(70 days)
Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.
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.
This is a 510(k) summary for a medical device called the "Promisemed Triple Safety Pen Needle." It's a type of hypodermic needle used with pen injector devices for subcutaneous insulin injections.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are compliance with established ISO standards for hypodermic needles and sharps injury protection, and the "reported device performance" is that the device complied with these standards. Specific numerical performance data or acceptance criteria thresholds for individual tests within these standards are not detailed in this summary.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 11608-2: Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles | Complied |
| ISO 7864: Sterile hypodermic needles for single use — Requirements and test methods | Complied |
| ISO 23908: Sharps injury protection — Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling | Complied |
| Trigger force (for new protective design) | ≤ 0.7N (implied acceptance criterion) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for performance testing (bench testing). It states that testing was performed according to ISO standards, which typically define minimum sample sizes for various tests.
The data provenance is from Promisemed Hangzhou Meditech Co., Ltd. in Zhejiang, China, the manufacturer, based on bench testing performed to demonstrate compliance with international standards. The study is retrospective in the sense that the testing was conducted on manufactured devices to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of device clearance (510(k) for a hypodermic needle) primarily relies on bench testing against established engineering and medical device standards (ISO standards), rather than clinical studies requiring expert consensus for ground truth on patient outcomes. Therefore, information about a number of experts establishing ground truth for a test set is not applicable or provided in this document. The "ground truth" here is the adherence to specified mechanical, physical, and safety performance parameters as defined by the ISO standards.
4. Adjudication method for the test set
Not applicable. This document describes bench testing against engineering standards, not a clinical study involving human judgment that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (a pen needle), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance claims is established by compliance with international standards (ISO 11608-2, ISO 7864, ISO 23908). These standards define the acceptable performance characteristics for sterile hypodermic needles and sharps injury protection. For example, for the "Trigger force" criterion, the ground truth is simply whether the device achieves a trigger force ≤ 0.7N.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not a machine learning model.
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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
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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
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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)
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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:
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
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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 |
|---|---|---|
| ------- | -------- | ----------- |
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| 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 TripleSafety Pen Needle | Dual Safety Pen Needle | Comments | |
| Manufacturer | Promisemed HangzhouMeditech Co., Ltd | Promisemed HangzhouMeditech Co., Ltd | ||
| Device Class | Class II | Class II | Same | |
| Product Code | FMI | FMI | Same | |
| Regulation number | 880.5570 | 880.5570 | Same | |
| RegulationName | Needle, Hypodermic,Single Lumen | Needle, Hypodermic,Single Lumen | Same | |
| Intended Use/Indications forUse | Promisemed TripleSafety Pen Needle isintended for use withpen injector devices forsubcutaneous injectionof insulin. | The Dual Safety PenNeedle is intended foruse with pen injectordevices forsubcutaneous injectionof insulin.The product has twosafety shields whichlock in place after use | DifferentThe Subject devicehas one moreprotective designcompared topredicate devicethat the needletube is covered | |
| (patient-end) and uponremoval of the needlefrom the pen (penconnector-end).The lock shields helpreduce the occurrenceof needle sticks fromboth ends of theneedle. | thoroughly bytrigger shield beforeuse.The difference inthe protectivemechanism to thepredicate did notaffect thesubstantiallyequivalence on safetyand effectiveness ofthe device | |||
| OperatingPrinciple | The needle tube iscovered by trigger shieldand is not exposedbefore usage.As the user proceedswith inserting the needleinto the skin the shieldwill retract. After theinjection is completedand needle is removedfrom the skin, the shieldwill automaticallyextend to cover theneedle again and lock inplace. A click of thepatient end shieldindicates the needle hasfully penetrated theskin. A second shieldcovers the pen connectorneedle when the needleis removed from the pen.Once the PromisemedTriple Safety Pen Needleis in the locked mode, itcan no longer be used. | As the user proceedswith inserting theneedle into the skin theshield will retract. Afterthe injection iscompleted and needle isremoved from the skin,the shield willautomatically extend tocover the needle andlock in place. A click ofthe patient end shieldindicates the needle hasfully penetrated theskin. A second shieldcovers the penconnector needle whenthe needle is removedfrom the pen. Once theDual Safety Pen Needleis in the locked mode, itcan no longer be used. | DifferentThe needle tube inthe subject deviceis covered by triggershield and is notexposed beforeusage. While thepredicate theneedle is notcovered beforeusage. However, thedifference in thecovering of theneedle tube doesnot affect thesubstantiallyequivalence on thesafety andeffectiveness | |
| Gauge | G29, G30, G31 | G29, G30, G31 | Same | |
| Needle Length | 4mm,5mm,6mm,8mm | 4mm,5mm,6mm,8mm | Same | |
| Needlewallthickness | Thin Wall | Thin Wall | Same | |
| Lubricant | Silicone Oil | Silicone Oil | Same | |
| Adhesive | UV glue | UV glue | Same | |
| Sharps InjuryPreventionFeatures | The needle tip iscovered by trigger shieldand is not exposedbefore use.The patient end of thedevice has a mechanismthat allows the needleto be shielded andlocked after use. Thenon-patient (pen | The patient end of thedevice has a mechanismthat allows the needleto be shielded andlocked after use. Thenon-patient (penconnection) end of thecannula is visible priorto attachment to thepen injector. Following | SimilarAn additionalprotective design isintroduced insubject devicewhich preventaccidental needlesticks during theinterval after the | |
| connection) end of thecannula is visible priorto attachment to thepen injector. Followingremoval of the devicefrom the pen injector,the needle is shieldedwith a mechanism thatis designed to reducethe occurrence ofaccidental needle stickinjuries. | removal of the devicefrom the pen injector,the needle is shieldedwith a mechanism thatis designed to reducethe occurrence ofaccidental needle stickinjuries. | needle container isremoved and beforeinserting the needleinto the skin. | ||
| Trigger force | $≤$ 0.7N | Not applicable | An additionalprotective design isintroduced in thesubject devicewhich preventaccidental needlesticks during theinterval after theneedle container isremoved and beforeinserting the needleinto the skin .Tested inaccordance to ISO7864:2016, Annex Dto ensure that thetrigger shield willretact duringinjection and afterinjection | |
| Method ofattachment tothe pen injector | (a) Removed the sealfrom the needlecontainer.(b) Push the needlestraight on to the peninjector and screw untilit is tight | (a) Removed the sealfrom the needlecontainer.(b) Push the needlestraight on to the peninjector and screw untilit is tight | Same | |
| Angle ofinsertion | 90 $^{\circ}$vertical tothedesired injection site | No particular angle | DifferentSince the needle ofsubject device isinside the shieldbefore use, theinsertion angle of90 $^{\circ}$ vertical isrecommended tomake sure theneedle inserts tothe desiredposition. Thedifference did notaffect thesubstantiallyequivalence on | |
| safety andeffectiveness. | ||||
| DifferentThe needle tube isnot exposed insubject device.While in thepredicate it isexposed beforeusage | ||||
| Configurationand 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 ButadieneStyrene (ABS) andPigment red 122(CAS:980-26-7) | Posterior Trigger:Acrylonitrile ButadieneStyrene (ABS) andPigment red 122(CAS:980-26-7) | Same | ||
| Trigger shield A:Acrylonitrile ButadieneStyrene (ABS) and coloradditive [Green:Chromium(III) oxide(CAS1308-38-9); Violet: P.V23 (CAS 6358-30-1);Orange: Nickel AntimonyTitanate Yellow (CAS8007-18-9); Blue:Pigment Blue 29 (CAS57455-37-5)] | Trigger shield A:Acrylonitrile ButadieneStyrene (ABS) and coloradditive [Green:Chromium(III) oxide(CAS1308-38-9); Violet: P.V23 (CAS 6358-30-1);Orange: NickelAntimony TitanateYellow (CAS 8007-18-9);Blue: Pigment Blue 29(CAS 57455-37-5)] | Material is thesame.The location slot insubject device ismoved downward.This change makesthe baselineposition of triggershield move upwardin finished subjectdevice whichallowing the needletube be coveredthoroughly. | ||
| Trigger shield B:Acrylonitrile ButadieneStyrene (ABS) | Trigger shield B:Acrylonitrile ButadieneStyrene (ABS) | Same | ||
| TriggerShieldSlot | Lower | Higher | DifferentThe location of theslot in subjectdevice is moveddownward. Thischange allows thetrigger shield coverthe needle tip | |
| completely beforeuse. Does not affectthe safety andeffectivity of thedevice or thesubstantiallyequivalence to thepredicate. | ||||
| Unit Packaging | Sterile barrier system isconsisting of needlecontainer and seal(Medical grade gluedialyzing paper) | Sterile barrier system isconsisting of needlecontainer and seal(Medical grade gluedialyzing paper) | Same | |
| Box | Paper board | Paper board | Same | |
| Performance | Complied with ISO 7864,ISO 9626, ISO 11608-2and ISO 23908 | Complied with ISO 7864,ISO 9626, ISO 11608-2and ISO 23908 | Same | |
| Sterilization | EO SterilizationSAL:10-6 | EO SterilizationSAL:10-6 | Same | |
| Shelf Life | 5 years | 5 years | Same | |
| Single use | Yes | Yes | Same | |
| Biocompatibility | Complied with ISO10993series standards, andthe following tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skinirritation- Skin Sensitization: Noevidence of sensitization-Acute SystemicToxicity:No systemictoxicity-Hemolysis: No evidenceof hemolysis-Pyrogen: No pyrogenic | Complied with ISO10993series standards, andthe following tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skinirritation- Skin Sensitization: Noevidence ofsensitization-Acute SystemicToxicity:No systemictoxicity-Hemolysis: No evidenceof hemolysis-Pyrogen: No pyrogenic | Same |
A detailed comparison to the predicate is provided in Table 1.
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Performance Testing Summary 8
The bench testing performed verifies that the performance of the subject devices is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- · ISO11608-2: Needle-based injection systems for medical use Requirements and test methods — Part 2: Needles
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- ISO 7864: Sterile hypodermic needles for single use Requirements and test methods
- · ISO 23908: Sharps injury protection Requirements and test methods -Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- の Conclusion
Based on the information provided within this 510(k) submission, proposed Promisemed Triple Safety Pen Needle is substantially equivalent to the predicate device (K191853) and does not raise different questions of safety or effectiveness.
§ 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).