(250 days)
Not Found
No
The summary describes mechanical surgical staplers and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used to create anastomoses and resect tissue during surgical procedures, which are therapeutic interventions.
No
Explanation: The device is a surgical stapler used for resection, transection, and creation of anastomoses, which are therapeutic procedures. It does not perform any diagnostic function.
No
The device description clearly outlines physical, mechanical staplers with various hardware components (staples, cartridges, different sizes/diameters). There is no mention of software as the primary or sole component of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states that these devices are surgical staplers used during surgical procedures to cut and staple tissues within the body. They are used for creating anastomoses (connecting two structures) and resecting (removing) tissue.
- Intended Use: The intended use describes surgical applications within the body (abdominal, gynecological, pediatric, thoracic, alimentary tract).
- No Specimen Testing: There is no mention of the device being used to test or analyze any specimens taken from the body.
Therefore, based on the provided information, the ShineMed Reloadable Open Cutting Staplers and Curved Intraluminal Cutting Staplers are surgical devices used in vivo (within the body), not in vitro (outside the body for diagnostic purposes).
N/A
Intended Use / Indications for Use
ShineMed Reloadable Open Cutting Staplers (ROCS) have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
ShineMed Curved Intraluminal Cutting Staplers (CICS) have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
Product codes
GDW
Device Description
Both ShineMed Reloadable Open Cutting Staplers and predicate DST Series™ GIA™ Staplers place two, double-staggered rows of titanium staples and simultaneously divide the tissues between the two double rows. The size of the staples is determined by the selection of the appropriate single use loading unit that is available in 60mm, 80mm, and 100mm lengths:
. 3.8mm staple size single use loading unit (blue cartridge) (60mm, 80mm, and 100mm lengths)
. 4.8mm staple size single use loading unit (green cartridge) (60mm, 80mm, and 100mm lengths)
Both ShineMed Curved Intraluminal Cutting Staplers and predicate Autosuture™ Circular EEA™ Surgical Staplers place a circular, double staggered row of titanium staples and resect the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries. The stapler is offered in 25mm (white), 28mm (blue), and 31mm (green) diameters and with 4.8mm staple size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecological, pediatric and thoracic (for Reloadable Open Cutting Staplers); alimentary tract (for Curved Intraluminal Cutting Staplers)
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)
Performance Bench Testing:
For ShineMed Reloadable Open Cutting Stapler,
- Functionality Testing:
- Functionality testing was completed to confirm device features were functioning as intended and identical to the predicate device.
- Safety lockout in the cartridge was deployed successfully after fired to prevent reloading a fired cartridge. This safety feature is identical to the predicate device.
- Locking lever handle was able to ensure proper tissue compression through securing distance between cartridge and anvil. This design is identical to the predicate device.
- Shipping wedge was provided to prevent misfiring during shipment. The design of the shipping wedge is identical to the predicate device.
- Performance Comparison Testing:
- Integrity of the stapler line was confirmed via visual inspection of the stapling, which was equivalent to the predicate devices.
- Performance of anastomosis was evaluated through anastomosis leak test and bursting test of the staple line. Comparison was performed to confirm that the performance of ShineMed products are substantially equivalent to the predicate devices.
- Dimensional tests were conducted to confirm that the staple formation heights of ShineMed products after firing are statistically identical to those of the predicate devices.
- Reliability Testing
- Reliability testing was performed to confirm that the ShineMed Reloadable Open Cutting Stapler can fire 8 times with consistent functionality and performance.
- Package Testing
- Integrity of the primary package of ShineMed products was confirmed through Visual Inspection and Dye Penetration Testing.
- Package seal strength testing was conducted to confirm that the seal strength of the primary packages of ShineMed products meet design requirements and are not compromised through sterilization and current shipping and handling methods.
- Shelf-Life Testing
- Shelf-life testing was completed and passed in accordance with ASTM F1980.
For ShineMed Curved Intraluminal Cutting Stapler,
- Functionality Testing:
- Functionality testing was completed to confirm device features were functioning as intended and identical to the predicate device.
- Safety mechanism was deployed successfully to prevent improper use. The safety release can prevent firing the device when the thickness of tissue between the cartridge and the anvil is not compressed to specified range. This safety feature is identical to the predicate device.
- Performance Comparison Testing:
- Integrity of the stapler line was confirmed via visual inspection of the stapling, which was equivalent to the predicate devices.
- Performance of anastomosis was evaluated through anastomosis leak test and bursting test of the staple line.
- Dimensional tests were conducted to confirm that the staple formation heights of ShineMed products after firing are statistically identical to those of the predicate devices.
- Package Testing
- Integrity of the primary package of ShineMed products was confirmed through Visual Inspection and Dye Penetration Testing.
- Package seal strength testing was conducted to confirm that the seal strength of the primary packages of ShineMed products meet design requirements and are not compromised through sterilization and current shipping and handling methods.
- Shelf-Life Testing
- Shelf-life testing was completed and passed in accordance with ASTM F1980.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2016
ShineMed, LLC Mr. Rogelio Insignares Operating Manager 7200 Aloma Ave., Winter Park, Florida 32792
Re: K160969
Trade/Device Name: ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 15, 2016 Received: November 23, 2016
Dear Mr. Insignares:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. 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
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 yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) 160969
Device Name
ShineMed Reloadable Open Cutting Stapler
Indications for Use (Describe)
ShineMed Reloadable Open Cutting Staplers (ROCS) have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
or sponsor, and a per rson is not rec information unless it displays a currently valid OMB number." ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) 160969
Device Name
ShineMed Curved Intraluminal Cutting Stapler
Indications for Use (Describe)
ShineMed Curved Intraluminal Cutting Staplers (CICS) have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 S |
|---|---|
| ----------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Subpart C)
4
510(k) Summary
| A. ASSIGNED 510(k) NUMBER: | K 160969 |
|---|---|
| B. SUBMITTER: | ShineMed LLC |
| 7200 Aloma Ave., Suite A | |
| Winter Park, FL 32792 | |
| Tel. No: (407) 960-5636 | |
| C. CONTACT PERSON: | Mr. Rogelio A. Insignares |
| Operating Manager | |
| D. DATE PREPARED: | December 5, 2016 |
| E. TRADE/PROPRIETARY NAME: | ShineMed Reloadable Open Cutting Stapler |
| ShineMed Curved Intraluminal Cutting Stapler | |
| F. COMMON/USUAL NAME: | Staple, Implantable |
| G. CLASSIFICATION NAME: | Staple, Implantable |
| H. REGULATORY CLASS: | II |
| I. PRODUCT CODE: | GDW |
| J. PREDICATE DEVICE(S): | Covidien™ Staplers, including: |
| DST Series™ GIATM Staplers (K111825) | |
| Autosuture™ Circular EEA™ Surgical Stapler | |
| (K062850) |
5
- K. DEVICE Both ShineMed Reloadable Open Cutting Staplers and predicate DST Series™ GIA™ Staplers place two, double-DESCRIPTION: staggered rows of titanium staples and simultaneously divide the tissues between the two double rows. The size of the staples is determined by the selection of the appropriate single use loading unit that is available in 60mm, 80mm, and 100mm lengths:
- . 3.8mm staple size single use loading unit (blue cartridge) (60mm, 80mm, and 100mm lengths)
- . 4.8mm staple size single use loading unit (green cartridge) (60mm, 80mm, and 100mm lengths)
Both ShineMed Curved Intraluminal Cutting Staplers and predicate Autosuture™ Circular EEA™ Surgical Staplers place a circular, double staggered row of titanium staples and resect the excess tissue, creating a circular anastomosis. They are indicated for use in the creation of anastomoses in various surgical procedures in both open and laparoscopic surgeries. The stapler is offered in 25mm (white), 28mm (blue), and 31mm (green) diameters and with 4.8mm staple size.
-
ShineMed Reloadable Open Cutting Staplers have applications L. INTENDED USE: in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
ShineMed Curved Intraluminal Cutting Staplers have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries, including bariatric surgery. -
ShineMed Reloadable Open Cutting Staplers and Curved M. COMPARISON TO PREDICATE Intraluminal Cutting Staplers are substantially equivalent in DEVICE: their Indications for Use to their predicate devices, respectively.
ShineMed Reloadable Open Cutting Staplers and Curved Intraluminal Cutting Staplers are substantially equivalent in design and performance specifications to their predicate devices. The only design difference is that the ShineMed Staplers are using round titanium wire for staples, rather than flat titanium wire used in the predicate devices. However, this difference will not impact the fundamental scientific technology of the predicate devices with regards to stapling technologies.
6
| Item | ShineMed Reloadable Open Cutting
Stapler | DST Series™ GIA™ Staplers
(K111825) | Item | ShineMed Curved Intraluminal
Cutting Stapler | Autosuture™ Circular EEATM
Surgical Stapler |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory Information | | | Regulatory Information | | |
| Product Code | GDW | GDW | Product Code | GDW | GDW |
| Regulation No. | 21 CFR 878.4750 | 21 CFR 878.4750 | Regulation No. | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Class | II | II | Class | II | II |
| Intended Use | | | Intended Use | | |
| Intended Use | ShineMed Reloadable Open Cutting
Staplers have applications in abdominal,
gynecological, pediatric and thoracic
surgical procedures for resection,
transection and creation of anastomosis. | DST Series™ GIA™ Staplers have
applications in abdominal,
gynecological, pediatric and thoracic
surgical procedures for resection,
transection and creation of anastomosis. | Intended Use | ShineMed Curved Intraluminal Cutting
Staplers have applications throughout
the alimentary tract for the creation of
end-to-end, end-to-side and side-to-side
anastomoses in both open and
laparoscopic surgeries, including
bariatric surgery. | Autosuture™ Circular EEATM Surgical
Staplers have applications throughout
the alimentary tract for the creation of
end-to-end, end-to-side and side-to-side
anastomoses in both open and
laparoscopic surgeries, including
bariatric surgery. |
| Technical Information | | | Technical Information | | |
| Deployment | Cartridge based deployment (up to 8
firings per stapler) for single patient use. | Cartridge based deployment (up to 8
firings per stapler) for single patient use. | Operation
Principle | Cut and staple by manually squeezing
the handle. | Cut and staple by manually squeezing
the handle. |
| Staple Line Length | 60mm, 80mm, and 100mm | 60mm, 80mm, and 100mm | Safety Mechanism | Safety release underneath the
handle for preventing misfiring.
Indicator window for preventing
inappropriate use on tissues. | Safety release underneath the
handle for preventing misfiring.
Indicator window for preventing
inappropriate use on tissues. |
| Open Staple
Height | 3.8mm and 4.8 mm | 2.5mm, 3.8mm and 4.8mm | Shell Outside
Diameter | 25.6mm, 28.6mm, 31.6 mm | 21mm, 25mm, 28mm, 31mm, 33mm |
| Closed Staples
Height | Image: Closed staples height ShineMed | Image: Closed staples height DST | Outside Knife
Diameter | 16.6mm, 19.6mm, 22.6mm | 12.5mm, 16.6mm, 19.5mm, 22.5mm,
24.6mm |
| Rows of Staple
Line per Side | 2 | 2 | Number of Staples | 22, 26, 30 | 18, 22, 26, 30, 32 |
| Staple Cross
Section: | Image: Staple cross section ShineMed | Image: Staple cross section DST | Open Staple
Height | 4.8 mm | 3.5mm, 4.8mm |
| | Material and Biocompatibility Information | | Closed Staples
Height | Image: [Closed Staples Height] 2.0mm (4.8mm Staple Size) | Image: [Closed Staples Height] 1.5mm (3.5mm Staple Size)
2.0mm (4.8mm Staple Size) |
| Implantable
Material | Unalloyed Titanium conforms to ASTM
F67-13. | Unalloyed Titanium | Rows of Staple
Line per Side | 2 | 2 |
| Body material
patient short-time
contact | Medical Grade Polycarbonate and
Stainless Steel | Medical Grade Polycarbonate and
Stainless Steel | Staple Cross
Section: | Image: [Staple Cross Section] | Image: [Staple Cross Section] |
| Biocompatibility | All components of ShineMed
Reloadable Open Cutting Staplers are
comprised of materials, which are in
accordance with relevant parts of ISO
Standard 10993. | All components of DST Series™ GIA™
Staplers are comprised of materials,
which are in accordance with relevant
parts of ISO Standard 10993. | Material and Biocompatibility Information | | |
| Packaging and Sterilization | | | Implantable
Material | Unalloyed Titanium conforms to
ASTM F67-13. | Unalloyed Titanium |
| Sterilization
Package | PET tray with Tyvek lid | PET tray with Tyvek lid | Body material
patient short-time
contact | Medical Grade Polycarbonate and
Stainless Steel | Medical Grade Polycarbonate and
Stainless Steel |
| Sterilization
Sterility Assurance
Level | Gamma Irradiation
SAL 10-6 | Ethylene Oxide
SAL 10-6 | | | |
| Labeling | Conforms to 21 CFR part 801 and 830 | Conforms to 21 CFR part 801 and 830 | | | |
The ShineMed Reloadable Open Cutting Stapler has similar features as compared to the predicate device as shown in table below:
7
The ShineMed Curved Intraluminal Cutting Stapler has similar features as compared to the predicate device as shown in table below:
8
| Item | ShineMed Curved Intraluminal
Cutting Stapler | Autosuture™ Circular EEA™
Surgical Stapler |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | All components of ShineMed Curved Intraluminal Cutting Staplers are comprised of materials, which are in accordance with relevant parts of ISO Standard 10993. | All components of Autosuture™ Circular EEA™ Surgical Staplers are comprised of materials, which are in accordance with relevant parts of ISO Standard 10993. |
| Packaging and Sterilization | | |
| Sterilization
Package | PET tray with Tyvek lid | PET tray with Tyvek lid |
| Sterilization
Sterility Assurance
Level | Gamma Irradiation
SAL 10-6 | Ethylene Oxide
SAL 10-6 |
| Labeling | Conforms to 21 CFR part 801 and 830 | Conforms to 21 CFR part 801 and 830 |
- N. IMPLANTABLE ShineMed Reloadable Open Cutting Staplers and Curved Intraluminal Cutting Staplers are using unalloyed titanium that MATERIALS: conforms to ASTM F67-13. The predicate devices are also using the unalloyed titanium.
- O. PATIENT SHORT-ShineMed Reloadable Open Cutting Staplers and Curved TIME CONTACT Intraluminal Cutting Staplers are using Medical Grade MATERIALS: Polycarbonate and Stainless Steel as patient direct contact material. The predicate devices are using the same material.
- P. BIO-All components of ShineMed Reloadable Open Cutting COMPATIBILITY: Staplers and Curved Intraluminal Cutting Staplers and the predicate devices are comprised of materials that are in accordance with relevant parts of ISO Standard 10993.
Biocompatibility Testing
The staplers are considered tissue contacting for a duration less than 24 hours, while the staples are considered permanent implants. The titanium material of implantable staples conforms to ASTM F67-13.
The biocompatibility evaluations of ShineMed Reloadable Open Cutting Stapler and Curved Intraluminal Cutting stapler were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA. The staplers of testing include the following tests:
9
- 10993-5:2009 Cytotoxicity (ISO "Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity")
- Sensitization (ISO 10993-10: 2010 "Biological . Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization")
- . Irritation (ISO 10993-10: 2010 "Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization")
- Acute Systemic Toxicity (ISO 10993-11: 2006 "Biological Evaluation of Medical Devices -- Part 11: Tests for Systemic Toxicity")
- ISO 10993-11:2006 Pyrogen Test. ●
- USP 38-NF33:2015, Bacterial Endotoxins Test.
The devices are biocompatible and meet pyrogen specification limits.
Q. TESTING DATA: Performance Bench Testing
Non-clinical bench tests were conducted to evaluate the function, performance, safety, reliability of ShineMed products and the equivalence to the predicate devices. Results are summarized as follows:
For ShineMed Reloadable Open Cutting Stapler,
- Functionality Testing:
- . Functionality testing was completed to confirm device features were functioning as intended and identical to the predicate device.
- Safety lockout in the cartridge was deployed successfully after fired to prevent reloading a fired cartridge. This safety feature is identical to the predicate device.
- Locking lever handle was able to ensure proper tissue compression through securing distance between cartridge and anvil. This design is identical to the predicate device.
- . Shipping wedge was provided to prevent misfiring during shipment. The design of the shipping wedge is identical to the predicate device.
-
- Performance Comparison Testing:
- Integrity of the stapler line was confirmed via visual ● inspection of the stapling, which was equivalent to the predicate devices.
10
- . Performance of anastomosis was evaluated through anastomosis leak test and bursting test of the staple line. Comparison was performed to confirm that the performance of ShineMed products are substantially equivalent to the predicate devices.
- . Dimensional tests were conducted to confirm that the staple formation heights of ShineMed products after firing are statistically identical to those of the predicate devices.
-
- Reliability Testing
- Reliability testing was performed to confirm that the . ShineMed Reloadable Open Cutting Stapler can fire 8 times with consistent functionality and performance.
-
- Package Testing
- Integrity of the primary package of ShineMed products ● was confirmed through Visual Inspection and Dye Penetration Testing.
- . Package seal strength testing was conducted to confirm that the seal strength of the primary packages of ShineMed products meet design requirements and are not compromised through sterilization and current shipping and handling methods.
-
- Shelf-Life Testing
- Shelf-life testing was completed and passed in ● accordance with ASTM F1980.
For ShineMed Curved Intraluminal Cutting Stapler, 1. Functionality Testing:
- Functionality testing was completed to confirm device ● features were functioning as intended and identical to the predicate device.
- . Safety mechanism was deployed successfully to prevent improper use. The safety release can prevent firing the device when the thickness of tissue between the cartridge and the anvil is not compressed to specified range. This safety feature is identical to the predicate device.
-
- Performance Comparison Testing:
- Integrity of the stapler line was confirmed via visual ● inspection of the stapling, which was equivalent to the predicate devices.
- . Performance of anastomosis was evaluated through anastomosis leak test and bursting test of the staple line.
11
Comparison was performed to confirm that the performance of ShineMed products are substantially equivalent to the predicate devices.
- . Dimensional tests were conducted to confirm that the staple formation heights of ShineMed products after firing are statistically identical to those of the predicate devices.
-
- Package Testing
- Integrity of the primary package of ShineMed products was confirmed through Visual Inspection and Dye Penetration Testing.
- . Package seal strength testing was conducted to confirm that the seal strength of the primary packages of ShineMed products meet design requirements and are not compromised through sterilization and current shipping and handling methods.
-
- Shelf-Life Testing
- Shelf-life testing was completed and passed in . accordance with ASTM F1980.
Clinical Evaluation
Clinical evaluation is not applicable. Clinical Data is not required to support this submission.
- R. CONCLUSION: ShineMed Reloadable Open Cutting Stapler and Curved Intraluminal Cutting Stapler are compared to legally marketed devices with respect to intended use and technological characteristics. In addition, non-clinical bench testing is completed to validate the performance of the device and ensure the ShineMed Reloadable Open Cutting Stapler and Curved Intraluminal Cutting Stapler function as intended. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate devices for its intended use.