(27 days)
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.
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
The provided text describes a 510(k) premarket notification for the SafeStitch AMID Stapler, a surgical stapler for fixation of mesh in hernia repairs and approximation of tissue. The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing.
Here's an analysis of the requested information based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document states: "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)."
However, the specific acceptance criteria (e.g., minimum staple retention force, maximum staple deployment force, staple formation consistency) and the quantitative reported performance of the AMID Stapler against these criteria are not provided in the given text. It only vaguely mentions "internal specifications" and "substantially equivalent to the predicate device(s)" without detailing what those specifications or equivalence metrics are.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document mentions "bench testing" but does not specify the sample size used for these tests. There is no information provided about the country of origin of the data or whether the study was retrospective or prospective. Bench testing typically falls under laboratory or engineering studies rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable to the "Performance Data" described. The performance data discussed is "bench testing" which usually involves engineering measurements and evaluations, not expert opinion or a ground truth established by medical experts in the way clinical studies for diagnostic devices might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As with point 3, this is not applicable to the type of performance data (bench testing) described. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish a "ground truth" for ambiguous cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a surgical stapler, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This question is not applicable as the device is a medical device (surgical stapler), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench testing, the "ground truth" would be the established engineering specifications or performance characteristics of the predicate device(s) that the AMID Stapler aimed to demonstrate substantial equivalence to. However, the exact nature of these "ground truths" (e.g., specific tensile strength, staple formation under specific tissue thickness) is not detailed in the provided document.
8. The sample size for the training set:
This is not applicable. Surgical staplers are mechanical devices and typically do not involve "training sets" in the context of machine learning or AI. The product validation involves engineering tests against predefined specifications.
9. How the ground truth for the training set was established:
This is not applicable for the same reasons as point 8.
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| Company: | SafeStitch LLC | NOV 12 2009 |
|---|---|---|
| Contact: | Stewart B. Davis M.D.Chief Operating OfficerSafeStitch LLC and SafeStitch Medical Inc.4400 Biscayne BoulevardSuite A-100Miami, FL 33137Phone 305.575.4145Fax 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 StatesSurgical Corporation, a division of Tyco Healthcare(K771177)AutoSuture Disposable Stapling Instrument, UnitedStates Surgical Corporation, a division of TycoHealthcare (K780695)AutoSuture Titanium Surgical Staples, United StatesSurgical Corporation, a division of Tyco Healthcare(K855047) | |
| Device Description: | The AMID Stapler is a sterile, single use disposablestapler. The AMID Stapler consists of a manual staplerand 17 titanium staplers. It is designed for the stapling oftissue and mesh, specifically for hernia repairs | |
| Indications for use: | The SafeStitch AMID Stapler has application in generalsurgery procedures for fixation of mesh, in the repair ofhernia defects and in other surgical specialties for theapproximation 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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§ 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.