(250 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a simple, single-use needle, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
A pen needle is a delivery device for medication, not a therapeutic device. It is designed to assist in the subcutaneous injection of insulin, which is the therapeutic agent.
No
The device description clearly states its purpose is for the subcutaneous injection of insulin, not for diagnosing any condition.
No
The device description clearly outlines physical components (needle tubing, needle tip shield, etc.) and manufacturing processes (radiation sterilization), indicating it is a hardware medical device, not software-only.
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 its components designed for injection. There is no mention of reagents, test strips, or any components typically associated with in vitro testing.
- Lack of IVD Indicators: 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 diagnostic information
In summary, the device is a delivery system for medication, not a diagnostic tool that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
Product codes
FMI
Device Description
The proposed device, Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tubing, needle tip shield, needle base, needle base shield, sealing dialysis paper, glue and silicone oil. The needle base can be connected screwed onto the insulin pen.
The Pen Needle is offered in various gauge size and length.
The proposed device is available in radiation 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
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 to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Materials: The needle shall be made of tubing materials specified in ISO 9626.
- Dimensions: The needles shall fit the test apparatus specified in item 7.3 of ISO 11608-2.
- Flow rate through the needle: The needles were tested in accordance with Annex A to ISO 11608-2.
- Binding force between needle base and needle tubing: The union of the hub and needle tube shall not break when tested in accordance with Clause 9 of ISO 11608-2.
- Needle tip appearance, needle tubing flawlessness, size of inside and outside diameter and puncturing force: The needle tip appearance shall fulfil the 4.5 of ISO 11608-2.The needle tubing flawlessness shall fulfil the requirements of ISO 7864:1993, 11.3.
- Dislocation of measuring point patient end: Dislocation of the cannula point at the patient end shall be in accordance with Table 2 (ISO 11688-2) when tested in accordance with Clause 8 of ISO 11608-2.
- Functional compatibility with needle-based injected systems: Compatibility with any NIS shall be claimed only after testing in accordance with Clause 11 of ISO 11608-2.
- Easy of assemble and disassembly: Attachment of the needle shall be possible without removing the needle from its opened unit packaging. Compliance is checked according to the requirements of Clause 11 of ISO 11608-2.
- Biocompatibility:
- Cytotoxicity: ISO 10093-5 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- Sensitization: ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization
- Irritation: ISO 10993-10 Biological evaluation of medical devices -Part 10:Tests for irritation and skin sensitization
- Haemocompatibility: ISO 10993-4 Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood ASTM F765 Standard Practice for Assessment of Hemolytic Properties of Materials
- System toxicity (acute): ISO 10993-11:2006/(R)2010, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- Pyrogen: USP 34 NF 29 Pyrogen Test & USP .
Key results: All nonclinical testing performed on new devices demonstrate the substantial equivalence to the predicate device. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the compliance to the standards and matching the performance of new devices to the predicate devices.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring three stylized human profiles facing to the right, with flowing lines beneath them. The emblem is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2016
SteriLance Medical (Suzhou) Inc. c/o Mr. Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. No. 55 Shizhou Middle Road Nanshan District, Shenzhen, GD755 CHINA
Re: K153706
Trade/Device Name: Easy Drip Disposable Insulin Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: July 15, 2016 Received: July 28, 2016
Dear Mr. Fu:
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. 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.
1
Page 2 - Mr. Field Fu
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
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
Indications for Use
510(k) Number (if known) K153706
Device Name Easy Drip Disposable Insulin Needle
Indications for Use (Describe)
The Insulin Pen Needle is intended for use with pen injector device for 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)
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3
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | SteriLance Medical (Suzhou) Inc. |
|---|---|
| Address | No.68 LiTangHe Rd, XiangCheng, Suzhou, China |
| Phone No. | +86-512-65799308 |
| Fax No. | +86-512-67217663 |
| Contact person | Juanjuan Sun |
| Contact person's e-mail | juanjuans@sterilance.com |
| Company e-mail | smc@sterilance.com |
| Date Prepared | July 22, 2016 |
| Website | www.sterilance.com |
1.2 Submission Correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | Room 2032, International Mayors Communication Centre, NO. 55 |
| Shizhou middle road, Nanshan District, Shenzhen | |
| Phone No. | +86-755-86069197 |
| Contact person | Field Fu |
| Contact person's e-mail | cefda13485@163.com; elly@cefda.com |
| Website | http://www.cefda.com |
2. Device information
| Trade name | Easy Drip Disposable Insulin Needle |
|---|---|
| Common name | Insulin Pen Needle |
| Model | 29G/30G/31G/32G |
| Classification | II |
| Classification name | Needle, Hypodermic, Single Lumen |
| Product code | FMI |
| Regulation No. | 880.5570 |
3. Legally Marketed Predicate Device
| Trade Name | Insulin Pen Needle |
|---|---|
| 510(k) Number | K133059 |
| Product Code | FMI |
| Manufacturer | Wenzhou Beipu Science & Technology Co., Ltd |
4
Product: Insulin Pen Needle
Device Description 4.
The proposed device, Pen Needle, is a single-use device, which is designed for use with a pen injector for the subcutaneous injection of insulin. It consists of needle tubing, needle tip shield, needle base, needle base shield, sealing dialysis paper, glue and silicone oil. The needle base can be connected screwed onto the insulin pen.
The Pen Needle is offered in various gauge size and length.
The proposed device is available in radiation sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.
Intended Use/Indication for Use 5.
The Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin.
| Item | Proposed Device:
Insulin Pen Needle | Predicate Device:
Insulin Pen Needle
(K133059) | Comments |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Code | FMI | FMI | Same |
| Intended Use | The Insulin Pen Needle is
intended for use with pen
injector device for
subcutaneous injection of
insulin. | The Insulin Pen Needle is
intended for use with pen
injector devices for the
subcutaneous injection of
insulin. | Same |
| Configuration | Needle tubing (Needle Tube),
Needle tip shield (Tube
Sheath), Needle base (Hub),
Needle base shield (Hub
Sheath), Sealing dialysis paper
(Sealed Paper). | Needle Tube, Hub, Tube
Sheath, Hub Sheath and
Sealed Paper. | Same |
| Operation mode | Manual | Manual | Same |
| Needle Gauge | 29G/30G/31G/32G | 29G/30G/31G/32G | Same |
| Material | Tube: 304 Stainless Steel
Needle base:
Polyformaldehyde | Tube: 304 Stainless Steel
Hub: Polypropylene | Similar (*1) |
| Sterilization | SAL: 10-6
Method: Radiation Sterilized | SAL: 10-6
Method: EO Sterilized | Same
Different (*2) |
| Performance | Complied with ISO 7864, ISO
9626, and ISO 11608-2 | Complied with ISO 7864, ISO
9626, and ISO 11608-2 | Same |
| Shelf Life | 5 years | 5 years | Same |
| Single Use | Yes | Yes | Same |
| Biocompatibility | Complied with ISO10993
series standards | Complied with ISO10993
series standards | Same |
| Cytotoxicity | Under the conditions of the | Under the conditions of the | Same |
6. Substantial Equivalence Comparison
5
Product: Insulin Pen Needle
| | study, the subject device
showed no evidence of
cytotoxicity | study, the subject device
showed no evidence of
cytotoxicity | |
|----------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------|
| Skin Irritation | Under the conditions of the
study, the subject device
showed no evidence of skin
irritation | Under the conditions of the
study, the subject device
showed no evidence of skin
irritation | Same |
| Skin
Sensitization | Under the conditions of the
study, the subject device
showed no evidence of
sensitization | Under the conditions of the
study, the subject device
showed no evidence of
sensitization | Same |
| Acute Systemic
Toxicity | Under the conditions of the
study, the subject device
showed no evidence of
systemic toxicity | Under the conditions of the
study, the subject device
showed no evidence of
systemic toxicity | Same |
| Hemolysis | Under the conditions of the
study, the subject device
showed no evidence of
hemolysis | Under the conditions of the
study, the subject device
showed no evidence of
hemolysis | Same |
| Pyrogen | non-pyrogenic | non-pyrogenic | Same |
*1: The needle base materials are different, but Polyformaldehyde and Polypropylene are all the common plastic materials. The biocompatibility and performance testing reports of the proposed device demonstrate that subject device is biocompatible and the performance as intended.
*2: The sterilization methods between the proposed device and the predicate device are different. The radiation sterilization method for the proposed device is proved by the Microbiological Validation Report of Gamma Radiation Sterilization and Radiation Sterilization Dose Audit Test reports. The validation report demonstrates that the sterilization of the proposed device can achieve a Sterility Assurance Level (SAL) of 108, and the radiation dose audit test reports showed that the minimum gamma radiation dose to achieve a 10° SAL was acceptable according to ISO 11737-2:2012. Therefore, the difference does not affect substantially equivalency between the proposed device and predicate device.
Non-clinical Testing 7.
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 results demonstrated that the proposed device complies with the following standards:
| Test | Requirements |
|---|---|
| Materials | The needle shall be made of tubing materials specified |
| in ISO 9626. | |
| Dimensions | The needles shall fit the test apparatus specified in item |
| 7.3 of ISO 11608-2. |
6
Product: Insulin Pen Needle
| Flow rate through the needle | The needles were tested in accordance with Annex A
to ISO 11608-2. | |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Binding force between needle base and
needle tubing | The union of the hub and needle tube shall not break
when tested in accordance with Clause 9 of ISO
11608-2. | |
| Needle tip appearance, needle tubing
flawlessness, size of inside and outside
diameter and puncturing force | The needle tip appearance shall fulfil the 4.5 of ISO
11608-2.The needle tubing flawlessness shall fulfil the
requirements of ISO 7864:1993, 11.3. | |
| Dislocation of measuring point patient end | Dislocation of the cannula point at the patient end shall
be in accordance with Table 2 (ISO 11688-2) when
tested in accordance with Clause 8 of ISO 11608-2. | |
| Functional compatibility with needle-based
injected systems | Compatibility with any NIS shall be claimed only after
testing in accordance with Clause 11 of ISO 11608-2. | |
| Easy of assemble and disassembly | Attachment of the needle shall be possible without
removing the needle from its opened unit packaging.
Compliance is checked according to the requirements
of Clause 11 of ISO 11608-2. | |
| Biocompatibility | | |
| | Cytotoxicity | ISO 10093-5 Biological evaluation of medical devices
-Part 5: Tests for in vitro cytotoxicity |
| | Sensitization | ISO 10993-10 Biological evaluation of medical devices
-Part 10:Tests for irritation and skin sensitization |
| | Irritation | ISO 10993-10 Biological evaluation of medical devices
-Part 10:Tests for irritation and skin sensitization |
| | Haemocompatibility | ISO 10993-4 Biological evaluation of medical devices
Part 4: Selection of tests for interactions with blood
ASTM F765 Standard Practice for Assessment of
Hemolytic Properties of Materials |
| | System toxicity (acute) | ISO 10993-11:2006/(R)2010, Biological evaluation of
medical devices - Part 11: Tests for systemic toxicity. |
| | Pyrogen | USP 34 NF 29 Pyrogen Test & USP . |
All nonclinical testing performed on new devices demonstrate the substantial equivalence to the predicate device. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the compliance to the standards and matching the performance of new devices to the predicate devices.
8. Clinical Testing
Substantial equivalence does not depend on the clinical test data.
9. Conclusions
Based on device comparison information and non-clinical bench testing, the proposed device is substantially equivalent to legally marketed predicate device (K133059).