← Product Code [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK) · K211890 # Promisemed Sharps container (K211890) _Promisemed Hangzhou Meditech Co., Ltd. · MMK · Nov 17, 2021 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K211890 ## Device Facts - **Applicant:** Promisemed Hangzhou Meditech Co., Ltd. - **Product Code:** [MMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK.md) - **Decision Date:** Nov 17, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5570 - **Device Class:** Class 2 - **Review Panel:** General Hospital ## 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. ## Device Story Promisemed Sharps Container is a single-use, disposable, non-sterile receptacle for hazardous medical sharps; includes hypodermic needles, syringes, and lancets. Device consists of injection-molded polypropylene base, lid, closure, and handle. Used in healthcare facilities by qualified personnel to safely contain sharps during transport to disposal. Provides physical enclosure to prevent accidental injury. No patient contact. Output is a secure, puncture-resistant container. ## Clinical Evidence Bench testing only. No clinical data. Performance verified via compliance with ISO 23907-1, ASTM F2132-01(2008), 49 CFR 178.606 (Stacking), and 49 CFR 178.608 (Vibration). ## Technological Characteristics Materials: Polypropylene. Manufacturing: Injection molded. Form factor: Various capacities (0.05L to 15.142L). Non-sterile. Single-use. Standards: ISO 23907-1, ASTM F2132-01(2008), 49 CFR 178.606, 49 CFR 178.608. ## Regulatory 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. ## Predicate Devices - Tiger Sharps Containers ([K190240](/device/K190240.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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: 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 {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. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K211890](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/MMK/K211890) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com