(113 days)
Not Found
No
The 510(k) summary describes a mechanical fixation device and does not mention any AI or ML components or functionalities.
No
The device is described as a fixation device for prosthetic material to soft tissues during surgical procedures, specifically for hernia repairs, which is a structural or supportive function rather than a therapeutic one (i.e., treating a disease or disorder directly).
No
Explanation: This device is described as a fixation device for prosthetic material to soft tissues, used in surgical procedures like hernia repairs. Its purpose is to physically secure materials, not to diagnose conditions or diseases.
No
The device description clearly states it is a "5mm laparoscopic device" and a "multi-fire, single-use device pre-loaded with 25 absorbable straps," indicating it is a physical hardware device with absorbable components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hemia repairs." This describes a surgical device used in vivo (within the body) for mechanical fixation.
- Device Description: The description details a "5mm laparoscopic device for hernia repair" that applies "absorbable straps." This further confirms its use as a surgical tool.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with biological specimens for diagnostic purposes.
Therefore, the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repair.
Product codes
GDW
Device Description
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is a 5mm laparoscopic device for hernia repair. It is a multi-fire, single-use device pre-loaded with 25 absorbable straps. The straps are composed of a blend of polydioxanone and L(-)-lactide and glycolide dyed with D&C Violet No. 2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissues (specifically mentioned for hernia repair)
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)
An appropriate and complete performance testing program, including bench and animal, supports that the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device fulfills the device requirements as defined in used specifications, functions as intended, and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Traditional 510(k) — ETHICON
5 page 1/2
510(K) SUMMARY 5
| Applicant: | Ethicon Inc.
P.O. Box 151
Route 22 West
Somerville, NJ 08876
USA
Phone: +1-908-218-2954
Fax: +1-908-218-2595 | APR - 7 2010 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------|
| Date:
Contact Person: | November 25, 2009
Joseph Kiceina | |
| Proprietary Device Name: | ETHICON SECURESTRAP™ 5mm Absorbable Strap
Fixation Device | |
| Common Device Name: | Implantable staple; 21CFR 878.4750 | |
| Classification: | GDW; Class II | |
| Predicate Devices: | AbsorbaTack™ Absorbable Fixation Device (K091900) | |
| Manufacturer: | Ethicon LLC
Guaynabo, Puerto Rico 00969
USA | |
1
5.1 Substantially Equivalent To:
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is substantially equivalent to the Covidien AbsorbaTack™ Absorbable Fixation Device (K091900).
The ETHICON SECURESTRAPTM 5mm Absorbable Strap Fixation Device has the same intended use, and similar indications for use, technological characteristics, and principles of operation as its predicate device.
The minor technological differences between the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device and the AbsorbaTack™ Absorbable Fixation Device raise no new issues of safety or effectiveness as verified by performance data.
5.2 Description of the Device Subject to Premarket Notification:
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is a 5mm laparoscopic device for hernia repair. It is a multi-fire, single-use device pre-loaded with 25 absorbable straps. The straps are composed of a blend of polydioxanone and L(-)-lactide and glycolide dyed with D&C Violet No. 2.
5.3 Indications for Use:
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hemia repairs.
5.4 Performance Data:
An appropriate and complete performance testing program, including bench and animal, supports that the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device fulfills the device requirements as defined in used specifications, functions as intended, and is substantially equivalent to the predicate device.
5.5 Overall Performance Conclusion:
An appropriate and complete performance testing program, including bench and animal testing was performed. Results support that the ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device meets the device requirements as defined in user specifications, functions as intended, and is substantially equivalent to the predicate device. The materials that are used in the manufacturing of this device have been evaluated in accordance with ISO 10993-1:2003, Biological Evaluation of Medical Devices - Part 1 Evaluation and Testing and are equivalent to the predicate device.
2
Image /page/2/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 image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 7 2010
Ethicon Inc. % Mr. Joseph Kiceina Manager, Regulatory Affairs · P.O. Box 151, Route 22 West Somerville, New Jersey 08876
Re: K093845
Trade/Device Name: Ethicon SECURESTRAP™ 5mm Absorbable Strap Fixation Device Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: March 31, 2010 Received: April 01, 2010
Dear Mr. Kiceina:
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 - Mr. Joseph Kiceina
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/ucm11.5809.htm for the 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,
For
N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4 INDICATIONS FOR USE STATEMENT
510(k) No (if known):
Device Name: ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device
Indications for Use:
The ETHICON SECURESTRAP™ 5mm Absorbable Strap Fixation Device is intended for fixation-of-prosthetic-material-to-soft-tissues-in-various-minimally-invasive-and-open surgical procedures such as hernia repair.
Prescription Use V (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)
Page 1 of 1
Daniel Kane for MxM
Division Blue-Off
(Division Slun-Of Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K093845