(149 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and safety standards of a sharps container, with no mention of AI or ML technology.
No
The device is a sharps container for disposing of hazardous medical waste, not for treating or diagnosing medical conditions.
No
This device, a sharps container, is designed for the safe disposal of hazardous medical waste, not for diagnosing medical conditions. Its function is containment, not analysis or detection of disease.
No
The device description explicitly states it is a physical container made of injection molded polypropylene plastic, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "safe disposal of hazardous sharps." This is a physical containment and disposal function, not a diagnostic test performed on biological samples.
- Device Description: The description focuses on the physical characteristics of the container (material, components) and its purpose for holding sharps. It explicitly states that "No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers." This further reinforces that it's not interacting with biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of any components, reagents, or processes that would be used to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies listed (ASTM F2132-01, ISO 23907-1, 49 CFR 178.606, 49 CFR 178.608) are related to the physical integrity and safety of the container for sharps disposal, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment. This sharps container does not fit that definition.
N/A
Intended Use / Indications for Use
It is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
The Sharps container is 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.
It is made of injection molded polypropylene plastic, and is composed of base, lid, closure and handle (except pocket collectors). No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified personnel in health care facilities and other facilities in which medical sharps may be used.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- ・ASTM F2132-01(2008)
- ISO 23907-1
- 49 CFR 178.606 Stacking
- 49 CFR 178.608 Vibration
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 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.
November 17, 2021
Promisemed Hangzhou Meditech Co., Ltd. % Wei Shan Hsu Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China
Re: K211890
Trade/Device Name: Promisemed Sharps container Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: MMK Dated: May 27, 2021 Received: June 21, 2021
Dear Wei Shan Hsu:
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211890
Device Name Promisemed Sharps Container
Indications for Use (Describe)
It is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.
| 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
510(k) Summary (K211890)
Date Prepared 1
June 10th , 2021
2 Submitter's Information
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou
City, 311121 Zhejiang, China
Contact Name:
Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
ന Trade Name, Common Name, Classification
Trade/Product Name: Promisemed Sharps Container
Common Name: Sharps container
Classification name: Container, Sharps
Regulation Number: 21 CFR 880.5570
Device Class: Class II
Product Code: MMK
ldentification of Predicate Device ব K190240 Tiger Sharps Containers
4
റ Description of the Device
The Sharps container is 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.
It is made of injection molded polypropylene plastic, and is composed of base, lid, closure and handle (except pocket collectors). No part of the container is intended to come in contact with patients and the sharps objects that will be placed within the containers.
- 6 Indication
lt is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.
| Model | Capacity
(Total) | Capacity
(Full line) | Dimensions
LxWxH (mm) | Thickness | Empty
Weight
(grams) | Color |
|----------|---------------------|-------------------------|--------------------------|---------------------------------|----------------------------|-------------------------------------------------|
| SSC-005L | 0.05 L | 0.043 L | 60 x 27 x 87 | Base:1.3-3.2mm
Lid:1.2-1.5mm | 27 | Base:black
(opaque)
Lid:black
(opaque) |
| SSC-020L | 0.2 L | 0.17 L | 65 x 55 x 100 | Base: 1.2-4mm | 40 | Base:colorless |
| SSC-050L | 0.5 L | 0.425 L | 74 x 74 x 114 | Lid: 1.2- 3.2mm | 56 | (translucent)
Lid:yellow
(opaque) |
| SSC-100L | 1 L | 0.85 L | 100 x 100 x 155 | Base:1.3-2.6mm | 84 | Base: |
| SSC-150L | 1.5 L | 1.275 L | 539 x 248 x 381 | Lid:1.3-1.5mm | 134 | red (opaque) |
| SSC-100G | 3.785 L | 3.217 L | 546 x 536 x 393 | Base:1.3-3mm
Lid:1.3-2 mm | 486 | Lid: |
| SSC-200G | 7.571 L | 6.435 L | 517 x 355 x 387 | Base:1.3- 4mm
Lid:1.5-2.2mm | 785 | Colorless
(Transparent) |
| SSC-300G | 11.356L | 9.653 L | 355 x 304 x 558 | Base:1.5- 4mm
Lid:1.2-4mm | 953 | |
| SSC-400G | 15.142L | 12.871 L | 398 x 317 x 463 | Base:1.5- 4mm
Lid:1.2-4mm | 1625 | |
| SSC-100Q | 0.946 L | 0.804 L | 100 x 100 x 155 | Base:1.3-2.6mm
Lid:1.3-1.5mm | 84 | |
| SSC-200Q | 1.892 L | 1.608 L | 565 x 314 x 387 | Base:1.3-3mm
Lid:1.3-2 mm | 158 | |
| SSC-500Q | 4.73L | 4.021 L | 603 x 438 x 292 | Base:1.3- 4mm
Lid:1.5-2.2mm | 523 | |
7 Specification
5
8 Similarities and Differences of the Proposed Devices to the Predicate Devices
The Promisemed Sharps Container is substantially equivalent to the predicate device, the Tiger Sharps Containers (K190240) in that these devices have same intended use, technological characteristics and method of manufacturer. Both the subject and predicate devices are disposable, nonsterile, single use devices. The differences between the subject device and predicate device do not affect the basic design principle, usage of the subject device.
| Subject Device | Predicate Device (K190240) | ||
|---|---|---|---|
| Trade Name | Promisemed Sharps | ||
| Container | Tiger Sharps Containers | Comments | |
| Manufacturer | Promisemed Hangzhou | ||
| Meditech Co., Ltd | International Marketing | ||
| Specialists Inc. | |||
| Device Class | Class II | Class II | Same |
| Product Code | MMK | MMK | Same |
| Regulation number | 880.5570 | 880.5570 | Same |
| Regulation Name | Hypodermic single lumen | ||
| needle. | Hypodermic single lumen | ||
| needle. | Same | ||
| Intended Use/ | |||
| Indications for Use | It is intended to be used | ||
| for health care purposes | |||
| for safe disposal of | |||
| hazardous sharps such as | |||
| hypodermic needles, | |||
| syringes, lancets and | |||
| blood needles and so on. | Tiger 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 hypodermic | |||
| needles, syringes, lancets and | |||
| blood needles. The target | Same |
A detailed comparison to the predicate is provided in Table 1.
6
| | | population is for qualified
personnel in health care
facilities and other facilities
in which medical sharps may
be used. All device models are
not for use in areas with
unsupervised patient access. | |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Capacity | 0.05 litre/0.2 litre/ 0.5
litre/ 1 litre/1.5 litre/1
Quart/2 Quart/5 Quart/1
Gallon/2 Gallon/3
Gallon/4 Gallon | 1 Quart / 5 Quart / 2 Gallon /
2 Gallon B/ 15 Liter/ 3
Gallon/ 8 Gallon | Different |
| Prescribed | OTC | OTC | Same |
| Weight range (g) | 27-1625 | 109-1172 | Different |
| No. of piece | 2-3 | 2-3 | Same |
| Material | Polypropylene | Polypropylene | Same |
| Color | Base: Red or yellow or
black
Lid: Transparent or black | Base: Red
Lid: Transparent | Different |
| Clarity | Opaque/translucent | Opaque/translucent | Same |
| Non-sterile | Yes | Yes | Same |
| Method of
manufacture | Injection Molded | Injection Molded | Same |
| Performance
testing | Complied with ISO23907,
ASTM F2132 | Complied with ISO23907,
ASTM F2132 | Same |
| Disposable or Re-
usable | Disposable | Disposable | Same |
9 Performance Testing Summary
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- ・ASTM F2132-01(2008)
- ISO 23907-1
- 49 CFR 178.606 Stacking
7
- 49 CFR 178.608 Vibration
10 Conclusion
Based on the information provided within this 510(k) submission, proposed subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.