(26 days)
Not Found
No
The device description focuses on mechanical and electrical components for remote control and data tracking, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
No.
The device is a surgical stapler system used for resection, transection, and creation of anastomosis during surgical procedures, which is an interventional device, not a therapeutic device.
No
The device description and intended use indicate that the SurgASSIST™ System with FlexShaft 2 is a surgical tool used for procedures like resection, transection, and creation of anastomosis. It does not mention any function related to diagnosing a condition or disease.
No
The device description clearly details multiple hardware components including the FlexShaft 2, drive shafts, motors, printed circuit board, hall-effect transistors, steering cables, and electrical contacts, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes surgical procedures for anastomosis, resection, and transection within the alimentary tract, gastrointestinal, gynecological, general abdominal, and thoracic areas. This involves direct surgical intervention on the body.
- Device Description: The device description details a system with a flexible shaft, drive shafts, steering cables, and electronic components designed to mechanically operate surgical staplers (Circular Stapler and Right Angle Linear Cutter). This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for in vivo (within the body) surgical procedures.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, gastrointestinal, gynecological, general abdominal and thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
-
- Submitter Information:
Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 215-862-4450 Ph 215-862-1009 Fax
- Submitter Information:
Applicant:
Barbara J. Whitman
April 17, 2002 Date of Notification:
-
- 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
1
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:
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.
2
K021249 (P.3 of 4)
Power Medical Interventions, Inc. SurgASSIST™ System with FlexShaft 2 Special 510(k) Device Modification PreMarket Notification April 17, 2002
-
- 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.
- Indications For Use The FlexShaft 2 will have identical Indications For Use as the predicate device.
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.
-
- Comparison to Predicate Devices
The following table compares the subject FlexShaft 2 device to the previously cleared predicate FlexShaft device:
- Comparison to Predicate Devices
| Features & Description | SurgASSIST™ w/ FlexShaft 2 (FS214) | Predicate
SurgASSIST™ w/ the original
FlexShaft (FS14) |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Name | SurgASSIST™ System with FlexShaft 2 | SurgASSIST System with FlexShaft
component |
| Manufacturer of Record | Power Medical Interventions, Inc. | Power Medical Interventions, Inc. |
| Contract Manufacturer | Gore & Associates, Inc.
Newark, DE | Design Standards Corporation
Charlestown, NH |
| 510(k) Clearance Numbers | Subject of this Notification | K003277 |
| Product Codes | FS214 | FS14 |
| Intended use | Applications throughout the alimentary
tract for end to end, end to side, and
side to side anastomosis. Also,
applications in gastrointestinal,
gynecological, general abdominal and
thoracic surgical procedures for
resection, transection, and creation of
anastomoses. | Applications throughout the alimentary
tract for end to end, end to side, and
side 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 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 |
| 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 module
relating to the # of DLUs fired. | No |
| How Supplied | Non-Sterile, plastic wrapped in single
unit corrugated box | Non-Sterile, plastic wrapped in single
unit corrugated box |
| Recommended Method of
Sterilization | Steam (Flash) Sterilization; ETO; Cold
liquid sterilant (FDA cleared); and Gas
plasma sterilization | ETO; Cold liquid sterliant (FDA cleared) |
FlexShaft Product Features Comparison Chart
3
K021249 (4 of 4)
FlexShaft Product Features Comparison Chart - continued from previous page
4
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.
5
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
6
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.
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.
(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