The EEA™ Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.

Device Description

The EEA™ Hemorrhoid stapler is designed for use as a stapling instrument for control of hemorrhoid disease. The instrument places a circular, double-staggered row of titanium DST™ staples. The EEA™ Hemorrhoid Stapler is offered in a 33mm diameter and with 3.5mm and 4.8mm staple sizes.

The accompanying accessories are comprised of a purse-string suture Anoscope, a Port, and a Dilator.

AI/ML Overview

The provided text describes a 510(k) summary for the EEA™ Hemorrhoid Stapler and accessories, which focuses on device description, intended use, and substantial equivalence to predicate devices. It does not present acceptance criteria or detailed study results in the way typically found for diagnostic AI/ML devices. Therefore, I cannot construct a table of acceptance criteria vs. reported device performance, nor can I answer many of the specific questions regarding clinical study design, ground truth, or human-in-the-loop performance.

However, based on the information provided, I can infer some general aspects and state what is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Safety	"safe and effective and perform as intended" (general statement)
Effectiveness	"safe and effective and perform as intended" (general statement)
Intended Use	The device performs surgical treatment of hemorrhoidal disease and creates end-to-end and end-to-side anastomosis in the lower alimentary tract. This aligns with statements.
Technological Characteristics	Substantially equivalent to predicate devices regarding stapling technologies.
Materials	All components are comprised of materials in accordance with ISO Standard 10993-1.
Sterility/Biocompatibility	(Implied by ISO 10993-1 compliance)

Missing Information: Specific quantitative acceptance criteria (e.g., success rates, complication rates, staple line integrity metrics) are not provided in this document.

2. Sample size used for the test set and the data provenance:

The document states "In-vitro, in-vivo and ex-vivo performance evaluations were completed".
Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This type of detail is not typically relevant for a surgical stapler's performance evaluation and is not provided. The "ground truth" for a stapler would be its mechanical performance and clinical outcome, not expert interpretation of an image or signal.

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

Not applicable/not provided for this type of device.

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:

No, an MRMC study is not mentioned as this is a surgical device, not a diagnostic AI/ML system.

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

Not applicable as this is a physical surgical device, not an algorithm.

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

The document mentions "In-vitro, in-vivo and ex-vivo performance evaluations." For such a device, ground truth would likely involve:
- In-vitro: Mechanical testing (e.g., staple formation, burst pressure of staple lines, force to fire, integrity checks).
- Ex-vivo: Application on animal tissue or cadaveric human tissue to assess staple formation, tissue compression, and seal integrity.
- In-vivo: Animal studies or possibly human clinical data (though not detailed here) to assess short-term safety and effectiveness, healing, and complication rates.
Specific "ground truth" methods like pathology or expert consensus typically apply to diagnostic or AI devices, which this is not.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary

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K083781

EB = 4 2009

510(k) Summary of Safety and Effectiveness

SUBMITTER:

Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: (203) 492-6060

CONTACT PERSON:

Frank Gianelli Senior Associate, Regulatory Affairs

DATE PREPARED:

TRADE/PROPRIETARY NAME: EEA™ Hemorrhoid Stapler and accessories

COMMON/USUAL NAME: Surgical Stapler with Implantable Staple

December 18, 2008

CLASSIFICATION NAME: Staple, Implantable

PREDICATE DEVICE(S):

DEVICE DESCRIPTION:

INTENDED USE:

TECHNOLOGICAL CHARACTERISTICS:

MATERIALS:

PERFORMANCE DATA:

Autosuture™ DST Series™ EEA™ Surgical Stapler (K062850) Ethicon Endo-Surgery Proximate® PPH Hemorrhoidal Circular Stapler and Accessories (K051301)

The accompanying accessories are comprised of a purse-string suture Anoscope, a Port, and a Dilator.

The EEA™ Hemorrhoid Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The EEA™ Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.

The EEA™ Hemorrhoid Stapler and accessories are substantially equivalent to the predicate devices with regard to the stapling technologies.

All components of the EEA™ Hemorrhoid Stapler and accessories are comprised of materials, which are in accordance with ISO Standard 10993-1.

In-vitro, in-vivo and ex-vivo performance evaluations were completed to verify that the EEA™ Hemorrhoid Stapler and accessories are safe and effective and perform as intended.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Public Health Service

FEB = 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Devices d/b/a Covidien . % Mr. Frank Gianelli Senior Associate, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473

Re: K083781

Trade/Device Name: EEA™ Hemorrhoid Stapler and accessories Regulation Number: 21 CFR 878.4750 Regulatory Class: II Product Code: GDW Dated: December 18, 2008 Received: December 19, 2008

Dear Mr. Gianelli:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Frank Gianelli

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH) s) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Mulhern

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and, Radiological Health
Enclosure

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Indications For Use

510(k) Number (if known): _ KOB37BI

Device Name: EEA™ Hemorrhoid Stapler and accessories

Indications For Use:

The EEA™ Hemorrhoid Stapler and accessories has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The EEA™ Hemorrhoid Stapler and accessories can also be used in the lower alimentary tract for the creation of end-to-end and end-to-side anastomosis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. McKenna

(Division Sign=Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083781

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.