(209 days)
The Insulin Syringes without needle is intended for medical purpose in conjunction with sterile needle for the manual aspiration and injection of U100 insulin into subcutaneous tissues.
The Insulin Syringes without needle is a sterile and single use syringe intended for injection of U-100 insulin into the body, in conjunction with a sterile needle. The proposed device is available in 1 ml. The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10-6 and supplied in immediate package to maintain the sterility of the device during the shelf life of 5 years.
This document is a 510(k) Summary for a medical device called "Insulin Syringes without needle" (K221045) from Berpu Medical Technology Co., Ltd. It compares the proposed device to a predicate device (K162180) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and supporting studies as presented in the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance for a specific study. Instead, it describes adherence to recognized standards and successful completion of various tests. For the purpose of this request, I will synthesize the information into a table based on the non-clinical testing performed and the standards referenced.
| Acceptance Criteria (Inferred from Standards) | Reported Device Performance |
|---|---|
| Material Performance | |
| Compliance with ISO 8537:2016 for insulin syringes (performance, dimensions, etc.) | Complied with ISO 8537:2016 |
| Compliance with ISO 80369-7:2021 for small-bore connectors (Luer lock performance) | Complied with ISO 80369-7:2021 (performance test conducted with proposed device) |
| Biocompatibility (as per ISO 10993-1 for prolonged contact) | |
| Absence of Cytotoxicity | Addressed |
| Absence of Sensitization | Addressed |
| Absence of Intracutaneous Reactivity | Addressed |
| Absence of Acute Systemic Toxicity | Addressed |
| Absence of Material-Mediated Pyrogenicity | Addressed |
| Absence of Subchronic/Subacute Toxicity | Addressed |
| Hemocompatibility | Addressed |
| Particulate Matter in Injections (USP <788>) | Met the USP acceptance criteria |
| Sterility & Shelf Life | |
| Sterilization validated per ISO 11135:2014 (Ethylene Oxide) | Validated to achieve a SAL of 10^-6^ |
| Shelf life of 5 years (validated per ASTM F1980-16) | 5 years shelf life determined based on stability studies (accelerated aging and simulated shipping) |
| EO and ECH residuals within limits (ISO 10993-7:2008) | Complied |
| Bacterial Endotoxin Limit (USP <85>) | Complied |
| Packaging Integrity (after accelerated aging, environmental conditioning, transport) | |
| Visual Inspection (ASTM F1886 / F1886M-16) | Performed |
| Seal Strength (ASTM F88/F88M-15) | Performed |
| Dye Penetration (ASTM F1929-15) | Performed. "All packaging deemed acceptable for protection of product and sterility maintenance." This implies passing criteria for these tests, although specific numerical results/criteria are not provided in this summary. |
2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for "test sets" in the context of clinical studies, as it explicitly states "No clinical study is included in this submission."
For non-clinical tests (e.g., performance, biocompatibility, sterilization validation, shelf-life, packaging), specific sample sizes used for testing are not provided in this summary. The data provenance would be from the manufacturer's internal testing or contracted laboratories performing tests according to the cited ISO and ASTM standards. This testing is typically prospective, performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical studies were conducted, and therefore, no expert-established ground truth for a clinical test set is relevant to this submission.
4. Adjudication method for the test set
Not applicable. No clinical studies were conducted, and therefore, no adjudication method for a clinical test set is relevant to this submission.
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 device is an insulin syringe, not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned or would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an insulin syringe, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is established by the specified international (ISO) and national (ASTM, USP) standards. The device is tested against these standards, and its performance is compared to the requirements outlined in those standards. For example, for particulate matter, the ground truth is the maximum particle count allowed by USP <788>. For sterility, the ground truth is a SAL of 10^-6^ as per ISO 11135.
8. The sample size for the training set
Not applicable. No AI/machine learning component is involved, so there is no training set in this context.
9. How the ground truth for the training set was established
Not applicable. No AI/machine learning component is involved, so there is no training set or corresponding ground truth establishment in this context.
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Berpu Medical Technology Co., Ltd Buxin Yu Official Correspondent No. 14 Xingji Road, Yongxing Street, Longwan District Wenzhou. Zheiiang 325000 China
Re: K221045
Trade/Device Name: Insulin Syringes without needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: October 6, 2022 Received: October 6, 2022
Dear Buxin Yu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 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) K221045
Device Name Insulin Syringes without needle
Indications for Use (Describe)
The Insulin Syringes without needle is intended for medical purpose in conjunction with sterile needle for the manual aspiration and injection of U100 insulin into subcutaneous tissues.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K221045 510(k) Summary
Submitter:
Berpu Medical Technology Co., Ltd. NO.14 Xingji Road, Yongxing Street, Longwan District, Wenzhou, Zhejiang, China 325000
Establishment Registration Number: 3004496829
Contact person: Buxin Yu Position: Official Correspondent, Management Representative Tel.: +86-18868131179 Fax: 0577-86630389 E-mail: 274269118@qq.com
Preparation date: October 31, 2022
Device Regulation:
| Trade Name of Device: | Insulin Syringes without needle |
|---|---|
| Common name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Regulatory Class: | Class II |
| Product code: | FMF |
| Review Panel: | General Hospital |
Predicate Device:
| 510(k) Number: | K162180 |
|---|---|
| Trade name: | Disposable Insulin Syringe |
| Common name: | Piston Syringe |
| Classification: | Class II |
| Product Code: | FMF |
| Manufacturer: | Berpu Medical Technology Co., Ltd |
Device Description:
The Insulin Syringes without needle is a sterile and single use syringe intended for injection of U-100 insulin into the body, in conjunction with a sterile needle. The proposed device is available in 1 ml.
The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 10 ° and supplied in immediate package to maintain the sterility of the device during the shelf life of 5 years.
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Insulin Syringes without needle materials of construction are as provided in Table 1 below. For other device characteristics please refers to Table 2.
| Part name | Material |
|---|---|
| Plunger | Polypropylene (PP) |
| Barrel | Polypropylene (PP) |
| Piston | Polyisoprene Rubber |
| Lubricant | Polydimethylsiloxane |
| Table 1 Materials of Insulin Syringes without needle | |
|---|---|
| ------------------------------------------------------ | -- |
| Items | Proposed device |
|---|---|
| Intended users | Adults and Pediatrics |
| Mechanism of action | The needle tube is punctured into body for insulin injection operation, the insulin will flow into body due to the pull force of plunger. |
| Environment of use | Prescription use |
| Single use | Yes |
| Volume | 1 ml |
Table 2 Insulin Syringes without needle characteristics
Indications for Use:
The Insulin Syringes without needle is intended for medical purpose in conjunction with sterile needle for the manual aspiration and injection of U100 insulin into subcutaneous tissues.
Comparison of Technological Characteristics with the Predicate Device:
The comparison and discussion between the subject device and the predicate device is listed in Table 3 below:
| Item | Proposed device | Predicate device | Discussion |
|---|---|---|---|
| (K162180) | |||
| Product name | Insulin Syringeswithout needle | Disposable InsulinSyringe | - |
| Product Code | FMF | FMF | Same |
| Regulation No. | 21 CFR 880.5860 | 21 CFR 880.5860 | Same |
| Class | II | II | Same |
| Indication for use | The Insulin Syringeswithout needle isintended for medicalpurpose in conjunctionwith sterile needle forthe manual aspirationand injection of U100insulin intosubcutaneous tissues. | The disposable insulinsyringe is intended formedical purposes for themanual aspiration of U-100 insulin, and for theinjection of insulin intoparts of the body belowthe surface skin. | Same |
| Environment ofuse | Prescription Use | Prescription Use | Same |
| Intended users | Adults and Pediatrics | Adult and Pediatric | Same |
| Materials ofConstruction | (1) Plunger (PP)(2) Barrel (PP)(3) Piston(PolyisopreneRubber)(4) Lubricant(Polydimethylsiloxane) | (1) Protective end cap(PP)(2) Needle (Stainless Steel304)(3) Piston (PolyisopreneRubber)(4) Plunger (PP)(5) Barrel (PP)(6) Lubricant(Polydimethylsiloxane) | Difference1 |
| Size | 1ml | 0.3ml, 0.5ml, 1ml | Difference2 |
| Method ofattachment toneedle | Luer lock | Permanently attachedneedle | Difference3 |
| Shelf life | 5 years | 5 years | Same |
| Syringeperformance | Complied withISO 8537, ISO80369-7 | Complied with ISO8537, ISO 9626, ISO7864. | Difference4 |
| Biocompatibility | Conforms to therequirements ofISO 10993 seriesstandards. | Conforms to therequirements of ISO10993 seriesstandards. | Same |
| Method | EO Sterilized | EO Sterilized | Same |
| SAL | 10-6 | 10-6 | Same |
| OperationPrinciple | For Manual UseOnly, For SingleUse Only | For Manual Use Only,For Single Use Only | Same |
| Label/Labeling | Complied with 21CFR part 801 | Complied with 21CFR part 801 | Same |
Table 3 General Comparison of Insulin Syringes without needle
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1 The subject syringes' materials are same as the predicate device (K162180) except that the subject syringe does not have a needle. Therefore, the differences on configuration and materials of construction do not raise new questions about safety and effectiveness.
2 The size for subject device is different from the predicate device. However, predicate device's size range covers that of subject device. Therefore, the differences in size do not raise new questions about safety and effectiveness.
3 The method of attachment to needle is different for proposed device and predicate device. Proposed device connection method with needle is luer lock. The needle is permanently attached with nozzle in predicate device. The performance test according to ISO 80369-7:2021 have been conducted with proposed device. Therefore, the differences on method of attachment to needle do not raise new questions about safety and effectiveness.
4 Proposed device and predicate device are complied with the insulin syringes standard ISO 8537:2016. Therefore, the difference on performance tests due to the method of attachment to needle do not raise new questions about safety and effectiveness.
Non-Clinical Testing:
The Insulin syringes without needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 8537: 2016, Sterile single-use syringes, with or without needle, for insulin. ●
- ISO 80369-7:2021 Second edition, Small-bore connectors for liquids and gases in healthcare . applications - Part 7: Connectors for intravascular or hypodermic applications
Biocompatibility Testing:
In accordance with ISO 10993-1, the syringe is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hours to 30days). The following biocompatibility endpoints were addressed:
- Cytotoxicity
- Sensitization ●
- Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Material-Mediated Pyrogenicity ●
- Subchronic/Subacute Toxicity ●
- Hemocompatibility ●
Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections - Method 1: Light Obscuration Particle Count Test and met the USP acceptance criteria.
Sterility, Shipping and Shelf Life:
The sterilization method has been validated per ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. The shelf life of the Insulin syringes without needle is 5 years, determined
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based on stability studies which includes accelerated aging and simulated shipping.
Sterilization shelf-life studies were conducted in compliance with the following standards:
| Item | Standard |
|---|---|
| EO and ECH residuals | ISO 10993-7:2008 Biological evaluation of medical devices –Part 7: Ethylene oxide sterilization residuals |
| Bacteria Endotoxin Limit | USP <85> Bacterial Endotoxins |
| Shelf-Life Evaluation | Shelf life of 5 years is validated using the FDA recognizedstandard ASTM F1980-16 Standard Guide for AcceleratedAging of Sterile Barrier Systems for Medical Devices |
- Package integrity testing, after accelerated aging, environmental conditioning and simulated transportation in accordance with ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance.
- Sterile Barrier Packaging Testing performed on the proposed device:
- Visual Inspection in accordance with ASTM F1886 / F1886M-16
- Seal Strength in accordance with ASTM F88/F88M-15
- Dye Penetration in accordance with ASTM F1929-15
Clinical Testing
No clinical study is included in this submission.
Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Insulin Syringes without needle is substantially equivalent to the Disposable Insulin Syringe with respect to the indications for use, target populations, treatment method, and technological characteristics.
§ 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).