PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON
Device Facts
| Record ID | K151249 |
|---|---|
| Device Name | PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTOR 2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON |
| Applicant | Pureway Compliance, Inc. |
| Product Code | MMK · General Hospital |
| Decision Date | Sep 4, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5570 |
| Device Class | Class 2 |
Indications for Use
The PureWay® Sharps Collector Container is a disposable infectious waste container in 1.2 gallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector Container will be ultimately destroyed through incineration.
Device Story
PureWay® Sharps Collector Container is a single-use, disposable, blow-molded HDPE infectious waste container available in 1.2, 2, and 3-gallon sizes. Device features a rectangular body with a circular aperture (1.25-inch diameter) and an insert to prevent hand access or accidental spillage. Used in healthcare settings (hospitals, clinics, labs) by clinicians and staff for one-handed disposal of contaminated sharps. Once filled to the designated line, the container is sealed with a screw-top lid for transport and final destruction via incineration. Device provides a physical barrier to prevent sharps injuries and biohazard exposure during collection and transport.
Clinical Evidence
Bench testing only. No clinical data. Performance testing demonstrated compliance with ISO 23907 (stability, handle strength, penetration resistance, drop/leakage resistance), CSA Z316.6-07 (fill capacity), and ASTM F2132-01.
Technological Characteristics
Materials: Blow-molded High Density Polyethylene (HDPE) container; Low Density Polyethylene (LDPE) aperture insert. Design: Rectangular, single-use, non-sterile, red opaque. Features: 1.25-inch diameter circular aperture, screw-top lid closure, fill-line indicator. Standards: ISO 23907, CSA Z316.6-07, ASTM F2132-01. Connectivity: None. Energy source: None (mechanical).
Indications for Use
Indicated for use in healthcare settings as a receptacle for used, contaminated medical sharps, including angio-caths, blood needles, lancets, cap needles, and syringes, for enclosure during transport to ultimate disposal via incineration.
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
- GRP Sharps Container (K132476)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2015
PureWay Compliance, Inc. Jeffery Miglicco VP of Sales & Operations 201 Santa Monica Blvd. Suite 400 Santa Monica, CA 90401
Re: K151249
> Trade/Device Name: PureWay® Sharps Collector Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: August 7, 2015 Received: August 10, 2015
Dear Mr. 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. 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.
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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
**Tejashri Purohit-Sheth, M.D.**
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K151249
Device Name PureWay® Sharps Collector Container
#### Indications for Use (Describe)
The PureWay® Sharps Collector Container is a disposable infectious waste container in 1.2 gallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector Container will be ultimately destroyed through incineration.
There are three indications for use statements corresponding to three sizes of container. These are reproduced below: Indications for Use Statement: 1.2 Gallon PureWay® Sharps Collector Container
The empty device, as it sits, is a red container that measures 10.75" x 6" x 7.27" and weighs 7oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Indications for Use Statement: 2 Gallon PureWay® Sharps Collector Container
The empty device, as it sits, is a red container that measures 10.75" x 11.15" and weighs 11b 1oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Indications for Use Statement: 3 Gallon PureWay® Sharps Collector Container
The empty device, as it sits, is a red container that measures 10.75" x 15.73" and weighs 2 lbs. The aperture includes an inset which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X 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. On the left is an orange circle with a white star-like shape inside. To the right of the circle is the company name, "PureWay" in a modern, sans-serif font, with "TOTAL COMPLIANCE" in smaller, uppercase letters underneath.
Image /page/3/Picture/1 description: The image shows three red medical waste containers of different sizes. The containers are rectangular with a handle on top and a white circular opening on the side. Each container has a label with text and a biohazard symbol.
# 5. 510 (k) Summary
| a. | Submitter | PureWay Compliance, Inc. |
|----|--------------------|---------------------------------------------------------------------------------------------------------------------------|
| | Headquarters | 201 Santa Monica Blvd, Suite 400<br>Santa Monica, CA 90401 |
| | Regional Office | 20501 Katy Freeway, Suite 206<br>Katy, TX 77450<br>Main: 877.765.3030 ext. 118<br>Cell: 713.248.2289<br>Fax: 310.752.1944 |
| | Manufacturing site | 1908 East Dominguez Street<br>Carson, CA 90810 |
| | Contact Person: | Jeffery Miglicco, VP of Sales & Operations<br>E-mail: Jeffm@pureway.com |
- Date prepared b. 4/22/15
#### Device Identification C.
| Trade or Proprietary Name | PureWay® Sharps Collector Container |
|---------------------------|------------------------------------------------|
| Common Name | Sharps Containers |
| 510(k) number | K151249 |
| Classification Name | Hypodermic single lumen needle (CFR: 880.5570) |
| Product code | MMK |
| Classification | Class II device |
| Classification Panel | General Hospital |
#### d. Predicate Device
GRP Sharps Container 510(k) number K132476
#### Device -Description e.
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic and is available in 1.2 Gallon and 3 Gallon sizes. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal.
Each container is non-sterile, single use, disposable infectious waste container).
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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, followed by the text "PureWay" in a stylized font. Below "PureWay" is the text "TOTAL COMPLIANCE" in a smaller, sans-serif font.
Image /page/4/Picture/1 description: The image shows three red medical waste containers of different sizes. The containers are rectangular with a handle on top and a circular opening on the side. Each container has a label with a biohazard symbol and text. The containers appear to be made of plastic and are designed for the safe disposal of medical waste.
The containers are designed to contain and hold sharps such as anqio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture.
In summary, all PureWay® Sharps Collector containers are blow molded usinq High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure.
#### f. Indications for Use
The PureWay® Sharps Collector container is a disposable infectious waste container in 1.2 qallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector container will be ultimately destroyed through incineration.
There are three indications for use statements corresponding to three sizes of container. These are reproduced below:
### Indications for Use Statement: 1.2 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75″ x 6″ x 7.27″ and weighs 7oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, sinqle use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
### Indications for Use Statement: 2 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75″ x 6″ x 11.15″ and weighs 11b 1oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
### Indications for Use Statement: 3 Gallon PureWay® Sharps Collector container
The empty device, as it sits, is a red container that measures 10.75" x 15.73" and weighs 2 Ibs. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
### Directions for use
- 1. Carefully place sharps into container
- 2. Do not fill past line on container
- 3. Seal the container with the lid provided
- 4. Destroy by incineration
#### Standards & Test Methods g.
The following FDA recognized standards were used in the preparation of this 510(k)
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Image /page/5/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" are the words "TOTAL COMPLIANCE" in smaller, sans-serif font.
Image /page/5/Figure/1 description: The image shows three red medical waste containers of different sizes. The containers have a white circular opening on top and a white circular cap on the side. Each container has a label with text and a biohazard symbol.
| Standards | Standard section | Validation test conducted |
|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 23907 First<br>edition 2012-09-01<br>Sharps injury<br>protection -<br>Requirements and<br>test methods - Sharps<br>containers | 5.1 container stability | Container filled to fill line and placed in the most<br>adverse position for toppling on a surface with a<br>minimum inclination angle of 15 degrees. |
| | 5.2 Strength of handle(s) | Fill the container with a mass equal to 150% of<br>maximum allowable gross mass, close the container<br>and suspend the container by its handle(s) at the<br>intended carrying point9s) from a rigid support for 1<br>hour at a temperature of (23+/- 5) degrees Celsius. |
| | 5.3 resistance to<br>penetration | Test the thickness and strength of the container at the<br>worst-case area for needle penetration. |
| | 5.4 Resistance to damage<br>and leakage after dropping | The container is dropped minimum height of 1m(39.5")<br>at a specified temperature on all sides of the container. |
#### Comparison of Technological Characteristics with the Predicate Device h.
The following table compares the PureWay® Sharps Collector container to the GRP Sharps Container with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.
| Manufacturer | PureWay Compliance | GRP and Associates |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | PureWay® Sharps Collector | GRP Sharps Container, models 1G, 2G and 3G |
| Common/Usual Name | Sharps Container | Sharps Container |
| 510(k) Number | K151249 | K132476 |
| Product Code | MMK (same) | MMK |
| Classification | 21CFR 880.5570 (same) | 21 CFR 880.5570 |
| Classification Name | Hypodermic single lumen needle | Hypodermic single lumen needle |
| Indications for Use | The PureWay® Sharps Collector container is a<br>disposable infectious waste container in 1.2<br>gallon, 2 gallon and 3 gallon sizes, intended for<br>use in a healthcare setting. The PureWay®<br>Sharps Collector container will be ultimately<br>destroyed through incineration. | The empty device, as it sits, is a red container<br>that measures comes in three different sizes 1<br>gallon, 2 gallon and 3 gallon. The intended<br>use of the vertical entry, single use, sharps<br>containers, is to provide a receptacle for<br>used, contaminated medical sharps, and for<br>enclosure during transport to ultimate<br>disposal. The container is intended to be<br>used in hospitals, clinics, operating rooms,<br>and laboratories by technicians, doctors,<br>dentist, and veterinarians. |
| Product classification | Class II -(Same) | Class II |
| Labeling: Biohazard<br>labels visible on device | Yes (same) | Yes |
### Table 5A - Comparison of Characteristics
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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, sans-serif font.
Image /page/6/Picture/1 description: The image shows three different sizes of red medical waste containers. The containers are all rectangular with a handle on top and a circular opening on the side. The containers have labels on the front with the biohazard symbol. The containers appear to be made of plastic.
| Disposal procedures<br>including in labeling | Yes (same) | Yes |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assembly, mounting<br>procedures | None. Free standing on wide rectangular base<br>(same) | None. Free standing on wide base |
| Operating Instructions | Yes - IFU - (Same) | Yes - IFU |
| Device Description &<br>Volume | 1.2 gallon, 2 gallon, and 3 gallon sharps<br>containers (similar) | 1.5 Qt, 1 gallon, 2 gallon, and 3 gallon sharps<br>containers |
| Materials of<br>Construction | Blow molded HDPE (High Density<br>Polyethylene) (same) | Blow molded HDPE |
| Color | Red, opaque (same) | Red, opaque |
| Puncture Resistance | YES | YES |
| Closure | 1.25" circular aperture at the top of the<br>container allowing vertical drop of sharps and is<br>closed using a screw top lid - (similar) | Spun-weld iris, functions as an aperture<br>allowing vertical drop of sharps |
| Leak-proof on sides<br>and bottom | YES | YES |
| Labeled or color-<br>coded | Labeled and color coded, biohazard labeled.<br>Picture provided below - (same) | Labeled and color coded, biohazard labeled |
| Single use or reusable | Single Use (same) | Single Use |
| Intended location | The container is intended to be used in a<br>healthcare setting. | The container is intended to be used in<br>nursing homes, doctor's offices, dental<br>offices, emergency room, emergency vehicles<br>and labs for the safe disposal of hazardous<br>sharps |
| Includes features to<br>bend, break or shear<br>needles | No (same) | No |
| Container full<br>indication | Yes - clearly marked fill line on container<br>(same) | Yes - clearly marked fill line on container |
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Image /page/7/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 company name "PureWay" in a stylized font, with the words "TOTAL COMPLIANCE" in smaller letters underneath.
Image /page/7/Picture/1 description: The image shows three red medical waste containers of different sizes. The containers are all rectangular with a handle on top and a circular opening on the side. The containers have a label on the front with the words "Pegasus" and a biohazard symbol. The containers are arranged in a row, with the smallest container on the left and the largest container on the right.
### Non-Clinical Performance Data
The PureWay® Sharps Collector container has been performance tested and demonstrates compliance with the recognized consensus standard, ISO 23907 First edition 2012-09-01 Sharps injury protection – Requirements and test methods - Sharps containers (Stability, Handle Strength, Penetration, Handling and Leak Resistance). In addition, the FDA Guidance Document "Guidance on the content of Format of Premarket Notification (510(k)) submission for Sharps, dated October 1993, was used to help identify applicable physical and mechanical features of the subject device.
Testing was conducted in accordance with:
- ISO 23907 First edition 2012-09-01 Sharps injury protection Requirements and test methods Sharps ● containers (Stability, Handle Strength, Penetration, Handling and Leak Resistance)
- CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for bio hazardous and ● cytotoxic waste - Fill Capacity
- ASTM F2132-01
The performance testing demonstrates compliance with all the recognized consensus standards listed above. Testing results show the PureWay® Sharps Collector containers (sizes 1.2, 2 and 3 qallon) pass all applicable and required tests. An independent testing laboratory performed all the test listed in this section according to the standards requirements. Additional testing data is presented in the performance testing section. In addition, the FDA Guidance Document "Guidance on the Content of Premarket Notification (510(k)) submissions for Sharps, dated October 1993, was used to help identify applicable physical and mechanical features of the subject device.
#### i. Conclusion
The subject device is substantially equivalent to the predicate device.
