(28 days)
Not Found
No
The description mentions "computer mediated steering and stapling" but does not provide any details suggesting the use of AI or ML algorithms for decision-making, image processing, or other functions typically associated with these technologies in medical devices. The lack of mentions of AI, DNN, ML, training/test sets, or performance metrics further supports this conclusion.
No
This device is a surgical stapler used for anastomoses, which is a surgical procedure to connect two tubular structures, rather than directly treating or preventing a disease or condition.
No
The device is a surgical stapler used for anastomoses (joining tubular structures) by applying staples and cutting tissue. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states that the device contains implantable titanium staples and integral cutting blades, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures within the alimentary tract for creating anastomoses (connecting tubular structures). This is a surgical device used directly on the patient's tissue.
- Device Description: The description details a surgical stapler system that implants staples and cuts tissue. This is a mechanical surgical tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on in vitro analysis.
Therefore, the SurgASSIST™ Circular Stapler Digital Loading Units® are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SurgASSIST™ Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
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
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.
-
- Submitter Information:
Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax
- Submitter Information:
Barbara J. Whitman Applicant:
August 29, 2003 Date of Notification:
-
- 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
-
- 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).
1
4) 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.
-
- 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.
- Device Modification
-
- 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.
- Indications For Use
2
| Features & Description | SurgASSIST™
Circular Stapler
Digital Loading Units® (DLUs)
21 mm, 25 mm, 29 mm, 33 mm
REF: CS21, CS25, CS29, CS33 | Predicate
SurgASSIST™
Circular Stapler
Digital Loading Units® (DLUs)
21 mm, 25 mm, 29 mm, 33 mm | Predicate
Ethicon Endo-Surgery, Inc.
Endopath ILS Endoscopic Circular
Stapler
21 mm, 25 mm, 29 mm, 33 mm |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Name | Circular Stapler
Digital Loading Units®
21 mm, 25 mm, 29 mm, 33 mm | Circular Stapler
Digital Loading Units®
21 mm, 25 mm, 29 mm, 33 mm | Ethicon Endo-Surgery, Inc.
Endopath ILS Endoscopic
Circular Stapler
21 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 Manufacturing
Bridgeport, CT | Lacey Manufacturing
Bridgeport, CT | Ethicon Endo-Surgery, Inc |
| 510(k) Clearance Numbers | Subject of this Notification | K003277 | K920752 |
| Intended use | Applications throughout the alimentary
tract for end-to-end, end-to-side and
side-to-side anastomoses. | Applications throughout the alimentary
tract for end-to-end, end-to-side and
side-to-side anastomoses. | Applications throughout the alimentary
tract for end-to-end, end-to-side and
side-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 mm
Circular Staplers | 21 mm, 25 mm, 29 mm, 33 mm
Circular Staplers | 21 mm, 25 mm, 29 mm, 33 mm
Circular Staplers |
| Staple Shape | B-Shaped | B-Shaped | B-Shaped |
| Features & Description | SurgASSIST™
Circular Stapler
Digital Loading Units® (DLUs)
21 mm, 25 mm, 29 mm, 33 mm
REF: CS21, CS25, CS29, CS33 | Predicate
SurgASSIST™
Circular Stapler
Digital Loading Units® (DLUs)
21 mm, 25 mm, 29 mm, 33 mm | Predicate
Ethicon Endo-Surgery, Inc.
Endopath ILS Endoscopic Circular
Stapler
21 mm, 25 mm, 29 mm, 33 mm |
| Closed Staple Height | Approximately
1.5 mm - 2.3 mm | Approximately
1.5 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 grade
stainless steels, adhesives, and
lubricants | Polymeric materials, surgical grade
stainless steels, adhesives, and
lubricants | Polymeric materials, surgical grade
stainless steels, adhesives, and
lubricants |
| Cutting Mechanism | Circular Knife | Circular Knife | Circular Knife |
| DLU Internal Power | None | None | None |
| Power | Electrically powered via a remote
Power Console | Electrically powered via a remote
Power Console | Manually powered |
| Software containing | Yes | Yes | No |
| Digital Information | Memory module containing digital data
for identification, etc. | Memory module containing digital data
for identification, etc. | None |
| How Supplied | Sterile - Single Patient Use | Sterile - Single Patient Use | Sterile - Single Patient Use |
| Features & Description | SurgASSIST™
Circular Stapler
Digital Loading Units® (DLUs)
21 mm, 25 mm, 29 mm, 33 mm
REF: CS21, CS25, CS29, CS33 | Predicate
SurgASSIST™
Circular Stapler
Digital Loading Units® (DLUs)
21 mm, 25 mm, 29 mm, 33 mm | Predicate
Ethicon Endo-Surgery, Inc.
Endopath ILS Endoscopic Circular
Stapler
21 mm, 25 mm, 29 mm, 33 mm |
| Safety Mechanism | Will not deploy until within an
appropriate range for desired closed
staple height | Will not deploy until within an
appropriate range for desired closed
staple height | Contains indicators for appropriate
range 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
3
Circular Stapler DLU Product Features Comparison Chart (continued from previous page)
4
Circular Stapler DLU Product Features Comparison Chart (continued from previous page)
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.
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.
6
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
7
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
OR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K03270/