Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421

K222906 · Ningbo Maxcon Medical Technology Co., Ltd. · MMK · Jun 16, 2023 · General Hospital

Device Facts

• Record ID: K222906
• Device Name: Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421
• Applicant: Ningbo Maxcon Medical Technology Co., Ltd.
• Product Code: MMK · General Hospital
• Decision Date: Jun 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

Maxcon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Device Story

Maxcon Reusable Sharps Container is an injection-molded high-density polyethylene (HDPE) container designed for the collection and transport of used medical sharps. It is intended for use in clinical settings (hospitals, clinics, ORs, labs) by healthcare professionals. The device is non-sterile and designed for 250 reuse cycles. It features a red body and black sliding lid; users deposit sharps via gravity through an adjustable aperture. The lid slides to a temporary closed position during use and is permanently locked with a 6-inch cable tie upon reaching the fill line. The device is supplied to waste management services for decanting, decontamination, and destruction. It is not intended for patient contact or use in areas with unsupervised patient access. The container provides puncture and leak resistance, benefiting patient and staff safety by preventing accidental sharps injuries.

Clinical Evidence

No clinical data. Bench testing only. Performance validated against ISO 23907-2:2019 and 49 CFR 178.606/608, including 250-cycle process simulation, handle strength, penetration resistance, drop/leakage testing, stability, and microbiological validation.

Technological Characteristics

Material: High-density polyethylene (HDPE). Form factor: 17-gallon injection-molded container. Dimensions: 445.5mm x 335mm x 631.5mm. Features: Sliding lid with temporary/permanent locking mechanism (cable tie). Reusability: 250 cycles. Sterilization: Non-sterile. Standards: ISO 23907-2:2019, 49 CFR 178.606/608.

Indications for Use

Indicated for collection and transportation of used medical sharps in hospitals, clinics, operating rooms, and laboratories. Intended for use by technicians, doctors, dentists, and veterinarians in 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

• Sharps Tank Reusable Sharps Container (K111085)
• Med-Tainer Single Deposit Container (SDC) (K153274)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

June 16, 2023

Ningbo Maxcon Medical Technology Co., Ltd. % Henry Zhang President Shenglin (Hangzhou) Consultants Inc. Room 2506, Unit 1#, Building 5#, Ronghui Business Center, Economic Development Zone Hangzhou, Zhejiang 310018 China

Re: K222906

Trade/Device Name: Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: May 10, 2023 Received: May 17, 2023

Dear Henry Zhang:

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.

{1}------------------------------------------------

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 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 (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 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.

# Clarence W. Murray III -S

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

{2}------------------------------------------------

### Indications for Use

510(k) Number (if known) K222906

#### Device Name

Maxcon Reusable Sharps Container17 Gallon Reusable Sharps Container MA1421

Indications for Use (Describe)

Maxoon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Type of Use (Select one or both, as applicable)

| <input type="checkbox"/> Residential Use (Part 21 CFR 601 Subpart E) |
|---------------------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 601 Subpart G) |

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Ningbo Maxcon Medical Technology Co., Ltd. The logo consists of the word "MAXCON" in bold, black letters with a plus sign inside the letter "O". Below the logo are the company's name in both Chinese and English. The Chinese characters are above the English translation, "Ningbo Maxcon Medical Technology Co., Ltd".

## K22906: 510(k) Summarv

#### Date Prepared: June 10, 2023 1.

#### 2. Submitted by:

Mr. Puhai Ma

Ningbo Maxcon Medical Technology Co., Ltd

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

Establishment Registration Number: 3013584693

#### 3. Primary Contact:

Mr.Henry Zhang

Shenglin (Hangzhou) Consultants Inc.

Room 2506, Unit 1#, Building 5#, Ronghui Business Center, Economic Development

Zone, Hangzhou City, Zhejiang Province, China

Telephone:[phone], E-mail:[e-mail]

#### 4. Name of the Device

Common Name: Sharps Container

Trade Name:Maxcon Reusable Sharps Container

Model: 17 Gallon Reusable Sharps Container MA1421

#### ನ. Classification Information:

Product Code: MMK

Device Class: Class II

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are all capitalized and black. There are three vertical lines to the left of the word. The plus sign is in the middle of the letter "O".

Ningbo Maxcon Medical Technology Co., Ltd

CFR Reference: 21 CFR 880.5570

Classification: hypodermic single lumen needles

Classification Panel:General Hospital

#### 6. Predicate Device Information:

#### ● Primary Predicate Device:

Trade name:Sharps Tank Reusable Sharps Container

The device (K111085), manufactured by Rehrig Pacific Company, located in 614

Hunters Lane, Brentwood, Tennessee 37027, USA.

Common name: Sharps Container,

Product code: MMK

Classification:Hypodermic single lumen needles

CFR Reference: 21CFR 880.5570-Class II

Classification Panel: General Hospital

#### ● Second Predicate Device:

Trade name:Med-Tainer Single Deposit Container (SDC)

The device ( K153274 ) manufactured by Snyder Industries, Inc., located in 6940 O

Street, Suite 100,Lincoln, NE 68510, USA.

Common name: Sharps Container,

Product code: MMK

Classification:Hypodermic single lumen needles

CFR Reference: 21CFR 880.5570-Class II

Classification Panel: General Hospital

#### 7. Intended Use / Indication for Use:

Maxcon Reusable Sharps Container is intended to be used for the collection and transportation of used medical sharps. The container is intended to be used in hospitals and clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are all capitalized and black. There is a plus sign inside the letter "O".

Ningbo Maxcon Medical Technology Co., Ltd

#### 8. Device Description:

Maxcon Reusable Sharps Container is of injection molded high density polyethylene plastic, and designed for a multiple-use of 250 cycles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. No part of the container is intended to come in contact with patients. The containers are designed to be non-sterile, puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. The recommended fill level is engraved onto the plastic and corresponds to the product identification label's level line. The container body is in the color of red, while the container lid is in the color of black. The products are supplied to waste management companies that are responsible for transporting, decanting, decontaminating, and destroying the containers. The black lid is used to slide across the container top. When in use, move the lid to show an opening with a size depending on the sharps waste to be dropped, and drop sharps waste into the container safely and effectively by gravitational force, allows easy disposal of sharps. After the sharps is deposited, slide the lid closed along the groove to recover the container body for temporary closure. When the content reaching to the fill line, use a 6" cable tie to lock together the lid and container body for final closure. The container is not for use in area with unsupervised patient access.

| Model | Weight<br>(empty)gram | Capacity<br>(total) | Capacity<br>(full line) | Dimensions of<br>finished goods<br>(mm) (L x W x H) | Colors | Acceptable sites of use |
|--------|-----------------------|---------------------|-------------------------|-----------------------------------------------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MA1421 | 3760 | 17 gallon | 13.6 gallon | 445.5*335*631.5 | Red | The target population is for<br>qualified personnel in<br>health care facilities and<br>other facilities in which<br>medical sharps may be<br>used. All the containers are<br>intended to be used in areas<br>where there is no<br>unsupervised patient<br>access. |

#### General Specifications of the Sharps Container

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Ningbo Maxcon Medical Technology Co., Ltd. The logo consists of the word "MAXCON" in a bold, sans-serif font, with a plus sign inside the letter "O". Below the logo are the company's name in both Chinese and English. The Chinese name is "宁波迈克斯康医疗科技有限公司", and the English name is "Ningbo Maxcon Medical Technology Co., Ltd".

### General Description of the Lid

| Model | Lid<br>configuration | Dimensions of<br>Sharps disposal<br>aperture (mm) | Color | Temporary<br>Locking<br>mechanism lid to<br>container | Permanent Locking<br>mechanism |
|--------|---------------------------------------|---------------------------------------------------|-------|-------------------------------------------------------------------|----------------------------------------------------------------|
| MA1421 | One lid (lid<br>number:<br>MA1400Z(R) | 416*280 | Black | Slid the lid along the<br>groove to cover the<br>container body . | Lock together the lid and the<br>container body by a cable tie |

### 9. Technological Characteristics Comparison:

| Characteristic | Submitted Subject Device | Primary Predicate Device | Second predicate device | Comparison/Comments |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 510(k) | K22906 | K111085 | K153274 | -- |
| Device Name | Maxcon Sharps reusable<br>container | Sharps Tank Reusable Sharps<br>Container | Med-Tainer Single Deposit<br>Container | -- |
| Product code | MMK | MMK | MMK | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | II | Same |
| Indication for use | Maxcon Reusable Sharps<br>Container is intended to be<br>used for the collection and<br>transportation of used medical<br>sharps. The container is<br>intended to be used in<br>hospitals and clinics,<br>operating rooms, and<br>laboratories by technicians,<br>doctors, dentists, and<br>veterinarians. The device is<br>only intended for use in areas<br>with no unsupervised patient<br>access. | Rehrig Healthcare Systems<br>reusable 17gallon sharps container<br>is intended to be used for the<br>collection and transportation of<br>used medical sharps. The container<br>is intended to be used in hospitals<br>and clinics, operating rooms, and<br>laboratories by technicians,<br>doctors, dentists, and veterinarians.<br>The device is only intended for use<br>in areas with no unsupervised<br>patient access. | Med-Tainer Single Deposit<br>Containers are intended for the<br>safe collection and transport of<br>medical sharps. The reusable<br>10gallon and 17gallon<br>containers are to be used in<br>supervised areas of healthcare<br>institutions such as hospitals,<br>clinics, veterinary offices and<br>laboratories.<br>The Med-Tainer Single<br>Deposit Container is available<br>in Kelly green, Ascent blue,<br>teal, red and yellow. | Same |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. The letters are slightly slanted to the right, giving the word a dynamic appearance. The plus sign in the middle of the letter "O" is a notable feature of the logo.

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

| Physical properties | | | | | Target population | Qualified personnel in health<br>care facilities and other<br>facilities in which medical<br>sharps may be used. All the<br>containers are intended to be<br>used in areas where there is no<br>unsupervised patient access | Qualified personnel in health care<br>facilities and other facilities in<br>which medical sharps may be used.<br>All the containers are intended to<br>be used in areas where there is no<br>unsupervised patient access | Qualified personnel in health<br>care facilities and other<br>facilities in which medical<br>sharps may be used. All the<br>containers are intended to be<br>used in areas where there is no<br>unsupervised patient access | Same | Method of<br>Manufacture | Injection Molded | Injection Molded | Rotationally molded | Different No new<br>issues of safety<br>or effectiveness |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | MA1421 | MW009 | 780310E74100 | NA | Color | Red, with embossed and<br>inked fill line; contrasting<br>label includes Biohazard<br>symbol | Red with contrasting Biohazard<br>Symbol | Red with embossed and inked<br>fill line; contrasting label<br>includes Biohazard symbol | Similar, No new<br>issues of safety or<br>effectiveness | Technological properties | | | | |
| Weight and<br>Capacity | 8.3pounds and 17gallons | 9.4 pounds and 17 gallons | 7pounds and 17 gallons | Similar, no new<br>issues of safety or<br>effectiveness | Material of<br>construction | High density polyethylene | High density polyethylene | Linear Low density<br>polyethylene | Similar, No new<br>issues of safety or<br>effectiveness | Sterile or non-<br>sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Product Picture | Image: MA1421 | Image: MW009 | Unavailable | Similar, no new<br>issues of safety or<br>effectiveness | Reprocessing<br>solution | hot water (82°C) and<br>5.25% hypochlorite<br>solution<br>diluted to 1:10 part hot water<br>(82°C) | hot water (82°C) and 5.25%<br>hypochlorite solution<br>diluted to 1:10 part hot water<br>(82°C) | unavailable | Similar, No new<br>issues of safety or<br>effectiveness | Reusable or not | Reusable | Reusable | Reusable | Same |
| Lid Style<br>Illustration | Image: MA1421 Lid | Image: MW009 Lid | Unavailable | Different styles.<br>Subject Device is<br>flat plate slider<br>style and Predicate<br>device is hinged<br>design. Both can<br>be secured in<br>place for transport<br>and both met test<br>requirements of<br>the Standard, so<br>no new issues of<br>safety or efficacy. | Whether<br>reprocessing steps<br>are required to be<br>automatic or not | Yes | Yes | Yes | Same | Reusable cycles | 250 cycles | 400 cycles | 750 cycles | Different, defined<br>in labeling so no<br>new issues of<br>safety or<br>effectiveness |
| Approximate Size | 445.5mm Length<br>335mm Width<br>631.5mm Height | 508mm Length<br>317.5mm Width<br>655.3mm Height<br>20.00"L x 12.50"W x 25.8"h | 457.2mm Length<br>330.2mm Width<br>635mm Height<br>18 "L x 13 "W x 25" | Similar, no new<br>issues of safety or<br>effectiveness | | | Requirement for Reprocessing Site | | | Performance testing (Non-Clinical Testing) | | | | |
| Opening<br>dimensions<br>(length x width) | 416mm x 280mm total<br>(maximum) and variable slide-<br>opening up to the maximum<br>for sharps deposit with slide<br>control | 457.2mm x 271.8mm total and<br>hinged-opening of 203.2mm x<br>152.4mm for sharps deposit | 146.1mm x 247.7mm for<br>sharps deposit | Similar, no new<br>issues of safety or<br>effectiveness | Working<br>environment | Operating Temperatures :20° -<br>30°C<br>Storage Temperature :20° -<br>30°C<br>Transportation Temperature:0° -<br>38°C | Operating Temperatures :20° - 30°C<br>Storage Temperature :20° - 30°C<br>Transportation Temperature:0° -<br>38°C | Unavailable | Same as primary<br>predicate device | Life Span<br>Processing<br>Simulation | Meets requirements of<br>ISO23907-2:2019, Reusable<br>sharps containers, Sharps injury<br>protection - Requirements and<br>test methods - Sharps containers<br>- Part 2: Reusable sharps<br>containers.<br>(Containers were processed 250<br>times to simulate their intended<br>life cycle: filled with sharps,<br>closed for transport, opened,<br>decanted, rinsed and<br>decontaminated. | Unavailable | Met requirements of CAN/CSA<br>Z316.6-14 BA.8.3.1, Sharps<br>injury protection -<br>Requirements and test methods -<br>Sharps containers.<br>( Containers were processed 780<br>times to simulate their intended<br>life cycle: filled with sharps,<br>closed for transport, opened,<br>decanted, rinsed and<br>decontaminated.) | Met<br>requirements of<br>the relevant and<br>current<br>standards/regulat<br>ions that cite<br>comparable<br>requirements.<br>No new issues<br>of safety or<br>effectiveness |
| Training | Please read user manual<br>carefully, no special training is<br>required | Please read user manual carefully, no<br>special training is required | Unavailable | Same as primary<br>predicate device | Life Span<br>Transport<br>Simulation | Meets requirements of<br>ISO23907-2:2019, Reusable<br>sharps containers, Sharps injury<br>protection - Requirements and<br>test methods - Sharps containers<br>- Part 2: Reusable sharps<br>containers. | Unavailable | Met requirements of CAN/CSA<br>Z316.6-14 BA.8.3.1, Sharps<br>injury protection -<br>Requirements and test methods -<br>Sharps containers. | Met<br>requirements of<br>the relevant and<br>current<br>standards/regulat<br>ions that cite<br>comparable<br>requirements.<br>No new issues<br>of safety or<br>effectiveness | | | | | |
| Expected controls<br>and Qualification<br>methods | The recommended guidelines<br>for decanting and<br>decontamination are provided in<br>the user manual and it is<br>recommended that the<br>decanting/cleaning facility<br>develop cycles and processes<br>through a formal qualification<br>process based on the specific<br>automatic machines to be used | The recommended guidelines for<br>decanting and decontamination are<br>provided in the user manual and it is<br>recommended that the<br>decanting/cleaning facility develop<br>cycles and processes through a<br>formal qualification process based on<br>the specific automatic machines to be<br>used | Unavailable | Same as primary<br>predicate device | Container<br>Stability Test | Meets requirements of<br>ISO23907-2:2019, Reusable<br>sharps containers, Sharps injury<br>protection - Requirements and<br>test methods - Sharps containers<br>- Part 2: Reusable sharps<br>containers. | Unavailable | Met requirement of<br>ISO23907:2012, Sharps injury<br>protection Requirements and<br>test methods – Sharps<br>containers | Met requirements<br>of the relevant and<br>current<br>standards/regulatio<br>ns that cite<br>comparable<br>requirements. No<br>new issues of<br>safety or<br>effectiveness | | | | | |

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for MAXCON. The logo is in black and white and features the word "MAXCON" in bold, sans-serif font. The letter "O" in "CON" is stylized with a plus sign inside of it. There are also three vertical lines to the left of the word "MAXCON".

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

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are black, and the background is white. There are diagonal lines to the left of the letter "M". The letter "O" has a plus sign inside of it.

### 宁波迈克斯康医疗科技有限公司

# Ningbo Maxcon Medical Technology Co., Ltd

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are black, and there are two diagonal lines to the left of the "M". A plus sign is located in the center of the letter "O".

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

| Strength of<br>Handles | Meets requirements of<br>ISO23907-2:2019, Reusable<br>sharps containers, Sharps injury<br>protection - Requirements and<br>test methods - Sharps containers<br>- Part 2: Reusable sharps<br>containers. | Unavailable | Met requirement of<br>ISO23907:2012, Sharps injury<br>protection Requirements and<br>test methods - Sharps<br>containers | Met requirements<br>of the relevant and<br>current<br>standards/regulatio<br>ns that cite<br>comparable<br>requirements. No<br>new issues of<br>safety or<br>effectiveness |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resistance to<br>Damage and<br>Leakage after<br>Dropping | Meets requirements of<br>ISO23907-2:2019, Reusable<br>sharps containers, Sharps injury<br>protection - Requirements and<br>test methods - Sharps containers<br>- Part 2: Reusable sharps<br>containers. | Unavailable | Met requirement of<br>ISO23907:2012, Sharps injury<br>protection Requirements and<br>test methods - Sharps<br>containers | Met requirements<br>of the relevant and<br>current<br>standards/regulatio<br>ns that cite<br>comparable<br>requirements. No<br>new issues of<br>safety or<br>effectiveness |
| Resistance to<br>penetration | Meets requirements of<br>ISO23907-2:2019, Reusable<br>sharps containers, Sharps injury<br>protection - Requirements and<br>test methods - Sharps containers<br>- Part 2: Reusable sharps<br>containers.<br>(The criteria to pass is the<br>penetration force shall be a<br>minimum of 20N or greater) | Unavailable | Met requirements for Puncture<br>Resistance per ASTM F2132-01<br>Standard Specification of<br>Materials Used in Containers<br>for Discarded Medical Needles<br>and Other Sharps.<br>(The criteria to pass the<br>puncture resistance test are an<br>average value not less than 3.4<br>lbf (15 N) with no value less<br>than 2.81bf or 12.5 N). | Met requirements<br>of the relevant and<br>current<br>standards/regulatio<br>ns that cite<br>comparable<br>requirements. No<br>new issues of<br>safety or<br>effectiveness |
| Stack Test | 178.606, Specification for<br>Packagings - Subpart M -<br>Testing of Non-Bulk Packaging<br>and Packages | Unavailable | Met requirements of 49 CFR<br>178.606 Specification for<br>Packagings - Subpart M -<br>Testing of Non-Bulk Packaging<br>and Packages | Meet current<br>requirements, No<br>new<br>issues of safety or<br>effectiveness |
| | | | | |
| Vibration Testing | Met requirements of 49 CFR<br>178.608 Specification for<br>Packagings – Subpart M –<br>Testing of Non-Bulk<br>Packagings and Packages | Unavailable | Met requirements of 49 CFR<br>178.608 Specification for<br>Packagings – Subpart M –<br>Testing of Non-Bulk<br>Packagings and Packages | Meet current<br>requirements, No<br>new<br>issues of safety or<br>effectiveness |

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. The letters are slightly slanted to the right, giving the word a sense of forward motion. The "O" in "MAXCON" has a plus sign inside of it. There are three black lines to the left of the word.

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

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image displays the logo for Ningbo Maxcon Medical Technology Co., Ltd. The logo features the word "MAXCON" in a bold, sans-serif font, with a plus sign incorporated into the letter "O". Below the English name is the company's name in Chinese characters. The text is clean and professional, suggesting a focus on medical technology.

#### 10. Summarv of Non-Clinical Tests:

Maxcon Reusable Sharps Containers have the same indications for use and technological characteristics as the predicate device(s). The results of non-clinical testing demonstrated that the subject device successfully met requirements, as follows:

| Test Conducted | Standard | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------|
| Tumbling with sharps<br>simulation | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | No rupture, leakage,<br>or deterioration that<br>could adversely affect<br>its safe use or<br>functionality. | Passed |
| Transport Simulations | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | No rupture, leakage,<br>or deterioration that<br>could adversely affect<br>its safe use or<br>functionality. | Passed |
| Process simulations,<br>including opening,<br>decanting,<br>decontamination, and<br>closing processes of<br>250 cycles | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | No rupture, leakage,<br>or deterioration that<br>could adversely affect<br>its safe use or<br>functionality. | Passed |
| Container Stability | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | Container shall not<br>topple over | Passed |
| Strength of Handles | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | Handle/carrying<br>feature shall not<br>break or detach | Passed |
| Resistance to<br>penetration | ISO 23907-2:2019<br>Sharps injury | Force needed to<br>penetrate test | Passed |

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. The letters are slightly stylized, with the "M" having two vertical lines to the left of it. The "O" in "CON" has a plus sign inside of it. The text is centered and takes up most of the image.

# 宁波迈克斯康医疗科技有限公司

### Ningbo Maxcon Medical Technology Co., Ltd

| | protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | specimens shall be a<br>minimum of 20 N or<br>greater. | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Resistance to damage<br>and leakage after<br>dropping | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | No evidence of<br>leakage and no<br>breach of the sharps<br>containment area. | Passed |
| Label Integrity Test | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | Labels are intact and<br>legible after<br>decontamination<br>processing | Passed |
| Resistance to spillage<br>by toppling | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | No evidence of<br>breach of the sharps<br>containment are | Passed |
| Microbiological<br>validation | ISO 23907-2:2019<br>Sharps injury<br>protection -<br>Requirements and<br>test methods, Part 2:<br>Reusable sharps<br>containers | No organisms are<br>recovered from areas<br>where a 104/ml<br>challenge-suspension<br>of representative<br>pathogens in whole<br>blood has been<br>applied and dried. | Passed |
| Stacking Test | 49CFR 178.606 | No leakage,<br>deterioration,<br>buckling that might<br>affect transportation<br>safety or damage to<br>contents | Passed |
| Vibration Test | 49CFR 178.608 | No rupture or leakage | Passed |
| Usable Capacity Test | ---- | The real using<br>capacity should be ±<br>3% different from<br>designed capacity. | Passed |
| Leak Proof on the | ---- | The side and bottom | Passed |

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. The letters are slightly slanted to the left, and there are three horizontal lines underneath the word. The "C" in "MAXCON" has a plus sign in the middle of it.

宁波迈 康矢疗科技有限

#### Ningbo Maxcon Medical Technology Co., Ltd

| sides and bottom | should be of no water<br>leakage after soaking<br>with water for 24<br>hours. |
|------------------|-------------------------------------------------------------------------------|
|------------------|-------------------------------------------------------------------------------|

#### 11. Sterility Information

The subject device container is non-sterile; therefore, no sterility testing was performed.

#### 12. Discussion of Clinical Tests Performed:

There was no clinical testing required to support the review of this medical device.

#### 13. Conclusions:

The Maxcon Reusable Sharps Container, as designed and manufactured, is as safe, as effective, and performs as well as or better than the legally marketed device identified in this submission.