(251 days)
Not Found
No
The device description and intended use clearly define a physical container for sharps disposal, with no mention of software, data processing, or any AI/ML related terms or functionalities.
No
Explanation: The device is a sharps container, intended for the safe disposal of medical sharps, not for treating or diagnosing any medical condition.
No
Explanation: The device is a sharps container, intended for the disposal of contaminated medical sharps. Its function is containment and transport of waste, not the diagnosis of any medical condition.
No
The device is described as injection molded polypropylene plastic containers with physical characteristics like puncture resistance, leak resistance, and impact resistance. It is a physical product for the disposal of medical sharps, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a receptacle for the safe disposal of used medical sharps. This is a physical containment and disposal function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the container (material, design, puncture resistance, etc.) for safe disposal. There is no mention of any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Elements: There are no mentions of analyzing samples, detecting analytes, or providing any kind of diagnostic result.
- Predicate Devices: The predicate devices are also sharps containers, which are not IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This sharps container does not perform any such function.
N/A
Intended Use / Indications 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, 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.
Product codes
MMK
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified personnel in health care facilities and other facilities in which medical sharps may be used.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Study type: Non-clinical tests including:
- Container Stability
- Strength of Handles
- Resistance to penetration
- Resistance to damage and leakage after dropping
- Resistance to spillage by toppling
- Stacking Test
- Vibration Test
- Sharps access and closure for repeated openings and closings
- Label Integrity Test
- Usable Capacity Test
- Leak Proof on the sides and bottom
Sample size: Not specified
Data source: Not specified
Annotation protocol: Not specified
AUC: Not Found
MRMC: Not Found
Standalone performance: Not Found
Key results: All tests were Passed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image 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
1
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
2
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/model
number of the
| device 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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3
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
4
Image /page/4/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are all capitalized and black. There are three 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
5
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/model
number
of the
device
model | Size/
capacity
of the
device
model | Dimensions of
the device
model(L x
W x H)
(mm, $\pm$ 0.1) | Colors
available
for the
model | Description
and
dimensions
of the sharps
disposal
aperture(s)
(mm, $\pm$ 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:
43.430
(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 |
| MA1212 | 5.4 QT | 311.13113.85291.06 | Red
base,
white lid | 194.550
(L×W) | Counter
balanced
door | Locking
wall bracket | Other facilities
in which
medical
sharps may be
used. All the |
| MA1213 | 5.4QT | 310116.2315.31 | Red
base,
white lid | 222.9363.47
(L×W) | Counter
balanced
door | Locking
wall bracket | containers are
intended to be
used in areas
where there is |
| MA1324 | 7L | 248200*232 | Yellow
base,
translucent
lid | 102
(diameter) | Star-hinged door | Free
standing | no unsupervised
patient 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.
6
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 of
finished 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 for
qualified personnel in
health care facilities and |
| MA1212 | 357 | 5.4 Quart | 4.32 Quart | 311.13113.85291.06 | other facilities in which |
| MA1213 | 422 | 5.4Quart | 4.32
Quarts | 310116.2315.31 | medical sharps may be
used. All the containers are
intended to be used in areas |
| MA1324 | 300 | 7 Liter | 5.6 Liter | 248200232 | where there is no
unsupervised patient access. |
General Specifications of the sharps containers
General description of the lids
| Model | Lid
configuration | Dimensions of
Sharps disposal
aperture (mm)( $\pm$ 0.1) | Locking
mechanism | Requirements for mounting |
|--------|------------------------------|---------------------------------------------------------------------|-------------------------|------------------------------------------|
| MA1112 | Double
opening Hinge | Opening 1:
$43.4 \times 30$ (L×W)
Opening 2:
14 (diameter) | Hinged closure | Holder with Double face
adhesive tape |
| MA1212 | Counter
Balance (Up) | $194.5 \times 50$ (L×W) | Counterbalanced
door | Locking wall bracket |
| MA1213 | Counter
Balance
(Down) | $222.93 \times 63.47$
(L×W) | Counterbalanced
door | Locking wall bracket |
7
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 Subject
Device | Predicate Device | Second
Predicate Device | Comparison |
|----------------|-----------------------------|----------------------|----------------------------|------------|
| 510(k) | K222905 | K211464 | K190240 | n/a |
| Device Name | Maxcon Sharps
container | Nitta M&T Safety Box | Tiger Sharps Containers | |
8
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 / 2 | |||
| Gallon B / 15 Liter /3 Gallon/ 8 | ||||
| Gallon | 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 150 | |||
| x137 / 132 x 246 x 198 / | ||||
| 136 x 279 x 210 / 132 x 246 | ||||
| x 400 / 136 x 235 x 210 / | ||||
| 136 x 245 x 422 / 78 x 50 x | ||||
| 82 | 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 or | ||||
| re-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 of | ||||
| Manufacture | Injection Molded | Injection Molded | Injection Molded | Same |
| Performance | ||||
| testing | ||||
| (puncture, | ||||
| impact, drop, | ||||
| stability, | ||||
| integrity) | Pass | Pass | Pass | Same |
| Standards | ISO23907-1:2019 | ISO23907-1:2019 | ISO 23907, ASTM F 2132 | Same |
| Lid | ||||
| configurations | 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 face | ||||
| adhesive tape is available | ||||
| for use with 1 quart | ||||
| container (MA1112) in | ||||
| locking on desk top by | ||||
| double face adhesive | ||||
| tape. | ||||
| 5.4 Quart sharps | ||||
| container (MA1212 and | ||||
| MA1213) is available | ||||
| for use with a mounting | ||||
| brackets (made of ABS) | ||||
| which is to be locked by | ||||
| a key (made of P.P). | Mounting accessories | |||
| (brackets) are available for | ||||
| use with 1.0L, 1.5L, 3.2L | ||||
| and 7.6L containers in | ||||
| locking and non-locking | ||||
| variations. | Mounting accessories (brackets) are | |||
| available for use with 1qt, 5qt, 2g and | ||||
| 3g containers in locking and | ||||
| nonlocking variations. | Different |
9
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 :
10
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| Test
name | Natur
e of
Tests | Brief description | Standards
used | Acceptance criteria | Test
results |
|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Conta
iner
Stabil
ity | Physi
cs test | Fill one container to the fill line with
material of a density of (0.20 ± 0.01)
kg/1 or with syringes with a capacity of