(225 days)
Not Found
No
The device description and performance studies focus on the mechanical safety features of the syringe and do not mention any AI or ML components.
No.
The device is a syringe for insulin injection, which delivers a therapeutic substance but is not itself a therapeutic device. It is a delivery mechanism.
No
Explanation: The device is a syringe intended for injecting insulin, not for diagnosing any medical condition. Its function is to administer medication, which is a therapeutic action, not a diagnostic one.
No
The device description clearly describes a physical syringe with a needle and a safety feature, indicating it is a hardware device. There is no mention of software as the primary or sole component.
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 "injection of U-100 insulin into the body". This is a therapeutic action performed on the patient, not a test performed on a sample taken from the patient to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of a syringe designed for injection and safety features related to that injection. There is no mention of analyzing biological samples.
- Lack of IVD Keywords: The document does not contain keywords typically associated with IVDs, such as "in vitro," "diagnostic," "assay," "test," "sample," "analyte," etc.
- Performance Studies: The performance study described is a "Simulated Clinical Use" study evaluating the safety mechanism during injection, not a study evaluating the accuracy or performance of a diagnostic test.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This syringe is used to administer a substance into the body for treatment.
N/A
Intended Use / Indications for Use
The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
Product codes
FMF, MEG
Device Description
The Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10 ° and supplied in immediate package which could maintain the sterility of the device during the shelf life of 5 years.
The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1).
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
Adult and Pediatric
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)
Non-Clinical Testing:
The sterile single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical . devices- Requirements and methods
- ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test ● methods
- ISO 8537: 2016 Sterile single-use syringes, with or without needle, for insulin. ●
- ISO 23908- First edition: Sharps injury protection- Requirements and test methods-● Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Biocompatibility Testing:
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hours to 30days). The following testing was conducted:
- Cytotoxicity
- Sensitization ●
- Irritation or intracutaneous reactivity ●
- Acute systemic toxicity .
- Pyrogenicity .
- Hemocompatibility
- Subacute Systemic Toxicity .
Particulate Testing, USP
Sterility, Shipping and Shelf Life:
The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Safety Insulin Syringe is 5 years, determined based on stability studies which includes accelerated aging.
Sterilization and shelf life testing listed were performed on the proposed device.
| Item | Standard |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device. Shelf-Life of 5 years is validated using ASTM F1980-16 |
- Simulated transportation Test was conducted in accordance with ASTM D4169-16 used ● final packaged sterile device after accelerated aging, which were stored for 72 hours under the environment of temperature and humidity (-35 °C±2°C, 24 hours, 40°C±2°C, 90%RH±5%RH, 24 hours, 60°C±2°C, 24 hours).
- Sterile Barrier Packaging Testing performed on the proposed device: ●
- Visual Inspection in accordance with ASTM F1886 / F1886M-16 1
- Seal Strength in accordance with ASTM F88/F88M-15 .
- Dye Penetration in accordance with ASTM F1929-15 1
Simulated Clinical Use:
A simulated clinical use study was performed on 500 device samples for the safety insulin syringe according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
Clinical Testing:
No clinical study is included in this submission.
Key results: The proposed device is substantially equivalent to the predicate device based on performance testing data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
August 23, 2022
Berpu Medical Technology Co., Ltd. David Yu Management Representative No. 14 Xingji Road, Yongxiing Street Wenzhou. Zhejiang 325000 China
Re: K220061
Trade/Device Name: Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: July 26, 2022 Received: July 26, 2022
Dear David Yu:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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,
CAPT Alan 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) K220061
Device Name Safety Insulin Syringe
Indications for Use (Describe)
The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
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
K220061
510kSummary
I. Submitter
Berpu Medical Technology Co., Ltd. NO.14 Xingji Road, Yongxing Street, Longwan District, Wenzhou, Zhejiang, China 325000
Establishment Registration Number: 3004496829
Contact person: David Yu Position: Management representative Tel.: +86-18868131179 Fax: 0577-86630389 E-mail: 274269118@qq.com
Preparation date:
Proposed Device II.
| Trade Name of Device: | Safety Insulin Syringe |
|---|---|
| Common name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Regulatory Class: | Class II |
| Product code: | FMF, MEG |
| Review Panel | General Hospital |
III. Predicate Devices
Insulin Syringe with Safety Retractable
IV .Device description
The Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10 ° and supplied in
1
4
immediate package which could maintain the sterility of the device during the shelf life of 5 years.
The proposed syringes are available in different combination of syringe volumes and/or needle sizes (refer to Table 1).
| Syringe volume | Needle sizes | ||
|---|---|---|---|
| Needle length (mm) | Needle gauge | Wall | |
| 0.3ml | 4, 5, 6, 8, 9, 10, 12, | 30G, 31G, 32G, | RW |
| 0.5ml | 13 | 33G, 34G | TW |
| 1ml | ETW | ||
| 0.3ml | 4, 5, 6, 8, 9, 10, 12, | 26G, 27G, 28G, | RW |
| 0.5ml | 13 | 29G | TW |
| 1ml |
Table 1 specification of proposed device
V. Indication for use
| Characteristic | Proposed Device
Safety Insulin Syringe
K220061 | Predicate Device
Insulin Syringe with Safety Retractable
K202570 |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. | The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse |
Discussions of differences in Indications for Use statement
There are only editorial differences to the indications for use statement between the predicate and the subject device which do not change the indications.
VI. Comparison of technological characteristics with the predicate devices
The comparison and discussion between the subject device and the predicate devices are listed in below table 2:
| Item | Proposed device
(K220061) | Predicate device
(K202570) | Discussion |
|------|------------------------------|-------------------------------|------------|
| | | | |
| Table 2. Technological Characteristics | |
|---|---|
| ---------------------------------------- | -- |
5
| Prescription/ove
r-the-counter
| use | Prescription Use | Prescription Use | Same |
|---|---|---|---|
| Configuration | |||
| and material | 1) (1) needle cap | ||
| (Polypropylene) | 1) Needle Cap | ||
| (Polypropylene) | Same | ||
| 2) (2) needle tube (Stainless | |||
| Steel 304) | 2) Needle Tube | ||
| (SUS304) | Same | ||
| 3) (3) Rubber piston | |||
| (Polyisoprene Rubber) | 3) Plunger Stopper | ||
| (Polyisoprene | |||
| Rubber) | It's the same | ||
| component, | |||
| just with a | |||
| different | |||
| name | |||
| 4) barrel (Polypropylene) | 4) Barrel | ||
| (Polypropylene) | Same | ||
| 5) plunger (Polypropylene) | 5) Plunger | ||
| (Polypropylene) | Same | ||
| 6) Safety protector | |||
| (Polypropylene) | 6) Safety-shield | ||
| (Polypropylene) | It's the same | ||
| component, | |||
| just with a | |||
| different | |||
| name | |||
| 7) Fixed hub | |||
| (Polypropylene) | / | Different | |
| See comment | |||
| #1 | |||
| 8) end cap (Polypropylene) | / | ||
| 9) Lubricant | |||
| (Polydimethylsiloxane) | unknown | ||
| 10) Adhesive (UV Curing | |||
| Adhesive) | unknown | ||
| Size | 0.3ml, 0.5ml, 1ml | 0.5ml, 1ml | Different- |
| Needle Gauge | 26G to 34G | 27G to 31G | See comment |
| #2 | |||
| Needle Length | |||
| (mm) | 4, 5, 6, 8, 9, 10, 12, 13 | 1/2", 5/16", 1/4" | |
| Wall type | RW, TW, ETW | / |
6
| Needle
performance | ISO 9626
ISO 7864 | ISO 9626
ISO 7864 | Same |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Syringe
performance | ISO 8537 | ISO 8537 | Same |
| Safety feature
performance | The force to activate the
safety mechanism is less than
5N
The force that the safety
mechanism is destroyed is
greater than 20N | In-Safe mode force: not
be more than 5N
Resist force:
60s with 20N weights,
and the protective device
shall not be opened | Difference
See comment
3 |
| Intended user
population | Adult and Pediatric | Adult and Pediatric | Same |
Discussions of differences in technological characteristics
Comment# 1
The configurations and raw materials of Safety Insulin Syringe are different from predicate device. These differences do not raise new questions of safety or effectiveness. The biocompatibility for the subject device has been evaluated and the results comply with the requirements of ISO 10993.
Comment# 2
The needle gauge and length for proposed devices is different from the predicate devices. The differences do not raise new questions of safety or effectiveness.
Comment# 3
The Safety feature performance specification for predicate device is a little difference. The safety mechanism of proposed device is implemented by the upper and lower buckle of the vertical axis (After the injection is completed, manually pull the safety protector toward the needle tip until it cannot slide anymore, the protection mechanism is triggered, the safety protector can't return, and the needle tube is completely protected by the safety protector). while the safety mechanism of predicate device is implemented by the convex points of the vertical axis + horizontal axis. However, the safety feature performance test for proposed device has been evaluated and the test result conforms to requirements of ISO 23908:2011 standards. Therefore, the differences on configuration and materials does not affect substantially equivalence.
7
VII .Non-Clinical Testing
The sterile single lumen hypodermic needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical . devices- Requirements and methods
- ISO 7864:2016 Sterile hypodermic needles for single use-Requirements and test ● methods
- ISO 8537: 2016 Sterile single-use syringes, with or without needle, for insulin. ●
- ISO 23908- First edition: Sharps injury protection- Requirements and test methods-● Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Biocompatibility Testing:
In accordance with ISO 10993-1, the needle is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hours to 30days). The following testing was conducted:
- . Cytotoxicity
- Sensitization ●
- Irritation or intracutaneous reactivity ●
- Acute systemic toxicity .
- Pyrogenicity .
- . Hemocompatibility
- Subacute Systemic Toxicity .
Particulate Testing, USP
Sterility, Shipping and Shelf Life
The sterilization method has been validated per ISO 11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Safety Insulin Syringe is 5 years, determined based on stability studies which includes accelerated aging.
Sterilization and shelf life testing listed were performed on the proposed device.
| Item | Standard |
|---|---|
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests were |
| performed on aging samples to verify the claimed shelf | |
| life of the device. Shelf-Life of 5 years is validated | |
| using ASTM F1980-16 |
8
- Simulated transportation Test was conducted in accordance with ASTM D4169-16 used ● final packaged sterile device after accelerated aging, which were stored for 72 hours under the environment of temperature and humidity (-35 °C±2°C, 24 hours, 40°C±2°C, 90%RH±5%RH, 24 hours, 60°C±2°C, 24 hours).
- Sterile Barrier Packaging Testing performed on the proposed device: ●
- Visual Inspection in accordance with ASTM F1886 / F1886M-16 1
- Seal Strength in accordance with ASTM F88/F88M-15 .
- Dye Penetration in accordance with ASTM F1929-15 1
Simulated Clinical Use
A simulated clinical use study was performed on 500 device samples for the safety insulin syringe according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 and ISO 23908 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria.
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristics as the predicate device. Performance testing data demonstrates that the proposed device is substantially equivalent. Accordingly, the proposed device is substantially equivalent to the predicate device.