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.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the easyPPH™ Hemorrhoidal Stapler for Single Use (K183477). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving independent acceptance criteria for a novel AI/imaging device. Therefore, many of the requested elements for describing a study proving an AI device meets acceptance criteria are not applicable in this context.

However, I can extract the relevant information regarding the non-clinical tests used to support the substantial equivalence claim.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

The document primarily relies on non-clinical performance and biocompatibility tests to demonstrate substantial equivalence to a predicate device. It doesn't explicitly state distinct "acceptance criteria" with numerical thresholds alongside "reported device performance" in a table format for each test. Instead, it states that the tests verified that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The implication is that the proposed device's performance in these non-clinical tests was comparable to or within acceptable limits relative to the predicate.

Test Item	Acceptance Criteria (Implied: Comparable to Predicate Device and Design Specifications)	Reported Device Performance (Implied: Met Criteria)
Firing Force Test	Performance comparable to predicate device	Performed and found to be SE
Staple Formation Test	Staple formation comparable to predicate device	Performed and found to be SE
Staple Line Pressure Test	Staple line pressure comparable to predicate device	Performed and found to be SE
Staple Line Tensile Test	Staple line tensile strength comparable to predicate device	Performed and found to be SE
Closed Staple Height Test	1.0-1.6mm (explicitly stated in comparison table)	Met (implied by SE conclusion)
Package Integrity Test	Maintain sterility and integrity	Performed and found to be SE
Bacterial Endotoxin Test	<= 20 EU (explicitly stated in comparison table)	Met (implied by SE conclusion)
Biocompatibility (Cytotoxicity)	Conforms to ISO 10993-5:2009	Met (implied by SE conclusion)
Biocompatibility (Sensitization)	Conforms to ISO 10993-10:2010	Met (implied by SE conclusion)
Biocompatibility (Intracutaneous Irritation)	Conforms to ISO 10993-10:2010	Met (implied by SE conclusion)
Biocompatibility (Pyrogenicity)	Conforms to USP 39-NF 34 <151>	Met (implied by SE conclusion)
Shelf Life Test	Maintain performance over specified shelf life	Performed and found to be SE

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for each non-clinical test. The document states "performance tests were performed on both proposed device and predicate device" but does not quantify the number of units tested.
Data Provenance: Not explicitly stated (e.g., country of origin, specific labs). These were non-clinical, in-vitro/bench tests. The applicant is Ezisurg Medical Co., Ltd. located in Shanghai, China, suggesting the testing was likely conducted in China. The data would be considered prospective for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as this is a medical stapler device, not an AI or imaging device requiring expert consensus for ground truth on a test set. The "ground truth" for the non-clinical tests would be the objective measurements obtained through standard test methods.

4. Adjudication Method for the Test Set

Not applicable for non-clinical bench testing.

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

Not applicable. This is not an AI-assisted device. The study was non-clinical.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm. Its performance is inherent to the physical device.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established by objective laboratory measurements based on recognized standards (e.g., ISO, ASTM, USP) for properties like staple dimensions, firing force, tensile strength, and biocompatibility. The comparison was primarily against the predicate device's characteristics and the device's own design specifications.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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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
1. 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: +86-21-50456176 Fax: +86-21-50676156 Email: xialiang@ezisurg.com

1. 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: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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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:

1. 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 <85> 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 <151> Pyrogen
1. 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 Staplerfor Single Use has applicationthroughout the anal canal to performsurgical treatment of hemorrhoidaldisease.	The PROXIMATE® PPH HemorrhoidalCircular Stapler and accessories haveapplication throughout the anal canal toperform surgical treatment ofhemorrhoidal disease.
Cutting Mechanism	Circular	Circular
Operation Principle	Manual	Manual
Safety Mechanism	Safety release for prevent frommis-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.

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.