(11 days)
Not Found
No
The description focuses on the mechanical function of a stapler and does not mention any AI/ML components or capabilities.
No.
The device is used for surgical fixation and approximation of tissues, not for treating or preventing a disease or condition.
No
The device is described as a stapler used for fixation of mesh or approximation of tissue, which is a therapeutic or surgical function, not a diagnostic one.
No
The device description explicitly states it "contains 17 titanium staples" and is an "instrument's handle," indicating it is a physical hardware device that deploys staples.
Based on the provided information, the SafeStitch AMID Stapler® is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for "fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissue(s), including skin." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a mechanical stapler that physically places staples into tissue or mesh. This is a surgical instrument, not a device designed to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze blood, urine, tissue samples, or any other biological material in vitro (outside the body).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SafeStitch AMID Stapler® does not fit this description.
N/A
Intended Use / Indications for Use
"The SafeStitch AMID Stapler® has application in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues(s), including skin."
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The SafeStitch AMID Stapler™ contains 17 titanium staples. The AMID Stapler™ places a staple each time the instrument's handle is squeezed. The staple legs first penetrate the tissue or mesh and then fully form, thus anchoring or approximating the tissue(s) and/or mesh.
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)
Design verification testing was conducted to verify that the subject device meets the required acceptance criteria and functions equivalent to the predicate device.
Results of testing:
Staple Pull Strength: Pass
Maximum Staple Penetration: Pass
Formed Staple Height: Pass
Formed Staple Width: Pass
Maximum Deployment Force: Pass
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
Image /page/0/Picture/0 description: The image shows the text "SafeStitch Medical, Inc." on the first line and "AMID Stapler" on the second line. The text is in a simple, sans-serif font and is likely part of a document or label. The text is clear and legible, suggesting it is intended for easy reading.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be "K120268". The characters are written in a cursive style, with some connections between the numbers. Below the sequence of characters, the text "Special 510(k) Notification" is present.
FEB 1 0 2012
510(k) Summary
This 510(k) Summary is provided per the requirements of 21 CFR 807.92.
Submitter Information:
| Name: | SafeStitch Medical, Inc. |
|---|---|
| Address: | 4400 Biscayne Blvd. |
| Miami, FL 33137 | |
| Contact Person: | Alina Caraballo |
| Director, Regulatory Affairs and Quality Assurance | |
| Telephone: 305-575-4637 | |
| Fax: 305-575-4130 | |
| Email: acaraballo@safestitch.com |
Device Information:
| Trade Name: | AMID Stapler® |
|---|---|
| Common Name: | Surgical Stapler |
| Classification: | Stapler - Class I; Staple - Class II |
| Classification Name: | Stapler - Manual surgical instrument for general use; Staple - Implantable staple |
Predicate Devices:
The prodicate device is the AMID Stapler® that was cleared via 510(k) K093253 on November 12, 2009.
Device Description:
The SafeStitch AMID Stapler™ contains 17 titanium staples. The AMID Stapler™ places a staple each time the instrument's handle is squeezed. The staple legs first penetrate the tissue or mesh and then fully form, thus anchoring or approximating the tissue(s) and/or mesh.
Indications for Use:
The indications for use of the subject device, as described in its labeling, have not changed as a result of the modifications. The indications for use of the subject and predicate devices are identical.
"The SafeStitch AMID Stapler® has application in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues(s), including skin."
1
Comparison to Predicate Device:
The subject AMID Stapler® is essentially the same as the predicate device with minor modifications and manufacturing process improvements aimed at improving manufacturing efficioncies while maintaining product robustness. These modifications do not change the mechanism of action of the device. In addition, the label and Instructions for Use were revised to better align them with the requirements of 21 CFR 801. To summarize, the subject and predicate devices share the same indications for use, materials, basic design, fundamental scientific technology, labeling, packaging materials and configuration, shelf life, and sterilization processes.
Non-Clinical Testing:
Design verification testing was conducted to verify that the subject device meets the required acceptance criteria and functions equivalent to the predicate device. Results of that testing is presented below:
| Test Method | Predicate Device Test
Results | Subject Device Test
Results |
|-------------------------------|----------------------------------|--------------------------------|
| Staple Pull Strength | Pass | Pass |
| Maximum Staple
Penetration | Pass | Pass |
| Formed Staple
Height | Pass | Pass |
| Formed Staple
Width | Pass | Pass |
| Maximum
Deployment Force | Pass | Pass |
Substantial Equivalence:
In esublishing substantial equivalence to the predicate device, SafeStitch Medical, Inc. evaluated the indications for use, materials, basic design, fundamental scientific technology, labeling, packaging materials and configuration, shelf life, and sterilization processes. The performance testing included in this submission demonstrates that the differences between the subject and predicate devices do not impact safety and effectiveness. Thus, based on the information presented herein, the subject AMID Stapler® is substantially equivalent to the predicate AMID Stapler® cleared via 510(k) K093253 on November 12, 2009.
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 eagle with three heads, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 1 0 2012
SafeStitch Medical, Inc. % Ms. Alina Caraballo 4400 Biscayne Boulevard, Suite 670 Miami. Florida 33137
Re: K120268
Trade/Device Name: Amid Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: January 27, 2012 Received: January 30, 2012
Dear Ms. Caraballo:
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
3
Page 2 - Ms. Alina Caraballo
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 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: AMID Stapler®
Indications for Use:
The SafeStitch AMID Stapler® has application in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissue(s), including skin.
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)
Daniel Kane for MXM
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K120268
e for