The SurgASSIST™ System with Right Angle Linear Cutter DLU has applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.

Device Description

The SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™ (DLU) is a cutter/stapler component addition to a Eodaing cleared device, K003277, SurgASSIST™ System with Circular Stapler Disposable Loading Unit. This Notification offers an additional style of cutting/stapling configuration, specifically, a right angle linear cutter/stapler of 45mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Right Angle Linear Cutter is utilizing the identical technology and system approach which the previously cleared device currently utilizes.

The technological features of the SurgASSIST™ System with Right Angle 45mm Linear Cutter are identical to that of the predicate device, K003277.

A steerable FlexShaft that serves as the interface between the . Digital Loading Unit™ (DLU) and the Power Console and provides the means of insertion of the DLU. The FlexShaft is steerable for surgical positioning of the DLU for access and visualization.

A hand held Remote Control Unit that contains pushbuttons . that actuate steering, extension and retraction of the anvil, stapling, and cutting.

Right Angle Linear Cutter Digital Loading Unit (DLU) that . contains implantable staples that form in a double staggered linear row of staples and a steel knife blade which transects the tissue between the two rows of formed staples. The Cutter is designed to between the center line of the FlexShaft, permitting access to tissue which may not normally be accessed via current stapling tissue whilen may re. The Right Angle Linear Cutter DLU is offered currently in a 45mm length size, in non-reloadable configuration.

AI/ML Overview

This is a medical device, not an AI/ML powered device, so many of the requested fields are not applicable.

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate device (Ethicon's Proximate® Linear Cutter with Safety Lock-Out (TLC55)) based on preclinical study in porcine subjects.	Deemed "substantially equivalent" for intended use based on a preclinical study in porcine subjects and additional laboratory bench testing. The specific performance metrics assessed and their achievement of equivalence are not detailed in the provided text, but the FDA's final letter confirms substantial equivalence.
Substantial equivalence to predicate device (Ethicon's Proximate® Linear Cutter with Safety Lock-Out (TLC55)) based on additional Laboratory Bench Testing.	Deemed "substantially equivalent" for intended use based on a preclinical study in porcine subjects and additional laboratory bench testing. The specific performance metrics assessed and their achievement of equivalence are not detailed in the provided text, but the FDA's final letter confirms substantial equivalence.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "preclinical study in porcine subjects," but the exact number of subjects or procedures (sample size) is not specified.
- Data Provenance: Prospective (as it's a preclinical study specifically designed for this purpose). The location is not explicitly stated but is implied to be within a controlled laboratory or animal study setting, likely in the US where the submitter is located.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For medical devices like linear cutters, ground truth is typically assessed through objective measurements of stapling integrity, transection completeness, and tissue healing, rather than expert consensus on subjective interpretations. The preclinical study would likely involve veterinary surgeons or researchers specializing in animal models.
Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective interpretations, which is not relevant for this type of device and study. Performance would be assessed by objective criteria.
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 a surgical stapler, not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical stapler.
The type of ground truth used:
- For the preclinical study: Ground truth would be based on objective evaluations of the stapling performance in live tissue (porcine subjects), likely including:
  - Staple formation and integrity.
  - Hemostasis at the staple line.
  - Tissue transection completeness.
  - Healing characteristics over time.
  - Comparison against the predicate device's performance in the same parameters.
- For the laboratory bench testing: Ground truth would be based on objective physical measurements and tests of the device's mechanical properties, staple formation, and cutting ability.
The sample size for the training set: Not applicable. This is a medical device (linear stapler), not an AI/ML algorithm that requires a training set. The device design and manufacturing processes are developed through traditional engineering methods.
How the ground truth for the training set was established: Not applicable, as there is no "training set" in the AI/ML sense for this device.

Summary

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K012809 (p. 1 of 3)

Power Medical Interventions, Inc. SurgASSIST™ Right Angle Linear Cutter DLU 510(k), August-17-01

PREMARKET NOTIFICATION 510(K SAFETY AND EFFECTIVENESS SUMMARY

SurgASSIST™ Right Angle Linear Cutter Digital Loading Unit™ (DLU)

In Accordance with 21 CFR section 807.92, Power Medical Interventions, Inc., is submitting the following Safety and Effectiveness Summary.

Submitter Information:

Power Medical Interventions, Inc. 4 B East Bridge St. New Hope, PA 18938 USA 215-862-4450 215-862-1009 FAX

Applicant: Laurence A. Potter

Date of Notification: August 17, 2001

Name of Device:

Trade Name: SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™

Common Name: Linear Cutter with Implantable Staples

Classification Name: Staple, Implantable, GDW, Stapler, GAG

Predicate Devices:

LINEAR CUTTERS / STAPLING INSTRUMENTS

A. SurgASSIST™ System, Circular Stapler Digital Loading Unit. Power Medical Interventions, Inc., New Hope, PA. REF CS21, CS25, CS29, CS33. (K003277)

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O'2809(P.2 of 3)

Power Medical Interventions, Inc. SurgASSIST™ Right Angle Linear Cutter DLU 510(k), August-17-01

B. Proximate® Linear Cutter and Four Row with Safety Lock-Out. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF TLC55 (K890841)
C. United States Surgical Powered Endoscopic GIA Stapler. United States Surgical Corp., Norwalk, CT. ( K913802).
1. Device Description:

The technological features of the SurgASSIST™ System with Right Angle 45mm Linear Cutter are identical to that of the predicate device, K003277.

A hand held Remote Control Unit that contains pushbuttons . that actuate steering, extension and retraction of the anvil, stapling, and cutting.

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la809 (p.3 of 3)

Power Medical Interventions, Inc. SurgASSIST™ Right Angle Linear Cutter DLU 510(k), August-17-01

5) Indications For Use

1. Comparison to Predicate Devices
- SurgASSIST™ System, Circular Stapler Digital Loading Unit. 1. Interventions, Inc., Inc., New Hope, PA. Medical Power (K003277)
- Proximate® Linear Cutter and Four Row with Safety Lock-2. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF Out. TLC55 (K890841)
- United States Surgical Powered Endoscopic GIA Stapler. 3. United States Surgical, Norwalk, CT. USA (K913802)

Substantial equivalence includes the predicate SurgASSIST™ System with Circular Staple Disposable Loading Unit literature including descriptions, specifications, identification of standard components, and identification of tissue contact materials.

Substantial Equivalence for this Notification also includes a preclinical study in porcine subjects to assess the SurgASSIST™ System Right Angle Linear Cutter DLU against a predicate device, Ethicon's Proximate® Linear Cutter with Safety Lock-Out (TLC55), having comparable intended use. Additional Laboratory Bench Testing of the subject device against the Proximate predicate is also defined within this Notification and summarized as equivalent.

0017

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OCT 2 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Laurence A. Potter Vice President Regulatory Affairs & Quality Assurance Power Medical Interventions, Inc. 4 B East Bridge Street New Hope, Pennsylvania 18938

Re: K012809

Trade/Device Name: SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™ Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: August 17, 2001 Received: August 22, 2001

Dear Mr. Potter:

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

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Page 2 -- Mr. Laurence A. Potter

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to over maing of substantial equivalence of your device to a legally premaired 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 and If you desire specific ad 1.80 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of Compliance at (301) 274-4657. Ticalities)), list contribution at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 8th-Other general information on your responsibilities under the Act may be obtained from the Outer general miormation of your respectional 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,

Susan Walker, MD

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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SECTION D

STATEMENT OF INTENDED USE

Power Medical Interventions, Inc.

510(k) No. K O/2809

Device Name:

SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™

INDICATIONS FOR USE:

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

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use

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

510(k) Number LO1280 J

0013

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.