(233 days)
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI/ML or related concepts like image processing or data-driven decision making.
No
The provided text indicates that the devices are used for surgical procedures like transection, resection, and creating anastomoses, as well as for general treatment of hemorrhoids, which are not considered therapeutic actions in themselves but rather surgical interventions.
No
The provided text describes surgical staplers used for transection, resection, and creation of anastomoses, which are therapeutic procedures. There is no mention of the device being used to identify or determine the nature of a disease or condition.
No
The device description clearly details physical, disposable surgical staplers made of titanium, which are hardware components.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described are for surgical procedures (treatment of hemorrhoids, transection, resection, and creation of anastomoses in various surgical fields). These are direct interventions on the body, not tests performed on samples taken from the body to diagnose a condition.
- Device Description: The device descriptions detail surgical staplers and their mechanisms for cutting and stapling tissue. This aligns with surgical tools, not diagnostic devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies described focus on the mechanical performance of the staplers (staple formation, burst pressure, force required to fire, etc.) and biocompatibility, which are relevant to surgical devices, not IVDs.
In summary, the device is clearly described as a surgical instrument used for physically manipulating tissue during surgery. This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Disposable Anorectal Staplers have application for general treatment of hemorrhoids.
The Disposable Linear Cutting Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
The Disposable Endoscopic Cutting Staplers has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The Disposable Anorectal Staplers are a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 33mm. The staple size is 4.0mm. It cannot be reloaded.
The Disposable Linear Cutting Stapler places two double-staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutting Staplers is available in 60mm, 80mm and 100mm three specifications, and in two staple sizes 3.8mm and 4.8mm, to accommodate various tissue thickness. Each Disposable Linear Cutting Staplers may be reloaded up to 10 times in a single procedure.
The Disposable Endoscopic Cutting Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.5mm, 4.0mm and 4.8mm. The device may be reloaded and fired up to 10 times in a single procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Anorectal, abdominal, gynecological, thoracic, pediatric
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-1:2018 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- USP Bacterial Endotoxins Test
- USP Pyrogen Test
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ISO 10993-11:2017 Biological Evaluation of Medical Device- Part 11: Tests for Systemic Toxicity
- ASTM D 4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- ASTM F 756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
The biocompatibility tests conducted on the proposed device include cytotoxicity test, skin sensitization test, intracutaneous irritation test, acute systemic toxicity test, pyrogen test and hemolysis test.
A simulation transportation test was conducted on the proposed device per ASTM D 4169 and package integrity test include dye penetration and sealing strength test were followed to demonstrate that the package materials can maintain the package integrity without compromising the product sterility.
Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Rest, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for less than 2.5mm staple height. Burst pressure, closed staple height and staple formation were evaluated in jugular vein test.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ningbo VeryKind Medical Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120 China
Re: K211458
Trade/Device Name: Disposable Anorectal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW. GAG Dated: November 25, 2021 Received: November 29, 2021
Dear Diana Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Dr. Mark Trumbore, Ph.D. Assistant Director for Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K211458
Device Name
Disposable Anorectal Staplers; Disposable Linear Cutting Staplers; Disposable Endoscopic Cutting Staplers
Indications for Use (Describe)
The Disposable Anorectal Staplers have application for general treatment of hemorrhoids.
The Disposable Linear Cutting Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
The Disposable Endoscopic Cutting Staplers has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
Type of Use (Select one or both, as applicable)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K211458
-
- Date of Preparation: 12/30/2021
-
- Sponsor Identification
Ningbo VeryKind Medical Device Co., Ltd.
#100 Jinghua Road, High-tech Industrial Development Zone, Ningbo 315040 Zhejiang,P.R. China
Establishment Registration Number: Not registered yet.
Contact Person: Pengfei Hong Position: QA Manager Tel: +86-15888523540 Fax: +86-574-87910572 Email: pfhong@nbverkind.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Disposable Anorectal Staplers; Disposable Linear Cutting Staplers; Disposable Endoscopic Cutting Staplers
Common Name: Stapler, implantable
Regulatory Information Classification Name: Staple, Implantable Classification: II; Product Code: GDW Regulation Number: 21CFR 878.4750 Review Panel: General & Plastic Surgery
Classification Name: Stapler, Surgical; Classification: I Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4800 Review Panel: General & Plastic Surgery
Indication for Use:
The Disposable Anorectal Staplers have application for general treatment of hemorrhoids.
The Disposable Linear Cutting Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection and the creation of anastomoses.
The Disposable Endoscopic Cutting Staplers has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
Device Description:
The Disposable Anorectal Staplers are a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler are available in 33mm. The staple size is 4.0mm. It cannot be reloaded.
The Disposable Linear Cutting Stapler places two double-staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Disposable Linear Cutting Staplers is available in 60mm, 80mm and 100mm three specifications, and in two staple sizes 3.8mm and 4.8mm, to accommodate various tissue thickness. Each Disposable Linear Cutting Staplers may be reloaded up to 10 times in a single procedure.
5
The Disposable Endoscopic Cutting Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 3.5mm, 4.0mm and 4.8mm. The device may be reloaded and fired up to 10 times in a single procedure.
-
- Identification of Predicate Devices
Predicate Device 1 510(k) Number: K161757 Product Name: Single Use Hemorrhoidal Staplers, Single Use Linear Cutters and Reloads
- Identification of Predicate Devices
Predicate Device 2 510(k) Number: K142577 Product Name: Panther Endo Linear Cutter Staplers with Single Use Loading
-
- Reference Device
510(k) Number: K202709 Product Name: Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges
- Reference Device
-
- Summary of Technological characteristics
Table 1 Technological Characteristics Comparison of Disposable Anorectal Staplers
- Summary of Technological characteristics
| ITEM | Proposed Device | Predicate Device 1
K161757 | Remark |
|-----------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------|
| Product Code | GDW | GDW | Same |
| Regulation No. | 878.4750 | 878.4750 | Same |
| Class | II | II | Same |
| Indication for Use | The Disposable Anorectal
Staplers have application for
general treatment of
hemorrhoids. | The Single Use Hemorrhoidal
Staplers have application for
general treatment of
hemorrhoids. | Same |
| Main
Configuration | Staple
Knife
Stapler | Staple
Knife
Stapler | Same |
| Operate Principle | Manual | Manual | Same |
| Cutting
Mechanism | Circular Knife | Circular Knife | Same |
6
| Safety
Mechanism | Safety release for preventing from
mis-firing | Safety release for preventing
from mis-firing | Same |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------|
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Diameter (mm) | 33mm | 32mm, 34mm | Different |
| Staple Height
(mm) | 4.0mm | 4.0mm | Same |
| Row number of
Staple | 2 | 2 | Same |
| Closed Staple
form | B-shape | B-shape | Same |
| Staple material | Unalloyed Titanium | Unalloyed Titanium | Same |
| Patient-contact
material | Unalloyed Titanium
Acrylonitrile-Butadiene-styrene
Stainless Steel
Polycarbonate
Polyamide (nylon)
Poly (ether sulfones) | Unalloyed Titanium
Acrylonitrile-Butadiene-Styrene
Stainless Steel | Different |
| Sterilization | EO sterilization | Irradiation Sterilization | Different |
| Endotoxin Limit | 20EU | 20EU | Same |
| Biocompatibility | | | |
| Cytotoxicity Test | No cytotoxicity | | |
| Sensitization Test | No sensitization | | |
| Instracutaneous
Test | No irritation | Comply with ISO 10993 | Same |
| System
Toxicity
Test | No systemic toxicity | | |
| Pyrogen Test | No pyrogen | | |
Different- Diameter
The diameter of the proposed device is different from the predicate device. However, the diameter of the proposed device is within the range of that of the predicate device. Therefore, the difference will not raise any safety issues.
Different- Patient-contact material
The patient-contact material of the proposed device is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material of the proposed device does not have any adverse effect.
Different- Sterilization
7
The sterilization method of the proposed device is different from the predicate device. However, the sterilization process has been validated per ISO 11135 and the validation result showed that the sterilization method is effective.
| ITEM | Proposed Device | Predicate Device 1
K161757 | Remark |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | GDW | GDW | Same |
| Regulation No. | 878.4750 | 878.4750 | Same |
| Class | II | II | Same |
| Indication for Use | The Disposable Linear Cutting
Staplers have application in
abdominal, gynecological,
thoracic and pediatric surgery
transection, resection and the
creation of anastomoses. | The Single Use Linear Cutters
and Reloads have application in
abdominal, gynecological,
thoracic and pediatric surgery
transection, resection and the
creation of anastomoses. | Same |
| Main
Configuration | Staple
Knife
Stapler | Staple
Knife
Stapler | Same |
| Operate Principle | Manual | Manual | Same |
| Cutting
Mechanism | Linear knife | Linear knife | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Suture length (mm) | 60mm, 80mm and 100mm | 60mm, 80mm and 100mm | Same |
| Staple
Height
(mm) | 3.8mm and 4.8mm. | 3.8mm and 4.8mm. | Same |
| Row number of
Staple | 4 | 4 | Same |
| Closed Staple form | B-shape | B-shape | Same |
| Staple material | Unalloyed Titanium | Unalloyed Titanium | Same |
| Patient-contact
material | Unalloyed Titanium
Liquid crystal polymer
Poly (etherimide)
Stainless Steel | Unalloyed Titanium
Polycarbonate
Stainless Steel | Different |
| Sterilization | EO sterilized | Irradiation Sterilization | Different |
| Endotoxin Limit | 20 EU | 20 EU | Same |
| Biocompatibility | | | |
| Cytotoxicity Test | No cytotoxicity | Comply with ISO 10993 | Same |
| Sensitization Test | No sensitization | | Same |
| Instracutaneous
Test | No irritation | | |
| System Toxicity
Test | No systemic toxicity | | |
| Pyrogen Test | No pyrogen | | |
Table 2 Technological Characteristics Comparison of Disposable Linear Cutting Staplers
8
Different- Patient-contact material
The patient-contact material of the proposed device is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material of the proposed device does not have any adverse effect.
Different- Sterilization
The sterilization method of the proposed device is different from the predicate device. However, the sterilization process has been validated per ISO 11135 and the validation result showed that the sterilization method is effective.
| ITEM | Proposed Device | Predicate Device 2 | Remark |
|---|---|---|---|
| Product Code | GDW | K142577 | Same |
| Regulation No. | 878.4750 | GDW | Same |
| Class | II | 878.4750 | Same |
| Indication for Use | Disposable Endoscopic Cutting | ||
| Staplers has applications in | |||
| abdominal, gynecologic, | |||
| pediatric and thoracic surgery | |||
| for resection, transaction and | |||
| creation of anastomosis. | PANTHER Endo Linear Cutter | ||
| Stapler with Single Use Loading | |||
| Units has applications in | |||
| abdominal, gynecologic, | |||
| pediatric and thoracic surgery | |||
| for resection, transaction and | |||
| creation of anastomosis. They | |||
| may be used for transection and | |||
| resection of liver substance, | |||
| hepatic vasculature and biliary | |||
| structures. | Similar | ||
| Main | |||
| Configuration | Staple | ||
| Knife | |||
| Stapler | Staple | ||
| Knife | |||
| Stapler | Same | ||
| Operate Principle | Manual | Manual | Same |
| Cutting | |||
| Mechanism | Linear Knife | Linear Knife | Same |
| Safety Mechanism | Safety release for preventing from | Safety release for preventing from | Same |
Table 3 Technological Characteristics Comparison of Disposable Endoscopic Cutting Staplers
9
| mis-firing | mis-firing | ||
|---|---|---|---|
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Specification | 30mm, 45mm and 60mm | 30mm, 45mm and 60mm | Same |
| Staple Height (mm) | 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm | 2.0 mm, 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm | Similar |
| Row number of Staple | 6 | 6 | Same |
| Closed Staple form | B-shape | B-shape | Same |
| Staple material | Unalloyed titanium | Unalloyed titanium | Same |
| Patient-contact material | Unalloyed Titanium | ||
| Polyamide (nylon) | |||
| Stainless Steel | Unalloyed titanium | ||
| Stainless steel | |||
| Polymeric materials | |||
| Surgical grade stainless steels | |||
| Adhesives and lubricants | Different | ||
| Sterilization | EO sterilized | EO sterilized | Same |
| Endotoxin Limit | 20 EU | 20 EU | Same |
| Biocompatibility | |||
| Cytotoxicity Test | No cytotoxicity | Comply with ISO 10993 | Same |
| Sensitization Test | No sensitization | ||
| Instracutaneous Test | No irritation | ||
| System Toxicity Test | No systemic toxicity | ||
| Pyrogen Test | No pyrogen |
Similar-Indication for Use
The proposed device is not indicated for transection of solid organ. However, the indication for use for the proposed device can be covered by the predicate device. Therefore, this difference will not raise any safety issues.
Similar- Staple Height
The proposed device staple height is not exactly same as the predicate device. However, the staple height of the proposed device can be covered by the predicate device. The difference will not raise any safety issues.
Different- Patient-contact material
The patient-contact material is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material of the proposed device does not have any adverse effect.
10
8. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-1:2018 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
- A USP Bacterial Endotoxins Test
-
USP Pyrogen Test
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials.
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- A ISO 10993-11:2017 Biological Evaluation of Medical Device- Part 11: Tests for Systemic Toxicity
-
ASTM D 4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
-
ASTM F 756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
The biocompatibility tests conducted on the proposed device include cytotoxicity test, skin sensitization test, intracutaneous irritation test, acute systemic toxicity test, pyrogen test and hemolysis test.
The material of implanted staple for the proposed devices is identical to that of the reference device, Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges, as cleared in K202709 at 05/18/2021, which is also manufactured by the sponsor. The biocompatibility safety of the proposed device was addressed by leveraging the biocompatibility data of reference device and no additional biocompatibility tests were not tested on the staple.
A simulation transportation test was conducted on the proposed device per ASTM D 4169 and package integrity test include dye penetration and sealing strength test were followed to demonstrate that the package materials can maintain the package integrity without compromising the product sterility.
Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Rest, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for less than 2.5mm staple height. Burst pressure, closed staple height and staple formation were evaluated in jugular vein test.
11
-
Clinical Test Conclusion 9.
No clinical study is included in this submission. -
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate devices.
- Substantially Equivalent (SE) Conclusion