The subject 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 consists of needle tube, inner sheath, outer sheath, hub and sealed paper. The hub can be connected screwed onto the insulin pen. The subject device is not intended for neonates, newborn infants or children. The subject device is used in conjunction with following pen injector during clinical use.

AI/ML Overview

This document is a 510(k) Summary for a Disposable Insulin Pen Needle. It does not describe an AI/ML medical device, but rather a physical, single-use medical device. Therefore, the questions related to AI/ML device performance, such as MRMC studies, training/test sets, and ground truth establishment, are not applicable.

The acceptance criteria and proof of "performance" for this device are demonstrated through non-clinical bench testing to show compliance with various international standards and substantial equivalence to a predicate device.

Here's an interpretation based on the provided document, restructured to address the questions where applicable for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

For a physical device like a pen needle, "acceptance criteria" are generally compliance with relevant standards and demonstration of substantial equivalence to a predicate device. The "reported device performance" refers to the results demonstrating this compliance.

Acceptance Criterion (Standard Compliance)	Reported Device Performance (Compliance Claim)
ISO 7864: 1993 Sterile hypodermic needles for single use	Complies with standard
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices	Complies with standard
ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles	Complies with standard
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals	Complies with standard (for residuals)
ASTM F88/F88M-09 Standard test method for seal strength of flexible barrier materials	Complies with standard
ASTM F1140/F1140M-13 Standard test methods for internal pressurization failure resistance of unrestrained packages	Complies with standard
USP 39-NF 34 <85> Bacterial Endotoxins Test	Complies with standard
ASTM F2096-11 Standard Test Method For Detecting Gross Leak in Medical Packaging by Internal Pressurization (Bubble Test)	Complies with standard
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration	Complies with standard
Biocompatibility (ISO 10993 series): - ISO 10993-5:2009 (Cytotoxicity) - ISO 10993-10:2010 (Irritation and skin sensitization) - ISO 10993-11:2006 (Systemic toxicity) - ASTM F756-13 (Hemolytic properties)	Patient-contact materials meet requirements of these standards
Sterility Assurance Level (SAL)	EO sterilized, SAL: 10^-6
Single Use Compliance	Designed and labeled for single use
Labeling Compliance	Conforms with 21 CFR 801
Substantial Equivalence to Predicate Device (K152824)	Achieved through non-clinical bench testing and comparison of technological characteristics

2. Sample sized used for the test set and the data provenance

The document states "Non-clinical tests were conducted..." but does not specify the sample sizes for these tests. Data provenance is implied to be from the manufacturer's internal testing in China (Jiangsu Caina Technology Co., Ltd. is based in China), as is typical for 510(k) submissions focusing on bench testing. The tests are "non-clinical," meaning they are not performed on human subjects and are simulated or lab-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as there is no "ground truth" in the context of an AI/ML system or a clinical test set in this document. The "ground truth" for a physical device is its adherence to a standard's specifications as verified by laboratory testing.

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

This question is not applicable for the type of bench testing described. Adjudication methods are relevant for human expert review, typically in clinical studies or image interpretation.

5. 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

This question is not applicable. This document details the submission for a physical medical device (pen needle), not an AI-assisted diagnostic or therapeutic device.

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

This question is not applicable as it pertains to AI/ML algorithms.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

As explained in point 3, the concept of "ground truth" for this device relates to compliance with established international and ASTM standards as measured through instrumental and chemical analyses in a laboratory setting. There is no biological or expert consensus ground truth defined in the context of this device's performance evaluation for a 510(k).

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/ML device.

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

This question is not applicable. There is no "training set" or "ground truth" for a training set.

In summary: The provided document is a 510(k) summary for a Disposable Insulin Pen Needle. Its "acceptance criteria" and "proof of performance" are entirely based on non-clinical bench testing and adherence to recognized international and ASTM standards, along with demonstrating substantial equivalence to a previously cleared predicate device. The concepts of AI/ML performance evaluation, such as training/test sets, human readers, ground truth establishment by experts, and MRMC studies, are not relevant to this type of device submission.

Summary

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December 13, 2017

Jiangsu Caina Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai 200120. China

Re: K170846

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: November 9, 2017 Received: November 13, 2017

Dear Ms. 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. 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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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 of medical device-related 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.

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.

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.

Tina Kiang -S

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

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Indications for Use

510(k) Number (if known) K170846

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)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K170846

1. Date of Preparation: 12/12/2017
1. Sponsor Identification

Jiangsu Caina Technology Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin, Jiangsu, 214425, China

Establishment Registration Number: 3005670221

Contact Person: Jun Lu Position: General Manager Tel: +86-510-86205183 Fax: +86-510-86215183 Email: jun.lu@cainamedical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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Identification of Subject device 4.
Trade Name: Disposable Insulin Pen Needle Common Name: Insulin Pen Needle

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 Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

Device Description

K Number	Product Name	Manufacturer
K123766	NovoPen	Novo Nordisk Inc
K142518	HumaPen	Eli Lilly and Company

1. Identification of Predicate Device
  510(k) Number: K152824 Product Name: MEDT Pen Needle Manufacturer: Shandong Caremed Medical Products Co., Ltd.

6. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

ISO 7864: 1993 Sterile hypodermic needles for single use

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ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices
ISO 11608-2:2012 Needle-based injection systems for medical use- Requirements and test methods-Part 2: Needles
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
ASTM F88/F88M-09 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
USP 39-NF 34 <85> Bacterial Endotoxins Test
ASTM F2096-11 Standard Test Method For Detecting Gross Leak in Medical Packaging by Internal Pressurization (Bubble Test)
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

The biocompatibility testing, including cytotoxicity, irritation, sensitization, systemic toxicity and hemolysis were referenced to demonstrate that the patient-contact materials of subject device meets the requirements of following ISO 10993 series standards.

ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro Cytotoxicity;
ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity;
ASTM F756-13, Standard Practice for Assessment of Hemolytic Properties of Materials.
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

	Item	Subject device	Predicate Device
			K152824
	Product Code	FMI	FMI
	Regulation Number	880.5570	880.5570
	Indications for Use	The Disposable Insulin Pen Needle is intendedfor use with pen injector devices for thesubcutaneous injection of insulin.	The MEDT Pen Needle is intended for use with peninjector devices for the subcutaneous injection ofinsulin.
C	Cannula	304 Stainless Steel	304 Stainless Steel

Table 1 Comparison of Technology Characteristics

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Hub	Polypropylene	Polypropylene
Lubricant	Polydimethylsiloxane	Polydimethylsiloxane
Needle Cap	Polyethylene	Polyethylene
Needle HubProtector	Polypropylene	Polypropylene
SealedPaper	Paper	Paper
Operation Mode	Manual	Manual
Needle Gauge	29G, 30G, 31G, 32G	29G, 30G, 31G, 32G
Needle Dimension(mm)	0.23×40.25×4, 0.25×5, 0.25×6, 0.25×8,0.30×8, 0.30×100.33×12	0.23×4, 0.23×5, 0.23×6,0.25×4, 0.25×5, 0.25×6, 0.25×8,0.30×5, 0.30×6, 0.30×8,0.33×10, 0.33×12
Performance	Comply with ISO 7864, ISO 9626, and ISO11608-2	Comply with ISO 7864, ISO 9626, and ISO11608-2
Sterile	EO sterilized, SAL: 10-6	EO sterilized, SAL: 10-6
Single Use	Single use	Single use
Labeling	Conform with 21 CFR 801	Conform with 21 CFR 801
Biocompatibility	Conform with ISO 10993 standards	Conform with ISO 10993 standards

The subject device has eight needle sizes; the predicate device heedles sizes. There are seven needle sizes of subject device are identical to those of the predicate device, only one needle size (0.30×10) of the subject device is different from the predicate device; this size (0.30×10) has same needle gauge as the predicate, but has a longer length than the predicate. The needle size (0.30×10) meets the performance requirements of ISO 7864. ISO 9626 and ISO 11608 standards, and the needle length (10mm) is one common insulin needle length for clinical use, therefore we think the difference on needle length will not raise new problem for the subject device.

All the subject devices are complied with the same performance standards. Through performance bench testing, the subject device has demonstrated that it is substantially equivalent to the predicate.

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the subject device is determined to be Substantially Equivalent (SE) to the predicate device.

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).