(157 days)
Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.
Sharps container are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers.
The Sharps Container constructed of polypropylene plastic. 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.
The provided text describes the acceptance criteria and a study proving that Sharps Containers meet these criteria. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| NO. | Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| 1 | Anti-penetrability | The puncture resistance of each section of the container greater than 15 N and the puncture resistance performance should met. | Pass |
| 2 | Resistance to damage and leakage after dropping | Containers remained upside down for 60 minutes while being observed for leakage. No leakage observed and there is also no liquid leakage. | Pass |
| 3 | Stack Test | The minimum height of the stack, including the test sample, is 3 meters. Upon completion of the stack test, containers observed for deformation. The containers should not be deteriorated. | Pass |
| 4 | Vibration Test | The containers should not be deteriorated. | Pass |
| 5 | Stability | The container should not slide or topple. | Pass |
| 6 | Strength of handles | The containers remained intact and handles should not rupture, tear, crack, or separate from the container. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for each non-clinical test (e.g., how many sharps containers were subjected to each test).
The provenance of the data is not specified in terms of country of origin of the data or whether it was retrospective or prospective. These are lab tests conducted on the physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the described tests are non-clinical hardware performance tests, not studies requiring expert interpretation of results or ground truth establishment by medical professionals. The acceptance criteria are based on physical measurements and observations against established standards (ASTM F2132-01, ISO 23907, 49 CFR 178.606, 49 CFR 178.608).
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective measurements and observations against pre-defined acceptance criteria, not subjective assessments requiring adjudication by a panel of experts.
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
This information is not applicable. The device is a Sharps Container, which is a physical medical device for waste disposal, not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical Sharps Container, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Sharps Containers is based on:
- Established International Standards: ASTM F2132-01 (Reapproved 2008e1), ISO 23907, and 49 CFR 178.606, 49 CFR 178.608. These standards define the test methods and performance requirements (acceptance criteria) for sharps containers.
- Direct Physical Measurement and Observation: The tests involve physical manipulation (e.g., dropping, stacking, vibrating, puncturing) of the containers and subsequent observation and measurement of specific parameters (e.g., puncture resistance in Newtons, absence of leakage, absence of deterioration, stability, integrity of handles).
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device as it is a physical product and not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above.
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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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 12, 2020
Zhejiang Gongdong Medical Technology Co., Ltd % Ivy Wang Techinical Manager Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave. Shanghai, Shanghai 200122 China
Re: K201523
Trade/Device Name: Sharps container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: October 16, 2020 Received: October 16, 2020
Dear Ivy Wang:
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/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,
Clarence W. Murray, III, Ph.D. Acting 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
Enclosure
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Indications for Use
510(k) Number (if known) K201523
Device Name Sharps Container
Indications for Use (Describe)
Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.
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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| Model No. | Capacity(full line) | capacity(total) | Weight | Dimension(mm) | Thickness(mm) | Requirementsfor mounting | Acceptablesites of use | Description andDimension ofdisposalaperture(cm) |
|---|---|---|---|---|---|---|---|---|
| GDC-03-F | 2143ml | 2972ml | 224.80g | 188.4158.1193.2 | 1.4 | Free standing | 8.2*5.2 | |
| GDC-03-X | 2143ml | 2972ml | 234.15g | 183.4153.3189.3 | 1.4 | Free standing | The targetpopulation isforqualifiedpersonnel inhealthcarefacilities andotherfacilities inwhichmedicalsharps maybe used. Allthecontainersare intendedto beused in areaswhere thereisnounsupervisedpatientaccess. | 16 sq. |
| GDC-05-F | 4049ml | 320.50g | 226.3199.0218.5 | 1.5 | Free standing | 9.5*5.5 | ||
| GDC-05-X | 4049ml | 5234ml | 322.76g | 221.0195.9217.5 | 1.5 | Free standing | 21sq. | |
| GDC-07-F | 5288ml | 6875ml | 435.28g | 241.4220.9231.7 | 1.7 | Free standing | 9.5*5.5 | |
| GDC-07-X | 5288ml | 6875ml | 425.32g | 240.6218.8230.0 | 1.7 | Free standing | 21sq. | |
| GDC-013-X | 10038ml | 13253ml | 628.54g | 281.8252.5307.8 | 1.8 | Free standing | 32sq. | |
| SC-01Q | 670ml | 763ml | 77.53g | 108.288.4173.7 | 1.05 | Free standing | 5*3.7 | |
| SC-02Q | 910ml | 1063ml | 77.85g | 108.688.3222.8 | 1.2 | Free standing | 5*3.7 | |
| SC-05Q | 4367ml | 5111ml | 513.61g | 270.3116.1289.5 | 1.3 | Free standingLocking wallbracket | 22*4.5 | |
| SC-01G | 2623ml | 3863 | 220.72g | 257.3174.5155.2 | 1.15 | Free standing | 14*5.5 | |
| SC-02G | 6066ml | 7424ml | 489.21g | 257.3175.0259.5 | 1.15 | Free standingLocking wallbracket | 14*6 | |
| SC-06G | 14013ml | 21024ml | 801.56g | 377.0235.9415.2 | 1.5 | Free standing | 21*4.5 |
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| Model No. | Material description | Color | lidconfigurations | Lock Method | Unwinding feature |
|---|---|---|---|---|---|
| GDC-03-F | Cap: PP;Body:Copolymerization PP | Cap:Semitransparent;Body: Yellow | Folding cap | Buckle on fold over cover andfasten cover | Located in the lid and abovethe containment area. Theunwinder has a round entryport for the needle to passthrough, allowing it to befully enclosed within thecontainer. |
| GDC-03-X | Cap, small cover,handle: PP;Body:Copolymerization PP | Cap:Semitransparent;Small cover andhandle: Red;Body: Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side ofthe small red cover that canrotate, and there is a small roundhole on the cover. When thesmall cylinder rotates to theposition of the small round hole,the two kinds of small cylinderscooperate and buckle eachother. | The models GDC-03-F,GDC-03-X, DC-05-F,GDC-05-X, GDC-07-F,GDC-07-X, GDC-13--XSC-01Q, SC-06G, SC-02Qhave the needle unwinding |
| GDC-05-F | Cap: PP;Body:Copolymerization PP | Cap:Semitransparent;Body: Yellow | Folding cap | Buckle on fold over cover andfasten cover | features |
| GDC-05-X | Cap, K7:K9small cover,handle: PP;Body:Copolymerization PP | Cap:Semitransparent;Small cover andhandle: Red;Body: Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side ofthe small red cover that canrotate, and there is a small roundhole on the cover. When thesmall cylinder rotates to theposition of the small round hole,the two kinds of small cylinderscooperate and buckle eachother. | |
| GDC-07-F | Cap: PP;Body:Copolymerization PP | Cap:Semitransparent;Body: Yellow | Folding cap | Buckle on fold over cover andfasten cover | |
| GDC-07-X | Cap, small cover,handle: PP;Body:Copolymerization PP | Cap:Semitransparent;Small cover andhandle: Red;Body: Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side ofthe small red cover that canrotate, and there is a small roundhole on the cover. When thesmall cylinder rotates to theposition of the small round hole,the two kinds of small cylinderscooperate and buckle eachother. | |
| GDC-013-X | Cap, small cover:PP;Body:Copolymerization PP | Cap:Semitransparent;Small cover andhandle: Red;Body: Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side ofthe small red cover that canrotate, and there is a small roundhole on the cover. When thesmall cylinder rotates to theposition of the small round hole,the two kinds of small cylinderscooperate and buckle eachother. | |
| SC-01Q | Cap, small cover:PP;Body:Copolymerization PP | Cap: White;Small cover andhandle: | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-02Q | Cap, small cover:PP;Body:Copolymerization PP | Cap:Semitransparent;Body: Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-05Q | Cap and small cover:PP;Body:Copolymerization PP;Bottom and keys: ABS | Cap: White; Smallcover: Red, BodyRed; Bottom andkey: Grey | Revolving cap | Small cap could revolvinginside and fasten tight with thebuckle in the cap | |
| SC-01G | Cap, small cover:PP;Body:Copolymerization PP | Cap: White;Small cover andhandle:Semitransparent;Body: Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-02G | Cap and small cover:PP;Body:Copolymerization PP;Bottom and keys: ABS | Cap: White;Small cover andhandle:Semitransparent;Body: Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-06G | Cap, small cover:PP;Body:Copolymerization PP | Cap: White;Small cover andhandle:Semitransparent;Body: Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap |
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510(K) Summary
Date of Summary prepared: 2020-11-11
A. Applicant:
Zhejiang Gongdong Medical Techonology Co., Ltd
Address: No.10, Beiyuan Avenue, Huangyan, Taizhou City, Zhejiang Province, China
Contact Person: WEIFENG ZHONG Tel: 86 - 576 - 84081133 Email: fda.sungo@gmail.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Central Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Sharps Container Common Name: container, sharps Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: MMK Review Panel: General Hospital
C. Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Submitted Device |
|---|---|---|---|
| International MarketingSpecialists Inc. | Tiger Sharps container | K190240 | Tiger SharpsContainers |
D. Indications for Use:
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Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health- - care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used.
The following Sharps Container models and accessories are described in this submission:
| Model No. | Capacity(full line) | capacity(total) | Weight | Dimension(mm) | Thickness(mm) | Requirementsfor mounting | Acceptablesites of use | Description andDimension ofdisposalaperture(cm) |
|---|---|---|---|---|---|---|---|---|
| GDC-03-F | 2143ml | 2972ml | 224.80g | 188.4158.1193.2 | 1.4 | Free standing | The targetpopulation isforqualifiedpersonnel inhealthcare facilitiesand otherfacilities in | 8.2*5.2 |
| GDC-03-X | 2143ml | 2972ml | 234.15g | 183.4153.3189.3 | 1.4 | Free standing | healthcare facilitiesand otherfacilities in | 16 sq. |
| GDC-05-F | 4049ml | 320.50g | 226.3199.0218.5 | 1.5 | Free standing | whichmedicalsharps maybe used. Allthecontainers are | 9.5*5.5 | |
| GDC-05-X | 4049ml | 5234ml | 322.76g | 221.0195.9217.5 | 1.5 | Free standing | be used. Allthecontainers areintended tobeused in areas | 21sq. |
| GDC-07-F | 5288ml | 6875ml | 435.28g | 241.4220.9231.7 | 1.7 | Free standing | where there isnounsupervised | 9.5*5.5 |
| GDC-07-X | 5288ml | 6875ml | 425.32g | 240.6218.8230.0 | 1.7 | Free standing | patientaccess. | 21sq. |
| GDC-013-X | 10038ml | 13253ml | 628.54g | 281.8252.5307.8 | 1.8 | Free standing | 32sq. | |
| SC-01Q | 670ml | 763ml | 77.53g | 108.288.4173.7 | 1.05 | Free standing | 5*3.7 | |
| SC-02Q | 910ml | 1063ml | 77.85g | 108.688.3222.8 | 1.2 | Free standing | 5*3.7 | |
| SC-05Q | 4367ml | 5111ml | 513.61g | 270.3116.1289.5 | 1.3 | Free standingLocking wallbracket | 22*4.5 | |
| SC-01G | 2623ml | 3863 | 220.72g | 257.3174.5155.2 | 1.15 | Free standing | 14*5.5 | |
| SC-02G | 6066ml | 7424ml | 489.21g | 257.3175.0259.5 | 1.15 | Free standingLocking wallbracket | 14*6 | |
| SC-06G | 14013ml | 21024ml | 801.56g | 377.0235.9415.2 | 1.5 | Free standing | 21*4.5 |
Table1: specification of the sharps container
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| ModelNo. | Material description | Color | lidconfigurations | Lock Method | Unwinding feature |
|---|---|---|---|---|---|
| GDC-03-F | Cap : PP ; Body :CopolymerizationPP | Cap :Semitransparent ;Body : Yellow | Folding cap | Buckle on fold over cover andfasten cover | |
| GDC-03-X | Cap, small cover, handle: PP ; Body :CopolymerizationPP | Cap :Semitransparent ;Small cover andhandle: Red;Body : Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side of thesmall red cover that can rotate,and there is a small round hole onthe cover. When the smallcylinder rotates to the position ofthe small round hole, the twokinds of small cylinders cooperateand buckle each other. | Located in the lid andabove the containmentarea. The unwinder has around entry port for theneedle to pass through,allowing it to be fullyenclosed within thecontainer. The modelsGDC-03-F, GDC-03-X,DC-05-F, GDC-05-X,GDC-07-F, GDC-07-X, GDC-13-X, SC-01Q,SC-06G, SC-02Q havethe needle unwindingfeatures. |
| GDC-05-F | Cap : PP ; Body :CopolymerizationPP | Cap :Semitransparent ;Body : Yellow | Folding cap | Buckle on fold over cover andfasten cover | |
| GDC-05-X | Cap, K7:K9small cover,handle:PP; Body:CopolymerizationPP | Cap :Semitransparent ;Small cover andhandle: Red;Body : Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side of thesmall red cover that can rotate,and there is a small round hole onthe cover. When the smallcylinder rotates to the position ofthe small round hole, the twokinds of small cylinders cooperateand buckle each other. | |
| GDC-07-F | Cap : PP ; Body :CopolymerizationPP | Cap :Semitransparent ;Body: Yellow | Folding cap | Buckle on fold over cover andfasten cover | |
| GDC-07-X | Cap, small cover, handle: PP ; Body :CopolymerizationPP | Cap :Semitransparent ;Small cover andhandle: Red;Body : Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side of thesmall red cover that can rotate,and there is a small round hole onthe cover. When the smallcylinder rotates to the position ofthe small round hole, the twokinds of small cylinders cooperateand buckle each other. | |
| GDC-013-X | Cap, small cover : PP ;Body : CopolymerizationPP | Cap :Semitransparent ;Small cover andhandle: Red;Body : Yellow | Revolving cap | There is a protruding smallcylinder on the reverse side of thesmall red cover that can rotate,and there is a small round hole onthe cover. When the smallcylinder rotates to the position ofthe small round hole, the twokinds of small cylinders cooperateand buckle each other. | |
| SC-01Q | Cap, small cover : PP ;Body : CopolymerizationPP | Cap : White ;Small cover andhandle:Semitransparent; | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-02Q | Cap, small cover: PP ;Body : CopolymerizationPP | Cap : White ;Small cover andhandle:Semitransparent;Body : Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-05Q | Cap and small cover :PP ;Body : CopolymerizationPP ;Bottom and keys : ABS | Cap: White; Smallcover: Red, BodyRed; Bottom andkey: Grey | Revolving cap | Small cap could revolving insideand fasten tight with the buckle inthe cap | |
| SC-01G | Cap, small cover : PP ;Body : CopolymerizationPP | Cap : White ;Small cover andhandle:Semitransparent;Body : Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-02G | Cap and small cover :PP ;Body : CopolymerizationPP ;Bottom and keys : ABS | Cap : White ;Small cover andhandle:Semitransparent;Body : Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap | |
| SC-06G | Cap, small cover : PP ;Body : CopolymerizationPP | Cap : White ;Small cover andhandle:Semitransparent;Body : Red | Slid cap | Slid the buckle on the small cap,fasten tight with cap |
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E. Device Description:
Sharps container are used to collect hazardous sharps such as needles, syringes, lancets and etc. The containers are single-use, disposable, non-sterile containers.
{12}------------------------------------------------
The Sharps Container constructed of polypropylene plastic. 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.
F. Technological Characteristics
| Element ofComparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| Manufacture | Zhejiang Gongdong MedicalTechonology Co., Ltd | International Marketing SpecialistsInc. | |
| FDA510(K) Number | / | K190240 | -- |
| Device Name | Sharps Containers | Tiger Sharps Containers | Similar |
| Intended Use | Sharps Containers are intended toprovide a receptacle for used,contaminated medical sharps and act asan enclosure during transport to ultimatedisposal. | Tiger Sharps Containers are intended toprovide a receptacle for used,contaminated medical sharps and act asan enclosure during transport toultimate disposal. | Same |
| Product code | MMK | MMK | Same |
| RegulationNumber | 21CFR880.5570 | 21CFR880.5570 | Same |
| Class | II | II | Same |
| Capacities | 2972ml,2972ml,5234ml,6875ml,6875ml,13253ml,763ml,1063ml,5111ml,3863,7424ml,21024ml | 1 Quart / 5 Quart / 2 Gallon / 2 GallonB / 15 Liter3 Gallon/ 8 Gallon | Analysis |
| Prescribed | OTC | OTC | Same |
| Weight Range(grams) | 77.53-801.56g | 109 - 1172 | Analysis |
| No. of Piece | 2-3 | 2-3 | Similar |
| Material | Polypropylene,Copolymerization polypropylene | Polypropylene | Similar |
| Non-sterile | Yes | Yes | Same |
Table 2: comparison of the proposed and Predicate device
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| Method ofManufacture | Injection Molded | Injection Molded | Same |
|---|---|---|---|
| Performancetesting(puncture, impact,drop, stability,integrity etc.) | Pass | Pass | Same |
| Disposable orReusable? | Disposable | Disposable | Same |
Difference analysis:
The design and manufacture process of the Sharps Containers is similar to the predicate chosen. There are minor differences between the devices including Size, Capacities, Weight Range.
G. Non-Clinical Performance Testing:
Performance testing was performed to validate and verify that the Sharps Container met all the requirements of related international standards and product specifications. Results of these tests demonstrate the device meets the acceptance criteria of these standards.
| NO. | Test | Test method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|---|
| 1 | Anti-penetrability | ASTM F2132-01(Reapproved2008e1) | Prevent thesharps in thecontainer frompenetrating theside and bottomof the containerand hurting theuser. | The puncture resistance ofeach section of the containergreater than 15 N and thepuncture resistanceperformance should met. | Pass |
| 2 | Resistance todamage andleakageafter dropping | ISO 23907 | Prevent thecontainer frombreaking whenfalling from aheight, and thesharps leak fromthe container. | Containers remained upsidedown for 60 minutes whilebeing observed for leakage.No leakage observed andthere is also no liquid leakage | Pass |
| 3 | Stack Test | 49 CFR178.606 | The containerwill not bedamaged duringstorage andshipping whilestacking. | The minimum height of thestack, including the testsample, is 3 meters. Uponcompletion of the stack test,containers observed fordeformation. The containersshould not be deteriorated. | Pass |
Table 3: Non-Clinical Performance Testing
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| 4 | Vibration Test | 49 CFR178.608 | Packagingcartons andproducts will notbe damaged dueto producttransportationvibration | The containers should not bedeteriorated. | Pass |
|---|---|---|---|---|---|
| 5 | Stability | ISO 23907 | Prevent theproduct fromdumping duringuse. | The container should notslide or topple. | Pass |
| 6 | Strength of handles | ISO 23907 | Prevent thehandle frombreaking orseparating duringuse | The containers remainedintact and handles should notrupture, tear, crack, orseparate from the container. | Pass |
Clinical Testing: Not Applicable.
H. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device (K190240).
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).