(76 days)
Not Found
No
The summary describes a mechanical surgical stapler/cutter and does not mention any AI or ML components or functionalities.
Yes
The device is used for surgical procedures like resection, transection, and creation of anastomoses, which are therapeutic interventions.
No
This device is a surgical instrument (linear cutter and stapler) used for resection, transection, and creation of anastomoses during surgical procedures, not for diagnosing conditions.
No
The device description explicitly states the devices are "reusable CMLC DLUs" and are "designed to be cleaned and sterilized for multi-patient use," indicating they are physical hardware components.
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 performed on the patient's body (resection, transection, creation of anastomoses, occlusion). IVDs are used to examine specimens from the body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is described as a surgical instrument (linear cutter digital loading units) used in conjunction with reloads. This is consistent with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on laboratory tests.
Therefore, the SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® have applications for general endoscopic surgery in gastrointestinal, and gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The devices described here are reusable CMLC DLUs used in conjunction with a variety of Reloads, which were previously cleared to market under K020719 and K030653. The DLUs are designed to be cleaned and sterilized for multi-patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal, gynecological, general abdominal and thoracic, heart’s left atrial appendage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general and endoscopic surgery
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
K040720 Page 1/2
Power Medical Interventions, Inc. SurgASSIST® Computer Mediated Linear Cutter DLUs Traditional 510(k) Premarket Notification · March 17, 2004
JUN 0 3 2004
Section E
Traditional 510(k) - Summary
In Accordance with 21 CFR Section 807.92 Power Medical Interventions, Inc., is submitting the following 510(k) Summary:
- Submitter Information:
Power Medical Interventions, Inc. 110 Union Square Drive New Hope, PA 18938 267-775-8151 Ph 267-775-8123 Fax
Applicant:
Barbara J. Whitman
March 17, 2004 Date of Notification:
- Name of Device:
| Trade Name: | SurgASSIST®
Computer Mediated Linear Cutter (CMLC)
Digital Loading Units® (DLUs)
30 mm, 55 mm, 75 mm |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Linear Staplers with Implantable Staples |
| Classification
Name: | Staple, Implantable, GDW |
-
- Predicate Devices:
- a. SurgASSIST® Straight Linear Cutter Digital Loading Units® with Reloads, Power Medical Interventions, Inc., New Hope, PA. REF SLC55B, SLCR55B, SLC55G, SLCR55G, SLC30B, SLCR30B, SLC30G, SLCR30G (K020719).
- b. SurgASSIST® Straight Linear Stapler Digital Loading Units® with Reloads and Straight Linear 4 Row No Knife Digital Loading Units® with Reloads, Power Medical Interventions, Inc., New Hope, PA. |REF SLS55B, SLSR55B, SLS55G, SLSR55G, SLSR55G, SLS55B4, SLSR55B4 (K040398).
1
K040720 page 2/2
- c. USSC Auto Suture TA & GIA Staplers, United States Surgical, Norwalk, CT. REF TA, GIA (K032696).
-
- Device Description:
devices described here are reusable CMLC DLUs used in The conjunction with a variety of Reloads, which were previously cleared to market under K020719 and K030653. The DLUs are designed to be cleaned and sterilized for multi-patient use.
-
- Device Modification
The CMLC DLUs have identical technological features as the predicate devices (K020719). The CMLC DLUs underwent material changes in order for the DLUs to withstand multiple cleaning and autoclave cycles for the purpose of multi-patient use. The average anvil clamp force was increased from 50 lbs. on the predicate device to 100 lbs. on the Computer Mediated Linear Cutter DLUs.
- Device Modification
-
- Indications For Use
The SuraASSIST® Computer Mediated Linear Cutter Digital Loading Units® have applications for general and endoscopic surgery in gastrointestinal, gynecological, general abdominal and thoracic suraical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
- Indications For Use
-
- Comparison to Predicate Devices
The CMLC DLUs have the same function as the previously cleared predicate Straight Linear Cutter Digital Loading Units® with Reloads (K020719). Material changes in the DLUs allow for cleaning, sterilizing, and multi-patient use. The average anvil clamp force was increased in the CMLC DLUs. For further details, please refer to Section J for predicate comparison chart.
- Comparison to Predicate Devices
The CMLC DLUs Indications For Use statement is identical to that which appears in the following two predicate devices, K040398 and K032696.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HEALTH & HUMAN SERVICES - USA" are arranged around the top of the symbol. The logo is black and white and has a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 0 3 2004
Ms. Barbara J. Whitman Regulatory Affairs Manager Power Medical Interventions, Inc. 110 Union Square Drive New Hope, Pennsylvania 18938
Re: K040720
Trade/Device Name: SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: March 18, 2004 Received: March 19, 2004
Dear Ms. Whitman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use slated in the elerosure) to 1egars atment date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuired in accessaried of a premarket approval application (PMA). and Cosmette Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, ulcrefore, market the device, books requirements for annual registration, listing of general controls provisions of all rist leveling, 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 classified (see above) and class of regulations affecting your device can may be subject to back acated as a legulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obas acements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that i Dri brisoaanso o vour device complies with other requirements of the Act that I DA has made a aother regulations administered by other Federal agencies. You must of any I coclar statutes and regulations and limited to: registration and listing (21 Comply with an the rice brequirements)01); good manufacturing practice requirements as set CITY art 607), adomig (21 CFR Part 820); and if applicable, the electronic 101th in the quant) Bybellio (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Barbara J. Whitman
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin marketing your antial equivalence of your device to a legaliy premarket notification. The FDA Inding of substantial equilies 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 If you desire specific advice for your de 110 your ac 9. Also, please note the regulation entitled, contact the Office of Complance at (301) 597 1707 (21) Part 807.97). You may obtain " Misoranding by reference to premarked nonlineaus in the Act from the Division of Small other general Informational and Consumer Assistance at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance on and also and also and Manufacturers, International and Consulter Parison Parison of Carb/dsmaldsmamain.html
Sincerely yours,
Miriam 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
4
Section D
Indications for Use
Power Medical Interventions, Inc. New Hope, PA 18938
510(k) Number (if known):
Device Name: SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units®
Indications For Use:
The SurgASSIST® Computer Mediated Linear Cutter Digital Loading Units® have applications for general endoscopic surgery in gastrointestinal, and gynecological, general abdominal and thoracic surgical procedures for resection, transection, creation of anastomoses, and for open occlusion of the heart's left atrial appendage.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of
000012
510(k) Number K0140720