The proposed device, MEDT Pen Needle, is a single-use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. It consist of three components, which are (1) needle, (2) hub and (3) inner sheath; it is sealed in a package consists of (1) a outer sheath and (2) Tyvek Paper.

AI/ML Overview

The provided text describes the 510(k) summary for the MEDT Pen Needle, focusing on its substantial equivalence to a predicate device rather than a study proving the device meets acceptance criteria in the context of an AI/ML medical device. The document outlines non-clinical tests conducted to demonstrate the device meets design specifications and complies with relevant standards.

Therefore, many of the requested categories for AI/ML device studies (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this submission, as it pertains to a physical medical device (hypodermic needle) and not an AI/ML algorithm.

However, I can extract the acceptance criteria and reported performance based on the non-clinical tests mentioned.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Item	Reported Device Performance	Relevant Standard
Physical, Mechanical, and Chemical Tests
Materials, Surface finish, Cleanliness	Complies with relevant ISO standards	ISO 7864:1993, ISO 9626:1991 AMD 2001, ISO 11608-2:2012
Limits for acidity and alkalinity	Complies with relevant ISO standards	ISO 7864:1993
Size designation, Dimensions	Complies with relevant ISO standards (Needle gauges: 29G, 30G, 31G, 32G; 12 different needle dimensions)	ISO 7864:1993, ISO 9626:1991 AMD 2001, ISO 11608-2:2012
Stiffness, Resistance to breakage	Complies with relevant ISO standards	ISO 7864:1993, ISO 9626:1991 AMD 2001
Resistance to corrosion	Complies with relevant ISO standards	ISO 7864:1993
Limits for extractable metals	Complies with relevant ISO standards	ISO 9626:1991 AMD 2001
Colour coding, Needle hub, Sheath	Complies with relevant ISO standards	ISO 11608-2:2012
Needle tube, Needle point, Performance	Complies with relevant ISO standards	ISO 7864:1993, ISO 11608-2:2012
Determination of flow rate through the needle	Complies with relevant ISO standards	ISO 7864:1993
Bond between hub and needle tube	Complies with relevant ISO standards	ISO 7864:1993
Freedom from defects, Lubrication	Complies with relevant ISO standards	ISO 7864:1993
Dislocation of measuring point at patient end	Complies with relevant ISO standards	ISO 11608-2:2012
Functional compatibility with pen injectors	Compatible with NovoPen Echo, HumaPen Luxura (Same as predicate)	ISO 11608-2:2012
Ease of assembly and disassembly	Complies with relevant ISO standards	ISO 11608-2:2012
Sterile Barrier Packaging Testing
Seal Strength	Complies with ASTM F88/F88M-09	ASTM F88/F88M-09
Sterilization and Shelf Life Testing
EO residue, ECH residue	Complies with ISO 10993-7:2008	ISO 10993-7:2008
Bacteria Endotoxin Limit	Complies with USP 37-NF 32 <85>, 20 EU per product	USP 37-NF 32 <85>
Shelf Life Evaluation	Verified claimed shelf life through accelerated aging; Physical, Mechanical, Chemical, Package tests
Sterility Test	Performed per USP 38-NF 33 <71>, SAL: 10-6	USP 38-NF 33 <71>
Biocompatibility Testing
Cytotoxicity test	No cytotoxicity	ISO 10993-5:2009
Intracutaneous Reactivity test	No Intracutaneous reactivity	ISO 10993-10:2010
Skin Sensitization Test	No significant evidence of sensitization	ISO 10993-10:2010
Acute Systemic Toxicity Test	No systemic toxicity	ISO 10993-11:2006
Hemolysis Test	No evidence of hemolysis	ASTM F 756-13
Pyrogen Test	No pyrogen	USP 38-NF 33 <151>
Labeling	Conforms with 21 CFR 801	21 CFR 801

Inapplicability to AI/ML Device Study Criteria:

The provided document is a 510(k) summary for a physical medical device (hypodermic pen needle), not an AI/ML medical device. Therefore, the following requested information related to AI/ML device studies is not applicable and not found within the document:

Sample sized used for the test set and the data provenance: Not applicable. The "test set" here refers to physical samples of the device undergoing laboratory testing, not a dataset for algorithm evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through compliance with engineering standards and laboratory measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. The "ground truth" for this device is based on established engineering and biocompatibility standards, and physical measurements.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2016

Shandong Caremed Medical Products Co., Ltd. % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K152824

Trade/Device Name: MEDT Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: January 28, 2016 Received: February 3, 2016

Dear Ms. 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 (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 -

for Erin I. Keith, M.S. 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)

K152824

Device Name MEDT Pen Needle

Indications for Use (Describe)

The MEDT 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 Title 21, CFR Section 807.92. The assigned 510(k) Number: K152824

1. Date of Preparation: 03/03/2016
Sponsor Identification 2.

Shandong Caremed Medical Products Co., Ltd.

(Yantai) Industrial Park, DingTao County (The East of Zhanqian Road), Shandong, 274100, China

Contact Person: Lin Yanyan Position: Management representative Tel: 86-530-7397700 Fax: 86-530-7397711 Email: lyyan@shanghaicarelife.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (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

1. Identification of Proposed Device
  Trade Name: MEDT Pen Needle Common Name: Insulin Pen Needle

Regulatory Information Classification Name: Needle, Hypodermic, Single Lumen; Classification: II; Product Code: FMI; Regulation Number: 21 CFR 880.5570;

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Review Panel: General Hospital;

Intended Use Statement:

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

Device Description

ડ. Identification of Predicate Device(s)
510(k) Number: K133059 Product Name: Insulin Pen Needle Manufacturer: Wenzhou Beipu Science & Technology Co., Ltd
1. Non-Clinical Test Conclusion
  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:

Physical, Mechanical and Chemical Tests performed on the proposed device

ISO 7864: 1993 Sterile hypodermic needles for single use
ISO 9626:1991 AMD 2001 Stainless steel needle tubing for the manufacture of medical devices
A ISO 11608-2:2012 Needle-based injection systems for medical use- Requirements and test methods-Part 2: Needles

Test Item

Materials Surface finish Cleanliness Limits for acidity and alkalinity Size designation Dimensions Stiffness Resistance to breakage Resistance to corrosion

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Cleanliness Limits for acidity or alkalinity Limits for extractable metals Size designation Colour coding Needle hub Sheath Needle tube Needle point Performance Materials Dimensions Determination of flow rate through the needle Bond between hub and needle tube Needle points Freedom form defects Lubrication Dislocation of measuring point at patient end Determination of functional compatibility with needle-based injection systems Ease of assembly and disassembly Sterility

Sterile Barrier Packaging Testing performed on the proposed device:

Seal Strength: ASTM F88/F88M-09 Standard test method for seal strength of flexible barrier materials

Sterilization and Shelf Life Testing performed on the proposed device:

EO residue	ISO 10993-7:2008 Biological evaluation of medical devices- Part7: Ethylene oxide sterilization residuals
ECH residue	ISO 10993-7:2008 Biological evaluation of medical devices- Part7: Ethylene oxide sterilization residuals
Bacteria Endotoxin Limit	USP 37-NF 32 <85> Bacterial Endotoxins Limits
Shelf Life Evaluation	Physical, Mechanical, Chemical, Package were performed onaccelerated aging samples to verify the claimed shelf life of thedevice
	Sterility Test was performed per USP 38-NF 33 <71> SterilityTests

Biocompatibility test on the proposed device:

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Cytotoxicity test	ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
Intracutaneous Reactivity test	ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
Skin Sensitization Test	ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization
Acute Systemic Toxicity Test	ISO 10993-11:2006 Biological evaluation of medical devices- Part 11: Tests for systemic toxicity
Hemolysis Test	ASTM F 756-13 Standard practice for assessment of hemolytic properties of materials
Pyrogen Test	USP 38-NF 33 <151> Pyrogen test

1. Substantially Equivalent (SE) Comparison

Item	Proposed DeviceK152824	Predicate DeviceK133059
Product Code	FMI	Same
Regulation Number	880.5570	Same
Intended Use	The MEDT Pen Needle is intended foruse with pen injector devices for thesubcutaneous injection of insulin.	Same
Configuration andmaterial	Needle tube Stainless Steelhub PolypropyleneInner sheath PolyethyleneOuter sheath PolypropyleneTyvek paper Paper	Needle tube Stainless Steelhub PolypropyleneTube sheath PolypropyleneHub sheath PolypropyleneSealed paper Paper
Operation mode	Manual	Same
Needle Gauge	29G, 30G, 31G, 32G	Same
Needle Dimension(mm)	$0.23 \times 4, 0.23 \times 5, 0.23 \times 6,$$0.25 \times 4, 0.25 \times 5, 0.25 \times 6, 0.25 \times 8,$$0.30 \times 5, 0.30 \times 6, 0.30 \times 8,$$0.33 \times 10, 0.33 \times 12$	$0.23 \times 4,$$0.25 \times 4, 0.25 \times 5, 0.25 \times 6, 0.25 \times 8,$$0.30 \times 8, 0.30 \times 10,$$0.33 \times 12$
Performance	Comply with ISO 7864, ISO 9626, andISO 11608-2	Same
Compatible peninjectors	NovoPen EchoHumaPen Luxura	Same
Sterile	EO sterilized, SAL: 10-6	Same
Single Use	Single use	Same
Endotoxin Limit	20 EU per product	Same

Table 1 Comparison of Technology Characteristics

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Labeling	Conform with 21 CFR 801	Same
Biocompatibility	Conform with ISO 10993 standards	Same
Cytotoxicity	No cytotoxicity
IntracutaneousReactivity	No Intracutaneous reactivity
Skin Sensitization	No significant evidence of sensitization
Acute SystemicToxicity	No systemic toxicity
Hemolysis	No evidence of hemolysis
Pyrogen	No pyrogen

Comparison discussion:

The subject device has the same indications for use and the same principle of operation as the predicate device. Both subject and predicate devices are provided as sterile, nonpyrogenic and individually packaged.

The differences between the subject and the predicate devices include:

. The material used for Inner sheath of the subject device is Polyethylene. The material used for Tube sheath of the predicate device is Polypropylene.
. The subject and predicate devices have same needle gauges but different needle lengths. The subject device contains twelve (12) needle sizes. The predicate device contains eight (8) needle sizes.

The performance testing of the subject device met all acceptance criterial. These differences do not have impacts to product technology and performance to the subject device, and do not raise new issues of product performance.

8. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are 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).