easyPPHTM Hemorrhoidal Stapler for Single Use

• K Number: K183477
• Device Name: easyPPHTM Hemorrhoidal Stapler for Single Use
• Manufacturer: Ezisurg Medical Co., Ltd.
• Date Cleared: 2019-02-11 ( 56 days)
• Product Code: GDW GAG
• Regulation Number: 878.4750

Intended Use

The easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal to perform surgical treatment of hemorhoidal disease.

Device Description

The easyPPH™ Hemorrhoidal Stapler for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size.

Predicate Devices

K030411

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML terms or capabilities.

Therapeutic

Yes
The device is described as having application "throughout the anal to perform surgical treatment of hemorrhoidal disease," indicating its use in treating a medical condition.

Diagnostic

No
The device is described as a surgical stapler used for treating hemorrhoidal disease, which involves cutting and dividing tissue, indicating a therapeutic rather than diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical surgical stapler with titanium staples, designed to cut and divide tissue, and performance testing includes physical characteristics like firing force and staple formation.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use: The intended use is to "perform surgical treatment of hemorhoidal disease" by placing staples and cutting tissue. This is a surgical procedure performed directly on the patient's body.
• Device Description: The device is a surgical stapler designed for internal use within the anal canal.
• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on samples.

The information provided clearly describes a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal to perform surgical treatment of hemorhoidal disease.

Product codes (comma separated list FDA assigned to the subject device)

GDW

Device Description

The easyPPH™ Hemorrhoidal Stapler for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anal canal

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 provided in this submission include package integrity test, bacteria endotoxin test, biocompatibility tests. The shelf life test and performance tests were performed on both proposed device and predicate device to determine substantial equivalence, the performance test include following items:

• Firing Force Test
• . Staple Formation Test
• . Staple Line Pressure Test
• . Staple Line Tensile Test
• . Closed Staple Height Test

Biocompatibility tests included cytotoxicity, sensitization, intracutaneous irritation and pyrogenicity.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030411

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 878.4750 Implantable staple.

(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.

Summary

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February 11, 2019

Ezisurg Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn

Re: K183477

Trade/Device Name: easyPPHTM Hemorrhoidal Stapler for Single Use Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 6, 2018 Received: December 17, 2018

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Figure/6 description: The image shows a digital signature from David Krause. The signature includes the name "David Krause - S" on the left side of the image. On the right side of the image, it says "Digitally signed by David Krause - S" and the date and time of the signature: "2019.02.11 09:02:04 -05'00'".

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183477

Device Name

easyPPHTM Hemorrhoidal Stapler for Single Use

Indications for Use (Describe)

The easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal to perform surgical treatment of hemorhoidal disease.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Tab #7 510(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:___K183477

• 1. Date of Preparation: 1/28/2019
• 2. Sponsor Identification

Ezisurg Medical Co., Ltd.

Rm.103, Bldg.2,No.1690 Cailun Road, China (Shanghai) Pilot Free Trade Zone, 201203 Shanghai, China.

Establishment Registration Number: 3014264910

Contact Person: Liang Xia Position: Non-active Device Senior Regulatory Affairs Supervisor Tel: [phone] Fax: [phone] Email: [e-mail]

• 3. Designated Submission Correspondent
     Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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Identification of Proposed Device 4.

Trade Name: easyPPHTM Hemorrhoidal Stapler for Single Use Common Name: Stapler and Reload Size: PPH33

Regulatory Information

Classification Name: Staple, Implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery

Classification Name: Stapler, Surgical; Classification: I Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery

Intended Use Statement:

The easyPPH™ Hemorrhoidal Stapler for Single Use has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

Device Description:

The easyPPH™ Hemorrhoidal Stapler for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size.

• 5. Identification of Predicate Device
     510(k) Number: K030411 Product Name: PROXIMATE®PPH Hemorrhoidal Circular Stapler and Accessories

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 provided in this submission include

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package integrity test, bacteria endotoxin test, biocompatibility tests. The shelf life test and performance tests were performed on both proposed device and predicate device to determine substantial equivalence, the performance test include following items:

• Firing Force Test
• . Staple Formation Test
• . Staple Line Pressure Test
• . Staple Line Tensile Test
• . Closed Staple Height Test

Biocompatibility tests included cytotoxicity, sensitization, intracutaneous irritation and pyrogenicity.

The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.

• ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity. >
  ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and A delayed-type hypersensitivity

• USP 38-NF 33 Bacterial Endotoxins Tests

• ASTM F 88/F88M-09 Standard test method for seal strength of flexible barrier materials;

• ASTM F 1929

ISO 11137-2:2013 Sterilization of health care products -Radiation- Part 2: Establishing the sterilization dose

• A USP 39-NF 34 Pyrogen
• 7. Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

Table 1 Comparison for easyPPHTM Hemorrhoidal Stapler for Single Use

Item	Proposed Device	Predicate Device
Product Code	GDW	GDW
Regulation Number	21 CFR 878.4750	21 CFR 878.4750
Intended Use	The easyPPHTM Hemorrhoidal Stapler
for Single Use has application
throughout the anal canal to perform
surgical treatment of hemorrhoidal
disease.	The PROXIMATE® PPH Hemorrhoidal
Circular Stapler and accessories have
application throughout the anal canal to
perform surgical treatment of
hemorrhoidal disease.
Cutting Mechanism	Circular	Circular
Operation Principle	Manual	Manual
Safety Mechanism	Safety release for prevent from
mis-firing	Safety release for prevent from mis-firing
Staple size	3.5mm	3.5mm
Closed Staple Height	1.0-1.6mm	1.0-1.6mm
Closed staple form	Image: staple form	Image: staple form
Endotoxin Limit	20 EU	20EU
Labeling	Conforms with 21 CFR 801	Conforms with 21 CFR 801

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.