(129 days)
Not Found
No
The summary describes a mechanical pen injector for insulin delivery and does not mention any computational or data-driven features indicative of AI/ML. The performance studies focus on mechanical accuracy, biocompatibility, and shelf life, not algorithmic performance.
Yes
The device is used to administer insulin, which is a therapeutic intervention for diabetes. Therefore, the device itself, by facilitating this therapy, can be considered a therapeutic device.
No
The device is described as a pen injector for self-injection of insulin, which is a therapeutic delivery device, not a device used to diagnose a medical condition.
No
The device is a physical pen injector assembly designed for insulin delivery, explicitly mentioning hardware components like a 3 mL cartridge and a pen needle. It does not describe any software functionality as its primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Disposable Pen Injector Assembly is a device used to deliver a substance (insulin) into the body. It is a drug delivery device, not a diagnostic test.
- Intended Use: The intended use clearly states it's for "subcutaneous self-injection of a desired dose insulin." This is a therapeutic action, not a diagnostic one.
- Device Description: The description focuses on its mechanical function of injecting a dose of insulin.
- Performance Studies: The performance studies focus on aspects like biocompatibility, dose accuracy, shelf life, and transportation, which are relevant to a drug delivery device, not an IVD.
The device is a drug delivery device, specifically a pen injector for insulin.
N/A
Intended Use / Indications for Use
The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Disposable Pen Injector Assembly is a disposable single-patient use pen injector capable of injecting a dose of up to 80 units of insulin in 1 unit increments. The pen injector is intended for use with 3mL insulin cartridges and single-use, disposable insulin pen needles (supplied separately). After the intended insulin cartridge is used up, the Disposable Pen Injector Assembly should be disposed. The Disposable Pen Injector Assembly is intended for single user only and provided 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
general population.
Intended User / Care Setting
Home healthcare 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: The proposed device is categorized as skin contact with a duration of category A-limited (
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
August 15, 2024
Wuxi NEST Biotechnology Co., Ltd. % Ryan Li, Consultant ICAS Group No.155 Pingbei Road, Minhang District Shanghai, 201109, China
Re: K240961
Trade/Device Name: Disposable Pen Injector Assembly Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: July 16, 2024 Received: July 16, 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 (QS) 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
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Indications for Use
510(k) Number (if known) K240961
Device Name Disposable Pen Injector Assembly
Indications for Use (Describe)
The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population.
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 - K240961
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: Cheng Zhiwei Position: Registration Director Tel.: +86-0510-68006788-5021 Email: project01@nest-wuxi.com
Date of Preparation: August 12, 2024
II. Proposed Device
Device Trade Name: Disposable Pen Injector Assembly 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 Disposable Pen Injector Assembly is a disposable single-patient use pen injector capable of injecting a dose of up to 80 units of insulin in 1 unit increments. The pen injector is intended for use with 3mL insulin cartridges and single-use, disposable insulin pen needles (supplied separately). After the intended insulin cartridge is used up, the Disposable Pen Injector Assembly should be disposed. The Disposable Pen Injector Assembly is intended for single user only and provided non-sterile.
V. Indication for use
The Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 1 to up to 80 units in 1 unit increments. It is intended for general population.
VI. Comparison of technological characteristics with the predicate devices The following table summarizes the proposed device technological characteristics
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| Item | Proposed Device | Primary Predicate Device
(K182387) | Discussion |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Name | Disposable Pen Injector Assembly | 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 Disposable Pen Injector Assembly is a disposable pen injector designed for single patient use by diabetics for the subcutaneous self-injection of a desired dose insulin. The disposable pen injector assembly uses 3 mL cartridge of HUMALOGTM (U-100, insulin lispro for injection), and a single use detachable and disposable insulin pen needle (supplied separately). The pen injector allows the user to dial the desired dose up to 80 units in 1 unit increments. It is intended for general population. | 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 | Different
Note 1 |
| User Environment | Home healthcare environment | Home healthcare environment | Same |
| Reusable Device | No | Yes | Different
Note 2 |
| Compatible 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 3 |
| Maximum Delivered Dose | 80 Units | 30 Units | Different
Note 4 |
| Shelf Life | 5 years | 5 years | Same |
| Biocompatibility | Cytotoxicity
Skin Sensitization
Irritation | Unknown | Different
Note 5 |
| Sterility | Not a sterile device | Not a sterile device | Same |
with compared to the predicate device under K182387.
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Discussion
Note 1
The first difference in indications for use is that the proposed device is a disposable device while the predicate device is a reusable device. This difference does not affect the substantial equivalence because the risk of single use is lower compared to the multiple use risk of the predicate device. Another is the difference in maximum delivered dose and dial increments: The subject pen injector allows the user to dial the desired dose from 1 to up to 80 units in 1 unit increments, where the predicate pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 unit increments. The third difference is the intended insulin brand: The subject pen injector uses 3 mL cartridge of HUMALOG (U-100, insulin lispro for injection), where the predicate pen injector uses PenFill® 3 mL cartridge of NovoLog®, 100 units/mL (U-100) [insulin aspart injection] and Fiasp® 100 units/mL (U-100) [insulin aspart injection]. These differences do not affect the substantial equivalence because adequate performance of the subject device has been demonstrated by testing per ISO 11608-1: 2022.
Note 2
The proposed device is disposable while the predicate device is reusable. However, this difference does not affect the substantial equivalence because the risk of single use is lower compared to the multiple use risk of the predicate device.
Note 3
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 compliance with the ISO 11608-1: 2022 standard. Therefore, this difference would not affect the substantial equivalence.
Note 4
Although the maximum delivered dose between the proposed device and the predicate device is different, corresponding performance tests were conducted on the proposed device to demonstrate that its dose accuracy performance complies with the ISO 11608-1: 2022 standard. Therefore, this difference would not affect the substantial equivalence.
Note 5
The biocompatibility tests were conducted to demonstrate the proposed device's biological safety for its intended use. Therefore, this difference would not affect the substantial equivalence.
VII. Performance Data
Non-Clinical Performance Test Conclusion
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Biocompatibility
The proposed device, Disposable Pen Injector Assembly is categorized as skin contact with a duration of category A-limited (