(27 days)
Not Found
No
The summary describes a manual surgical stapler and staples, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
Explanation: The device is a surgical stapler used for fixation and approximation of tissues during surgical procedures. While it aids in the repair of conditions, its primary function is mechanical support during surgery rather than directly treating or curing a disease or condition. Therapeutic devices typically deliver energy, substances, or perform actions that directly alter physiological processes to treat a disease or improve health.
No
Explanation: The device is described as a stapler used for fixation and approximation of tissues, primarily in general surgery procedures like hernia repair. Its function is to mechanically fasten tissues, not to diagnose a condition.
No
The device description explicitly states it is a "manual stapler and 17 titanium staplers," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in surgical procedures for fixation of mesh and approximation of tissue(s). This is a direct surgical intervention on the patient's body.
- Device Description: The device is described as a manual stapler and titanium staples for stapling of tissue and mesh. This is a mechanical device used during surgery.
- Lack of IVD Characteristics: An IVD is a medical device intended to be used in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided information does not mention any of these activities. There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory tests.
Therefore, the SafeStitch LLC AMID Stapler & Non-Absorbable Staples is a surgical device used directly on the patient during a procedure, not an in vitro diagnostic device.
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 tissue(s), including skin. The SafeStitch LLC AMID Stapler & Non-Absorbable Staples has applications 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.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The AMID Stapler is a sterile, single use disposable stapler. The AMID Stapler consists of a manual stapler and 17 titanium staplers. It is designed for the stapling of tissue and mesh, specifically for hernia repairs
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)
Bench testing was performed to verify the AMID Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the AMID Stapler is substantially equivalent to the predicate device(s).
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.
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| Company: | SafeStitch LLC | NOV 12 2009 |
|---|---|---|
| Contact: | Stewart B. Davis M.D. | |
| Chief Operating Officer | ||
| SafeStitch LLC and SafeStitch Medical Inc. | ||
| 4400 Biscayne Boulevard | ||
| Suite A-100 | ||
| Miami, FL 33137 | ||
| Phone 305.575.4145 | ||
| Fax 305.575.4130 | ||
| Trade Name: | AMID Stapler | |
| Device Type: | Surgical Stapler | |
| Classification Regulation: | 878.4750 | |
| Class: | II | |
| Panel: | General and Plastic Surgery | |
| Product Code: | GDW | |
| Predicate Devices: | AutoSuture Surgical Stapling Instrument, United States | |
| Surgical Corporation, a division of Tyco Healthcare | ||
| (K771177) | ||
| AutoSuture Disposable Stapling Instrument, United | ||
| States Surgical Corporation, a division of Tyco | ||
| Healthcare (K780695) | ||
| AutoSuture Titanium Surgical Staples, United States | ||
| Surgical Corporation, a division of Tyco Healthcare | ||
| (K855047) | ||
| Device Description: | The AMID Stapler is a sterile, single use disposable | |
| stapler. The AMID Stapler consists of a manual stapler | ||
| and 17 titanium staplers. It is designed for the stapling of | ||
| tissue and mesh, specifically for hernia repairs | ||
| 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. | ||
| Technological Characteristics: | The SafeStitch AMID Stapler is similar to the predicate devices in design and operation. The primary difference are the firing end does not swivel and the tip is angled. | |
| Performance Data: | Bench testing was performed to verify the AMID Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the AMID Stapler is substantially equivalent to the predicate device(s). |
SafeStitch AMID Stapler 510(k) Summary
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CONFIDENTIAL
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Safestitch LLC % Stewart B. Davis, M.D. Chief Operating Officer 4400 Biscayne Boulevard, Suite A-100 Miami. Florida 33137
JAN - 4 2010
Re: K093253
Trade/Device Name: Safestitch LLC AMID Stapler & Non-Absorbable Staples Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: November 12, 2009 Received: November 12, 2009
Dear Dr. Davis:
This letter corrects our substantially equivalent letter of November 12, 2009.
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 (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.
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
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Page 2 - Stewart B. Davis, M.D.
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K093253
Device Name: SafeStitch LLC AMID Stapler & Non-Absorbable Staples
The SafeStitch LLC AMID Stapler & Non-Absorbable Staples has applications 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)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
| 510(k) Number | 1093253 |
|---|---|
| --------------- | --------- |
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