(266 days)
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.
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.
The provided text is a 510(k) Premarket Notification for a medical device: Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421. This document describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices. It is crucial to understand that this is not an AI/ML-based medical device. Therefore, the questions related to AI/ML model performance, such as MRMC studies, training/test sets, ground truth establishment by experts, and adjudication methods, are not applicable to this submission.
The document focuses on the physical and functional performance of the reusable sharps container.
Here's a breakdown of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The non-clinical tests are summarized in a table on pages 12-14.
| Test Conducted | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 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 protection - Requirements and test methods, Part 2:Reusable sharps containers | Force needed to penetrate test specimens shall be a minimum of 20 N or greater. | Passed |
| 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 area | 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 10^4/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 sides and bottom | ---- | The side and bottom should be of no water leakage after soaking with water for 24 hours. | Passed |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the "sample size" in terms of number of units tested for each non-clinical test. Instead, it indicates that the container was subject to various process simulations over its intended life cycle, specifically "250 cycles" for process simulations (filling, closing, decanting, decontaminating). This implies a single or very small number of physical samples would undergo these cyclical tests.
The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" in the context of device testing. The tests are "non-clinical" and likely conducted in a laboratory setting. The applicant is Ningbo Maxcon Medical Technology Co., Ltd. in China, so the testing would presumably be done in China or by a contracted lab that adheres to the stated ISO and CFR standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This question is not applicable. This is a physical medical device (sharps container), not a diagnostic device relying on expert interpretation of data or images. Ground truth is established by objective physical measurements and functional performance against defined standards (e.g., "no rupture, leakage," "force needed to penetrate").
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The testing results are objective pass/fail criteria based on physical and mechanical properties.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This question is not applicable. This is not an AI/ML-based device, and therefore, no MRMC studies involving human readers and AI assistance were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance is established by international and national standards (e.g., ISO 23907-2:2019, 49 CFR 178.606, 49 CFR 178.608) that define acceptable physical and functional performance for sharps containers. This includes objective measurements such as:
- Absence of rupture or leakage.
- Resistance to penetration (minimum force in Newtons).
- Container stability (not toppling).
- Handle integrity (not breaking or detaching).
- Legibility of labels after processing.
- Microbiological validation (no organism recovery).
- Usable capacity within a percentage deviation.
- Leak-proof property after soaking.
8. The sample size for the training set:
This question is not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established:
This question is not applicable. There is no training set as it's not an AI/ML model.
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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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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
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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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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
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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.
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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 offinished 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 forqualified personnel inhealth care facilities andother facilities in whichmedical sharps may beused. All the containers areintended to be used in areaswhere there is nounsupervised patientaccess. |
General Specifications of the Sharps Container
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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 | Lidconfiguration | Dimensions ofSharps disposalaperture (mm) | Color | TemporaryLockingmechanism lid tocontainer | Permanent Lockingmechanism |
|---|---|---|---|---|---|
| MA1421 | One lid (lidnumber:MA1400Z(R) | 416*280 | Black | Slid the lid along thegroove to cover thecontainer body . | Lock together the lid and thecontainer 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 reusablecontainer | Sharps Tank Reusable SharpsContainer | Med-Tainer Single DepositContainer | -- |
| 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 SharpsContainer is intended to beused for the collection andtransportation of used medicalsharps. The container isintended to be used inhospitals and clinics,operating rooms, andlaboratories by technicians,doctors, dentists, andveterinarians. The device isonly intended for use in areaswith no unsupervised patientaccess. | Rehrig Healthcare Systemsreusable 17gallon sharps containeris intended to be used for thecollection and transportation ofused medical sharps. The containeris intended to be used in hospitalsand clinics, operating rooms, andlaboratories by technicians,doctors, dentists, and veterinarians.The device is only intended for usein areas with no unsupervisedpatient access. | Med-Tainer Single DepositContainers are intended for thesafe collection and transport ofmedical sharps. The reusable10gallon and 17galloncontainers are to be used insupervised areas of healthcareinstitutions such as hospitals,clinics, veterinary offices andlaboratories.The Med-Tainer SingleDeposit Container is availablein Kelly green, Ascent blue,teal, red and yellow. | Same |
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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 healthcare facilities and otherfacilities in which medicalsharps may be used. All thecontainers are intended to beused in areas where there is nounsupervised patient access | Qualified personnel in health carefacilities and other facilities inwhich medical sharps may be used.All the containers are intended tobe used in areas where there is nounsupervised patient access | Qualified personnel in healthcare facilities and otherfacilities in which medicalsharps may be used. All thecontainers are intended to beused in areas where there is nounsupervised patient access | Same | Method ofManufacture | Injection Molded | Injection Molded | Rotationally molded | Different No newissues of safetyor effectiveness | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Model | MA1421 | MW009 | 780310E74100 | NA | Color | Red, with embossed andinked fill line; contrastinglabel includes Biohazardsymbol | Red with contrasting BiohazardSymbol | Red with embossed and inkedfill line; contrasting labelincludes Biohazard symbol | Similar, No newissues of safety oreffectiveness | Technological properties | ||||
| Weight andCapacity | 8.3pounds and 17gallons | 9.4 pounds and 17 gallons | 7pounds and 17 gallons | Similar, no newissues of safety oreffectiveness | Material ofconstruction | High density polyethylene | High density polyethylene | Linear Low densitypolyethylene | Similar, No newissues of safety oreffectiveness | Sterile or non-sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Product Picture | Image: MA1421 | Image: MW009 | Unavailable | Similar, no newissues of safety oreffectiveness | Reprocessingsolution | hot water (82°C) and5.25% hypochloritesolutiondiluted to 1:10 part hot water(82°C) | hot water (82°C) and 5.25%hypochlorite solutiondiluted to 1:10 part hot water(82°C) | unavailable | Similar, No newissues of safety oreffectiveness | Reusable or not | Reusable | Reusable | Reusable | Same |
| Lid StyleIllustration | Image: MA1421 Lid | Image: MW009 Lid | Unavailable | Different styles.Subject Device isflat plate sliderstyle and Predicatedevice is hingeddesign. Both canbe secured inplace for transportand both met testrequirements ofthe Standard, sono new issues ofsafety or efficacy. | Whetherreprocessing stepsare required to beautomatic or not | Yes | Yes | Yes | Same | Reusable cycles | 250 cycles | 400 cycles | 750 cycles | Different, definedin labeling so nonew issues ofsafety oreffectiveness |
| Approximate Size | 445.5mm Length335mm Width631.5mm Height | 508mm Length317.5mm Width655.3mm Height20.00"L x 12.50"W x 25.8"h | 457.2mm Length330.2mm Width635mm Height18 "L x 13 "W x 25" | Similar, no newissues of safety oreffectiveness | Requirement for Reprocessing Site | Performance testing (Non-Clinical Testing) | ||||||||
| Openingdimensions(length x width) | 416mm x 280mm total(maximum) and variable slide-opening up to the maximumfor sharps deposit with slidecontrol | 457.2mm x 271.8mm total andhinged-opening of 203.2mm x152.4mm for sharps deposit | 146.1mm x 247.7mm forsharps deposit | Similar, no newissues of safety oreffectiveness | Workingenvironment | Operating Temperatures :20° -30°CStorage Temperature :20° -30°CTransportation Temperature:0° -38°C | Operating Temperatures :20° - 30°CStorage Temperature :20° - 30°CTransportation Temperature:0° -38°C | Unavailable | Same as primarypredicate device | Life SpanProcessingSimulation | Meets requirements ofISO23907-2:2019, Reusablesharps containers, Sharps injuryprotection - Requirements andtest methods - Sharps containers- Part 2: Reusable sharpscontainers.(Containers were processed 250times to simulate their intendedlife cycle: filled with sharps,closed for transport, opened,decanted, rinsed anddecontaminated. | Unavailable | Met requirements of CAN/CSAZ316.6-14 BA.8.3.1, Sharpsinjury protection -Requirements and test methods -Sharps containers.( Containers were processed 780times to simulate their intendedlife cycle: filled with sharps,closed for transport, opened,decanted, rinsed anddecontaminated.) | Metrequirements ofthe relevant andcurrentstandards/regulations that citecomparablerequirements.No new issuesof safety oreffectiveness |
| Training | Please read user manualcarefully, no special training isrequired | Please read user manual carefully, nospecial training is required | Unavailable | Same as primarypredicate device | Life SpanTransportSimulation | Meets requirements ofISO23907-2:2019, Reusablesharps containers, Sharps injuryprotection - Requirements andtest methods - Sharps containers- Part 2: Reusable sharpscontainers. | Unavailable | Met requirements of CAN/CSAZ316.6-14 BA.8.3.1, Sharpsinjury protection -Requirements and test methods -Sharps containers. | Metrequirements ofthe relevant andcurrentstandards/regulations that citecomparablerequirements.No new issuesof safety oreffectiveness | |||||
| Expected controlsand Qualificationmethods | The recommended guidelinesfor decanting anddecontamination are provided inthe user manual and it isrecommended that thedecanting/cleaning facilitydevelop cycles and processesthrough a formal qualificationprocess based on the specificautomatic machines to be used | The recommended guidelines fordecanting and decontamination areprovided in the user manual and it isrecommended that thedecanting/cleaning facility developcycles and processes through aformal qualification process based onthe specific automatic machines to beused | Unavailable | Same as primarypredicate device | ContainerStability Test | Meets requirements ofISO23907-2:2019, Reusablesharps containers, Sharps injuryprotection - Requirements andtest methods - Sharps containers- Part 2: Reusable sharpscontainers. | Unavailable | Met requirement ofISO23907:2012, Sharps injuryprotection Requirements andtest methods – Sharpscontainers | Met requirementsof the relevant andcurrentstandards/regulations that citecomparablerequirements. Nonew issues ofsafety oreffectiveness |
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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
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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
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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 ofHandles | Meets requirements ofISO23907-2:2019, Reusablesharps containers, Sharps injuryprotection - Requirements andtest methods - Sharps containers- Part 2: Reusable sharpscontainers. | Unavailable | Met requirement ofISO23907:2012, Sharps injuryprotection Requirements andtest methods - Sharpscontainers | Met requirementsof the relevant andcurrentstandards/regulations that citecomparablerequirements. Nonew issues ofsafety oreffectiveness |
|---|---|---|---|---|
| Resistance toDamage andLeakage afterDropping | Meets requirements ofISO23907-2:2019, Reusablesharps containers, Sharps injuryprotection - Requirements andtest methods - Sharps containers- Part 2: Reusable sharpscontainers. | Unavailable | Met requirement ofISO23907:2012, Sharps injuryprotection Requirements andtest methods - Sharpscontainers | Met requirementsof the relevant andcurrentstandards/regulations that citecomparablerequirements. Nonew issues ofsafety oreffectiveness |
| Resistance topenetration | Meets requirements ofISO23907-2:2019, Reusablesharps containers, Sharps injuryprotection - Requirements andtest methods - Sharps containers- Part 2: Reusable sharpscontainers.(The criteria to pass is thepenetration force shall be aminimum of 20N or greater) | Unavailable | Met requirements for PunctureResistance per ASTM F2132-01Standard Specification ofMaterials Used in Containersfor Discarded Medical Needlesand Other Sharps.(The criteria to pass thepuncture resistance test are anaverage value not less than 3.4lbf (15 N) with no value lessthan 2.81bf or 12.5 N). | Met requirementsof the relevant andcurrentstandards/regulations that citecomparablerequirements. Nonew issues ofsafety oreffectiveness |
| Stack Test | 178.606, Specification forPackagings - Subpart M -Testing of Non-Bulk Packagingand Packages | Unavailable | Met requirements of 49 CFR178.606 Specification forPackagings - Subpart M -Testing of Non-Bulk Packagingand Packages | Meet currentrequirements, Nonewissues of safety oreffectiveness |
| Vibration Testing | Met requirements of 49 CFR178.608 Specification forPackagings – Subpart M –Testing of Non-BulkPackagings and Packages | Unavailable | Met requirements of 49 CFR178.608 Specification forPackagings – Subpart M –Testing of Non-BulkPackagings and Packages | Meet currentrequirements, Nonewissues of safety oreffectiveness |
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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
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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 sharpssimulation | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | No rupture, leakage,or deterioration thatcould adversely affectits safe use orfunctionality. | Passed |
| Transport Simulations | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | No rupture, leakage,or deterioration thatcould adversely affectits safe use orfunctionality. | Passed |
| Process simulations,including opening,decanting,decontamination, andclosing processes of250 cycles | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | No rupture, leakage,or deterioration thatcould adversely affectits safe use orfunctionality. | Passed |
| Container Stability | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | Container shall nottopple over | Passed |
| Strength of Handles | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | Handle/carryingfeature shall notbreak or detach | Passed |
| Resistance topenetration | ISO 23907-2:2019Sharps injury | Force needed topenetrate test | Passed |
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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 andtest methods, Part 2:Reusable sharpscontainers | specimens shall be aminimum of 20 N orgreater. | ||
|---|---|---|---|
| Resistance to damageand leakage afterdropping | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | No evidence ofleakage and nobreach of the sharpscontainment area. | Passed |
| Label Integrity Test | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | Labels are intact andlegible afterdecontaminationprocessing | Passed |
| Resistance to spillageby toppling | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | No evidence ofbreach of the sharpscontainment are | Passed |
| Microbiologicalvalidation | ISO 23907-2:2019Sharps injuryprotection -Requirements andtest methods, Part 2:Reusable sharpscontainers | No organisms arerecovered from areaswhere a 104/mlchallenge-suspensionof representativepathogens in wholeblood has beenapplied and dried. | Passed |
| Stacking Test | 49CFR 178.606 | No leakage,deterioration,buckling that mightaffect transportationsafety or damage tocontents | Passed |
| Vibration Test | 49CFR 178.608 | No rupture or leakage | Passed |
| Usable Capacity Test | ---- | The real usingcapacity should be ±3% different fromdesigned capacity. | Passed |
| Leak Proof on the | ---- | The side and bottom | Passed |
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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 waterleakage after soakingwith water for 24hours. |
|---|---|
| ------------------ | ------------------------------------------------------------------------------- |
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.
§ 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).