(147 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a standard insulin syringe, with no mention of AI or ML technologies.
No
The device is an insulin syringe, used to administer insulin, but it does not inherently provide therapeutic effect itself. It's a delivery method for a therapeutic substance.
No
Explanation: The device is an insulin syringe used for injecting insulin, which is a therapeutic purpose, not for diagnosing conditions.
No
The device description clearly describes a physical syringe with a needle, plunger, and barrel, intended for manual injection of insulin. This is a hardware device, not software.
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 manual aspiration and injection of insulin into the body. This is a direct therapeutic intervention, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a syringe with a needle, designed for delivering a substance (insulin) into the body. This aligns with a medical device for drug delivery, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing a sample (blood, urine, tissue, etc.), detecting a substance or marker, or providing diagnostic information.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This insulin syringe does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
FMF
Device Description
The proposed device is a syringe with fixed needle tube which is intended for injection the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The insulin is injected to subcutaneous tissue by pushing force generated through pushing plunger rod of the insulin syringe. The proposed devices are provided sterile, single use.
The proposed device is available in 0.3ml, 0.5ml and 1ml volumes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface skin.
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test provided in this submission include: Physical, Mechanical and Chemical Tests performed on the proposed device, Sterile Barrier Packaging Testing performed on the proposed device, Sterilization and Shelf Life Testing performed on the proposed device, Biocompatibility Testing. No clinical study is included in this submission.
Key Metrics
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in a simple, black line drawing, and the text is also in black, creating a clean and professional look.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 29, 2016
Berpu Medical Technology Co., Ltd % Diana Hong Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120 CHINA
Re: K162180
Trade/Device Name: Disposable Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 28, 2016 Received: December 2, 2016
Dear Diana Hong:
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. 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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image shows a signature and the name Tina Kiang-S. The signature is a stylized design with loops and curves. The name is written in a simple, sans-serif font, with the first name above the last name.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162180
Device Name Disposable Insulin Syringe
Indications for Use (Describe)
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.
| 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)
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
Exhibit #2 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: __K162180
-
- Date of Preparation: 12/22/2016
-
- Sponsor Identification
Berpu Medical Technology Co., Ltd
No. 14 Xingji Road, Yongxing Street, Longwan District, 325000, Wenzhou, Zhejiang Province
Establishment Registration Number: 3004496829
Contact Person: Jundong Tan Position: Management Representative Tel: +86-577-86651999 Fax: +86-577-86630389 Email: BERPU@BERPU.COM
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: Disposable Insulin Syringe Common Name: Insulin syringe with needle
Regulatory Information
Classification Name: Syringe, Piston; Classification: II; Product Code: FMF Regulation Number: 21CFR 880.5860 Review Panel: General Hospital;
Indication for Use:
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.
Device Description
The proposed device is a syringe with fixed needle tube which is intended for injection the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The insulin is injected to subcutaneous tissue by pushing force generated through pushing plunger rod of the insulin syringe. The proposed devices are provided sterile, single use.
The proposed device is available in 0.3ml, 0.5ml and 1ml volumes.
-
- Identification of Predicate Device
510(k) Number: K072739 Product Name: Sterile Insulin Syringe for single use with fixed needle
- Identification of Predicate Device
Manufacturer: ShanDong Weigao Group Medical Polymer Products Co., Ltd
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test provided in this submission include:
5
Physical, Mechanical and Chemical Tests performed on the proposed device
| Materials | Clause 3 of ISO 9626:1991/AMD-1:2001 |
|---|---|
| Surface finish | Clause 4 of ISO 9626:1991/AMD-1:2001 |
| Cleanliness | Clause 5 of ISO 9626:1991/AMD-1:2001 |
| Limits for acidity and alkalinity | Clause 6 of ISO 9626:1991/AMD-1:2001 |
| Size designation | Clause 7 of ISO 9626:1991/AMD-1:2001 |
| Dimensions | Clause 8 of ISO 9626:1991/AMD-1:2001 |
| Stiffness | Clause 9 of ISO 9626:1991/AMD-1:2001 |
| Resistance to breakage | Clause 10 of ISO 9626:1991/AMD-1:2001 |
| Resistance to corrosion | Clause 11 of ISO 9626:1991/AMD-1:2001 |
| Cleanliness | Clause 4 of ISO 7864:1993 |
|---|---|
| Limits for acidity or alkalinity | Clause 5 of ISO 7864:1993 |
| Limits for extractable metals | Clause 6 of ISO 7864:1993 |
| Size designation | Clause 7 of ISO 7864:1993 |
| Colour coding | Clause 8 of ISO 7864:1993 |
| Needle hub | Clause 9 of ISO 7864:1993 |
| Sheath | Clause 10 of ISO 7864:1993 |
| Needle tube | Clause 11 of ISO 7864:1993 |
| Needle point | Clause 12 of ISO 7864:1993 |
| Performance | Clause 13 of ISO 7864:1993 |
| Freedom from extraneous matter | Clause 5 of ISO 8537:2007 |
|---|---|
| Limits for extraneous matter | Clause 6 of ISO 8537:2007 |
| Lubrication of syringes and needles | Clause 7 of ISO 8537:2007 |
| Range of size | Clause 8 of ISO 8537:2007 |
| Graduated scale | Clause 9 of ISO 8537:2007 |
| Barrel | Clause 10 of ISO 8537:2007 |
| Piston/plunger assembly | Clause 11 of ISO 8537:2007 |
| Needle tubing and needles | Clause 13 of ISO 8537:2007 |
| Performance of assembled syringe | Clause 14 of ISO 8537:2007 |
| Dose Accuracy testing | Clause 9.1 of ISO 8537:2007 |
Sterile Barrier Packaging Testing performed on the proposed device:
| Seal strength | ASTM F88/F88-09 |
|---|---|
| Internal pressure | ASTM F1140/F1140M-13 |
| Dye penetration | ASTM F 1929-12 |
6
Sterilization and Shelf Life Testing performed on the proposed device:
| SAL | 10-6 |
|---|---|
| Validation method | ISO 11135:2014 |
| EO residue | ISO 10993-7:2008 |
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 38-NF 33 |
| LAL Pyrogen Test | ISO 10993-11:2006 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package and Sterility |
| Tests were performed on accelerated aging samples to | |
| verify the claimed shelf life of the device |
Biocompatibility Testing
The patient-contact materials of Disposable Insulin Syringe are identified and biocompatibility testing is performed according to ISO 10993 standards
7. Clinical Test Conclusion
No clinical study is included in this submission.
7
Substantially Equivalent (SE) Comparison 8.
| Item | Proposed Device | Predicate Device
K072739 | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|------------------------|--|--|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Product Code | FMF | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation No. | 21CFR 880.5860 | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification | II | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Indication for Use | 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. | The sterile insulin syringe for single use with fixed needle 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 | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Configuration and Material | Configuration Material Protective end cap Polypropylene (PP) Plunger Polypropylene (PP) Barrel Polypropylene (PP) Piston Polyisoprene Rubber Needle Stainless Steel (SUS304) Needle cover Polypropylene (PP) | | | | | | | | | | | | | | | Configuration Material Protective end cap Polypropylene (PP) Plunger Polypropylene (PP) Barrel Polypropylene (PP) Piston Polyisoprene Rubber Needle Stainless Steel (SUS304) Needle cover Polypropylene (PP) | | | | | | | | | | | | | | |
| Syringe Volume | 0.3ml, 0.5ml, 1.0ml | 0.5ml, 1.0ml | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Needle Gauge | 31G, 30G, 29G, 28G, 27G | 30G, 29G, 28G | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Needle Diameter | 0.25mm, 0.30mm, 0.33mm,0.36mm, 0.40mm | 0.30mm, 0.33mm, 0.36mm | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Needle Length | 5mm, 6mm, 8mm, 12mm | Unknown | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Performance Test | Comply with
ISO 9626
ISO 7864
ISO 8536 | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Sterile | EO Sterilized | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Single Use | Single Use | Same | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Biocompatibility | Cytotoxicity No cytotoxicity Irritation No irritation reactivity Sensitization No significant evidence of skin sensitization Systemic Toxicity No significant evidence of systemic toxicity Hemolysis No evidence of hemolysis | | | | | | | | | | | Conform with ISO 10993 | | | | | | | | | | | | | | | | | | |
Table 1 Comparison of Technology Characteristics
8
| K162180 | S001 | E2 510(k) Summary |
|---|---|---|
| --------- | ------ | ------------------- |
| Pyrogen | No evidence of |
|---|---|
| pyrogens |
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.