(136 days)
It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
A sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both). It is made of stainless steel needle, plastic and silicone materials, and is manually operated. It is intended for various medical applications and is not dedicated to medication administration.
It is intended be used by health-care personnel (doctors, nurses, etc.). The needle is lubricated with silicone. Product is sterile and sterilization process is validated according to ISO 11135:2014.
This document is a 510(k) Premarket Notification for Promisemed Sterile Hypodermic Syringes and Verifine Sterile Hypodermic Syringes. It is not a study proving the device meets acceptance criteria for an AI/ML powered device. Instead, it demonstrates substantial equivalence to a legally marketed predicate device (Sol-M TB Syringe K153537) for a standard medical device (syringes).
Therefore, the requested information about acceptance criteria, study design for AI/ML performance, ground truth establishment, expert adjudication, MRMC studies, and training set details are not applicable to this document.
The document primarily focuses on:
- Device Description: Sterile hypodermic syringes with a fixed needle.
- Intended Use: To inject or withdraw fluids from the body for medical purposes.
- Substantial Equivalence: Comparison to a predicate device (Sol-M TB Syringe K153537) in terms of intended use, technological characteristics, and performance.
- Performance Testing: Bench testing according to recognized ISO standards (ISO 7886-1, ISO 9626, ISO 7864) and USP <85> for bacterial endotoxin, along with sterility, package integrity, shelf-life, and biocompatibility testing per ISO 10993 series. These tests confirm the physical and biological safety of the device, not the performance of an AI algorithm.
Summary of Device Performance (from the document), adapted to fit a "performance" concept for a non-AI device:
| Acceptance Criteria (Bench Test Standards) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7886-1:2017 (Sterile hypodermic syringes for manual use) | Complied |
| ISO 9626:2016 (Stainless steel needle tubing) | Complied |
| ISO 7864:2016 (Sterile hypodermic needles for single use) | Complied |
| USP <85> (Bacterial Endotoxin Test - limit < 20 EU/Device) | Complied (non-pyrogenic, endotoxin < 20 EU/Device) |
| ISO 11135:2014 (Ethylene oxide sterilization - SAL 10^-6) | Complied (Sterilization validated, EO/chlorohydrin residuals within limits) |
| ASTM D4169 (Simulated transportation) / ASTM F88/F88-15 (Seal strength) / ASTM F1929-15 (Dye penetration) (Package integrity/sterility maintenance) | Complied (Packaging acceptable for product protection and sterility maintenance) |
| ASTM F1980-16 (Accelerated Aging - Shelf Life) | 5 years shelf life validated |
| ISO 10993-5:2009 (Cytotoxicity) | No cytotoxicity |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | No evidence of skin irritation or sensitization |
| ISO 10993-11:2006 (Acute Systemic Toxicity) | No systemic toxicity |
| USP 42-NF37 <151> (Pyrogen Test) | Non pyrogenic |
| USP <788> (Particulate matter in injections) | Complied |
| ISO 10993-4:2017 (Interactions with blood) | Complied (No evidence of hemolysis) |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Within limit |
The remaining questions are not applicable as this is a traditional medical device submission, not an AI/ML device:
- Sample sized used for the test set and the data provenance: Not applicable. Performance is based on bench testing of device characteristics, not a clinical test set from patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic or prognostic purposes is established. Device performance is determined by objective physical and chemical tests against recognized standards.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable. Performance is based on compliance with established engineering and biocompatibility standards.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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September 9, 2021
Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China
Re: K211242
Trade/Device Name: Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 9, 2021 Received: August 9, 2021
Dear Wei Hsu:
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,
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
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Indications for Use
510(k) Number (if known) K211242
Device Name
Promisemed Sterile Hypodermic Syringes Verifine Sterile Hypodermic Syringes
Indications for Use (Describe)
It is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
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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K211242 510(k) Summary
1 Date Prepared
Sep 9th, 2021
Submitter's Information 2
Name of Sponsor:
Promisemed Hangzhou Meditech Co., Ltd.
Address:
No. 1388 Cangxing Street, Cangqian Community, Yuhang District, Hangzhou
City, 311121 Zhejiang, China
Contact Name:
Zearou Yang
Telephone No.:
+86 571 88772985
Fax No.:
+86 571 88772985
Email Address:
Trade Name, Common Name, Classification ന
Trade/Product Name: Promisemed Sterile Hypodermic Syringes
Verifine Sterile Hypodermic Syringes
Common Name: Sterile Hypodermic Syringes
Classification name: Syringe, Piston
Regulation Number: 21 CFR 880.5860
Device Class: Class II
Product Code: FMF
- ldentification of Predicate Device ব K153537: Sol-M TB Syringe
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Description of the Device ഗ
A sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both). It is made of stainless steel needle, plastic and silicone materials, and is manually operated. It is intended for various medical applications and is not dedicated to medication administration.
It is intended be used by health-care personnel (doctors, nurses, etc.). The needle is lubricated with silicone. Product is sterile and sterilization process is validated according to ISO 11135:2014.
| Capacity | Gauge | Length |
|---|---|---|
| 0.5ml | 28G | |
| 27G | ||
| 26G | ||
| 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | |
| 23G | ||
| 22G | ||
| 21G | ||
| 1.0 ml | 28G | |
| 27G | ||
| 26G | ||
| 24G | 10mm, 12mm, 16mm, 20mm, 25mm, 32mm, 38mm, 50mm | |
| 23G | ||
| 22G | ||
| 21G |
This is a single-use device without any accessory.
Indications for use statement 6
lt is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
- 7 Similarities and Differences of the Proposed Devices to the Predicate Devices
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The Sterile Hypodermic Syringes is substantially equivalent to the predicate device, the Sol-M TB Syringe (K153537) in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. The differences between the subject device and predicate device do not affect the basic design principle and usage.
| Subject Device | Predicate Device(K153537) | ||
|---|---|---|---|
| Trade Name | Promisemed SterileHypodermic SyringesVerifine SterileHypodermic Syringes | Sol-M TB Syringe | Comments |
| Manufacturer | Promisemed HangzhouMeditech Co., Ltd | Sol-Millennium Medical,Inc. | |
| Device Class | Class II | Class II | Same |
| Product Code | FMF | FMF | Same |
| Regulation number | 880.5860 | 880.5860 | Same |
| Regulation Name | Piston syringe | Piston syringe | Same |
| Intended Use/Indications for Use | It is intended to be usedfor medical purposes toinject fluids into orwithdraw fluids from thebody. | It is intended to be usedfor medical purposes toinject fluids into orwithdraw fluids from thebody. | Same |
| OperatingPrinciple | Plunger is used to fillsyringe as well asdischarge the fluid. | Plunger is used to fillsyringe as well asdischarge the fluid. | Same |
| Volume | 0.5ml,1.0ml | 0.5ml,1.0ml | Same |
| Tip type | Fixed Needle | Fixed Needle | Same |
| Gauge | 28G, 27G, 26G, 25G,24G, 23G, 22G, 21G | 23G, 26G, 27G | DifferentSubject devicehas wider gaugesize thanpredicate device.Differences areaddressed throughtesting per ISO9626:2016 and ISO7864:2016. |
| Needle Length | 10mm, 12mm, 16mm,20mm, 25mm, 32mm,38mm, 50mm | 1/2" (12.5mm), 3/8"(9.6 mm) | DifferentSubject devicehas wider needlelength thanpredicate device.Differences areaddressed through |
| testing per ISO9626:2016 and ISO7864:2016. | |||
| Gradationslegibility | Bold markings | Bold markings | Same |
| Lubricant | Silicone | Silicone | Same |
| Barreltransparency | Transparent | Transparent | Same |
| Reuse durability | Single Use | Single Use | Same |
| Biocompatibility | Complied with ISO10993series standards, and thefollowing tests areperformed- Cytotoxicity: Nocytotoxicity- Skin Irritation: Noevidence of skin irritation- Skin Sensitization: Noevidence of sensitization- Acute Systemic Toxicity:No systemic toxicity- Hemolysis: No evidenceof hemolysis- Pyrogen: Non pyrogenic- USP <788> Particulatematter | Per ISO 10993-1 | Same |
| Materials | Needle: Stainless Steel(X5CrNi18-10)Barrel: PolypropylenePlunger: Polypropylene/Acrylonitrile ButadieneStyreneNeedle cap:Polyethylene/PolypropylenePiston: Polyisoprenerubber | Needle: Stainless SteelBarrel: PolypropylenePlunger: PolypropyleneNeedle cap:PolypropyleneGasket: Santoprene | The needle ofboth devices ismade of stainlesssteel.The syringe bodiesof subject deviceand predicatedevice havematerialdifferences.Differences areaddressed throughbiocompatibilitytesting per ISO10993. |
| Performance | Complied withISO 7886-1, ISO 9626, ISO7864 | Complied withISO 7886-1, ISO 9626, ISO7864 | Same |
| Sterilizationmethod | EO Sterilization | EO Sterilization | Same |
A detailed comparison to the predicate is provided in Table 1.
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Discussions of differences in technological characteristics
· The subject device has wider gauge size and needle length than predicate device. Differences are addressed through testing per ISO 9626:2016 and ISO 7864:2016. The difference in gauge size and needle length does not affect the effectiveness and safety of the device.
· The syringe bodies of subject device and predicate device have material differences. The biocompatibility tests conducted demonstrate the safety of subject device. Difference do not affect the effectiveness and safety of the device.
8 Performance Testing Summary
The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- · ISO 7886-1:2017, Sterile hypodermic syringes for single use. Part 1: Syringes for manual use
- · ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
- · ISO 7864:2016, Sterile hypodermic needles for single use Requirements and test methods
- USP<85> Bacterial Endotoxin Test
Sterility, Shipping and Shelf-Life
The sterilization of the product is achieved using ethylene oxide sterilization. Sterilization condition is validated per ISO 11135: 2014 overkill half-cycle approach. The sterility assurance level (SAL) is 10-6. The amount of ethylene oxide and chlorohydrin residual levels are within the limit and in compliance with ISO 10993-7: 2008 requirement.
The device is non-pyrogenic. Endotoxin is tested per USP<85> and is conducted on every batch. Endotoxin limit for the subject device is less than 20 EU/Device.
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- . Package integrity testing, after environmental conditioning and simulated transportation in accordance with ASTM D4169, 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 subject device: . Seal strength ASTM F88/F88-15 Dye penetration ASTM F1929-15
- . Shelf life of 5 years is validated using the FDA recognized standard ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- · Biocompatibility
In accordance with ISO 10993-1 the device is classified as External communicating device, Blood path, indirect, with limited contact duration (≤ 24h). The biosafety tests that required consideration were validated:
- a. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity
- b. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization
- c. ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test
- d. USP42-NF37<151> Pyrogen Test
- e. USP<788> Particulate matter in injections
- f. ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood
- g. ISO 10993-7:2008, Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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Conclusion 9
Based on the information provided within this 510(k) submission, the proposed subject device is substantially equivalent to the predicate device and is as safe and as effective as the legally marketed 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).