(127 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a disposable insulin pen needle, with no mention of AI or ML.
Yes
Explanation: The device is intended for the subcutaneous injection of insulin, which is a therapeutic treatment for diabetes. As it is an accessory used in the delivery of a therapeutic drug, it serves a therapeutic purpose.
No
The device, a Disposable Insulin Pen Needle, is used for the subcutaneous injection of insulin, which is a treatment delivery method, not a diagnostic one.
No
The device description clearly outlines physical components (needle tube, inner sheath, cup, hub, sealed paper) and the testing performed focuses on physical and material properties, not software functionality.
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 describes a therapeutic action (delivering medication into the body), not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device designed for injection, consisting of a needle, hub, and protective components. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for the delivery of a substance (insulin) into the body, which falls under the category of a therapeutic or drug delivery device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Product codes
FMI
Device Description
The proposed device, Disposable Insulin Pen Needle, is a single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of needle tube, inner sheath, cup, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The proposed device is available in following specifications
Gauge: 33G; Length (mm): Available in 4mm, 6mm; Wall: TW
Gauge: 32G; Length (mm): Available in 4mm, 6mm and 8mm; Wall: TW
Gauge: 31G; Length (mm): Available in 4mm, 6mm and 8mm; Wall: TW
Gauge: 30G; Length (mm): Available in 4mm, 6mm and 8mm; Wall: TW
Gauge: 29G; Length (mm): Available in 6mm, 8mm and 12mm; Wall: RW
Gauge: 28G; Length (mm): Available in 6mm, 8mm and 12mm; Wall: TW
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Summary:
Lubrication
Ease of assembly and disassembly
Cleanliness (Clause 4.3 of ISO 7864:2016)
Limits for acidity or alkalinity (Clause 4.4 of ISO 7864:2016)
Limits for extractable metals (Clause 4.5 of ISO 7864:2016)
Size designation (Clause 4.6 of ISO 7864:2016)
Colour coding (Clause 4.7 of ISO 7864:2016)
Needle hub (Clause 4.8 of ISO 7864:2016)
Needle Cap (Clause 4.9 of ISO 7864:2016)
Needle tube (Clause 4.10 of ISO 7864:2016)
Needle point (Clause 4.11 of ISO 7864:2016)
Bond between hub and needle tube (Clause 4.12 of ISO 7864:2016)
Patency of lumen (Clause 4.13 of ISO 7864:2016)
Surface finish (Clause 5.2 of ISO 9626:2016)
Cleanliness (Clause 5.3 of ISO 9626:2016)
Limits for acidity and alkalinity (Clause 5.4 of ISO 9626:2016)
Size designation (Clause 5.5 of ISO 9626:2016)
Dimensions (Clause 5.6 of ISO 9626:2016)
Stiffness (Clause 5.8 of ISO 9626:2016)
Resistance to breakage (Clause 5.9 of ISO 9626:2016)
Resistance to corrosion (Clause 5.10 of ISO 9626:2016)
Material (Clause 4.1 of ISO 11608-2:2012)
Dimensions (Clause 4.2 of ISO 11608-2:2012)
Determination of flow rate through the needle (Clause 4.3 of ISO 11608-2:2012)
Bond between hub and needle tube (Clause 4.4 of ISO 11608-2:2012)
Needle points (Clause 4.5 of ISO 11608-2:2012)
Freedom from defects (Clause 4.6 of ISO 11608-2:2012)
Dislocation of measuring point at patient end (Clause 4.7 of ISO 11608-2:2012)
Determination of functional compatibility with Clause 4.9 of ISO 11608-2:2012 needle-based injection systems (Clause 4.8 of ISO 11608-2:2012)
Clause 4.10 of ISO 11608-2:2012
Sterile Barrier Packaging Testing: Seal strength (ASTM F88/F88-15), Dye penetration (ASTM F1929-15)
Sterilization and Shelf Life Testing: EO residue (ISO 10993-7:2008), ECH residue (ISO 10993-7:2008), Bacteria Endotoxin Limit (USP ), Shelf Life Evaluation (Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device), Sterilization validation (ANSI/AAMI/ISO 11135-1:2007)
Biocompatibility Testing: Cytotoxicity, Intracutaneous Reactivity, Skin Sensitization, Acute Systemic Toxicity, Pyrogen and Hemolysis Test.
Key results: The test results comply with the related standard requirements.
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 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 28, 2018
Zhejiang Kindley Medical Devices Co.,Ltd % Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K181069
Trade/Device Name: Disposable Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: July 20, 2018 Received: July 30, 2018
Dear Diana Hong:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Disposable Insulin Pen Needle
Indications for Use (Describe)
The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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Tab #7 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: __K181069
Date of Preparation: 08/28/2018
Submitter Identification
Zhejiang kindly medical devices Co., Ltd. No.758, 5th Binhai Road, Binhai Industrial Park, Longwan District, 325025 Wenzhou, Zhejiang Province, PRC.
Establishment Registration Number: Not yet registered
Contact Person: Yong Zhang Position: General Manager Tel: +86-577-86960616 Fax: +86-577-86374972 Email: zjkdl(@kdlchina.com
Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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Identification of Proposed Device
Trade Name: Disposable Insulin Pen Needle Common Name: Insulin Pen Needle
Regulatory Information
Classification Name: Needle, Hypodemic, Single Lumen; Classification: 2; Product Code: FMI; Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;
Identification of Predicate Device
510(k) Number: K133059 Product Name: Insulin Pen Needle
Intended Use Statement
The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
Device Description
The proposed device, Disposable Insulin Pen Needle, is a single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of needle tube, inner sheath, cup, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The proposed device is available in following specifications
| Gauge | Length (mm) | Wall |
|---|---|---|
| 33G | Available in 4mm, 6mm | TW |
| 32G | Available in 4mm, 6mm and 8mm | TW |
| 31G | Available in 4mm, 6mm and 8mm | TW |
| 30G | Available in 4mm, 6mm and 8mm | TW |
| 29G | Available in 6mm, 8mm and 12mm | RW |
| 28G | Available in 6mm, 8mm and 12mm | TW |
5
Non-Clinical Test Summary
Lubrication
Ease of assembly and disassembly
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test result comply with the related standard requirements, the test conducted on proposed devices include following
| Cleanliness | Clause 4.3 of ISO 7864:2016 |
|---|---|
| Limits for acidity or alkalinity | Clause 4.4 of ISO 7864:2016 |
| Limits for extractable metals | Clause 4.5 of ISO 7864:2016 |
| Size designation | Clause 4.6 of ISO 7864:2016 |
| Colour coding | Clause 4.7 of ISO 7864:2016 |
| Needle hub | Clause 4.8 of ISO 7864:2016 |
| Needle Cap | Clause 4.9 of ISO 7864:2016 |
| Needle tube | Clause 4.10 of ISO 7864:2016 |
| Needle point | Clause 4.11 of ISO 7864:2016 |
| Bond between hub and needle tube | Clause 4.12 of ISO 7864:2016 |
| Patency of lumen | Clause 4.13 of ISO 7864:2016 |
| Surface finish | Clause 5.2 of ISO 9626:2016 |
| Cleanliness | Clause 5.3 of ISO 9626:2016 |
| Limits for acidity and alkalinity | Clause 5.4 of ISO 9626:2016 |
| Size designation | Clause 5.5 of ISO 9626:2016 |
| Dimensions | Clause 5.6 of ISO 9626:2016 |
| Stiffness | Clause 5.8 of ISO 9626:2016 |
| Resistance to breakage | Clause 5.9 of ISO 9626:2016 |
| Resistance to corrosion | Clause 5.10 of ISO 9626:2016 |
| Material | Clause 4.1 of ISO 11608-2:2012 |
| Dimensions | Clause 4.2 of ISO 11608-2:2012 |
| Determination of flow rate through the needle | Clause 4.3 of ISO 11608-2:2012 |
| Bond between hub and needle tube | Clause 4.4 of ISO 11608-2:2012 |
| Needle points | Clause 4.5 of ISO 11608-2:2012 |
| Freedom from defects | Clause 4.6 of ISO 11608-2:2012 |
Clause 4.7 of ISO 11608-2:2012 Dislocation of measuring point at patient end Clause 4.8 of ISO 11608-2:2012 Determination of functional compatibility with Clause 4.9 of ISO 11608-2:2012 needle-based injection systems
Clause 4.10 of ISO 11608-2:2012
6
Sterile Barrier Packaging Testing performed on the proposed device:
| Seal strength | ASTM F88/F88-15 |
|---|---|
| Dye penetration | ASTM F1929-15 |
Sterilization and Shelf Life Testing performed on the proposed device:
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests |
| were performed on aging samples to verify the | |
| claimed shelf life of the device | |
| Sterilization validation | ANSI/AAMI/ISO 11135-1:2007 |
Biocompatibility Testing: Biocompatibility testing was performed according to ISO 10993 standards. The test conducted on proposed device include Cytotoxicity, Intracutaneous Reactivity, Skin Sensitization, Acute Systemic Toxicity, Pyrogen and Hemolysis Test.
Clinical Test Summary
No clinical study is included in this submission.
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Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device
K133059 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Product Code | FMI | Same |
| Regulation Number | 880.5570 | Same |
| Intended Use | The Disposable Insulin Pen Needle
is intended for use with pen injector
devices for the subcutaneous
injection of insulin. | Same |
| Configuration and material | Needle Tube Stainless Steel
Hub Polypropylene
Inner Sheath Polypropylene
Cup Polyethylene
Sealed Paper Paper | Needle Tube Stainless Steel
Hub Polypropylene
Inner Sheath Polypropylene
Cup Polypropylene
Sealed Paper Paper |
| Needle Gauge | Available in 28G, 29G, 30G, 31G,
32G and 33G | Available in 29G, 30G, 31G and 32G |
| Needle Length | Available in 4mm, 6mm, 8mm and
12mm | Available in 4mm, 5mm, 6mm, 8mm
10mm, and 12mm |
| Operation mode | Manual | Same |
| Sterile | EO sterilized, SAL: 10-6 | Same |
| Single Use | Single Use | Same |
| Endotoxin Limit | 20EU per device | Same |
| Labeling | Conform with 21 CFR 801 | Same |
| Biocompatibility | | Conform with ISO 10993 standards |
| Cytotoxicity | No Cytotoxicity | |
| Intracutaneous reactivity | No Irritation to Skin | |
| Skin Sensitization | No skin sensitization | |
| Acute Systemic Toxicity | No Systemic Toxicity | |
| Pyrogen | No pyrogen | |
| Hemolysis | No hemolysis | |
| Table 1 Comparison of Technology Characteristics | |
|---|---|
From above comparison table, the material, needle gauge and needle length for proposed device is different from predicate device. For the difference material used in the device, biocompatibility test has been performed on proposed device and the test result can meet the requirements of ISO 10993 standards. The propose device has the additional needle gauge of 28G and 33G compared to predicate device. However, the all proposed models have been tested and the test result can meet the standard requirements. For the different in needle length, the proposed needle length can be covered by predicate device. Therefore, these differences will not raise any safety and effectiveness issues.
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Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, performance testing conducted and passed, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.