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 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for two medical devices: the ShineMed Reloadable Open Cutting Stapler (ROCS) and the ShineMed Curved Intraluminal Cutting Stapler (CICS). The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical bench testing. There is no information about an AI/algorithm-based device, nor is there data from a clinical trial or a multi-reader multi-case (MRMC) study involving human readers.

Therefore, the following information is extracted and presented as per the request, acknowledging the absence of AI/clinical/MRMC data.

Acceptance Criteria and Device Performance

The devices (ShineMed Reloadable Open Cutting Stapler and ShineMed Curved Intraluminal Cutting Stapler) were evaluated against the performance of their respective predicate devices. The acceptance criteria are implicit in the comparison studies and aim to demonstrate substantial equivalence to the legally marketed predicates.

Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance
*ShineMed Reloadable Open Cutting Stapler*
Functionality Testing	Device features function as intended and are identical to the predicate device. Safety lockout, locking lever handle, and shipping wedge functioning correctly.	- Safety lockout in cartridge deployed successfully (identical to predicate).- Locking lever handle ensured proper tissue compression (identical to predicate).- Shipping wedge prevented misfiring (identical to predicate).
Performance Comparison Testing
Integrity of stapler line	Stapler line integrity equivalent to predicate devices.	- Integrity confirmed via visual inspection of stapling, equivalent to predicate devices.
Anastomosis Leak & Bursting Test	Performance of anastomosis (leak and bursting) substantially equivalent to predicate devices.	- Evaluated; comparison confirmed performance of ShineMed products is substantially equivalent to predicate devices.
Dimensional Tests (Staple Formation Heights)	Staple formation heights statistically identical to predicate devices.	- Conducted; confirmed staple formation heights are statistically identical to those of the predicate devices.
Reliability Testing	Can fire 8 times with consistent functionality and performance.	- Performed; confirmed the device can fire 8 times with consistent functionality and performance.
Package Testing	Primary package integrity, seal strength meet design requirements and are not compromised by sterilization/shipping.	- Integrity confirmed through Visual Inspection and Dye Penetration Testing.- Seal strength testing confirmed meeting design requirements and no compromise from sterilization/shipping.
Shelf-Life Testing	Passed in accordance with ASTM F1980.	- Completed and passed in accordance with ASTM F1980.
*ShineMed Curved Intraluminal Cutting Stapler*
Functionality Testing	Device features function as intended and are identical to the predicate device. Safety mechanism deployed successfully.	- Device features functioned as intended and identically to the predicate device.- Safety mechanism deployed successfully to prevent improper use (identical to predicate, preventing firing when tissue thickness is outside specified range).
Performance Comparison Testing
Integrity of stapler line	Stapler line integrity equivalent to predicate devices.	- Integrity confirmed via visual inspection of stapling, equivalent to predicate devices.
Anastomosis Leak & Bursting Test	Performance of anastomosis (leak and bursting) substantially equivalent to predicate devices.	- Evaluated; comparison confirmed performance of ShineMed products is substantially equivalent to predicate devices.
Dimensional Tests (Staple Formation Heights)	Staple formation heights statistically identical to predicate devices.	- Conducted; confirmed staple formation heights are statistically identical to those of the predicate devices.
Package Testing	Primary package integrity, seal strength meet design requirements and are not compromised by sterilization/shipping.	- Integrity confirmed through Visual Inspection and Dye Penetration Testing.- Seal strength testing confirmed meeting design requirements and no compromise from sterilization/shipping.
Shelf-Life Testing	Passed in accordance with ASTM F1980.	- Completed and passed in accordance with ASTM F1980.
Biocompatibility Testing	Conforms to ISO 10993-1, 10993-5, 10993-10, 10993-11, and USP 38-NF33. Meets pyrogen limits.	- All components are in accordance with relevant parts of ISO Standard 10993. Tested for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogen (ISO 10993-11), and Bacterial Endotoxins (USP 38-NF33). Devices are biocompatible and meet pyrogen specifications.

Study Details

This submission is a 510(k) premarket notification primarily relying on non-clinical bench testing to demonstrate substantial equivalence to predicate devices, not on AI/algorithmic performance or human clinical studies.

Sample size used for the test set and the data provenance:
- The document does not specify a distinct "test set" in terms of patient data. The evaluation was done using non-clinical bench tests on the devices themselves.
- Data Provenance: The data is from laboratory bench testing of the ShineMed devices and comparisons against predicate devices. Country of origin for the testing data is not explicitly stated, but the submission is to the U.S. FDA. The data is prospective as it pertains to the evaluation of the new ShineMed devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the evaluation was non-clinical bench testing. Ground truth in a clinical sense (e.g., expert consensus on medical images) was not established. Performance was directly measured or visually inspected against engineering specifications and predicate device performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as this was non-clinical bench testing, not a clinical study requiring adjudication of expert interpretations.
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 MRMC comparative effectiveness study was done. The device is a surgical stapler, not an AI software/device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical surgical stapler, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For performance metrics (e.g., staple integrity, leak/burst pressure, dimensional measurements), the "ground truth" or reference was based on engineering specifications, direct measurements, visual inspections compared to predicate device performance, and adherence to recognized standards (e.g., ASTM F1980 for shelf-life, ISO 10993 for biocompatibility).
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.

Summary

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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

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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

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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

PRAStaff@fda.hhs.gov

"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." ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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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)

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)

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510(k) Summary

A. ASSIGNED 510(k) NUMBER:	K 160969
B. SUBMITTER:	ShineMed LLC7200 Aloma Ave., Suite AWinter Park, FL 32792Tel. No: (407) 960-5636
C. CONTACT PERSON:	Mr. Rogelio A. InsignaresOperating Manager
D. DATE PREPARED:	December 5, 2016
E. TRADE/PROPRIETARY NAME:	ShineMed Reloadable Open Cutting StaplerShineMed 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)

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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)

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.

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Item	ShineMed Reloadable Open CuttingStapler	DST Series™ GIA™ Staplers(K111825)	Item	ShineMed Curved IntraluminalCutting Stapler	Autosuture™ Circular EEATMSurgical 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 CuttingStaplers have applications in abdominal,gynecological, pediatric and thoracicsurgical procedures for resection,transection and creation of anastomosis.	DST Series™ GIA™ Staplers haveapplications in abdominal,gynecological, pediatric and thoracicsurgical procedures for resection,transection and creation of anastomosis.	Intended Use	ShineMed Curved Intraluminal CuttingStaplers have applications throughoutthe alimentary tract for the creation ofend-to-end, end-to-side and side-to-sideanastomoses in both open andlaparoscopic surgeries, includingbariatric surgery.	Autosuture™ Circular EEATM SurgicalStaplers have applications throughoutthe alimentary tract for the creation ofend-to-end, end-to-side and side-to-sideanastomoses in both open andlaparoscopic surgeries, includingbariatric surgery.
Technical Information			Technical Information
Deployment	Cartridge based deployment (up to 8firings per stapler) for single patient use.	Cartridge based deployment (up to 8firings per stapler) for single patient use.	OperationPrinciple	Cut and staple by manually squeezingthe handle.	Cut and staple by manually squeezingthe handle.
Staple Line Length	60mm, 80mm, and 100mm	60mm, 80mm, and 100mm	Safety Mechanism	Safety release underneath thehandle for preventing misfiring.Indicator window for preventinginappropriate use on tissues.	Safety release underneath thehandle for preventing misfiring.Indicator window for preventinginappropriate use on tissues.
Open StapleHeight	3.8mm and 4.8 mm	2.5mm, 3.8mm and 4.8mm	Shell OutsideDiameter	25.6mm, 28.6mm, 31.6 mm	21mm, 25mm, 28mm, 31mm, 33mm
Closed StaplesHeight	Image: Closed staples height ShineMed	Image: Closed staples height DST	Outside KnifeDiameter	16.6mm, 19.6mm, 22.6mm	12.5mm, 16.6mm, 19.5mm, 22.5mm,24.6mm
Rows of StapleLine per Side	2	2	Number of Staples	22, 26, 30	18, 22, 26, 30, 32
Staple CrossSection:	Image: Staple cross section ShineMed	Image: Staple cross section DST	Open StapleHeight	4.8 mm	3.5mm, 4.8mm
	Material and Biocompatibility Information		Closed StaplesHeight	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)
ImplantableMaterial	Unalloyed Titanium conforms to ASTMF67-13.	Unalloyed Titanium	Rows of StapleLine per Side	2	2
Body materialpatient short-timecontact	Medical Grade Polycarbonate andStainless Steel	Medical Grade Polycarbonate andStainless Steel	Staple CrossSection:	Image: [Staple Cross Section]	Image: [Staple Cross Section]
Biocompatibility	All components of ShineMedReloadable Open Cutting Staplers arecomprised of materials, which are inaccordance with relevant parts of ISOStandard 10993.	All components of DST Series™ GIA™Staplers are comprised of materials,which are in accordance with relevantparts of ISO Standard 10993.	Material and Biocompatibility Information
Packaging and Sterilization			ImplantableMaterial	Unalloyed Titanium conforms toASTM F67-13.	Unalloyed Titanium
SterilizationPackage	PET tray with Tyvek lid	PET tray with Tyvek lid	Body materialpatient short-timecontact	Medical Grade Polycarbonate andStainless Steel	Medical Grade Polycarbonate andStainless Steel
SterilizationSterility AssuranceLevel	Gamma IrradiationSAL 10-6	Ethylene OxideSAL 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:

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The ShineMed Curved Intraluminal Cutting Stapler has similar features as compared to the predicate device as shown in table below:

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Item	ShineMed Curved IntraluminalCutting 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
SterilizationPackage	PET tray with Tyvek lid	PET tray with Tyvek lid
SterilizationSterility AssuranceLevel	Gamma IrradiationSAL 10-6	Ethylene OxideSAL 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:

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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,

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.
1. Performance Comparison Testing:
- Integrity of the stapler line was confirmed via visual ● inspection of the stapling, which was equivalent to the predicate devices.

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

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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.
1. 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.
1. 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.

Regulation Number and Section

§ 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.