(265 days)
Maxcon Sharps containers(2.2QTSharpsContainer,MA1122;2GSharps Container MA1321;2GSharp Container MA1221; 8GSharps Container MA1352) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal ofhazardous sharps such as hypodermic needles, syringes, lancets and blood needles.The target population is for qualified personnel in health care facilities in which medical sharps may be used. All the containers are intended to be used in areas where is no unsupervised patient access.
Maxcon Sharps Containers are made of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other facilities in which medical sharps may be used, the same as that of the comparable predicate devices.
Maxcon Sharps Containers are composed of 3 parts (base+lid+closure).No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers. The lid and the closure come pre-assembled with the base not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the lid to the base.
Labels are on a red background with printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with the fill line warning matching the engraved fill line on the container.
There is no feature to bend, break, or shear needle ,includes blunting and melting of needle in the containers.
The provided document details the 510(k) submission for the Maxcon Sharps Container. Since this is for a medical device (sharps container) and not an AI/ML-driven diagnostic or therapeutic device, the concepts of "acceptance criteria," "device performance," "sample sizes," "ground truth," "experts," and "MRMC studies" are applied differently than described in the prompt, which is more suited for AI/ML outputs.
Instead, the acceptance criteria are based on established performance standards for sharps containers, and the "study" is a series of non-clinical tests demonstrating the device's adherence to these standards.
Here's the information adapted to the context of a sharps container:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Puncture Resistance | ASTM F2132-01 (Reapproved 2008) - "Standard Specification for Puncture Resistance of Material Used in Containers for Discarded Medical Needles and Other Sharps". The device must resist puncture. | Passed |
| Container Stability | ISO 23907:2012 - "Sharps injury protection - Requirements and test methods - Sharps containers". The container must maintain a stable and upright position. | Passed |
| Drop/Impact Test | ISO 23907:2012 - "Sharps injury protection - Requirements and test methods - Sharps containers". The device must resist damage and leakage after dropping. | Passed |
| Handle Strength | ISO 23907:2012 - "Sharps injury protection - Requirements and test methods - Sharps containers". The handle must demonstrate adequate strength. | Passed |
| Stacking Test | 49 CFR 178.606 - Performance test for packaging. The containers must withstand stacking without damage. | Passed |
| Vibration Test | 49 CFR 178.606 - Performance test for packaging. The containers must withstand vibration without damage. | Passed |
| Sharps access and closure for repeated openings and closings | Implied functional requirement for safe disposal and containment during use. | Passed |
| Label Integrity Test | ISO 23907:2012. Labels must remain legible and affixed after testing. | Passed |
| Usable Capacity Test | Implied functional requirement that the container meets its stated usable capacity. | Passed |
| Minimum Sharps Container wall Thickness Evaluation | Implied structural requirement that the container walls meet minimum thickness specifications for safety and durability. | Passed |
| Shelf-life study | Real-time aging and accelerated-time aging studies to support a shelf life of 3 years. The device must maintain its functionality and integrity over this period. | Passed (3 years supported) |
| Simulated life cycle test | Implied functional requirement that the container performs throughout its intended use cycle. | Passed |
| Leak Proof on the sides and bottom | Implied functional requirement to prevent leakage of contents. | Passed |
| Clarity | Each container must have one translucent component, allowing visibility to check whether the wasted sharp reaches the fill line. | Yes (as per device description) |
| Capable of maintaining a stable and upright position | Yes | Yes (as per device description) |
| Performance, effectiveness and safety | Must pass all tests listed above (Puncture, Stability, Drop, Handle, etc.). | Passed (all listed tests) |
| End-color change | No color change. | No color change (as per comparison to predicate) |
| Claimed sterilization cycles | Device must be non-sterile, as stated. | Non-sterile (as per comparison to predicate) |
| Operation way | Drop the wasted sharps into container by one hand. | Same as predicate (as per comparison) |
| Single use or not | Single used and disposable ones. | Single used and disposable ones (as per comparison) |
| Labeling | Biohazard labels visible on device. | Biohazard labels visible on device (as per comparison) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It only states that the tests were successfully passed ("Passed"). The data provenance is through the manufacturer's internal testing as part of their 510(k) submission, confirming compliance with international and US standards. This is prospective testing performed on the final device design. The country of origin of the device and testing is implied to be China (Ningbo Maxcon Medical Technology Co., Ltd. is based in China), under the guidance of US FDA recognized consensus standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not directly applicable to the evaluation of a sharps container. The "ground truth" for a sharps container's performance is defined by established engineering and safety standards (e.g., ASTM, ISO, CFR). The "experts" in this context would be the engineers and technicians performing the tests according to the specified methodologies and the regulatory bodies (like FDA) that define and enforce these standards. There is no mention of external clinical experts retrospectively reviewing test results for "ground truth" establishment in the way it applies to diagnostic algorithms.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 (common in clinical trials or AI performance evaluations involving human readers) are not applicable here. The assessment of whether a sharp container "passed" a test is based on objective measurements and predefined pass/fail criteria outlined in the standardized test protocols (e.g., did the container resist puncture up to a certain force, did it leak after a drop, etc.).
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
An MRMC study is not applicable to a sharps container. This type of study is designed to evaluate the performance of diagnostic imaging devices or AI algorithms by having multiple human readers interpret cases, often comparing performance with and without AI assistance. The Maxcon Sharps Container is a physical medical device for waste disposal, not an imaging or diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This concept is not applicable. The Maxcon Sharps Container is a physical product, not an algorithm. Its performance is inherent in its physical design and materials, and it functions independently, although it is used by humans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" used for evaluating the Maxcon Sharps Container is defined by adherence to established international and national performance standards (e.g., ASTM F2132-01, ISO 23907:2012, 49 CFR 178.606, OSHA 29 CFR 1910.1030). These standards themselves represent a consensus of expert engineering and safety knowledge that defines what constitutes a safe and effective sharps container. There is no "pathology" or "outcomes data" in the sense of clinical disease diagnosis.
8. The sample size for the training set
This concept is not applicable. Sharps containers are physical devices manufactured through injection molding. They do not involve "training sets" in the context of machine learning. The design and manufacturing processes are refined through engineering principles, material science, and iterative prototype testing, not data-driven algorithm training.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an algorithm. The "ground truth" for the design and manufacturing of the sharps container is the adherence to the performance requirements stipulated by the aforementioned safety and engineering standards. Manufacturing processes are validated to consistently produce devices that meet these specifications.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 3, 2019
Ningbo Maxcon Medical Technology Co., Ltd. Yang Song Sales Manager No.30 Dongbei Road/No.228 Dong Xin Road, Dong Qiao Town Ningbo, 315157 Cn
Re: K180984
Trade/Device Name: Maxcon Sharps Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: November 21, 2018 Received: December 7, 2018
Dear Yang Song:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K180984
Device Name Maxcon Sharps Container
Indications for Use (Describe)
MaxconSharps containers(2.2QTSharpsContainer,MA1122;2GSharps Container MA1321;2GSharp Container MA1221; 8GSharps Container MA1352) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal ofhazardous sharps such as hypodermic needles, syringes, lancets and blood needles.The target population is for qualified personnel in health care facilities in which medical sharps may be used. All the containers are intended to be used in areas where is no unsupervised patient access.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Ningbo Maxcon Medical Technology Co., Ltd
510(k) Summary
The assigned 510(k) number is: K180984
-
- Date Prepared: January 3, 2019
2. Submitter's Identification:
Ningbo Maxcon Medical Technology Co.,Ltd
Address:No.228,Dongxin Road,Dongqiao Town,Yinzhou.Ningbo,Zhejiang province,China
Contact person: Mr.Song Yang, Sales manager of business department Telephone:
(+86)18656003277
E-mail:song.yang@maxcon.net.cn
Zip code:315157
-
- Name of the Device:
Device Name:Sharps Container
- Name of the Device:
Trade Name:Maxcon Sharps Container
Including models: 2.2 QT Sharps Container, MA1122; 2G Sharps Container MA1321 ; 2 G Sharp Container MA1221; 8G Sharps Container MA1352
4. Classification Information:
Product Code: MMK
Device Class: Class II
CFR Reference: 21 CFR 880.5570
Classification: accessory to hypodermic single lumen needles
Classification Panel:General Hospital
ર. Predicate Device Information:
Trade name: Oak Ridge Products Sharps Container, manufactured by Oak Ridge
Products L.L.C, located in 4612 Century Court, McHenry, Illinois,
60050 USA
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Ningbo Maxcon Medical Technology Co., Ltd
Common name: Sharps Container
Product code: MMK
Classification: Accessory to hypodermic single lumen needles
CFR Reference: 21CFR 880.5570-Class II
Classification Panel: General Hospital
Legally Marketed Equivalent Device:
| Company | Product description | Oak Ridge partnumber | 510(K)# |
|---|---|---|---|
| Oak RidgeProducts | 2.2 Quart Rotary LidSharps-rotary door | 0322-150R | K161180(Primarypredicate ) |
| Oak RidgeProduct | 1 Gallon SharpsContainer-sliding door | 0319-1500 | K161180(Primarypredicate ) |
| Oak RidgeProduct | 2 GallonSharps-w/folding door | 0320-150F | K161180(Primarypredicate ) |
| Oak RidgeProduct | 7 Gallon SharpsContainer -hinged door | 0370-1500 | K141759(Referencedevice) |
Intended use / Indication for Use: 6.
Maxcon Sharps containers (2.2 QT Sharps Container, MA1122; 2G Sharps Container MA1321 ; 2 G Sharp Container MA1221; 8G Sharps Container MA1352 ) are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All the containers are intended to be used in areas where there is no unsupervised patient access.
7. Device Description:
Maxcon Sharps Containers are made of injection molded polypropylene plastic, and designed for a single-use by qualified personnel in health care facilities and other
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Nin Maxcon Medical Technology Co., Ltd
facilities in which medical sharps may be used, the same as that of the comparable predicate devices.
Maxcon Sharps Containers are composed of 3 parts (base+lid+closure).No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers. The lid and the closure come pre-assembled with the base not attached. Components are nested together to reduce room occupation in storage and shipping. The final on-site assembly is performed in health care facility by snapping the lid to the base.
Labels are on a red background with printed in black text and a black bio-hazard symbol. Labels are adhered to the containers at the time of the manufacture with the fill line warning matching the engraved fill line on the container.
There is no feature to bend, break, or shear needle ,includes blunting and melting of
| Product | Product description | Access | Overall | Weight | Total | Capaci | Mounting |
|---|---|---|---|---|---|---|---|
| Model | and closure type | opening | size L×W×H(mm) | (grams)empty | capacity | tyatfullline | |
| MA1122 | 2.2 quart red sharpscontainer-rotarydoor | 86x38 | 160x120x181 | 175 | 2.1 L | 1.6 L | Free standingordoubleface adhesivetape |
| MA1221 | 2 gallon red sharpscontainer-foldingdoor | 203x63 | 316x152x230 | 421 | 7.5 L | 6 L | Free standingor bracket |
| MA1321 | 2 gallon red sharpscontainer-slidingdoor | 139x61 | 275x180x254 | 365 | 7.5 L | 6 L | Free standingor bracket |
| MA1352 | 8 gallon red sharpscontainer-hingeddoor | 226x126 | 390x276x435 | 1220 | 27.3L | 21 L | Free-standing |
needle in the containers.
The maximum allowable gross mass of the container is defined as follows:
| Model | Maximum allowable gross mass in the container |
|---|---|
| MA1122 | 0.5kg |
| MA1321 | 2kg |
| MA1221 | 2kg |
| MA1352 | 8kg |
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Ningbo Maxcon Medical Technology Co., Ltd
Needle unwinder Feature:
The unwinder feature on the 2.2 quart container(model: MA1122, rotary door), 2 gallon container (model: MA1221, folding door) and 8 gallon container (model:MA1352, hinged door) is located in the lid and above the containment area. The unwinder has a round entry port for the needle to pass through, allowing it to be fully enclosed within the container. Once the needle is inserted into the round port, the Luer end of the needle is guided into the tapered slot which secures the needle body allowing for the syringe to be rotated and detached from the needle. The needle is unscrewed from the syringe body allowing it to drop into the container without the need to be touch or handled.
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8. _Comparing to Predicate Device:
| Characteristics | Subject device manufactured by NingboMaxcon Medical Technology Co.,Ltd | Predicate deviceOak Ridge Products(K161180)(Predicate device) | Predicate deviceOak Ridge Products(K141759)(Reference device) | S.EComparison | |||||
|---|---|---|---|---|---|---|---|---|---|
| Productcode/class/regulation number | MMK/class II/ 21 CFR 880.5570 | MMK/class II/ 21 CFR 880.5570 | MMK/class II/ 21 CFR 880.5570 | Same | |||||
| Indications foruse/intended use | Maxcon Sharps containers are single-use,disposable, non-sterile containers intendedto be used for health-care purposes forsafe disposal of hazardous sharps such ashypodermic needles, syringes, lancets andblood needles.The target population is forqualified personnel in health care facilitiesand other facilities in which medicalsharps may be used. All the containers areintended to be used in areas where there isno unsupervised patient access. | Oak Ridge Products SharpsContainers are a single-use,disposable, non-sterile containersintended to be used for healthcarepurposes for safe disposal ofhazardous sharps such ashypodermic needles, syringes,lancets and blood needles. Thetarget population is for trainedhealthcare professional.All thecontainers are intended to be usedin areas where there is nounsupervised patient access. | Oak Ridge Products SharpsContainers are a single-use,disposable, non-sterilecontainers intended to be usedfor healthcare purposes forsafe disposal of hazardoussharps such as hypodermicneedles, syringes, lancets andblood needles. The targetpopulation is for trainedhealthcare professional. | Same | |||||
| Device design | All is comprised of 3 components, a container base+a lid+a closure. Its closure is designed of 4 types: Rotarydoor ,Folding door, sliding door and hinged door. The lid and the closure come pre-assembled with the base notattached. Components are nested together to reduce storage and shipping requirements. The health care facilityperforms the final assembly on-site by snapping the lid to the base. | ||||||||
| Where it is used | Health care facility and other facility inwhich medical sharps may be used | Health care facility | Health care facility | Same | |||||
| Materials used | Injection molded of Poly-propylene | Injection molded ofPoly-propylene | Injection molded ofPoly-propylene | Same | |||||
| Size | 2.2 Quart | 2 gallon2 gallon | 8 gallon | 2.2 Quart1 Gallon2 Gallon | 7 Gallon | Different | |||
| Dimensions(inches ) | 6.25×4.6×6.7 | 12.4x6x9 | 10.8x7.1x10 | 15.35x10.9x17.1 | 6.25×4.6×6.7 | 10.3×7.0×5.5 | 10.3×7.0×10.1 | 15.5×12×13.75 | Different |
| Weight (grams) | 175 | 421 | 365 | 1220 | 172 | 280 | 397 | 1228 | Different |
| Access openingsize(inches) | 3.4×1.5 | 8×2.5 | 5.5×2.4 | 8.9x5(Major),3.4×1.5(minor) | 3.4×1.5 | 5.6×2.3 | 8.2×2.1 | 13.75×4.75 (Major),8.75×1.75 (minor) | Different |
| Non-clinicaltesting | Successfully passed through tests ofimpact resistance, puncture resistance andleak resistance | Successfully passed through testsof impact resistance, punctureresistance and leak resistance | Successfully passed throughtests of impact resistance,puncture resistance and leakresistance | Same | |||||
| No features tobend, break, orshear needle | No feature present | No feature present | No feature present | Same |
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l td Ningbo Maxcon Medical Technolog
| Clarity | Each container has one translucent component, allowing visibility to check whether the wasted sharp reach to fill line or not | Each container has one translucent component, allowing visibility to check whether the wasted sharp reach to fill line or not | Each container has one translucent component, allowing visibility to check whether the wasted sharp reach to fill line or not | Same | |
|---|---|---|---|---|---|
| Capable of maintaining a stable and upright position | Yes | Yes | Yes | Same | |
| Performance, effectiveness and safety | All container has been successfully passed through test items as follows:Puncture Resistance as per FDA Recognized Consensus Standards, 6-215, ASTM F2132 -01 Standard Specification for Puncture Resistance of Material Used in Containers for Discarded Medical Needles and Other Sharps (Reapproved 2008)e1, Container stability, as well as bracket stability as per FDA Recognized Consensus Standards, 6-293, ISO 23907 First edition 2012-09-01Sharps injury protection - Requirements and test methods - Sharps containers. Handle strength as per FDA Recognized Consensus Standards, 6-293 , ISO 23907 First edition 2012-09-01Sharps injury protection - Requirements and test methods - Sharps containers. Resistance to damage and leakage after dropping as per FDA Recognized Consensus Standards, 6-293, ISO 23907 First edition 2012-09-01Sharps injury protection - Requirements and test methods - Sharps containers. Occupational Safety and Health Administration - Occupational Exposure to Bloodborne Pathogens; final rule (29 CFR 1910.1030; Federal Register 1991 December 6; 56, No. 235:64175-82. | Same | |||
| End-color change | No color change | No color change | No color change | Same | |
| Claimed sterilization cycles | Non sterile | Non sterile | Non sterile | Same | |
| Operation way | Drop the wasted sharps into container by one hand | Drop the wasted sharps into container by one hand | Drop the wasted sharps into container by one hand | Same | |
| Single use or not | Single used and disposable ones | Single used and disposable ones | Single used and disposable ones | Same | |
| Labeling | Biohazard labels visible on device | Biohazard labels visible on device | Biohazard labels visible on device | Same |
9. Performance Data
Maxcon Sharps Containers have similar indications for use and technological
characteristics as the predicate device, based on the subject containers can be
successfully passed through the tests as follows:
- Puncture Resistance (based on ASTM F 2132-01 (2008)) Passed ロ
- ロ Container Stability (based on ISO 23907:2012)- Passed
- Drop/impact Test (based on ISO 23907:2012)-Passed
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Ningbo Maxcon Medical Technology
- Handle Strength (based on ISO 23907:2012)- Passed ロ
- Stacking Test (based on 49CFR 178.606)- Passed ロ
- Vibration Test (based on 49CFR 178.606)-Passed ロ
- Sharps access and closure for repeated openings and closings-Passed
- Label Integrity Test (based on ISO23907:2012)-Passed
- Usable Capacity Test-Passed ロ
- ロ Minimum Sharps Container wall Thickness Evaluation-Passed
- ロ Shelf-life study (including real-time aging and accelerated-time aging to support its shelf life of
3 years)-Passed
- Simulated life cycle test-Passed ロ
- Leak Proof on the sides and bottom-Passed ロ
Although the subject device and predicate devices differ in containers size, dimensions, and containers capacities etc, the difference in technological characteristics do not impair the subject devices from their intended functions of disposal and storage of sharp waste, and did not compromise the SE (Substantially equivalent) to the predicated device.
-
- Discussion of Clinical Tests Performed:
There was no clinical testing required to support the medical device
- Discussion of Clinical Tests Performed:
-
- Conclusions:
We have demonstrated in this 510(k) submission that based on the nonclinical tests performed the subject devices, Maxcon Sharps containers (2.2 QT Sharps Container, MA1122; 2G Sharps Container MA1321; 2 G Sharp Container MA1221; 8G Sharps Container MA1352), are as safe, as effective and performs at least as safely and effectively as the legally marketed predicate devices (Oak
- Conclusions:
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宁波迈克斯康医疗科技有限公司 Ningbo Maxcon Medical Technology Co., Ltd
Ridge Products Sharps, K141759 (Reference device) and K161180(Primary
predicate device), Class II (21 CFR 880.5570), product code MMK
§ 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).