(107 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a simple mechanical device (insulin pen needle). There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
A therapeutic device is one that treats a disease or condition. This device is a pen needle, which is used to administer a therapeutic substance (insulin) but does not itself have a therapeutic effect. It serves as a delivery mechanism rather than a therapeutic agent.
No
This device, an insulin pen needle, is used for subcutaneous injection of insulin, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components (needle tube, needle shield, etc.) and mentions sterilization and bench testing related to physical properties, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "Insulin pen needle" intended for "subcutaneous injection of insulin." This is a device used to deliver a substance into the body, not to analyze a specimen from the body.
- Lack of Diagnostic Information: The device description and intended use do not mention any analysis of biological samples or the generation of diagnostic information.
Therefore, based on the provided information, the insulin pen needle is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Insulin pen needle is intended for use with pen injector for subcutaneous injection of insulin.
Product codes
FMI
Device Description
Insulin pen needle is a single-use device, which consists of needle tube, needle shield, needle seat, needle seat protection cover, and seat seal paper. Needle gauge includes 29G, 30G, 31G, and 32G. Needle length can be produced to various sizes. After sterilization by EO, it's sterile, pyrogen free, and non-toxic. Its shelf life is 5-year.
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)
Bench test proves the subject device complies with requirements of ISO 11608-2, ISO 9626, and ISO 7864. Besides, biocompatibility tests prove it meets applicable requirements of ISO 10993.
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
K 120690
510(k) Summary
JUN 2 2 2012
As Required by 21 CFR 807.92
-
- Date of Preparation: Feb. 24, 2012
2. Sponsor Information:
Tiger Medical Products Ltd. Liulin Tower, Suit 1910, 1 Huaihai Zhong Road Shanghai 200021, China
Contact Person:
David Wang, RA Manager Tiger Medical Products Ltd. Phone Number: 86-21-6386 6300 Fax Number: 86-21-6386 5086 E-mail: davidwang@tigermedicalgroup.com
3. Submission Correspondent
David Wang, RA Manager, Tiger Medical Products Ltd. Phone Number: 86-21-6386 6300 Fax Number: 86-21-6386 5086 E-mail: davidwang@tigermedicalgroup.com
4. Device Name and Classification:
- a. Common Name: insulin pen needle
- b. Regulation Number: 880.5570
- c. Product code: FMI
- d. Class: II
- e. Review Panel: General Hospital
5. Predicate Device Identification: K051899
Trade Name: BD Pen Needles
K112332
Trade Name: Fine Ject Insulin Pen Needle
6. Device Description:
Insulin pen needle is a single-use device, which consists of needle tube, needle shield, needle seat, needle seat protection cover, and seat seal paper. Needle gauge includes 29G, 30G, 31G, and 32G. Needle length can be produced to various sizes. After sterilization by EO, it's sterile, pyrogen free, and non-toxic. Its shelf life is 5-year.
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7. Summary of Non-clinical Testing Data
Bench test proves the subject device complies with requirements of ISO 11608-2, ISO 9626, and ISO 7864. Besides, biocompatibility tests prove it meets applicable requirements of ISO 10993.
8. Statement of Intended Use:
Insulin pen needle is intended for use with pen injector device for subcutaneous injection of insulin.
| Item | Insulin pen needle | BD pen needles (K051899) | Fine Ject Insulin Pen Needle (K112332) |
|---|---|---|---|
| Intended use | Insulin pen needle is intended for use with pen injector device for subcutaneous injection of insulin. | BD pen needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide. | Fine Ject insulin pen needles are intended for subcutaneous injection of insulin in the treatment of diabetes. |
| Needle gauge and length | Various sizes | Various sizes | Various sizes |
| Labeling and labels | Meet FDA requirements | Meet FDA requirements | Meet FDA requirements |
| Needle tube material | SUS 304 stainless steel | Stainless steel | Stainless steel |
| Material of needle seat, needle shield, and needle seat protection cover | PP | Unknown plastic | Unknown plastic |
| Material of needle seat seal | Dialysis paper | Paper | Paper |
| Performance specification (technology characteristics) | Conforms to ISO 11608-2 | Conforms to ISO 11608-2 | Conforms to ISO 11608-2 |
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Sterility | SAL: 1x10-6 | ||
| EtO Sterilization | SAL: 1x10-6 | ||
| Gamma irradiation | SAL: 1x10-6 | ||
| Gamma irradiation |
9. Summary of Comparison with Predicate Devices
10. Substantial Equivalence Conclusion
The subject device is substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
JUN 2 2 2012
Mr. David Wang Regulatory Affairs Manager Tiger Medical Products. Limited 1 Huaihai Zhong Road Liulin Tower. Suite 1910 Shanghai, China 200021
Re: K120690
Trade/Device Name: Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: May 17, 2012 Received: May 17, 2012
Dear Mr. Wang:
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.
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Page 2- Mr. Wang
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Nh.for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K120690 510(k) Number (if known):
Device Name: Insulin Pen Needle
Indications for Use:
Insulin pen needle is intended for use with pen injector for subcutaneous injection of insulin.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
h
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division Control, Dental Devices
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510(k) Number: K120690