(264 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML or data processing for decision making.
No.
The device is an insulin syringe designed for drug delivery, not for therapeutic action itself.
No
Explanation: The device is an insulin syringe designed for injection of insulin, which is a therapeutic function. It is not intended for the diagnosis of a disease or condition.
No
The device description clearly outlines multiple physical components (plunger, piston, barrel, needle, spring, etc.) and describes a mechanical function (needle retraction). It is a physical medical device, not software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the "injection of U-100 insulin into the body". This is a direct therapeutic intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a syringe designed for injecting medication and preventing needle sticks. This aligns with a medical device used for administering treatment, not for diagnostic testing.
- Anatomical Site: The anatomical site is "into the body," which is where the insulin is injected. IVDs typically interact with samples from the body (like blood, urine, tissue) rather than being inserted into the body for treatment.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Retractable Safety Insulin Syringe is a sterile, single use, disposable and non-reusable, automatically 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.
Product codes
MEG
Device Description
The Retractable Safety Insulin Syringe has the same technological characteristics as the Retractable Safety Syringe(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03. The difference between the Retractable Safety Insulin Syringe and the 1ml Retractable Safety Syringe is only the scale.
The Retractable Safety Insulin Syringe works like a conventional insulin syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
The Retractable Safety Insulin Syringe is available in various specifications. The proposed device consists of eleven components: (1) plunger. (2) piston. (3) barrel. (4) needle cap. (5) sealing plug. (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.
The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five 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
Home or Hospital
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization
Residuals - ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and A delayed-type hypersensitivity
- ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- USP Pyrogen Test
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
- ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- USP Bacterial Endotoxins Test
- ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method.
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devices-requirements and test method
- ISO 8537:2016 Sterile Single-use syringes, with or without needle ,for insulin
- ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
Simulated clinical study was not conducted on proposed device. No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Force to activation: not be more than 25N; test value 10.48-20.91
Force to move plunger: not be less than 70N; test value 83.67-116.97
Force to separate plunger lid: not be less than 20N; test value 25.14-32.67
Predicate Device(s)
Reference Device(s)
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 contains 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
July 20, 2020
Jiangsu Caina Medical Co.,Ltd. Xinyan Ruan Quality Engineer No.23, Huanxi Road, Zhutang Town Jiangyin, 214415 Cn
Re: K193022
Trade/Device Name: Retractable Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG Dated: June 18, 2020 Received: June 22, 2020
Dear Xinyan Ruan:
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 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,
For 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)
Device Name
Indications for Use (Describe)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Tab 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: K193022
-
- Date of Preparation: 04/29/2020
-
- Sponsor Identification
Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China
Establishment Registration Number: 3005670221
Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamed.com
-
- Designated Submission Correspondent
Mr. Jianwei pan (Primary Contact Person) Email: jianwei.pan@cainamed.com Ms. Xinyan Ruan (Alternative Contact Person) Email: sherry.ruan@cainamed.com Tel: +86-510-86866666-8027 Fax: +86-510-86866666-8009
- Designated Submission Correspondent
-
- Identification of Proposed Device
Trade Name: Retractable Safety Insulin Syringe
- Identification of Proposed Device
Regulatory Information Classification Name: Syringe, Anitstick Classification: II Product Code: MEG Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital
4
Indications for Use Statement:
The Retractable Safety Insulin Syringe is a sterile, single use, disposable and non-reusable, automatically 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.
ર. Device Description
The Retractable Safety Insulin Syringe has the same technological characteristics as the Retractable Safety Syringe(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03. The difference between the Retractable Safety Insulin Syringe and the 1ml Retractable Safety Syringe is only the scale.
The Retractable Safety Insulin Syringe works like a conventional insulin syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
The Retractable Safety Insulin Syringe is available in various specifications. The proposed device consists of eleven components: (1) plunger. (2) piston. (3) barrel. (4) needle cap. (5) sealing plug. (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.
The proposed device is provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
- న్. Identification of Predicate Device
Predicate Device 510(k) Number: K152808 Product Name: U&U Insulin Syringe with/without Safety Retractable Device
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 results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization
5
Residuals
-
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and A delayed-type hypersensitivity
-
ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
-
USP Pyrogen Test
-
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
-
ISO 10993-4:2017 Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood
-
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
-
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
- A ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
USP Bacterial Endotoxins Test
-
ISO 7864:2016 Sterile hypodermic needles for single use-requirements and test method.
- A ISO 9626:2016 Stainless steel needle tubing for the manufacture of the medical devices-requirements and test method
-
ISO 8537:2016 Sterile Single-use syringes, with or without needle ,for insulin
-
ISO 23908:2011 Sharps injury protection -- Requirements and test methods -- Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
The structure principle, safety function and operation method of the proposed devices are identical with Retractable Safety Syringes(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03.Simulated clinical study was not conducted on proposed device.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
-
- Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device
K152808 | Comment |
|-------------------|-----------------|-----------------------------|---------|
| Product code | MEG | MEG and FMF | Same |
| Regulation
No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
Table 1 Comparison of Technology Characteristics with K152808
6
| Class | II | II | Same |
|---|---|---|---|
| Indications | |||
| for use | The Retractable Safety | ||
| Insulin Syringe is a sterile, | |||
| single use, disposable and | |||
| non-reusable, automatically | |||
| 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. | The U&U Insulin Syringe | ||
| with Safety Retractable | |||
| Device a sterile, single use, | |||
| disposable 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. | |||
| The U&U insulin syringe is | |||
| a sterile, single use, | |||
| disposable and non-reusable, | |||
| insulin syringe intended for | |||
| injection of U-100 insulin | |||
| into the body. | Same | ||
| Configuration | Piston | ||
| Plunger | |||
| Barrel | |||
| Needle Hub | |||
| Needle | |||
| Safety feature | Piston | ||
| Plunger | |||
| Barrel | |||
| Needle Hub | |||
| Needle | |||
| Safety feature | Same | ||
| Sterility | |||
| condition | EO Sterilized | EO Sterilized | Same |
| Environment | |||
| of use | Home or Hospital | Home or Hospital | Same |
| Safety feature | |||
| principle | Spring retraction | manual retraction | See Comment 1 |
| Volume | 1ml | 1ml | Same |
| Needle gauge | 27-31G (0.25mm~0.40mm) | 27-31G | Same |
| Needle length | 8mm,10mm,13mm | Unknown | See Comment 2 |
| Single use | Yes | Yes | Same |
| Operation | |||
| mode | For Manual Use Only, For | ||
| Single Use only | For Manual Use Only, For | ||
| Single Use only | Same | ||
| Label/labeling | Complied with 21 CFR part | ||
| 801 | Complied with 21 CFR part | ||
| 801 | Same | ||
| Materials | PP, Polysoprene, TPE, | ||
| Stainless Steel, MABS and | PP,TPE,Stainless | ||
| Steel Silicone Oil | See Comment 3 | ||
| Polydimethysiloxane | |||
| Performance | |||
| Testing | Conform to: | Conform to: | Same |
| ISO 7864 | ISO 7864 | ||
| ISO 9626 | ISO 9626 | ||
| ISO 8537 | ISO 8537 | ||
| ISO 23908 | ISO 23908 | ||
| Force to activation: not be | |||
| more than 25N; | |||
| test value 10.48-20.91 | Test value 10.18-20.45N; | Same | |
| Force to move plunger: not | |||
| be less than 70N; | |||
| test value 83.67-116.97 | NA; | Comment 4 | |
| Safety Feature | |||
| Performance | Reuse prevention: | ||
| It is achieved through the | |||
| barrel barb and convex point | |||
| are stuck when the plunger is | |||
| pushed to the bottom. | Reuse prevention: | ||
| It is achieved through | |||
| pulling back the plunger and | |||
| snapped off. | |||
| Force to separate plunger | |||
| lid: not be less than 20N; | |||
| test value 25.14-32.67 | Test value 25.18-32.92N; | Same | |
| Biocompatibil | |||
| ity | Cytotoxicity | Conforms to ISO10993 | |
| (Part1:Evaluation and | |||
| testing, Part 4: Selection of | |||
| tests for interactions with | |||
| blood, Part 5: Tests for in | |||
| vitro cytotoxicity, Part 7: | |||
| Ethylene oxide sterilization | |||
| residuals,Part 10: Tests for | |||
| irritation and delayed-type | |||
| hypersensitivity, Part 11: | |||
| Tests for systemic toxicity) | |||
| Sensitization | |||
| Irritation | |||
| Acute systemic toxicity | |||
| Material mediated | |||
| pyrogenicity | |||
| Hemocompatibility | |||
| Subchronic toxicity | |||
| Particulate matters |
7
Comment 1
Differences in safety feature principle between the predicate and subject device were addressed through ISO 23908 Safety Feature Performance Test.The safety feature principle of subject devicer is identical with Retractable Safety Syringes(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03.
Comment 2
Differences in needle length between the predicate and subject device were addressed through ISO 8537 performance testing.
8
Comment 3
Differences in materials between the predicate and subject device were addressed through Biocompatibility Statement and copy of test report.
Comment 4
Differences in reuse prevention, for the predicate device this is achieved through pulling back the plunger and snapped off, for the proposed device a convex point is designed on the plunger and a barrel barb is designed in the barrel. When the plunger is pushed to the bottom, the barb and convex point are stuck, the plunger can not be re-moved to prevent reuse. At the same time, the front end of the slide bushing opens the barrel to release the needle hub and activate the safety function. Under the spring, the needle hub falls back into the plunger, and the needle tube is shielded inside the plunger. Force to re-move plunger have be tested in Safety Feature Performance Test Report, which is more than 70N. Proposed Device and Predicate Device are different designs, however performance demonstrated the differences do not raise any new safety concerns.
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 device.