(151 days)
Not Found
No
The device description and performance studies focus on mechanical function and physical properties, with no mention of AI/ML or data processing.
Yes
The devices described (Intraluminal Stapler, PPH Stapler, and TST Stapler) are surgical instruments used for treating conditions like anastomoses, hemorrhoids, and anorectal wall defects, which are interventions aimed at curing or alleviating diseases, thus classifying them as therapeutic devices.
No
The devices described are surgical staplers used for treatment (creating anastomoses, treating hemorrhoids, resecting tissue), not for diagnosing conditions.
No
The device description clearly outlines physical surgical instruments (staplers) made of titanium, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the devices as surgical instruments for creating anastomoses and treating hemorrhoids and anorectal wall defects. These are surgical procedures performed directly on the patient's body.
- Device Description: The descriptions detail the mechanical function of the staplers in placing staples and resecting tissue during surgery. There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
- Measuring analytes.
The devices described are surgical tools used for treatment, not for diagnosis based on in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The CSC Series Intraluminal Stapler for Single Use 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.
The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.
The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The proposed device, CSC Series Intraluminal Stapler for Single Use is a sterilized and disposable surgical instrument intended to be 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 surgeries. It places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created.
The proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids. It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.
The proposed device, TST Series Tissue-Selecting Therapy Stapler is a sterilized and disposable surgical instrument, to be used in the surgical treatment of prolapse and hemorrhoids. This device also uses the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome, with a single-fire staple. It is a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is also Used for other applications where circular or semicircular or 1/3 circular stapling of anorectal tissue is desired.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
anorectal wall
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include:
Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair and Force Required to Fire Stapler.
Endotoxin Limit
Package Integrity, including dye penetration tests and seal strength test.
Shelf Life
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are connected by a flowing line that forms a wing-like shape above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2014
Touchstone International Medical Science Company, Ltd. Mr. Jo Qiao Management Representative 21A Science Plaza, International Science Park No. 1355 Jinjihu Avenue Suzhou, 215021 P.R. CHINA
Re: K141097
Trade/Device Name: CSC Series Intraluminal Stapler for Single Use, PPHplus Series PPH Stapler, and TST Series Tissue-Selecting Therapy Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW Dated: August 26, 2014 Received: August 29, 2014
Dear Mr. Qiao:
This letter corrects our substantially equivalent letter of September 26, 2014.
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.
1
Page 2 - Mr. Jo Qiao
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 8091 ); medical device reporting (reporting of medical 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809] ), 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" (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 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,
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
CSC Series Intraluminal Stapler for Single Use
Indications for Use (Describe)
The CSC Series Intraluminal Stapler for Single Use 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.
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)
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)
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 information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
PPHplus Series PPH Stapler and Purse Sets for Single Use
Indications for Use (Describe)
The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.
Type of Use (Select one or both, as applicable)
즈 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)
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 information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known)
Device Name
TST Series Tissue-Selecting Therapy Stapler
Indications for Use (Describe)
The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
Type of Use (Select one or both, as applicable)
즈 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)
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 information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
5
Section 3 510(k) Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number:
- Submission Date: 04/18/2014 1.
- Sponsor Identification 2.
Touchstone International Medical Science Co., Ltd. 21A Science Plaza, International Science Park, No.1355 Jinjihu Avenue, Suzhou, 215021 P.R.CHINA
Establishment Registration Number:
Contact Person: Jo.Qiao Position: Management Representative Tel: +86 512 62991985 Fax: +86 512 62991998 Email: tsmo@touchstone.hk
6
Proposed Device Identification 3.
Proposed Device for CSC Series 3.1
- Proposed Device Name: CSC Series Intraluminal Stapler for Single Use 3.1.1
3.1.2 Proposed Device Common Name: Stapler
3.1.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery
3.1.4 Intended Use Statement
The CSC Series Intraluminal Stapler for Single Use 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.
3.1.5 Device Description
The proposed device, CSC Series Intraluminal Stapler for Single Use is a sterilized and disposable surgical instrument intended to be 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 surgeries.
It places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, and then a circular anastomosis is created.
7
3.2 Proposed Device for PPHplus Series
- 3.2.1 Proposed Device Name: PPHplus Series PPH Stapler and Purse Sets for Single Use
- 3.2.2 Proposed Device Common Name: Stapler
3.2.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery
3.2.4 Intended Use Statement
The PPHplus Series PPH Stapler and Purse Sets for Single Use have application for general surgical treatment of hemorrhoids.
3.2.5 Device Description
The proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids.
It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.
8
3.3 Proposed Device for TST Series
- 3.3.1 Proposed Device Name: TST Series Tissue-Selecting Therapy Stapler
- 3.3.2 Proposed Device Common Name: Stapler
3.3.3 Regulatory Information Classification Name: staple, implantable Classification: II Product Code: GDW Regulation Number: 21 CFR 878.4750 Review Panel: General & Plastic Surgery
3.3.4 Intended Use Statement
The TST Series Tissue-Selecting Therapy Stapler have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
3.3.5 Device Description
The proposed device, TST Series Tissue-Selecting Therapy Stapler is a sterilized and disposable surgical instrument, to be used in the surgical treatment of prolapse and hemorrhoids. This device also uses the Stapled Transanal Rectal Resection (STARR) surgical treatment of anorectal wall defects and obstructed defecation syndrome, with a single-fire staple.
It is a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is also Used for other applications where circular or semicircular or 1/3 circular stapling of anorectal tissue is desired.
9
-
- Predicate Device Identification
- Predicate Device for Disposable Circular Stapler 4.1
510(k) Number: K131511
Product Name: Disposable Circular Stapler
Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd.
4.2 Predicate Device for Disposable Hemorrhoidal Stapler
510(k) Number: K131511
Product Name: Disposable Hemorrhoidal Stapler
Manufacturer: Changzhou Sinolinks Medical Innovation Co., Ltd.
4.3 Predicate Device for PROXIMATE® HCS
510(k) Number: K030925
Product Name: PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories(PPH01) Manufacturer: Ethicon Endo-Surgery, Inc.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include:
- Non-Clinical Test Conclusion
Performance Testing, including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance Evaluation, Maximum Tensile Strength of Staple Line Repair and Force Required to Fire Stapler.
Endotoxin Limit
Package Integrity, including dye penetration tests and seal strength test.
Shelf Life
-
- Substantially Equivalent (SE) Conclusion
The following table compares the device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
- Substantially Equivalent (SE) Conclusion
10
| Item | Proposed Device | Predicate
Device |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The CSC Series Intraluminal Stapler for Single Use 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. | Same |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Circular Knife | Same |
| Safety Mechanism | Indicator for appropriate range of desired closed staple
height.
Safety Release for preventing from mis-firing | Same |
| Outsider Diameter | 21, 25, 29, 33 mm | Similar |
| Cutting Diameter | 12.7, 16.4, 20.0, 24.4, mm | Similar |
| Number of Staples | 16, 20, 24, 28 | Similar |
| Closed Staple Height | 2.0 mm | Similar |
| Closed Staple Form | Image: staple form | Same |
| Hardness (Circular knife) | $≥380HV0.2$ | Same |
| Pressure Resistance after Suturing | $≥3.6kPa$ | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Same |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-1 CSC Series Intraluminal Stapler for Single Use
Difference in Outsider Diameter, Cutting Diameter, Number of Staples, Closed Staple Height. Between the proposed and the predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, CSC Series Intraluminal Stapler for Single Use, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Circular Stapler (K131511), in respect of safety and effectiveness.
11
| Item | Proposed Device | Predicate
Device |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The PPHplus Series PPH Stapler and Purse Sets for Single
Use have application for general surgical treatment of
hemorrhoids. | Same |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Circular Knife | Same |
| Safety Mechanism | Indicator for appropriate range of desired closed staple
height. | Same |
| | Safety Release for preventing from mis-firing | Same |
| Outsider Diameter | 33.5 mm | Similar |
| Cutting Diameter | 24.4 mm | Similar |
| Number of Staples | 32 | Same |
| Closed Staple Height | 1.3, 1.6 mm | Similar |
| Closed Staple Form | UD | Same |
| Hardness (Circular knife) | ≥380HV0.2 | Same |
| Pressure Resistance after Suturing | ≥3.6kPa | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Same |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-2 PPHplus Series PPH Stapler and Purse Sets for Single Use
Difference in Outsider Diameter, Cutting Diameter, Closed Staples Height. Between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, PPHplus Series PPH Stapler and Purse Sets for Single Use, is determined to be Substantially Equivalent (SE) to the predicate device, Disposable Hemorrhoidal Stapler(K131511), in respect of safety and effectiveness.
12
| Item | Proposed Device | Predicate
Device |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Product Code | GDW | Same |
| Regulation No. | 21 CFR 878.4750 | Same |
| Class | II | Same |
| Intended Use | The TST Series Tissue-Selecting Therapy Stapler have
application for general surgical treatment of anorectal wall
defects by means of transanal stapling and resection of
mucosal and musculomucosal tissue. | Same |
| Operation Principle | Manual | Same |
| Cutting Mechanism | Circular Knife | Same |
| Safety Mechanism | Indicator for appropriate range of desired closed staple
height. | Same |
| | Safety Release for preventing from mis-firing | Same |
| Outsider Diameter | 31.5, 33.5, 36.5 mm | Similar |
| Cutting Diameter | 22.4, 24.4, 26.4 mm | Similar |
| Number of Staple | 30, 32, 34 | Similar |
| Closed Staple Height | 1.3, 1.6, 2.0 mm | Similar |
| Closed Staple Form | Image: Closed Staple Form | Same |
| Hardness (Circular knife) | $\ge$ 380HV0.2 | Same |
| Pressure Resistance after Suturing | $\ge$ 3.6kPa | Same |
| Staple Materiel | Unalloyed Titanium conforms to ASTM F 67-06 | Same |
| Stapler Materials | Stainless Steel, Polycarbonate | Same |
| Sterilization | Irradiation Sterilized, SAL: 10-6 | Same |
| Endotoxin Limit | 20 EU per Product | Same |
| Package | Tray with Tyvek Paper | Same |
| Labeling | Conforms to 21 CFR part 801 | Same |
Table 3-3 TST Series Tissue-Selecting Therapy Stapler
Difference in Outsider Diameter, Cutting Diameter, Number of Staple, Closed Staple Height. Between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.
The proposed device, TST Series Tissue-Selecting Therapy Stapler, is determined to be Substantially Equivalent (SE) to the predicate device, PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories(K030925), in respect of safety and effectiveness.