(270 days)
K 120179
Not Found
No
The document describes a mechanical surgical stapler and does not mention any AI or ML components or functionalities.
No
The device is a surgical stapler used for cutting and stapling tissues, which is a surgical tool, not a therapeutic device.
No
The device is described as a surgical instrument used for resection, transection, and creating anastomoses, placing staples, and dividing tissue. This falls under therapeutic or surgical functions, not diagnostic ones which involve identifying or characterizing a disease or condition.
No
The device description clearly describes a physical surgical instrument (stapler) with disposable loading units, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Description: The description clearly states that this device is a "sterilized and disposable surgical instrument" used for "resection, transection of anastomoses" and placing staples. This is a surgical tool used directly on the patient's body during a procedure.
- Intended Use: The intended use is for surgical procedures in various specialties, involving the cutting and stapling of tissue. This is a therapeutic or procedural use, not a diagnostic one based on analyzing specimens.
The device's function is to physically manipulate tissue during surgery, which is fundamentally different from the purpose of an IVD.
N/A
Intended Use / Indications for Use
The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The proposed devices, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU), are sterilized and disposable surgical instruments, which have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and billiary structures.
It places four or six rows of titanium staples and simultaneously divides the tissue from central line. The Endoscopic Linear Cutter Staplers can be adapted for all of the SULU sizes available, and they may be reloaded and fired no more than 10 times in a single procedure.
The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver substance, hepatic vasculature, biliary structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general, gynecologic, pediatric and thoracic 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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing.
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.
K 120179
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
Section III 510(k) Summary
Project #: M0032012Aa
DEC 1 3 2013
Proposed Device Identification 4.
Proposed Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Device Common Name: Stapler
Regulatory Information: Classification Name: Staple, Implantable; Classification: II; Product Code: GDW: Regulation Number: 21 CFR 878.4750; Review Panel: General & Plastic Surgery;
Intended Use Statement:
The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.
Predicate Device Identification 5.
510(k) Number:K 120179
Product Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Manufacturer: Reach Surgical, Inc.
6. Device Description
The proposed devices, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU), are sterilized and disposable surgical instruments, which have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and billiary structures.
It places four or six rows of titanium staples and simultaneously divides the tissue from central line. The Endoscopic Linear Cutter Staplers can be adapted for all of the SULU sizes available, and they may be reloaded and fired no more than 10 times in a single procedure.
The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.
- Non-Clinical Test Conclusion 7.
111-2
1
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing.
-
- Substantially Equivalent (SE) Conclusion
The following table compares the proposed device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
- Substantially Equivalent (SE) Conclusion
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation Number | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The Endoscopic Linear Cutting Staplers with Single | |
| Use Loading Units have applications in general, | ||
| gynecologic, pediatric and thoracic surgery for | ||
| resection, transection, and creation of anastomoses. | ||
| They may be used for transection and resection of | ||
| liver substance, hepatic vasculature and biliary | ||
| structures. | Same | |
| Cutting Mechanism | Linear | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Green button for preventing from mis-firing. | Same |
| Suture Length | 46, 61 mm | Similar |
| Closed Staples Height | 0.75, 1.0, 1.5, 2.0 mm | Same |
| Closed Staples Form | Image: staple form | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Similar |
.Table 111-1 Comparison of Technology Characteristics
The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units, is determined to be Substantially Equivalent (SE) to the predicate device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (K120179), in respect of safety and effectiveness.
2
Image /page/2/Picture/0 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 symbol that resembles a human figure embracing or supporting another, representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Nanjing Maidixin Medical Device Company, LTD % Ms. Diana Hong Mid-Link Consulting Company LTD P.O. Box 120-119 Shanghai, China 200120
December 13, 2013
Re: K130738
Trade/Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 7, 2013 Received: November 12, 2013
Dear Ms. Hong:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Diana Hong
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
For
Sincerely vours.
Joshua
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Section II Indications for Use
510(k) Number: K130738 Device Name: Endoscopic Linear Cutting Staplers with Single Use Loading Units
Indications for Use:
The Endoscopic Linear Cutting Staple Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)
OR
OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
David Krause SS
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130738
II-I