(265 days)
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.
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 closure system is designed, comprising of 4 components: Gasketed lid, Lid gasket pad, Screw-on cap, Cap gasket.
The provided text describes the 510(k) premarket notification for the Maxcon Two Gallon Chemotherapy Container (Model, MC1321). This document focuses on demonstrating substantial equivalence to a predicate device (Bemis Two Gallon Chemotherapy Container, K964858) through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a table format with pass/fail results for each criterion. Instead, it lists the tests performed and indicates that the device "Passed" each of them. The regulatory standards referenced effectively serve as the acceptance criteria.
| Test/Characteristic | Standard/Criterion | Reported Device Performance |
|---|---|---|
| Puncture Resistance | ASTM F 2132-01 (2008) | Passed |
| Container Stability | ISO 23907:2012 | Passed |
| Drop/Impact Test | ISO 23907:2012 | Passed |
| Handle Strength | ISO 23907:2012 | Passed |
| Stacking Test | 49CFR 178.606 | Passed |
| Vibration Test | 49CFR 178.606 | Passed |
| Suitability for chemotherapy drugs | Not explicitly stated as a standard, but a specific test was performed. | Passed |
| Chemical Resistance (H2SO4, NaOH) | Not explicitly stated as a standard, but specific chemicals were used. | Passed |
| Shelf-life study | Real-time aging and accelerated-time aging to support a 3-year shelf life. | Passed |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the sample size (number of containers) used for each test.
- Data provenance: The tests were conducted by Ningbo Maxcon Medical Technology Co., Ltd in China, as indicated by the submitter's identification. The data is non-clinical performance data gathered for regulatory submission. It is not specified if the tests were conducted prospectively or retrospectively, though typically such performance testing is done prospectively for new device submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a physical chemotherapy waste container and the "ground truth" for its performance is established through adherence to engineering and safety standards (e.g., puncture resistance, leak resistance, stability) rather than expert interpretation of medical images or patient outcomes. The evaluation is based on objective measurements against established test methods.
4. Adjudication method for the test set:
This information is not applicable for this type of device and testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where expert consensus is needed to establish ground truth for subjective interpretations (e.g., medical image diagnosis). For physical device testing, the results are typically objective measurements against a defined standard.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The Maxcon Two Gallon Chemotherapy Container is a physical medical waste container, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. As stated above, this device is a physical chemotherapy waste container, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by objective measurements against recognized industry standards and regulatory requirements. This includes:
- ASTM F 2132-01 (2008) for puncture resistance.
- ISO 23907:2012 for container stability, drop/impact, and handle strength.
- 49CFR 178.606 for stacking and vibration tests.
- Internal testing for suitability with chemotherapy drugs and chemical resistance, and shelf-life studies.
8. The sample size for the training set:
This information is not applicable. This is a physical device and does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable. As mentioned above, there is no "training set" for this type of device.
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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
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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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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.
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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 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
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Image /page/5/Picture/0 description: The image shows the word "MAXCON" in a bold, sans-serif font. The letters are all capitalized and black. 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 Chemotherapycontainer (K180983) manufacturedby Ningbo Maxcon MedicalTechnology Co.,Ltd with address inNo.228,Dongxin Road,DongqiaoTown, Yinzhou.Ningbo,Zhejiangprovince,China | Bemis Two Gallon ChemotherapyContainer (K964858) manufacturedby Bemis Health Care with address in300 Mill Street Sheboygan Falls, WI53085, 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 ChemotherapyContainer (Model, MC1321 ) isintended for safe collection andcontainment of trace chemotherapywaste including needles, syringes, andempty vials.The container isnon-sterile, to be single-used in areaswith controlled access, such asnurse's stations, pharmacies andchemo treatment rooms, and thetarget population is for trainedhealth-care professionals. | The Bemis Two GallonChemotherapy Container is a sharpsdisposal container.It is intended forthe safe disposal of needles, syringes,and other chemotherapy waste inareas with controlled access whichtypically include nurse's stations,oncology, pharmacies, andchemotherapy treatment rooms. | Same |
| Size | 2Gallon | 2Gallon | Same |
| Dimensions | 292mmx193mmx216 mm | 215.9mmx292.1mmx193mm | Different |
| Weight range | 470 gram | 1LB 2OZ | Different |
| Material used ofplastic components | Poly-propylene | Poly-propylene | Same |
| Material used of Padand gasket | Ethylene Vinyl Acetate (EVA) foam | Ethylene Vinyl Acetate (EVA) foam | Same |
| Claimed sterilizationcycles | 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 chemotreatment rooms | stations, pharmacies and chemotreatment rooms | ||
| Base Color | Yellow | Yellow | Same |
| Clarity | Translucent of the base,allowingvisibility of fill level | Translucent of the base, allowingvisibility of fill level | Same |
| Device design | Base+Gasketed lid +screw on plasticcap | Base+Gasketed lid +screw on plasticcap | Same |
| Single use or not | Single used and disposable ones | Single used and disposable ones | Same |
| Non-clinical testing | Successfully passed through tests ofpuncture resistance, leak resistance,stability,free standing and impactresistance | Successfully passed through tests ofpuncture resistance, leak resistance,stability, free standing and impactresistance | Same |
| Operation way | One-handed operation | One-handed operation | Same |
| Method ofManufacture | Injection Molded | Injection Molded | Same |
| Performance,effectiveness andsafety | The containers successfully passedthrough the tests described in1) FDA Recognized ConsensusStandards, 6-215, ASTM F2132-01 Standard Specification forPuncture Resistance of MaterialUsed in Containers for DiscardedMedical Needles and Other Sharps(Reapproved 2008)e1,2) FDA Recognized ConsensusStandards, 6-293, ISO 23907 Firstedition 2012-09-01Sharps injuryprotection - Requirements and testmethods - Sharps containers,3) Occupational Safety and HealthAdministration - OccupationalExposure to BloodbornePathogens; final rule (29 CFR1910.1030; Federal Register 1991December 6; 56, No.235:64175-82. | The predicated device wascleared in 1990s, with its testconducted as per:1) ASTM proposed standard forpuncture resistance/ECRIPuncture Resistance Criteria2) ECRI Health Devices LeakResistance Criteria3) OSHA4) ECRI free-standing capabilitycriteria | Similar |
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/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)
§ 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).