The SurgASSIST™ System with Circular Stapler Digital Loading Unit™ (DLU), has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis.

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 anastomosis.

Device Description

The FlexShaft 2 resembles a colonoscope and provides the mechanical and electrical interface between the PC and the DLU. The FlexShaft 2 has a rigid mechanical assembly at the proximal end that provides the mechanical interface between the FlexShaft 2 and PC. The remainder of the FlexShaft 2 is flexible throughout its length and incorporates an articulation section near the distal end that allows for remote positioning of the DLU. The distal tip of the FlexShaft 2 has features that allow for the attachment and removal of various configurations of a DLU.

The FlexShaft 2 contains two drive shafts that couple two motors in the PC to the two inputs of a DLU. Rotary motion provided by the motors located in the PC is delivered to the DLU through these drive shafts for various purposes such as clamping tissue or forming staples.

The distal assembly of the FlexShaft 2 contains a printed circuit board that has two pairs of hall-effect transistors mounted. Each pair of hall-effect transistors is arranged for quadrature output to enable tracking of the rotation of the two drive shafts at the distal end. This tracking provides the signal to the PC to insure that the appropriate number of shaft revolutions is delivered to the DLU.

Internal to the FlexShaft 2 are four braided (steering) cables. The purpose of these cables is to provide the means for articulating the steering section of the FlexShaft 2. Articulation is achieved when tension is applied to the cable or cables located in the desired articulation direction. Rotary motion, provided by motors in the PC, is translated into linear "cable pull" motion through a pairs of bevel gears that are coupled to capstans.

Since the DLU contains an electronic "chip" carrying its identification and usage status, it must be able to communicate with the micro controller within the PC. The FlexShaft 2 incorporates two electrical contacts that mate with corresponding contacts on the DLU when the DLU is attached to the FlexShaft 2.

Internal to the FlexShaft 2 is a usage counter. The purpose of this counter is to allow the storage of information relating to the number of DLU's fired and the number of FlexShaft 2 attachments to the PC. Each memory module has a unique serial number that will be used for FlexShaft 2 identification.

AI/ML Overview

This Special 510(k) Device Modification for the SurgASSIST™ System with FlexShaft 2 is a submission for a modified device, not a new device. Therefore, the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a full clinical study with acceptance criteria.

The submission highlights changes in manufacturing and the addition of a usage counter memory module while asserting that the device's indications for use and most physical characteristics remain identical to the predicate. As such, direct "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial for efficacy or diagnostic performance are not present in this document.

However, based on the information provided, we can infer some "acceptance criteria" through the comparison to the predicate devices, focusing on functional and physical equivalence.

Here's an attempt to structure the information as requested, though some sections will indicate "Not Applicable" or "Not Provided" due to the nature of a 510(k) modification submission for an already cleared device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a device modification, the "acceptance criteria" are generally tied to demonstrating substantial equivalence to the predicate device in terms of design, materials, and functional performance. The "reported device performance" is primarily presented as meeting or being equivalent to the predicate specifications.

Feature / Criterion	Acceptance Criteria (Implied from Predicate Equivalence)	Reported Device Performance (SurgASSIST™ w/ FlexShaft 2)
Indications for Use	Identical to predicate devices (K003277 & K012809)	Applications throughout the alimentary tract for end-to-end and side-to-side anastomosis. Also, applications in gastrointestinal, gynecological, general abdominal and thoracic surgical procedures for resection, transection, and creation of anastomoses.
Length of FlexShaft	2 meters ± 3cm	2 meters ± 3cm
Length of Articulation Section	10cm ± 2cm	10cm ± 2cm
Diameter of Articulation Section	15mm ± .25mm	15mm ± .25mm
Articulated tip Steering	4 Braided Cables	4 Braided Cables
Diameter of flexible non-articulation section	13.5mm ± .25mm	13.5mm ± .25mm
Weight	2.15 lbs ± .25 lbs	2.15 lbs ± .25 lbs
Electrical Contacts	2	2
Internal Power	None	None
Usage Counter	Addition of usage counter memory module	Yes - Usage counter memory module relating to the # of DLUs fired. (This is a new feature, the acceptance would be that it functions as intended and does not negatively impact existing functions).
Sterilization Method Recommendation	ETO; Cold liquid sterilant (FDA cleared)	Steam (Flash) Sterilization; ETO; Cold liquid sterilant (FDA cleared); and Gas plasma sterilization. (This is an expanded method; acceptance would be validation of these new methods).

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

Sample Size: Not applicable. This submission does not involve a "test set" from a patient population for clinical efficacy or diagnostic performance. The testing would have been engineering verification and validation of the device components and functions against specifications.
Data Provenance: Not provided, but given the nature of the submission (device modification), testing would have involved engineering performance evaluations specific to the modified components and overall system functionality to ensure it performs as intended and equivalently to the predicate.

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

Not applicable. This submission is for a medical device (surgical stapler system) modification, not an AI/diagnostic device that requires expert ground truth establishment for patient data. Expert input would relate to surgical use cases and device functionality, but not "ground truth" for a test set in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" requiring adjudication in this context.

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 device is a surgical stapler system, not an AI or diagnostic device that would involve human readers or AI assistance.

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

Not applicable. This device is a surgical stapler system, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. The "ground truth" for this type of device modification would be its engineering specifications, functional performance requirements (e.g., proper stapling, articulation, electrical communication), and safety standards, rather than expert consensus on diagnostic images or pathology.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve machine learning or a "training set" in the context of data used for algorithm development.

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

Not applicable.

Summary

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K021249 (Pilot$)

MAY 1 5 2002

Power Medical Interventions, Inc. SurgASSIST™ System with FlexShaft 2 Special 510(k) Device Modification PreMarket Notification April 17, 2002

Special 510(k) Device Modification PREMARKET NOTIFICATION SAFETY AND EFFECTIVENESS SUMMARY

SurgASSIST™ System with FlexShaft 2

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 215-862-4450 Ph 215-862-1009 Fax

Applicant:

Barbara J. Whitman

April 17, 2002 Date of Notification:

1. Name of Device:

Trade Name:	SurgASSIST ™ System
	With FlexShaft 2

Common Name: FlexShaft 2, Flexible Shaft

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

3) Predicate Devices:

a) SurgASSIST™ System with Circular Stapler Disposable Loading Unit with Titagium Implantable Staple, Power Medical Interventions, Inc., K003277.

000016

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K024034 (P.2 of 4)

Power Medical Interventions, Inc. SurgASSIST™ System with FlexShaft 2 Special 510(k) Device Modification PreMarket Notification April 17, 2002

b) SurgASSIST™ System with Right Angle Linear Cutter Digital Loading Unit™, Power Medical Interventions, Inc., K012809.

4) Device Description:

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K021249 (P.3 of 4)

Power Medical Interventions, Inc. SurgASSIST™ System with FlexShaft 2 Special 510(k) Device Modification PreMarket Notification April 17, 2002

1. Indications For Use The FlexShaft 2 will have identical Indications For Use as the predicate device.
  The SurgASSIST™ System with Circular Stapler DLU, has applications throughout the alimentary tract for end-to-end and sideto-side anastomosis.

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

1. Comparison to Predicate Devices
  The following table compares the subject FlexShaft 2 device to the previously cleared predicate FlexShaft device:

Features & Description	SurgASSIST™ w/ FlexShaft 2 (FS214)	PredicateSurgASSIST™ w/ the originalFlexShaft (FS14)
Name	SurgASSIST™ System with FlexShaft 2	SurgASSIST System with FlexShaftcomponent
Manufacturer of Record	Power Medical Interventions, Inc.	Power Medical Interventions, Inc.
Contract Manufacturer	Gore & Associates, Inc.Newark, DE	Design Standards CorporationCharlestown, NH
510(k) Clearance Numbers	Subject of this Notification	K003277
Product Codes	FS214	FS14
Intended use	Applications throughout the alimentarytract for end to end, end to side, andside to side anastomosis. Also,applications in gastrointestinal,gynecological, general abdominal andthoracic surgical procedures forresection, transection, and creation ofanastomoses.	Applications throughout the alimentarytract for end to end, end to side, andside to side anastomosis
FDA Class (System)	II	II
Physical Characteristics	------------------------------------------------	------------------------------------------------
Length of FlexShaft	2 meters ± 3cm	2 meters ± 3cm
Length of Articulation Section	10cm ± 2cm	10cm ± 2cm
Diameter of ArticulationSection	15mm ± .25mm	15mm ± .25mm
Articulated tip Steering	4 Braided Cables	4 Braided Cables
Diameter of flexiblenon-articulationsection	13.5mm ± .25mm	13.5mm ± .25mm
Weight	2.15 lbs ± .25 lbs	2.15 lbs ± .25 lbs
Color -Articulation Sheath	Black	Black
Color -Insertion Tube	Black	Black
Color -Proximal End Receptacle	Black	Black
Color -Distal End Receptacle	Stainless Steel	Stainless Steel
Color -Lettering	White	White
Internal Power	None	None
Electrical Contacts	2	2
Software Containing	Yes - Usage counter memory modulerelating to the # of DLUs fired.	No
How Supplied	Non-Sterile, plastic wrapped in singleunit corrugated box	Non-Sterile, plastic wrapped in singleunit corrugated box
Recommended Method ofSterilization	Steam (Flash) Sterilization; ETO; Coldliquid sterilant (FDA cleared); and Gasplasma sterilization	ETO; Cold liquid sterliant (FDA cleared)

FlexShaft Product Features Comparison Chart

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K021249 (4 of 4)

FlexShaft Product Features Comparison Chart - continued from previous page

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AY 1 5 2002

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

Re: K021249

Trade/Device Name: SurgASSIST™ System with FlexShaft 2 Regulation Number: 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 18, 2002 Received: April 19, 2002

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 for abound in the 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). Tour coosinede Prov (110) the device, subject to the general controls provisions of the Act. The I ou may , and severy in 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 – 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 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 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

for 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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031249

Power Medical Interventions, Inc. SurgASSIST™ System with FlexShaft 2 Power Modification PreMarket Notification PreMarket Notification April 17, 2002

Power Medical Interventions, Inc. New Hope, PA 18938

510(k) No. K 021249

Device Name:

SurgASSIST™ System with FlexShaft 2

INDICATIONS FOR USE: (Note: The intended use for this product modification will be substantially identical to that of Power Medical Interventions, Inc. immediate 510(k) Notification's, K003277 & K012809).

The SurgASSIST™ System with Circular Stapler Digital Loading Unit™ (DLU), has applications throughout the alimentary tract for end-to-end and side-to-side anastomosis.

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

Prescription Use
Per 21CFR §801.109

Over-The-Counter Use OR

Muriam C. Provost

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

510(k) Number K021249
000014

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.