(206 days)
Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.
Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider, protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.
Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.
Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.
The provided text is a 510(k) Premarket Notification for a Disposable Insulin Pen Needle. It focuses on demonstrating substantial equivalence to predicate devices through design comparisons and a summary of performance testing. The document does not describe a study that involves acceptance criteria for device performance based on AI or diagnostic accuracy. Instead, it details the physical and functional performance of the device based on established medical device standards.
Therefore, I cannot provide information about:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI.
- Sample size used for the test set and data provenance for an AI model.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
However, I can extract information regarding the device's general performance testing and criteria based on the provided document:
The device's performance is evaluated against recognized international standards for medical devices and sterility.
Here's a summary of the performance testing and criteria mentioned, which serves as the "acceptance criteria" in the context of this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Standard / Requirement) | Reported Device Performance |
|---|---|---|
| Sterilization | - EO gas sterilization with Sterility Assurance Level (SAL) of 10⁻⁶, validated per ISO 11135:2014. - Maximum EO residual < 0.8mg. - Maximum ECH residual < 1.8mg, according to ISO 10993-7:2008. | - Device is sterilized by EO gas; SAL is 10⁻⁶. - Process validated per ISO 11135:2014. - EO residual < 0.8mg. - ECH residual < 1.8mg. |
| Product Performance (General) | - Meet criteria specified in ISO 11608-2:2012 (Needle-based injection systems). - Meet criteria specified in ISO 9626:2016 (Stainless steel needle tubing). - Meet criteria specified in ISO 7864:2016 (Sterile hypodermic needles). | - Meets criteria specified in ISO 11608-2, ISO 9626, and ISO 7864 and other applicable standards. |
| Functional Compatibility | - Compatible with commonly used insulin pens in the U.S. market. | - Tests completed; insulin pens declared in label are compatible with the needle. (Specific compatible pens listed: NovoPen Echo, Humapen Luxura, Humapen Luxura HD, HumanPen Ergo II) |
| Transport | - Meet requirements of ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems). | - Simulated transportation test completed per ASTM D4169-16. Test result: passed (for Model CT and Model ST). |
| Shelf Life | - Maintain performance (ISO 11608-2), chemical properties, bacterial endotoxin, and leakage (ASTM F1929-2015) after accelerated aging. | - Performance, chemical properties, bacterial endotoxin, and leakage tested before accelerated aging, after 4 years, and 5 years of accelerated aging. Determined shelf life: 5 years. (Accelerated aging test by ASTM F88/F88M-2015). |
| Biocompatibility | - Meet requirements of ISO 10993 series standards. - Specific tests: Cytotoxicity, skin sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, subchronic toxicity, material-mediated pyrogenicity. - Particulate matter for injections per USP <788>. | - Meets requirements of ISO 10993 series standards. - All listed specific tests performed. - Particulate matter for injections performed per USP <788>. |
| Sharps Protection Features | - For Model ST: Meet requirements of safe-lock guard activation and safety overriding/unlocking force after activation (triggering performance) as per ISO 23908:2011 (Sharps injury protection). | - Model ST meets the requirements of safe-lock guard activation and safety overriding/unlocking force after activation per ISO 23908:2011. |
| Clinical Simulated Use | - For Model ST: Demonstrate sharps injury prevention feature through clinical simulated use testing, according to ISO 23908:2011 and FDA Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features. | - Clinical simulated use testing completed for Model ST. Test results show good sharps injury prevention feature. |
| Hub/Needle Bond Strength | - Conform with ISO 11608-2. | - Conform with ISO 11608-2. |
| Method of Attachment | - Screw structure, conform with ISO 11608-2. | - Screw structure, conform with ISO 11608-2. |
| Needle Tip Configuration | - Tri-bevel edge needle. | - Tri-bevel edge needle. |
| Endotoxin Limit | - 20 EU per device. | - 20 EU per device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of diagnostic performance or AI. Instead, it refers to samples of the device being manufactured and subjected to various physical, chemical, and biological tests according to the standards listed above. The provenance of these test samples would be the manufacturer's production line (Ningbo Medsun Medical Co., Ltd., China). The tests are prospective in the sense that they are performed on the manufactured device models to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as this is not a diagnostic device involving expert interpretation or AI. The "ground truth" here is compliance with established international and national medical device standards, which are defined by committees of experts in the field.
4. Adjudication Method for the Test Set
Not applicable. The criteria are objective measurements and validations against standards.
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, as this is not a diagnostic device or AI-driven system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device.
7. The type of ground truth used
The "ground truth" is defined by the technical specifications and performance requirements outlined in the cited international and national standards (e.g., ISO 11135, ISO 11608-2, ISO 9626, ISO 7864, ISO 10993 series, ASTM D4169-16, ASTM F1929-2015, USP <788>, ISO 23908:2011). These standards represent established scientific and engineering principles for medical device safety and efficacy.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.
November 17, 2022
Ningbo Medsun Medical Co., Ltd. % Marvin Li Consultant Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313. No. 620 Zhennan Road (Building 9, Tongji University Science Park), Putuo District Shanghai, 200331 China
Re: K221178
Trade/Device Name: Disposable Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: October 18, 2022 Received: October 21, 2022
Dear Marvin Li:
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).
CAPT. Alan M. Stevens Assistant Director 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
Sincerely,
Alan M.
Stevens -
S3
Alan Str
Image /page/1/Picture/8 description: The image shows the word "Sincerely," followed by a signature and the name "Alan M. Stevens - S3". The signature is in black ink and is difficult to read. The name is in a simple, sans-serif font. The image is likely a scan of a document.
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Indications for Use
510(k) Number (if known) K221178
Device Name Disposable Insulin Pen Needle
Indications for Use (Describe)
Disposable Insulin Pen Needle(Model CT) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Disposable Insulin Pen Needle(Model ST) : Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.
| 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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K221178
510(k) Summary
1.Date Prepared: November 17th, 2022
2.Submitter
Ningbo Medsun Medical Co., Ltd.
No.55 Jinxi Road, Zhenhai, 315221, Ningbo, P.R.China
Contact Person: Liu Ping, Regulation Affairs Manager
Tel: +86-574-86301708 Fax:+86-574-86301778
Primary correspondent: Marvin Li, Consultant Tel:+86-15257179656 E-mail: leeking0908@126.com Shanghai Mihe Enterprise Management Consulting Co., Ltd. Room 313, No. 620 Zhennan Road(Building 9, Tonqii University Science Park), Putuo District, 200331, Shanghai, P.R.China Date Prepared: November 17th, 2022
3.Device
Trade Name: Disposable Insulin Pen Needle Common Name: Hypodermic single lumen needle Classification Name: Needle, Hypodermic, Single Lumen Regulation Number:21 CFR 880.5570 Regulatory Class: II Product Code: FMI Review Panel: General Hospital 4. Predicate device 4.1 Primary Predicate device A Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Disposable Insulin Pen Needle 510(k) number: K170846 Secondary Predicate device B Manufacturer: Jiangsu Caina Technology Co., Ltd. Device name: Safety Pen Needle 510(k) number: K192677
5.Device description
Disposable Insulin Pen Needle, could be divided into Model CT (normal type) and model ST(safety type) according to whether there is sharps protection features. Model CT consists of needle hub, needle container, needle tube, needle shield and seal (dialyzing paper). Model ST consists of needle hub, needle container, protective cap, needle tube, spring, slider,
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510(k) Notification document-Disposable Insulin Pen Needle
protective jacket and seal (dialyzing paper). The device is sterilized by EO gas and for single use. The shelf life is 5 years.
Needle tube is fixed in the center of the needle hub with UV glue, the needle tip is protected with needle shield or protective jacket before use, medical dialyzing paper is covered and sealed needle container to maintain sterile of the cartridge end of needle can be inserted into the rubber of insulin pen, meanwhile the needle hub is connected to insulin pen with screw thread to provide sterile fluid path for injection of insulin during use. When Disposable Insulin Pen Needle is connected to insulin pen operates on the principles of common piston syringes. The patient end and the cartridge end of the needle tube are lubricated with silicone oil for ease of injection and rubber penetration.
Model ST has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.
6.Indications for use
Disposable Insulin Pen Needle (Model CT): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Disposable Insulin Pen Needle (Model ST): Disposable Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, it has sharps injury protection feature that it can reduce the occurrence of accidental needlesticks from the patient end of the needle due to the effect of safe-lock guard.
7.Comparison of technological characteristics with the predicate device
7.1Comparison between Model CT Disposable Insulin Pen Needle and Predicate Device A
| Description | Subject Device (Model CT)(K221178) | Predicate Device A(K170846) | Remark |
|---|---|---|---|
| Proprietary/trade name | Disposable InsulinPen Needle | Disposable InsulinPen Needle | / |
| Product Code | FMI | FMI | Same |
| RegulationNumber | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Indicationsfor use | Disposable Insulin PenNeedle is intended for usewith pen injector device forsubcutaneous injection ofinsulin. | The Disposable InsulinPen Needle is intended foruse with pen injectordevices for thesubcutaneous injection ofinsulin. | Same |
| Prescription/over-the counter use | Over-the counter use | Over-the counter use | Same |
| Operation Mode | Manual | Manual | Same |
| Environmentof use | Home, Health center | Home, Health center | Same |
| 510(k) Notification document-Disposable Insulin Pen Needle | K221178 | ||
| Intended users | For self-administrationor by a caregiver | Same | |
| Hub/needlebond strength | Conform with ISO 11608-2 | Same | |
| Method ofattachment topen injector | Screw structure, conform with ISO 11608-2 | Same | |
| Needle tipconfiguration | Tri-bevel edge needle | Same | |
| Shelf life | 5 years | 3 years(Note 1) | |
| Size(s) | Outerdiameter | Length | Similar(Note 2) |
| 0.33mm | 10mm,12mm | ||
| 0.30mm | 5mm | ||
| 0.25mm | 5mm,6mm,8mm | ||
| 0.23mm0.20mm | 4mm,5mm,6mm,8mm4mm | ||
| Configurationand Material | Needle tube | StainlesssteelSUS304 | Cannula304 Stainless Steel |
| Needle hub | PP | HubPolypropylene | |
| Needlecontainer | PP | NeedleCapPolyethylene | |
| Needleshield | PP | Needle HubProtectorPolypropylene(Note 3) | |
| Lubricant | Silicon oil | LubricantPolydimethyls iloxane | |
| Adhesive | UV glue | / | |
| Seal | Medicaldialyzingpaper | SealedPaperPaper | |
| Needle Gauge:29G, 30G,31G, 32GNeedle Dimension (mm):0.23×4, 0.25×4, 0.25×5,0.25×6, 0.25×8, 0.30×8,0.30×10, 0.33×12 | |||
| 510(k) Notification document-Disposable Insulin Pen Needle | K221178 | ||
| Performance | Meet the requirements ofISO 7864, ISO 9626, ISO11608-2 | Comply with ISO 7864,ISO 9626, and ISO11608-2 | Same |
| Sterilization | EO Sterilization | EO sterilized, SAL: 10-6 | Same |
| SAL:10-6 | |||
| Labeling | Conform with 21 CFR 801 | Conform with 21 CFR 801 | Same |
| Biocompatibility | Meet the requirements ofISO10993 seriesstandards, and thefollowing tests areperformed: In vitrocytotoxicity, skinsensitization,intracutaneous reactivity,acute systemic toxicity,hemocompatibility,subchronic toxicity,particulate matter forinjections and pyrogen. | Conform with ISO 10993standards | Similar(Note 4) |
| Reuse orsingle use | Single use | Single use | Same |
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Note 1: The shelf life of the predicate device A is 3 years. The shelf life of the subject device is 5 years according to the result of accelerated aging test by ASTM F88/F88M-2015, which will not affect the safety and effectiveness of the subject device.
Note 2: The outer diameter (gauge) of the predicate device A is covered by the subject device. The subject device has a 0.20mm(33G) type, while the predicate device A doesn't have. The lengths of the subject device for each outer diameter(gauge) have some differences that are physical, the performance bench testing of needle tube with lengths for subject device are demonstrated to meet the requirements of ISO 11608-2.
Note 3: The configuration and material of the predicate device A are mostly the same as the subject device. For the subject device, the adhesive is UV glue, where the predicate device's adhesive is unknown. UV glue is widely used for Insulin Pen Needle hub and needle tube. The safety of UV glue is demonstrated with the biocompatibility of final product.
Note 4: Subject Device has been tested for all required biocompatibility endpoints per ISO 10993.
| Description | Subject Device (ModelST) (K221178) | Predicate Devices B(K192677) | Remark |
|---|---|---|---|
| Proprietary/trade name | Disposable InsulinPen Needle | Safety Insulin Pen Needle | / |
| Product Code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Class | II | II | Same |
7.2Comparison between Model ST Disposable Insulin Pen Needle and Predicate Device B
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| 510(k) Notification document-Disposable Insulin Pen Needle | K221178 | ||
|---|---|---|---|
| Indicationsfor use | Disposable Insulin PenNeedle is intended for usewith pen injector device forsubcutaneous injection ofinsulin. Additionally, it hassharps injury protectionfeature that it can reduce theoccurrence of accidentalneedlesticks from the patientend of the needle due to theeffect of safe-lock guard. | The Safety Insulin PenNeedle is intended for usewith pen injector devicesfor the subcutaneousinjection of insulin. Theattached safety shieldautomatically locks afterinjection and reduces theoccurrence of accidentalneedle sticks from thepatient end of the needle. | Same |
| Prescription/over-the counter use | Over-the counter use | Over-the counter use | Same |
| Environmentof use | Home, Health center | Home, Health center | Same |
| Intended users | For self-administrationor by a caregiver | For self-administrationor by a caregiver | Same |
| Hub/needle bondstrength | Conform with ISO 11608-2 | Conform with ISO 11608-2 | Same |
|---|---|---|---|
| Method ofattachment topen injector | Screw structure, conform withISO 11608-2 | Screw structure,conform with ISO 11608-2 | Same |
| Needle tipconfiguration | Tri-bevel edge needle | Tri-bevel edge needle | Same |
| Shelf life | 5 years | 3 years | Different(Note 5) |
| Method ofactivation forthe safetymechanism | Before use, red slider ishidden in the protective cap,needle tip is in protectivejacket and seen. In use,protective jacket is presseddown and the needle tip isexposed for injection.After use, protective jacketwill rebound and red slider isexposed in the transparentprotective jacket. The redslider will be seen by userand indicate that safe-lockguard have be activated.The needle cannot be usedagain. | Before use, red slider isexposed in the protectivecap, needle tip is inprotective jacket and seen.In use, protective jacket ispressed down and theneedle tip is exposed forinjection. After use,protective jacket willrebound and red slider ishidden in the transparentprotective jacket. The redslider will be not seen byuser and indicate thatsafe-lock guard have beactivated. The needlecannot be used again. | Similar(Note 6) |
| Designspecificationsof the safetymechanism | Dimensions | Slider:3.4mmProtectivejacket:10.3mm | Similar(Note 7) |
| Dimensions | unknown | ||
| Color | Slider:redProtectivejacket:colorless | ||
| Color | Slider:redProtectivejacket:colorless | ||
| Strength | $\leq$ 6N | ||
| Strength | unknown |
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| 510(k) Notification document-Disposable Insulin Pen Needle | K221178 | |||
|---|---|---|---|---|
| Outerdiameter | Length | |||
| Size(s) | 0.30mm | 5mm,8mm | Needle gauge:29G, 30G,31G, 32GNeedle length:4mm, 5mm,6mm, 8mm, 10mm | Similar(Note 8) |
| 0.25mm | 6mm,8mm | |||
| 0.23mm | 4mm,8mm | |||
| Wall type | Thin-walled | Thin-walled,Extra-thin-walled | Similar(Note 9) | |
| Configurationand Material | Needle tube | StainlesssteelSUS304 | ||
| Needle hub | PP | |||
| Protectivecap | PP | |||
| Spring | StainlesssteelSUS304H | |||
| Slider | PP | Needle tube ,Hub ,Spring,Safety seat, Seal paper,Outer container, Safetyshield, Housing | Similar(Note 10) | |
| Protectivejacket | PP | |||
| Needlecontainer | PP | |||
| Lubricant | Silicon oil | |||
| Adhesive | UV glue | |||
| Seal | Medicaldialyzingpaper | |||
| Performance | Meet the requirements ofISO 7864, ISO 9626, ISO11608-2, ISO 23908 | Complied withISO 7864:2016ISO 9626:2016ISO 11608-1:2014ISO 11608-2:2012 | Similar(Note 11) | |
| Sterilization | EO SterilizationSAL:10-6 | EO SterilizationSAL: 10-6 | Same | |
| Biocompatibility | Meet the requirements ofISO10993 series standards,and the following tests areperformed: In vitrocytotoxicity, skinsensitization, intracutaneousreactivity, acute systemictoxicity, hemocompatibility,subchronic toxicity,particulate matter forinjections and pyrogen. | Conform with ISO 10993standards | Similar(Note 12) | |
| Reuse orsingle use | Single use | Single use | Same | |
| 510(k) Notification documents-Disposable Insulin Pen Needle | K221178 | |||
| Sharps injuryprotection feature | Meet the requirements ofsafe-lock guard activationand safety overriding/unlocking force afteractivation (triggeringperformance) as per ISO23908. | With safety feature | Same | |
| Label/Labeling | Complied with21 CFR part 801 | Complied with21 CFR part 801 | Same | |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
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Note 5: The shelf life of the predicate device B is 3 years. The shelf life of the subject device is 5 years according to the result of accelerated aging test by ASTM F88/F88M-2015, which will not affect the safety and effectiveness of the subject device.
Note 6: The method of activation for the safety mechanism is similar between the subject device and predicate device B. In fact, the structure of the safety mechanism is same, but the design of red slider (show the status of the activation) is opposite. Functionality of the safety mechanism has been verified by performing testing per ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Note 7: The design specifications of the safety mechanism is similar between the subject device and predicate device B. The color is the same. The dimensions and strength of the subject device is unknown. The design specifications of the safety mechanism of subject device can achieve the function of preventing needlesticks, which is proved by various performance testing.
Note 8: The outer diameter(gauge) and length of the subject device are covered by the predicate device B. The performance bench testing of the outer diameter(gauge) and length for subject device are demonstrated to meet the requirements of ISO 7864, ISO 9626 and ISO 11608-2.
Note 9: The wall type of the subject device are covered by the predicate device B. The predicate device B has extra-thin-walled type, which is a difference. The performance bench testing of the thin-walled for subject device are demonstrated to meet the requirements of ISO 9626. This difference does not impact safety and effectiveness.
Note 10: The configuration of the subject device is mostly the same as the predicate device B, just the name is different. The materials of subject device are common materials and widely used for Insulin Pen Needle in the market, such as stainless steel SUS304,
PP, silicon oil, UV glue and Medical dialyzing paper. The safety of materials is demonstrated with the biocompatibility of final product.
Note 11: There are some differences in standards cited for conformance. These differences do not raise new questions of safety and effectiveness.
Note 12: Subject Device has been tested for additional subchronic toxicity and particulate matter for injections compared to the predicate device A.
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8.Performance testing summary
| Items | Summary |
|---|---|
| Sterilization | Disposable Insulin Pen Needle is sterilized by EO gas andthe sterility assurance level (SAL) is 10⁻⁶. The process hasbeen validated according to ISO 11135: 2014 Sterilization ofhealth-care products – Ethylene oxide - Requirements for thedevelopment, validation and routine control of a sterilizationprocess for medical devices. The maximum EO residual thatremain on the device is less than 0.8mg, the maximum ECHresidual that remain on the device should be less than1.8mg according to ISO 10993-7:2008 Biological evaluationof medical devices - Part 7: Ethylene oxide sterilizationresiduals. |
| Product performance | After sterilization, Disposable Insulin Pen Needle meetscriteria specified in ISO 11608-2: 2012 Needle-basedinjection systems for medical use – Requirements and testmethods - Part 2: Needles; ISO 9626: 2016 Stainless steelneedle tubing for the manufacture of medical devices -Requirements and test methods; ISO 7864: 2016 Sterilehypodermic needles for single use - Requirements and testmethods and other applicable standards. |
| Functional compatibility withneedle-based injectionsystems | Selected the insulin pens of commonly used in the U.S.market for compatibility verification. The tests have beencompleted, the insulin pens which are declared in the labelare compatible with the needle. |
| Transport | The simulated transportation test has been completedaccording to the requirements of ASTM D4169-16Standard Practice for Performance Testing of ShippingContainers and Systems. Model CT and Model ST of theproducts are implemented simulated transportation test.The test result is passed. |
| Shelf life | The performance of ISO 11608-2, chemical properties,bacterial endotoxin and leakage test (according to ASTMF1929-2015) of Model CT and Model ST have been testedindividually before accelerated aging, after 4 years ofaccelerated aging and 5 years of accelerated aging.According to the accelerated aging test results, the shelflife of the product is determined to be 5 years. |
| Biocompatibility | Disposable Insulin Pen Needle meets the requirements ofISO 10993 series standards, and the following tests areperformed: Cytotoxicity, skin sensitization, intracutaneousreactivity, acute systemic toxicity, hemocompatibility,subchronic toxicity and material-mediated pyrogenicity.With the requirement of USP <788>, particulate matter forinjections also is performed. |
| Sharps protection features | Model ST product meets the requirements of safe-lockguard activation and safety overriding/unlocking force afteractivation(triggering performance) as per ISO 23908:2011Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermicneedles, introducers for catheters and needles used forblood sampling |
| Clinical simulated use testing | Model ST of Disposable Insulin Pen Needle is a sterile, single-use medical device with an integral sharps injury prevention feature, intended for use with pen injector device for subcutaneous injection of insulin. According to ISO 23908:2011 Sharps injury protection-Requirements and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling and Guidance for Industry and FDA Staff-Medical Devices with Sharps Injury Prevention Features, we have completed the test of clinical simulated use testing for sharps injury protection. The test results show that Model ST of the product has well sharps injury prevention feature. |
| The compatible pen injectors | 1. NovoPen Echo, K162602, Novo Nordisk Inc.2. Humapen Luxura, K142518, Eli Lilly and Company3. Humapen Luxura HD, K100988, Eli Lilly and Company4. HumanPen Ergo II, K151686, Eli Lilly and Company |
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510(k) Notification documents-Disposable Insulin Pen Needle
Conclusions
Based on device comparison information and non-clinical bench testing, the subject device is substantially equivalent to the predicate device.
§ 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).