Maxcon Sharps Container

K180984 · Ningbo Maxcon Medical Technology Co., Ltd. · MMK · Jan 3, 2019 · General Hospital

Device Facts

• Record ID: K180984
• Device Name: Maxcon Sharps Container
• Applicant: Ningbo Maxcon Medical Technology Co., Ltd.
• Product Code: MMK · General Hospital
• Decision Date: Jan 3, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

Maxcon Sharps containers (2.2 QT Sharps Container, MA1122; 2G Sharps Container MA1321; 2 G Sharp Container MA1221; 8G Sharps Container MA1352) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All the containers are intended to be used in areas where there is no unsupervised patient access.

Device Story

Maxcon Sharps Containers are single-use, non-sterile, injection-molded polypropylene containers for the disposal of hazardous medical sharps. The device consists of a base, lid, and closure, which are shipped nested and assembled on-site by healthcare personnel. The containers feature various door types (rotary, folding, sliding, hinged) and an integrated needle unwinder on specific models (MA1122, MA1221, MA1352) to allow for hands-free detachment of needles from syringes. The containers are used in healthcare facilities to provide a stable, puncture-resistant, and leak-proof receptacle for sharps waste. They are labeled with biohazard symbols and include a fill line to prevent overfilling. The device does not bend, break, or shear needles. The primary benefit is the safe containment of sharps to prevent injury to healthcare workers.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including puncture resistance (ASTM F2132-01), container/bracket stability, handle strength, drop/impact resistance, stacking, vibration, and leak-proof testing (ISO 23907).

Technological Characteristics

Materials: Injection-molded polypropylene. Design: 3-part assembly (base, lid, closure). Features: Integrated needle unwinder (select models), translucent component for fill-level monitoring. Energy: None (mechanical). Connectivity: None. Sterilization: Non-sterile. Standards: ASTM F2132-01 (puncture resistance), ISO 23907 (stability, handle strength, drop/leakage), 49CFR 178.606 (stacking/vibration).

Indications for Use

Indicated for safe disposal of hazardous sharps (hypodermic needles, syringes, lancets, blood needles) by qualified personnel in healthcare or other facilities where sharps are used. Intended for areas without unsupervised patient access.

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

• Oak Ridge Products Sharps Container (K161180)

Reference Devices

• Oak Ridge Products Sharps Container (K141759)

Submission Summary (Full Text)

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January 3, 2019

Ningbo Maxcon Medical Technology Co., Ltd. Yang Song Sales Manager No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town Ningbo, 315157 Cn

Re: K180984

Trade/Device Name: Maxcon Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: November 21, 2018 Received: December 7, 2018

Dear Yang Song:

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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Elizabeth F. Claverie -S

For Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K180984

Device Name Maxcon Sharps Container

Indications for Use (Describe)

MaxconSharps containers(2.2QTSharpsContainer,MA1122;2GSharps Container MA1321;2GSharp Container MA1221; 8GSharps Container MA1352) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal ofhazardous sharps such as hypodermic needles, syringes, lancets and blood needles.The target population is for qualified personnel in health care facilities in which medical sharps may be used. All the containers are intended to be used in areas where is no unsupervised patient access.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
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Image /page/3/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are black, and there are three diagonal lines to the left of the word. A plus sign is embedded in the letter "O".

Ningbo Maxcon Medical Technology Co., Ltd

## 510(k) Summary

The assigned 510(k) number is: K180984

- 1. Date Prepared: January 3, 2019
#### 2. Submitter's Identification:

Ningbo Maxcon Medical Technology Co.,Ltd

Address:No.228,Dongxin Road,Dongqiao Town,Yinzhou.Ningbo,Zhejiang province,China

Contact person: Mr.Song Yang, Sales manager of business department Telephone:

([phone]

E-mail:[e-mail]

Zip code:315157

- 3. Name of the Device:
Device Name:Sharps Container

Trade Name:Maxcon Sharps Container

Including models: 2.2 QT Sharps Container, MA1122; 2G Sharps Container MA1321 ; 2 G Sharp Container MA1221; 8G Sharps Container MA1352

#### 4. Classification Information:

Product Code: MMK

Device Class: Class II

CFR Reference: 21 CFR 880.5570

Classification: accessory to hypodermic single lumen needles

Classification Panel:General Hospital

#### ર. Predicate Device Information:

Trade name: Oak Ridge Products Sharps Container, manufactured by Oak Ridge

Products L.L.C, located in 4612 Century Court, McHenry, Illinois,

60050 USA

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Ningbo Maxcon Medical Technology Co., Ltd

Common name: Sharps Container

Product code: MMK

Classification: Accessory to hypodermic single lumen needles

CFR Reference: 21CFR 880.5570-Class II

Classification Panel: General Hospital

Legally Marketed Equivalent Device:

| Company | Product description | Oak Ridge part<br>number | 510(K)# |
|-----------------------|--------------------------------------------|--------------------------|------------------------------------|
| Oak Ridge<br>Products | 2.2 Quart Rotary Lid<br>Sharps-rotary door | 0322-150R | K161180<br>(Primary<br>predicate ) |
| Oak Ridge<br>Product | 1 Gallon Sharps<br>Container-sliding door | 0319-1500 | K161180<br>(Primary<br>predicate ) |
| Oak Ridge<br>Product | 2 Gallon<br>Sharps-w/folding door | 0320-150F | K161180<br>(Primary<br>predicate ) |
| Oak Ridge<br>Product | 7 Gallon Sharps<br>Container -hinged door | 0370-1500 | K141759<br>(Reference<br>device) |

#### Intended use / Indication for Use: 6.

Maxcon Sharps containers (2.2 QT Sharps Container, MA1122; 2G Sharps Container MA1321 ; 2 G Sharp Container MA1221; 8G Sharps Container MA1352 ) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All the containers are intended to be used in areas where there is no unsupervised patient access.

#### 7. Device Description:

Maxcon Sharps Containers are made of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other

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Nin Maxcon Medical Technology Co., Ltd

facilities in which medical sharps may be used, the same as that of the comparable predicate devices.

Maxcon Sharps Containers are composed of 3 parts (base+lid+closure).No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers. The lid and the closure come pre-assembled with the base not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the lid to the base.

Labels are on a red background with printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with the fill line warning matching the engraved fill line on the container.

There is no feature to bend, break, or shear needle ,includes blunting and melting of

| Product | Product description | Access | Overall | Weight | Total | Capaci | Mounting |
|---------|--------------------------------------------------|---------|------------------------|------------------|--------------|--------------------------|--------------------------------------------------------|
| Model | and closure type | opening | size L×<br>W×<br>H(mm) | (grams)<br>empty | capacit<br>y | ty<br>at<br>full<br>line | |
| MA1122 | 2.2 quart red sharps<br>container-rotary<br>door | 86x38 | 160x120x<br>181 | 175 | 2.1 L | 1.6 L | Free standing<br>or<br>double<br>face adhesive<br>tape |
| MA1221 | 2 gallon red sharps<br>container-folding<br>door | 203x63 | 316x152x<br>230 | 421 | 7.5 L | 6 L | Free standing<br>or bracket |
| MA1321 | 2 gallon red sharps<br>container-sliding<br>door | 139x61 | 275x180x<br>254 | 365 | 7.5 L | 6 L | Free standing<br>or bracket |
| MA1352 | 8 gallon red sharps<br>container-hinged<br>door | 226x126 | 390x276x<br>435 | 1220 | 27.3L | 21 L | Free-standing |

needle in the containers.

The maximum allowable gross mass of the container is defined as follows:

| Model | Maximum allowable gross mass in the container |
|--------|-----------------------------------------------|
| MA1122 | 0.5kg |
| MA1321 | 2kg |
| MA1221 | 2kg |
| MA1352 | 8kg |

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Image /page/6/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. There are two diagonal lines to the left of the word. The plus sign is in the middle of the word, between the letters C and O. The letters are all capitalized and have a sans-serif font.

Ningbo Maxcon Medical Technology Co., Ltd

#### Needle unwinder Feature:

The unwinder feature on the 2.2 quart container(model: MA1122, rotary door), 2 gallon container (model: MA1221, folding door) and 8 gallon container (model:MA1352, hinged door) is located in the lid and above the containment area. The unwinder has a round entry port for the needle to pass through, allowing it to be fully enclosed within the container. Once the needle is inserted into the round port, the Luer end of the needle is guided into the tapered slot which secures the needle body allowing for the syringe to be rotated and detached from the needle. The needle is unscrewed from the syringe body allowing it to drop into the container without the need to be touch or handled.

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#

## 8. _Comparing to Predicate Device:

| Characteristics | Subject device manufactured by Ningbo<br>Maxcon Medical Technology Co.,Ltd | Predicate device<br>Oak Ridge Products<br>(K161180)<br>(Predicate device) | Predicate device<br>Oak Ridge Products<br>(K141759)<br>(Reference device) | S.E<br>Comparison | | | | | |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------|-----------------------|----------------------------------------------------------------------------------------------------------|-----------|
| Product<br>code/class/regulation number | MMK/class II/ 21 CFR 880.5570 | MMK/class II/ 21 CFR 880.5570 | MMK/class II/ 21 CFR 880.5570 | Same | | | | | |
| Indications for<br>use/intended use | Maxcon Sharps containers are single-use,<br>disposable, non-sterile containers intended<br>to be used for health-care purposes for<br>safe disposal of hazardous sharps such as<br>hypodermic needles, syringes, lancets and<br>blood needles.The target population is for<br>qualified personnel in health care facilities<br>and other facilities in which medical<br>sharps may be used. All the containers are<br>intended to be used in areas where there is<br>no unsupervised patient access. | Oak Ridge Products Sharps<br>Containers are a single-use,<br>disposable, non-sterile containers<br>intended to be used for healthcare<br>purposes for safe disposal of<br>hazardous sharps such as<br>hypodermic needles, syringes,<br>lancets and blood needles. The<br>target population is for trained<br>healthcare professional.All the<br>containers are intended to be used<br>in areas where there is no<br>unsupervised patient access. | Oak Ridge Products Sharps<br>Containers are a single-use,<br>disposable, non-sterile<br>containers intended to be used<br>for healthcare purposes for<br>safe disposal of hazardous<br>sharps such as hypodermic<br>needles, syringes, lancets and<br>blood needles. The target<br>population is for trained<br>healthcare professional. | Same | | | | | |
| Device design | All is comprised of 3 components, a container base+a lid+a closure. Its closure is designed of 4 types: Rotary<br>door ,Folding door, sliding door and hinged door. The lid and the closure come pre-assembled with the base not<br>attached. Components are nested together to reduce storage and shipping requirements. The health care facility<br>performs the final assembly on-site by snapping the lid to the base. | | | | | | | | |
| Where it is used | Health care facility and other facility in<br>which medical sharps may be used | Health care facility | Health care facility | Same | | | | | |
| Materials used | Injection molded of Poly-propylene | Injection molded of<br>Poly-propylene | Injection molded of<br>Poly-propylene | Same | | | | | |
| Size | 2.2 Quart | 2 gallon<br>2 gallon | 8 gallon | 2.2 Quart<br>1 Gallon<br>2 Gallon | 7 Gallon | Different | | | |
| Dimensions<br>(inches ) | 6.25×4.6<br>×6.7 | 12.4x6x<br>9 | 10.8x<br>7.1x1<br>0 | 15.35x1<br>0.9x17.<br>1 | 6.25×4.6×6.<br>7 | 10.3×7.<br>0×5.5<br> | 10.3×<br>7.0×1<br>0.1 | 15.5×12×13.75 | Different |
| Weight (grams) | 175 | 421 | 365 | 1220 | 172 | 280 | 397 | 1228 | Different |
| Access opening<br>size(inches) | 3.4×1.5 | 8×2.5 | 5.5×2.<br>4 | 8.9x5<br>(Major),<br>3.4×1.5<br>(minor) | 3.4×1.5 | 5.6×2.3 | 8.2×2.<br>1 | 13.75×4.75 (Major),<br>8.75×1.75 (minor) | Different |
| Non-clinical<br>testing | Successfully passed through tests of<br>impact resistance, puncture resistance and<br>leak resistance | | | | Successfully passed through tests<br>of impact resistance, puncture<br>resistance and leak resistance | | | Successfully passed through<br>tests of impact resistance,<br>puncture resistance and leak<br>resistance | Same |
| No features to<br>bend, break, or<br>shear needle | No feature present | | | | No feature present | | | No feature present | Same |

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Image /page/8/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. There are two black lines to the left of the word. The "+" symbol is in the middle of the letter "O".

#### l td Ningbo Maxcon Medical Technolog

| Clarity | Each container has one translucent component, allowing visibility to check whether the wasted sharp reach to fill line or not | Each container has one translucent component, allowing visibility to check whether the wasted sharp reach to fill line or not | Each container has one translucent component, allowing visibility to check whether the wasted sharp reach to fill line or not | Same | |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------|------|
| Capable of maintaining a stable and upright position | Yes | Yes | Yes | Same | |
| Performance, effectiveness and safety | All container has been successfully passed through test items as follows:<br>Puncture Resistance as per FDA Recognized Consensus Standards, 6-215, ASTM F2132 -01 Standard Specification for Puncture Resistance of Material Used in Containers for Discarded Medical Needles and Other Sharps (Reapproved 2008)e1, Container stability, as well as bracket stability as per FDA Recognized Consensus Standards, 6-293, ISO 23907 First edition 2012-09-01Sharps injury protection - Requirements and test methods - Sharps containers. Handle strength as per FDA Recognized Consensus Standards, 6-293 , ISO 23907 First edition 2012-09-01Sharps injury protection - Requirements and test methods - Sharps containers. Resistance to damage and leakage after dropping as per FDA Recognized Consensus Standards, 6-293, ISO 23907 First edition 2012-09-01Sharps injury protection - Requirements and test methods - Sharps containers. Occupational Safety and Health Administration - Occupational Exposure to Bloodborne Pathogens; final rule (29 CFR 1910.1030; Federal Register 1991 December 6; 56, No. 235:64175-82. | | | | Same |
| End-color change | No color change | No color change | No color change | Same | |
| Claimed sterilization cycles | Non sterile | Non sterile | Non sterile | Same | |
| Operation way | Drop the wasted sharps into container by one hand | Drop the wasted sharps into container by one hand | Drop the wasted sharps into container by one hand | Same | |
| Single use or not | Single used and disposable ones | Single used and disposable ones | Single used and disposable ones | Same | |
| Labeling | Biohazard labels visible on device | Biohazard labels visible on device | Biohazard labels visible on device | Same | |

### 9. Performance Data

Maxcon Sharps Containers have similar indications for use and technological

characteristics as the predicate device, based on the subject containers can be

successfully passed through the tests as follows:

- Puncture Resistance (based on ASTM F 2132-01 (2008)) Passed ロ
- ロ Container Stability (based on ISO 23907:2012)- Passed
- Drop/impact Test (based on ISO 23907:2012)-Passed

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Image /page/9/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. There are three diagonal lines to the left of the word. The "+" symbol is embedded in the letter "O".

Ningbo Maxcon Medical Technology

- Handle Strength (based on ISO 23907:2012)- Passed ロ
- Stacking Test (based on 49CFR 178.606)- Passed ロ
- Vibration Test (based on 49CFR 178.606)-Passed ロ
- Sharps access and closure for repeated openings and closings-Passed
- Label Integrity Test (based on ISO23907:2012)-Passed
- Usable Capacity Test-Passed ロ
- ロ Minimum Sharps Container wall Thickness Evaluation-Passed
- ロ Shelf-life study (including real-time aging and accelerated-time aging to support its shelf life of

3 years)-Passed

- Simulated life cycle test-Passed ロ
- Leak Proof on the sides and bottom-Passed ロ

Although the subject device and predicate devices differ in containers size, dimensions, and containers capacities etc, the difference in technological characteristics do not impair the subject devices from their intended functions of disposal and storage of sharp waste, and did not compromise the SE (Substantially equivalent) to the predicated device.

- 10. Discussion of Clinical Tests Performed:
There was no clinical testing required to support the medical device

- 11. Conclusions:
We have demonstrated in this 510(k) submission that based on the nonclinical tests performed the subject devices, Maxcon Sharps containers (2.2 QT Sharps Container, MA1122; 2G Sharps Container MA1321; 2 G Sharp Container MA1221; 8G Sharps Container MA1352), are as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices (Oak

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Image /page/10/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. There are three lines to the left of the word "MAXCON". The letter "O" in "MAXCON" has a plus sign inside of it. The font is sans-serif.

宁波迈克斯康医疗科技有限公司 Ningbo Maxcon Medical Technology Co., Ltd

Ridge Products Sharps, K141759 (Reference device) and K161180(Primary

predicate device), Class II (21 CFR 880.5570), product code MMK