The Suzhou Beinuo Circular Staple Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-to-side and side-to-side anastomoses.

· Hemorrhoidal Circular Stapler for Single Use

The Suzhou Beinuo Hemorthoidal Circular Staple Use is a Circular Stapler product, with accessories, that is indicated in anorectal surgical procedures for the treatment of hemorrhoids and anorectal wall defects.

· Linear Stapler and Reloads for Single Use

The Suzhou Beinuo Linear Stapler and Reloads for Single Use (and reloads) is indicated for the closure of tissue in abdominal, gynecological, and thoracic surgical procedures.

· Linear Cutter Stapler and Reloads for Single Use

The Suzhou Beinuo Linear Cutter Staple Use (and reloads) is indicated for use in the resection, transection, transection and anastomosis of tissue in gastrointestinal, gynecological, and thoracic surgical procedures.

Device Description

The Suzhou Beinuo Staplers were designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go or by pushing the firing knob as far as it will go. Specifics for each stapler include:

The Suzhou Beinuo Circular Stapler for Single Use places a circular, double staggered row of titanium staples. Immediately after staple formation, the instrument's central knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 28mm, or 32mm stapler. Note that there are two product codes for this stapler (SBW and SBCS L). The total length of SBW stapler is 420mm and the total length of SBCS L version is 520mm. The staplers are identical except for the length.
The Suzhou Beinuo Hemorrhoidal Circular Staplers for Single Use places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal tissue above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal tissue. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.
The Suzhou Beinuo Linear Staplers and Reloads for Single Use places a double(or triple in the case of the SBF 30B) staggered row of titanium staples used for mechanical suturing and closure of tissue. The Linear Stapler is available in 32mm, 60mm, and 88mm line lengths for use in various applications. The instrument may be reloaded during a single procedure.
The Suzhou Beinuo Linear Cutter Staplers and Reloads for Single Use delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 101mm). The instrument may be reloaded during a single procedure.

AI/ML Overview

The provided text is a 510(k) summary for the Suzhou Beinuo family of Surgical Staplers, seeking substantial equivalence to the predicate device, the Suzhou Frankenman Surgical Staplers (K101378). The submission focuses on non-clinical performance data and does not involve a clinical study as typically understood for AI/ML devices or new medical treatments requiring human subject trials.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) for a diagnostic or AI/ML device. Instead, it relies on demonstrating equivalence to a predicate device through adherence to voluntary standards and an evaluation of physical and performance characteristics.

Acceptance Criteria Category	Specific Criteria / Standard	Reported Device Performance (Suzhou Beinuo Surgical Staplers)
Materials of Construction	ISO 5382-2-1999 (Surgical Instruments - Metallic Materials - Part 2 - Unalloyed titanium)	Complies with the standard.
Sterilization	ISO 11737-1:2006 (Determination of a population of microorganisms on products)	Complies with the standard.
Sterilization	ISO 11137-1:2006 (Requirements for the development, validation and routine control of a sterilization process for medical devices)	Complies with the standard.
Biocompatibility	AAMI / ANSI / ISO 10993-5:2009 (Tests for In Vitro cytotoxicity)	Complies with the standard.
Biocompatibility	ISO 10993-10:2010 (Tests for irritation and skin sensitization)	Complies with the standard.
Risk Management	ISO 14971:2007 (Application of risk management to medical devices)	Complies with the standard.
Packaging for Terminally Sterilized Devices	ISO 11607:2003 (Packaging for Terminally Sterilized Medical Products)	Complies with the standard.
Physical Characteristics	Appearance, dimensions, stapler compatibility with the cartridge	Evaluated to validate; output meets design inputs and specifications.
Performance Characteristics	Strength, closure performance	Evaluated to validate; output meets design inputs and specifications.
Comparative Performance (to predicate)	"Similar results (in terms of post-operative healing, pain management, anastomotic leakage, and bleeding) as compared to manual suturing and competitors' devices."	Non-statistically quantified claim. No specific metrics are provided, just a qualitative statement of "similar results."

2. Sample Size Used for the Test Set and Data Provenance

The submission explicitly states: "There was no prospective clinical studies required to support the medical device as the indications for use, technology, materials of construction are virtually identical to the predicate device." Therefore, there is no test set of clinical data from human subjects in the context of typical AI/ML or drug studies.

The "testing" mentioned refers to non-clinical tests (material, sterilization, biocompatibility, mechanical performance). The sample sizes for these engineering tests are not specified in the summary but would typically involve a certain number of units or material samples to ensure statistical validity for the specific test (e.g., burst pressure testing on a few devices, cytotoxicity testing on cell cultures). The provenance of this test data would be lab data generated internally or by contract testing organizations.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. As no clinical study was conducted in terms of patient data, there was no need for experts to establish ground truth for a test set based on patient outcomes or interpretations. The determination of device meeting engineering and material standards is typically done by engineers and quality assurance specialists.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring human adjudication for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted. The device is a surgical stapler, not an AI/ML diagnostic tool that assists human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a hardware medical device (surgical stapler), not a software or AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Compliance with established voluntary standards (e.g., ISO standards for materials, sterilization, biocompatibility, risk management, packaging).
Engineering specifications and design inputs for physical and performance characteristics (e.g., appearance, dimensions, strength, closure performance).
Comparison to the predicate device's established performance and characteristics.

There is no "expert consensus," "pathology," or "outcomes data" ground truth established for a new clinical test set within this submission, as no new clinical study was performed.

8. Sample Size for the Training Set

Not applicable. This is a hardware device submission, not an AI/ML model. Therefore, there is no training set in the AI/ML context.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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Section 5 - 510(k) Summary

1. Submission Sponsor

Suzhou Beinuo Medical Equipment Co., Ltd. 158-38 Huashan Road Suzhou High - New District China, 215129 Phone: +86 512 66629925 Fax: +86 512 66626238 Contact: Ms Living Huang, Office Manager

2. Submission Correspondent

Emergo Group Suite 1400 816 Congress Ave. Austin, TX 78701 Cell Phone: 940 390 0961 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Robert Seiple, RAC, Senior Consultant, QA/RA Email: project.management@emergogroup.com

3. Date Prepared

November 12, 2013

4. Device Identification

Suzhou Beinuo family of Surgical Staplers Trade/Proprietary Name: Common/Usual Name: Staple, Implantable Classification Name: Implantable staple Classification Regulation: 21CFR 878.4750 Product Code: GDW Device Class: Class II Classification Panel: General and Plastic Surgery

5. Predicate Devices

The Suzhou Frankenman Surgical Staplers (K101378) which includes:

· Disposable Alimentary Canal Staplers;
· Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids;
· Disposable Reloadable Linear Stapler and Reloads; and
· Disposable Reloadable Linear Cutter Stapler and Reloads;

JAN 2 4 2014

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EMERGO GROUP

The Frankenman Surgical Staplers are substantially to the Suzhou Beinuo family of surgical staplers. The Suzhou Beinuo surgical staplers are virtually identical to the predicate device(s) described above.

6. Device Description

The Suzhou Beinuo Circular Stapler for Single Use places a circular, double staggered row of titanium staples. Immediately after staple formation, the instrument's central knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 28mm, or 32mm stapler. Note that there are two product codes for this stapler (SBW and SBCS L). The total length of SBW stapler is 420mm and the total length of SBCS L version is 520mm. The staplers are identical except for the length.
The Suzhou Beinuo Hemorrhoidal Circular Staplers for Single Use places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal tissue above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal tissue. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.
The Suzhou Beinuo Linear Staplers and Reloads for Single Use places a double(or triple in the case of the SBF 30B) staggered row of titanium staples used for mechanical suturing and closure of tissue. The Linear Stapler is available in 32mm, 60mm, and 88mm line lengths for use in various applications. The instrument may be reloaded during a single procedure.
The Suzhou Beinuo Linear Cutter Staplers and Reloads for Single Use delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 101mm). The instrument may be reloaded during a single procedure.

7. Intended Use

Suzhou Beinuo surgical staplers are indicated for use as follows:

. Circular Stapler for Single Use

The Suzhou Beinuo Circle Stapler for Single Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-toside and side-to-side anastomoses.

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K133499 EMERGO GROUP

. Hemorrhoidal Circular Stapler for Single Use The Suzhou Beinuo Hemorrhoidal Circular Stapler for Single Use is a Circular Stapler product, with accessories, that is indicated in anorectal surgical procedures for the treatment of hemorrhoids and anorectal wall defects.
. Linear Stapler and Reloads for Single Use

The Suzhou Beinuo Linear Stapler for Single Use (and reloads) is indicated for the closure of tissue in abdominal, gynecological, and thoracic surgical procedures.

. Linear Cutter Stapler and Reloads for Single Use
The Suzhou Beinuo Linear Cutter Stapler for Single Use (and reloads) is indicated for use in the resection, transection and anastomosis of tissue in gastrointestinal, gynecological, and thoracic surgical procedures.

8. Comparison of Technological Characteristics

The following table compares the Suzhou Beinuo family of surgical staplers to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
510(k) Number	TBD	K101378	n/a
Product Code	GDW	GDW	Identical
Regulation Number	21CFR 878.4750	21CFR 878.4750	Identical
Regulation Name	Implantable staple	Implantable staple	Identical
Indications for Use	Circular Stapler for Single UseThe Suzhou Beinuo CircularStapler for Single Use is usedthroughout the alimentarytract for the reconstruction ofthe alimentary tract and thecreation of end-to-end, end-to-side and side-to-sideanastomoses.	Disposable Alimentary CanalStaplerThe Frankenman DisposableAlimentary Canal Stapler isused throughout thealimentary tract for thecreation of end-to-end, end-to-side and side-to-sideanastomoses in both openand laparoscopic techniques.	Virtually Identical
	Hemorrhoidal Circular Staplerfor Single UseThe Suzhou BeinuoHemorrhoidal Circular Staplerfor Single Use is a CircularStapler product, withaccessories, that is indicatedin anorectal surgicalprocedures for the treatment	Single Use Circular Stapler forRectal Prolapse andHemorrhoidThe Frankenman Single UseCircular Stapler for RectalProlapse and Hemorrhoids is aCircular Stapler product, withaccessories, that has	Essentially identical. SuzhouBeinuo indication and theFrankenman indicationsdiscuss the same procedures.No safety or efficacy impact tothe difference in wording
Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
	of hemorrhoids and anorectalwall defects.	application for general surgicaltreatment of haemorrhoidsand anorectal wall defects bymeans of transanal staplingand resection of mucosal andmusculo-mucosal tissueresulting in occlusion ofhaemorrhoidal inflow,restoring the haemorrhoidaltissue to its normalphysiological position.
	Linear Stapler and Reloadsfor Single UseThe Suzhou Beinuo LinearStapler for Single Use (andreloads) is indicated for theclosure of tissue in abdominal,gynecological, and thoracicsurgical procedures.	Disposable Reloadable LinearStapler and ReloadsThe Frankenman DisposableReloadable Linear Stapler (andReloads) is used in theresection or transaction oftissue for abdominal,gynecological, pediatric andthoracic surgical procedures.	Essentially identical. SuzhouBeinuo Indication and theFrankenman indication discussthe same procedures. Nosafety or efficacy impact tothe difference in wording
	Linear Cutter Stapler andReloads for Single UseThe Suzhou Beinuo LinearCutter Stapler for Single Use(and reloads) is indicated foruse in the resection,transection and anastomosisof tissue in gastrointestinal,gynecological, and thoracicsurgical procedures	Disposable Reloadable LinearCutter Stapler and ReloadsThe Frankenman DisposableReloadable Linear CutterStapler (and Reloads) hasapplication in abdominal,gynecological, thoracic andpediatric surgery transaction,resection, and the creation ofanastomoses.	Essentially identical. SuzhouBeinuo Indication and theFrankenman indication discussthe same procedures. Nosafety or efficacy impact tothe difference in wording
ProductDescriptions	Circular Staplers for SingleUseThe Circular Stapler for SingleUse is a surgical device for thereconstruction of alimentarytract with mechanical methodto replace traditional handoperation.This device is designed on theprincipal of staplers. It createsside to end, end to endanastomosis in alimentarycanal with peripheral double	The Frankenman DisposableAlimentary Canal Stapler (i.e.,CS Stapler, is primarilycomposed of plastic, titanium,and stainless steel and is usedfor the reconstruction andanastomosis in the alimentarycanal. These disposablestaplers place a circular,double staggered row oftitanium (ISO 5832-2) staplesand then resect the excesstissue, creating a circular	The products are virtuallyidentical.
Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
	staggered rows of staples, andcut off the residue tissue withthe circular cutting blade inthe center to ensure a bigenough canal for thereconstructed alimentarytract. By squeezing the firinghandle, the staples form andthe circular knife blade resectsthe excess tissue, creating acircular anastomosis. Thediameter of the staple line isdetermined by the selection ofthe 21mm, 25mm, 28mm, or32mm stapler.	anastomosis. The CS Stapler isactivated by squeezing thehandle firmly.The outer diameter of thestaple line is determined bythe selection of the 21mm,25mm, 28mm, or 32mmstapler. The stapler is availablein one staple diameter,0.28mm and two shaftlengths, 420mm and 520mm.
	The Circular Stapler for SingleUse is made of plasticparticles, pure titanium,aluminum alloy and stainlesssteel, packed in speciallydesigned sterile packs andboxes and sterilized by Cobalt-60. The Circular Stapler forSingle Use is used forreconstruction andanastomosis in the alimentarycanal. The device has a shelf-life of 3 years.
	Hemorrhoidal Circular Staplerfor Single UseProduct descriptionHemorrhoidal Circular Staplersfor Single Use is made ofplastic particles, puretitanium, aluminum alloy andstainless steel, packed inspecially designed sterilepacks and boxes and sterilizedby Cobalt-60. The product'sshelf life is 3 years.	The Frankenman Single UseCircular Stapler for RectalProlapse and Hemorrhoids(i.e., stapledHaemorrhoidopexy (CPH), isprimarily manufactured fromplastic, titanium, aluminumalloy and stainless steel and isused in the treatment of rectalhaemorrhoids and anorectaldefects of transanal stapling(otherwise known as staplestransanal rectal resection orSTARR procedure) and
Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
	Hemorrhoidal Circular Staplersfor Single Use is used in thetreatment of rectal walldefects and internalhemorrhoids during anorectalsurgery. The BeinuoHemorrhoidal Circular Staplersfor Single Use places acircular, double staggeredrows of titanium staples,thereby sealing off the rectalmucosa or rectum above theanal canal. The central circularcutting blade cuts the surplustissue after the sealing toreconstruct the rectal mucosaor rectum. The diameter ofthe staple line is determinedby the selection of the 32mmor 34mm stapler.	resection of rectal mucosaland musculo-mucosal tissueresulting in occlusion ofhaemorrhoidal inflow,restoring the haemorrhoidaltissue to its normalphysiological position.Specifically, the rectal mucosaabove the anal canal is sealedby the placement of twocircular peripheral lines ofalternating and overlapping oftitanium (ISO 5832-2) staples.The central circular cuttingblade cuts the surplus tissueafter the sealing toreconstruct the rectal mucosa.
	Linear Staplers and Reloadsfor Single UseProduct descriptionLinear Stapler and Reloads forSingle Use are made of plasticparticles, titanium andstainless steel, packed inspecially designed sterilepacks and boxes and sterilizedby Cobalt-60. Linear Staplersand Reloads for Single Use isused in the closure of incisionand stump of inner organs ingeneral surgery. The shelf lifeis 3 years.The Beinuo Linear Staplersand Reloads for Single Useplaces a double staggered rowof titanium staples (3 rows forwhite cartridge only) used formechanical suturing andclosure of tissue. The LinearStapler is available in 32mm.	The Frankenman DisposableReloadable Linear Stapler ismanufactured primarily fromplastic, titanium, and stainlesssteel. Single Use, reloadablelinear staplers are used in theprocess of mechanicalsuturing and closure of tissue,prior to the removal of excesstissue. Specific surgicalprocedures where the LSwould be used includegeneral, thoracic,gynecological and colorectalsurgeries.The LS places a doublestaggered row of titanium (ISO5832-2) staples, with theexception of model numberLS30W which places threestaggered rows of staples. Thisthird row provides additionalsecurity for closing vesselswhere bleeding is a significantrisk.
Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
	46mm, 60mm, and 88mm line lengths for use in various applications. The instrument may be reloaded during a single procedure.	The LS is available in 30mm, 45mm, 60mm, and 90mm staple line lengths for use in various applications and three stapler sizes (2.5, 3.8mm and 4.5mm) to accommodate various tissue thicknesses.
	Linear Cutter Staplers and Reloads for Single UseProduct descriptionLinear Cutter Staplers and Reloads for Single Use are made of plastic particles, pure titanium and stainless steel, packed in specially designed sterile packs and boxes and sterilized by Cobalt-60. Linear Cutter Staplers and Reloads for Single Use is used in transection, resection and suture in GI, gynecological, thoracic surgeries. The shelf is three years.The Beinuo Linear Cutter Staplers and Reloads for Single Use delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 101mm). The instrument may be reloaded during a single procedure.	The Frankenman Disposable Reloadable Linear Cutter Stapler (i.e. LC Stapler The Frankenman LC Disposable Reloadable Stapler delivers two doubled staggered rows of titanium staples and is used to resect and/or anastomose the internal tissues during surgical procedures and reloads are manufactured primarily from plastic, titanium, and stainless steel. The Frankenman Disposable Reloadable Linear Cutter stapler is used for abdominal, gynecological, thoracic, and pediatric surgery for transaction, resection, and the creation of anastomoses
Basic Principle of Operation	The stapler places a circular, double-staggered row of staples and then resects any excess tissue, creating a circular anastomosis.	Stapler places a circular, double staggered row of staples and then resects the excess tissue, creating a circular anastomosis.	Identical
Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
Material	Stainless steel (staplers) &titanium (staples)	Stainless steel (staplers) &titanium (staples)	Identical
Sterile	Yes, radiation sterilized	Yes, radiation sterilized	Identical
Single-Use	Staplers are single use.Staplers + reloads may bereloaded with additionalstaples during the procedure(single patient - no re-use orre-sterilization).	Staplers are single use.Staplers + reloads may bereloaded with additionalstaples during the procedure(single patient - no re-use orre-sterilization).	Identical
Shelf Life	36 months based on thesterilization validation of thepackaging.	24 months based onsterilization validation of thepackaging	The Suzhou Beinuo device has12 months additional shelf lifebased on sterilizationvalidation data.
Biocompatibility	Complies with ISO 10993-1and other pertinent standards	Complies with ISO 10993-1and other pertinent standards	Identical

Table 5A - Comparison of Characteristics

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. . . . . . . . .

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;

EMERGO GEROUP

{5}------------------------------------------------

K133499

Suzhou Beinuo Traditional 510(k) Premarket Submission Surgical Staplers

EMERGO GGROUP

{6}------------------------------------------------

{7}------------------------------------------------

Suzhou Beinuo . Traditional 510(k) Premarket Submission Surgical Staplers

EMERGO GROUP

K133499

Conclusion:

The Suzhou Beinuo surgical staple device shares the same indications for use, device operation, overall technical and functional capabilities, meets the same standards and therefore are substantially equivalent to the predicate device(s). The Suzhou Beinuo device is similar in design and function to the predicate devices for the modes of operation and use.

9. Non-Clinical Performance Data

The Suzhou Beinuo surgical stapler complies with the applicable voluntary standards as shown below:

. Materials of Construction - ISO 5382-2-1999 - Surgical Instruments - Metallic Materials - Part 2 - Unalloyed titanium
. Sterilization
- o ISO 11737-1: 2006, Sterilization of medical devices -- Microbiological methods -Part 1, Determination of a population of microorganisms on products
- o ISO 11137-1:2006 , Sterilization of healthcare products Radiation Part 1, Requirements for the development, validation and routine control of a sterilization process for medical devices.
. Biocompatibility - contact materials were tested per the schema in ISO 10993-1. Specifically:
- O AAMI / ANSI / ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. (Biocompatibility)
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for o irritation and skin sensitization. (Biocompatibility)
. Risk Management activities were carried out as described in ISO 14971: 2007, Medical devices -- Application of risk management to medical devices
. Packaging for Terminally Sterilized Devices – ISO 11607:2003, Packaging for Terminally Sterilized Medical Products.

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Suzhou Beinuo Traditional 510(k) Premarket Submission Surgical Staplers

EMERGO GROUP

Additionally, the surgical staplers were evaluated to validate physical characteristics (appearance, dimensions, stapler compatibility with the cartridge) and performance characteristics (strength, closure performance). The Suzhou Beinuo staplers were also evaluated for performance testing compared to the analogous Suzhou Frankenman staplers. Evaluation of the two stapler products similar results (in terms of post-operative healing, pain management, anastomotic leakage, and bleeding) as compared to manual suturing and competitors' devices.

Based on this testing, the design and construction of the Suzhou Beinuo and Suzhou Frankenman staplers were determined to be substantially equivalent. The Suzhou Beinuo family of surgical staplers meets all the requirements for overall design, sterilization, biocompatibility, and clinical utility confirming that the output meets the design inputs and specifications. The Suzhou Beinuo surgical staplers passed all testing and supports the claims of substantial equivalence and safe operation.

The Suzhou Beinuo surgical staplers comply with the applicable voluntary standards for biocompatibility and sterilization. The device passed all the testing in accordance with national and international standards.

10. Clinical Testing

There was no prospective clinical studies required to support the medical device as the indications for use, technology, materials of construction are virtually identical to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The nonclinical testing detailed in this submission supports the substantial equivalence of the device.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.

It has been shown in this 510(k) submission that the difference between the Suzhou Beinuo surgical staplers and the Suzhou Frankenmann surgical staplers do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the Suzhou Beinuo surgical staplers are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, sterilization, biocompatibility, performance characteristics, and intended use. The Suzhou Beinuo surgical staplers, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate devices.

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Image /page/9/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 14, 2014

Suzhou Beinuo Medical Equipment Co., Ltd. C/O Emergo Group Robert Seiple, RAC, Senior Consultant, QA/RA 816 Congress Avenue, Suite 1400 Austin, Texas 78701

Re: K133499

Trade/Device Name: Suzhou Beinuo Family of Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: November 13, 2013 Received: November 14, 2013

Dear Mr. Seiple:

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

{10}------------------------------------------------

Page 2 - Robert Seiple, RAC, Senior Consultant, QA/RA

.... . ..

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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,

Binita S. Ashar 2014.01.17403.40:56 -05'00'

Binita Ashar, MD, MBA, FACS Acting 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

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K133499

Device Name

Suzhou Beinuo Surgical Staplers

Indications for Use (Describe)

Suzhou Beinuo surgical staplers are indicated for use as follows:

· Circular Stapler for Single Use

The Suzhou Beinuo Circular Staple Use is used throughout the alimentary tract for the reconstruction of the alimentary tract and the creation of end-to-end, end-to-side and side-to-side anastomoses.

· Hemorrhoidal Circular Stapler for Single Use

· Linear Stapler and Reloads for Single Use

The Suzhou Beinuo Linear Stapler and Reloads for Single Use (and reloads) is indicated for the closure of tissue in abdominal, gynecological, and thoracic surgical procedures.

· Linear Cutter Stapler and Reloads for Single Use

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.