(265 days)
Not Found
No
The device description and performance studies focus on the physical properties and containment capabilities of a chemotherapy waste container, with no mention of AI or ML technologies.
No
The device is a container for waste, not a device used to treat or diagnose a medical condition.
No.
The device is a container for collecting and containing trace chemotherapy waste, not for diagnosing medical conditions.
No
The device description clearly outlines a physical container made of plastic components (Poly-propylene and Ethylene Vinyl Acetate foam) with a specific size, weight, and closure system. It is a hardware device for collecting and containing waste.
Based on the provided information, the Maxcon Two Gallon Chemotherapy Container (Model, MC1321) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials." This is a containment and disposal function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description focuses on the physical characteristics of the container (size, material, closure system) designed for waste containment.
- Performance Studies: The performance studies are related to the physical integrity and safety of the container for waste disposal (puncture resistance, stability, drop test, etc.), not diagnostic accuracy or performance with biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for the safe handling and disposal of medical waste.
N/A
Intended Use / Indications for Use
Maxcon Two Gallon Chemotherapy Container (Model, MC1321) is intended for safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials. The container is non-sterile, to be single-used in areas with controlled access, such as nurse's stations, pharmacies and chemo treatment rooms, and the target population is for trained health-care professionals.
Product codes
MMK
Device Description
Maxcon Two Gallon Chemotherapy Container (Model: MC1321) is of 2 gallon capability, weight about 470gram, size of 275.6mm (length) ×181.5mm (width)× 275mm (height), and the maximum allowable gross mass of the container defined by the company is 2 Kg.There is no feature to bend, break, or shear needle (includes blunting and melting of needle)in the containers.
The container is made of base+gasketed cap+screw-on cap. The plastic components are made of injection-moulded of Poly-propylene (PP). The pad and gasket are made of Ethylene Vinyl Acetate (EVA) foam.
The mechanism of temporarily locking and permanently locking includes a special structure embedded in the screw thread. When the cap is screwed to the end, a gap will engage a bulge, with a sound of click, and the cap will not be opened again.
The container base: Size (mm) 275.6x181.5x275mm, Material PP, Weight 375 Gram, Color Translucent yellow.
Wall Thickness of the container (mm): Base thickness 1.6±0.1, Lid thickness 1.6±0.1, Cap thickness 1.6±0.1.
The closure system is designed, comprising of 4 components:
Gasketed lid: Material: P.P, Size: 181.5mmX261.4mm, Weight: 94 grams.
Lid gasket pad: Material: Ethylene Vinyl Acetate (EVA) foam, Size: 175mmX255mm, Weight: 10 grams.
Screw-on cap: Material: P.P, Size: 108mmX17mm, Weight: 22 grams.
Cap gasket: Material: Ethylene Vinyl Acetate (EVA) foam, Size: 103mmX1mm, Weight: 2 grams.
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
Trained health-care professionals in areas with controlled access, such as nurse's stations, pharmacies and chemo treatment rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing successfully passed through tests of:
- Puncture Resistance (based on ASTM F 2132-01 (2008)) - Passed
- Container Stability (based on ISO 23907:2012)- Passed
- Drop/impact Test (based on ISO 23907:2012)-Passed
- Handle Strength (based on ISO 23907:2012)- Passed
- Stacking Test (based on 49CFR 178.606)- Passed
- Vibration Test (based on 49CFR 178.606)-Passed
- Test to demonstrate MAXCON TWO GALLON CHEMOTHERPAY CONTAINER suitable for chemotherapy drugs-Passed
- Chemical Resistance test (with H2SO4 and NaOH used to demonstrate its chemical resistance ) -Passed
- Shelf-life study (including real-time aging and accelerated-time aging to support its shelf life of 3 years)-Passed
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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: K180983
Trade/Device Name: Maxcon Two Gallon Chemotherapy Container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: November 22, 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
1
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
2
Indications for Use
510(k) Number (if known) K180983
Device Name
Maxcon Two Gallon Chemotherapy Container (Model, MC1321)
Indications for Use (Describe)
Maxcon Two Gallon Chemotherapy Container (Model, MC1321) is intended for safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials. The container is non-sterile, to be single-used in areas with controlled access, such as nurse's stations, pharmacies and chemo treatment rooms, and the target population is for trained health-care professionals.
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. The letters are sans-serif and appear to be a custom font. There are three vertical lines to the left of the word. The plus sign is in the middle of the letter "O".
510(k) Summary
The assigned 510(k) number is:K180983
Date Prepared: December 29, 2018 1.
Submitter's Identification: 2.
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
3. Name of the Device:
Common Name:Sharps Disposal Container
Trade Name:Maxcon Two Gallon Chemotherapy Container (Model: MC1321)
Classification name: Hypodermic single lumen needle
4. Classification Information:
Product Code: MMK
Device Class: II
CFR Reference: 21 CFR880.5570
Classification Panel:General Hospital
ട്. Predicate Device Information:
The Maxcon Two Gallon Chemotherapy Containers (Model: MC1321) are equivalent to Bemis Two Gallon Chemotherapy Containers (K964858) manufactured by Bemis Manufacturing Company, located in 300 Mill Street, Sheboygan Falls, WI 53085, USA, which has the same intended use and is similar in design to the predicate devices.
4
Image /page/4/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are black, and there are two diagonal lines to the left of the "M". There is a plus sign inside the letter "O".
Intended use / Indication for Use: 6.
Maxcon Two Gallon Chemotherapy Container (Model, MC1321 ) is intended for safe collection and containment of trace chemotherapy waste including needles, syringes, and empty vials. The container is non-sterile, to be single-used in areas with controlled access, such as nurse's stations, pharmacies and chemo treatment rooms, and the target population is for trained health-care professionals.
7. Device Description:
Maxcon Two Gallon Chemotherapy Container (Model: MC1321) is of 2 gallon capability, weight about 470gram, size of 275.6mm (length) ×181.5mm (width)× 275mm (height), and the maximum allowable gross mass of the container defined by the company is 2 Kg.There is no feature to bend, break, or shear needle (includes blunting and melting of needle)in the containers.
The container is made of base+gasketed cap+screw-on cap. The plastic components are made of injection-moulded of Poly-propylene (PP). The pad and gasket are made of Ethylene Vinyl Acetate (EVA) foam.
The mechanism of temporarily locking and permanently locking
Image /page/4/Figure/8 description: The image shows two diagrams of a product assembly. Each diagram shows a base with a circular indentation, a circular cap, and a ring. The cap is shown with a curved arrow indicating a twisting motion, and the ring is labeled with the number "2" and an arrow pointing towards the base. The base also has the number "1" and an arrow pointing towards the circular indentation.
As Indicated in the above-mentioned pictures, there is a special structure embedded in the screw thread, which can lock the cap firmly and be resistant to manual opening.
-
- A bulge located in the end of screw thread.
-
- A gap located in the beginning of screw thread
5
Image /page/5/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are all capitalized and black. To the left of the word are three vertical black lines. The "O" in "MAXCON" has a plus sign inside of it.
When the cap is screwed to the end, the gap will engage the bulge, with a sound of click, and the cap will not be opened again.
Information of the container base
| Size (mm) | Material | Weight | Color |
|---|---|---|---|
| 275.6x181.5x275mm | PP | 375 Gram | Translucent yellow |
Wall Thickness of the container (mm)
| Base thickness | Lid thickness | Cap thickness |
|---|---|---|
| $1.6\pm0.1$ | $1.6\pm0.1$ | $1.6\pm0.1$ |
The closure system is designed, comprising of 4 components:
| Gasketed lid | Lid gasket pad | Screw-on cap | Cap gasket |
|---|---|---|---|
| Material: P.P | Material: Ethylene | Material: P.P | Material: Ethylene |
| Size: | |||
| 181.5mmX261.4mm | Vinyl Acetate (EVA) | ||
| foam | Size: 108mmX17mm | Vinyl Acetate (EVA) | |
| foam | |||
| Weight: 94 grams | Size: 175mmX255mm | Weight: 22 grams | Size: 103mmX1mm |
| Weight: 10 grams | Weight: 2 grams |
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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 all capitalized and black. There are two diagonal lines to the left of the word. The letter "O" in "CON" has a plus sign inside of it.
8. Comparing to Predicate Device:
| Proposed Device | Predicate Device | ||
|---|---|---|---|
| Characteristic | Maxcon Two Gallon Chemotherapy | ||
| container (K180983) manufactured | |||
| by Ningbo Maxcon Medical | |||
| Technology Co.,Ltd with address in | |||
| No.228,Dongxin Road,Dongqiao | |||
| Town, Yinzhou.Ningbo,Zhejiang | |||
| province,China | Bemis Two Gallon Chemotherapy | ||
| Container (K964858) manufactured | |||
| by Bemis Health Care with address in | |||
| 300 Mill Street Sheboygan Falls, WI | |||
| 53085, USA | S.E. | ||
| on | |||
| Product Code | MMK | MMK | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
| Indications For Use | Maxcon Two Gallon Chemotherapy | ||
| Container (Model, MC1321 ) is | |||
| intended for safe collection and | |||
| containment of trace chemotherapy | |||
| waste including needles, syringes, and | |||
| empty vials.The container is | |||
| non-sterile, to be single-used in areas | |||
| with controlled access, such as | |||
| nurse's stations, pharmacies and | |||
| chemo treatment rooms, and the | |||
| target population is for trained | |||
| health-care professionals. | The Bemis Two Gallon | ||
| Chemotherapy Container is a sharps | |||
| disposal container.It is intended for | |||
| the safe disposal of needles, syringes, | |||
| and other chemotherapy waste in | |||
| areas with controlled access which | |||
| typically include nurse's stations, | |||
| oncology, pharmacies, and | |||
| chemotherapy treatment rooms. | Same | ||
| Size | 2Gallon | 2Gallon | Same |
| Dimensions | 292mmx193mmx216 mm | 215.9mmx292.1mmx193mm | Different |
| Weight range | 470 gram | 1LB 2OZ | Different |
| Material used of | |||
| plastic components | Poly-propylene | Poly-propylene | Same |
| Material used of Pad | |||
| and gasket | Ethylene Vinyl Acetate (EVA) foam | Ethylene Vinyl Acetate (EVA) foam | Same |
| Claimed sterilization | |||
| cycles | Non-sterile | Non-sterile | Same |
| End-color change | No color change | No color change | Same |
| Where it used | controlled access, such as nurse's | controlled access, such as nurse's | Same |
| Ningbo Maxcon Medical Technology Co., Ltd | |||
| stations, pharmacies and chemo | |||
| treatment rooms | stations, pharmacies and chemo | ||
| treatment rooms | |||
| Base Color | Yellow | Yellow | Same |
| Clarity | Translucent of the base,allowing | ||
| visibility of fill level | Translucent of the base, allowing | ||
| visibility of fill level | Same | ||
| Device design | Base+Gasketed lid +screw on plastic | ||
| cap | Base+Gasketed lid +screw on plastic | ||
| cap | Same | ||
| Single use or not | Single used and disposable ones | Single used and disposable ones | Same |
| Non-clinical testing | Successfully passed through tests of | ||
| puncture resistance, leak resistance, | |||
| stability,free standing and impact | |||
| resistance | Successfully passed through tests of | ||
| puncture resistance, leak resistance, | |||
| stability, free standing and impact | |||
| resistance | Same | ||
| Operation way | One-handed operation | One-handed operation | Same |
| Method of | |||
| Manufacture | Injection Molded | Injection Molded | Same |
| Performance, | |||
| effectiveness and | |||
| safety | The containers successfully passed | ||
| through the tests described in |
- 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, - 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. | The predicated device was
cleared in 1990s, with its test
conducted as per: - ASTM proposed standard for
puncture resistance/ECRI
Puncture Resistance Criteria - ECRI Health Devices Leak
Resistance Criteria - OSHA
- ECRI free-standing capability
criteria | Similar |
7
/MAXCGN
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/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 "M". A plus sign is embedded in the letter "O".
Ningbo Maxcon Medical Technology Co., Ltd
9. Performance data
Maxcon Two Gallon Chemotherapy Container has similar indications for use and technological
characteristics as the predicate device (K964858) manufactured by Bemis Health Care, based on the
subject device, Maxcon Two Gallon Chemotherapy container, is found to successfully pass through the
tests as follows:
- Puncture Resistance (based on ASTM F 2132-01 (2008)) - Passed
- Container Stability (based on ISO 23907:2012)- Passed
- Drop/impact Test (based on ISO 23907:2012)-Passed
- Handle Strength (based on ISO 23907:2012)- Passed
- Stacking Test (based on 49CFR 178.606)- Passed
- Vibration Test (based on 49CFR 178.606)-Passed
- Test to demonstrate MAXCON TWO GALLON CHEMOTHERPAY CONTAINER suitable for chemotherapy drugs-Passed
- Chemical Resistance test (with H2SO4 and NaOH used to demonstrate its chemical resistance ) -Passed
- Shelf-life study (including real-time aging and accelerated-time aging to support its shelf life of 3 years)-Passed
Therefore, although the subject device and predicate device differ in container dimensions and the weight, it is believed that the difference in technological characteristics do not impair the subject device from the intended functions of disposal and storage of trace chemotherapy waste including needles, syringes, and empty vials, and did not compromise the SE (Substantially equivalent) to the predicated device.
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Image /page/9/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are black, and the background is white. There are three diagonal lines to the left of the letter "M". A plus sign is located in the center of the letter "O".
Discussion of Clinical Tests Performed: 10.
There was no clinical testing required to support the medical device -
11. Conclusions:
We have demonstrated in this 510(k) submission that based on the nonclinical tests performed the subject device, Maxcon Two Gallon Chemotherapy Container, is as safe, as effective and performs at least as safely and effectively as the legally marketed predicate device, Bemis Two Gallon Chemotherapy Container (K964858)