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

Device Description

The SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm is a cutter/stapler component addition to a previously cleared device, K012809, SuraASSIST™ System Right Angle Linear Cutter - 45mm Digital Loading Unit™. This Notification offers an additional style of cutting/stapling configuration, specifically, Straight Linear Cutters/staplers, both Blue and Green, of 55mm and 30mm in length. The computer mediated, powered steering, tissue cutting and stapling of the Straight Linear Cutters are utilizing the identical technology and system approach which the previously cleared device currently utilizes.

The technological features of the SurgASSIST™ System Straight Linear Cutters are identical to that of the predicate device, K012809.

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.
Straight Linear Cutter Digital Loading Unit™ (DLU) that . contain 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 Straight Linear Cutter DLU is offered currently in a 55mm and 30mm length size, in reloadable configuration.

AI/ML Overview

This 510(k) submission (K020719) for the SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU) does not contain detailed acceptance criteria or a study that proves the device meets specific performance metrics in the way modern AI/ML device submissions typically do.

The submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device (the predicate device) that does not require premarket approval (PMA). The primary evidence presented is a comparison of technological features and indications for use, rather than a quantifiable performance study against acceptance criteria.

Therefore, many of the requested sections (e.g., sample size for test set, expert qualifications, effect size of AI assistance, training set details) are not applicable or n/a as they relate to a different type of regulatory submission framework, specifically for AI/ML devices with performance metrics, which this 2002 submission is not.

Here's a breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance	Comments
Safety and Effectiveness	The device is deemed "substantially equivalent" to legally marketed predicate devices, implying it meets the same safety and effectiveness standards.	The submission relies on demonstrating similarity to predicate devices rather than novel performance criteria.
Technological Features	"The technological features of the SurgASSIST™ System Straight Linear Cutters are identical to that of the predicate device, K012809."	This is the primary method of demonstrating equivalence. Specific performance metrics (e.g., staple formation strength, cutting efficiency) are not explicitly stated as numerical acceptance criteria or reported values in this summary.
Indications for Use	"The SurgASSIST™ System Straight Linear Cutter DLU has applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses."	These indications are aligned with the predicate devices. There are no specific performance thresholds tied to these indications within this document.
Compliance with General Controls	The FDA states: "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."	This is a regulatory acceptance, not a performance metric.

2. Sample sized used for the test set and the data provenance

Sample Size: Not applicable (n/a). The document does not describe a performance study with a test set of data points in the context of AI/ML or statistical clinical trials. The evaluation is based on device design comparison to predicates.
Data Provenance: Not applicable (n/a).

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

Not applicable (n/a). Ground truth establishment for a test set of data is not described in this type of submission.

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

Not applicable (n/a).

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 (n/a). This device is a surgical stapler, not an AI-assisted diagnostic or interpretative tool.

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

Not applicable (n/a). The device is a mechanical surgical instrument.

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

Not applicable (n/a), in the context of data for an AI/ML device. The "ground truth" for this device's safety and effectiveness is implicitly established by the long-standing use and regulatory clearance of its predicate devices, which are also mechanical stapling instruments.

8. The sample size for the training set

Not applicable (n/a). This device does not involve a "training set" in the sense of machine learning.

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

Not applicable (n/a).

Summary

{0}------------------------------------------------

Power Medical Interventions, Inc SurgASSIST™ Straight Linear Cutter DLUs with Blue and Green Reload Cartridges 510(k), March 1, 2002

Ko20719

PREMARKET NOTIFICATION 510(K) SAFETY AND EFFECTIVENESS SUMMARY

SurgASSIST™ Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm

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 Street New Hope, PA 18938 USA 215-862-4450 215-862-3073 FAX

Applicant: Barbara J. Whitman

Date of Notification: 03/01/2002

1. Name of Device:
  Trade Name: SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™, 55mm, 30mm with Blue and Green Reload Cartridges

Common Name: Linear Cutter with Implantable Staples

Classification Name: Staple, Implantable, GDW; Stapler, GAG; Cutter, FZT; Endoscope, GCJ

Predicate Devices: LINEAR CUTTERS / STAPLING INSTRUMENTS

A. SurgASSIST™ System, Right Angle Linear Cutter Digital Loading Unit™. Power Medical Interventions, Inc., New Hope, PA. REF RALC45 (K012809).
B. EZ45 Endoscopic Linear Cutter. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815).

000015

{1}------------------------------------------------

C. Endopath® EZ45 Endoscopic Linear Cutter/Stapler Reloads. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ZR45B ( K980815).
1. Device Description:

The technological features of the SurgASSIST™ System Straight Linear Cutters are identical to that of the predicate device, K012809.

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.
Straight Linear Cutter Digital Loading Unit™ (DLU) that . contain 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 Straight Linear Cutter DLU is offered currently in a 55mm and 30mm length size, in reloadable configuration.

{2}------------------------------------------------

5) Indications For Use

1. Comparison to Predicate Devices
- SurgASSIST™ System, Right Angle Linear Cutter Digital 1. Loading Unit. Power Medical Interventions, Inc., New Hope, PA. REF RALC45 (K012809).
- 1. EZ45 Endoscopic Linear Cutter. Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. REF ET45B (K980815).
- Endopath® EZ45 Endoscopic Linear Cutter/Stapler Reloads. 3. Ethico0n Endo-Surgery, Inc., Cincinnati, Ohio. REF ZR45B ( K980815).

Substantial equivalence includes the predicate SurgASSIST™ System Right Angle Linear Cutter Digital Loading Unit™ literature including descriptions, specifications, identification of standard components, and identification of tissue contact materials.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2002

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

Re: K020719

SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™ (DLU), 55mm, 30mm with Blue and Green Reload Cartridges Regulation Number: 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: March 1, 2002 Received: March 5, 2002

Dear Ms. Whitman:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave reviewed your concernined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the exerces, 1976, the enactment date of the Medical Device Amendments, or to conniner of the 10 may 20, 2018 11:14 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 If your device is classinonal controls. Existing major regulations affecting your device can thay be subject to back acceral 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 or any I 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.

{4}------------------------------------------------

Page 2 - Ms. Barbara J. Whitman

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally premated predicated 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the O inter go at 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,

Muriam C. Provost

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

{5}------------------------------------------------

Power Medical Interventions, Inc. SurgASSIST™ Straight Linear Cutter DLUs with Blue and Green Reload Cartridges 510(k), March 1, 2002

SECTION D

STATEMENT OF INTENDED USE

Power Medical Interventions, Inc.

510(k) No. K020719

Device Name:

SurgASSIST™ System Straight Linear Cutter Digital Loading Unit™, 55mm, 30mm with Reload Cartridges

INDICATIONS FOR USE:

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

Miriam C. Phovost (Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K020719
Prescription Use X Over-The-Counter Use
(per 21 CFR 801.109)

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.