(257 days)
Not Found
No
The summary describes a standard insulin pen needle and its physical and performance characteristics. There is no mention of AI, ML, or any computational processing that would suggest the use of such technologies.
Yes.
The device facilitates the subcutaneous injection of insulin, which is a treatment for diabetes, thereby performing a therapeutic function.
No
Explanation: The device is an Insulin Pen Needle, which is used for the subcutaneous injection of insulin. Its purpose is to deliver insulin, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (needle container, needle shield, needle hub, needle tube) and mentions manufacturing processes like sterilization and physical testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the subcutaneous injection of insulin. This is a therapeutic action, delivering a substance into the body, not performing a diagnostic test on a sample taken from the body.
- Device Description: The device is a needle used in conjunction with an insulin pen. Needles are instruments for delivery or withdrawal, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are designed to perform tests in vitro (outside the body) on samples to provide diagnostic information. This device is used in vivo (inside the body) for therapeutic delivery.
N/A
Intended Use / Indications for Use
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).
Product codes
FMI
Device Description
The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube.
The insulin pen needle for single use is offered in various gauge sized and length.
The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
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
"Adult Use Only" (ages 21yrs old and above).
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
The chemical performance and physical performance have been tested in compliance with the following standard:
- ISO11608-2: 2012
- ISO 9626: 2016 and
- ISO 7864: 2016.
The testing results are in conformance with the corresponding standard.
Sterility and Shelf-life:
The sterilization process of the proposed device has been validated in compliance with ISO 11135. The EO residual doesn't exceed the limit according to ISO 10993-7. The shelf-life validation study was conducted under the accelerated ageing condition in compliance with ASTM F1980-16 to verify the claimed 5 years shelf-life.
Package Testing:
The packaging testing has been performed in compliance with the following FDA recognized consensus standards.
- Vacuum Leak Test, ASTM D3078-02;
- Dye Penetration Test ASTM F1929-15.
- Microbial Barrier Properties Test DIN 58953-6: 2016;
- Seal Strength Test ASTM F88/F88M-21.
Biocompatibility Testing:
The biocompatibility evaluation for the insulin pen needles were conducted in accordance with the guidance that is "Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Systemic Toxicity
- Hemolysis
- Pyrogen
- Subacute Toxicity
- Particulate Matter
Particulate testing was conducted in accordance with USP . The testing results and met the USP acceptance criteria.
Simulated Clinical Use Testing:
Simulated clinical use testing of the proposed device has been conducted in compliance with the FDA Guidance for industry and FDA Stuff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005.
Clinical testing: Not Applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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 in blue and includes the letters "FDA" and the words "U.S. Food & Drug Administration".
September 20, 2023
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. % Alice Huang RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road, Minhang District Shanghai, 201114 China
Re: K230043
Trade/Device Name: Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: August 20, 2023 Received: August 23, 2023
Dear Alice Huang:
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
1
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 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,
Image /page/1/Picture/7 description: The image shows the text "Courtney Evans -S" in a large, sans-serif font. The text is arranged vertically, with "Courtney" on the top line, "Evans" on the second line, and "-S" on the third line. The background of the image is white, with a faint, light blue watermark pattern.
Digitally signed by Courtney Evans -S Date: 2023.09.20 11:28:53 -04'00'
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
2
Indications for Use
510(k) Number (if known) K230043
Device Name Insulin Pen Needle
Indications for Use (Describe)
The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).
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
K230043- 510(K) Summary
4
I. SUBMITTER:
Manufacture Name: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. Address : No.2 Guanyin Road, Taihu Economic Development Zone, Anqing City, Anhui Province, China. Tel: +86-556 5129666 Fax: +86-556 4249999 Contact Person: Bingyi Xiang Title:General Manager Phone: +86-556 5129666 Email:hwj1@hongyu-wuzhou.cn
Submission Correspondent: Alice Huang Email: alice.huang@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai
Summary prepared: September 15, 2023
II. DEVICE
Name of Device:Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Common Name: Insulin Pen Needle for single use Classification Panel: General Hospital Regulatory Class: II Product Code: FMI
III. PREDICATE DEVICE
Primary predicate device: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (K202319)
5
DEVICE DESCRIPTION IV.
The proposed device, Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. The Insulin Pen Needle is composed of a needle container, a needle shield, a needle hub, a needle tube.
The insulin pen needle for single use is offered in various gauge sized and length.
The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 106.
| Designated
metric size
(mm) | Gauge | Bevel
angle | | Outer
diameter of
stylet (mm) | | Nominal length of needle tube
(mm) | | | | | | ID
(mm) | | OD
(mm) | | Color |
|-----------------------------------|-------|----------------|----|-------------------------------------|------|---------------------------------------|---|---|---|----|----|------------|-------|------------|-------|------------|
| | | LB | SB | RW | TW | 4 | 5 | 6 | 8 | 10 | 12 | RW | TW | MIN | MAX | |
| 0.18 | 34G | √ | √ | / | / | √ | √ | √ | – | – | – | 0.064 | 0.091 | 0.178 | 0.191 | Orange |
| 0.20 | 33G | √ | √ | / | / | √ | √ | √ | √ | – | – | 0.089 | 0.105 | 0.203 | 0.216 | Black |
| 0.23 | 32G | √ | √ | / | / | √ | √ | √ | √ | √ | – | 0.089 | 0.105 | 0.229 | 0.241 | Deep green |
| 0.25 | 31G | √ | √ | / | / | √ | √ | √ | √ | √ | – | 0.114 | 0.125 | 0.254 | 0.267 | White |
| 0.30 | 30G | √ | √ | 0.11 | 0.13 | √ | √ | √ | √ | √ | √ | 0.133 | 0.165 | 0.298 | 0.320 | Yellow |
| 0.33 | 29G | √ | √ | 0.11 | 0.15 | √ | √ | √ | √ | √ | √ | 0.133 | – | 0.324 | 0.351 | Red |
| 0.36 | 28G | √ | √ | 0.11 | 0.15 | √ | √ | √ | √ | √ | √ | 0.133 | – | 0.349 | 0.370 | Blue-green |
Table 1 Specification of Insulin Pen Needle
V. INDICATIONS FOR USE
The Insulin Pen Needle is intended for use with pen iniector devices for subcutaneous injection of insulin. The intended user population of insulin pen needle is for "Adult Use Only" (ages 21yrs old and above).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
Insulin pen needle and insulin injection pen are use cooperatively to inject insulin into the human body. Additionally, the Insulin Pen Needle is similar to the Insulin Pen Needle (Ordinary Type) (K202319) in regard to insertion, design, size ranges, and material.
Table 2 General Comparison for Insulin Pen Needle
6
| Item | Proposed Device
Insulin Pen Needle | Predicate Device
Insulin Pen Needle
(Ordinary Type) | Remark |
|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| K number | TBD | K202319 | |
| Classification | Class II | Class II | Same |
| Product Code | FMI | FMI | Same |
| Regulation No. | 880.5570 | 880.5570 | Same |
| Intended use | Insulin pen needle and insulin
injection pen are use
cooperatively to inject insulin
into the human body. | The Insulin Pen Needle
(Ordinary Type) is intended
for use with pen injector
devices for the
subcutaneous injection
of insulin. | Similar
Note 1 |
| Indications for use | The Insulin Pen Needle is
intended for use with pen
injector devices for
subcutaneous injection of
insulin. The intended user
population of insulin pen
needle is for “Adult Use Only”
(ages 21yrs old and above). | The Insulin Pen Needle
(Ordinary Type) is intended
for use with pen injector
devices for the
subcutaneous injection
of insulin. | Similar
Note 1 |
| User population | “Adult Use Only” (ages 21yrs
old and above) | Adult and Pediatric | Different
Note 2 |
| Type-of-use | Prescription only | Over the counter | Different
Note 3 |
| Configuration and
materials of
construction for all
components | Needle tube 304 stainless
steel | Needle tube 304 stainless
steel | |
| | Needle hub Polypropylene | Needle hub Polypropylene | |
| | Needle container Polypropylene | Outer Sheath Polypropylene | Same |
| | Needle shield Polypropylene | Inner Sheath Polypropylene | |
| | Sealed Paper Paper | Sealed Paper Paper | |
| Operation Mode | For Manual Use Only | For Manual Use Only | Same |
| Method of
attachment to pen
injector | Through threaded connection | Through threaded
connection | Same |
| Item | Proposed Device
Insulin Pen Needle | Predicate Device
Insulin Pen Needle (Ordinary
Type) | Remark |
| Needle Gauge | 28G, 29G, 30G, 31G, 32G, 33G,
34G | 29G, 30G, 31G, 32G, 33G | Different
Note 4 |
| Needle Length | 4mm, 5mm, 6mm, 8mm, 10mm,
12mm | 4mm, 5mm, 6mm, 8mm, 10mm,
12mm | Same |
| Patient-contact materials | | | |
| Needle Tube | 304 stainless steel | 304 stainless steel | Different
Note 5 |
| Needle Hub | PP | Polypropylene | Note 5 |
| Lubricant | Silicone oil | MDX4-4159 | |
| adhesive | Uv-curable adhesive | UV glue | |
| Design
specification of
the inner sheath
(dimensions,
color, materials
and strength) | 14.55.85.8mm;
Transparent color; Polypropylene;
Tensile stress at yield>24MPa;
Flexural Modulus:>1000MPa;
Charpy Notched Impact
Strength (23°C) >7kJ/m2 | 14.35.85.8mm;
Transparent color; Polypropylene;
Tensile stress at yield>20MPa;
Flexural Modulus:>800MPa;
Charpy Notched Impact
Strength (23°C) >2.8kJ/m2 | Similar |
| Design
specification of
the outer sheath
(dimensions,
color, materials
and strength) | 301616mm;
Transparent color; Polypropylene;
Tensile stress at yield>24MPa;
Flexural Modulus:>1000MPa;
Charpy Notched Impact
Strength (23°C) >7kJ/m2 | 30.313.413.4mm;
Transparent color; Polypropylene;
Tensile stress at yield>20MPa;
Flexural Modulus:>800MPa;
Charpy Notched Impact
Strength (23°C) >2.8kJ/m2 | Similar |
| Bond between
hub and needle
tube | Clause 4.4 of ISO 11608-2:2012;
Clause 4.12 of ISO 7864:2016 | Clause 4.4 of ISO 11608-2:2012;
Clause 4.12 of ISO 7864:2016 | Same |
| Needle tip
configuration | Conform with ISO 7864 standards | Conform with ISO 7864 standards | Same |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Intracutaneous
reactivity | No Irritation to Skin | No Irritation to Skin | |
| Skin
Sensitization | No Skin Sensitization | No Skin Sensitization | |
| Acute Systemic
Toxicity | No Systemic Toxicity | No Systemic Toxicity | |
| Pyrogen | No pyrogen | No pyrogen | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| | | | |
| Subacute
Systemic Toxicity | No Subacute Systemic Toxicity | No Subacute Systemic Toxicity | |
| | | | |
| Method | EO Sterilized | Irradiation Sterilized | Different
Note 6 |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20 EU per device | 20 EU per device | Same |
| Shelf life | 5 years | 5 years | Same |
| Label/ Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
7
Table 3 Safety and Performance Comparison for Insulin Pen Needle
8
Discussion in details:
Note 1: Intended Use and Indications for use
Insulin pen needle and insulin pen needle (Ordinary Type) have similar intended use and indications for use, which are intended to be used with Insulin Pen for injection of insulin.
Note 2: User population
The subject device' s user population is covered by the range of user population in the predicate devices. This different will do not raise different questions of safety and effectiveness than the predicate device because all necessary information will be labeled on the packaging and the Instruction for Use.
Note 3: Type-of-use
The subject device' s type-of use is more rigorous than predicate devices. This different will do not raise different questions of safety and effectiveness than the predicate device because all necessary information will be labeled on the packaging and Instruction for Use.
Note 4: Needle gauge
The needle gauge of proposed device is more than that of predicate devices. The difference in needle gauges is made of the same raw materials and the same manufacturing process. Different gauge of needle tube will be selected by users. This difference does not affect intended use and not affect substantially equivalence on safety and effectiveness. In addition, all the needle size of proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantially Equivalency (SE) between the proposed and predicate device.
Note 5: Patient-contact Material
Although the material of proposed and the predicate device is different, the MSDS of Silicone oil and UV-curable adhesive is provided, and the patient-contact material of the proposed device material conforms to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
9
Note 6: Sterilize Method
Although the Sterilize Method of proposed and the predicate device is different, the sterilize of the proposed device conforms to the ISO 11135:2014 of standards. And the EO residue result was comply with ISO 10993-7 standard requirement. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device.
VII. PERFORMANCE DATA
The non-clinical tests of the proposed device are tested in conformance with the following standards.
Bench Testing
The chemical performance and physical performance have been tested in compliance with the following standard:
- . ISO11608-2: 2012,
- ISO 9626: 2016 and ●
- ISO 7864: 2016. ●
The testing results are in conformance with the corresponding standard.
Sterility and Shelf-life
The sterilization process of the proposed device has been validated in compliance with ISO 11135. The EO residual doesn't exceed the limit according to ISO 10993-7. The shelf-life validation study was conducted under the accelerated ageing condition in compliance with ASTM F1980-16 to verify the claimed 5 years shelf-life.
Package Testing
The packaging testing has been performed in compliance with the following FDA recognized consensus standards.
- Vacuum Leak Test, ASTM D3078-02;
- Dye Penetration Test ASTM F1929-15.
- Microbial Barrier Properties Test DIN 58953-6: 2016;
- Seal Strength Test ASTM F88/F88M-21.
Biocompatibility Testing
The biocompatibility evaluation for the insulin pen needles were conducted in accordance with the guidance that is "Use of International Standard ISO 10993-1,"Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within Risk Management Process," as
10
recognized by FDA. The battery of testing included the following tests:
- Cytotoxicity
- · Sensitization
- · Irritation
- Systemic Toxicity
- Hemolysis
- Pyrogen
- Subacute Toxicity
- Particulate Matter
Particulate testing was conducted in accordance with USP . The testing results and met the USP acceptance criteria.
Simulated Clinical Use Testing
Simulated clinical use testing of the proposed device has been conducted in compliance with the FDA Guidance for industry and FDA Stuff, Medical Devices with Sharps Injury Prevention Features, August 9, 2005.
Clinical testing
Not Applicable.
VIII. 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.