(266 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a reusable sharps container, with no mention of AI or ML technologies.
No
The device is a sharps container used for the collection and transportation of used medical sharps, not for treating a disease or condition.
No
The device description indicates it is a container for the collection and transportation of medical sharps, not for diagnosing conditions.
No
The device description clearly outlines a physical container made of injection molded high density polyethylene plastic, designed for the collection and transportation of medical sharps. It does not mention any software components.
Based on the provided information, the Maxcon Reusable Sharps Container is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the collection and transportation of used medical sharps. This is a physical containment and disposal function, not a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description focuses on the physical properties of the container (material, design, resistance to penetration, leakage, etc.) and its function in safely holding and transporting sharps waste. There is no mention of any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Reagents or assays
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Diagnostic results or interpretations
- Measurement of analytes
The device is clearly intended for the safe handling and disposal of medical waste, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
MMK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Maxcon Reusable Sharps 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: Tumbling with sharps simulation; Standard: ISO 23907-2:2019; Acceptance Criteria: No rupture, leakage, or deterioration that could adversely affect its safe use or functionality; Results: Passed
- Test Conducted: Transport Simulations; Standard: ISO 23907-2:2019; Acceptance Criteria: No rupture, leakage, or deterioration that could adversely affect its safe use or functionality; Results: Passed
- Test Conducted: Process simulations, including opening, decanting, decontamination, and closing processes of 250 cycles; Standard: ISO 23907-2:2019; Acceptance Criteria: No rupture, leakage, or deterioration that could adversely affect its safe use or functionality; Results: Passed
- Test Conducted: Container Stability; Standard: ISO 23907-2:2019; Acceptance Criteria: Container shall not topple over; Results: Passed
- Test Conducted: Strength of Handles; Standard: ISO 23907-2:2019; Acceptance Criteria: Handle/carrying feature shall not break or detach; Results: Passed
- Test Conducted: Resistance to penetration; Standard: ISO 23907-2:2019; Acceptance Criteria: Force needed to penetrate test specimens shall be a minimum of 20 N or greater; Results: Passed
- Test Conducted: Resistance to damage and leakage after dropping; Standard: ISO 23907-2:2019; Acceptance Criteria: No evidence of leakage and no breach of the sharps containment area; Results: Passed
- Test Conducted: Label Integrity Test; Standard: ISO 23907-2:2019; Acceptance Criteria: Labels are intact and legible after decontamination processing; Results: Passed
- Test Conducted: Resistance to spillage by toppling; Standard: ISO 23907-2:2019; Acceptance Criteria: No evidence of breach of the sharps containment are; Results: Passed
- Test Conducted: Microbiological validation; Standard: ISO 23907-2:2019; Acceptance Criteria: No organisms are recovered from areas where a 104/ml challenge-suspension of representative pathogens in whole blood has been applied and dried; Results: Passed
- Test Conducted: Stacking Test; Standard: 49CFR 178.606; Acceptance Criteria: No leakage, deterioration, buckling that might affect transportation safety or damage to contents; Results: Passed
- Test Conducted: Vibration Test; Standard: 49CFR 178.608; Acceptance Criteria: No rupture or leakage; Results: Passed
- Test Conducted: Usable Capacity Test; Standard: ----; Acceptance Criteria: The real using capacity should be ± 3% different from designed capacity; Results: Passed
- Test Conducted: Leak Proof on the sides and bottom; Standard: ----; Acceptance Criteria: The side and bottom should be of no water leakage after soaking with water for 24 hours; Results: Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Residential Use (Part 21 CFR 601 Subpart E) |
|---|
| 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)
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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:0086-13809598661, E-mail:zyhenry@163.com
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
(empty)gram | Capacity
(total) | Capacity
(full line) | Dimensions of
finished goods
(mm) (L x W x H) | Colors | Acceptable sites of use |
|--------|-----------------------|---------------------|-------------------------|-----------------------------------------------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MA1421 | 3760 | 17 gallon | 13.6 gallon | 445.5335631.5 | Red | 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. |
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
configuration | Dimensions of
Sharps disposal
aperture (mm) | Color | Temporary
Locking
mechanism lid to
container | Permanent Locking
mechanism |
|--------|---------------------------------------|---------------------------------------------------|-------|-------------------------------------------------------------------|----------------------------------------------------------------|
| MA1421 | One lid (lid
number:
MA1400Z(R) | 416*280 | Black | Slid the lid along the
groove to cover the
container body . | Lock together the lid and the
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 | |||
| container | Sharps Tank Reusable Sharps | |||
| Container | Med-Tainer Single Deposit | |||
| 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 | |||
| 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. | Rehrig Healthcare Systems | |||
| reusable 17gallon 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. | Med-Tainer Single Deposit | |||
| Containers are intended for the | ||||
| safe collection and transport of | ||||
| medical sharps. The reusable | ||||
| 10gallon and 17gallon | ||||
| containers are to be used in | ||||
| supervised areas of healthcare | ||||
| institutions such as hospitals, | ||||
| clinics, veterinary offices and | ||||
| laboratories. | ||||
| The Med-Tainer Single | ||||
| Deposit Container is available | ||||
| in Kelly green, Ascent blue, | ||||
| 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
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 | 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 | 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 | Same | Method of
Manufacture | Injection Molded | Injection Molded | Rotationally molded | Different No new
issues of safety
or effectiveness |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | MA1421 | MW009 | 780310E74100 | NA | Color | Red, with embossed and
inked fill line; contrasting
label includes Biohazard
symbol | Red with contrasting Biohazard
Symbol | Red with embossed and inked
fill line; contrasting label
includes Biohazard symbol | Similar, No new
issues of safety or
effectiveness | Technological properties | | | | |
| Weight and
Capacity | 8.3pounds and 17gallons | 9.4 pounds and 17 gallons | 7pounds and 17 gallons | Similar, no new
issues of safety or
effectiveness | Material of
construction | High density polyethylene | High density polyethylene | Linear Low density
polyethylene | Similar, No new
issues of safety or
effectiveness | Sterile or non-
sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Product Picture | Image: MA1421 | Image: MW009 | Unavailable | Similar, no new
issues of safety or
effectiveness | Reprocessing
solution | hot water (82°C) and
5.25% hypochlorite
solution
diluted to 1:10 part hot water
(82°C) | hot water (82°C) and 5.25%
hypochlorite solution
diluted to 1:10 part hot water
(82°C) | unavailable | Similar, No new
issues of safety or
effectiveness | Reusable or not | Reusable | Reusable | Reusable | Same |
| Lid Style
Illustration | Image: MA1421 Lid | Image: MW009 Lid | Unavailable | Different styles.
Subject Device is
flat plate slider
style and Predicate
device is hinged
design. Both can
be secured in
place for transport
and both met test
requirements of
the Standard, so
no new issues of
safety or efficacy. | Whether
reprocessing steps
are required to be
automatic or not | Yes | Yes | Yes | Same | Reusable cycles | 250 cycles | 400 cycles | 750 cycles | Different, defined
in labeling so no
new issues of
safety or
effectiveness |
| Approximate Size | 445.5mm Length
335mm Width
631.5mm Height | 508mm Length
317.5mm Width
655.3mm Height
20.00"L x 12.50"W x 25.8"h | 457.2mm Length
330.2mm Width
635mm Height
18 "L x 13 "W x 25" | Similar, no new
issues of safety or
effectiveness | | | Requirement for Reprocessing Site | | | Performance testing (Non-Clinical Testing) | | | | |
| Opening
dimensions
(length x width) | 416mm x 280mm total
(maximum) and variable slide-
opening up to the maximum
for sharps deposit with slide
control | 457.2mm x 271.8mm total and
hinged-opening of 203.2mm x
152.4mm for sharps deposit | 146.1mm x 247.7mm for
sharps deposit | Similar, no new
issues of safety or
effectiveness | Working
environment | Operating Temperatures :20° -
30°C
Storage Temperature :20° -
30°C
Transportation Temperature:0° -
38°C | Operating Temperatures :20° - 30°C
Storage Temperature :20° - 30°C
Transportation Temperature:0° -
38°C | Unavailable | Same as primary
predicate device | Life Span
Processing
Simulation | Meets requirements of
ISO23907-2:2019, Reusable
sharps containers, Sharps injury
protection - Requirements and
test methods - Sharps containers
- Part 2: Reusable sharps
containers.
(Containers were processed 250
times to simulate their intended
life cycle: filled with sharps,
closed for transport, opened,
decanted, rinsed and
decontaminated. | Unavailable | Met requirements of CAN/CSA
Z316.6-14 BA.8.3.1, Sharps
injury protection -
Requirements and test methods -
Sharps containers.
( Containers were processed 780
times to simulate their intended
life cycle: filled with sharps,
closed for transport, opened,
decanted, rinsed and
decontaminated.) | Met
requirements of
the relevant and
current
standards/regulat
ions that cite
comparable
requirements.
No new issues
of safety or
effectiveness |
| Training | Please read user manual
carefully, no special training is
required | Please read user manual carefully, no
special training is required | Unavailable | Same as primary
predicate device | Life Span
Transport
Simulation | Meets requirements of
ISO23907-2:2019, Reusable
sharps containers, Sharps injury
protection - Requirements and
test methods - Sharps containers - Part 2: Reusable sharps
containers. | Unavailable | Met requirements of CAN/CSA
Z316.6-14 BA.8.3.1, Sharps
injury protection -
Requirements and test methods -
Sharps containers. | Met
requirements of
the relevant and
current
standards/regulat
ions that cite
comparable
requirements.
No new issues
of safety or
effectiveness | | | | | |
| Expected controls
and Qualification
methods | The recommended guidelines
for decanting and
decontamination are provided in
the user manual and it is
recommended that the
decanting/cleaning facility
develop cycles and processes
through a formal qualification
process based on the specific
automatic machines to be used | The recommended guidelines for
decanting and decontamination are
provided in the user manual and it is
recommended that the
decanting/cleaning facility develop
cycles and processes through a
formal qualification process based on
the specific automatic machines to be
used | Unavailable | Same as primary
predicate device | Container
Stability Test | Meets requirements of
ISO23907-2:2019, Reusable
sharps containers, Sharps injury
protection - Requirements and
test methods - Sharps containers - Part 2: Reusable sharps
containers. | Unavailable | Met requirement of
ISO23907:2012, Sharps injury
protection Requirements and
test methods – Sharps
containers | Met requirements
of the relevant and
current
standards/regulatio
ns that cite
comparable
requirements. No
new issues of
safety or
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
Handles | Meets requirements of
ISO23907-2:2019, Reusable
sharps containers, Sharps injury
protection - Requirements and
test methods - Sharps containers
- Part 2: Reusable sharps
containers. | Unavailable | Met requirement of
ISO23907:2012, Sharps injury
protection Requirements and
test methods - Sharps
containers | Met requirements
of the relevant and
current
standards/regulatio
ns that cite
comparable
requirements. No
new issues of
safety or
effectiveness |
|----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Resistance to
Damage and
Leakage after
Dropping | Meets requirements of
ISO23907-2:2019, Reusable
sharps containers, Sharps injury
protection - Requirements and
test methods - Sharps containers - Part 2: Reusable sharps
containers. | Unavailable | Met requirement of
ISO23907:2012, Sharps injury
protection Requirements and
test methods - Sharps
containers | Met requirements
of the relevant and
current
standards/regulatio
ns that cite
comparable
requirements. No
new issues of
safety or
effectiveness |
| Resistance to
penetration | Meets requirements of
ISO23907-2:2019, Reusable
sharps containers, Sharps injury
protection - Requirements and
test methods - Sharps containers - Part 2: Reusable sharps
containers.
(The criteria to pass is the
penetration force shall be a
minimum of 20N or greater) | Unavailable | Met requirements for Puncture
Resistance per ASTM F2132-01
Standard Specification of
Materials Used in Containers
for Discarded Medical Needles
and Other Sharps.
(The criteria to pass the
puncture resistance test are an
average value not less than 3.4
lbf (15 N) with no value less
than 2.81bf or 12.5 N). | Met requirements
of the relevant and
current
standards/regulatio
ns that cite
comparable
requirements. No
new issues of
safety or
effectiveness |
| Stack Test | 178.606, Specification for
Packagings - Subpart M -
Testing of Non-Bulk Packaging
and Packages | Unavailable | Met requirements of 49 CFR
178.606 Specification for
Packagings - Subpart M -
Testing of Non-Bulk Packaging
and Packages | Meet current
requirements, No
new
issues of safety or
effectiveness |
| | | | | |
| Vibration Testing | Met requirements of 49 CFR
178.608 Specification for
Packagings – Subpart M –
Testing of Non-Bulk
Packagings and Packages | Unavailable | Met requirements of 49 CFR
178.608 Specification for
Packagings – Subpart M –
Testing of Non-Bulk
Packagings and Packages | Meet current
requirements, No
new
issues of safety or
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 | |||
| simulation | ISO 23907-2:2019 | ||
| Sharps injury | |||
| protection - | |||
| Requirements and | |||
| test methods, Part 2: | |||
| Reusable sharps | |||
| containers | No rupture, leakage, | ||
| or deterioration that | |||
| could adversely affect | |||
| its safe use or | |||
| functionality. | Passed | ||
| Transport Simulations | ISO 23907-2:2019 | ||
| Sharps injury | |||
| protection - | |||
| Requirements and | |||
| test methods, Part 2: | |||
| Reusable sharps | |||
| containers | No rupture, leakage, | ||
| or deterioration that | |||
| could adversely affect | |||
| its safe use or | |||
| functionality. | Passed | ||
| Process simulations, | |||
| including opening, | |||
| decanting, | |||
| decontamination, and | |||
| closing processes of | |||
| 250 cycles | ISO 23907-2:2019 | ||
| Sharps injury | |||
| protection - | |||
| Requirements and | |||
| test methods, Part 2: | |||
| Reusable sharps | |||
| containers | No rupture, leakage, | ||
| or deterioration that | |||
| could adversely affect | |||
| its safe use or | |||
| functionality. | Passed | ||
| Container Stability | ISO 23907-2:2019 | ||
| Sharps injury | |||
| protection - | |||
| Requirements and | |||
| test methods, Part 2: | |||
| Reusable sharps | |||
| containers | Container shall not | ||
| topple over | Passed | ||
| Strength of Handles | ISO 23907-2:2019 | ||
| Sharps injury | |||
| protection - | |||
| Requirements and | |||
| test methods, Part 2: | |||
| Reusable sharps | |||
| containers | Handle/carrying | ||
| feature shall not | |||
| break or detach | Passed | ||
| Resistance to | |||
| penetration | ISO 23907-2:2019 | ||
| Sharps injury | Force needed to | ||
| 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 -
Requirements and
test methods, Part 2:
Reusable sharps
containers | specimens shall be a
minimum of 20 N or
greater. | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Resistance to damage
and leakage after
dropping | ISO 23907-2:2019
Sharps injury
protection -
Requirements and
test methods, Part 2:
Reusable sharps
containers | No evidence of
leakage and no
breach of the sharps
containment area. | Passed |
| Label Integrity Test | ISO 23907-2:2019
Sharps injury
protection -
Requirements and
test methods, Part 2:
Reusable sharps
containers | Labels are intact and
legible after
decontamination
processing | Passed |
| Resistance to spillage
by toppling | ISO 23907-2:2019
Sharps injury
protection -
Requirements and
test methods, Part 2:
Reusable sharps
containers | No evidence of
breach of the sharps
containment are | Passed |
| Microbiological
validation | ISO 23907-2:2019
Sharps injury
protection -
Requirements and
test methods, Part 2:
Reusable sharps
containers | No organisms are
recovered from areas
where a 104/ml
challenge-suspension
of representative
pathogens in whole
blood has been
applied and dried. | Passed |
| Stacking Test | 49CFR 178.606 | No leakage,
deterioration,
buckling that might
affect transportation
safety or damage to
contents | Passed |
| Vibration Test | 49CFR 178.608 | No rupture or leakage | Passed |
| Usable Capacity Test | ---- | The real using
capacity should be ±
3% different from
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
leakage after soaking
with water for 24
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.