(114 days)
PureWay Compliance 1.4 Quart Sharps Collector Container is single-use, disposable, non-sterile and intended to be used for healthcare purposes for safe containment and disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target user is for healthcare professionals.
The PureWay Sharps Collector is injection molded with High Density Polyethylene plastic (HDPE). Designed for single use, the container is puncture resistant, leak resistant on the sides and bottom, closable and stable. The container is labeled with a fill line and instructions for snapping the container lid closed. "Do Not Overfill" to prevent overfill. The label is white and blue with white text and a black biohazard symbol is printed on a red background. The container is made of two parts, (Base and Lid) that form a single unit. The red colored base is conical shaped, and the lid is a clamshell design snapped in place for a tight seal when the container is full. The device is a non-sterile, single use, disposable infectious waste container and is designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container is conical which allows for one hand disposal of sharps and a clamshell lid for means of closure.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Test Method/Applicable Standard(s) | Acceptance Criteria | Reported Device Performance (PureWay 1.4 Quart) |
|---|---|---|---|
| Container stability | ISO 23907-1:2019 Section 5.1 | The container shall not topple over when tested. | Pass |
| Resistance to penetration | ISO 23907-1:2019 Section 5.3 | When tested, the force needed to penetrate test specimens shall be a minimum of 16 N and an average of 18 N or greater. | Pass |
| Resistance to damage or leakage after dropping | ISO 23907-1:2019 Section 5.4 | When tested there shall be no evidence of leakage and no breach of the sharp's containment area. Minimum five minutes after each topple, the following points shall be visually checked: 1. No evidence that the performance or function of the container has been compromised. 2. Container's temporary closure shall remain intact. | Pass |
| Resistance to damage or leakage after toppling | ISO 23907-1:2019 Section 5.5 | There shall be no evidence of breach of the sharps containment area. Minimum five minutes after each topple, the following points shall be visually checked: 1. There shall be no evidence that the performance or function of the container has been compromised. 2. The container's temporary closure shall remain intact. | Pass |
| Fill line indicator | ISO 23907-1:2019 Section 4.2.7 | 1. Fill line shall be determined by the design of the container, taking into account the risk of sharps extending above the fill line, and shall be at a level no greater than 85% of the total volume of the container. 2. Fill line feature helps prevent overfilling and is a critical safety feature of a sharps container. 3. It shall be possible to ensure the sharps are not above the fill line. This can be achieved either visually or mechanically. | Pass |
| Strength of Handles | ISO 23907-1:2019 4.2.2 and 5.2 | 1. All sharps containers shall be provided with one or several handles. 2. The handle/carrying feature shall not break or detach during testing. 3. The position of the handles(s), finger recesses, protrusions or flanges shall not interfere with the normal use of the container. 4. Fill the container with a mass equivalent to 150% of manufacturer's maximum allowable gross mass. Suspend the container by its handles(s) at the intended carrying points(s) from a rigid support for 1 h at a temperature of (23+/- 5) degrees Celsius. Remove the container from the support and inspect the handles for integrity and for any evidence of detachment of the handles(s) from the container. | Pass, no evidence of detachment of the handles(s) from the container. (Note: Predicate Device listed as N/A - No Handles) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of sharps containers) used for the non-clinical tests. It refers to the tests performed "when tested," implying a defined test protocol, but the specific number of units tested for each criterion is not provided.
The data provenance is from non-clinical bench testing performed by PureWay Compliance Inc., as indicated by the "Summary of Non-Clinical Performance Data" section and the overall context of a 510(k) submission for a medical device. The tests were performed to ISO 23907-1:2019 standards, which are international standards. The country of origin for the testing itself is not explicitly stated, but the company headquarters is in Carson, CA, USA. The data is prospective in the sense that these tests were conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the "study" described is entirely non-clinical (bench testing) of a physical product (sharps collector). There is no "ground truth" to be established by human experts in the context of diagnostic or interpretive performance.
4. Adjudication Method for the Test Set
This section is not applicable as the "study" is non-clinical bench testing and does not involve human interpretation or adjudication for establishing ground truth. The results are based on objective physical measurements and observations against pre-defined engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This device is a physical sharps collector and does not involve AI or human readers for diagnostic or interpretive purposes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a physical sharps collector and does not involve any algorithms or software for standalone performance evaluation.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is defined by the acceptance criteria specified in the international standard ISO 23907-1:2019 for "Sharps containers – Part 1: Requirements for sharps containers for single-use." These are objective, measurable physical properties and functional requirements for the sharps collector.
8. The Sample Size for the Training Set
This section is not applicable. This is a physical medical device, not a machine learning or AI model. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2023
PureWay Compliance Inc. Jeffery Miglicco Director of Quality 201 Santa Monica Blvd. Suite 400 Santa Monica, California 90401
Re: K231484
Trade/Device Name: PureWay 1.4 Quart Sharps Collector Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: Mav 23, 2023 Received: May 23, 2023
Dear Jeffery Miglicco:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher K. Dugard -S
Christopher K. Dugard, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231484
Device Name PureWay 1.4 Quart Sharps Collector
Indications for Use (Describe)
PureWay Compliance 1.4 Quart Sharps Collector Container is single-use, disposable, non-sterile and intended to be used for healthcare purposes for safe containment and disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target user is for healthcare professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for PureWay Total Compliance. The logo consists of an orange circle with a white star-like design inside, followed by the company name in black lettering. The words "TOTAL COMPLIANCE" are written in smaller letters below the company name.
510(k) Number: K231484 PureWay 1.4 Quart Sharps Collector
| Device Information | Comments |
|---|---|
| Submitter | PureWay Compliance, Inc. |
| Headquarters | 1908 E. Dominguez St, Carson CA 90801 |
| Correspondent Contact Information | Jeffery Miglicco, Director of QualityE-mail: jeffm@pureway.comCell: 713.248.2289 Fax: |
| Device Common Name | Sharps Container |
| Device Classification Name | Hypodermic single lumen needle (CFR 880.5570) |
| Product Code | MMK |
| Classification | Class II Device |
| Classification Panel | General Hospital |
Table 1: Device Information
| Predicate Device Information | |
|---|---|
| Sharps Container | |
| Manufacturer Name | Oakridge Products LLC. |
| Common Name | Sharps Container |
| Premarket Notification NO. | K130281 |
| Device Classification Name | Hypodermic single lumen needle (CFR 880.5570) |
| Product Code | MMK |
| Classification | Class II Device |
| Classification Panel | General Hospital |
Table 2: Predicate Device Information
- b. Date Prepared 05/23/2023
- c. Description of Device
The PureWay Sharps Collector is injection molded with High Density Polyethylene plastic (HDPE). Designed for single use, the container is puncture resistant, leak resistant on the sides and bottom, closable and stable. The container is labeled with a fill line and instructions for snapping
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Image /page/4/Picture/0 description: The image shows the logo for PureWay Total Compliance. The logo consists of an orange circle with a white star-like shape inside on the left. To the right of the circle is the text "PureWay" in a stylized font, with the words "TOTAL COMPLIANCE" in smaller letters underneath.
the container lid closed. "Do Not Overfill" to prevent overfill. The label is white and blue with white text and a black biohazard symbol is printed on a red background.
The container is made of two parts, (Base and Lid) that form a single unit. The red colored base is conical shaped, and the lid is a clamshell design snapped in place for a tight seal when the container is full.
The device is a non-sterile, single use, disposable infectious waste container and is designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container is conical which allows for one hand disposal of sharps and a clamshell lid for means of closure.
| ProductDescription | Access Opening Sizein Inches | Overall Sizein Inches | Weight(grams) | Capacity atfill line |
|---|---|---|---|---|
| 1.3 Quart | 1.25 inch | 7.75 x 3.9x 3.9 | 425 | 1 Quart |
Table 3: Device Description
d. Indications for Use
PureWay Compliance 1.4 Quart Sharps Collector Container is single-use, disposable, non-sterile and intended to be used for healthcare purposes for safe containment and disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target user is for healthcare professionals.
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Image /page/5/Picture/0 description: The image contains the logo for PureWay Total Compliance. The logo consists of an orange circle with six white shapes inside, resembling a star or flower. To the right of the circle is the text "PureWay" in a clean, sans-serif font, with "TOTAL COMPLIANCE" in smaller letters underneath.
e. Technological Characteristic Comparison
| Characteristics | Predicate Device Oakridge 1 Quart Container(K130281) | PureWay 1.4 Quart Sharps Collector(K231484) | Comparison |
|---|---|---|---|
| Indication for Use | The Oak Ridge Products Sharps containers aresingle-use, disposable, non-sterile containersintended to be used for healthcare purposesfor safe disposal of hazardous sharps such ashypodermic needles, syringes, lancets and | The PureWay Sharps container is a single-use,disposable, non-sterile container intended tobe used for healthcare purposes for safedisposal of hazardous sharps such ashypodermic needles, syringes, lancets and | Same |
| Use Location | The target population is for trainedhealthcare professionals. | The target population is for trained healthcareprofessionals. | Same |
| Material | Plastic PolypropyleneMaterial thickness .045" minimumInjection MoldedColor Red | Plastic Polyethylene HDPEMaterial thickness .045" minimumInjection MoldedColor Red | SimilarSameSameSame |
| Is Container Reusableor Single Use? | Single Use | Single Use | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Design | ClosableConstructed to contain all contents andprevent leakage during handling, storage,transport, or shipping.Impact resistantPuncture resistantLeak resistantOverfill indicationStable (maintaining upright position) | ClosableConstructed to contain all contents andprevent leakage during handling, storage,transport, or shipping.Impact resistantPuncture resistantLeak resistantOverfill indicationStable (maintaining upright position) | SameSameSameSameSameSameSameSame |
| Dimensions | Same | ||
| Access opening andclosure | Slide | Opening door | Same |
| Overall Size | 4.5" x 4.5"x 7.5" | 4.5" x 4.5" x 8" | Similar |
| Weight (grams) | 115 grams | 125 grams | Similar |
| Capacity at full line | .8 quarts | 1.0 quarts | Similar |
| No features to bend,break or shear needle. | No feature present | No feature present | Same |
| Clarity | Minimum of one translucent component,either base or top | Minimum one translucent component eitherbase or top | Same |
The PureWay 1.3 quart sharps collector is intended use and technology to the predicate device, Oakridge Products LLC. 1 Quart Sharps Container (K130281).
Both devices are injection molded plastic, designed for single use, puncture resistant, impact resistance, leak resistant, closable, and stable. The container is labeled with a fill line and instructions for snapping the container lid closed.
Both containers are made of three parts, (Base, Lid, and Label) that form a single unit. The red colored base is conical shaped, and the lid is designed to snap in place for a tight seal.
Both devices are single use only and not sterile.
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Image /page/6/Picture/0 description: The image shows the logo for PureWay Total Compliance. The logo consists of an orange circle with a white star-like shape inside, followed by the text "PureWay" in a stylized font. Below "PureWay" is the text "TOTAL COMPLIANCE" in smaller, all-caps letters.
f. Summary of Non-Clinical Performance Data
| Test Performed | Test Method/ApplicableStandard (s) | Acceptance Criteria | PredicateDevice(K130281) | PureWay 1.4Quart(K231484) |
|---|---|---|---|---|
| Container stability | ISO 23907-1:2019 Section 5.1Container stability | The container shall not topple over when tested. | Pass | Pass |
| Resistance topenetration | ISO 23907-1:2019 Section 5.3Resistance to penetration | When tested the force needed to penetrate test specimensshall be a minimum of 16 N and an average of 18 N orgreater. | Pass | Pass |
| Resistance to damageor leakage afterdropping | ISO 23907-1:2019 Section 5.4Resistance to damage andleakage after dropping | When tested there shall be no evidence of leakage and nobreach of the sharp's containment area.Minimum five minutes after each topple, the followingpoints shall be visually checked: | Pass | Pass |
| 1. No evidence that the performance or function ofthe container has been compromised. | Pass | Pass | ||
| 2. Container's temporary closure shall remain intact. | Pass | Pass | ||
| Resistance todamage or leakageafter toppling | ISO 23907-1:2019 Section 5.5Resistance to spillage bytoppling | There shall be no evidence of breach of the sharpscontainment area.Minimum five minutes after each topple, the followingpoints shall be visually checked: | Pass | Pass |
| 1. There shall be no evidence that the performanceor function of the container has beencompromised. | Pass | Pass | ||
| 2. The container's temporary closure shall remainintact | Pass | Pass | ||
| Fill line indicator | ISO 23907-1:2019 Section4.2.7 Fill line indicator | 1. Fill line shall be determined by the design of thecontainer, taking into account the risk of sharpsextending above the fill line, and shall be at alevel no greater than 85 % of the total volume ofthe container.2. Fill line feature helps prevent overfilling and is acritical safety feature of a sharps container.3. It shall be possible to ensure the sharps are notabove the fill line. This can be achieved eithervisually or mechanically. | Pass | Pass |
| Strength of Handles | ISO 23907-1:2019 4.2.2 and5.2 | 1. All sharps containers shall be provided with oneor several handles.2. The handle/carrying feature shall not break ordetach during testing.3. The position of the handles(s), finger recesses,protrusions or flanges shall not interfere with thenormal use of the container.4. Fill the container with a mass equivalent to 150% ofmanufacturer's maximum allowable gross mass.Suspend the container by its handles(s) at theintended carrying points(s) from a rigid support for 1h at a temperature of (23+/- 5) degrees Celsius.Remove the container from the support and inspectthe handles for integrity and for any evidence ofdetachment of the handles(s) from the container. | N/ANo Handles | Pass, noevidence ofdetachmentof thehandles(s)from thecontainer. |
Bench testing has demonstrated that the device is in compliance with ISO 23907-11:2019 for Single Use Sharps Container and the expectation of the FDA Guidance Document, "Guidance on the content of Format of Premarket Notification (510(k)) submission for Sharps, dated October 1993.
g. Summary of Clinical Data: Not Applicable
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Image /page/7/Picture/0 description: The image contains the logo for PureWay Total Compliance. The logo consists of an orange circle with a white star-like shape inside, followed by the text "PureWay" in a stylized font. Below "PureWay" is the text "TOTAL COMPLIANCE" in a smaller, sans-serif font.
h. Conclusion
The conclusions drawn for the non-clinical tests demonstrate that the device is as safe, as effective and performs as well as or better than the legally marketed predicate device.
§ 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).