(145 days)
No
The description focuses on mechanical safety features and does not mention any computational or data-driven components.
No
Explanation: This device is an insulin pen needle, which is used for the subcutaneous injection of insulin. While it is used in the management of a therapeutic condition (diabetes), the device itself is a delivery mechanism for a drug, and its primary function is not to treat or cure a disease directly, but rather to facilitate the administration of a therapeutic substance.
No
This device is a safety insulin pen needle used for subcutaneous insulin injection, designed to prevent accidental needle sticks. It is not involved in diagnosing medical conditions but rather in delivering medication.
No
The device description clearly outlines physical components like a hub, spring, needle tube, safety shield, housing, safety seat, outer container, and sealed paper, 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 using a pen injector device. This is a direct administration of a substance into the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a needle and safety mechanism for injection, not components for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The focus is entirely on the physical act of injection and safety features related to that process.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Safety Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The attached safety shield automatically locks after injection and reduces the occurrence of accidental needle sticks from the patient end of the needle.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Safety Insulin Pen Needle consists of hub, spring, needle tube, safety shield, housing, safety seat, outer container and sealed paper. The sharps protection feature can be passively activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
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
The proposed device is not intended for neonates, newborn infants or children.
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 tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices- Requirements and test methods
- ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
- ISO 7864:2016 Sterile hypodermic needles for single use- Requirements and test methods
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ISO 11608-1:2014 Needle-based injection systems for medical use-Requirements and test methods-Part 1: Needle-based injection systems
- ISO 11608-2:2012 Needle-based injection systems for medical use-Requirements and test methods-Part 2:Needles
- 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
- USP Bacterial Endotoxins Test
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packing by Visual Inspection
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
February 18, 2020
Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 Cn
Re: K192677
Trade/Device Name: Safety Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: December 27, 2019 Received: January 14, 2020
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/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,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K192677
Device Name Safety Insulin Pen Needle
Indications for Use (Describe)
The Safety Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The attached safety shield automatically locks after injection and reduces the occurrence of accidental needle sticks from the patient end of the needle.
| 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)
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3
510(k) Summary K192677
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K192677
-
- Date of Preparation: 2/17/2020
-
- Sponsor Identification
Jiangsu Caina Medical Co., Ltd. No.23, Huaxi Road, Zhutang Town, Jiangyin, Jiangsu, 214415, China
Establishment Registration Number: 3005670221
Contact Person: Jianwei Pan Position: Management Representative Tel: +86-510-8686 6666-8027 Fax: +86-510-8686 6666-8009 Email: jianwei.pan@cainamed.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Chen (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Safety Insulin Pen Needle Common Name: Safety insulin needle for single use
Regulatory Information
Classification Name: Hypodermic single lumen needle; Classification: II; Product Code: FMI; Regulation Number: 21 CFR 880.5570 Review Panel: General Hospital;
Indications for Use:
The Safety Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. The attached safety shield automatically locks after injection and reduces the occurrence of accidental needle sticks from the patient end of the needle.
Device Description
The Safety Insulin Pen Needle consists of hub, spring, needle tube, safety shield, housing, safety seat, outer container and sealed paper. The sharps protection feature can be passively activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The proposed device is not intended for neonates, newborn infants or children. Pen injector compatible with pen needle is provided as follows:
| Manufacturer | Pen Injector | 510(k) Number |
|---|---|---|
| Novo Nordisk Inc. | NovoPen Echo® | K123766 |
| Eli Lily and Company | HumaPen Luxura | K142518 |
The proposed Safety Insulin Pen Needle is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 % and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
5. Identification of Predicate Device
510(k) Number: K181447 Trade/Device Name: Safety insulin needle for single use
5
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices- Requirements and test methods
-
ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
-
A ISO 7864:2016 Sterile hypodermic needles for single use- Requirements and test methods
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
ISO 11608-1:2014 Needle-based injection systems for medical use-Requirements and test methods-Part 1: Needle-based injection systems
-
ISO 11608-2:2012 Needle-based injection systems for medical use-Requirements and test methods-Part 2:Needles
-
A 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
-
A USP Bacterial Endotoxins Test
-
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packing by Visual Inspection
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
A ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
8. Substantially Equivalent (SE) Comparison
| Table 1 General Comparison of Technology Characteristics | ||
|---|---|---|
| ITEM | Proposed Device | Predicate Device |
| K181447 | ||
| Product Code | FMI | FMI |
| Regulation No. | 21 CFR 880.5570 | 21 CFR 880.5570 |
| Class | II | II |
| Indication for Use | The Safety Insulin Pen Needle is | |
| intended for use with pen injector | ||
| devices for the subcutaneous | ||
| injection of insulin. The attached | ||
| safety shield automatically locks | ||
| after injection and reduces the | ||
| occurrence of accidental needle | ||
| sticks form the patient end of the | ||
| needle. | The Safety insulin needle for single | |
| use is intended for use with pen | ||
| injector devices for the subcutaneous | ||
| injection of insulin. | ||
| Needle gauge | 29G, 30G, 31G, 32G | 29G, 30G, 31G, 32G, 33G, 34G |
| Needle length | 4mm, 5mm, 6mm, 8mm, 10mm | 4mm, 5mm, 6mm, 8mm |
| Wall type | Thin-walled | Thin-walled |
| Extra-thin-walled | Extra-thin-walled | |
| Needle | ||
| performance | Complied with | Complied with |
| ISO 7864:2016 | ISO 7864:2016 | |
| ISO 9626:2016 | ISO 9626:2016 | |
| ISO 11608-1:2014 | ISO 11608-2 | |
| ISO 11608-2:2012 | ||
| Needle tube | Needle Tube | |
| Configuration and | ||
| material | Hub | Hub |
| Spring | Spring | |
| Safety seat | Safety seat | |
| Seal paper | Sealed paper | |
| Outer container | Safety protective cover | |
| Safety shield | Self-destruction seat | |
| Housing | Hub sheath | |
| Safety feature | ||
| functions | With safety feature | With safety feature |
| Biocompatibility | ||
| Cytotoxicity | Biocompatibility is demonstrated | No cytotoxicity |
| Irritation | by reference device (K170846) | No intracutaneous reactivity |
| Sensitization | No skin sensitization | |
| Systemic Toxicity | No systemic toxicity | |
| Hemolysis | No hemolysis | |
| Pyrogen | No pyrogen | |
| Single use | Single use | Single use |
| Sterilization | EO sterilization | EO sterilization |
| SAL | 10-6 | 10-6 |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 |
| Endotoxin Limit | 20 EU per device | 20 EU per device |
Table 1 General Comparison of Technology Characteristics
7
Analysis on the differences between the predicate and proposed device:
Analysis on indications for use:
Both the predicate and proposed device are intended for use with pen injector devices for the subcutaneous injection of insulin. And they have the safety feature to reduce the occurrence of accidental needle sticks. Therefore, although they have different expression on the indication for use, the predicate and proposed device has the same indicatiosn for use.
Analysis on configuration
The proposed device and predicate device have the same configuration; the difference is the naming of each component.
Analysis on needle gauge
The needle gauge of the proposed device is different from the predicate device. However, the needle gauge within the range of predicate device needle gauges.Additionally, the performance of needle has been evaluated and the test results comply with related standards requirements. Therefore, this difference does not affect equivalence of the proposed device and predicate device.
Analysis on needle length
The propose device has an additional 10mm in the needle length, which is outside the range of the predicate device (K181447). However, information provided in the reference device Disposable Insulin Pen Needle (K170846) (Jiangsu Caina Medical Co., Ltd) which validated the 10mm needle length which is also the product of the sponsor has the same needle length as the subject device.
8
Analysis on safety feature functions
The safety feature functions of predicate device is not exposured in the predicate device's 510(k) summary. ISO 23908 Safety Feature Testing was conducted to compare the needle safety activation force and force to challenge safe mode both on the predicate and proposed device. The test results demonstrated that they have the similar safety feature functions. Therefore, this item is considered to be substantial equivalent.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.