PureWay 1.4 Quart Sharps Collector

K231484 · Pureway Compliance, Inc. · MMK · Sep 14, 2023 · General Hospital

Device Facts

• Record ID: K231484
• Device Name: PureWay 1.4 Quart Sharps Collector
• Applicant: Pureway Compliance, Inc.
• Product Code: MMK · General Hospital
• Decision Date: Sep 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended 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.

Device Story

The PureWay 1.4 Quart Sharps Collector is a single-use, non-sterile, injection-molded HDPE plastic container designed for the safe containment and disposal of hazardous sharps (e.g., hypodermic needles, syringes, lancets). The device features a conical base and a snap-on clamshell lid to ensure a tight seal. It is intended for use by healthcare professionals in clinical settings. The container is puncture-resistant, leak-resistant, and stable. It includes a fill line indicator to prevent overfilling. The device is operated manually; the user places sharps into the container through the access opening and snaps the lid closed when full. The device provides a secure, puncture-resistant environment for sharps disposal, reducing the risk of accidental needlestick injuries to healthcare staff.

Clinical Evidence

No clinical data. Bench testing only. The device was tested for compliance with ISO 23907-1:2019, including container stability, resistance to penetration, resistance to damage/leakage after dropping and toppling, fill line indicator accuracy, and handle strength.

Technological Characteristics

Material: High Density Polyethylene (HDPE); Injection molded; Red color. Dimensions: 4.5" x 4.5" x 8". Capacity: 1.0 quart at fill line. Features: Conical base, snap-on clamshell lid, puncture/leak-resistant, fill line indicator. Standards: ISO 23907-1:2019. Sterilization: Non-sterile.

Indications for Use

Indicated for healthcare professionals for the safe containment and disposal of hazardous sharps, including hypodermic needles, syringes, lancets, and blood needles.

Regulatory Classification

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.

Predicate Devices

• Oakridge Products LLC. 1 Quart Sharps Container (K130281)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="white-space: nowrap;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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 Quality<br>E-mail: [e-mail]<br>Cell: 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.

| Product<br>Description | Access Opening Size<br>in Inches | Overall Size<br>in Inches | Weight<br>(grams) | Capacity at<br>fill 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<br>(K130281) | PureWay 1.4 Quart Sharps Collector<br>(K231484) | Comparison |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Indication for Use | The Oak Ridge Products Sharps containers are<br>single-use, disposable, non-sterile containers<br>intended to be used for healthcare purposes<br>for safe disposal of hazardous sharps such as<br>hypodermic needles, syringes, lancets and | The PureWay Sharps container is a single-use,<br>disposable, non-sterile container intended to<br>be used for healthcare purposes for safe<br>disposal of hazardous sharps such as<br>hypodermic needles, syringes, lancets and | Same |
| Use Location | The target population is for trained<br>healthcare professionals. | The target population is for trained healthcare<br>professionals. | Same |
| Material | Plastic Polypropylene<br>Material thickness .045" minimum<br>Injection Molded<br>Color Red | Plastic Polyethylene HDPE<br>Material thickness .045" minimum<br>Injection Molded<br>Color Red | Similar<br>Same<br>Same<br>Same |
| Is Container Reusable<br>or Single Use? | Single Use | Single Use | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Design | Closable<br>Constructed to contain all contents and<br>prevent leakage during handling, storage,<br>transport, or shipping.<br>Impact resistant<br>Puncture resistant<br>Leak resistant<br>Overfill indication<br>Stable (maintaining upright position) | Closable<br>Constructed to contain all contents and<br>prevent leakage during handling, storage,<br>transport, or shipping.<br>Impact resistant<br>Puncture resistant<br>Leak resistant<br>Overfill indication<br>Stable (maintaining upright position) | Same<br>Same<br>Same<br>Same<br>Same<br>Same<br>Same<br>Same |
| Dimensions | | | Same |
| Access opening and<br>closure | 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,<br>break or shear needle. | No feature present | No feature present | Same |
| Clarity | Minimum of one translucent component,<br>either base or top | Minimum one translucent component either<br>base 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/Applicable<br>Standard (s) | Acceptance Criteria | Predicate<br>Device<br>(K130281) | PureWay 1.4<br>Quart<br>(K231484) |
|------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------|
| Container stability | ISO 23907-1:2019 Section 5.1<br>Container stability | The container shall not topple over when tested. | Pass | Pass |
| Resistance to<br>penetration | ISO 23907-1:2019 Section 5.3<br>Resistance to penetration | When tested the force needed to penetrate test specimens<br>shall be a minimum of 16 N and an average of 18 N or<br>greater. | Pass | Pass |
| Resistance to damage<br>or leakage after<br>dropping | ISO 23907-1:2019 Section 5.4<br>Resistance to damage and<br>leakage after dropping | When tested there shall be no evidence of leakage and no<br>breach of the sharp's containment area.<br>Minimum five minutes after each topple, the following<br>points shall be visually checked: | Pass | Pass |
| | | 1. No evidence that the performance or function of<br>the container has been compromised. | Pass | Pass |
| | | 2. Container's temporary closure shall remain intact. | Pass | Pass |
| Resistance to<br>damage or leakage<br>after toppling | ISO 23907-1:2019 Section 5.5<br>Resistance to spillage by<br>toppling | There shall be no evidence of breach of the sharps<br>containment area.<br>Minimum five minutes after each topple, the following<br>points shall be visually checked: | Pass | Pass |
| | | 1. There shall be no evidence that the performance<br>or function of the container has been<br>compromised. | Pass | Pass |
| | | 2. The container's temporary closure shall remain<br>intact | Pass | Pass |
| Fill line indicator | ISO 23907-1:2019 Section<br>4.2.7 Fill line indicator | 1. Fill line shall be determined by the design of the<br>container, taking into account the risk of sharps<br>extending above the fill line, and shall be at a<br>level no greater than 85 % of the total volume of<br>the container.<br>2. Fill line feature helps prevent overfilling and is a<br>critical safety feature of a sharps container.<br>3. It shall be possible to ensure the sharps are not<br>above the fill line. This can be achieved either<br>visually or mechanically. | Pass | Pass |
| Strength of Handles | ISO 23907-1:2019 4.2.2 and<br>5.2 | 1. All sharps containers shall be provided with one<br>or several handles.<br>2. The handle/carrying feature shall not break or<br>detach during testing.<br>3. The position of the handles(s), finger recesses,<br>protrusions or flanges shall not interfere with the<br>normal use of the container.<br>4. Fill the container with a mass equivalent to 150% of<br>manufacturer's maximum allowable gross mass.<br>Suspend the container by its handles(s) at the<br>intended carrying points(s) from a rigid support for 1<br>h at a temperature of (23+/- 5) degrees Celsius.<br>Remove the container from the support and inspect<br>the handles for integrity and for any evidence of<br>detachment of the handles(s) from the container. | N/A<br>No Handles | Pass, no<br>evidence of<br>detachment<br>of the<br>handles(s)<br>from the<br>container. |

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.