(89 days)
Not Found
No
The device description and performance studies focus on mechanical function and standard biocompatibility/performance testing, with no mention of AI or ML.
Yes.
The device is designed for the self-injection of insulin, which is a therapeutic treatment for diabetes. It delivers a substance (insulin) that has a beneficial medical effect on the body.
No
The device is described as a "re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin." Its function is to deliver insulin, not to diagnose a condition.
No
The device description clearly outlines a mechanical pen injector with physical components like a body, push block, buttons, and a dose display window. The mechanism of action is described as mechanical, involving rotation of a knob and depression of a button to expel insulin. There is no mention of software as a component or function of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the self-injection of insulin by diabetics. This is a drug delivery device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a mechanical pen-injector for delivering a substance (insulin). It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, or any other biological specimen. There are no references to reagents, assays, or diagnostic results.
- Performance Studies: The performance studies focus on the mechanical function of the device (dose accuracy, injection force, shelf life, service life), not on the accuracy or reliability of a diagnostic test.
Therefore, this device falls under the category of a drug delivery device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pen Injector is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The Pen Injector uses HUMALOG (insulin lispro) injection (U-100) available in 3 mL cartridges, and a single use detachable and disposable insulin pen needle (supplied separately, needle sizes including: 32G4mm, 31G4mm, 31G5mm, and 31G6mm).
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Pen Injector is a reusable mechanical pen-injector capable of injecting a dose of up to 80 units of insulin, in 1 unit increments. The Pen Injector consists of a pen injector body, a push block, a injection button, a dose display window, a dose adjustment knob, a reservoir and a pen injector cap. The intended dose is mechanically set by rotating a dose adjustment knob. The insulin is injected by depressing the knob which mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The Pen Injector is intended for single user and provided for non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare facilities and home environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Test Conclusion:
Biocompatibility tests were conducted according to ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 to verify that the proposed devices are not adverse to human tissue.
Performance Testing: Device Verification Tests confirm that the Pen Injector meets the requirements of ISO 11608-1:2022. Dose accuracy, injection force and injection time performance tests were conducted with 3mL cartridges of HUMALOG (insulin lispro) injection (U-100) and compatible pen needles, meeting the requirements of ISO 11608-1:2022.
Shelf Life and Service Life: Aging studies were conducted in accordance with ASTM F1980-16 to verify a five-year shelf life. A service life verification test was conducted for 3000 times of reuse.
Simulated Transportation: A test was conducted according to ASTM D4169:2022 to demonstrate the device functions as intended after transportation.
Clinical Test Conclusion: No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
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June 18, 2024
Wuxi NEST Biotechnology Co., Ltd. % Ryan Li, Consultant ICAS Group No.155 Pingbei Road, Minhang District Shanghai, 201109, China
Re: K240774
Trade/Device Name: Pen Injector Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 19, 2024 Received: March 21, 2024
Dear Ryan 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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Shruti N. Mistry -S
Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240774
Device Name Pen Injector
Indications for Use (Describe)
The Pen Injector is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The Pen Injector uses HUMALOG (insulin lispro) injection (U-100) available in 3 mL cartridges, and a single use detachable and disposable insulin pen needle (supplied separately, needle sizes including: 32G4mm, 31G4mm, 31G5mm, and 31G6mm).
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K240774
I. Submitter Information
Submitter Name: Wuxi NEST Biotechnology Co., Ltd. Submitter Address: No. 530, Xida Road, Meicun Industrial Park, Xinwu District, Wuxi, Jiangsu, China Contact Person: Ryan Li Position: Consultant Tel.: + 86 13701581791 Email: IryryanO211@gmail.com Date of Preparation: May 22, 2024
II. Proposed Device
Device Trade Name: Pen Injector Common Name: Pen-injector Classification Name: Piston Syringe Regulation Number: 21 CFR 880.5860 Regulatory Class: Class II Product Code: FMF Review Panel: General Hospital
III. Predicate Device
Primary predicate device 510(k) Number: K182387 Trade Name: NovoPen Echo®
IV. Device Description
The Pen Injector is a reusable mechanical pen-injector capable of injecting a dose of up to 80 units of insulin, in 1 unit increments. The Pen Injector consists of a pen injector body, a push block, a injection button, a dose display window, a dose adjustment knob, a reservoir and a pen injector cap. The intended dose is mechanically set by rotating a dose adjustment knob. The insulin is injected by depressing the knob which mechanical coupling causes the piston in the insulin cartridge to move forward thereby expelling the intended dose. The Pen Injector is intended for single user and provided for non-sterile.
V. Indication for use
The Pen Injector is a re-usable pen injector designed for single patient use by diabetics for the self-injection of a desired dose of insulin. The Pen Injector uses HUMALOG (insulin lispro) injection (U-100) available in 3 mL cartridges, and a single use detachable and disposable insulin pen needle (supplied separately, needle sizes including: 32G4mm, 31G4mm, 31G5mm, and 31G6mm).
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VI. Comparison of technological characteristics with the predicate devices
Table 1 summarizes the proposed device technological characteristics with compared to the predicate device under K182387.
| Item | Proposed Device | Primary Predicate Device
(K182387) | Discussion |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Product Name | Pen Injector | NovoPen Echo® | N/A |
| Product Code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | Class II | Class II | Same |
| Indications for Use | The Pen Injector is a re-usable
pen injector designed for single
patient use by diabetics for the
self-injection of a desired dose
of insulin. The Pen Injector
uses HUMALOG (insulin
lispro) injection (U-100)
available in 3 mL cartridges,
and a single use detachable and
disposable insulin pen needle
(supplied separately, needle
sizes including: 32G4mm,
31G4mm, 31G5mm, and
31G6mm). | The NovoPen Echo® is a
re-useable pen injector
designed for single patient use
by diabetics for the
self-injection of a desired
dose of insulin. The pen
injector uses PenFill® 3 mL
cartridge of NovoLog®, 100
units/mL (U-100) [insulin
aspart injection], Fiasp® 100
units/mL (U-100) [insulin
aspart injection], and a single
use detachable and disposable
pen needle (supplied
separately). The pen injector
allows the user to dial the
desired dose from 0.5 to 30
units in 0.5 unit
increments | Same |
| User
Environment | Professional healthcare
facilities and home
environment | Unknown | Different
Note 1 |
| Reusable Device | Yes | Yes | Same |
| Cartridge
Volume | 3 mL (300 units of U-100
insulin) | 3 mL (300 units of U-100
insulin) | Same |
| Dose Accuracy | Meets ISO 11608-1:2022
requirements | Meets ISO 11608-1:2014
requirements | Same |
| Dial Increments | 0.01 mL per increment
providing one unit (1U) dose
increments | 0.005 mL per increment
providing half unit (0.5U)
dose increments | Different
Note 2 |
| Maximum
Delivered Dose | 80 Units | 30 Units | Different
Note 3 |
| Shelf Life | 5 years | 5 years | Same |
| Service Life | 3,000 times of reuse | Unknown | Different |
| | | | Note 4 |
| Biocompatibility | Cytotoxicity
Skin Sensitization
Irritation | Unknown | Different
Note 5 |
| Sterility | Not a sterile device | Not a sterile device | Same |
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Discussion
Note 1
The user environment for the predicate device is unknown. However, this does not raise different questions of safety and effectiveness as both device are prescription use devices.
Note 2
Although the dial increments between the proposed device and the predicate device are different, corresponding performance tests were conducted on the proposed device to demonstrate its comply with the ISO 11608-1 standard. Therefore, this difference would not affect the substantial equivalence.
Note 3
Although the maximum delivered dose between the proposed device and the predicate device are different, corresponding performance tests were conducted on the proposed device to demonstrate the dose accuracy performance comply with the ISO 11608-1 standard. Therefore, this difference would not affect the substantial equivalence.
Note 4
A service life verification test was conducted to demonstrate that the proposed device is valid during its service life. Therefore, this difference would not affect the substantial equivalence.
Note 5
The biocompatibility tests were conducted to demonstrate the proposed device is biocompatible with intended users. Therefore, this difference would not affect the substantial equivalence.
VII. Performance Data
Non-Clinical Performance Test Conclusion
Biocompatibility
The proposed device, Pen Injector is categorized as skin contact with a duration of category A-limited(≤24hrs) according to FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process". The Biocompatibility tests were conducted to verify that the proposed devices are not adverse to human tissue based on the following standards:
- ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation .
6
and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for ● in vitro cytotoxicity
- ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization
- ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests ● for irritation
Performance Testing
Device Verification Tests confirm that the Pen Injector meets the requirements of ISO 11608-1:2022 Needle-based injection systems for medical use - Requirement and test methods - Part 1: Needle-based injection systems.
The Pen Injector is intended to be used with 3mL cartridges of HUMALOG (insulin lispro) injection (U-100). Therefore, the dose accuracy, injection force and injection time performance tests of the 3mL cartridges of HUMALOG (insulin lispro) injection (U-100) with Pen Injector was performed which meets the requirements of ISO 11608-1:2022. In addition, corresponding tests are conducted between the Pen Injector and the compatible pen needles to demonstrate the compatibility.
Shelf Life and Service Life
The Pen Injector has a five-year shelf life, as well as 3000 times of reuse service life. For shelf life, in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify a five-year shelf life of the proposed device and ensure that its functionality is successfully maintained throughout the duration of this shelf life. In addition, a service life verification test was conducted on the proposed device to ensure its validity within its service life.
Simulated Transportation
A test is conducted according to ASTM D4169:2022 to demonstrate the proposed device could function as intended after transportation.
Clinical Test Conclusion
No clinical study is included in this submission.
VIII. Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the proposed device, Pen Injector is as safe, as effective, and performs as well as the legally marketed predicate device NovoPen Echo® (K182387).