(251 days)
Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212 ; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, and blood needles by qualified personnel in health care facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
Maxcon Sharps Containers are of injection molded polypropylene plastic, and designed for a single-use 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 puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable. Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of polypropylene , the same as that of the comparable predicate devices. Labels are printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with a fill line warning not to fill above this line. The cover base and the lid (closure) come pre-assembled with the body not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the cover to the body. There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
Acceptance Criteria and Device Performance Study for Maxcon Sharps Containers
This document outlines the acceptance criteria for Maxcon Sharps Containers and summarizes the non-clinical test study demonstrating the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Container Stability | The container shall not topple over when tested. | Passed |
| Strength of Handles | The handle/carrying feature shall not break or detach during testing. | Passed |
| Resistance to Penetration | The force needed to penetrate test specimens of the container shall be a minimum of 16N and an average of 18N or greater. | Passed |
| Resistance to Damage and Leakage after Dropping | There shall be no evidence of leakage and no breach of the sharps containment area after tested. | Passed |
| Resistance to Spillage by Toppling | There shall be no evidence of leakage and no breach of the sharps containment area after tested. | Passed |
| Stacking Test | No test sample may leak. No test sample may show any deterioration which could adversely affect transportation safety or any distortion likely to reduce its strength, cause instability in stacks of packages, or cause damage to inner packagings likely to reduce safety in transportation. | Passed |
| Vibration Test | There is no rupture or leakage from any of the packages. No test sample should show any deterioration which could adversely affect transportation safety or any distortion liable to reduce packaging strength. | Passed |
| Sharps Access and Closure for Repeated Openings and Closings | After the simulated time of Sharps access and closure for repeated openings and closings of the Sharps containers, all locking mechanism of the samples should be of no malfunction, and should lock sharps container permanently and securely. | Passed |
| Label Integrity Test | Any marking or labelling on the container that is essential for safe use shall be visible and easily legible. And the required information are included in labels. | Passed |
| Usable Capacity Test | The difference between the measured capacity volume and designed capacity should be ±3%. | Passed |
| Leak Proof on the Sides and Bottom | leak proof on the sides and bottom. | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific number of units (sample size) for each test set. However, for "Resistance to Penetration," it mentions cutting the external surface of "the container" into 24 approximately equal sized areas, implying at least one container was used per test. For "Stacking Test" and "Vibration Test," it mentions using "Three sample packagings" selected at random.
The data provenance is not specified in terms of country of origin. The study appears to be a retrospective non-clinical test conducted by the manufacturer, Ningbo Maxcon Medical Technology Co., Ltd.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the tests performed are non-clinical (physical and mechanical tests) and do not involve human interpretation or subjective assessment by experts to establish ground truth. The results are based on objective measurement and observation against predefined criteria in relevant standards.
4. Adjudication Method for the Test Set
This information is not applicable as there is no human interpretation or subjective assessment that would require adjudication. The tests involve quantifiable measurements and observations of physical performance.
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
There was no MRMC comparative effectiveness study conducted. The device is a physical sharps container and does not involve AI or human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical sharps container and does not involve any algorithm or AI.
7. The type of ground truth used
The ground truth for these non-clinical tests is established by fulfilling the objective, quantifiable criteria defined by recognized international and national standards, specifically:
- ISO 23907-1:2019 (Sharps injury protection — Part 1: Requirements and test methods for sharps containers)
- 49CFR 178.606 (US Department of Transportation hazardous materials regulations for drumming and packaging – specifically related to stacking tests)
- 49CFR 178.608 (US Department of Transportation hazardous materials regulations for drumming and packaging – specifically related to vibration tests)
- OSHA Regulations (Standards - 29 CFR) Bloodborne Pathogens. 1910.1030, (d)(2)(viii)(C) (for leak proof testing)
These standards define the methodologies and acceptable performance limits.
8. The sample size for the training set
This is not applicable as the device is a physical product and does not involve any machine learning models that require a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a physical product and does not involve any machine learning models or training sets.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 1, 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: K222905
Trade/Device Name: Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK. Dated: August 31, 2022 Received: September 23, 2022
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
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal 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 medical devices and radiation-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.
Christopher K. Dugard -S
for Clarence W. Murray, III. Ph.D. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K222905
Device Name
Maxcon Sharps Container (1 OT Sharps Container, MA1112), Maxcon Sharps Container (5.4 OT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
Indications for Use (Describe)
Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212 ; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, and blood needles by qualified personnel in health care facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
| Description of the devices |
|---|
| Name/modelnumber of thedevice model | Size/capacity of the device model | Dimensions of the device model, (L x W x H) (mm,± 0.1) | Colors available for the model | Description and dimensions of the sharps disposal aperture(s) (mm,±0.1) | Special features (locking mechanism , needle unwinders) | Requirements for mounting | Acceptable sites of use (patient access) |
|---|---|---|---|---|---|---|---|
| MA1112 | 1 Quart | 101.82108.31154 | Red base, translucent lid | Opening 1:43.4*30 (L×W)Opening 2:14 (diameter) | Hinged closure | Holder with Double face adhesive tape | 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. |
| MA1212 | 5.4 QT | 311.13113.85291.06 | Red base, white lid | 194.5*50 (L×W) | Counterbalanced door | Locking wall bracket | 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. |
| MA1213 | 5.4QT | 310116.2315.31 | Red base, white lid | 222.93*63.47 (L×W) | Counterbalanced door | Locking wall bracket | 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. |
| MA1324 | 7L | 248200232 | Yellow base, translucent lid | 102 (diameter) | Star-hinged door | Freestanding | 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. |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. There are two vertical lines to the left of the word. The letter "O" in "MAXCON" has a plus sign inside of it. The font is sans-serif and the letters are tightly spaced.
510(k) Summary
The assigned 510(k) number is: K222905
Revised Date : February 21, 2023
1. 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
2. Primary Contact:
Mr.Henry Zhang, President
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
3. Name of the Device:
Device Name: Sharps Container
Trade Name:Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324)
4. 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 diagonal lines to the left of the letter "M". A plus sign is located in the middle of the letter "O".
CFR Reference: 21 CFR 880.5570
Classification: Hypodermic single lumen needle
Classification Panel:General Hospital
5. Predicate Device Information:
● Predicate Device:
Trade name: Nitta M&T Safety Box
Regulation Description: Hypodermic single lumen needle.
Product Code: MMK
Regulation Number: CFR880.5570
Device Class: II
The device 510k number is K211464. manufactured by Nitta M&T (Thailand) Co., Ltd,
located in 19/52 Unit G5, Phaholyothin Road, Moo 10 Khlong Hueng, Khlong Luang
Pathumthani, 12120 Thailand.
● Second Predicate Device:
Trade Name: Tiger Sharps Container
Regulation Number: 21 CFR880.5570
Regulation Name: Hypodermic single lumen needle
Regulatory Class: II
Product Code: MMK
The device 510k number is K190240, manufactured by International Marketing Specialists Inc.,located in 1278 Highway 461, Somerset, Kentucky 42503, USA.
6. Intended use / Indication for Use:
Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212 ; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are single-use, disposable, non-sterile containers, intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device
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Image /page/5/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. There are two diagonal lines to the left of the word "MAXCON". A plus sign is located inside of the letter "O".
models are not in contact with or available to the patient in normal use, and all device
models are not for use in areas with unsupervised patient access.
Description of the devices
| Name/modelnumberof thedevicemodel | Size/capacityof thedevicemodel | Dimensions ofthe devicemodel(L xW x H)(mm, $\pm$ 0.1) | Colorsavailablefor themodel | Descriptionanddimensionsof the sharpsdisposalaperture(s)(mm, $\pm$ 0.1) | Specialfeatures(lockingmechanism, needleunwinders) | Requirements formounting | Acceptable sitesof use (patientaccess) |
|---|---|---|---|---|---|---|---|
| MA1112 | 1 Quart | 101.82108.31154 | Red base,translucentlid | Opening 1:43.4*30(L×W)Opening 2:14(diameter) | Hingedclosure | Holder withDouble faceadhesivetape | The targetpopulation isfor qualifiedpersonnel inhealth carefacilities and |
| MA1212 | 5.4 QT | 311.13113.85291.06 | Redbase,white lid | 194.5*50(L×W) | Counterbalanceddoor | Lockingwall bracket | Other facilitiesin whichmedicalsharps may beused. All the |
| MA1213 | 5.4QT | 310116.2315.31 | Redbase,white lid | 222.93*63.47(L×W) | Counterbalanceddoor | Lockingwall bracket | containers areintended to beused in areaswhere there is |
| MA1324 | 7L | 248200232 | Yellowbase,translucentlid | 102(diameter) | Star-hinged door | Freestanding | no unsupervisedpatient access. |
7. Device Description:
Maxcon Sharps Containers are of injection molded polypropylene plastic, and designed for a single-use 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 puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable.
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Image /page/6/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are black, and there are three horizontal lines to the left of the "M". The "+" symbol is embedded within the letter "O".
宁波迈克斯康医疗科技有限公司
Large access openings allow for disposal of sharps with one hand use. The plastic used for the sharps containers are of polypropylene , the same as that of the comparable predicate devices.
Labels are printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with a fill line warning not to fill above this line.
The cover base and the lid (closure) come pre-assembled with the body not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the cover to the body. There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
| Model | Weight(empty)gram | Capacity(total) | Capacity(full line) | Dimensions offinished goods (mm)(L x W x H)(±0.1) | Acceptable sites of use |
|---|---|---|---|---|---|
| MA1112 | 90.6 | 1 Quart | 0.8 Quart | 101.82108.31154 | The target population is forqualified personnel inhealth care facilities and |
| MA1212 | 357 | 5.4 Quart | 4.32 Quart | 311.13113.85291.06 | other facilities in which |
| MA1213 | 422 | 5.4Quart | 4.32Quarts | 310116.2315.31 | medical sharps may beused. All the containers areintended to be used in areas |
| MA1324 | 300 | 7 Liter | 5.6 Liter | 248200232 | where there is nounsupervised patient access. |
General Specifications of the sharps containers
General description of the lids
| Model | Lidconfiguration | Dimensions ofSharps disposalaperture (mm)( $\pm$ 0.1) | Lockingmechanism | Requirements for mounting |
|---|---|---|---|---|
| MA1112 | Doubleopening Hinge | Opening 1:$43.4 \times 30$ (L×W)Opening 2:14 (diameter) | Hinged closure | Holder with Double faceadhesive tape |
| MA1212 | CounterBalance (Up) | $194.5 \times 50$ (L×W) | Counterbalanceddoor | Locking wall bracket |
| MA1213 | CounterBalance(Down) | $222.93 \times 63.47$(L×W) | Counterbalanceddoor | Locking wall bracket |
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Image /page/7/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 two horizontal lines to the left of the word. The letter "O" in "CON" has a plus sign inside of it.
宁波迈克斯康医疗科技有限公司
| MA1324 | Star hinge | 102 (diameter) | Star-hinged door | Freestanding |
|---|---|---|---|---|
| -------- | ------------ | ---------------- | ------------------ | -------------- |
Accessory Description
The accessories are manufactured by the firm and available for the containers as follows: 1 quart container (MA1112) : a holder (made of P.P) with Double face adhesive tape for locking on desk top .
5.4 Quart sharps container (MA1212):a wall bracket ( made of ABS) which is to be locked by a key (made of P.P).
5.4 Quart sharps container ( MA1213): a wall brackets (made of ABS) which is to be locked by a key (made of P.P).
Needle unwinder Feature:
The unwinder feature in Maxcon Sharps containers (1 QT Sharps Container, MA1112; 7 Liter Sharps Container MA1324 ) is located in the lid and above the containment area. The unwinder has a round entry port for the needle to pass through, allowing it to be fully enclosed within the container. Once the needle is inserted into the round port, the Luer end of the needle is guided into the tapered slot which secures the needle body allowing for the syringe to be rotated and detached from the needle. The needle is unscrewed from the syringe body allowing it to drop into the container without the need to be touch or handled.
8. Target population
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.
9. Comparing to Predicate Device:
| Characteristic | Submitted SubjectDevice | Predicate Device | SecondPredicate Device | Comparison |
|---|---|---|---|---|
| 510(k) | K222905 | K211464 | K190240 | n/a |
| Device Name | Maxcon Sharpscontainer | Nitta M&T Safety Box | Tiger Sharps Containers |
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Image /page/8/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are black, and there are three black lines to the left of the word. The "O" in "MAXCON" has a plus sign inside of it. The overall design is simple and modern.
宁波迈克斯康医疗科技有限公司 Ningbo Maxcon Medical Technology Co., Ltd
| 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 |
| Size | 1 Quart / 5.4 Quart /5.4 Quart/ 7 Liter | 0.2 / 1L / 1.5L / 3.2L / 5.0L/ 7.6L | 1 Quart / 5 Quart / 2 Gallon / 2Gallon B / 15 Liter /3 Gallon/ 8Gallon | Different |
| Dimensions(mm)(L x W x H) | 154101.82108.31/311.13113.85291.06/315.31116.2310/248200232 | 113 x 109 x 135 / 151 x 150x137 / 132 x 246 x 198 /136 x 279 x 210 / 132 x 246x 400 / 136 x 235 x 210 /136 x 245 x 422 / 78 x 50 x82 | 3.91x3.91x6.37/10.60x4.70x10.64/10.84x6.86x10.36/10.22x7.02x13.30/ 9.50x14.77x12.03/ 14.86x7.25x14.00/10.92x15.61x17.27 | Different |
| Single orre-usable use | Single use/disposable | Single use/disposable | Single use/disposable | Same |
| Weight range | 90.6-422g | 48-674 g | 109-1172 g | Different |
| No. of Pieces | 2-4 | 2-6 | 2-3 | Different |
| Sterile or not | Non-sterile | Non-sterile | Non-sterile | Same |
| Material | Poly-propylene (P.P) | Poly-propylene (P.P) | Poly-propylene (P.P) | Same |
| Body Color | Red/Yellow | Red / Yellow | Red | Similar |
| Clarity | Opaque/translucent | Opaque/translucent | Opaque/translucent | Same |
| Method ofManufacture | Injection Molded | Injection Molded | Injection Molded | Same |
| Performancetesting(puncture,impact, drop,stability,integrity) | Pass | Pass | Pass | Same |
| Standards | ISO23907-1:2019 | ISO23907-1:2019 | ISO 23907, ASTM F 2132 | Same |
| Lidconfigurations | Opening hinge,counter-balance (up),counter-balance( down),star-hinge | Opening Hinge,counter-balance (up) , | Opening hinge, counter-balance(down), star hinge, sliding,rotary/hinge | Same |
| Accessories | Holder (made of P.P)with Double faceadhesive tape is availablefor use with 1 quartcontainer (MA1112) inlocking on desk top bydouble face adhesivetape.5.4 Quart sharpscontainer (MA1212 andMA1213) is availablefor use with a mountingbrackets (made of ABS)which is to be locked bya key (made of P.P). | Mounting accessories(brackets) are available foruse with 1.0L, 1.5L, 3.2Land 7.6L containers inlocking and non-lockingvariations. | Mounting accessories (brackets) areavailable for use with 1qt, 5qt, 2g and3g containers in locking andnonlocking variations. | Different |
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Image /page/9/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. The letters are sans-serif and appear to be a custom font. There are three horizontal lines to the left of the word. The letter "O" has a plus sign inside of it.
宁波迈克斯康医疗科技有限公司
10.Summary of technological characteristics
Maxcon Sharps Container have equivalent indications for use and technological characteristics as the predicate device, based on the facts as follows:
-
- The same indication for use, and targeted population, and similar site of use
-
- The same product structure, disposable and non-sterile sharps containers.
-
- The same method of manufacture: injection molded of polypropylene.
-
- The same lid configuration: Opening hinge, counter-balance (Up), counter-balance (Down), and star-hinge
-
- All containers can be successfully passed through the same test items (i.e. Container Stability, Strength of Handle, Resistance to penetration and Resistance to Damage and leakage after dropping and Resistance to Damage and leakage after toppling as described in ISO23907-1:2019).
Although the subject device and predicate device differ in containers size, dimensions; and containers capacities etc, the difference in technological characteristics do not impair the subject devices from their intended functions of disposal and storage of sharp waste.
11. Summary of Non-Clinical Tests :
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Image /page/10/Picture/0 description: The image shows the logo for MAXCON, a medical technology company. The logo is in black and features the company name in bold letters with a plus sign incorporated into the design. Below the logo, the company name is written in Chinese characters: 宁波迈克斯康医疗科技有限公司.
| Testname | Nature ofTests | Brief description | Standardsused | Acceptance criteria | Testresults |
|---|---|---|---|---|---|
| ContainerStability | Physics test | Fill one container to the fill line withmaterial of a density of (0.20 ± 0.01)kg/1 or with syringes with a capacity of<2 ml. Do not lock or close thepermanent or temporary closures.Placethe container in the most adverseposition on its base for toppling on asurface with a minimum inclinationangle of 15°. Ensure that the containerdoes not slide before toppling. | ISO23907-1:2019 | The container shall nottopple over when tested | Passed |
| Strength ofHandles | Physics test | Fill one container with a massequivalent to 150% of themanufacturer's allowable gross mass.Close and lock the permanent closure asif the sharps container is ready for finaldisposal. Suspend the container by itshandles at the intended carrying pointsfrom a rigid support for 1 h at 23 ±5 °C.Remove the container from the supportand inspect the handles for integrity andfor any evidence of detachment of thehandles form the container. | ISO23907-1:2019 | The handle/carryingfeature shall not breakor detach during testing | Passed |
| Resistancetopenetration | Physics test | Cut the entire external surface of thecontainer into 24 approximately equalsized areas. In each of these 24 areas,measure the thickness to determinewhere it is thinnest; conduct thepenetration test on the thinnest part ofeach of these 24 test specimens.Condition the test specimens at 23±2 °C for at least 2h and carry out thetest at the same temperature. Fix ahypodermic needle in a needle holder.Place the test specimen centrally on thetest specimen support with the insidecontainer surface facing upwards. Donot distort the test specimens byattempting to flatten any curves. Lowerthe needle vertically 90° ±5° towards thespecimen at rate of 100±10 mm/min.allow the needle to pass through the testspecimen and record the penetrationforce. | ISO23907-1:2019 | The force needed topenetrate test specimensof the container shall bea minimum of 16N andan average of 18N orgreater | Passed |
| Resistanceto | Physics test | Condition the test specimens at 23±5 °C for at least 2h and carry out thetest at the same temperature. Fill the | ISO23907-1:2019 | There shall be noevidence of leakage andno breach of the sharps | Passed |
| Ningbo Maxcon Medical Technology Co., Ltd | |||||
| damageandleakageafterdropping | sharps container with a volume ofwater at 23 ±5 °C equal to 1% of thevolume measured to the fill line ofthe container. Fill the sharpscontainer with a mass fraction ofPE/PP granules equal to 100% of themanufacturer's maximum allowablegross mass. Test to be performedfrom a height of 1 ±0.02 m, asmeasured by the distance between thelowest point on the sharps containerand the nearest point on the impactsurface. Release the container, do notobstruct its fall or restrict movementof the container after it has struck theimpact surface. | containment area aftertested | |||
| Resistancetospillage bytoppling | Physics test | impact surface.Condition the test specimens at 23±5 °C for at least 2h and carry out thetest at the same temperature. Fill onecontainer with 2ml syringes (withoutneedles) up to the fill line. Engage thetemporary closure feature of thecontainer. Stand the sharps container onits intended base on the impact surface.Apply increasing force at a suitablepoint above the center of gravity so thatthe sharps container rotates about theopposite lower edge until point ofbalance is reached. Then permit thecontainer to overbalance without thrustso that it falls freely opposite to wherethe force is applied. Leave the sharpscontainer where it has fallen for 5 min. | ISO23907-1:2019 | There shall be noevidence of leakage andno breach of the sharpscontainment area aftertested | Passed |
| StackingTest | Physics test | The test sample must be subjected to aforce applied to the top surface of thetest sample equivalent to the totalweight of identical packages whichmight be stacked on it duringtransport. The minimum height of thestack, including the test sample, must be3.0 m (10 feet). The duration of the testmust be 24 hours. | 49CFR178.606 | No test sample mayleak.No test samplemay show anydeterioration whichcould adversely affecttransportation safety orany distortion likely toreduce its strength,cause instability instacks of packages, orcause damage to innerpackagings likely toreduce safety intransportation. | Passed |
| Vibration Test | Physicstest | Three sample packagings, selected atrandom, must be filled and closed as forshipment. The three samples must beplaced on a vibrating platform that hasa vertical or rotary double-amplitude(peak-to-peak displacement) of oneinch. The test must be performed for | 49CFR178.608 | There is no rupture orleakage from any of thepackages. No testsample should showany deterioration whichcould adversely affecttransportation safety or | Passed |
| Ningbo Maxcon Medical Technology Co., Ltd | |||||
| one hour at a frequency that causes thepackage to be raised from the vibratingplatform to such a degree that a piece ofmaterial of approximately 1.6 mm(0.063 inch) thickness (such as steelstrapping or paperboard) can be passedbetween the bottom of any package andthe platform | any distortion liable toreduce packagingstrength. | ||||
| Sharpsaccessandclosureforrepeatedopenings andclosings | Physicstest | All locking mechanism of thecontainers after its access andclosure for repeated opening andclosings tantamount to the timesduring its life cycle should be ofno malfunction, and canlock sharps container permanentlyand securely | After the simulated timeof Sharps access andclosure for repeatedopenings and closingsof the Sharpscontainers, all lockingmechanism of thesamples should be of nomalfunction,and should lock sharpscontainer permanentlyand securely | Passed | |
| LabelIntegrity Test | Physicstest | The marking or labelling on thecontainer should include the followinginformation: A clear indication of thefill line.The word "Danger".Anindication that the container is notre-usable.Identification of the totaland/or fill volume of thecontainer.Name and address of themanufacture.Lot or batch identification.Commercial reference for theContainer.Packaging information.Warning regarding "not filling abovefill line and not forcing sharps intoContainer. | ISO23907-1:2019 | Any marking orlabelling on thecontainer that isessential for safe useshall be visible andeasily legible. And therequired informationare included in labels. | Passed |
| UsableCapacity Test | Physicstest | Measure the water volume for fillingthe sharp container to the fill line andfully respectively. Compare themeasured volume against the designvolume capacity of the container | The difference betweenthe measured capacityvolume and designedcapacity should be±3%. | Passed | |
| LeakProofon thesidesandbottom | Physicstest | Prepare empty barrels with adequatesize and bags of heavy weight. Placeinto the barrel one sample of sharpscontainer and then put a bag of heavyweight into the sample of sharpscontainer. Introduce water into thebarrel until water reaching to the topedge of the sample of sharps container.Keep them still for 24 hrs, and thencheck whether there is waterleakage/stain/mark in inner sides andbottom of the sample of sharpscontainer or not. | OSHARegulations(Standards- 29 CFR)BloodbornePathogens.1910.1030,(d)(2)(viii)(C) | leak proof on thesides and bottom | Passed |
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Image /page/11/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 word. The letter "C" 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/12/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. The letters are closely spaced together, and the "O" in "CON" has a plus sign inside of it. There are also three horizontal 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
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the word "MAXCON" in bold, black letters. The letters are sans-serif and appear to be a custom font. There are three black lines to the left of the word. The plus sign is in the middle of the letter "O".
宁波迈克斯康医疗科技有限公 Ningbo Maxcon Medical Technology Co., Ltd
12. Sterility Information
The subject device container is non-sterile; therefore, no sterility testing was performed.
13. Discussion of Clinical Tests Performed:
There was no clinical testing required to support the medical device.
13. Conclusions:
The conclusions drawn from the nonclinical tests demonstrate that the Maxcon Sharps containers (1 QT Sharps Container, MA1112; 5.4 QT Sharp Container MA1212; 5.4 QT Sharps Container MA1213; 7 Liter Sharps Container MA1324) are as safe, as effective, and performs as well as or better than the legally marketed devices marketed under K211464 and K190240.
§ 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).