(201 days)
Not Found
No
The description focuses on the mechanical safety features of a standard hypodermic needle and does not mention any computational or data-driven components.
No
The device is a safety needle intended for aspiration of fluids and designed to minimize needle sticks. It does not provide any therapeutic benefit or treatment to the patient.
No
The device is described as a sterile, single-use hypodermic needle with a safety shield, intended for the aspiration of fluids. Its function is to cover the needle after use to minimize accidental needle sticks. This description indicates a device for fluid collection or delivery, not for diagnosing medical conditions.
No
The device description clearly indicates it is a physical medical device (needles, shield, hub, cap) and does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the aspiration of fluids for medical purposes." This describes a procedure performed on a patient, not a test performed on a sample in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a hypodermic needle with a safety shield, designed for use with syringes. This is a tool for administering or withdrawing substances from a patient, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on the analysis of a sample.
Therefore, this device falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
It is intended for use in the aspiration and injection of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.
Product codes
FMI
Device Description
The Verisafe Safety sterile needles are sterile, single use, standard hypodermic needle with a shield to enclose the needle after use.
The Verisafe Safety sterile needles are for use with syringes.
The device mainly consists of hub, needle cap and safety shield. It is packaged in a sealed sterility barrier. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.
Sterilized by ETO, shelf life 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 and standard are provided in Table 2 and Table 3.
Table 2 Performances lists tests including: Appearance, Cleanliness, Color code, Dimensions, Length of the needle, Lubricant, Needle point, Penetration force, Bond between needle and hub, Patency of lumen, Needle cap, Stiffness, Resistance to breakage, Resistance to corrosion, Safety feature (Activate force, Reuse Prevention, Safety Performance), Dimension, Positive pressure liquid leakage, Sub atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to unscrewing, Resistance to overriding, Particulate contamination, Acidity and alkalinity, Extractable metals, Package appearance, Seal strength, Dye penetration, Sterility, Bacterial endotoxin.
Table 3 Biocompatibility lists tests including: In Vitro Cytotoxicity - MTT Method, MEM with 10% FBS extract; Skin Sensitization – Guinea Pig Maximization, 0.9% sodium chloride extract and sesame oil extract; Intradermal reaction test, 0.9% sodium chloride extract and sesame oil extract; Acute systemic toxicity 0.9% sodium chloride extract and sesame oil extract; Pyrogen study in rabbits 0.9% sodium chloride injection; In Vitro Hemolytic Properties Test; Ethylene Oxide residues EO ECH Test.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2023
Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street. Cangqian Community Yuhang District Hangzhou City, Zhejiang 311121 China
Re: K222271
Trade/Device Name: Verisafe Safety sterile needles Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, hypodermic, single lumen Regulatory Class: Class II Product Code: FMI Dated: December 14, 2022 Received: December 14, 2022
Dear Zearou 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
1
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@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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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3
Indications for Use
510(k) Number (if known) K22271
Device Name
Verisafe Safety Sterile Needles
Indications for Use (Describe)
It is intended for use in the aspiration of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.
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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K22271 510k Summary
1. Date Prepared
February 14th, 2023
2. Submitter's Information
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:
3. Trade Name, Common Name, Classification
Trade/Product Name: Verisafe Safety sterile needles
Common Name: Safety sterile needles
Classification name: Needle, hypodermic, single lumen
Regulation Number: 880.5570
Device Class: Class II
Product Code: FMI
4. Identification of Predicate Device
K123684: Sol-Care Safety Needle
5. Description of the Device
The Verisafe Safety sterile needles are sterile, single use, standard hypodermic needle with a shield to enclose the needle after use.
The Verisafe Safety sterile needles are for use with syringes.
The device mainly consists of hub, needle cap and safety shield. It is packaged in a
5
sealed sterility barrier. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.
Sterilized by ETO, shelf life 5 years.
6. Indication
It is intended for use in the aspiration and injection of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.
7. Similarities and Differences of the Proposed Devices to the Predicate Devices
Promisemed Safety sterile needles are substantially equivalent to the predicate device, Sol-Care Safety Needle, K123684 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, usage of the subject device. A detailed comparison to the predicate is provided in Table 1.
| Items | Subject Device | Predicate Device
(K123684) | Comments |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Trade Name | Verisafe Safety sterile
needles | Sol-Care Safety Needle; | |
| Manufacturer | Promisemed Hangzhou
Meditech Co., Ltd | Sol-Millennium. Medical.
Inc. | |
| Device Class | Class II | Class II | Similar |
| Product Code | FMI | FMI | Similar |
| Regulation number | 880.5570 | 880.5570 | Similar |
| Regulation Name | Needle, hypodermic,
single lumen | Needle, hypodermic,
single lumen | Similar |
| Intended Use/
Indications for Use | It is intended for use in the
aspiration and injection of
fluids for medical purposes.
When the safety shield is
manually activated, it will
cover the needle
immediately after use to
minimize risk of accidental
needle stick. | It is intended for use in the
aspiration and injection of
fluids for medical purposes.
When the safety shield is
manually activated, it will
cover the needle
immediately after use to
minimize risk of accidental
needle stick. | Similar |
| Operating
Principle | When the safety shield is
manually activated, it will
cover the needle immediately
after use to minimize risk of
accidental needle stick. | The Sol-Care Safety Needle has
a shield that covers the needle
point after use. In the
activated position, the needle
shield guards against
accidental needle stick during
normal handling and disposal
of the used needle/syringe
combination. | Similar |
| Needle Gauge | 18G, 19G, 20G, 21G, 22G, 23G,
24G, 25G, 26G, 27G, 28G, 29G,
30G | 18G, 19G, 20G, 21G, 22G, 23G,
24G, 25G, 26G, 27G, 28G, 29G,
30G | Similar |
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| Needle Length | 1/2in, 3/4in, 5/8in, 1in, 1 1/4in,
1 1/2in, 2 in | 3/8 in to 1 1/2 in | Different, Subject
devices have more
needle lengths than
predicate device. |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Needle hub
color | Per ISO 6009:
Pink/18G, Cream/19G,
Yellow/20G, Light green/21G,
Black/22G, Light blue/23G,
Medium purple /24G,
Orange /25G, Brown /26G,
Medium grey /27G,
Blue - green /28G, Red /29G,
Yellow /30G. | Per ISO 6009:
Pink/18G, Cream/19G,
Yellow/20G, Light green/21G,
Black/22G, Light blue/23G,
Medium purple /24G,
Orange /25G, Brown /26G,
Medium grey /27G,
Blue - green /28G, Red /29G,
Yellow /30G. | Each color is in
accordance with ISO
6009. |
| Reuse durability | Single Use | Single Use | Similar |
| Biocompatibility | Complied with ISO10993 series
standards, and the following
tests are performed
- Cytotoxicity: No cytotoxicity
- Intracutaneous Reactivity
No evidence of irritation - Skin Sensitization: No
evidence of sensitization - Acute Systemic Toxicity: No
systemic toxicity - Pyrogen: Non pyrogenic
- Platelet Count: No effect
- Hemolysis: No effect | Per ISO 10993-1 | Similar |
| Materials | - Needle: Stainless Steel
(06Cr19Ni10) - Hub: Polypropylene (PP)
- Need Cap: Polypropylene
(PP) | - Needle: Stainless Steel
(06Cr19Ni10) - Hub: Polypropylene (PP)
- Need Cap: Polypropylene
(PP) | Similar |
| Performance | Complied with ISO 7864, ISO
9626, ISO 80369-7 | Complied with ISO 7864, ISO
9626, ISO 80369-7 | Similar |
| Sterilization
method | EO Sterilization | EO Sterilization | Similar |
Performance Testing Summary 8.
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 and standard are provided in Table 2 and Table 3.
• Table 2 Performances
| No. | Test item | Reference recognized standards |
|---|---|---|
| 1. | 1.1 Appearance | EN ISO 7864:2016, Sterile hypodermic syringes for single use - |
| Requirements and test methods | ||
| 1.2 Cleanliness | ||
| 2. | Color code | EN ISO 6009:2016, Hypodermic needles for single use - Colour |
| coding for identification | ||
| 3. | 3.1 Dimensions | EN ISO 7864:2016, Sterile hypodermic syringes for single use - |
| Requirements and test methods | ||
| EN ISO 9626:2016, Stainless steel needle tubing for the | ||
| manufacture of medical devices — Requirements and test methods | ||
| 3.2 Length of the | ||
| needle | EN ISO 7864:2016, Sterile hypodermic syringes for single use – | |
| Requirements and test methods | ||
| 4. | Lubricant | EN ISO 7864:2016, Sterile hypodermic syringes for single use - |
| Requirements and test methods | ||
| 5. | Needle point | EN ISO 7864:2016, Sterile hypodermic syringes for single use - |
| Requirements and test methods | ||
| 6. | Penetration force | EN ISO 7864:2016, Sterile hypodermic syringes for single use - |
| Requirements and test methods | ||
| 7. | Bond between | |
| needle and hub | EN ISO 7864:2016, Sterile hypodermic syringes for single use - | |
| Requirements and test methods | ||
| 8. | Patency of lumen | EN ISO 7864:2016, Sterile hypodermic syringes for single use – |
| Requirements and test methods | ||
| 9. | Needle cap | / |
| 10. | 10.1 Stiffness | EN ISO 9626:2016, Stainless steel needle tubing for the |
| manufacture of medical devices - Requirements and test methods | ||
| 10.2 Resistance to | ||
| breakage | EN ISO 9626:2016, Stainless steel needle tubing for the | |
| manufacture of medical devices - Requirements and test methods | ||
| 10.3 Resistance to | ||
| corrosion | EN ISO 9626:2016, Stainless steel needle tubing for the | |
| manufacture of medical devices — Requirements and test methods | ||
| 11. | 11.1 | |
| Safety feature | ||
| (Activate force) | EN ISO 23908:2013, Sharps injury protection- Requirements and | |
| test methods — Sharps protection features for single-use | ||
| hypodermic needles, introducers for catheters and needles used for | ||
| blood sampling | ||
| 11.2 | ||
| Safety feature | ||
| (Reuse | ||
| Prevention) | EN ISO 23908:2013, Sharps injury protection- Requirements and | |
| test methods — Sharps protection features for single-use | ||
| hypodermic needles, introducers for catheters and needles used for | ||
| blood sampling | ||
| 11.3 | ||
| Safety feature | ||
| (Safety | ||
| Performance) | EN ISO 23908:2013, Sharps injury protection- Requirements and | |
| test methods — Sharps protection features for single-use | ||
| hypodermic needles, introducers for catheters and needles used for | ||
| blood sampling | ||
| 12. | 12.1 Dimension | ISO 80369-7:2021, Small-bore connectors for liquids and gases in |
| healthcare applications - Part 7: Connectors for intravascular or | ||
| hypodermic applications | ||
| 12.2 Positive | ||
| pressure liquid | ||
| leakage | ISO 80369-7:2021, Small-bore connectors for liquids and gases in | |
| healthcare applications - Part 7: Connectors for intravascular or | ||
| hypodermic applications | ||
| 12.3 Sub | ||
| atmospheric | ||
| pressure air leakage | ISO 80369-7:2021, Small-bore connectors for liquids and gases in | |
| healthcare applications - Part 7: Connectors for intravascular or | ||
| hypodermic applications | ||
| 12.4 Stress cracking | ISO 80369-7:2021, Small-bore connectors for liquids and gases in | |
| healthcare applications - Part 7: Connectors for intravascular or | ||
| hypodermic applications | ||
| 12.5 Resistance to | ||
| separation from | ||
| axial load | ISO 80369-7:2021, Small-bore connectors for liquids and gases in | |
| healthcare applications - Part 7: Connectors for intravascular or | ||
| hypodermic applications | ||
| 12.6 Resistance to | ||
| separation from | ||
| unscrewing | ISO 80369-7:2021, Small-bore connectors for liquids and gases in | |
| healthcare applications - Part 7: Connectors for intravascular or | ||
| hypodermic applications | ||
| 12.7 Resistance to | ||
| overriding | ISO 80369-7:2021, Small-bore connectors for liquids and gases in | |
| healthcare applications - Part 7: Connectors for intravascular or | ||
| hypodermic applications | ||
| 13. | Particulate | |
| contamination | USP 39 $$ Particulate matter in injections | |
| 14. | Acidity and | |
| alkalinity | EN ISO 7864:2016, Sterile hypodermic syringes for single use – | |
| Requirements and test methods | ||
| 15. | Extractable metals | EN ISO 7864:2016, Sterile hypodermic syringes for single use – |
| Requirements and test methods | ||
| 16. | Package | |
| appearance | ASTM F1886/F1886M – 16 Standard Test Method for Determining | |
| Integrity of Seals for Flexible Packaging by Visual Inspection | ||
| 17. | Seal strength | EN 868-5:2018 Packaging for terminally sterilized medical devices |
| Part 5: Sealable pouches and reels of porous materials and plastic | ||
| film construction - Requirements and test methods | ||
| 18. | Dye penetration | ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in |
| Porous Medical Packaging by Dye Penetration | ||
| 19. | Sterility | USP 39 $$ Sterility tests |
| 20. | Bacterial endotoxin | USP 40 $$ Bacterial endotoxins test |
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・ Table 3 Biocompatibility
| No. | Test item | Reference recognized standards |
|---|---|---|
| 1. | In Vitro Cytotoxicity - MTT Method, | |
| MEM with 10% FBS extract | ISO 10993-5:2009 – Biological Evaluation of | |
| Medical Devices -- Part 5: Tests for in Vitro | ||
| Cytotoxicity | ||
| 2. | Skin Sensitization – Guinea Pig | |
| Maximization, 0.9% sodium chloride | ||
| extract and sesame oil extract | ISO 10993-10:2021, Biological Evaluation of | |
| Medical Devices -- Part 10: Tests for Irritation and | ||
| Skin Sensitization |
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| 3. | Intradermal reaction test,
0.9% sodium chloride extract and
sesame oil extract | ISO 10993-23:2021, Biological evaluation of
medical devices - Part 23: Tests for irritation |
|----|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. | Acute systemic toxicity
0.9% sodium chloride extract and
sesame oil extract | ISO 10993-11:2017, Biological evaluation of
medical devices - Part 11: Tests for systemic
toxicity- Acute systemic toxicity and pyrogen test |
| 5. | Pyrogen study in rabbits
0.9% sodium chloride injection | ISO 10993-11:2017, Biological evaluation of
medical devices - Part 11: Tests for systemic
toxicity- Acute systemic toxicity and pyrogen test
USP43-NF37 Pyrogen Test |
| 6. | In Vitro Hemolytic Properties Test | ASTM F756-17 Standard Practice for Assessment
of Materials |
| 7. | Ethylene Oxide residues EO ECH Test | ISO 10993-7:2008, Biological evaluation of
medical devices — Part 7: Ethylene oxide
sterilization residuals |
Conclusion 9.
The comparison of intended use, technological characteristics, and performance data of the subject device has demonstrated substantial equivalence to the predicate device.