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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for a Sharps Container. It describes the device, its intended use, and its similarities to a predicate device, along with performance testing. However, it does not contain information about an AI/ML-based medical device. Therefore, I cannot generate the requested information about acceptance criteria, study details, expert involvement, or AI-specific performance metrics.

The document discusses the following types of tests:

ASTM F2132-01(2008): Standard Specification for a Sharps Containers
ISO 23907-1: Sharps containers - Part 1: Requirements and test methods - Sharps containers for single use
49 CFR 178.606 Stacking: Regulations for stacking of packaging for hazardous materials.
49 CFR 178.608 Vibration: Regulations for vibration testing of packaging for hazardous materials.

These are physical performance tests for a sharps container, ensuring its safety and appropriate containment of hazardous waste, not tests related to an AI/ML algorithm's diagnostic or predictive performance.

Therefore, I am unable to fulfill your request as the provided input does not describe an AI/ML medical device.

Summary

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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 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.

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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

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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)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

zearou.yang@promisemed.ca

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

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റ Description of the Device

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)	DimensionsLxWxH (mm)	Thickness	EmptyWeight(grams)	Color
SSC-005L	0.05 L	0.043 L	60 x 27 x 87	Base:1.3-3.2mmLid: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:1.3-3mmLid:1.3-2 mm	486	Lid:
SSC-200G	7.571 L	6.435 L	517 x 355 x 387	Base:1.3- 4mmLid:1.5-2.2mm	785	Colorless(Transparent)
SSC-300G	11.356L	9.653 L	355 x 304 x 558	Base:1.5- 4mmLid:1.2-4mm	953
SSC-400G	15.142L	12.871 L	398 x 317 x 463	Base:1.5- 4mmLid:1.2-4mm	1625
SSC-100Q	0.946 L	0.804 L	100 x 100 x 155	Base:1.3-2.6mmLid:1.3-1.5mm	84
SSC-200Q	1.892 L	1.608 L	565 x 314 x 387	Base:1.3-3mmLid:1.3-2 mm	158
SSC-500Q	4.73L	4.021 L	603 x 438 x 292	Base:1.3- 4mmLid:1.5-2.2mm	523

7 Specification

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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 SharpsContainer	Tiger Sharps Containers	Comments
Manufacturer	Promisemed HangzhouMeditech Co., Ltd	International MarketingSpecialists Inc.
Device Class	Class II	Class II	Same
Product Code	MMK	MMK	Same
Regulation number	880.5570	880.5570	Same
Regulation Name	Hypodermic single lumenneedle.	Hypodermic single lumenneedle.	Same
Intended Use/Indications for Use	It is intended to be usedfor health care purposesfor safe disposal ofhazardous sharps such ashypodermic needles,syringes, lancets andblood needles and so on.	Tiger Sharps Containers areintended to provide areceptacle for used,contaminated medical sharpsand act as an enclosure duringtransport to ultimate disposal.The Containers are single-use,disposable, non-sterilecontainers intended to beused for health-care purposesfor safe disposal of hazardoussharps such as hypodermicneedles, syringes, lancets andblood needles. The target	Same

A detailed comparison to the predicate is provided in Table 1.

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		population is for qualifiedpersonnel in health carefacilities and other facilitiesin which medical sharps maybe used. All device models arenot for use in areas withunsupervised patient access.
Capacity	0.05 litre/0.2 litre/ 0.5litre/ 1 litre/1.5 litre/1Quart/2 Quart/5 Quart/1Gallon/2 Gallon/3Gallon/4 Gallon	1 Quart / 5 Quart / 2 Gallon /2 Gallon B/ 15 Liter/ 3Gallon/ 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 orblackLid: Transparent or black	Base: RedLid: Transparent	Different
Clarity	Opaque/translucent	Opaque/translucent	Same
Non-sterile	Yes	Yes	Same
Method ofmanufacture	Injection Molded	Injection Molded	Same
Performancetesting	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

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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.

Regulation Number and Section

§ 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).