(108 days)
Not Found
No
The device description and performance studies focus on the physical characteristics, biocompatibility, sterilization, and mechanical performance of a cannula and needle, with no mention of AI or ML capabilities. The sections related to training/test sets and key metrics, which are common for AI/ML devices, are marked as "Not Applicable" or "Not Found".
No
The device is described as injecting fluids intradermally, but it does not specify what fluids are being injected or for what therapeutic purpose, only that it is a "Sterile Aesthetic Cannula and Hypodermic Needle." Its intended use is more related to delivery of substances, potentially aesthetic, rather than a direct therapeutic action of the device itself.
No
The device is described as an aesthetic cannula and hypodermic needle intended for injecting fluids intradermally. Its purpose is to administer substances, not to diagnose conditions.
No
The device description explicitly states it is a "combined medical device, including a blunt needle-cannula and a hypodermic needle," which are physical hardware 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 injecting fluids intradermally." This describes a procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "Sterile Aesthetic Cannula and Hypodermic Needle." These are instruments used for delivering substances into the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (like blood, urine, tissue, etc.) or to provide diagnostic information.
- Performance Studies: The performance studies focus on the physical and biological properties of the device itself (biocompatibility, sterilization, strength, etc.), not on its ability to accurately detect or measure a substance in a sample.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for the delivery of substances into the skin.
N/A
Intended Use / Indications for Use
The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).
Product codes
FMI
Device Description
The Sterile Aesthetic Cannula and Hypodermic Needle is a combined medical device, including a blunt needle-cannula and a hypodermic needle. The sharp needle consists of a needle hub, a needle, and a protective cap. The blunt needle-cannula consists of a needle hub, a blunt cannula, and a protective cap.
The device is provided for single-used, sterilized, and prescription use only. It offers various model configurations, including multiple needle gauge sizes, lengths, and tips, to fit most usage scenarios.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intradermally
Indicated Patient Age Range
adult only (greater than 21 years old)
Intended User / Care Setting
Prescription Use
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 proposed device was tested in compliance with ISO 7864:2016 and ISO 9626:2016 for evaluating the overall non-clinical performance. Additionally, luer connector testing in compliance with ISO 80369-7:2016 and ISO 80360-20:2015 was completed. The performance and design testing results met the standards' requirements.
Biocompatibility testing was conducted in compliance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as the Externally Communicating Device, Blood Path Indirect, Limited Contact ( and USP /USP , respectively.
The sterilization method by using Ethylene Oxide (EO) gas was validated in compliance with ISO 11135:2014 to achieve the sterility assurance level (SAL) of 10-6. EO and Epoxy Chlorohydrin (ECH) residuals met the limit requirements of ISO 10993-7:2008, and Pyrogen testing met the requirements of USP 0.9% saline injection method.
The Shelf-Life validation study was conducted under accelerated aging condition in compliance with ASTM F1980-16 to verify the claimed shelf-life of 5 years. Package integrity testing under simulated shipping conditions was conducted to satisfy the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging was deemed acceptable for protection of product and sterility maintenance. Sterile barrier testing was conducted in compliance with ASTM F88/F88-15 (Seal Strength), ASTM F1929-15 (Dye penetration), ASTM F1140/F1140M:2013 (Internal Pressurization), and USP (Sterility).
Clinical testing: Not applicable for this submission.
Key Results: All performance and design testing results met the standards' requirements. All biocompatibility testing results met the requirements. EO and ECH residuals met the limit requirements. Pyrogen testing met the requirements. Shelf-life of 5 years was verified. Packaging was deemed acceptable for protection of product and sterility maintenance. Sterile barrier testing standards were met.
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
February 16, 2023
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: K223327
Trade/Device Name: Sterile Aesthetic Cannula and Hypodermic Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: February 10, 2023 Received: February 13, 2023
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,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K223327
Device Name
Sterile Aesthetic Cannula and Hypodermic Needle
Indications for Use (Describe)
The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).
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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3
1. Preparation date: 02/13/2023
2. Submitter
Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd. Address: No.658 Gaochao Road, 201803, Shanghai, China Contact person: Liu Hualong, 86-02169118232, henry liu@kdlchina.net Submission correspondent: Evan Hu, 86-18616124827, Evan.hu@mind-link.net
3. Device
Trading name: Sterile Aesthetic Cannula and Hypodermic Needle Common name: Aesthetic needle Regulation No.: 21 CFR 880.5570 Classification name: Needle, Hypodermic, Single Lumen Classification: Class II Product code: FMI
4. Predicate device
Predicate device: K200017-Eclipse DermaFlex Cannula
5. Device description
The Sterile Aesthetic Cannula and Hypodermic Needle is a combined medical device, including a blunt needle-cannula and a hypodermic needle. The sharp needle consists of a needle hub, a needle, and a protective cap. The blunt needle-cannula consists of a needle hub, a blunt cannula, and a protective cap.
The device is provided for single-used, sterilized, and prescription use only. It offers various model configurations, including multiple needle gauge sizes, lengths, and tips, to fit most usage scenarios. Details of the specification refer to Table 1.
| Cannula (Blunt needle) | Sharp needle (Normal needle) | ||||
|---|---|---|---|---|---|
| Gauge(G) | Length(mm) | Wall type | Gauge(G) | Length(mm) | Wall type |
| Group A: Only cannula | |||||
| 22 | 40, 50, 60, 70, 90 | ETW | N/A | ||
| 23 | 30, 40, 50, 60 | ETW | |||
| 25 | 30, 40, 50, 60 | ETW | |||
| 26 | 13, 25, 30, 40 | ETW | |||
| 27 | 13, 25, 30, 40 | ETW | |||
| 30 | 13, 25, 30 | ETW | |||
| Group B: Cannula and sharp needle with the same gauge | |||||
| 22 | 40 | ETW | 22 | 25 | TW |
| 22 | 50 | ETW | 22 | 25 | TW |
| 22 | 70 | ETW | 22 | 25 | TW |
| 23 | 30 | ETW | 23 | 25 | TW |
| 23 | 40 | ETW | 23 | 25 | TW |
| 23 | 50 | ETW | 23 | 25 | TW |
| 25 | 30 | ETW | 25 | 16 | TW |
| 25 | 40 | ETW | 25 | 16 | TW |
| 25 | 50 | ETW | 25 | 16 | TW |
| 26 | 13 | ETW | 26 | 16 | RW |
| 26 | 25 | ETW | 26 | 16 | RW |
| 27 | 13 | ETW | 27 | 13 | RW |
| 27 | 25 | ETW | 27 | 13 | RW |
| 27 | 40 | ETW | 27 | 13 | RW |
| 27 | 50 | ETW | 27 | 13 | RW |
| 30 | 13 | ETW | 30 | 13 | RW |
| 30 | 25 | ETW | 30 | 13 | RW |
| Group C: Cannula and sharp needle with different gauges | |||||
| 22 | 20 | ETW | 21 | 25 | TW |
| 22 | 25 | ETW | 21 | 25 | TW |
| 22 | 40 | ETW | 21 | 25 | TW |
| 22 | 50 | ETW | 21 | 25 | TW |
| 22 | 70 | ETW | 21 | 25 | TW |
| 23 | 40 | ETW | 22 | 25 | TW |
| 23 | 50 | ETW | 22 | 25 | TW |
| 23 | 70 | ETW | 22 | 25 | TW |
| 24 | 40 | ETW | 23 | 25 | TW |
| 24 | 50 | ETW | 23 | 25 | TW |
| 25 | 38 | ETW | 24 | 25 | TW |
| 25 | 50 | ETW | 24 | 25 | TW |
| 25 | 70 | ETW | 24 | 25 | TW |
| 26 | 13 | ETW | 25 | 25 | TW |
| 26 | 25 | ETW | 25 | 25 | TW |
| 26 | 35 | ETW | 25 | 25 | TW |
| 26 | 40 | ETW | 25 | 25 | TW |
| 26 | 50 | ETW | 25 | 25 | TW |
| 27 | 13 | ETW | 26 | 25 | RW |
| 27 | 25 | ETW | 26 | 25 | RW |
| 27 | 40 | ETW | 26 | 25 | RW |
| 27 | 50 | ETW | 26 | 25 | RW |
| 30 | 13 | ETW | 29 | 13 | RW |
| 30 | 25 | ETW | 29 | 13 | RW |
| 30 | 38 | ETW | 29 | 13 | RW |
Table 1. Device specifications
4
5
6. Indications for use/Intended use
The product is intended to use for injecting fluids intradermally. It is for adult only (greater than 21 years old).
7. Comparison of technological characters between proposed and predicate devices
| Characters | Proposed device
(K223327- Sterile Aesthetic
Cannula and Hypodermic Needle) | Predicate device
(K200017-Eclipse DermaFlex
Cannula) | Comments |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------|
| Indications for
use | The product is intended to use for
injecting fluids intradermally. It is
for adult only (greater than 21
years old). | The Eclipse DermaFlex Cannula is
intended to inject fluids
intradermally. | Same |
| Product code | FMI | FMI | Same |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 | Same |
| Structure and
materials | Needle hub: PP
Protective cap: PP (cannula and
sharp needle), PE (cannula)
Needle tube: SUS 304
Lubricant: Silicone oil
Adhesive: Epoxy resin, UV resin | Needle hub: PP
Protective cap: PP
Needle tube: SUS 304
Lubricant: Silicone oil | #1 |
| Color coding | Meet requirements of ISO 6009 | Meet requirements of ISO 6009 | Same |
| Needle gauge | Cannula: 22, 23, 24, 25, 26, 27,
30G
Sharp needle: 21, 22, 23, 24, 25,
26, 27, 29, 30G | Cannula: 21, 22, 23, 25, 26, 27,
30G
Sharp needle: 21, 22, 23, 25, 26,
27, 30G | #2 |
| Needle length | Cannula: 13, 25, 35, 38, 40, 50,
70mm
Sharp needle: 13, 16, 25mm | Cannula: 25, 38, 40, 50, 60,
70mm
Sharp needle: 25, 38, 40, 50, 60,
70mm | #3 |
| Tip configuration | Sharp needle: sharpened tip
Cannula: closed blunt tip with
lateral opening | Sharp needle: sharpened tip
Cannula: closed blunt tip with
lateral opening | Same |
| Connection to
syringe | Luer taper | Luer taper | Same |
| Physical
performance | Meet requirements of ISO 9626,
ISO 7864 and ISO 80369-7 | Meet requirements of ISO 9626,
ISO 7864 and ISO 80369-7 | Same |
| Biocompatibility
performance | Meet requirements of ISO 10993-
1, -4, -5, -10, -11 | Meet requirements of ISO 10993-
1, -4, -5, -10, -11 | Same |
| Sterilization
method | Sterilized by EO gas
SAL 10-6 | Sterilized by EO gas
SAL 10-6 | Same |
Table 2. Characters comparison
6
#1: The materials used for manufacturing protective cap are different. The function of the protective cap is for needle protection before use. The different materials do not raise new questions of safety or effectiveness. Performance data results also showed all testing met the requirements of standards or guidance.
#2 and #3: The proposed device's needle gauge specification range is within the predicate device's range. However, the proposed device has shorter needle lengths (13mm and 16mm) than the predicate device. Shorter needle lengths offer options for end users' choice. The performance of needles with shorter lengths was tested in compliance with ISO 9626 and ISO 7864. Performance data results showed all testing met the requirements of standards or guidance. The different needle lengths do not raise new questions of safety and effectiveness.
8. Non-clinical testing
PERFORMANCE TESTING
The proposed device was tested in compliance with ISO 7864:2016 and ISO 9626:2016 for evaluating the overall non-clinical performance. Additionally, luer connector testing in compliance with ISO 80369-7:2016 and ISO 80360-20:2015 was completed. The performance and design testing results met the standards' requirements.
BIOCOMPATIBILITY TESTING:
The proposed device was tested in compliance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as the Externally Communicating Device, Blood Path Indirect, Limited Contact ( and USP /USP , respectively.
STERILE, PACKAGE, AND SHELF-LIFE VALIDATION:
The sterilization method by using Ethylene Oxide (EO) gas was validated in compliance with ISO 11135:2014 to achieve the sterility assurance level (SAL) of 10-6.
EO and Epoxy Chlorohydrin (ECH) residuals met the limit requirements of ISO 10993-7:2008, and Pyrogen testing met the requirements of USP 0.9% saline injection method.
The Shelf-Life validation study was conducted under accelerated aging condition in compliance with ASTM F1980-16 to verify the claimed shelf-life of 5 years.
7
Package integrity testing under simulated shipping conditions was conducted to satisfy the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging was deemed acceptable for protection of product and sterility maintenance.
Sterile barrier testing was conducted in compliance with the following FDA recognized consensus standards.
- Seal Strength ASTM F88/F88-15 –
- Dye penetration ASTM F1929-15 ।
- -Internal Pressurization ASTM F1140/F1140M:2013
- -Sterility USP
9. Clinical testing
Not applicable for this submission.
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, technological characteristics, and performance.