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.

AI/ML Overview

The provided text describes a 510(k) submission for an insulin pen needle. This type of medical device is generally evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices, rather than through complex clinical studies with human participants, AI algorithms, or extensive ground truth establishment. Therefore, many of the requested categories are not applicable in this context.

Here's an analysis based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Mechanical/Physical Performance (ISO Compliance)	Conforms to ISO 11608-2 (Needle systems for medical use - Requirements and test methods - Part 2: Pen needles)	Bench tests prove compliance with ISO 11608-2
Material Composition (Needle Tube)	Made of SUS 304 stainless steel	Made of SUS 304 stainless steel
Material Composition (Needle Seat, Shield, Protection Cover)	Made of PP	Made of PP
Material Composition (Needle Seat Seal)	Made of Dialysis paper	Made of Dialysis paper
Biocompatibility	Conforms to ISO 10993 (Biological evaluation of medical devices)	Biocompatibility tests prove compliance with ISO 10993
Sterility	Sterility Assurance Level (SAL): 1x10^-6	SAL: 1x10^-6, EtO Sterilization
Pyrogenicity	Pyrogen free	Reported as "pyrogen free"
Toxicity	Non-toxic	Reported as "non-toxic"
Shelf Life	5-year shelf life	Reported as "5-year shelf life"
Labeling and Indications for Use	Meet FDA requirements for labeling and intended use	Meets FDA requirements, Intended for use with pen injector device for subcutaneous injection of insulin.

Study Details (Based on available information)

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly mentioned for specific test types, but implied to be sufficient for ISO compliance and biocompatibility testing. This typically involves a statistically relevant number of samples per test as outlined by the standards.
Data Provenance: The device manufacturer is Tiger Medical Products Ltd. in Shanghai, China. The testing was conducted by or on behalf of the manufacturer, likely in China or by certified labs. The tests are non-clinical (bench and biocompatibility).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This is a non-clinical device that relies on standardized performance and biocompatibility testing, not expert interpretation of diagnostic images or clinical outcomes. The "ground truth" is established by the specifications of the ISO standards and the verifiable results of the tests.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human interpretation is involved. For this device, performance is measured against established engineering and biological standards.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a single-use insulin pen needle, not a diagnostic or AI-powered device involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device does not incorporate any algorithms or AI component.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Standardized Test Results/Compliance with ISO Standards and Biocompatibility Protocols. The "ground truth" for this device lies in its ability to meet the defined technical specifications of ISO 11608-2, ISO 9626, ISO 7864, and the biological safety requirements of ISO 10993. This is verified through laboratory testing (e.g., force measurements, flow rates, sterility tests, cytotoxicity assays).

7. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

8. How the ground truth for the training set was established

Not Applicable. There is no "training set" or corresponding ground truth to establish.

Summary

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K 120690

510(k) Summary

JUN 2 2 2012

As Required by 21 CFR 807.92

1. 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:

Page 1 of 2

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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: 1x10-6EtO Sterilization	SAL: 1x10-6Gamma irradiation	SAL: 1x10-6Gamma 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

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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)

(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

Regulation Number and Section

§ 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).