(244 days)
Not Found
No
The description focuses on the mechanical and electrical components of the stapler and does not mention any AI or ML capabilities.
Yes.
Explanation: The device is intended for "transection, resection, and/or creation of anastomoses" in surgical procedures, which are therapeutic interventions.
No.
The device is a surgical stapler used for transection, resection, and creating anastomoses by cutting and stapling tissue. It is a therapeutic device, not a diagnostic one.
No
The device description clearly details physical hardware components including a battery-powered firing system, a primary lithium battery pack, a rotating shaft, articulation mechanism, and cartridges with staples. It also mentions sterilization methods for these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "transection, resection, and/or creation of anastomoses" in surgical procedures. This describes a surgical tool used directly on tissue within the body.
- Device Description: The description details a mechanical stapling and cutting device used during surgery. It talks about staples, cutting lines, shaft lengths, articulation, and a battery-powered firing system. These are all characteristics of a surgical instrument.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with patient specimens or diagnostic purposes.
Therefore, the Disposable Powered Endoscopic Linear Cutting Staplers and cartridges are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Disposable Powered Endoscopic Linear Cutting Staplers and cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, abdominal, thoracic, and pediatric surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments are packaged with a primary lithium battery pack which must be installed prior to use. The powered stapler and cartridges are sterilized by EO sterilization, and battery pack is sterilized by Gamma irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line.
The staplers are available in three shaft lengths: compact (Model DCE46 and DCE46, 280±10mm), regular (Model DSE46 and DSE60, 340±10mm) and long (Model DLE46 and DLE60. 440±10mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
According to the length of the anastomosis, the cartridges (DCR series) can be divided into two specifications of 46mm and 60mm; the staples inside the cartridges can be divided into 2.5mm, 3.5mm, 4.1mm according to the nail height, and they are distinguished by color. The color codes are white (W), blue (B), yellow (Y), and green (G). There are total 8 models of cartridges within the proposed device: two stapler line length: 46mm and 60mm, each length of the cartridges has four colors which stand for different staple heights: Green (4.1mm), Yellow (3.8mm), Blue (3.5mm), White (2.5mm).
The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are powered by the internal lithium battery, which has the rated specifications of DC voltage 12V and capability 1400mAh. Battery package model is BP813, composed of four lithium battery cells. The proposed device is resistant to water ingress. Grade of waterproof: Rotating knob to the end of tubular shaft (including rotating knob) is rated IPX4; the Body is rated IPX0.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric surgical procedures
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)
All nonclinical tests performed on new devices are to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards.
Biocompatibility testing: The biocompatibility evaluations of the proposed device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The biocompatibility testing includes the following: Cytotoxicity, Sensitization & irritation, Acute systemic toxicity, Pyrogen test. The staplers are considered tissue contacting for duration less than 24 hours, while the staples are considered permanent implants. The titanium material of implantable staples conforms to ASTM F67-13.
Sterilization validation: Ethylene oxide and Gamma Irradiation are used to sterilize the proposed device, and the following standards are followed: ISO 11135: 2014, ISO 11137-1:2006, ISO 11137-2:2013, ISO 11737-1:2018, ISO 10993-7:2008, ASTM F88:2015, ASTM F1929:2015, Endotoxin Test.
Performance testing: The following nonclinical tests were conducted: Form staple height, Stable line integrity, Reliability testing, Angle of articulation testing for the articulation connector change, Safety system tests, Reliability test for knife reverse button, Appearance, Dimension and Surface roughness.
Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012), IEC 60601-1-2: 2014, IEC 60086-4:2014.
Animal study: Carried out to assess: Success rate of anastomosis, Hemostasis evaluation test, Anastomotic pressure resistance, Anastomotic healing, Staple forming, Tensile strength & Burst pressure.
MR Compatibility Information: Non-clinical testing demonstrated the staples in the device are MR conditional.
Summary: All the testing results, including bench tests, sterilization, biocompatibility tests and animal study, demonstrate that the Disposable powered endoscopic linear cutting staplers and cartridges manufactured by Verykind Company meet the requirements of its pre-defined acceptance criteria and intended use, and it has a safety and effectiveness profile that is similar to the predicate device.
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
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
May 18, 2021
Ningbo Verykind Medical Device Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K202709
Trade/Device Name: Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: August 30, 2020 Received: September 16, 2020
Dear James Tsai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202709
Device Name
Disposable powered endoscopic linear cutting staplers and cartridges
Indications for Use (Describe)
Disposable Powered Endoscopic Linear Cutting Staplers and cartridges are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, abdominal, thoracic, and pediatric surgical procedures
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K202709
1. Administrative Information
| Date of Summary prepared | April 9, 2021 |
|---|---|
| Manufacturer information | Company: Ningbo Verykind Medical Device Co., Ltd. |
| Company address: | |
| #100 Jinghua Road, Hi-tech industrial development | |
| zone, Ningbo, Zhejiang 315040, China | |
| Contact person: Hong Pengfei | |
| Phone: +86-574-87910279 | |
| Fax: +86-574-87910279 | |
| E-mail: pfhong@nbverykind.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| Address: 1713A, 17th Floor, Block A, Zhongguan | |
| Times Square, Nanshan District, Shenzhen | |
| Contact person: James Tsai | |
| E-Mail: james_tsai@cefda.com; field@cefda.com | |
| Establishment registration number |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Powered Endoscopic Linear Cutting |
| Staplers and Cartridges | |
| Classification name: | Implantable Staple |
| Review Panel: | General and plastic surgery devices |
| Product Code: | GDW |
| Device Class: | II |
| Regulation Number: | 878.4750 |
3. Predicate Device Information
| Manufacturer: | Ethicon Endo-Surgery, LLC |
|---|---|
| Trade Device: | Echelon Flex Powered Articulating Endoscopic |
| Linear Cutters |
4
K130653 510(K) Number: Staple, Implantable; Stapler, Surgical Classification name: GDW Product Code: Device Class: ll Regulation Number: 878.4750
4. Device Descriptions
The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments are packaged with a primary lithium battery pack which must be installed prior to use. The powered stapler and cartridges are sterilized by EO sterilization, and battery pack is sterilized by Gamma irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line.
The staplers are available in three shaft lengths: compact (Model DCE46 and DCE46, 280±10mm), regular (Model DSE46 and DSE60, 340±10mm) and long (Model DLE46 and DLE60. 440±10mm). The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site.
According to the length of the anastomosis, the cartridges (DCR series) can be divided into two specifications of 46mm and 60mm; the staples inside the cartridges can be divided into 2.5mm, 3.5mm, 4.1mm according to the nail height, and they are distinguished by color. The color codes are white (W), blue (B), yellow (Y), and green (G). There are total 8 models of cartridges within the proposed device: two stapler line length: 46mm and 60mm, each length of the cartridges has four colors which stand for different staple heights: Green (4.1mm), Yellow (3.8mm), Blue (3.5mm), White (2.5mm).
The Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges are powered by the internal lithium battery, which has the rated specifications of DC voltage 12V and capability 1400mAh. Battery package model is BP813, composed of four lithium battery cells. The proposed device is resistant to water ingress. Grade of waterproof: Rotating knob to the end of tubular shaft (including rotating knob) is rated IPX4; the Body is rated IPX0.
5. Intended Use/ Indications for Use
Disposable Powered Endoscopic Linear Cutting Staplers and cartridges are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, abdominal, thoracic, and pediatric surgical procedures.
6. Comparison to predicate device
5
| Item | Disposable Powered Endoscopic
Linear Cutting Staplers and
Cartridges (Proposed device) | Echelon Flex Powered Articulating
Endoscopic Linear Cutters
(Predicate device, K130653) |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Ningbo Verykind Medical Device Co.,
Ltd. | Ethicon Endo-Surgery, LLC |
| Product Code | GDW | GDW |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) |
| Intended use/
Indications for
Use | Disposable Powered Endoscopic
Linear Cutting Staplers and
cartridges are intended for
transection, resection, and/or
creation of anastomoses.
The instruments have application in
multiple open or minimally invasive
general, gynecologic, abdominal,
thoracic, and pediatric surgical
procedures. | The Echelon families of endoscopic
linear cutters (articulating and
straight) are intended for transection,
resection, and/or creation of
anastomoses.
The instruments have application in
multiple open or minimally invasive
general, gynecologic, urologic,
thoracic, and pediatric surgical
procedures.
They can be used with staple line or
tissue buttressing materials.
The instruments may also be used for
transection and resection of liver
parenchyma (hepatic vasculature and
biliary structures), pancreas, kidney
and spleen. |
| Safety feature | Power stapler has empty-reload
safety protection mechanism | Power stapler has empty-reload
safety protection mechanism |
| Cutting
mechanism | Stapler places two, triple staggered
rows of staples and simultaneously
cuts and divides the tissue between
the two rows | Stapler places two, triple staggered
rows of staples and simultaneously
cuts and divides the tissue between
the two rows |
| Cutting
mechanism | Linear | Linear |
| Stapling power | Powered (Lithium Battery) | Powered |
| Suture Length | 46mm, 60mm | 45mm, 60mm |
| Staple
height | 2.5mm, 3.5mm, 3.8mm, 4.1mm | 2.0mm, 2.5mm, 3.5mm, 3.8mm,
4.1mm, 4.4mm |
| | 1.0mm, 1.5mm, 1.8mm, 2.0mm | 0.75mm, 1.0mm, 1.5mm, 1.8mm,
2.0mm, 2.3mm |
| Closed staple
form | Image: staple | Image: staple |
| Number of
staples | 70, 88 | 70, 88 |
| Articulation
angle | 15°-60° | 15°-45° |
| Rows of Staple
Line | Six staggered rows of staples, three
on either side of the cut line | Six staggered rows of staples, three
on either side of the cut line |
| Implantable
Material | Unalloyed Titanium conforms to
ASTM F67-13 | Unalloyed Titanium conforms to
ASTM F67-13 |
| Structures
(main | It consists of Shell, Adjusting knob,
Adjusting shell, Knife reverse button | It consists of Shell, Adjusting knob,
Adjusting shell, Knife reverse button |
| components) | Firing safety, Battery pack, Manual
override, Firing trigger, Close handle,
Shaft, Anvil jaw, Reload jaw,
Articulation protective sleeve, Cutting
knife, Staple, Staple holder, Stapler
holder cover | Firing safety, Battery pack, Manual
override, Firing trigger, Close handle,
Shaft, Anvil jaw, Reload jaw,
Articulation protective sleeve, Cutting
knife, Staple, Staple holder, Stapler
holder cover |
| | Reload jaw:
06Cr19Ni10(SUS304),
05Cr17Ni4Cu4Nb(SUS630) | Not publicly available |
| Body material
patient short-
time contact | Anvil jaw:
06Cr19Ni10(SUS304),
05Cr17Ni4Cu4Nb(SUS630) | Not publicly available |
| | Articulation protective sleeve:
TPU | Not publicly available |
| | Shaft:
06Cr19Ni10(SUS304) | Not publicly available |
| | Cutting Knife:
20Cr13 (SUS420J1),
30Cr13 (SUS420J2) | Not publicly available |
| | Staple:
Ti (TA1G) | Not publicly available |
| | Stapler holder & cover:
PC, ABS(PA757), PEI | Not publicly available |
| Biocompatibility | All components of the proposed
device are composed of materials,
which are in accordance with
relevant parts of ISO Standard
10993 | Conform to relevant parts of ISO
standard 10993 |
| Sterilization
Sterility
Assurance
Level | Stapler and
cartridges | Ethylene Oxide
(EO) sterilization
SAL 10-6 |
| | Battery | Gamma Irradiation
SAL 10-6 |
| Labeling | Conforms to 21 CFR part 801 and
830 | Conforms to 21 CFR part 801 and
830 |
6
The proposed device and the predicate device have the same indications for use and similar technological characteristics. The differences in the materials, articulation angle and sterilization method do not raise additional questions for safety and effectiveness based on series tests, trials and validations.
7. Brief discussions of the nonclinical tests
All nonclinical tests performed on new devices are to demonstrate the substantial equivalence to the predicate devices. Tests setup and execution are performed in accordance with applicable standards.
Biocompatibility testing
The biocompatibility evaluations of the proposed device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process", as recognized by FDA. The biocompatibility testing includes the following:
7
- Cytotoxicity
- Sensitization & irritation
- Acute systemic toxicity ●
- . Pvrogen test
The staplers are considered tissue contacting for duration less than 24 hours, while the staples are considered permanent implants. The titanium material of implantable staples conforms to ASTM F67-13.
Sterilization validation
Ethylene oxide and Gamma Irradiation are used to sterilize the proposed device, and the standards below are followed:
- ISO 11135: 2014 Sterilization of health-care products Ethylene oxide -. Requirements for the development, validation and routine control of a sterilization process for medical devices
- ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ISO 11737-1:2018 Sterilization of health care products Microbiological ● methods - Part 1: Determination of a population of microorganisms on product
- ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene ● oxide sterilization residuals
- . ASTM F88:2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
- . ASTM F1929:2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration
- . Endotoxin Test
Performance testing
The following nonclinical tests were conducted with Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges to verify that the proposed device is as safe and as effective as the predicate device, performs as intended, and meets all design specifications:
- Form staple height
- Stable line integrity ●
- Reliability testing ●
- Angle of articulation testing for the articulation connector change ●
- . Safety system tests
- . Reliability test for knife reverse button
- Appearance, Dimension and Surface roughness ●
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted, and the results show that the proposed device complies with the following standards:
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) . Medical electrical equipment - Part 1: General requirements for basic safety
8
and essential performance for safety
- . IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC
- IEC 60086-4:2014 Primary batteries Part 4: Safety of lithium batteries ●
Animal studv
To demonstrate the operation performance is as safe and as effective as the predicate device, the animal study was carried out to assess the following safety and performance criteria:
- Success rate of anastomosis ●
- Hemostasis evaluation test ●
- Anastomotic pressure resistance
- Anastomotic healing ●
- Staple forming ●
- Tensile strength & Burst pressure
MR Compatibility Information
Non-clinical testing demonstrated the staples in the device are MR conditional.
Summarv
All the testing results, including bench tests, sterilization, biocompatibility tests and animal study, demonstrate that the Disposable powered endoscopic linear cutting staplers and cartridges manufactured by Verykind Company meet the requirements of its pre-defined acceptance criteria and intended use, and it has a safety and effectiveness profile that is similar to the predicate device.
8. Clinical Testing
Substantial equivalence does not depend on clinical test data.
9. Conclusions
Based on device comparison information and performance data, the proposed device is as safety and effectiveness as predicate device, and the differences in technological characteristics do not raise different questions of safety and effectiveness. Therefore, the proposed device is substantially equivalent to the predicate device.