(181 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a disposable insulin syringe, with no mention of AI or ML capabilities.
No
The device is a syringe used for the subcutaneous injection of insulin, which is a drug for treating diabetes. While it aids in the delivery of a therapeutic drug, the device itself does not exert the therapeutic effect.
No
The device description clearly states its purpose is for "subcutaneous injection of U-40 insulin" and "subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes," indicating a therapeutic delivery function rather than a diagnostic one.
No
The device description clearly outlines physical components like a needle, barrel, plunger, etc., indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The described device is an insulin syringe. Its function is to deliver a substance (insulin) into the body. It does not analyze or examine any specimens taken from the body.
- Intended Use: The intended use is for "subcutaneous injection of U-40 insulin in the treatment of diabetes" and "subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes." This clearly describes a therapeutic delivery function, not a diagnostic one.
The device is a medical device, but it falls under the category of devices used for administering substances to the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The product is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Disposable Insulin Syringe is designed for subcutaneous injection of a desired dose of U-100 and U-40 insulin and has capacity of 0.3mL, 0.5mL, and 1.0mL. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, needle cap, plunger, piston, and plunger cap(only type A). The needle is a single ended lubricated stainless-steel cannula. The needle is covered by a polypropylene needle cap which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The piston is attached to the plunger and a Polypropylene plunger cap is placed over the plunger rod(only type A). All products are EO sterilized. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.
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
Not Found
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Disposable Insulin Syringe was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device - Blood path indirect" with a contact duration of Prolonged. The following tests were performed, as recommended:
- Cytotoxicity (ISO 10993-5: 2009)
- Skin sensitization (ISO 10993-10: 2010)
- Hemolysis (ISO 10993-4: 2017)
- Intradermal reactivity (ISO 10993-10: 2010)
- Acute systemic toxicity (ISO 10993-11: 2017)
- Subacute chronic toxicity (ISO 10993-11: 2017)
- Pyrogenicity (ISO 10993-11: 2017)
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Disposable Insulin Syringe is determined based on stability study which includes ageing test.
The testing is performed according to the following standards:
- ISO 11135:2014 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
- ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Performance testing
Performance testing is performed according to the following standards:
- ISO 7864:2016 Disposable Medical Safety Hypodermic Needles — Requirements and test methods
- ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
- ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin
- USP Particulate Matter in Injections
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
No cytotoxicity
No irritation reactivity
No significant evidence of skin sensitization
No significant evidence of systemic toxicity
No evidence of Hemolysis
No evidence of pyrogens
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
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 6, 2023
Hantech Medical Device Co., Ltd. Rachel Jin Consultant No 288, Sanheng Road Changhe Industridal Park, Cixi Ningbo, Zhejiang 315326 China
Re: K222672
Trade/Device Name: Disposable Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 7, 2023 Received: February 7, 2023
Dear Rachel Jin:
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 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
1
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,
Alan Sthe
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
2
Indications for Use
510(k) Number (if known) K222672
Device Name Disposable Insulin Syringe
Indications for Use (Describe)
The product is intended for subcutaneous injection of U-40 insulin in the treatment of diabetes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5 510(k) summary
l Submitter
Device submitter: Hantech Medical Device Co., Ltd. No 288, Sanheng Road Changhe Industridal Park, Cixi 315326, Ningbo PEOPLE'S REPUBLIC OF CHINA
Contact person: Name: Arnold Yang Title: Regulatory Affairs Manager Phone: +86 189 1736 8988 Fax: +86 574 5899 5557 E-mail: arnoldyang@hantechmedical.com
Date: 09/23/2022
II Device
Trade Name of Device: Disposable Insulin Syringe Common Name: Disposable Insulin Syringe Regulation Number: 21 CFR 880.5860 Classification: II Classification Name: Piston syringe Product code: FMF Review Panel: General Hospital
III Predicate Devices
| Trade name: | Insulin Syringe |
|---|---|
| Common name: | Insulin Syringe |
| Classification: | Class II, 21 CFR 880.5860 |
| Product Code: | FMF |
| Premarket Notification: | K193273 |
| Manufacturer: | Promisemed Hangzhou Meditech Co., Ltd. |
IV Device description
The Disposable Insulin Syringe is designed for subcutaneous injection of a desired dose of U-100 and U-40 insulin and has capacity of 0.3mL, 0.5mL, and 1.0mL. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, needle cap, plunger, piston, and plunger cap(only type A). The needle is a single ended lubricated stainless-steel cannula. The needle is covered by a polypropylene needle cap which is placed on the barrel. The barrel is
4
molded from polypropylene with the exterior permanently marked with the proper scale markings. The piston is attached to the plunger and a Polypropylene plunger cap is placed over the plunger rod(only type A). All products are EO sterilized. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years.
| Device | Needle length | Needle gauge | Type |
|---|---|---|---|
| Disposable Insulin Syringe | 4mm, 6mm, 8mm, 12mm, | 34G, 33G, 32G, 31G, 30G, 29G, 28G, 27G, | A |
| B |
V Indications for use
The product is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
VI Comparison of technological characteristics with the predicate devices
The Disposable Insulin Syringe has the same intended use, technology, and design as the predicate device and performance specifications are either identical or substantially equivalent to existing legally marketed predicate device. The differences between the Disposable Insulin Syringe and predicate device do not alter suitability of the proposed device for its intended use.
| Device
| feature | Subject Device | Predicate Device K193273 | Comments |
|---|---|---|---|
| Indications | |||
| for use | The product is intended for | ||
| subcutaneous injection of U- | |||
| 40 and U-100 insulin in the | |||
| treatment of diabetes. | Insulin Syringe is intended for | ||
| subcutaneous injection of U- | |||
| 40 and U-100 insulin in the | |||
| treatment of diabetes. | Same | ||
| Product code | FMF | FMF | Same |
| Regulation | |||
| number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | CLASS II | CLASS II | Same |
| Syringe Type | Piston syringe | Piston syringe | Same |
| Principle of | |||
| operation | The insulin is injected to | ||
| subcutaneous tissue by | |||
| pushing force generated | |||
| through pushing plunger rod | |||
| of the insulin syringe. | The insulin is injected to | ||
| subcutaneous tissue by | |||
| pushing force generated | |||
| through pushing plunger rod | |||
| of the insulin syringe. | Same | ||
| Specific drug | |||
| use | Insulin | Insulin | Same |
| Volume | 0.3ml, 0.5ml, 1.0ml | 0.3ml, 0.5ml, 1.0ml | Same |
| Needle | |||
| gauge | 27G, 28G, 29G, 30G, 31G, | ||
| 32G, 33G, 34G | 28G, 29G, 30G, 31G, 32G | Substantiall | |
| y equivalent | |||
| Device feature | Subject Device | Predicate Device K193273 | Comments |
| Needle Length | 4mm, 6mm, 8mm, 12mm | 6mm, 8mm, 12mm | Comment 1 |
| Needle dimensions | 0.18mm, 0.20mm, 0.23mm, | ||
| 0.25mm, 0.30mm, 0.33mm, | |||
| 0.36mm, 0.40mm | 0.23mm, 0.25mm, 0.30mm, | ||
| 0.33mm, 0.36mm | |||
| Needle tip configuration | 3 bevels | 3 bevels | Same |
| Numbering of scale | At every 5 units for the | ||
| 0.3mL and 0.5mL syringes, | |||
| and at every 5 units or | |||
| 10units for 1.0mL | At every five units for the | ||
| 0.3mL and 0.5mL syringes, | |||
| and at every 10units for | |||
| 1.0mL | Same | ||
| Gradations legibility | Legible | Legible | Same |
| Needle cover color | Red (U-40) and orange | ||
| (U-100) | Red (U-40) and orange | ||
| (U-100) | Same | ||
| Lubricant composition | Aminofuntional siloxane | Aminofuntional siloxane | Same |
| Lubricant amount/cm² | The lubricant is not form | ||
| pools of fluid on the interior | |||
| surface of the syringe or | |||
| outside surfaces of the | |||
| needle tube | The lubricant is not form | ||
| pools of fluid on the interior | |||
| surface of the syringe or | |||
| outside surfaces of the | |||
| needle tube | Same | ||
| Barrel transparency | Transparent | Transparent | Same |
| Reuse durability | Single Use | Single Use | Same |
| Hub/needle bond strength | >22N | >22N | Same |
| Configuration and Materials | Needle Stainless Steel (SUS304) | ||
| Barrel Polypropylene | |||
| Plunger Polypropylene | |||
| Piston Polyisoprene rubber | |||
| Needle cap Polypropylene | |||
| Plunger cap (only type A) Polypropylene | Needle Stainless Steel (SUS304) | ||
| Barrel Polypropylene | |||
| Plunger Polypropylene | |||
| Piston Polyisoprene rubber | |||
| Needle cap Polyethylene | |||
| Plunger cap (only type 8) Polyethylene | Substantially equivalent | ||
| Comment 2 | |||
| Sterilization | Sterilized by ethylene oxide | ||
| gas SAL = 10-6 | Sterilized by ethylene oxide | ||
| gas SAL = 10-6 | Same | ||
| Device | |||
| feature | Subject Device | Predicate Device K193273 | Comments |
| Biocompatibility | No cytotoxicity | No cytotoxicity | Same |
| No irritation reactivity | No irritation reactivity | ||
| No significant evidence of | |||
| skin sensitization | No significant evidence of | ||
| skin sensitization | |||
| No significant evidence of | |||
| systemic toxicity | No significant evidence of | ||
| systemic toxicity | |||
| No evidence of Hemolysis | No evidence of Hemolysis | ||
| No evidence of pyrogens | No evidence of pyrogens | ||
| Labeling | Meet the requirements of 21 | ||
| CFR Part 801 | Meet the requirements of 21 | ||
| CFR Part 801 | Same |
5
6
Discussion:
Comment 1
The subject device's needle gauge, needle length and Needle dimensions are different from the predicate device. This difference does not affect intended use. The differences on needle length and gauge does not raise new questions of safety and effectiveness. In addition, differences in needle length and gauge between the predicate and subject device were addressed through ISO 8537:2016 performance testing.
Comment 2
The materials of needle cap and protective end cap are different between the subject device and predicate device. This difference does not raise any new questions of safety and effectiveness. The biocompatibility test of the subject device was conducted to demonstrate that the subject device met the biocompatibility requirements.
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Disposable Insulin Syringe was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "External communication device
7
- Blood path indirect" with a contact duration of Prolonged. The following tests were performed, as recommended:
| Cytotoxicity | ISO 10993-5: 2009 |
|---|---|
| Skin sensitization | ISO 10993-10: 2010 |
| Hemolysis | ISO 10993-4: 2017 |
| Intradermal reactivity | ISO 10993-10: 2010 |
| Acute systemic toxicity | ISO 10993-11: 2017 |
| Subacute chronic toxicity | ISO 10993-11: 2017 |
| Pyrogenicity | ISO 10993-11: 2017 |
Sterilization and shelf life testing
The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Disposable Insulin Syringe is determined based on stability study which includes ageing test.
The testing is performed according to the following standards:
- △ ISO 11135:2014 Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices
-
ISO 10993-7:2008 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
- △ ISO 11607-1: 2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
-
ISO 11607-2: 2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
Performance testing
Performance testing is performed according to the following standards:
- △ ISO 7864:2016 Disposable Medical Safety Hypodermic Needles — Requirements and test methods
- A ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices
-
ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin
-
USP Particulate Matter in Injections
- Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston > Syringes
VIII Conclusion
8
The Disposable Insulin Syringe is substantially equivalent to its predicate device (Insulin Syringe). The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.