(301 days)
The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
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.
(1) Insulin Syringe
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
(2) Insulin Syringe with Safety Retractable
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube, safety shield and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
1. Acceptance Criteria and Reported Device Performance:
The document outlines the acceptance criteria by stating that the device "conforms with the requirements of ISO 7864 and ISO 8537" for performance, safety, and effectiveness, and "conforms to the requirement of ISO 10993 series Standards" for biocompatibility.
For the "Insulin Syringe with Safety Retractable," additional performance criteria specifically related to the safety feature are provided:
| Acceptance Criteria (Safety Feature) | Reported Device Performance |
|---|---|
| In-Safe mode force: not be more than 5N | Test value: 3.45-4.45N |
| Resist force: 60s with 20N weights, and the protective device shall not be opened. | Test value: >20N/60s |
For the general Insulin Syringe and Insulin Syringe with Safety Retractable, the following criteria are implicitly met by conformance to the cited ISO standards. The "Reported Device Performance" column indicates that the device did conform to these standards.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Biocompatibility: No cytotoxicity, no irritation to skin, no significant evidence of sterilization, no systemic toxicity, no hemolysis, no pyrogen (based on ISO 10993 series) | Conforms to ISO 10993 series Standards |
| Performance, Safety & Effectiveness (general syringe functionality): Cleanliness, limits for acidity or alkalinity, limits for extractable metals, needle cap, tolerances on length, freedom from defects, lubricant, needle point, bond between hub and needle tube, patency of lumen, sharps injury protection (based on ISO 7864) | Conforms with ISO 7864 |
| Performance, Safety & Effectiveness (insulin syringe specific): Color coding, limits for acidity or alkalinity, limits for extractable metals, lubrication of syringes, lubrication of needle tube, barrel and plunger stopper, finger grips, fit of plunger stopper in barrel, position of nozzle on end of barrel, needle tubing for specific syringe types, bond between hub and needle tube, dead space, freedom from leakage at needle, freedom from leakage past plunger stopper (based on ISO 8537) | Conforms with ISO 8537 |
| Stainless Steel Needle Tubing: Dimensions, Stiffness, Resistance to breakage, Resistance to corrosion (based on ISO 9626) | Conforms with ISO 9626 |
| Particulate matter testing | Performed per USP <788>, Method 1 |
| ETO residuals | Performed per ISO 10993-7:2008 |
| Packaging and Shelf life testing | Performed per ASTM D4169-16, ASTM F1929-15:1998 ASTM F88:2009 |
| Risk Management Report | Available (implied conformance) |
| Sharps Injury Protection | Performed per ISO 23908 |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the non-clinical tests. It refers to standards like ISO 7864, ISO 8537, ISO 10993, ISO 9626, USP <788>, ASTM D4169, ASTM F1929, ASTM F88, and ISO 23908. These standards likely define the minimum sample sizes for relevant tests. The data provenance is implied to be from testing conducted by Jiangsu Micsafe Medical Technology Co., Ltd in China, as it is the submitting company. The studies are prospective in nature, as they involve testing the device to ensure it meets established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" in the context of clinical or diagnostic studies. The evaluation is focused on demonstrating conformance to established international and national standards for medical devices. Therefore, the "ground truth" is defined by the technical specifications and performance requirements outlined in these standards. The experts involved would be the engineers, scientists, and technicians conducting the tests and interpreting the results in accordance with these standards. Their qualifications would align with the specific tests performed (e.g., biocompatibility specialists, mechanical testing engineers).
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are objective measurements against predefined criteria in recognized standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device (insulin syringe) that does not involve "readers" or Artificial Intelligence (AI) for diagnostic or interpretive tasks. The studies are related to the physical performance, safety, and biocompatibility of the syringe itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The Type of Ground Truth Used:
The ground truth used for these studies is defined by the established technical specifications and performance requirements detailed in the referenced international (ISO) and national (ANSI AAMI, ASTM, USP) standards. These standards set the benchmarks for characteristics like biocompatibility, sterility, physical dimensions, material properties, and safety features.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of a physical medical device undergoing performance and safety testing. This document describes the testing of a finished product against established standards, not the training of a machine learning model.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device submission.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the agency's name and abbreviation.
October 5, 2022
Jiangsu Micsafe Medical Technology Co., Ltd Tony Yang General Manager Xituan Industrial Park, Dafeng District Yancheng, Jiangsu 224125 China
Re: K202570
Trade/Device Name: Insulin Syringe, Insulin Syringe with Safety Retractable Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: MEG, FMF
Dear Tony Yang:
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 July 2, 2021. Specifically, FDA is updating this SE Letter because it was unsigned as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact CAPT Alan Stevens, OHT3, at alan.stevens(@fda.hhs.gov.
Sincerely.
Alan M.
Stevens -S3
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
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Image /page/1/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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
July 2, 2021 Jiangsu Micsafe Medical Technology Co., Ltd Tony Yang General Manager Xituan Industrial Park, Dafeng District Yancheng, Jiangsu 224125 China
Re: K202570
Trade/Device Name: Insulin Syringe, Insulin Syringe with Safety Retractable Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF Dated: April 10, 2021 Received: June 4, 2021
Dear Tony 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
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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(@;tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration,
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below
510(k) Number (if known) K202570
Device Name
Insulin Syringe. Insulin Syringe with Safety Retractable
Indications for Use (Describe)
The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
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 risk of sharps injuries and the potential for insulin syringe reuse.
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)
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.
FORM FDA 3881 (6/20)
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Image /page/4/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in black, with the "i" in "Micsafe" being red. Below "Micsafe" is the text "med" in gray, and to the right of "Micsafe" is a registered trademark symbol.
K202570 510(k) Summary
(As required by 21 CFR 807.92(a))
Date Prepared: June 30, 2021
7.1 Submitter Information
- . Company: Jiangsu Micsafe Medical Technology Co., Ltd
- . Address: Xituan Industrial Park, Dafeng District, Yancheng City,
Jiangsu Province, 224125, China
- . Phone: 086-13651929266
- . Email: info@micsafe.com
- . Contact: Tony Yang, General Manager
7.2 Device Information
-
Trade/Device Name: Insulin Syringe
Insulin Syringe with Safety Retractable -
. Common Name: Syringe, Antistick Piston Syringe
-
. Classification:
Regulation Name: Piston Syringe
Regulation Number: 21 CFR 880.5860
Product Code: MEG and FMF
Device Class: II
Type of Use: Prescription use only
7.3 Predicate Device Information
U&U Insulin Syringe, U&U Insulin Syringe with Safety Retractable Device
510(k) Number: K152808
7.4 Device Description
(1) Insulin Syringe
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel,
plunger, plunger stopper, needle tube and needle cap.
Page 1 of 9
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Image /page/5/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in a bold, italicized font. Below "Micsafe" is the word "med" in a smaller, non-italicized font. To the right of "Micsafe" is the registered trademark symbol.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification:
Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24
h to 30 d).
Models:
| Barrel Item | Specification of Needle | Length of Needle | |
|---|---|---|---|
| Insulin Syringe | 0.3ml | 29G | 1/2" |
| 30G | 5/16" | ||
| 31G | 1/2" | ||
| 1/4" | |||
| 5/16" | |||
| 0.5ml | 28G | 1/2" | |
| 29G | 1/2" | ||
| 30G | 1/2" | ||
| 5/16" | |||
| 31G | 1/4" | ||
| 5/16" | |||
| 1ml | 27G | 1/2" | |
| 28G | 1/2" | ||
| 29G | 1/2" | ||
| 30G | 1/2" | ||
| 5/16" | |||
| 31G | 1/4" | ||
| 5/16" |
(2) Insulin Syringe with Safety Retractable
This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube, safety shield and needle cap.
The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years.
Product Contact Classification:
Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
Models:
| Insulin Syringe withSafety Retractable | Barrel Item | Specification of Needle | Length of Needle |
|---|---|---|---|
| 0.5ml | 28G | 1/2" | |
| 0.5ml | 29G | 1/2" |
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Image /page/6/Picture/0 description: The image shows the logo for Micsafe med. The logo consists of four squares, two red and two blue, arranged in a 2x2 grid. To the right of the squares is the text "Micsafe" in bold, black letters, with a small red dot above the "i". Above the "e" is a small circled R. Below "Micsafe" is the word "med" in a smaller font.
| 30G | 1/2" | ||
|---|---|---|---|
| 5/16" | |||
| 31G | 1/4" | ||
| 5/16" | |||
| 1ml | 27G | 1/2" | |
| 28G | |||
| 29G | |||
| 30G | |||
| 31G | |||
| 5/16" |
7.5 Indications for Use
(1) Insulin Syringe
The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
(2) Insulin Syringe with Safety Retractable
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.
7.6 Comparison of Technological Characteristics with the Predicate Device
- (1) Insulin Syringe
| ComparisonItem | Subject Device(K20257) | Predicate Device(K152808) | Remark |
|---|---|---|---|
| Identification | Insulin Syringe | U&U Insulin Syringe | |
| Classification | Product Code: MEG and FMFClass: II | Product Code: MEG and FMFClass: II | Same |
| Indications forUse | Indicated:The Insulin Syringe is asterile, single use andnon-reusable, insulinsyringe intended forinjection of U-100 | Indicated:The U&U insulinsyringe is a sterile,single use, disposableand non-reusable, insulinsyringe intended for | Same |
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Image /page/7/Picture/1 description: The image contains the logo for "Micsafe med". The logo consists of a square made of four smaller squares, with the top left and top right squares being red, and the bottom left and bottom right squares being blue. To the right of the square is the word "Micsafe" in bold, black letters, with a registered trademark symbol above the "e". Below "Micsafe" is the word "med" in a smaller, non-bold font.
| insulin into the body. | injection of U-100 insulin into the body. | ||
|---|---|---|---|
| Configuration | Needle Cap (PP) | Needle Sheath (PP) | Same |
| Needle Tube (SUS304) | Needle (Stainless Steel) | Same | |
| Plunger Stopper(Polyisoprene Rubber) | Piston (TPE) | Different(Comment #1) | |
| Barrel (PP) | Barrel (PP) | Same | |
| Plunger (PP) | Plunger (PP) | Same | |
| Size | 0.3cc/ml Needle 29G to31G | 0.3cc/ml Needle 27G to31G | Different(Comment #2) |
| 0.5cc/ml Needle 28G to31G | 0.5cc/ml Needle 27G to31G | ||
| 1cc/ml Needle 27G to31G | 1cc/ml Needle 27G to31G | ||
| Sterile | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Conforms to therequirement of ISO10993 series Standards | Conforms to therequirement of ISO10993 series Standards | Same |
| No cytotoxicity | No cytotoxicity | Same | |
| No irritation to skin | No irritation to skin | Same | |
| No significant evidenceof sterilization | No significant evidenceof sterilization | Same | |
| No systemic toxicity | No systemic toxicity | Same | |
| No hemolysis | No hemolysis | Same | |
| No pyrogen | No pyrogen | Same | |
| Performance | Conforms with the | Conforms with the | Same |
| Safety &Effectiveness | requirements of ISO7864 and ISO 8537 | requirements of ISO7864 and ISO 8537 |
Brief Summary
The subject device has identical classification with the predicate device and boasts the same indications for use with the predicate device.
The two devices enjoy similar technological characteristics, such as they are both sterile and for single use. Though they differ slightly in configuration and sizes, such differences have been further verified by FDA recognized standards – ISO 7864 and ISO 8537, which ensures that the subject device is safe and effective for usage. Such facts further support that two devices are substantial equivalent.
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Image /page/8/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top two squares being red and the bottom two squares being blue. To the right of the square is the text "Micsafe" in a bold, sans-serif font, with the "i" in "Micsafe" being red. Below "Micsafe" is the text "med" in a smaller, sans-serif font.
The biocompatibility of both devices has been ensured by relevant ISO 10993 standards, which ensures that the subject device will be as safe for use as the predicate device.
Comment #1
The difference between subject device and predicate device is the materials of plunger stopper. However, the biocompatibility test for the subject device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence on safety and effectiveness.
Comment #2
The needle gauge and length of between the subjective device and predicate device is different. However, the difference is just in dimension. Different gauge and length device will be selected by the end user. This difference does not affect raise new or different questions of safety or effectiveness.
| ComparisonItem | Subject Device(K202570) | Predicate Device(K152808) | Remark |
|---|---|---|---|
| Identification | Insulin Syringe withSafety Retractable | U&U Insulin Syringewith Safety RetractableDevice - | |
| Classification | Product Code: MEG andFMFClass: II | Product Code: MEG andFMFClass: II | Same |
| Indications forUse | Indicated:The Insulin Syringe withSafety Retractable is asterile, single use andnon-reusable, manualretractable safety insulinsyringe intended forinjection of U-100insulin into the body,while reducing the riskof sharps injuries andthe potential for insulinsyringe reuse. | Indicated:The U&U Insulin Syringewith Safety RetractableDevice a sterile, singleuse, disposable and non-reusable, manualretractable safety insulinsyringe intended forinjection of U-100 insulininto the body, whilereducing the risk of sharpsinjuries and the potentialfor insulin syringe reuse. | Same |
| Needle Cap (PP) | Needle Sheath (PP) | Same | |
| Materials | Needle Tube (SUS304) | Needle (Stainless Steel) | Same |
| Plunger Stopper(Polyisoprene Rubber) | Piston (TPE) | Different(Comment #1) | |
| Barrel (PP) | Barrel (PP) | Same | |
| Safety-shield (PP) | Needle Sheath (PP) | Same | |
| Plunger (PP) | Plunger (PP) | Same | |
| Size | 0.5cc/ml Needle 28G to31G1cc/ml Needle 27G to31G | 1cc/ml Needle 27G to 31G | |
| Sterile | Yes | ||
| Single Use | Yes | Yes | |
| Safety feature | Manual retractionIt is achieved by pushingthe safety device andthen rotating it. | Manual retractionIt is achieved by pushingthe safety device and thenrotating it. | |
| Safety FeaturePerformance | In-Safe mode force: notbe more than 5N | Test value:3.45-4.45N | |
| Resist force:60s with 20N weights,and the protective deviceshall not be opened. | Test value: >20N/60s | ||
| Biocompatibility | Conforms to therequirement of ISO10993 series Standards | ||
| No cytotoxicity | No cytotoxicity | ||
| No irritation to skin | No irritation to skin | ||
| No significant evidenceof sterilization | No significant evidence ofsterilization | ||
| No systemic toxicity | No systemic toxicity | Same | |
| No hemolysis | No hemolysis | Same | |
| No pyrogen | No pyrogen | Same | |
| PerformanceSafety &Effectiveness | Conforms with therequirements of ISO7864 and ISO 8537 | Conforms with therequirements of ISO 7864and ISO 8537 |
(2) Insulin Syringe with Safety Retractable
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Image /page/9/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in a bold, sans-serif font. Below "Micsafe" is the word "med" in a smaller font size.
Brief Summary
The subject device has identical classification with the predicate device and boasts the same indications for use with the predicate device.
The two devices have similar technological characteristics, such as they are both sterile and for
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Image /page/10/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square design on the left, followed by the text "Micsafe" in bold, black letters. Below "Micsafe" is the word "med" in a smaller, lighter font.
single use. Though they differ slightly in configuration and sizes, such differences have been further verified by FDA recognized standards – ISO 7864 and ISO 8537, which ensures that the subject device is safe and effective for usage. Such facts further support that the two devices are substantially equivalent.
The biocompatibility of both devices has been ensured by relevant ISO 10993 standards, which ensures that the subject device will be as safe for use as the predicate device.
Comment #1
The difference between subject device and predicate device is the materials of plunger stopper. However, the biocompatibility test for the subject device has been tested and the results comply with the requirements of ISO 10993. Therefore, this difference is not determined to affect substantial equivalence on safety and effectiveness.
Comment #2
The needle gauge and length between the subject device and predicate device is different. However, the difference is just in dimension. These differences were assessed by performance testing, and the difference does not raise new or different questions of safety or effectiveness.
7.7 Discussion of Test Performed
7.7.1 Clinical Tests
Clinical testing was not performed for the subject device as part of the submission.
7.7.2 Non-Clinical Tests
The subject device was tested/analyzed according to the following standards in order to ensure its effectiveness and safety:
- (1) Biocompatibility according to
- . ANSI AAMI ISO 10993-5:2009/(R)2014, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity;
- . ANSI AAMI ISO 10993-10:2010/(R)2014, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization;
- . ISO 10993-11: Third Edition 2017-09, Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity;
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Image /page/11/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a square made up of four smaller squares, with the top left and top right squares being red, and the bottom left and bottom right squares being blue. To the right of the square is the text "Micsafe" in bold, black letters, with a small "®" symbol in the upper right corner. Below "Micsafe" is the word "med" in a smaller, non-bold font.
- . ISO 10993-4: Third Edition 2017-04. Biological Evaluation Of Medical Devices - Part 4: Selection Of Tests For Interactions With Blood;
- . ASTM F756-17, Standard Practice For Assessment Of Hemolytic Properties Of Materials.
- (2) Performance safety and effectiveness according to ISO 7864 Fourth Edition 2016-08-01,
Sterile Hypodermic Needles For Single Use Requirements And Test Methods:
- . Cleanliness
- . Limits for acidity or alkalinity
- . Limits for extractable metals
- . Needle cap
- . Tolerances on length
- . Freedom from defects
- . Lubricant
- Needle point
- . Bond between hub and needle tube
- . Patency of lumen
- Sharps injury protection
- (3) Performance safety and effectiveness according to ISO 8537 Third Edition 2016-03-15,
Sterile Single-use Syringes, With Or Without Needle, For Insulin:
- Colour coding
- . Limits for acidity or alkalinity
- . Limits for extractable metals
- Lubrication of syringes
- . Lubrication of needle tube
- . Barrel and plunger stopper
- . Finger grips
- Fit of plunger stopper in barrel
- . Position of nozzle on end of barrel
- . Needle tubing for syringe types 5, 6,7, and 8
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Image /page/12/Picture/1 description: The image shows the logo for "Micsafe med". The logo consists of a red and blue square symbol on the left, followed by the text "Micsafe" in bold, black font. Below "Micsafe" is the word "med" in a smaller, lighter font. There is a registered trademark symbol to the right of the word "safe".
- Bond between hub and needle tube
- . Dead space
- . Freedom from leakage at needle
- . Freedom from leakage past plunger stopper
- (4) Performance safety and effectiveness according to ISO 9626 Second Edition 2016-08-01, Stainless Steel Needle Tubing for The Manufacture of Medical Devices - Requirements and Test Methods:
- . Dimensions
- Stiffness
- . Resistance to breakage
- . Resistance to corrosion
- (5) Particulate matter testing per USP <788>, Method 1
- (6) ETO residuals ISO 10993-7:2008
- (7) Packaging and Shelf life testing per ASTM D4169-16, ASTM F1929-15:1998 ASTM F88:2009
- (8) Additional performance safety and effectiveness for Insulin Syringe/ Insulin Syringe with
Safety Retractable:
- Risk Management Report
- Sharps Injury Protection Test Report to ISO 23908 First Edition 2011-06-11
7.8 Conclusion
Based on the comparison and analysis above and the performance testing conducted, the subject
device is determined to be Substantiality Equivalent (SE) to the predicate device.
§ 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).