(157 days)
Not Found
No
The device is a simple physical container for sharps disposal and the summary contains no mention of AI or ML.
No
The device is a sharps container, intended for the safe disposal of medical sharps, not for treating or diagnosing any condition.
No
Explanation: The device is a sharps container, intended for the safe disposal of medical sharps. Its function is to contain waste, not to diagnose medical conditions or provide diagnostic information.
No
The device is a physical container made of polypropylene plastic, designed to hold and transport medical sharps. The description focuses on its material, construction, and physical performance characteristics, not software functionality.
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 and safely transport contaminated medical sharps. This is a physical containment and disposal function.
- Device Description: The device is a plastic container designed for physical containment. It does not interact with biological samples or perform any diagnostic testing.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) to diagnose diseases, monitor health conditions, or determine compatibility. This sharps container does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MMK
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.
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.
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. All the containers are intended to be used in areas where there is no unsupervised patient access.
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 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.
-
Test: Anti-penetrability; Test method: ASTM F2132-01(Reapproved 2008e1); Purpose: Prevent the sharps in the container from penetrating the side and bottom of the container and hurting the user.; Acceptance Criteria: The puncture resistance of each section of the container greater than 15 N and the puncture resistance performance should met.; Results: Pass
-
Test: Resistance to damage and leakage after dropping; Test method: ISO 23907; Purpose: Prevent the container from breaking when falling from a height, and the sharps leak from the container.; Acceptance Criteria: Containers remained upside down for 60 minutes while being observed for leakage. No leakage observed and there is also no liquid leakage; Results: Pass
-
Test: Stack Test; Test method: 49 CFR 178.606; Purpose: The container will not be damaged during storage and shipping while stacking.; Acceptance Criteria: 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.; Results: Pass
-
Test: Vibration Test; Test method: 49 CFR 178.608; Purpose: Packaging cartons and products will not be damaged due to product transportation vibration; Acceptance Criteria: The containers should not be deteriorated.; Results: Pass
-
Test: Stability; Test method: ISO 23907; Purpose: Prevent the product from dumping during use.; Acceptance Criteria: The container should not slide or topple.; Results: Pass
-
Test: Strength of handles; Test method: ISO 23907; Purpose: Prevent the handle from breaking or separating during use; Acceptance Criteria: The containers remained intact and handles should not rupture, tear, crack, or separate from the container.; Results: Pass
Clinical Testing: Not Applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
2
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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3
| Model No. | Capacity
(full line) | capacity
(total) | Weight | Dimension
(mm) | Thickness
(mm) | Requirements
for mounting | Acceptable
sites of use | Description and
Dimension of
disposal
aperture(cm) |
|-----------|-------------------------|---------------------|---------|-------------------|-------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| GDC-03-F | 2143ml | 2972ml | 224.80g | 188.4158.1193.2 | 1.4 | Free standing | | 8.25.2 |
| GDC-03-X | 2143ml | 2972ml | 234.15g | 183.4153.3189.3 | 1.4 | Free standing | 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. | 16 sq. |
| GDC-05-F | 4049ml | | 320.50g | 226.3199.0218.5 | 1.5 | Free standing | | 9.55.5 |
| 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 | | 9.55.5 |
| 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 | | 53.7 |
| SC-02Q | 910ml | 1063ml | 77.85g | 108.688.3222.8 | 1.2 | Free standing | 53.7 | |
| SC-05Q | 4367ml | 5111ml | 513.61g | 270.3116.1289.5 | 1.3 | Free standing
Locking wall
bracket | 224.5 | |
| SC-01G | 2623ml | 3863 | 220.72g | 257.3174.5155.2 | 1.15 | Free standing | 145.5 | |
| SC-02G | 6066ml | 7424ml | 489.21g | 257.3175.0259.5 | 1.15 | Free standing
Locking wall
bracket | 146 | |
| SC-06G | 14013ml | 21024ml | 801.56g | 377.0235.9415.2 | 1.5 | Free standing | 21*4.5 | |
4
| Model No. | Material description | Color | lid
configurations | Lock Method | Unwinding feature |
|---------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GDC-03-F | Cap: PP;
Body:
Copolymerization PP | Cap:
Semitransparent;
Body: Yellow | Folding cap | Buckle on fold over cover and
fasten cover | 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. |
| GDC-03-X | Cap, small cover,
handle: PP;
Body:
Copolymerization PP | Cap:
Semitransparent;
Small cover and
handle: Red;
Body: Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of
the small red cover that can
rotate, and there is a small round
hole on the cover. When the
small cylinder rotates to the
position of the small round hole,
the two kinds of small cylinders
cooperate and buckle each
other. | The models GDC-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
have the needle unwinding |
| GDC-05-F | Cap: PP;
Body:
Copolymerization PP | Cap:
Semitransparent;
Body: Yellow | Folding cap | Buckle on fold over cover and
fasten cover | features |
| GDC-05-X | Cap, K7:K9small cover,
handle: PP;
Body:
Copolymerization PP | Cap:
Semitransparent;
Small cover and
handle: Red;
Body: Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of
the small red cover that can
rotate, and there is a small round
hole on the cover. When the
small cylinder rotates to the
position of the small round hole,
the two kinds of small cylinders
cooperate and buckle each
other. | |
| GDC-07-F | Cap: PP;
Body:
Copolymerization PP | Cap:
Semitransparent;
Body: Yellow | Folding cap | Buckle on fold over cover and
fasten cover | |
| GDC-07-X | Cap, small cover,
handle: PP;
Body:
Copolymerization PP | Cap:
Semitransparent;
Small cover and
handle: Red;
Body: Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of
the small red cover that can
rotate, and there is a small round
hole on the cover. When the
small cylinder rotates to the
position of the small round hole,
the two kinds of small cylinders
cooperate and buckle each
other. | |
| GDC-013-
X | Cap, small cover:
PP;
Body:
Copolymerization PP | Cap:
Semitransparent;
Small cover and
handle: Red;
Body: Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of
the small red cover that can
rotate, and there is a small round
hole on the cover. When the
small cylinder rotates to the
position of the small round hole,
the two kinds of small cylinders
cooperate and buckle each
other. | |
| SC-01Q | Cap, small cover:
PP;
Body:
Copolymerization PP | Cap: White;
Small cover and
handle: | 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; Small
cover: Red, Body
Red; Bottom and
key: Grey | Revolving cap | Small cap could revolving
inside and fasten tight with the
buckle in the cap | |
| SC-01G | Cap, small cover:
PP;
Body:
Copolymerization PP | Cap: White;
Small cover and
handle:
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 and
handle:
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 and
handle:
Semitransparent;
Body: Red | Slid cap | Slid the buckle on the small cap,
fasten tight with cap | |
5
6
7
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 Marketing | |||
| Specialists Inc. | Tiger Sharps container | K190240 | Tiger Sharps |
| Containers |
D. Indications for Use:
8
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) | Requirements
for mounting | Acceptable
sites of use | Description and
Dimension of
disposal
aperture(cm) |
|-----------|-------------------------|---------------------|---------|-------------------|-------------------|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| GDC-03-F | 2143ml | 2972ml | 224.80g | 188.4158.1193.2 | 1.4 | Free standing | The target
population is
for
qualified
personnel in
health
care facilities
and other
facilities in | 8.25.2 |
| GDC-03-X | 2143ml | 2972ml | 234.15g | 183.4153.3189.3 | 1.4 | Free standing | health
care facilities
and other
facilities in | 16 sq. |
| GDC-05-F | 4049ml | | 320.50g | 226.3199.0218.5 | 1.5 | Free standing | which
medical
sharps may
be used. All
the
containers are | 9.55.5 |
| GDC-05-X | 4049ml | 5234ml | 322.76g | 221.0195.9217.5 | 1.5 | Free standing | be used. All
the
containers are
intended to
be
used in areas | 21sq. |
| GDC-07-F | 5288ml | 6875ml | 435.28g | 241.4220.9231.7 | 1.7 | Free standing | where there is
no
unsupervised | 9.55.5 |
| GDC-07-X | 5288ml | 6875ml | 425.32g | 240.6218.8230.0 | 1.7 | Free standing | patient
access. | 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 | | 53.7 |
| SC-02Q | 910ml | 1063ml | 77.85g | 108.688.3222.8 | 1.2 | Free standing | | 53.7 |
| SC-05Q | 4367ml | 5111ml | 513.61g | 270.3116.1289.5 | 1.3 | Free standing
Locking wall
bracket | | 224.5 |
| SC-01G | 2623ml | 3863 | 220.72g | 257.3174.5155.2 | 1.15 | Free standing | | 145.5 |
| SC-02G | 6066ml | 7424ml | 489.21g | 257.3175.0259.5 | 1.15 | Free standing
Locking wall
bracket | | 146 |
| SC-06G | 14013ml | 21024ml | 801.56g | 377.0235.9415.2 | 1.5 | Free standing | | 21*4.5 |
Table1: specification of the sharps container
9
10
| Model
No. | Material description | Color | lid
configurations | Lock Method | Unwinding feature |
|---------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GDC-03-
F | Cap : PP ; Body :
Copolymerization
PP | Cap :
Semitransparent ;
Body : Yellow | Folding cap | Buckle on fold over cover and
fasten cover | |
| GDC-03-
X | Cap, small cover, handle
: PP ; Body :
Copolymerization
PP | Cap :
Semitransparent ;
Small cover and
handle: Red;
Body : Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of the
small red cover that can rotate,
and there is a small round hole on
the cover. When the small
cylinder rotates to the position of
the small round hole, the two
kinds of small cylinders cooperate
and buckle each other. | 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. The models
GDC-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 have
the needle unwinding
features. |
| GDC-05-
F | Cap : PP ; Body :
Copolymerization
PP | Cap :
Semitransparent ;
Body : Yellow | Folding cap | Buckle on fold over cover and
fasten cover | |
| GDC-05-
X | Cap, K7:K9small cover,
handle:PP; Body:
Copolymerization
PP | Cap :
Semitransparent ;
Small cover and
handle: Red;
Body : Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of the
small red cover that can rotate,
and there is a small round hole on
the cover. When the small
cylinder rotates to the position of
the small round hole, the two
kinds of small cylinders cooperate
and buckle each other. | |
| GDC-07-
F | Cap : PP ; Body :
Copolymerization
PP | Cap :
Semitransparent ;
Body: Yellow | Folding cap | Buckle on fold over cover and
fasten cover | |
| GDC-07-
X | Cap, small cover, handle
: PP ; Body :
Copolymerization
PP | Cap :
Semitransparent ;
Small cover and
handle: Red;
Body : Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of the
small red cover that can rotate,
and there is a small round hole on
the cover. When the small
cylinder rotates to the position of
the small round hole, the two
kinds of small cylinders cooperate
and buckle each other. | |
| GDC-013-
X | Cap, small cover : PP ;
Body : Copolymerization
PP | Cap :
Semitransparent ;
Small cover and
handle: Red;
Body : Yellow | Revolving cap | There is a protruding small
cylinder on the reverse side of the
small red cover that can rotate,
and there is a small round hole on
the cover. When the small
cylinder rotates to the position of
the small round hole, the two
kinds of small cylinders cooperate
and buckle each other. | |
| SC-01Q | Cap, small cover : PP ;
Body : Copolymerization
PP | Cap : White ;
Small cover and
handle:
Semitransparent; | Slid cap | Slid the buckle on the small cap,
fasten tight with cap | |
| SC-02Q | Cap, small cover: PP ;
Body : Copolymerization
PP | Cap : White ;
Small cover and
handle:
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; Small
cover: Red, Body
Red; Bottom and
key: Grey | Revolving cap | Small cap could revolving inside
and fasten tight with the buckle in
the cap | |
| SC-01G | Cap, small cover : PP ;
Body : Copolymerization
PP | Cap : White ;
Small cover and
handle:
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 and
handle:
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 and
handle:
Semitransparent;
Body : Red | Slid cap | Slid the buckle on the small cap,
fasten tight with cap | |
11
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 of
| Comparison | Subject Device | Predicate Device | Result |
|---|---|---|---|
| Manufacture | Zhejiang Gongdong Medical | ||
| Techonology Co., Ltd | International Marketing Specialists | ||
| Inc. | |||
| FDA510(K) Number | / | K190240 | -- |
| Device Name | Sharps Containers | Tiger Sharps Containers | Similar |
| Intended Use | Sharps Containers are intended to | ||
| provide a receptacle for used, | |||
| contaminated medical sharps and act as | |||
| an enclosure during transport to ultimate | |||
| disposal. | Tiger Sharps Containers are intended to | ||
| provide a receptacle for used, | |||
| contaminated medical sharps and act as | |||
| an enclosure during transport to | |||
| ultimate disposal. | Same | ||
| Product code | MMK | MMK | Same |
| Regulation | |||
| Number | 21CFR880.5570 | 21CFR880.5570 | Same |
| Class | II | II | Same |
| Capacities | 2972ml,2972ml,5234ml,6875ml,6875ml, | ||
| 13253ml,763ml,1063ml,5111ml,3863,74 | |||
| 24ml,21024ml | 1 Quart / 5 Quart / 2 Gallon / 2 Gallon | ||
| B / 15 Liter | |||
| 3 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
13
| Method of
| Manufacture | Injection Molded | Injection Molded | Same |
|---|---|---|---|
| Performance | |||
| testing | |||
| (puncture, impact, | |||
| drop, stability, | |||
| integrity etc.) | Pass | Pass | Same |
| Disposable or | |||
| Reusable? | 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(Reapproved | |||||
| 2008e1) | Prevent the | ||||
| sharps in the | |||||
| container from | |||||
| penetrating the | |||||
| side and bottom | |||||
| of the container | |||||
| and hurting the | |||||
| user. | 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 | ISO 23907 | Prevent the | |||
| container from | |||||
| breaking when | |||||
| falling from a | |||||
| height, and the | |||||
| sharps leak from | |||||
| the container. | 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 | 49 CFR | |||
| 178.606 | The container | ||||
| will not be | |||||
| damaged during | |||||
| storage and | |||||
| shipping while | |||||
| stacking. | 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 |
Table 3: Non-Clinical Performance Testing
14
| 4 | Vibration Test | 49 CFR
178.608 | Packaging
cartons and
products will not
be damaged due
to product
transportation
vibration | The containers should not be
deteriorated. | Pass |
|---|---------------------|-------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|------|
| 5 | Stability | ISO 23907 | Prevent the
product from
dumping during
use. | The container should not
slide or topple. | Pass |
| 6 | Strength of handles | ISO 23907 | Prevent the
handle from
breaking or
separating during
use | The containers remained
intact and handles should not
rupture, tear, crack, or
separate 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).