(168 days)
The Sterile Safety Insulin Syringes For Single Use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.
KDL Sterile safety insulin syringes have a sliding sleeve which is designed to shield the injection needle to protect the user from needle puncture and the sliding sleeve helps protect against needle puncture once activated. The sliding sleeve can be activated manually.
The provided text is a 510(k) summary for a medical device (Sterile Safety Insulin Syringes for Single Use) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in the format requested.
The document outlines conformity to various ISO standards and other regulatory requirements but does not detail a specific study with an acceptance criteria table, sample sizes for test/training sets, expert qualifications, or MRMC study results as one might expect for a diagnostic AI/imaging device. Instead, it describes a series of non-clinical tests to verify design specifications and compliance with recognized standards.
Therefore, many sections of your request cannot be directly answered from the provided text.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document lists several ISO standards that the device "complies with" or "conforms to." These standards inherently contain acceptance criteria, and the statement of compliance/conformance indicates that the device met these criteria. However, specific numerical acceptance criteria and reported device performance values are not explicitly stated in a consolidated table format in this document. Instead, compliance with the standard is the reported performance.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ISO 8537:2016 (Sterile single-use syringes, with or without needle, for insulin) | Conforms to ISO 8537 |
| ISO 7864:2016 (Sterile hypodermic needles for single use-Requirements and test method) | Conforms to ISO 7864 |
| ISO 9626:2016 (Stainless steel needle tubing for medical device-Requirements and test method) | Conforms to ISO 9626 |
| ISO 23908:2011 (Sharps Injury Protection-Requirements and test methods) | Conforms to ISO 23908 |
| ISO 10993-1:2018 (Biological evaluation - Part 1: Evaluation and testing) | Complies with ISO 10993-1 |
| ISO 10993-4:2017 (Biological evaluation - Part 4: Interactions with blood) | Complies with ISO 10993-4 |
| ISO 10993-5:2009 (Biological evaluation - Part 5: In vitro cytotoxicity) | Complies with ISO 10993-5 |
| ISO 10993-7:2008 (Biological evaluation - Part 7: Ethylene oxide sterilization residuals) | Complies with ISO 10993-7 |
| ISO 10993-10:2010 (Biological evaluation - Part 10: Irritation and skin sensitization) | Complies with ISO 10993-10 |
| ISO 10993-11:2017 (Biological evaluation - Part 11: Systemic toxicity) | Complies with ISO 10993-11 |
| USP <788> (Particulate Matter for injection) | Conforms to USP <788> |
| Labeling requirements of 21 CFR Part 801 | Meets the requirements of 21 CFR Part 801 |
2. Sample size used for the test set and the data provenance
The document states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." However, specific sample sizes for these tests are not provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally relevant for studies involving human interpretation or subjective assessment, particularly in AI or imaging diagnostics. For a non-clinical device like a syringe, "ground truth" is established through physical and chemical testing against defined standards. Therefore, this information is not applicable and not provided in the document.
4. Adjudication method for the test set
Similarly, adjudication methods (e.g., 2+1, 3+1) are common in studies where multiple human readers interpret data that is then arbitrated. This is not applicable to the non-clinical testing of a syringe and therefore not provided.
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
An MRMC study is relevant for evaluating the impact of AI assistance on human performance, typically in diagnostic tasks. This document describes a physical medical device (syringe) and its non-clinical testing. Therefore, an MRMC comparative effectiveness study is not applicable and not performed/reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is also related to AI algorithm performance. As this document concerns a physical syringe, a standalone algorithm performance study is not applicable and not performed/reported. The non-clinical tests served as the "standalone" evaluation of the device's physical properties.
7. The type of ground truth used
For this device, the "ground truth" used for testing would be the specifications and requirements defined by the various ISO standards and USP <788>. This includes physical dimensions, material properties, sterility, particulate matter limits, and biocompatibility criteria.
8. The sample size for the training set
This question is relevant for AI/machine learning models. For the non-clinical testing of a physical medical device, there is no "training set" in the AI sense. This information is not applicable and not provided.
9. How the ground truth for the training set was established
Again, this is relevant for AI/machine learning. For this device's non-clinical testing, there is no training set. The "ground truth" for evaluating the device's conformance to standards is established by the scientific and regulatory consensus embodied in the ISO standards and USP monographs themselves. This information is not applicable and not provided.
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July 11, 2022
Shanghai Kindly Enterprise Development Group Co., Ltd. % Amy Li Technical Director Shanghai Mind-link Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai, 200040 China
Re: K220185
Trade/Device Name: Sterile Safety Insulin Syringes for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMI Dated: June 10, 2022 Received: June 13, 2022
Dear Amy Li:
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan M. 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
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Indications for Use
510(k) Number (if known) K220185
Device Name Sterile Safety Insulin Syringes For Single Use
Indications for Use (Describe)
The Sterile Safety Insulin Syringes For Single Use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.
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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This 510(k) summary is being submitted in accordance with the requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K220185
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- Date of preparation: July 8, 2022
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- Sponsor Identification
Shanghai Kindly Enterprise Development Group Co., Ltd. 658 Gaochao Road, Shanghai, 201803, China
Contact Person: Hualong Liu Position: Technology Director Tel: +86 02169118232 Email: henry liu@kdlchina.net
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- Designated submission correspondent
Ms.Amy Li (Primary Contact Person) Mind-Link Consulting Co., Ltd. Tel: +86 15721449974 Email: amy.li@mind-link.net
- Designated submission correspondent
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- Identification of Proposed Device
Trade Name: Sterile safety insulin syringes for single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Regulation Number: 21 CFR 880.5860 Review Panel: General hospital
- Identification of Proposed Device
-
- Indication for use statement
The Sterile Safety Insulin Syringes for single use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.
- Indication for use statement
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6. Device description
KDL Sterile safety insulin syringes have a sliding sleeve which is designed to shield the injection needle to protect the user from needle puncture and the sliding sleeve helps protect against needle puncture once activated. The sliding sleeve can be activated manually.
Models of Sterile safety insulin syringes for single use shown in Table 1-1 are available in various models according to different insulin concentration and syringe volume.
| Syringevolume(ml) | Insulinconcentration | Needlegauge(G) | Needlelength(mm) | Needle walltype | Bevel |
|---|---|---|---|---|---|
| 0.5ml | U40 | 27G | 13 | RW | 11°±2° |
| 28G | 13 | RW | 11°±2° | ||
| 29G | 13 | RW | 11°±2° | ||
| 30G | 8、13 | TW | 11°±2° | ||
| 31G | 6、8 | TW | 11°±2° | ||
| 0.5ml | U100 | 27G | 13 | RW | 11°±2° |
| 28G | 13 | RW | 11°±2° | ||
| 29G | 13 | RW | 11°±2° | ||
| 30G | 8、13 | TW | 11°±2° | ||
| 31G | 6、8 | TW | 11°±2° | ||
| 1ml | U40 | 27G | 13 | RW | 11°±2° |
| 28G | 13 | RW | 11°±2° | ||
| 29G | 13 | RW | 11°±2° | ||
| 30G | 8、13 | TW | 11°±2° | ||
| 31G | 6、8 | TW | 11°±2° | ||
| 1ml | U100 | 27G | 13 | RW | 11°±2° |
| 28G | 13 | RW | 11°±2° | ||
| 29G | 13 | RW | 11°±2° | ||
| 30G | 8、13 | TW | 11°±2° | ||
| 31G | 6、8 | TW | 11°±2° |
Table 1-1 Models of Sterile safety insulin syringes for single use
7. Identification of predicate device
510(k) Number: K191639 Product name: TK Insulin Syringe with/without Safety Retractable Device
8. 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:
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ISO 8537: 2016 Third edition, Sterile single-use syringes, with or without needle, for A insulin.
ISO 7864:2016 Fourth edition, Sterile hypodermic needles for single use-Requirements and test method.
ISO 9626:2016 Second edition 2016-08-01 Stainless steel needle tubing for A manufacture of medical device-Requirements and test method.
ISO 23908:2011 First edition 2011-06-11 Sharps Injury Protection- Requirements A and test methods-Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury A Prevention Features
ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation A and testing within a risk management process
A ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro A cytotoxicity
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for A irritation and skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for A systemic toxicity
USP <788>: Particulate Matter for injection A
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- Clinical test conclusion
No clinical study is included in this submission.
- Clinical test conclusion
- Substantially Equivalent(SE) comparison
| Items | Proposed device | Predicate deviceK191639 | Comment |
|---|---|---|---|
| Produce name | Sterile safety insulin syringesfor single use | TK Insulin Syringewith/without SafetyRetractable Device | Same |
| Product code | MEG, FMF,FMI | MEG, FMF | Same |
| Regulation number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | Class II | Class II | Same |
| Intended use | The Sterile Safety Insulin Syringes for Single Use aresterile, single-use, disposable, | The TK Insulin Syringewith Safety RetractableDevice is a sterile, single-use, | Different.Pleaserefer to |
| non-reusable and manuallyretractable safety insulinsyringes intended for injectionof insulin into the body. Thesliding sleeve helps protectagainst needle puncture onceactivated | disposable and non-reusable, manualretractable safetyinsulin syringe intended forinjection of U-100 insulin intothe body, while reducing therisk of sharps injuries andthe potential for insulinsyringe reuse.The TK Insulin Syringe is asterile, single-use, disposableand non-reusable, insulinsyringe intended for injectionof U-100 insulin into thebody. | Analysis 1. | |
| Principle of Operation | Normal. | Normal. | Same |
| Syringe Capacity | 1ml Needle 27Gx1/2"1ml Needle 28Gx1/2"1ml Needle 29Gx1/2"1ml Needle 30Gx1/2"1ml Needle 30Gx5/16"1ml Needle 31Gx5/16"1ml Needle 31Gx15/64"0.5ml Needle 27Gx1/2"0.5ml Needle 28Gx1/2"0.5ml Needle 29Gx1/2"0.5ml Needle 30Gx1/2"0.5ml Needle 30Gx5/16"0.5ml Needle 31Gx5/16"0.5ml Needle 31Gx15/64" | TK Insulin Syringe:0.3cc/ml Needle 27G x1/"0.3cc/ml Needle 28G x1/2"0.3cc/ml Needle 29G x1/2"0.3cc/ml Needle 30G x1/2"0.3cc/ml Needle 31G x3/8"0.5cc/ml Needle 27G x1/2"0.5cc/ml Needle 28G x1/2"0.5cc/ml Needle 29G x1/2"0.5cc/ml Needle 30G x1/2"0.5cc/ml Needle 31G x3/8"1cc/ml Needle 27G x1/2"1cc/ml Needle 28G x1/2"1cc/ml Needle 29G x1/2"1cc/ml Needle 30G x1/2"1cc/ml Needle 31G x3/8"TK Insulin Syringe withSafety Retractable Device:0.5cc/ml Needle 27G x1/2"0.5cc/ml Needle 28G x1/2"0.5cc/ml Needle 29G x1/2"0.5cc/ml Needle 30G x1/2"0.5cc/ml Needle 31G x3/8"1cc/ml Needle 27G x1/2"1cc/ml Needle 28G x1/2"1cc/ml Needle 29G x1/2" | Different.PleaserefertoAnalysis 2. |
| 1cc/ml Needle 30G ×1/2"1cc/ml Needle 31G ×3/8" | |||
| Nozzle Type | N.A | N.A | Same |
| Lubricant for Barrel | Silicone oil | Silicone oil | Same |
| Barrel Transparency | Transparency and clear | Transparency and clear | Same |
| Gradations Legibility | Legible | Legible | Same |
| Materials | Different.PleaserefertoAnalysis 3. | ||
| Barrel | PP | PP | |
| Plunger | PP | PP | |
| Piston | Rubber | Rubber | |
| Lubricant for Barrel | DC 360 | HC-SS36 | |
| Needle hub | PP | PP | |
| Needle tube | Stainless | Stainless | |
| Sliding sleeve | PP | PP | |
| Needle gauge andneedle length | Varies sizes | Various sizes | Same |
| Lubricant for needle | Silicone oil | Silicone | Same |
| Sterile safety insulinsyringes for singleuse: sharps injuryprevention features | Manual RetractableConforms to ISO 23908. | Manual RetractableConforms to ISO 23908. | Same |
| Performances | Conforms to ISO 8537,ISO 7864 and ISO 9626. | Conforms to ISO 8537and ISO 7864. | Same |
| Biocompatibility | Complies with:ISO 10993-1: Evaluation andTesting;Part 4: Selection of tests forinteractions with blood;Part 5: Tests for in vitrocytotoxicity;Part 7: Ethylene oxidesterilization residuals;Part 10: Tests for irritation anddelayed-type hypersensitivity;Part 11: Tests for systemictoxicity, tests for Bacterialendotoxins, Tests forPyrogenicityAnd Conforms to USP <788>:Particulate Matter for injection | Conforms to ISO10993(Part1: Evaluation andtesting, Part 4: Selection oftests for interactions withblood, Part 5: Tests for invitro cytotoxicity, Part 7:Ethylene oxide sterilizationresiduals, Part 10: Tests forirritation anddelayed-type hypersensitivity,Part 11: Tests for systemictoxicity, tests for Bacterialendotoxins, Tests forPyrogenicity)Conforms to USP <788>:Particulate Matterfor injection | Same |
| Labeling | Meet the requirements of 21CER Part 801 | Meet the requirements of 21CER Part 801 | Same |
Table 1-2 Comparison of Technology Characteristics
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SE Analysis 1: Indication for use
The proposed device and the predicate device have the same indication, that is, for insulin injection. The proposed device has another syringe type for U-40 insulin injection. However, the differences between U-40 insulin syringes and U-100 insulin syringes do not raise any new questions of safety and effectiveness. The difference between U-40 insulin syringe and U-100 insulin syringe is the insulin concentration delivery. The U-40 insulin syringe has red protective cap for color marking in accordance with ISO 8537 to distinguish the insulin concentration. In addition, the tolerance on graduated capacity has been validated in accordance with ISO 8537 Annex H. Therefore, this difference does not affect the Substantially Equivalency (SE) between the proposed and predicate devices.
SE Analysis 2: Syringe Capacity
The Syringe Capacity of the proposed device is covered by the predicate device.
The difference is that the proposed device doesn't include a 0.3ml syringe. This difference does not to affect the Substantially Equivalency (SE) between the proposed and predicate devices.
SE Analysis 3: Materials
The material of the lubricant is different between the proposed device and predicate device. The biocompatibility test of proposed device has been conducted to demonstrate that the proposed device met the biocompatibility requirements. The difference does not raise new questions of safety and effectiveness.
11. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device, Sterile Safety Insulin Syringes for Single Use are substantially equivalent to the legally marketed predicate device TK Insulin Syringe with/without Safety Retractable Device(K191639).
§ 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).