(114 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and containment capabilities of a sharps collector, with no mention of AI or ML.
No.
A therapeutic device is used to treat or cure a disease or condition, and this device is designed for the safe disposal of hazardous sharps, not for treatment.
No
Explanation: The device is a sharps collector and is intended for the safe containment and disposal of hazardous sharps. It does not perform any diagnostic function.
No
The device description explicitly states it is an injection molded plastic container made of two parts (Base and Lid), which are physical hardware components.
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 "safe containment and disposal of hazardous sharps". This is a physical containment function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the container (material, shape, closure, puncture resistance, etc.) for holding sharps waste.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples, detect substances, or provide any diagnostic information about a patient's health.
- Performance Studies: The performance studies focus on the physical integrity and safety of the container (stability, resistance to penetration, leakage, etc.), which are relevant to its function as a sharps collector, not a diagnostic device.
- Predicate Device: The predicate device is also a "Sharps Container", further confirming its classification as a waste containment device.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This sharps collector does not perform any such function.
N/A
Intended Use / 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.
Product codes
MMK
Device Description
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.
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
healthcare professionals / healthcare purposes
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)
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. The tests performed include:
- Container stability: Passed according to ISO 23907-1:2019 Section 5.1.
- Resistance to penetration: Passed according to ISO 23907-1:2019 Section 5.3, with force needed to penetrate test specimens being a minimum of 16 N and an average of 18 N or greater.
- Resistance to damage or leakage after dropping: Passed according to ISO 23907-1:2019 Section 5.4, with no evidence of leakage and no breach of the sharp's containment area, performance/function compromised, or temporary closure integrity.
- Resistance to damage or leakage after toppling: Passed according to ISO 23907-1:2019 Section 5.5, with no evidence of breach of the sharps containment area, performance/function compromised, or temporary closure integrity.
- Fill line indicator: Passed according to ISO 23907-1:2019 Section 4.2.7. The fill line is at a level no greater than 85% of total volume, and it is possible to ensure sharps are not above the fill line visually.
- Strength of Handles: Not applicable for the predicate device (No Handles). PureWay 1.4 Quart passed (no evidence of detachment of the handles(s) from the container) according to ISO 23907-1:2019 4.2.2 and 5.2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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 Quality |
| E-mail: jeffm@pureway.com | |
| 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
4
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
Description | Access Opening Size
in Inches | Overall Size
in Inches | Weight
(grams) | Capacity at
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
(K130281) | PureWay 1.4 Quart Sharps Collector
(K231484) | Comparison |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Indication for Use | The Oak Ridge Products Sharps containers are
single-use, disposable, non-sterile containers
intended to be used for healthcare purposes
for safe disposal of hazardous sharps such as
hypodermic needles, syringes, lancets and | The PureWay Sharps container is a single-use,
disposable, non-sterile container intended to
be used for healthcare purposes for safe
disposal of hazardous sharps such as
hypodermic needles, syringes, lancets and | Same |
| Use Location | The target population is for trained
healthcare professionals. | The target population is for trained healthcare
professionals. | Same |
| Material | Plastic Polypropylene
Material thickness .045" minimum
Injection Molded
Color Red | Plastic Polyethylene HDPE
Material thickness .045" minimum
Injection Molded
Color Red | Similar
Same
Same
Same |
| Is Container Reusable
or Single Use? | Single Use | Single Use | Same |
| Sterilization | Non-sterile | Non-sterile | Same |
| Design | Closable
Constructed to contain all contents and
prevent leakage during handling, storage,
transport, or shipping.
Impact resistant
Puncture resistant
Leak resistant
Overfill indication
Stable (maintaining upright position) | Closable
Constructed to contain all contents and
prevent leakage during handling, storage,
transport, or shipping.
Impact resistant
Puncture resistant
Leak resistant
Overfill indication
Stable (maintaining upright position) | Same
Same
Same
Same
Same
Same
Same
Same |
| Dimensions | | | Same |
| Access opening and
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,
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 either
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
Standard (s) | Acceptance Criteria | Predicate
Device
(K130281) | PureWay 1.4
Quart
(K231484) |
|------------------------------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|-----------------------------------------------------------------------------------------|
| Container stability | ISO 23907-1:2019 Section 5.1
Container stability | The container shall not topple over when tested. | Pass | Pass |
| Resistance to
penetration | ISO 23907-1:2019 Section 5.3
Resistance to penetration | 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 | Pass |
| Resistance to damage
or leakage after
dropping | ISO 23907-1:2019 Section 5.4
Resistance to damage and
leakage after dropping | 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: | Pass | Pass |
| | | 1. No evidence that the performance or function of
the container has been compromised. | Pass | Pass |
| | | 2. Container's temporary closure shall remain intact. | Pass | Pass |
| Resistance to
damage or leakage
after toppling | ISO 23907-1:2019 Section 5.5
Resistance to spillage by
toppling | 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: | Pass | Pass |
| | | 1. There shall be no evidence that the performance
or function of the container has been
compromised. | Pass | Pass |
| | | 2. The container's temporary closure shall remain
intact | Pass | Pass |
| Fill line indicator | ISO 23907-1:2019 Section
4.2.7 Fill line indicator | 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 | 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. | N/A
No Handles | Pass, no
evidence of
detachment
of the
handles(s)
from the
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.