(106 days)
No
The device description and performance studies focus on the physical characteristics and standard testing of a syringe, with no mention of AI or ML.
No
Explanation: An insulin syringe is used for administering medication (insulin), not for directly treating a disease or condition itself. It is a drug delivery device, not a therapeutic device.
No
An insulin syringe is used for administering a drug (insulin) to a patient, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical syringe made of plastic and silicone with an integrated needle, intended for subcutaneous injection. It is a hardware 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 "subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes." This describes a device used to administer a substance into the body, not to test a sample from the body.
- Device Description: The description details a syringe with a needle, designed for injection. This aligns with a device used for administering medication, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information.
IVD devices are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This insulin syringe does not fit that definition.
N/A
Intended Use / Indications for Use
Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
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 bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. The data are provided in submission, K193273.
Performance Testing:
The Insulin Syringes have been designed and successfully tested (relying on K193273 submission) to meet the applicable requirements outlined in ISO 8537, such as:
- Needle tube length;
- -Diameter of needle tube;
- Bond between hub and needle tube;
- -Needle points;
- -Freedom from defects;
- -Lubrication;
- -Fit of plunger stopper in barrel;
- -Dead space;
- -Freedom from leakage at needle;
- -Freedom from leakage past plunger stopper;
- -Tolerance on graduated capacity;
- -Limits for acidity or alkalinity;
- -Limits for extractable metals;
- -Fragmentation;
- -Penetration force ;
- -Particulate contamination;
Biocompatibility testing:
The material of the Insulin Syringes have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External communicating devices, Limited exposure.
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and Sensitization
ISO 10993-11: 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ISO 10993-4:2017 Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood.
ASTM F 756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
The United States Pharmacopeia (Pyrogen test), method of limulus amebocyte lysate [LAL].
Sterilization and Shelf-life Testing:
Sterilization of the Insulin Syringes has been validated according to ISO 11135 with half-cycle method.
Testing demonstrated maximum levels of residues of ethylene oxide (≤9mg/d) and ethylene chlorohydrins (≤4mg/d) met with the limits presented in ISO 10993-7. Shelf-life testing supports a shelf life of 5-years after sterilization.
Clinical study: No prospective clinical trials were conducted in support of this 510(K).
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 2023
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory affairs manager No. 1388 Cangxing Street, Cangqian Community, Yuhang District Hangzhou City, Zhejiang 311121 China
Re: K223453
Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: January 30, 2023 Received: January 30, 2023
Dear Zearou Yang:
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
1
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 (OS) 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 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,
Sincerely,
Alan St
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) K223453
Device Name Insulin Syringe
Indications for Use (Describe)
Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
1. Date Prepared
Feb. 24, 2023
2. Submitter's Information
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou City, 311121
Zhejiang, China
Contact Name: Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
3. Trade Name, Common Name, Classification
Trade/Product Name: Insulin Syringe
Common Name: Insulin Syringe
Classification name: Piston syringe
Regulation Number: 880.5680
Device Class: Class II
Product Code: FMF
4. Identification of Predicate Device K110421; Disposable Insulin Syringe
5. Description of the Device
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement. This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
4
6. Indications for use
Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
Similarities and Differences of the Proposed Devices to the Predicate Devices 7.
A detailed comparison to the predicate is provided in Table 1.
| Items | Subject Device
(K223453) | Predicate Device
(K110421) | Comments |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Insulin Syringe | Disposable Insulin
Syringe | |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Wen Zhou Wuzhou
Import & Export Co., Ltd. | |
| Device Class | Class II | Class II | Same |
| Product Code | FMF | FMF | Same |
| Regulation number | 880.5680 | 880.5680 | Same |
| Regulation Name | Piston syringe | Piston syringe | Same |
| Intended Use/
Indications for Use | Insulin Syringe is intended
for subcutaneous injection
of U-40 and U-100 insulin
in the treatment of
diabetes. | Disposable insulin syringe is a
device intended for medical
purposes for the manual
aspiration of insulin, and for
the injection of insulin into
parts of the body below the
surface skin. | Same |
| Type of use | Prescription use and over-
the-counter use | Over-the-counter use | Different.
- "Prescription use" of
subjective device has
been cleared with
K193273; - "Over-the-counter
use" is same with
Predicate device;
The difference of use type
does not impact safety
and effectiveness. |
| Operating
Principle | 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 |
| Length | 120mm | 120mm | Same |
| Volume | 0.3ml, 0.5ml, 1.0ml | 0.3ml, 0.5ml, 1.0ml | Same |
| Needle length | 6mm, 8mm,12mm | 5mm, 6mm, 8mm, 12mm | Different.
The needle length of
proposed device is covered
by the predicate device. |
| Needle gauge | 32G, 31G, 30G, 29G, 28G | 31G, 30G, 29G, 28G | Different.
Compared to the predicate
device, the proposed
device has an additional
32G model needle. 32G
model for insulin syringe |
| | | | 510(K) 223453
needle safety and
performance has been
confirmed by testing. This
difference does not raise
new questions of safety
and effectiveness. |
| Needle tip
configuration | 3 bevels | 3 bevels | Same |
| Nozzle type | Not applicable | Not applicable | Same |
| Numbering of
scale | At every five units for the
0.3mL and 0.5mL syringes,
and at every 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
dimensions | Length:25mm,
Diameter: 6mm | Length:25mm,
Diameter: 6mm | Same |
| Needle cover
color | Red (U-40) and orange
(U-100) | Red (U-40) and orange
(U-100) | Same |
| Lubricant
composition | Aminofunctional siloxane | Aminofunctional 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 |
| Needle cover
strength | 22N | >22N | Same |
| Biocompatibility | 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 | 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 | Same |
| Configuration
and Materials | Needle: Stainless Steel
(SUS304)
Barrel: Polypropylene
Plunger: Polypropylene
Piston: Polyisoprene
rubber
Needle cap: Polyethylene
Protective end cap (only
type 8): Polyethylene | Needle: Stainless Steel
(SUS304)
Barrel: Polypropylene (PP)
Plunger: Polypropylene (PP)
Piston: Polyisoprene Rubber
Needle cover: Polypropylene
(PP)
Protective end cap:
Polypropylene (PP) | Different.
The materials of needle
cap and protective end
cap are different
between the subject
device and predicate
device. The
biocompatibility test of
the subject device was
conducted to
demonstrate that the
subject device met the
biocompatibility
requirements. This
difference does not raise
any new safety and |
| | | | effectiveness questions. |
| Label | Device name,
indication, instruction
for use, precaution,
warning, shelf life,
manufacturer | Device name,
indication, instruction
for use, precaution,
warning, shelf life,
manufacturer | Same |
| Sterilization
method and SAL | Sterilized by ethylene
oxide gas SAL = 10-6 | Sterilized by ethylene
oxide gas SAL = 10-6 | Same |
| Sterilization method | EO Sterilization | EO Sterilization | Same |
| EO and ECH residues
testing | Conform ISO 10993-7 | Conform ISO 10993-7 | Same |
5
Insulin Syringe
510(k) 223453
6
Insulin Syringe
510(k) 223453
8. Performance Testing Summary
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. The data are provided in submission, K193273.
Performance Testing:
The Insulin Syringes have been designed and successfully tested (relying on K193273 submission) to meet the applicable requirements outlined in ISO 8537, such as:
- Needle tube length; -
- -Diameter of needle tube;
- Bond between hub and needle tube; -
- -Needle points;
- -Freedom from defects;
- -Lubrication;
- -Fit of plunger stopper in barrel;
- -Dead space;
- -Freedom from leakage at needle;
- -Freedom from leakage past plunger stopper;
- -Tolerance on graduated capacity;
- -Limits for acidity or alkalinity;
- -Limits for extractable metals;
- -Fragmentation;
- -Penetration force ;
- -Particulate contamination;
Biocompatibility testing:
The material of the Insulin Syringes have successfully passed testing as outlined in ISO 10993-1 for devices categorized as External communicating devices, Limited exposure.
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro
7
cytotoxicity
ISO 10993-10: 2010 Biological evaluation of medical devices Part 10: Test for Irritation and
Sensitization
ISO 10993-11: 2006 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
ISO 10993-4:2017 Biological evaluation of medical devices -Part 4: Selection of tests for interactions with blood.
ASTM F 756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
The United States Pharmacopeia (Pyrogen test), method of limulus amebocyte lysate [LAL].
Sterilization and Shelf-life Testing:
Sterilization of the Insulin Syringes has been validated according to ISO 11135 with half-cycle method.
Testing demonstrated maximum levels of residues of ethylene oxide (≤9mg/d) and ethylene chlorohydrins (≤4mg/d) met with the limits presented in ISO 10993-7. Shelf-life testing supports a shelf life of 5-years after sterilization.
Clinical study 9.
No prospective clinical trials were conducted in support of this 510(K).
10. Colorants
The colorant used in the needle cap was listed as below:
| Component | Color code | Colorant |
|---|---|---|
| Needle cap (U-100) | Orange | PE-M2766 |
| Needle cap (U-40) | Red | PE-M2282 |
11. Conclusion
Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device and is as safe, as effective and performs as well as the legally marketed predicate device.