(125 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML terms or functionalities.
No
The device is described as a fixation device used in surgical procedures to attach prosthetic material to soft tissues, which points to a surgical tool rather than a therapeutic device.
No
The device is described as a "Fixation Device" used for "fixation of prosthetic material to soft tissues," which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "triegersqueeze mechanical device with a curved cannula, pre-loaded with 20 absorbable straps," indicating it is a physical hardware device, not software only.
Based on the provided information, the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs." This describes a surgical device used directly on a patient's body during a procedure.
- Device Description: The description details a mechanical device with a cannula and absorbable straps made of specific materials. This is consistent with a surgical implant/fixation device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the human body to provide diagnostic information. This device is used in the body during surgery.
N/A
Intended Use / Indications for Use
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is a triegersqueeze mechanical device with a curved cannula, pre-loaded with 20 absorbable straps. The ETHICON SECURESTRAP™ Fixation Device straps are made of a blend of polydioxanone dyed with D&C Violet No. 2 and a L(-)-Lactide/glycolide copolymer. The inserted length of the strap is 6.7 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device underwent an extensive safety and performance testing program, including bench and animal testing, to support that the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device meets the device requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate device. The tests conducted include:
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 standard .
- Bench top physical/performance measurements including mesh fixation force and mesh . compatibility testing in animal tissue model
Conclusion: The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device has the same intended use, fundamental scientific technology, and principles of operation as its predicate device. Performance data demonstrates that the device is as safe and as effective as the predicate device for the intended use. The minor delivery system differences between the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device and the ETHICON SECURESTRAPTM Fixation Device raise no new issues of safety or effectiveness as verified by performance data.
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
5 510(K) SUMMARY
Applicant:
Ethicon Inc. P.O. Box 151 Route 22 West Somerville, NJ 08876 USA Phone: +1-908-218-2256 Fax: +1-908-218-2595
Contact Person:
Fixation Device
Implantable Staple
September 28, 2012
Susan Lin
Date:
Trade Device Name:
Class II, 21CFR 878.4750, Product Code: GDW
Common Device Name:
Classification:
Predicate Devices:
ETHICON SECURESTRAP™ 5 mm Absorbable Strap Fixation Device (K093845)
ETHICON SECURESTRAPTM Open Absorbable Strap
Manufacturer:
Ethicon LLC Guaynabo, Puerto Rico 00969 USA
Description of the Device Subject to Premarket Notification;
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is a triegersqueeze mechanical device with a curved cannula, pre-loaded with 20 absorbable straps. The ETHICON SECURESTRAP™ Fixation Device straps are made of a blend of polydioxanone dyed with D&C Violet No. 2 and a L(-)-Lactide/glycolide copolymer. The inserted length of the strap is 6.7 mm.
Indications for Use:
The ETHICON SECURESTRAPTM Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.
16
FEB
5 2013
1
23114 2002
Summary of Technological Characteristics of New Device to Predicate Devices:
The principle of operation and fundamental scientific technology of the proposed device are equivalent to the predicate device. Both the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device and the ETHICON SECURESTRAP™ 5 mm Absorbable Strap Fixation Device function in the same manner - they are designed for fixation of prosthetic material to soft tissues in surgical procedures, such as hernia repairs. They perform this function by delivering absorbable straps into the tissue of the abdominal wall. The strap delivery system in the proposed device is specifically designed for open surgical repair procedures and consists of a newly designed ergonomic handle and trigger, modified lockout counter, modified mesh positioning tip, and includes 20 preloaded absorbable straps.
Performance Data:
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device underwent an extensive safety and performance testing program, including bench and animal testing, to support that the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device meets the device requirements as defined in user specifications, performs as intended, and is substantially equivalent to the predicate device. The tests conducted include:
- Biocompatibility testing in accordance to the tests recommended in the ISO 10993-1 standard .
- Bench top physical/performance measurements including mesh fixation force and mesh . compatibility testing in animal tissue model
Conclusion:
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device has the same intended use, fundamental scientific technology, and principles of operation as its predicate device. Performance data demonstrates that the device is as safe and as effective as the predicate device for the intended use. The minor delivery system differences between the ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device and the ETHICON SECURESTRAPTM Fixation Device raise no new issues of safety or effectiveness as verified by performance data.
Thus we conclude that the proposed device is substantially equivalent to the predicate devices under the Federal Food, Drug, and Cosmetic Act.
17
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 representation of a human figure, composed of three overlapping profiles, symbolizing the department's focus on people and their well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role within the United States government.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2013
Ethicon, Incorporated % Ms. Susan Lin Manager, Regulatory Affairs Route 22 West P.O. Box 151 Somerville, New Jersey 08876-0151
Re: K123114
Trade/Device Name: ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: January 14, 2013 Received: January 16, 2013
Dear Ms. Lin:
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
3
Page 2 - Ms. Susan Lin
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 4
510(k) No (if known): __K123114
Device Name: ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device
Indications for Use:
The ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in open surgical procedures, such as hernia repairs.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Krause
Page 1 of 1
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123114