MEDT PEN NEEDLE

• K Number: K152824
• Device Name: MEDT PEN NEEDLE
• Manufacturer: SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD.
• Date Cleared: 2016-03-07 ( 160 days)
• Product Code: FMI
• Regulation Number: 880.5570

Intended Use

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

Device Description

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.

Predicate Devices

K133059

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and mechanical properties of a pen needle, with no mention of AI or ML.

Therapeutic

No.
A pen needle is a delivery device for insulin, not a therapeutic device. It does not actively treat or cure a disease itself, but rather facilitates the
administration of a therapeutic substance (insulin).

Diagnostic

No

The device is described as a "Pen Needle" intended for "subcutaneous injection of insulin," which indicates a therapeutic rather than a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical device consisting of a needle, hub, and inner sheath, and the performance studies involve physical, mechanical, and chemical tests, indicating it is not software-only.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "for use with pen injector devices for the subcutaneous injection of insulin." This describes a device used to administer a substance into the body, not to test samples from the body.
• Device Description: The description details a needle, hub, and sheath, designed for injection. This aligns with a delivery device, not a diagnostic one.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
• Performance Studies: The performance studies focus on physical, mechanical, chemical, sterilization, and biocompatibility testing, which are typical for devices that come into contact with the body for delivery, not for diagnostic testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is solely for the delivery of insulin.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

FMI

Device Description

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.

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)

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
• 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
• 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- Part 7: Ethylene oxide sterilization residuals
• ECH residue: ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals
• Bacteria Endotoxin Limit: USP 37-NF 32 Bacterial Endotoxins Limits
• Shelf Life Evaluation: Physical, Mechanical, Chemical, Package were performed on accelerated aging samples to verify the claimed shelf life of the device. Sterility Test was performed per USP 38-NF 33 Sterility Tests

Biocompatibility test on the proposed device:

• 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 Pyrogen test

Key Results:

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K133059

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone] Email: [e-mail]

• 3. 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: [phone], Fax: [phone] Email: [e-mail]

• 4. 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

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.

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

• 6. 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

5

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- Part
7: Ethylene oxide sterilization residuals |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| ECH residue | ISO 10993-7:2008 Biological evaluation of medical devices- Part
7: Ethylene oxide sterilization residuals |
| Bacteria Endotoxin Limit | USP 37-NF 32 Bacterial Endotoxins Limits |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package were performed on
accelerated aging samples to verify the claimed shelf life of the
device |
| | Sterility Test was performed per USP 38-NF 33 Sterility
Tests |

Biocompatibility test on the proposed device:

6

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 Pyrogen test

• 7. Substantially Equivalent (SE) Comparison

| Item | Proposed Device
K152824 | Predicate Device
K133059 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FMI | Same |
| Regulation Number | 880.5570 | Same |
| Intended Use | The MEDT Pen Needle is intended for
use with pen injector devices for the
subcutaneous injection of insulin. | Same |
| Configuration and
material | Needle tube Stainless Steel
hub Polypropylene
Inner sheath Polyethylene
Outer sheath Polypropylene
Tyvek paper Paper | Needle tube Stainless Steel
hub Polypropylene
Tube sheath Polypropylene
Hub sheath Polypropylene
Sealed 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, and
ISO 11608-2 | Same |
| Compatible pen
injectors | NovoPen Echo
HumaPen 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
Intracutaneous
Reactivity	No Intracutaneous reactivity
Skin Sensitization	No significant evidence of sensitization
Acute Systemic
Toxicity	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.