ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler

K160969 · Shinemed, LLC · GDW · Dec 12, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160969
• Device Name: ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler
• Applicant: Shinemed, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Dec 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Manual surgical staplers; used in abdominal, gynecological, pediatric, thoracic, and alimentary tract surgeries. ROCS places two double-staggered rows of titanium staples while dividing tissue; CICS places a circular double-staggered row of titanium staples while resecting excess tissue. Operated by surgeons in OR settings. Devices feature cartridge-based deployment; manual handle squeezing for cutting and stapling; safety lockouts to prevent misfiring or use on improperly compressed tissue. Output is a stapled anastomosis; facilitates tissue closure and healing. Benefits include consistent staple formation and reliable tissue approximation.

Clinical Evidence

Bench testing only. No clinical data required. Testing included functionality, anastomosis leak and bursting tests, dimensional analysis of staple formation, reliability (8-fire cycle), package integrity (dye penetration, seal strength), and shelf-life (ASTM F1980). Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Materials: Unalloyed titanium (ASTM F67-13), medical-grade polycarbonate, stainless steel. Principle: Manual mechanical cutting and stapling. ROCS: 60mm, 80mm, 100mm lengths; 3.8mm/4.8mm staple sizes. CICS: 25mm, 28mm, 31mm diameters; 4.8mm staple size. Sterilization: Gamma irradiation (SAL 10^-6).

Indications for Use

Indicated for patients undergoing abdominal, gynecological, pediatric, or thoracic surgery (ROCS) or alimentary tract surgery including bariatric procedures (CICS) requiring resection, transection, or anastomosis in open or laparoscopic settings.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• DST Series™ GIA™ Staplers (K111825)
• Autosuture™ Circular EEA™ Surgical Stapler (K062850)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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

[e-mail]

"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)

| <span style="text-decoration:overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration:overline;">☐</span> 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 [e-mail]

"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<br>7200 Aloma Ave., Suite A<br>Winter Park, FL 32792<br>Tel. No: [phone] |
| C. CONTACT PERSON: | Mr. Rogelio A. Insignares<br>Operating Manager |
| D. DATE PREPARED: | December 5, 2016 |
| E. TRADE/PROPRIETARY NAME: | ShineMed Reloadable Open Cutting Stapler<br>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:<br>DST Series™ GIATM Staplers (K111825)<br>Autosuture™ Circular EEA™ Surgical Stapler<br>(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<br>Stapler | DST Series™ GIA™ Staplers<br>(K111825) | Item | ShineMed Curved Intraluminal<br>Cutting Stapler | Autosuture™ Circular EEATM<br>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<br>Staplers have applications in abdominal,<br>gynecological, pediatric and thoracic<br>surgical procedures for resection,<br>transection and creation of anastomosis. | DST Series™ GIA™ Staplers have<br>applications in abdominal,<br>gynecological, pediatric and thoracic<br>surgical procedures for resection,<br>transection and creation of anastomosis. | Intended Use | ShineMed Curved Intraluminal Cutting<br>Staplers have applications throughout<br>the alimentary tract for the creation of<br>end-to-end, end-to-side and side-to-side<br>anastomoses in both open and<br>laparoscopic surgeries, including<br>bariatric surgery. | Autosuture™ Circular EEATM Surgical<br>Staplers have applications throughout<br>the alimentary tract for the creation of<br>end-to-end, end-to-side and side-to-side<br>anastomoses in both open and<br>laparoscopic surgeries, including<br>bariatric surgery. |
| Technical Information | | | Technical Information | | |
| Deployment | Cartridge based deployment (up to 8<br>firings per stapler) for single patient use. | Cartridge based deployment (up to 8<br>firings per stapler) for single patient use. | Operation<br>Principle | Cut and staple by manually squeezing<br>the handle. | Cut and staple by manually squeezing<br>the handle. |
| Staple Line Length | 60mm, 80mm, and 100mm | 60mm, 80mm, and 100mm | Safety Mechanism | Safety release underneath the<br>handle for preventing misfiring.<br>Indicator window for preventing<br>inappropriate use on tissues. | Safety release underneath the<br>handle for preventing misfiring.<br>Indicator window for preventing<br>inappropriate use on tissues. |
| Open Staple<br>Height | 3.8mm and 4.8 mm | 2.5mm, 3.8mm and 4.8mm | Shell Outside<br>Diameter | 25.6mm, 28.6mm, 31.6 mm | 21mm, 25mm, 28mm, 31mm, 33mm |
| Closed Staples<br>Height | Image: Closed staples height ShineMed | Image: Closed staples height DST | Outside Knife<br>Diameter | 16.6mm, 19.6mm, 22.6mm | 12.5mm, 16.6mm, 19.5mm, 22.5mm,<br>24.6mm |
| Rows of Staple<br>Line per Side | 2 | 2 | Number of Staples | 22, 26, 30 | 18, 22, 26, 30, 32 |
| Staple Cross<br>Section: | Image: Staple cross section ShineMed | Image: Staple cross section DST | Open Staple<br>Height | 4.8 mm | 3.5mm, 4.8mm |
| | Material and Biocompatibility Information | | Closed Staples<br>Height | Image: [Closed Staples Height] 2.0mm (4.8mm Staple Size) | Image: [Closed Staples Height] 1.5mm (3.5mm Staple Size)<br>2.0mm (4.8mm Staple Size) |
| Implantable<br>Material | Unalloyed Titanium conforms to ASTM<br>F67-13. | Unalloyed Titanium | Rows of Staple<br>Line per Side | 2 | 2 |
| Body material<br>patient short-time<br>contact | Medical Grade Polycarbonate and<br>Stainless Steel | Medical Grade Polycarbonate and<br>Stainless Steel | Staple Cross<br>Section: | Image: [Staple Cross Section] | Image: [Staple Cross Section] |
| Biocompatibility | All components of ShineMed<br>Reloadable Open Cutting Staplers are<br>comprised of materials, which are in<br>accordance with relevant parts of ISO<br>Standard 10993. | All components of DST Series™ GIA™<br>Staplers are comprised of materials,<br>which are in accordance with relevant<br>parts of ISO Standard 10993. | Material and Biocompatibility Information | | |
| Packaging and Sterilization | | | Implantable<br>Material | Unalloyed Titanium conforms to<br>ASTM F67-13. | Unalloyed Titanium |
| Sterilization<br>Package | PET tray with Tyvek lid | PET tray with Tyvek lid | Body material<br>patient short-time<br>contact | Medical Grade Polycarbonate and<br>Stainless Steel | Medical Grade Polycarbonate and<br>Stainless Steel |
| Sterilization<br>Sterility Assurance<br>Level | Gamma Irradiation<br>SAL 10-6 | Ethylene Oxide<br>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<br>Cutting Stapler | Autosuture™ Circular EEA™<br>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<br>Package | PET tray with Tyvek lid | PET tray with Tyvek lid |
| Sterilization<br>Sterility Assurance<br>Level | Gamma Irradiation<br>SAL 10-6 | Ethylene Oxide<br>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, <85> 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,

1. 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.
- 2. 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.
- 3. Reliability Testing
- Reliability testing was performed to confirm that the . ShineMed Reloadable Open Cutting Stapler can fire 8 times with consistent functionality and performance.
- 4. 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.
- 5. 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.
- 2. 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.
- 4. 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.
- 5. 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.