(406 days)
No
The device description and performance studies focus on the mechanical and material properties of a standard insulin syringe, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or manages a disease. The insulin syringe is a delivery device for insulin, which is the therapeutic agent. The syringe itself does not treat diabetes; it only administers the treatment.
No
The device is an insulin syringe, used for administering medication (insulin), not for diagnosing a condition.
No
The device description clearly states it is a physical syringe made of plastic and silicone with a needle, intended for administering insulin. 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 insulin in the treatment of diabetes. This is a direct administration of a substance into the body for therapeutic purposes.
- Device Description: The device is a syringe designed to administer a substance. It's a delivery mechanism, not a tool for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This insulin syringe does not perform any such function.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
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)
Performance Testing: The Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin.
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. Tests include ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (Irritation and Sensitization), ISO 10993-11 (systemic toxicity), ISO 10993-4 (interactions with blood), ASTM F 756-17 (Hemolytic Properties), The United States Pharmacopeia (Pyrogen test), and The United States Pharmacopeia (Particulate matters).
Sterilization and Shelf-life Testing: Sterilization of the Insulin Syringes has been validated according to ISO 11135. Testing demonstrated maximum levels of residues of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in ISO 10993-7. Shelf-life testing supports a shelf life of 5-years after sterilization.
No prospective clinical trials were conducted. The results of the non-clinical testing supported the conclusion of substantial equivalence.
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).
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February 26, 2021
Promisemed Hangzhou Meditech Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town. Nanshan Shenzhen, Guangdong 518000 China
Re: K193273
Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF
Dear Christy Young:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 5, 2021. Specifically, FDA is updating this SE Letter (E.G., typo in manufacturer name) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Rumi Young, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 301-796-6005, Rumi. Young@fda.hhs.gov.
Sincerely. Digitally signed by Rumi Rumi Young -S Date: 2021.02.26 Young -S Date: 2021.02.2 Rumi Young Acting 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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is a circular seal with an emblem in the center. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 5, 2021
Prominsemed Hangzhou Meditech Co., Ltd. % Christy Young Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town. Nanshan Shenzhen, 518000 Cn
Re: K193273
Trade/Device Name: Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 14, 2020 Received: December 8, 2020
Dear Christy Young:
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
2
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).
Sincerely,
Rumi Young - Digitally signed by Rumi Young -S Date: 2021.01.05 09:58:10 -05'00'
Rumi Young Acting 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
3
Indications for Use
510(k) Number (if known) K193273
Device Name Insulin Syringe
Indications for Use (Describe)
Insulin Syringe 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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510(k) Summary
510(k) Number: K193273
1. Contact Details
1.1 Applicant information
| Applicant Name | Promisemed Hangzhou Meditech Co., Ltd. | ||
|---|---|---|---|
| Address | No. 12, Longtan Road, Cangqian Street, Yuhang District, Hangzhou City | ||
| 311121 Zhejiang, China. | |||
| Phone No. | + 86(0571)88772985 | ||
| Fax No. | + 86(0571)88772985 | ||
| Contact person | Liqing Yang | ||
| Date Prepared | October 12, 2020 |
1.2 Submission Correspondent
| Image: logo
卓远天成 | Shenzhen Joyantech Consulting Co., Ltd
1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town,
Nanshan District, Shenzhen, Guangdong Province, China. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone No. | +86-755-86069197 |
| Contact person | Joyce Yang; |
| Contact person's e-mail | joyce@cefda.com; cefda@foxmail.com |
| Website | http://www.cefda.com |
2. Device information
| Trade name | Insulin Syringe |
|---|---|
| Common name | Insulin Syringe |
| Model/Type | Type7, Type8 |
| Classification | II |
| Classification name | Piston syringe |
| Product code | FMF |
| Regulation No. | 21 CFR 880.5860 |
3. Legally Marketed Predicate Device
| Primary Predicate Device | |
|---|---|
| Trade Name | Disposable Insulin Syringes |
| 510(k) Number | K162180 |
| Product Code | FMF |
| Manufacturer | Berpu Medical Technology Co.,Ltd. |
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4. 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.
5. Intended Use/Indications for Use
Insulin Syringe is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes.
| Element of
comparison | Proposed Device:
Insulin Syringe | Predicate Device:
Disposable Insulin Syringe
(K162180) | Comment |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | FMF | FMF | Same |
| Regulation number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Syringe type | Piston syringe | Piston syringe | Same |
| Intended use | Insulin Syringe is intended for
subcutaneous injection of
U-40 and U-100 insulin in the
treatment of diabetes. | The disposable insulin
syringe is intended for
medical purposes for the
manual aspiration of U-100
insulin, and for the injection of
insulin into parts of the body
below the surface skin. | Similar
(Note1) |
| 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 |
| 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 | Similar
(Note2) |
| Needle gauge | 32G, 31G, 30G, 29G, 28G | 31G, 30G, 29G, 28G, 27G | Similar
(Note2) |
| Needle dimensions | 0.23mm,0.25mm, 0.30mm,
0.33mm, 0.36mm, | 0.25mm, 0.30mm, 0.33mm,
0.36mm, 0.40mm | Similar
(Note2) |
| Needle tip
configuration | 3 bevels
Primary bevel length:
(0.84±0.15) mm
Primary bevel angle: 10° ± 2° | 3 bevels | Same |
| Element of
comparison | Proposed Device:
Insulin Syringe | Predicate Device:
Disposable Insulin Syringe
(K162180) | Comment |
| | | | |
| | Secondary bevel length:
$(0.64±0.15)$ mm
Secondary bevel angle: 17°
$±2°$
(The secondary bevel is
rotated 35° $±2°$ to form 2
bevels) | | |
| 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) | Orange (U-100) | Similar
(Note 1) |
| 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 |
| 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 | Needle: Stainless Steel
(SUS304)
Barrel: Polypropylene (PP) | Similar
(Note3) |
| Element of
comparison | Proposed Device:
Insulin Syringe | Predicate Device:
Disposable Insulin Syringe
(K162180) | Comment |
| | Plunger: Polypropylene
Piston: Polyisoprene rubber
Needle cap: Polyethylene
Protective end cap(only type
8): Polyethylene | Plunger: Polypropylene (PP)
Piston: Polyisoprene Rubber
Needle cover: Polypropylene (PP)
Protective end cap:
Polypropylene (PP) | Same |
| Label | Device name, indication,
instruction for use,
precaution, warning, shelf life,
manufacturer | Device name, indication,
instruction for use,
precaution, warning, shelf life,
manufacturer | |
| Sterilization method
and SAL | Sterilized by ethylene oxide
gas SAL = 10-6 | Sterilized by ethylene oxide
gas SAL = 10-6 | |
| Sterilization
validation standard | ISO 11135 | ISO 11135 | |
6. Substantial Equivalence Comparison
6
7
lssue:
Note1: The subject device and predicate device have the same indication, that is, for insulin injection. The subject device has another type of syringe for injection of U-40 insulin. The sizes, graduated scale and tolerance on graduated capacity of U-40 insulin syringe are same as the U-100 insulin syringe. The difference between U-40 and U-100 insulin syringe is delivery different insulin concentration. For U-40 insulin syringe, a red needle cap is used for color marking in accordance with ISO 8573. In addition, the tolerance on graduated capacity has been validated per ISO 8573 Annex H. Therefore, this difference does not affect the Substantially Equivalent between the subject device and predicate device.
Note 2: The needle length of proposed device is covered by the predicate device.
The proposed device has extra 32G than the predicate device, and the 32G needle is similar the 31G in dimension. This difference does not affect intended use. In addition, the legally marketed similar device such as Safety Insulin Needle (K181447) has the same needle gauge.
The gauge (32G) for proposed device is different from the predicate device. However, this difference is just in dimension. Different gauge will be selected by physician per patient's condition. This difference does not affect intended use. Differences in needle length and gauge between the predicate and subject device were addressed through ISO 8537:2016 performance testing. Therefore, this difference does not affect substantially equivalence on safety and effectiveness.
Note 3: 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. So this difference does not raise any safety and effectiveness problems.
7. Non-clinical studies and tests performed
The Insulin Syringes have been designed and tested to meet the requirements of voluntary standards and FDA guidance documents applicable to the subject and predicate device. The results
8
of the non-clinical testing supported the conclusion of substantial equivalence.
Performance Testing
The Insulin Syringes have been designed and successfully tested to meet the applicable requirements outlined in ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin.
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)
The United States Pharmacopeia Particulate matters
Sterilization and Shelf-life Testing
Sterilization of the Insulin Syringes has been validated according to ISO 11135.Testing demonstrated maximum levels of residues of ethylene oxide and ethylene chlorohydrins do not exceed the limits presented in ISO 10993-7. Shelf-life testing supports a shelf life of 5-years after sterilization.
8. Clinical study
No prospective clinical trials were conducted in support of this 510(K).
9. Conclusion
Based on the comparison and analysis above, the proposed devices Insulin Syringes are determined to be Substantially Equivalent (SE) to the predicate devices.