K Number

Device Name

SUZHOU BEINUO SURGICAL STAPLERS - CIRCULAR STAPLERS FOR SINGLE USE, HEMORRHOIDAL CIRCULAR STAPLERS FOR SINGLE USE, LINEA

Manufacturer

SUZHOU BEINUO MEDICAL EQUIPMENT CO. LTD.

Date Cleared

2014-01-14

(61 days)

Product Code

GDW

Regulation Number

878.4750

Intended Use

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K101378

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical operation and physical characteristics, with no mention of AI/ML or related concepts.

Therapeutic

Yes.
Explanation: The device is used for surgical procedures such as reconstructing the alimentary tract, treating hemorrhoids, and closing tissues in various surgical procedures, which are all therapeutic interventions aimed at treating medical conditions.

Diagnostic

Explanation: The device description clearly states that these are surgical staplers used for mechanical suturing, closure of tissue, resection, transection, and anastomosis. These are physical interventions, not diagnostic procedures.

SaMD (Software as a Medical Device)

The device description clearly outlines physical, mechanical surgical staplers with various lengths and features, activated by squeezing handles or pushing knobs. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the devices as surgical staplers used for mechanically joining or cutting tissue during surgical procedures. This is a direct intervention on the patient's body.
Device Description: The description details the mechanical function of the staplers, including placing staples and cutting tissue.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.

IVD devices are used in vitro (outside the body) to analyze biological samples. Surgical staplers are used in vivo (inside the body) during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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-to-side and side-to-side anastomoses.

· 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.

Product codes

GDW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Alimentary tract, anorectal, abdominal, gynecological, thoracic, gastrointestinal.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data: The Suzhou Beinuo surgical stapler complies with applicable voluntary standards including ISO 5382-2-1999 (Surgical Instruments - Metallic Materials - Part 2 - Unalloyed titanium), ISO 11737-1: 2006 (Sterilization of medical devices -- Microbiological methods - Part 1, Determination of a population of microorganisms on products), 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), ISO 10993-1, AAMI / ANSI / ISO 10993-5:2009 (Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity), ISO 10993-10:2010 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization), ISO 14971: 2007 (Medical devices -- Application of risk management to medical devices), and ISO 11607:2003 (Packaging for Terminally Sterilized Medical Products).
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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K101378

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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.

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 Use
The Suzhou Beinuo Circular
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-
to-side and side-to-side
anastomoses.	Disposable Alimentary Canal
Stapler
The Frankenman Disposable
Alimentary Canal Stapler is
used throughout the
alimentary tract for the
creation of end-to-end, end-
to-side and side-to-side
anastomoses in both open
and laparoscopic techniques.	Virtually Identical
	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	Single Use Circular Stapler for
Rectal Prolapse and
Hemorrhoid
The Frankenman Single Use
Circular Stapler for Rectal
Prolapse and Hemorrhoids is a
Circular Stapler product, with
accessories, that has	Essentially identical. Suzhou
Beinuo indication and the
Frankenman indications
discuss the same procedures.
No safety or efficacy impact to
the difference in wording
Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
	of hemorrhoids and anorectal
wall defects.	application for general surgical
treatment of haemorrhoids
and anorectal wall defects by
means of transanal stapling
and resection of mucosal and
musculo-mucosal tissue
resulting in occlusion of
haemorrhoidal inflow,
restoring the haemorrhoidal
tissue to its normal
physiological position.
	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.	Disposable Reloadable Linear
Stapler and Reloads
The Frankenman Disposable
Reloadable Linear Stapler (and
Reloads) is used in the
resection or transaction of
tissue for abdominal,
gynecological, pediatric and
thoracic surgical procedures.	Essentially identical. Suzhou
Beinuo Indication and the
Frankenman indication discuss
the same procedures. No
safety or efficacy impact to
the difference in wording
	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	Disposable Reloadable Linear
Cutter Stapler and Reloads
The Frankenman Disposable
Reloadable Linear Cutter
Stapler (and Reloads) has
application in abdominal,
gynecological, thoracic and
pediatric surgery transaction,
resection, and the creation of
anastomoses.	Essentially identical. Suzhou
Beinuo Indication and the
Frankenman indication discuss
the same procedures. No
safety or efficacy impact to
the difference in wording
Product
Descriptions	Circular Staplers for Single
Use
The Circular Stapler for Single
Use is a surgical device for the
reconstruction of alimentary
tract with mechanical method
to replace traditional hand
operation.
This device is designed on the
principal of staplers. It creates
side to end, end to end
anastomosis in alimentary
canal with peripheral double	The Frankenman Disposable
Alimentary Canal Stapler (i.e.,
CS Stapler, is primarily
composed of plastic, titanium,
and stainless steel and is used
for the reconstruction and
anastomosis in the alimentary
canal. These disposable
staplers place a circular,
double staggered row of
titanium (ISO 5832-2) staples
and then resect the excess
tissue, creating a circular	The products are virtually
identical.
Manufacturer	Suzhou Beinuo	Suzhou Frankenman	Significant Differences
	staggered rows of staples, and
cut off the residue tissue with
the circular cutting blade in
the center to ensure a big
enough canal for the
reconstructed alimentary
tract. By squeezing the firing
handle, the staples form and
the circular knife blade resects
the excess tissue, creating a
circular anastomosis. The
diameter of the staple line is
determined by the selection of
the 21mm, 25mm, 28mm, or
32mm stapler.	anastomosis. The CS Stapler is
activated by squeezing the
handle firmly.
The outer diameter of the
staple line is determined by
the selection of the 21mm,
25mm, 28mm, or 32mm
stapler. The stapler is available
in one staple diameter,
0.28mm and two shaft
lengths, 420mm and 520mm.
	The Circular Stapler for Single
Use is made of plastic
particles, pure titanium,
aluminum alloy and stainless
steel, packed in specially
designed sterile packs and
boxes and sterilized by Cobalt-

The Circular Stapler for
Single Use is used for
reconstruction and
anastomosis in the alimentary
canal. The device has a shelf-
life of 3 years. | | |
| | Hemorrhoidal Circular Stapler
for Single Use
Product description
Hemorrhoidal Circular Staplers
for Single Use is made of
plastic particles, pure
titanium, aluminum alloy and
stainless steel, packed in
specially designed sterile
packs and boxes and sterilized
by Cobalt-60. The product's
shelf life is 3 years. | The Frankenman Single Use
Circular Stapler for Rectal
Prolapse and Hemorrhoids
(i.e., stapled
Haemorrhoidopexy (CPH), is
primarily manufactured from
plastic, titanium, aluminum
alloy and stainless steel and is
used in the treatment of rectal
haemorrhoids and anorectal
defects of transanal stapling
(otherwise known as staples
transanal rectal resection or
STARR procedure) and | |
| Manufacturer | Suzhou Beinuo | Suzhou Frankenman | Significant Differences |
| | Hemorrhoidal Circular Staplers
for Single Use is used in the
treatment of rectal wall
defects and internal
hemorrhoids during anorectal
surgery. The Beinuo
Hemorrhoidal Circular Staplers
for Single Use places a
circular, double staggered
rows of titanium staples,
thereby sealing off the rectal
mucosa or rectum above the
anal canal. The central circular
cutting blade cuts the surplus
tissue after the sealing to
reconstruct the rectal mucosa
or rectum. The diameter of
the staple line is determined
by the selection of the 32mm
or 34mm stapler. | resection of rectal mucosal
and musculo-mucosal tissue
resulting in occlusion of
haemorrhoidal inflow,
restoring the haemorrhoidal
tissue to its normal
physiological position.
Specifically, the rectal mucosa
above the anal canal is sealed
by the placement of two
circular peripheral lines of
alternating and overlapping of
titanium (ISO 5832-2) staples.
The central circular cutting
blade cuts the surplus tissue
after the sealing to
reconstruct the rectal mucosa. | |
| | Linear Staplers and Reloads
for Single Use

Product description

Linear Stapler and Reloads for
Single Use are made of plastic
particles, titanium and
stainless steel, packed in
specially designed sterile
packs and boxes and sterilized
by Cobalt-60. Linear Staplers
and Reloads for Single Use is
used in the closure of incision
and stump of inner organs in
general surgery. The shelf life
is 3 years.

The Beinuo Linear Staplers
and Reloads for Single Use
places a double staggered row
of titanium staples (3 rows for
white cartridge only) used for
mechanical suturing and
closure of tissue. The Linear
Stapler is available in 32mm. | The Frankenman Disposable
Reloadable Linear Stapler is
manufactured primarily from
plastic, titanium, and stainless
steel. Single Use, reloadable
linear staplers are used in the
process of mechanical
suturing and closure of tissue,
prior to the removal of excess
tissue. Specific surgical
procedures where the LS
would be used include
general, thoracic,
gynecological and colorectal
surgeries.
The LS places a double
staggered row of titanium (ISO
5832-2) staples, with the
exception of model number
LS30W which places three
staggered rows of staples. This
third row provides additional
security for closing vessels
where bleeding is a significant
risk. | |
| 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 Use
Product description
Linear 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 be
reloaded with additional
staples during the procedure
(single patient - no re-use or
re-sterilization). | Staplers are single use.
Staplers + reloads may be
reloaded with additional
staples during the procedure
(single patient - no re-use or
re-sterilization). | Identical |
| Shelf Life | 36 months based on the
sterilization validation of the
packaging. | 24 months based on
sterilization validation of the
packaging | The Suzhou Beinuo device has
12 months additional shelf life
based on sterilization
validation data. |
| Biocompatibility | Complies with ISO 10993-1
and other pertinent standards | Complies with ISO 10993-1
and other pertinent standards | Identical |

Table 5A - Comparison of Characteristics

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . .

;

EMERGO GEROUP

K133499

Suzhou Beinuo Traditional 510(k) Premarket Submission Surgical Staplers

EMERGO GGROUP

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.

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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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

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

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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

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

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.

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)