(90 days)
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Curved Tip White and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
Each MicroCutter 30 Reload contains two double rows of 316L stainless steel staples. The size of the MicroCutter 30 Blue Reload and MicroCutter 30 Curved Tip Blue Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the MicroCutter30 White Reload and MicroCutter 30 Curved Tip White Reload staple is compatible with tissue that can be easily compressed to 1.0mm. If tissue cannot comfortably compress to the Maximum Tissue Thickness listed for each reload, or easily compresses to less than the Maximum Tissue Thickness listed for each reload, the tissue is contraindicated as it may be too thick or too thin for the selected staple size. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The MicroCutter 30 Reloads are deployed using the Dextera MicroCutter 5/80TM Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.
This document is a 510(k) Premarket Notification from the FDA regarding the Dextera MicroCutter 30 Reloads, which are implantable staples. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone study with detailed acceptance criteria and performance against those criteria.
However, based on the provided text, we can extract information regarding a performance comparison study.
Here's an analysis of the acceptance criteria and study information available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes a "functional performance testing" where the "results demonstrated the subject devices to be substantially equivalent to the predicate devices." This implies that the performance of the Dextera MicroCutter 30 Reloads (subject device) was at least as good as or not statistically worse than the Ethicon ENDOPATH® ETS-Flex45 Endoscopic Articulating Linear Cutters and their Reloads (predicate device).
The performance metric mentioned is "Tissue Burst Pressure." The acceptance criterion, though not explicitly quantified, is that the subject devices perform equivalently to the predicate devices in this test.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Performance equivalent to predicate device in Tissue Burst Pressure testing on porcine veins. | Demonstrated substantial equivalence to the predicate devices in Tissue Burst Pressure testing on porcine veins. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not explicitly stated in the provided text for the Tissue Burst Pressure testing. It mentions "porcine veins" without specifying the number of samples or trials.
- Data provenance:
- Country of origin: Not specified.
- Retrospective or prospective: This appears to be a prospective non-clinical performance study.
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 and not provided in the document. The study described is a non-clinical, in-vitro/ex-vivo functional performance test (Tissue Burst Pressure) on animal tissue, not a human reader study requiring expert interpretation of results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable nor provided. This refers to human reader studies, which is not what is described here.
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
No. This document describes non-clinical functional performance testing of a surgical stapler, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a medical device (surgical stapler) that is used by a human surgeon; it is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Tissue Burst Pressure" testing, the ground truth is the directly measured burst pressure of the stapled tissue, which is a quantitative physical property. There isn't an "expert consensus" or "pathology" in the typical sense for this type of mechanical performance testing.
8. The sample size for the training set
Not applicable. The described study is a non-clinical performance comparison, not an AI/algorithm training process.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/algorithm described in this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2017
Dextera Surgical, Inc. Ms. Pamela Segale Consulting VP, Regulatory Affairs 900 Saginaw Drive Redwood City, CA 94063
Re: K171561
Trade/Device Name: Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: May 27, 2017 Received: May 30, 2017
Dear Ms. Segale:
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
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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K171561
Device Name
MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 Curved Tip White Reload, Dextera MicroCutter 5/80 Stapler
Indications for Use (Describe)
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediativ surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Date Prepared A.
August 25, 2017
B. 510(k) Owner
Dextera Surgical Inc. 900 Saginaw Drive Redwood City, California 94063 Phone: 650-364-9975 Fax: 650-364-3134
C. Contact Person
Pamela Segale Consulting VP, Regulatory Affairs (650) 331-7131 (office) (650) 799-7162 (cell) psegale@dexterasurgical.com
D. Device Information
Trade name: MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 White Reload, and MicroCutter 30 Curved Tip White Reload
Common name: Staple Classification Name: Implantable staple Regulation Number: 21 CFR §878.4750 Product Code: GDW
E. Marketed Predicate Devices
Ethicon ENDOPATH® ETS-Flex45 Endoscopic Articulating Linear Cutters and (Reloads) (K070887)
Reference Devices
MicroCutter 30 Blue Reload, MicroCutter 30 Curved Tip Blue Reload, MicroCutter 30 White Reload and MicroCutter 30 Curved Tip White Reload used with the MicroCutter 5/80 Stapler (K151081 and K161137)
F. Device Description
Each MicroCutter 30 Reload contains two double rows of 316L stainless steel staples. The size of the MicroCutter 30 Blue Reload and MicroCutter 30 Curved Tip Blue Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the MicroCutter30 White Reload and MicroCutter 30 Curved Tip White Reload staple is compatible with tissue that can be easily compressed to 1.0mm. If tissue cannot comfortably compress to the Maximum Tissue Thickness listed for each reload, or easily compresses to less than the Maximum Tissue Thickness listed for each reload, the tissue
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is contraindicated as it may be too thick or too thin for the selected staple size. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The MicroCutter 30 Reloads are deployed using the Dextera MicroCutter 5/80TM Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.
G. Indications for Use
The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Curved Tip White and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.
The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.
H. Comparison to Predicate Device
A comparison of the subject devices to the predicate devices demonstrates that the devices have the same intended use, which is to transect, resect and create anastomoses in patients during surgery in a variety of surgical procedures including urologic, thoracic, pediatric, and intestinal surgery. Additionally, they have the same mechanism of action and similar technologies given both the subject and the predicate devices achieve their intended use by means of cartridge based metal staples that are delivered using stapling devices.
Chronic animal studies, previously submitted by Dextera Surgical (K151081), were conducted in which unilateral nephrectomies and unilateral lobectomies were performed comparing the Dextera Surgical subject staple and the predicate Ethicon staple. The endpoints of the studies were met with no demonstrable differences noted between the subject devices and the predicate devices. Non-clinical performance data was also previously submitted (K151081) in which the Dextera Surgical subject staple and the Ethicon predicate staple were compared during Tissue Burst Pressure testing in porcine arteries. The test data demonstrated the subject devices to be substantially equivalent to the predicate devices.
I. Performance Data
Non-Clinical Performance Data
Functional performance testing was conducted using the subject staple and the predicate staple on porcine veins during Tissue Burst Pressure testing. The testing simulated transection of vessels as may be encountered during surgery on solid organs. The results demonstrated the subject devices to be substantially equivalent to the predicate devices.
J. Conclusion
The subject devices and the predicate devices have intended use and similar indications for use. Additionally, the subject devices and the predicate devices have the same mechanism of action and utilize similar technologies. Functional performance testing (Tissue Burst Pressure) was conducted with the results demonstrating the subject
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devices to be substantially equivalent to the predicate devices. Thus, based on the data and the comparison of the devices, the subject devices are substantially equivalent to the predicate devices.
§ 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.