The SurgASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-toside, and side-to-side anastomoses.

Device Description

The SurqASSIST™ System with Circular Stapler Digital Loading Units® (DLUs) offers computer mediated steering and stapling. The DLUs contain implantable, titanium staples and integral cutting blades. The DLUs are used to anastomose tubular structures by applying a double staggered circular row of staples through the tissue. The staples form to controlled closed conditions to secure the lavers of tissue together. The DLUs also cut away the excess tissue at a controlled diameter inside the ring of staples. The Circular Stapler DLUs are available in the following four sizes: 21 mm, 25 mm, 29 mm, and 33 mm. The DLU is supplied sterilized and ready for use upon removal from its packaging.

AI/ML Overview

The provided text is a summary of a 510(k) premarket notification for a medical device called the SurgASSIST™ Circular Stapler Digital Loading Units®. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria, performance metrics, and a full statistical analysis. As such, much of the requested information regarding study design, sample sizes, and ground truth establishment is not present in the provided text.

Based on the available information, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes material and design specifications that align with the predicate device, implying that meeting these specifications serves as the "acceptance criteria" for substantial equivalence. The "reported device performance" is implicitly that the device is functionally equivalent to the predicate, even with modifications. No specific quantitative performance metrics or acceptance thresholds are provided in this summary.

Feature / Criterion (Implicit)	Reported Device Performance (Implicit)
Intended Use	Same as predicate device (K003277 and K920752)
Contraindications	Same as predicate device (K003277 and K920752)
FDA Class (System)	Class II (Same as predicate devices)
Sizes	21 mm, 25 mm, 29 mm, 33 mm (Same as predicate devices)
Staple Shape	B-Shaped (Same as predicate devices)
Closed Staple Height	Approximately 1.5 mm - 2.3 mm (Similar to predicate K003277, within range of K920752)
Staple Material	ASTM F-67 Unalloyed Titanium (Same as predicate devices)
Knife Material	Stainless steel (Same as predicate devices)
DLU Materials	Polymeric materials, surgical grade stainless steels, adhesives, and lubricants (Same as predicate devices)
Cutting Mechanism	Circular Knife (Same as predicate devices)
DLU Internal Power	None (Same as predicate K003277, different from K920752)
Power	Electrically powered via a remote Power Console (Same as predicate K003277, different from K920752)
Software Containing Digital Information	Yes, memory module (Same as predicate K003277, different from K920752)
How Supplied	Sterile - Single Patient Use (Same as predicate devices)
Safety Mechanism	Will not deploy until within appropriate range for desired closed staple height (Same as predicate K003277, superior to K920752)
Insertion Mechanism	Flexible, steerable (Same as predicate K003277, different from K920752)
Method of Sterilization	Ethylene Oxide Gas (ETO) (Same as predicate K003277, different from K920752)
Packaging	Blister Tray with Tyvek Lid (Same as predicate devices)
Modification: Latching Mechanism Failure Prevention	Improved engagement of latch fingers due to spline tube and trocar modification (Addresses root cause of recall for predicate K003277)

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

The provided document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The 510(k) summary focuses on comparing the modified device's design and materials to its predicate, and addressing a specific design modification (latching mechanism). It does not present data from an independent clinical or lab study as might be found for a novel device. The "study" here is primarily a design verification and validation against specified engineering standards and a comparison with the predicates.

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

This information is not provided in the document. As this is a 510(k) submission for a modification to an existing device, the "ground truth" for comparison is primarily the performance and characteristics of the predicate devices and the resolution of a known issue.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

This device is a surgical stapler, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This device is a surgical stapler. It has "computer mediated steering and stapling" and has "software containing digital information," but it is a physical surgical instrument. It is not an algorithm that performs actions "standalone" in the sense of an AI model without human intervention. The software likely manages the device's mechanical functions where a human is operating the system. Therefore, a standalone algorithm performance study as typically understood for AI is not applicable.

7. The type of ground truth used:

Given this is a physical medical device, the "ground truth" for its performance would typically involve:

Engineering specifications and test standards: Ensuring the staples form correctly, the cutting blade functions, and the latching mechanism is secure under various conditions.
Bench testing/ex-vivo models: Testing on tissue surrogates or cadaveric tissue to verify mechanical performance.
Animal studies (potentially): To evaluate in-vivo performance for prior versions or if significant changes were made.
Clinical experience & predicate device performance: The "ground truth" for safety and effectiveness is largely established by the performance of the predicate devices and the ability of the modified device to meet similar performance criteria, especially in resolving the known latching mechanism issue.

The document implicitly uses the performance and safety profile of the predicate devices as the primary "ground truth" for substantial equivalence. The modification addressed a specific failure mode in the predicate, so successful mitigation of that failure mode through design changes would be part of the "ground truth" demonstration.

8. The sample size for the training set:

This information is not provided and is not applicable in the context of this device and submission type. "Training set" typically refers to data used to train machine learning models. This device is a mechanical stapler with integrated software, not an AI/ML model in the typical sense.

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

This information is not provided and is not applicable.

Summary

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Power Medical Interventions, Inc SurgASSIST™ Circular Stapler DLUs Special 510(k) Corrective Action Being Effected - August 29, 2003

ψ32701 (P.1.AS)

Special 510(k) CORRECTIVE ACTION BEING EFFECTED SAFETY AND EFFECTIVENESS SUMMARY

SurgASSIST Circular Stapler Digital Loading Units®

In Accordance with 21 CFR section 807.92 Power Medical Interventions, Inc., is submitting the following safety and effectiveness summary.

1. Submitter Information:
  Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax

Barbara J. Whitman Applicant:

August 29, 2003 Date of Notification:

1. Name of Device:

Trade Name:	SurgASSIST™
	Circular Stapler DLUs
	21 mm, 25 mm, 29 mm, 33 mm

Circular Stapler with Implantable Staples Common Name:

Classification Name: Staple, Implantable, GDW

1. Predicate Devices:
- A. SurqASSIST™ System with Circular Stapler Digital Loading Units®, (21 mm, 25 mm, 29 mm, 33 mm), with Titanium Implantable Staple, Power Medical Interventions, Inc., New Hope, PA. REF CS21, CS25, CS29, CS33 (K003277).
- B. Endopath ILS Endoscopic Circular Staplers, 21 mm, 25 mm, 29 mm, 33 mm, Ethicon Endo-Surgery, Cincinnati, OH. (K920752).

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4) Device Description:

1. Device Modification
  Modifications were made to the predicate SurgASSIST™ Circular Stapler Digital Loading Units® (originally cleared under K003277) to address the root cause of the voluntary recall, which was a potential for latching mechanism failure, which could result in staple line failure and/or anvil jam. In order to further minimize the already low risk of latching mechanism failure, the spline tube and trocar were modified to improve engagement of the latch fingers. Further details of this modification can be found in Section H of this submission, under the "Device Modification" heading.
1. Indications For Use
  The SurqASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-toside, and side-to-side anastomoses.
1. Comparison to Predicate Devices
  The following table compares the subject Circular Stapler to the previously cleared predicates, Circular Stapler Cutter Digital Loading Units® (K003277) and Endopath ILS Endoscopic Circular Staplers (K920752).

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Features & Description	SurgASSIST™Circular StaplerDigital Loading Units® (DLUs)21 mm, 25 mm, 29 mm, 33 mmREF: CS21, CS25, CS29, CS33	PredicateSurgASSIST™Circular StaplerDigital Loading Units® (DLUs)21 mm, 25 mm, 29 mm, 33 mm	PredicateEthicon Endo-Surgery, Inc.Endopath ILS Endoscopic CircularStapler21 mm, 25 mm, 29 mm, 33 mm
Name	Circular StaplerDigital Loading Units®21 mm, 25 mm, 29 mm, 33 mm	Circular StaplerDigital Loading Units®21 mm, 25 mm, 29 mm, 33 mm	Ethicon Endo-Surgery, Inc.Endopath ILS EndoscopicCircular Stapler21 mm, 25 mm, 29 mm, 33 mm
Manufacturer of Record	Power Medical Interventions, Inc.	Power Medical Interventions, Inc.	Ethicon Endo-Surgery, Inc
Contract Manufacturer	Lacey ManufacturingBridgeport, CT	Lacey ManufacturingBridgeport, CT	Ethicon Endo-Surgery, Inc
510(k) Clearance Numbers	Subject of this Notification	K003277	K920752
Intended use	Applications throughout the alimentarytract for end-to-end, end-to-side andside-to-side anastomoses.	Applications throughout the alimentarytract for end-to-end, end-to-side andside-to-side anastomoses.	Applications throughout the alimentarytract for end-to-end, end-to-side andside-to-side anastomoses.
Contraindications	Same, refer to labeling	Same, refer to labeling	Same, refer to labeling
FDA Class (System)	II	II	II
Sizes	21 mm, 25 mm, 29 mm, 33 mmCircular Staplers	21 mm, 25 mm, 29 mm, 33 mmCircular Staplers	21 mm, 25 mm, 29 mm, 33 mmCircular Staplers
Staple Shape	B-Shaped	B-Shaped	B-Shaped
Features & Description	SurgASSIST™Circular StaplerDigital Loading Units® (DLUs)21 mm, 25 mm, 29 mm, 33 mmREF: CS21, CS25, CS29, CS33	PredicateSurgASSIST™Circular StaplerDigital Loading Units® (DLUs)21 mm, 25 mm, 29 mm, 33 mm	PredicateEthicon Endo-Surgery, Inc.Endopath ILS Endoscopic CircularStapler21 mm, 25 mm, 29 mm, 33 mm
Closed Staple Height	Approximately1.5 mm - 2.3 mm	Approximately1.5 mm - 2.3 mm	1.0 mm - 2.5 mm
Staple Material	ASTM F-67 Unalloyed Titanium	ASTM F-67 Unalloyed Titanium	ASTM F-67 Unalloyed Titanium
Knife Material	Stainless steel	Stainless steel	Stainless steel
DLU Materials	Polymeric materials, surgical gradestainless steels, adhesives, andlubricants	Polymeric materials, surgical gradestainless steels, adhesives, andlubricants	Polymeric materials, surgical gradestainless steels, adhesives, andlubricants
Cutting Mechanism	Circular Knife	Circular Knife	Circular Knife
DLU Internal Power	None	None	None
Power	Electrically powered via a remotePower Console	Electrically powered via a remotePower Console	Manually powered
Software containing	Yes	Yes	No
Digital Information	Memory module containing digital datafor identification, etc.	Memory module containing digital datafor identification, etc.	None
How Supplied	Sterile - Single Patient Use	Sterile - Single Patient Use	Sterile - Single Patient Use
Features & Description	SurgASSIST™Circular StaplerDigital Loading Units® (DLUs)21 mm, 25 mm, 29 mm, 33 mmREF: CS21, CS25, CS29, CS33	PredicateSurgASSIST™Circular StaplerDigital Loading Units® (DLUs)21 mm, 25 mm, 29 mm, 33 mm	PredicateEthicon Endo-Surgery, Inc.Endopath ILS Endoscopic CircularStapler21 mm, 25 mm, 29 mm, 33 mm
Safety Mechanism	Will not deploy until within anappropriate range for desired closedstaple height	Will not deploy until within anappropriate range for desired closedstaple height	Contains indicators for appropriaterange for desired closed staple height,but can be deployed out of range
Insertion Mechanism	Flexible, steerable	Flexible, steerable	Rigid
Method of Sterilization	Ethylene Oxide Gas (ETO)	Ethylene Oxide Gas (ETO)	Irradiation
Packaging	Blister Tray with Tyvek Lid	Blister Tray with Tyvek Lid	Blister Tray with Tyvek Lid

Circular Stapler DLU Product Features Comparison Chart

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Circular Stapler DLU Product Features Comparison Chart (continued from previous page)

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Circular Stapler DLU Product Features Comparison Chart (continued from previous page)

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SEP 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938

Re: K032701

Trade/Device Name: SurgASSIST™ Circular Stapler Digital Loading Units® 21mm, 25mm, 29mm, 33mm Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 29, 2003 Received: September 2, 2003

Dear Ms. Whitman:

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 (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.

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Page 2 - Ms. Barbara J. Whitman

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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

fed Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Power Medical Interventions, Inc. New Hope, PA 18938

510(k) No. K $32741

Device Name:

SurgASSIST™ Circular Stapler Digital Loading Units® 21 mm, 25 mm, 29 mm, 33 mm

INDICATIONS FOR USE:

The SurgASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-toside, and side-to-side anastomoses.

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

Prescription Use
Per 21CFR §801.109

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

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

510(k) Number K03270/

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.