Who is the manufacturer of Promisemed Triple Safety Pen Needle?

Promisemed Hangzhou Meditech Co., Ltd. filed the 510(k) submission for Promisemed Triple Safety Pen Needle (K202682).

What is the FDA product code for Promisemed Triple Safety Pen Needle?

FMI. It is classified under 21 CFR 880.5570 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Promisemed Triple Safety Pen Needle?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Promisemed Triple Safety Pen Needle?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Promisemed Triple Safety Pen Needle

Q: What are the predicate devices for Promisemed Triple Safety Pen Needle?

Dual Safety Pen Needle (K191853).

K202682 · Promisemed Hangzhou Meditech Co., Ltd. · FMI · Nov 24, 2020 · General Hospital

Device Facts

Record ID	K202682
Device Name	Promisemed Triple Safety Pen Needle
Applicant	Promisemed Hangzhou Meditech Co., Ltd.
Product Code	FMI · General Hospital
Decision Date	Nov 24, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5570
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.

Device Story

Promisemed Triple Safety Pen Needle is a sterile, single-use hypodermic needle for subcutaneous insulin delivery via pen injectors. It features a triple-safety mechanism: a trigger shield that covers the needle before use, retracts during skin insertion, and automatically extends/locks after injection; and a posterior trigger shield that covers the pen-connector end upon removal from the pen. The device is manually operated by the patient or clinician. The trigger shield provides a tactile 'click' upon full skin penetration. The design prevents accidental needle sticks before use (after container removal) and after use. The device is supplied in various gauges (29G-31G) and lengths (4-8mm). It benefits patients by reducing the risk of sharps injuries during the entire handling process.

Clinical Evidence

Bench testing only. Performance verified against ISO 7864 (sterile hypodermic needles), ISO 11608-2 (needle-based injection systems), and ISO 23908 (sharps injury protection). Biocompatibility testing performed per ISO 10993 series (cytotoxicity, irritation, sensitization, acute systemic toxicity, hemolysis, pyrogenicity).

Technological Characteristics

Materials: Needle (X5CrNi18-10), Hub/Fixer (POM), Spring (0Cr18Mn8Ni5N), Container (PP), Shields (ABS). Energy: Manual. Connectivity: None. Sterilization: EO (SAL 10^-6). Features: Triple-safety shielding, thin-wall needle, silicone oil lubrication, UV glue assembly.

Indications for Use

Indicated for patients requiring subcutaneous insulin injection using pen injector devices.

Regulatory Classification

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

Dual Safety Pen Needle (K191853)

Related Devices

K202681 — Promisemed Covered Safety Pen Needle · Promisemed Hangzhou Meditech Co., Ltd. · Dec 31, 2020
K213183 — Safety Insulin Pen Needles · Zhejiang Kindly Medical Devices Co., Ltd. · Oct 14, 2022
K210059 — Promisemed Insulin Pen Needle · Promisemed Hangzhou Meditech Co., Ltd. · Jul 21, 2021
K191853 — Dual-Safety Pen Needle · Promisemed Hangzhou Meditech Co., Ltd. · Sep 5, 2019
K172095 — Autokeeper · Medexel Co.,Ltd · Jul 24, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 24, 2020 Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong 0000 China Re: K202682 Trade/Device Name: Promisemed Triple Safety Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 22, 2020 Received: October 26, 2020 Dear Wei 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. 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, Rumi Young Acting Assistant Director Injection Team DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202682 ### Device Name Promisemed Triple Safety Pen Needle ### Indications for Use (Describe) Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. 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 K202682 #### 1 Date Prepared November 20th, 2020 #### 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 Triple Safety Pen Needle Common Name: Insulin Pen Needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI #### ldentification of Predicate Device ব 510(K) Number: K191853 Product Code: FMI Regulation Number: 21 CFR 880.5570 Product Name: Dual Safety Pen Needle {4}------------------------------------------------ #### Description of the Device റ Promisemed Triple Safety Pen Needle is designed for use with a pen injector for the subcutaneous injection of insulin. The user proceeds with inserting the needle into the skin manually. The Promisemed Triple Safety Pen Needle consists of needle tube, trigger shield, posterior trigger/posterior trigger spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. Promisemed Triple Safety Pen Needle is the modification of Dual Safety Pen Needle cleared in K91853. The baseline location of trigger shield (patient end shield) is adjusted to allow the needle tube be covered by trigger shield thoroughly before use. This modification prevents accidental needle sticks before inserting the needle into the skin while the needle container is removed. As the user proceeds with inserting the needle into the skin the shield will retract. A click of the trigger shield (patient end shield) indicates the needle has fully penetrated the skin. In addition to above protective design, Promisemed Triple Safety Pen Needle retains two safety shields lock as the predicate has: the shield will lock in place (i) after use (patient-end): after the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle again and lock in place and (ii) upon removal of the needle from the pen (pen connector-end): the posterior trigger (a second shield) covers the pen connector needle when it is removed from the pen. Once the Promisemed Triple Safety Pen Needle is in the locked mode, it can no longer be used. Promisemed Triple Safety Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length. | Gauge | Length | Wall Type | |-------|--------|-----------| |-------|--------|-----------| {5}------------------------------------------------ | 29G | 4,5,6,8 mm | Thin wall | |-----|------------|-----------| | 30G | 4,5,6,8 mm | Thin wall | | 31G | 4,5,6,8 mm | Thin wall | #### 6 Intended Use Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. ### 7 Similarities and Differences of the Proposed Device to the Predicate Device The Promisemed Triple Safety Pen Needle is substantially equivalent to the predicate device, the Dual Safety Pen Needle (K191853) in that these devices have similar designs, methods of construction and operation, and indications for use. The differences from the predicate is the change of assembled position of trigger shield, the performance of which was verified and validated through ISO 7864, ISO23908, and ISO 11608-2 testing (See Section 8). The differences above between the subject device and predicate device do not affect the basic design principle, usage of the subject device. | | Subject Device | Predicate Device (K191853) | | | |------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Promisemed Triple Safety Pen Needle | Dual Safety Pen Needle | Comments | | | Manufacturer | Promisemed Hangzhou Meditech Co., Ltd | Promisemed Hangzhou Meditech Co., Ltd | | | | Device Class | Class II | Class II | Same | | | Product Code | FMI | FMI | Same | | | Regulation number | 880.5570 | 880.5570 | Same | | | Regulation Name | Needle, Hypodermic, Single Lumen | Needle, Hypodermic, Single Lumen | Same | | | Intended Use/ Indications for Use | Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. | The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use | Different The Subject device has one more protective design compared to predicate device that the needle tube is covered | | | | | (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle. | thoroughly by trigger shield before use. The difference in the protective mechanism to the predicate did not affect the substantially equivalence on safety and effectiveness of the device | | | Operating Principle | The needle tube is covered by trigger shield and is not exposed before usage. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle again and lock in place. A click of the patient end shield indicates the needle has fully penetrated the skin. A second shield covers the pen connector needle when the needle is removed from the pen. Once the Promisemed Triple Safety Pen Needle is in the locked mode, it can no longer be used. | As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. A click of the patient end shield indicates the needle has fully penetrated the skin. A second shield covers the pen connector needle when the needle is removed from the pen. Once the Dual Safety Pen Needle is in the locked mode, it can no longer be used. | Different The needle tube in the subject device is covered by trigger shield and is not exposed before usage. While the predicate the needle is not covered before usage. However, the difference in the covering of the needle tube does not affect the substantially equivalence on the safety and effectiveness | | | Gauge | G29, G30, G31 | G29, G30, G31 | Same | | | Needle Length | 4mm,5mm,6mm,8mm | 4mm,5mm,6mm,8mm | Same | | | Needle wall thickness | Thin Wall | Thin Wall | Same | | | Lubricant | Silicone Oil | Silicone Oil | Same | | | Adhesive | UV glue | UV glue | Same | | | Sharps Injury Prevention Features | The needle tip is covered by trigger shield and is not exposed before use. The patient end of the device has a mechanism that allows the needle to be shielded and locked after use. The non-patient (pen | The patient end of the device has a mechanism that allows the needle to be shielded and locked after use. The non-patient (pen connection) end of the cannula is visible prior to attachment to the pen injector. Following | Similar An additional protective design is introduced in subject device which prevent accidental needle sticks during the interval after the | | | | connection) end of the cannula is visible prior to attachment to the pen injector. Following removal of the device from the pen injector, the needle is shielded with a mechanism that is designed to reduce the occurrence of accidental needle stick injuries. | removal of the device from the pen injector, the needle is shielded with a mechanism that is designed to reduce the occurrence of accidental needle stick injuries. | needle container is removed and before inserting the needle into the skin. | | | Trigger force | $≤$ 0.7N | Not applicable | An additional protective design is introduced in the subject device which prevent accidental needle sticks during the interval after the needle container is removed and before inserting the needle into the skin . Tested in accordance to ISO 7864:2016, Annex D to ensure that the trigger shield will retact during injection and after injection | | | Method of attachment to the pen injector | (a) Removed the seal from the needle container. (b) Push the needle straight on to the pen injector and screw until it is tight | (a) Removed the seal from the needle container. (b) Push the needle straight on to the pen injector and screw until it is tight | Same | | | Angle of insertion | 90 $^{\circ}$ vertical to the desired injection site | No particular angle | Different Since the needle of subject device is inside the shield before use, the insertion angle of 90 $^{\circ}$ vertical is recommended to make sure the needle inserts to the desired position. The difference did not affect the substantially equivalence on | | | | | | safety and effectiveness. | | | | | | Different The needle tube is not exposed in subject device. While in the predicate it is exposed before usage | | | Configuration and Material | Image: [purple needle] | Image: [blue needle] | | | | | Needle Tube: X5CrNi18- 10 | Needle Tube: X5CrNi18- 10 | Same | | | | Needle Hub: Polyformaldehyde (POM) | Needle Hub: Polyformaldehyde (POM) | Same | | | | Fixer: Polyformaldehyde (POM) | Fixer: Polyformaldehyde (POM) | Same | | | | Spring: 0Cr18Mn8Ni5N | Spring: 0Cr18Mn8Ni5N | Same | | | | Needle container: Polypropylene (PP) | Needle container: Polypropylene (PP) | Same | | | | Posterior Trigger: Acrylonitrile Butadiene Styrene (ABS) and Pigment red 122(CAS: 980-26-7) | Posterior Trigger: Acrylonitrile Butadiene Styrene (ABS) and Pigment red 122(CAS: 980-26-7) | Same | | | | Trigger shield A: Acrylonitrile Butadiene Styrene (ABS) and color additive [Green: Chromium(III) oxide(CAS 1308-38-9); Violet: P.V 23 (CAS 6358-30-1); Orange: Nickel Antimony Titanate Yellow (CAS 8007-18-9); Blue: Pigment Blue 29 (CAS 57455-37-5)] | Trigger shield A: Acrylonitrile Butadiene Styrene (ABS) and color additive [Green: Chromium(III) oxide(CAS 1308-38-9); Violet: P.V 23 (CAS 6358-30-1); Orange: Nickel Antimony Titanate Yellow (CAS 8007-18-9); Blue: Pigment Blue 29 (CAS 57455-37-5)] | Material is the same. The location slot in subject device is moved downward. This change makes the baseline position of trigger shield move upward in finished subject device which allowing the needle tube be covered thoroughly. | | | | Trigger shield B: Acrylonitrile Butadiene Styrene (ABS) | Trigger shield B: Acrylonitrile Butadiene Styrene (ABS) | Same | | | Trigger Shield Slot | | Lower | Higher | Different The location of the slot in subject device is moved downward. This change allows the trigger shield cover the needle tip | | | | | completely before use. Does not affect the safety and effectivity of the device or the substantially equivalence to the predicate. | | | Unit Packaging | Sterile barrier system is consisting of needle container and seal (Medical grade glue dialyzing paper) | Sterile barrier system is consisting of needle container and seal (Medical grade glue dialyzing paper) | Same | | | Box | Paper board | Paper board | Same | | | Performance | Complied with ISO 7864, ISO 9626, ISO 11608-2 and ISO 23908 | Complied with ISO 7864, ISO 9626, ISO 11608-2 and ISO 23908 | Same | | | Sterilization | EO Sterilization SAL:10-6 | EO Sterilization SAL:10-6 | Same | | | Shelf Life | 5 years…

Promisemed Triple Safety Pen Needle

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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Promisemed Triple Safety Pen Needle

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Related Devices

Submission Summary (Full Text)

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