(335 days)
Not Found
No
The device description and intended use focus on a mechanical safety mechanism for a hypodermic needle, with no mention of AI or ML capabilities.
No
The device is a safety needle used for aspiration and injection of fluids, designed to minimize needle-stick injuries. It does not provide any therapeutic effect itself but is a tool used in medical procedures for fluid management.
No
Explanation: The device is described as a safety hypodermic needle used for aspiration and injection of fluids, designed to prevent needle-stick injuries. Its function is to administer or withdraw substances, not to diagnose a condition.
No
The device description clearly describes a physical hypodermic needle with a safety sheath, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "aspiration and injection of fluids for medical purpose" and to "minimize risk of accidental needle-stick." This describes a device used for administering or withdrawing substances from the body, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of a hypodermic needle with a safety mechanism. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with IVD devices. The performance studies focus on physical properties, sterility, and biocompatibility, not analytical performance related to diagnosing a condition.
Therefore, the KDL Safety Needle is a medical device used for aspiration and injection, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The safety needles are intended to be used with a Luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.
Product codes
FMI
Device Description
The KDL Safety Needle is a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath could be manually activated when the needle is withdrawn from the body before disposal, minimizing the risk of needle sharps injury during disposal. It is activated manually by hand or any solid surface.
The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use.
The KDL Safety Needle has various colors, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the KDL Safety Needle is sterilized by ethylene oxide and without any pyrogen or latex.
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
Non-clinical tests were conducted in conformance with the following standards:
(1) Physical performance testing:
- ISO 7864:2016, Sterile hypodermic needles for single use.
- ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications - part 7: Connectors for intravascular or hypodermic applications.
- ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
- ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
- ISO 23908:2011, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
(2) Sterility:
- ISO 11135:2014 Sterilization of healthcare products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ISO 11138-2:2017 Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes.
- ISO 11737-1:2018 Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products.
- ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- ISO 10993-7:2008/AMD 1:2019 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants.
- EN 868-7:2017, Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
- EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods
- ASTM F1140: 2020, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F88: 2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1929: 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
(3) Biocompatibility testing:
- ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- 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 cytotoxicity.
- ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity and Pyrogenicity
- USP Medical Devices—Bacterial Endotoxin test
- USP Particulate Matter for Injections
Key results: The results demonstrate that device performances of selected models (including 6, 8, 9, 12 and 50mm) meet the requirements of ISO 7864 and ISO 9626.
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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 18, 2022
Shanghai Kindly Enterprise Development Group Co., Ltd % Evan Hu Marketing & Technical Manager Shanghai Mind-link Consulting Co., Ltd. 1399 Jiangyue Road, Minhang Shanghai, Shanghai 201114 China
Re: K212972
Trade/Device Name: KDL Safety Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 8, 2022 Received: July 18, 2022
Dear Evan Hu:
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,
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
2
Indications for Use
510(k) Number (if known) K212972
Device Name KDL Safety Needles
Indications for Use (Describe)
The safety needles are intended to be used with a Luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to 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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3
K212972 510(k) SUMMARY
1. Preparation date: 8/16/2022
2. Submitter
Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd. Address: No.658 Gaochao Road, 201803, Shanghai, China Contact person: Liu Huarong, 86 02169118232, henry_liu@kdlchina.net Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net
3. Device
Trade name: KDL Safety Needles Common name: Safety needle Regulation Number: §21 CFR 880.5570 Classification name: Hypodermic Single Lumen Needle Classification: Class II Product code: FMI
4. Predicate device
TK Safety Needle (K191644), FMI, §21 CFR 880.5570
5. Device description
The KDL Safety Needle is a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath could be manually activated when the needle is withdrawn from the body before disposal, minimizing the risk of needle sharps injury during disposal. It is activated manually by hand or any solid surface.
The self-locking mechanism is positioned within the center and the proximal end of the sheath. The hinge structure could let clinical personnel flexibly adjust the sheath to the designed position for use.
The KDL Safety Needle has various colors, needle gauge sizes, and needle length sizes, which could be applied in different clinic-use scenarios. Meanwhile, the KDL Safety Needle is sterilized by ethylene oxide and without any pyrogen or latex.
| Birmingham gauge | Length (mm) | Needle cutting edge | Needle wall |
|---|---|---|---|
| 18G | 25, 32, 38, 50 | SB, LB | RW, TW |
| 19G | 25, 32, 38, 50 | SB, LB | RW, TW |
| 20G | 25, 32, 38, 50 | LB | RW, TW |
| 21G | 25, 32, 38, 50 | LB | RW, TW |
Table 1. Device models
4
| 22G | 25, 32, 38, 50 | LB | RW, TW |
|---|---|---|---|
| 23G | 25, 38 | LB | RW, TW |
| 24G | 20, 25 | LB | RW, TW |
| 25G | 16, 25, 38 | LB | RW, TW |
| 26G | 9, 13 | SB, LB | RW, TW |
| 27G | 6, 8, 9, 12, 13, 15 | SB, LB | RW, TW |
| 28G | 6, 8, 12, 15 | SB, LB | RW, TW |
| 29G | 6, 8, 12, 15 | SB, LB | RW, TW |
| 30G | 6, 8, 9, 12, 13, 15 | SB, LB | RW, TW |
The KDL Safety Needles are available in various models, mainly 13 types with different needle lengths and configurations and a total of 120 sub-types, as shown in Table 1.
6. Indications for Use/Intended Use
The safety needles are intended to be used with a Luer slip or Luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle-stick.
7. Comparison of technological characters between proposed and predicate devices
| Characters | Proposed device
(K212972- KDL Safety Needles) | Predicate device
(K191644- TK Safety Needle) | Remark |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product code | FMI | FMI | Same |
| Indications for
Use | The safety needles are intended to
be used with a Luer slip or Luer lock
syringe for aspiration and injection
of fluids for medical purpose. After
withdrawal of the needle from the
body, the attached needle safety
shield can be manually activated to
cover the needle immediately after
use to minimize risk of accidental
needle-stick. | TK Safety Needle device is intended
for use in the aspiration and
injection of fluids for medical
purposes. The TK Safety Needle is
compatible for use with standard
luer slip and luer lock syringes.
Additionally, after withdrawal of the
needle from the body the attached
needle safety shield can be manually
activated to cover the needle
immediately after use to minimize
risk of accidental needle-stick. | Similar 1 |
| Prescription or
over-the-
counter use | Prescription | Prescription | Same |
| Material:
Needle hub | Polypropylene | Polypropylene | Same |
| Needle | Stainless steel | Stainless steel | Same |
Table 2. Characters comparison
5
| Needle sheath | Polypropylene | Polypropylene | |
|---|---|---|---|
| Adhesive | Epoxy sizes | Epoxy sizes | |
| Lubricant | Silicone oil | Silicone oil | |
| Needle Gauge | |||
| and length | 18G: 25, 32, 38, 50mm | 16G: 1 to 1 1/2" | Different 1 |
| 19G: 25, 32, 38, 50mm | 17G: 1 to 1 1/2" | ||
| 20G: 25, 32, 38, 50mm | 18G: 1 to 1 1/2" | ||
| 21G: 25, 32, 38, 50mm | 19G: 1 to 1 1/2" | ||
| 22G: 25, 32, 38, 50mm | 20G: 1 to 1 1/2" | ||
| 23G: 25, 38mm | 21G: 1 to 1 1/2" | ||
| 24G: 20, 25mm | 22G: 1 to 1 1/2" | ||
| 25G: 9, 13, 16, 25, 38mm | 23G: 1 to 1 1/2" | ||
| 26G: 9, 13mm | 24G: 1 to 1 1/2" | ||
| 27G: 6, 8, 9, 12, 13, 15mm | 25G: 1 to 1 1/2" | ||
| 28G: 6, 8, 12, 15mm | 26G: 1 to 1 1/2" | ||
| 29G: 6, 8, 12, 15mm | 27G: 1 to 1 1/2" | ||
| 30G: 6, 8, 9, 12, 13, 15mm | 28G: 1/2 to 1" | ||
| 29G: 1/2 to 1" | |||
| 30G: 1/2 to 1" | |||
| Tip | |||
| configuration | Bevel | Bevel | Same |
| Protective | |||
| feature | Extra safety sheath | Extra safety sheath | Same |
| Meet ISO 23908 | Meet ISO 23908 | ||
| Color | Per ISO 6009 | Per ISO 6009 | Same |
| Sterility | Sterilized by EO | Sterilized by EO | Same |
| Single-use | Single-use | Single-use | Same |
| Physical | |||
| performance | Meet ISO 7864 and ISO 9626 | Meet ISO 7864 and ISO 9626 | Same |
| Biocompatibility | Meet ISO 10993 | Meet ISO 10993 | Same |
Similar 1: The intended use of the proposed and predicate device is the same that is intended for fluid aspiration and injection. Meanwhile, they both have the same safety protection features. The only difference is that the indications for use of the predicate device includes its trade name. It does not impact the device's safety and effectiveness.
Different 1: 1" is equal to 25.4mm. The needle length range of the predicate device is 13 to 38mm for various gauges. However, the proposed device has models that are longer length (50mm) and shorter length (6~12mm). The difference in needle length could impact the device's performance, so performance testing were conducted to cover the difference. The results demonstrate that device performances of selected models (including 6, 8, 9, 12 and 50mm) meet the requirements of ISO 7864 and ISO 9626. Therefore, the difference in needle length does not impact the device's safety and effectiveness.
6
8. Non-clinical testing results
The non-clinical tests of this proposed device are tested in conformance with the following standards.
(1) Physical performance testing:
- (a) ISO 7864:2016, Sterile hypodermic needles for single use.
- (b) ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications - part 7: Connectors for intravascular or hypodermic applications.
- (c) ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacture of Medical Device.
- (d) ISO 6009:2016 Hypodermic needles for single use Colour coding for identification
- (e) ISO 23908:2011, Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
(2) Sterility:
- (a) ISO 11135:2014 Sterilization of healthcare products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices.
- (b) ISO 11138-2:2017 Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes.
- (c) ISO 11737-1:2018 Sterilization of health care products Microbiological methods Part 1: Determination of a population of microorganisms on products.
- (d) ISO 11737-2:2019 Sterilization of health care products Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.
- (e) ISO 10993-7:2008/AMD 1:2019 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants.
- (f) EN 868-7:2017, Packaging for terminally sterilized medical devices Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
- (g) EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized - Part 1: General requirements and test methods
- (h) ASTM F1140: 2020, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- (i) ASTM F88: 2015, Standard Test Method for Seal Strength of Flexible Barrier Materials
- (j) ASTM F1929: 2015, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
(3) Biocompatibility testing:
- (a) ISO10993-1:2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.
- (b) ISO 10993-4:2017 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood.
- (c) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity.
7
- (d) ISO 10993-10:2010, Biological evaluation on medical device Part 10: Test for irritation and Skin Sensitization.
- (e) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity and Pyrogenicity
- (f) USP Medical Devices—Bacterial Endotoxin test
- (g) USP Particulate Matter for Injections
9. Clinical testing
No clinical testing is available for this device.
10. Conclusion
The differences between the predicate and the proposed device do not raise any new or different questions of safety or effectiveness. The proposed device is substantially equivalent to the predicate device with respect to indications for use and technological characteristics.