closure |
| Puncture Resistant | Same
ASTM F2132-01 (2008),
"Standard Specification for
Puncture Resistance of
Materials Used in Containers
for Discarded Medical
Needles and Other Sharps". | Yes Passes proposed ASTM
F04.65.01 procedure
(Current draft in 1994) |
| Leakproof on sides
and
Bottom | Same | Yes |
| Labeled or Color-
Coded: | Same | Sharps/Infectious Waste
Yes |
| Biohazard Warning
Label | | |
| Fluorescent orange
or orange-red with
lettering in
contrasting color | Same | Yes |
| Affixed to container | Same | Yes |
| Red Container or
label | Same | Yes |
| Recycled Content
Label | Patient Room Collectors
Recycled Content- Minimum
20%
Nestable Collectors
Minimum 50% Recycled
Content | NA |
| FEATURE | MODIFIED DEVICE
BD RECYKLEENTM
SHARPS COLLECTOR | PREDICATE DEVICE
BD GUARDIANTM SHARPS
COLLECTOR |
| Capable of
maintaining stable,
upright position. | Same | Yes |
| No feature to bend,
break, or shear
needle. | Same | No feature present. |
| Unwinder | Same | Unwinder is designed for one-
handed operation on containers.
Labeling is "Single Use Only" |
| Reusable Sharp
Container | Same | |
| Overfill Indication | Same | "Do Not Overfill" or "Fill to this
Level Only" is labeled or
embossed on container at the
location of overfill. Labeling
includes a "Fill Line." |
| Locking Enclosure | Same | All models have the option for
use of security locks and keys |
| Holder to secure to
walls | Same | Product is capable of attaching to
wall-mount or cart-mount. |
| Materials | Polyolefinic resins:
Virgin polypropylene
Post consumer
Post industrial
Post hospital | Polyolefinic resins- Virgin
Polypropylene |
| Construction | Same | Injection molded Container,
Injection molded Lids/Closures |
| Clarity | Same | Each Collector has a minimum
of one translucent component,
either base or top. Some models
with clear "see thru" tops. |
| Recycled Content | Nestable Sharps Collectors
minimum 50% | N/A |
3
The Device Models Subject to this submission are listed below. The BD Recykleen™ Sharps collector's dimensions, access openings, features and capacity are essentially equivalent to the predicate devices.
4
| Family | BD
Recykleen™Sharps
Collector | Access Opening
and Closure | Access
Opening
Size | Length (in) | Width
(in) | Height
(in) | Weight
(grams) | Capacity |
|----------------------------------|-------------------------------------|--------------------------------------------------------------|------------------------------------------------|-------------|---------------|----------------|-------------------|-----------|
| Nestable
Sharps
Collectors | 8 Quart
Model No. 305059 | Funnel Top, with
restricted access
petals
Hinge Cap | 1.5 "x
1.125"
with
flexible
petals | 9.75 | 10.00 | 6.75 | 446 | 8 Quarts |
| | 6 Gallon
Model No. 305160 | Open top with
restricted access
opening
Hinge Cap | 2.5"
diameter | 17.50 | 12.50 | 8.50 | 935 | 6 Gallons |
8. Discussion of Similarities and Differences in New and Predicate Product
Intended Use Comparison
The indications for use of the new BD Recykleen™ Sharps Collector are not new indications in that they are the same as those for the predicated devices. Sharps collectors-and-other-predicated-devices-are-containers-intended-for-the-disposal-ofcontaminated medical waste within healthcare facilities.
\ Design and Materials Comparison
The design and functionality of the sharps collectors and predicated devices are identical. They are constructed from polypropylene and contain a component(s) made from recycled polyolefin plastics and are intended for single use only. All of the devices conform to recognized standard, ASTM F-2132-01 for needle penetration resistance. They have features to prevent contact between user and the contents, and are designed for easy and safe determination of fullness. None of the devices have features that bend, break, or shear needles.
9. Summary of Performance Bench Testing of Device Modifications
9.1 Performance Standards:
5
No performance standards have been established under Section 514 for this product code. All recognized standards and other regulations and guidance documents that were used in this 510(k) have been listed in Section 20.
The performance testing demonstrates compliance with the recognized consensus standard, ASTM F 2132-01 (Reapproved 2008) e1, "Standard Specification for Puncture Resistance of Materials Used in Collectors for Discarded Medical Needles and Other Sharps." In addition the relevant FDA guidance document, "Guidance on the Content and Format of Premarket Notification [510(K)] Submission for Sharps Collectors" dated October 1993, was used to identify applicable physical and mechanical features of the modified and predicate devices.
All applicable standards have been used to show that the BD Recykleen Container family is substantially equivalent to the appropriately listed predicate devices.
The performance testing summary demonstrates substantial equivalence between the modified device and the predicate devices. The new sharps collectors have been tested by appropriate methods with respect to relevant FDA guidance documents, FDA recognized ASTM standards F 2132-01 and OSHA regulations 29 CFR Part 1910:1030. No new issues of safety and effectiveness were raised with the testing performed, and the BD Recykleen Containers are considered substantially equivalent to its predicate device.
Performance Testing (Bench) -Product Testing 9.2
The BD Recykleen™ Sharps Containers incorporate the identical collector design features, performance characteristics, manufacturing technology. The results of product_performance_testing_demonstrated_equivalent_performance_to_predicate_device performance and no new issues of concern-were raised.
Impact Resistance
ﺔ ﻣﻤﺜﻠ
Impact resistance was assessed such that no open fractures or disassembly results when a filled collector is dropped. The container is filled with assorted sharps or syringes with or without needles, or equivalent weight using resin beads and sealed as if ready for transport. The collector is dropped 39" from the base onto a hard surface floor.
Pass/Fail Criteria: No gross fractures (external wall of container is open enough to allow escape of solid contents) or loss of contents are permitted. Stress fractures (crack in external wall where wall does not separate to release solid contents) are permitted.
Needle Penetration Resistance
6
Needle Penetration Resistance is based on ASTM F2132-01, "Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps". for minimum and average needle penetration force. The test method involves cutting 12 samples from needle containment areas of the sharps collector. Each sample is tested using a motorized mechanical tester (Instron, ATS or equivalent) with a new 21 gauge x 1" needle, each penetration is tested at 4"/minute.
Pass/Fail Criteria: No one needle puncture force can be less than 2.8 lbf and average puncture force of 3.4 lbf must be met to be acceptable.
Leak Resistance
The Leak Resistance testing is based on OSHA Specification (29 CFR 1910.1030) -The container is filled with water to the labeled fill line and left to stand on its base 1 hour.
Pass/Fail Criteria: No leaks are observed with product standing in upright position.
Transit Damage Resistance:
Transit Damage testing demonstrates the product is free from any visible damage that may affect customer usage, safety, or satisfaction when products are packaged in shipping cases and dropped. The appropriate number of products are packaged in the appropriate shipping case and sealed as if ready for shipment. The shipping case is dropped from 24" onto a hard surface floor in 10 different orientations.
Pass/Fail Criteria: The product is free from any visible damage that may affect customer usage, safety, or satisfaction when products are packaged in the shipping case and dropped with a 90% pass rate.
Performance Testing- Needle Penetration Resistance- Comparison of all Recycled Resin Grades and blend of resins in use
The critical performance characteristic for Sharps Collectors is Needle Penetration Resistance (NPR). 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. The NPR regression curves were completed for each virgin material, recycled resin blend formulation. Each resin material is characterized to have a unique minimum wall thickness to meet ASTM F 2132-01.
ਰੇ ਤੇ Safety Tests
To demonstrate that post hospital recycled resins are substantially equivalent to the PC and PI recycled resins and virgin resins used in the predicate Sharps Collectors. additional safety tests were conducted. These tests were selected to eliminate
BD Recykleen Sharps Collector 510k Summary
7
potential concerns of residual resin contamination after completion of the sanitization, separation, recycling and extrusion processes.
Pellet samples or test plaques representing 100% PH, 100% PI, and 100% PC recycled and virgin resins were tested according to those listed in Table 6.
All Safety Tests demonstrated equivalent performance between the principle and predicate Sharps Collectors and individual resins tests.
| Safety Test | Standards/Method | Principle Device | Predicate Device |
|---|---|---|---|
| Biocompatibility Testing | |||
| Cell Toxicity Murine Local Lymph Node Assay Primary Dermal Irritation | ISO 10993 | ||
| ISO 10993 | |||
| ISO 10993 | passed | ||
| passed | |||
| passed | passed | ||
| passed | |||
| passed | |||
| Bioburden- | |||
| All test samples- non sterile Samples | |||
| Resin | |||
| Pellets | ISO 11737-1 | (PI,PC,PH) | Virgin PP |
| Sharps Collectors | |||
| Interior exterior |