(464 days)
No
The summary describes a mechanical stapling device with a battery-powered firing system and articulation mechanism. There is no mention of AI, ML, image processing, or data analysis capabilities that would indicate the use of such technologies. The performance studies listed are standard tests for mechanical and electrical safety and biocompatibility.
No
The device is a surgical stapler used for cutting and stapling tissue during procedures, which is an interventional tool, not typically considered a therapeutic device designed to treat a disease or condition itself.
No
The device is described as a "Powered Articulating Endoscopic Linear Cutter Stapler" intended for "transection, resection, and/or creation of anastomoses." This indicates a surgical function that performs physical modifications to tissue, not one that gathers information about health status.
No
The device description clearly indicates it is a physical instrument (stapler) with a battery-powered firing system, not a software-only device.
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 device used on the patient's body during surgery, not a device used to test samples from the body in a laboratory setting.
- Device Description: The description details a surgical stapler that cuts and staples tissue. This is a surgical instrument, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Disposable Powered Articulating Endosopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line.
The instruments are available in three shaft lengths: compact (192±20mm), regular (252±20mm) and long (352±20mm). 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.
Model 30mm series include FSMS30, FSMM30, FSML30; 45mm series include FSMS45, FSMM45, FSML45; 60mm series include FSMS60, FSMM60, FSML60. The difference between the three series lies in the different anatomized lengths.
There are total 18 models of reloads within the proposed device, three stapler line length: 35.2±2.0mm,49.3±2.0mm and 61.3±2.0mm; six staple heights: Gray (0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), Black (2.3mm).
Power type: internal power supply; DC voltage 12V, rated power 40W
Applied parts: Type CF
Mode of operation: Non-Continuous Operation
Degree of safety when used in the presence of flammable anesthetic gas mixed with flammable anesthetic gas or nitrous oxide mixed with air: Flammable anesthetic gas that cannot be mixed with flammable anesthetic gas or nitrous oxide mixed with air.
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads 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
general abdominal, gynecologic, thoracic, and pediatric
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: Appearance, Flexibility, Assembling capacity, Hardness, Anastomosis and cutting performance, Resistance to Pressure, Safety Device, Sharpness, Surface Roughness, Package Seal, Rotation and Articulation, Firing Electric Current, Battery Voltage, Motor Rotate Speed, Size, Sterility Test, Accelerated Aging Test (ASTM F1980-16), Seal Strength Test (ASTM F 88/F-15), Dye Penetration Test (ASTM F1929-15, ASTM F3039-15), Vacuum Leak Test(ASTM D3078-2002(2013)), Packaging Resistance Bacteria Performance Test(DIN 58953-6-2010).
Biocompatibility Tests: In Vitro Cytotoxicity Test (ISO 10993-5: 2009), Skin Sensitization Test (ISO 10993-10:2010), Intracutaneous reactivity Test (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2006), Pyrogen Test (ISO 10993-11:2006), Subchronic Systemic Toxicity (ISO 10993-11:2006), Ames test (ISO 10993-3: 2014), In vitro Mammalian Chromosome Aberration Test (ISO 10993-3:2014), In Vivo Mammalian Erythrocyte Micronucleus Test (ISO 10993-3:2014), Muscle Implantation Test (ISO 10993-6: 2016).
Electrical Safety Test: Electrical Safety Test (AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012,c1:2009/(r)2012 and a2:2010/(r)2012).
EMC Test: EMC Test (IEC60601-1-2:2014).
Key Results: The device passed all listed tests.
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.
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/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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
December 18, 2019
Fengh Medical Co., Ltd. Jiao Liu RA Manager D3 No.6 Dongsheng West Road, Jiangyin National High-tech Zone Jiangyin, 214437 Cn
Re: K182476
Trade/Device Name: Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: November 13, 2019 Received: November 18, 2019
Dear Jiao Liu:
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 medical devices and radiation-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. Acting 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182476
Device Name
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads, Model include 30mm series and 60mm series
Indications for Use (Describe)
The Disposable Powered Articulating Endosopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric 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) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| 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
(As Required by 21 CFR 807.92)
1. Date Prepared [21 CFR 807.92(a)(1)]
Jan 29th, 2019
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Company Name: | Fengh Medical Co., Ltd. |
|---|---|
| Company Address: | D3 No.6 Dongsheng West Road, Jiangyin National High-tech Zone, 214437 Jiangsu, China |
| Contact Person: | Jiao Liu |
| Phone: | 0086-13815132106 |
| Email: | Jiao.liu@fenghmedical.com |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | Disposable Powered Articulating Endoscopic Linear Cutter
Stapler & Reloads, Model include 30mm series, 45mm
series and 60mm series |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Implantable staple |
| Product Code: | GDW |
| Regulation Number: | 21 CFR 878.4750 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)[
The identification of predicates within this submission is as follow:
| Manufacturer: | Ethicon Endo-Surgery, LLC |
|---|---|
| Trade Name: | Echelon Flex Powered Articulating Endoscopic Linear |
| Cutters | |
| Common Name: | Cutter/Stapler |
| Product Code: | GDW |
| Classification Name: | Staple, Implantable; Stapler, Surgical |
| Regulation Number: | 21 CFR 878.4750 |
| Classification: | Class II |
Page 1 of 8
4
K130653 (K130653 is a modification to their original FDA 510 (k) #: product cleared under K110385)
5. Description of the Device [21 CFR 807.92(a)(4)]
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The Power Stapler and Reloads are sterilized by irradiation. The instruments deliver six staggered rows of staples, three on either side of the cut line.
The instruments are available in three shaft lengths: compact (192±20mm), regular (252±20mm) and long (352±20mm). 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.
Model 30mm series include FSMS30, FSMM30, FSML30; 45mm series include FSMS45, FSMM45, FSML45; 60mm series include FSMS60, FSMM60, FSML60. The difference between the three series lies in the different anatomized lengths.
There are total 18 models of reloads within the proposed device, three stapler line length: 35.2±2.0mm,49.3±2.0mm and 61.3±2.0mm; six staple heights: Gray (0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), Black (2.3mm).
Power type: internal power supply; DC voltage 12V, rated power 40W Applied parts: Type CF Mode of operation: Non-Continuous Operation
Degree of safety when used in the presence of flammable anesthetic gas mixed with flammable anesthetic gas or nitrous oxide mixed with air: Flammable anesthetic gas that cannot be mixed with flammable anesthetic gas or nitrous oxide mixed with air .
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads 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.
Page 2 of 8
5
Image /page/5/Figure/1 description: The image shows a medical instrument with two labels, IPX4 and IPX0, indicating different sections of the device. IPX4 is positioned above the long, slender part of the instrument, while IPX0 is located above the handle. The instrument appears to be a type of surgical tool, possibly used for grasping or cutting tissue during medical procedures. The design includes a handle for manual operation and an extended arm with a specialized tip.
6. Indications For Use [21 CFR 807.92(a)(5)]
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general abdominal, gynecologic, thoracic, and pediatric surgical procedures.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The technological characteristics are the same or very similar to the predicate device.
Surgical stapling is the technological principle for both the subject and predicate device. It is based on the use of endoscopic instrumentation for transection, resection, and/or creation of anastomoses.
The subject and predicate staplers and reloads share the following features:
- Intended Use
- Technological characteristics
- Operational principles
- Sterilization Method
8. Non-Clinical and Clinical Tests
The device passed the following tests.
| Non-Clinical Test | Appearance |
|---|---|
| Flexibility | |
| Assembling capacity | |
| Hardness | |
| Anastomosis and cutting performance | |
| Resistance to Pressure | |
| Safety Device | |
| Sharpness | |
| Surface Roughness | |
| Package Seal | |
| Rotation and Articulation | |
| Firing Electric Current | |
| Battery Voltage | |
| Motor Rotate Speed | |
| Size | |
| Sterility Test | |
| Accelerated Aging Test (ASTM F1980-16) | |
| Seal Strength Test (ASTM F 88/F-15) | |
| Dye Penetration Test (ASTM F1929-15, ASTM | |
| F3039-15) | |
| Vacuum Leak Test(ASTM D3078-2002(2013)) | |
| Packaging Resistance Bacteria Performance Test(DIN | |
| 58953-6-2010) | |
| Biocompatibility Test | In Vitro Cytotoxicity Test (ISO 10993-5: 2009) |
| Skin Sensitization Test (ISO 10993-10:2010) | |
| Intracutaneous reactivity Test (ISO 10993-10:2010) | |
| Acute Systemic Toxicity (ISO 10993-11:2006) | |
| Pyrogen Test (ISO 10993-11:2006) | |
| Subchronic Systemic Toxicity (ISO 10993-11:2006) | |
| Ames test (ISO 10993-3: 2014) | |
| In vitro Mammalian Chromosome Aberration Test | |
| (ISO 10993-3:2014) | |
| In Vivo Mammalian Erythrocyte Micronucleus Test | |
| (ISO 10993-3:2014) | |
| Muscle Implantation Test (ISO 10993-6: 2016) | |
| Electrical Safety Test | Electrical Safety Test (AAMI / ANSI ES60601- |
| 1:2005/(R)2012 and A1:2012,c1:2009/(r)2012 and | |
| a2:2010/(r)2012) | |
| EMC Test | EMC Test (IEC60601-1-2:2014) |
Page 3 of 8
6
7
9. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
| Product Name | Disposable Powered Articulating Endoscopic
Linear Cutter Stapler & Reloads | Echelon Flex Powered Articulating Endoscopic
Linear Cutters (K130653)
K130653 is a modification to their original product
cleared under K110385 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | II | II |
| Regulation Number | 21 CFR 878.4750 | 21 CFR 878.4750 |
| Product Code | GDW | GDW |
| Intended Use | The Disposable Powered Articulating Endoscopic
Linear Cutter Stapler & Reloads are intended for
transection, resection, and/or creation of
anastomoses. The instruments have application in
multiple open or minimally invasive general
abdominal, gynecologic, 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. |
| Cutting Mechanism | Stapler places two, triple staggered rows of staples
and simultaneously cuts and divides the tissue
between the two row. | Stapler places two, triple staggered rows of staples
and simultaneously cuts and divides the tissue
between the two row. |
| Manual/Powered | Powered | Powered |
| Safety Feature | Power stapler has empty-reload safety protection
mechanism. | Power stapler has empty-reload safety protection
mechanism. |
| Main Components | Closing Trigger, Red Firing Trigger Lock, Firing
Trigger, Anvil Release Button, Battery Pack,
Battery Pack Release Tab, Manual Override | Closing Trigger, Red Firing Trigger Lock, Firing
Trigger, Anvil Release Button, Battery Pack,
Battery Pack Release Tab, Manual Override |
8
| | Access Panel, Knife Reverse Switch, Rotating
Knob, Articulation Fins, Reload(Cartridge),
Reload Gripping Surface, Reload Alignment Tab,
Reload Alignment Slot, Staple Retaining Cap,
Anvil Jaw, Cartridge Jaw, Staple Line, Cut Line,
Proximal Black Line , Knife Blade Indicator,
Indicator | Access Panel, Knife Reverse Switch, Rotating
Knob, Articulation Fins, Reload(Cartridge),
Reload Gripping Surface, Reload Alignment Tab,
Reload Alignment Slot, Staple Retaining Cap,
Anvil Jaw, Cartridge Jaw, Staple Line, Cut Line,
Proximal Black Line , Knife Blade Indicator | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Staple Line Length | 30mm | N/A | |
| | 45mm | 45mm | |
| | 60mm | 60mm | |
| Open Staple Height | 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.4mm | No Known | |
| Open Staple Picture | Image: Open Staple | Image: Open Staple | |
| Closed Staple Height | 0.75mm | 0.75mm | |
| | 1.0mm | 1.0mm | |
| | 1.5mm | 1.5mm | |
| | 1.8mm | 1.8mm | |
| | 2.0mm | 2.0mm | |
| | 2.3mm | 2.3mm | |
| Closed Staple Picture | Image: Closed Staple | Image: Closed Staple | |
| Number of Staples | 36 | N/A | |
| | 70 | 70 | |
| | 88 | 88 | |
| Staple Cross Section | 0.03 mm2 | No Known | |
| Patient-Contact Material | Contact
Material
Component | No Known | |
| | Anvil | SUS420(Stainless 20Cr13)
SUS630(Stainless
05Cr17Ni4Cu4Nb/0Cr17Ni4Cu4Nb) | |
| | Reload seat | SUS630(Stainless
05Cr17Ni4Cu4Nb/0Cr17Ni4Cu4Nb) | |
| | Cutting knife | SUS440(Stainless 85Cr17) | |
| | Aluminum
ring | 2A12-T4 | |
| | Left Pipe | SUS304(Stainless 06Cr19Ni10) | |
| | Right Pipe | SUS304 (Stainless 06Cr19Ni10) | |
| | Reload | LCP, PC | |
| | Pushing plate | RTP4007A | |
| | Bracket | SUS304(Stainless 06Cr19Ni10) | |
| | Cover | PU | |
| | Staple | Ti-3AL-2.5V(TA18) | |
| Sterilization | Sterilized by Irradiation | | Sterilized by Irradiation |
| SAL | 10-6 | | Not Known, but assumed to be 10-6 |
Page 6 of 8
9
10
10. Conclusion [21 CFR 807.92(b)(3)]
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads device is substantially equivalent to the predicate device because both devices use the same or similar technology and have the same intended use. Testing to relevant standards demonstrate the device will perform as intended. The differences between the devices are insignificant and do not raise different questions of safety and effectiveness for the Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads device.