(281 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
This device is a surgical stapling system for mechanical tissue cutting and sealing, not a therapeutic device designed to treat a condition.
No
This device is a surgical stapling system for transecting, resecting, and sealing tissue, not for diagnosing conditions.
No
The device description clearly describes a physical, sterile, single-use stapling system with various hardware components (shaft lengths, reload lengths, staples). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical stapling system used for mechanically transecting, resecting, and sealing tissue during surgical procedures. This is an active surgical tool used directly on the patient's body.
- Device Description: The description details a mechanical stapling system with physical components (shaft, jaws, staples) designed for surgical manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. IVDs are typically used in laboratories or point-of-care settings to analyze biological samples.
The device is a surgical instrument used for physical manipulation of tissue during surgery, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Applied Medical Laparoscopic Linear Cutter has applications in open and/or minimally invasive general, urologic, gynecologic, pediatic and thoracic surgery for resection and or creation of anastomosis. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. It can be used with staple line or tissue buttressing materials.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The Applied Medical Laparoscopic Linear Cutter (LLC) is a sterile, single-use stapling system that is intended to be used for mechanically transecting, resecting, and sealing tissue during laparoscopic and open surgical procedures. The stapler places six staggered rows of titanium staples, three on either side of the transection line. The shaft can rotate freely in both directions and the jaws articulate to facilitate access to the operative site.
The Applied LLC is available in 3 different shaft lengths (20cm, 37cm, 50cm) that can each accommodate 3 different industry-standard reload lengths (60mm, 45mm, 30mm). Each of the reload lengths is available in three industry-standard reload colors and formed staple heights to accommodate various tissue thicknesses: 1.0mm (white reload), 1.5mm (blue reload), and 2.0mm (green reload).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen
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)
Evidence of safety and effectiveness of the subject device in support of substantial equivalence was obtained from bench testing, preclinical testing, and biocompatibility testing. No human clinical studies were required to demonstrate the safety and effectiveness of the subject device in support of this premarket notification. A summary of the performance tests used to evaluate the technological and performance characteristics in support of substantial equivalence is presented in Table 5-2. All performance testing acceptance criteria were met.
Bench Tests:
- Firing Force: To evaluate the input force required to actuate the trigger
- Leak Test: To evaluate staple line leak pressures
- Articulation Testing: To evaluate device performance when fully articulated
- Reinforcement Material Compatibility: To evaluate device performance with reinforcement material
- Shelf Life Testing: To evaluate device performance after simulated transit and storage conditions
- Staple Formation: To evaluate staple formation in media and out of media
- Formed Staple Height: To measure the formed staple height
- Radiograph Imaging: To evaluate location and quality of staple formation in media
- Tissue Compression Evaluation: To evaluate tissue effects associated with application of the device
- Crossed Staple Line: To evaluate device performance when fired across existing staple line
Preclinical Tests:
- 21-Day Porcine Chronic Survival Study: To evaluate in vivo device performance including in vivo hemostasis and histopathological evaluations
- Acute Porcine In-Vivo Study: To evaluate device performance on high pressure arteries and thin-walled veins
Biocompatibility Tests:
- Ethylene Oxide Residual (per ISO 10993-7)
- Material Mediated Pyrogenicity (per USP 40-NF 35:)
- Cytotoxicity (per ISO 10993-5)
- Sensitization (per ISO 10993-10)
- Acute Systemic Toxicity (per ISO 10993-11)
- Intracutaneous Reactivity (per ISO 10993-10)
- Intramuscular Implant Testing (2 week and 13 week, per ISO 10993-6)
Chemical Characterization and Subsequent Toxicological Risk Assessment (per ISO 10993-18) was performed to evaluate the safety of the implantable staples. Results from the testing were used to assess the following endpoints:
- Reproductive and Developmental Toxicity
- Subacute Toxicity
- Subchronic Toxicity
- Chronic Toxicity
- Genotoxicity
- Carcinogenicity
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.
Ethicon Echelon Flex Endopath, K081146
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
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November 22, 2019
Applied Medical Resources Corporation Aditi Iyengar Regulatory Affairs Specialist II 22872 Avenida Empresa Rancho Santa Margarita, California 92688
Re: K190331
Trade/Device Name: Applied Medical Laparoscopic Linear Cutter Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: October 23, 2019 Received: October 24, 2019
Dear Ms. Iyengar:
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 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
1
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. 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190331
Device Name Applied Medical Laparoscopic Linear Cutter
Indications for Use (Describe)
Applied Medical Laparoscopic Linear Cutter has applications in open and/or minimally invasive general, urologic, gynecologic, pediatic and thoracic surgery for resection and or creation of anastomosis. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. It can be used with staple line or tissue buttressing materials.
| 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) |
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3
510(k) Summary
| 510(K) Submitter | Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Aditi Iyengar
Regulatory Affairs Specialist II
Applied Medical Resources Corp.
aiyengar@appliedmedical.com
Tel: (949) 713-8007
Fax: (949) 713-8205 |
| Date of Preparation | February 12, 2019 |
| Trade Name | Applied Medical Laparoscopic Linear Cutter |
| Common Name | Surgical Stapler/Implantable Staple |
| Classification | Regulation: 21 CFR 878.4750
Regulation Name: Implantable Staple
Device Class: Class II
Product Code: GDW
Regulation: 21 CFR 878.4800
Regulation Name: Surgical Stapler
Device Class: Class I
Product Code: GAG |
| Predicate Device | Ethicon Echelon Flex Endopath
510(k)#: K081146
Product Code: GDW, GAG |
| Intended Use | The Applied Medical Laparoscopic Linear Cutter has applications
in open and/ or minimally invasive general, urologic, gynecologic,
pediatric and thoracic surgery for resection, transection and/or
creation of anastomosis. The instruments may also be used for
transection and resection of liver parenchyma (hepatic vasculature
and biliary structures), pancreas, kidney and spleen. It can be used
with staple line or tissue buttressing materials. |
4
Device Description The Applied Medical Laparoscopic Linear Cutter (LLC) is a sterile, single-use stapling system that is intended to be used for mechanically transecting, resecting, and sealing tissue during laparoscopic and open surgical procedures. The stapler places six staggered rows of titanium staples, three on either side of the transection line. The shaft can rotate freely in both directions and the jaws articulate to facilitate access to the operative site.
The Applied LLC is available in 3 different shaft lengths (20cm, 37cm, 50cm) that can each accommodate 3 different industrystandard reload lengths (60mm, 45mm, 30mm). Each of the reload lengths is available in three industry-standard reload colors and formed staple heights to accommodate various tissue thicknesses: 1.0mm (white reload), 1.5mm (blue reload), and 2.0mm (green reload).
Summary of Technological Characteristics with the Predicate Device
The subject Applied Medical Laparoscopic Linear Cutter (LLC) and the predicate Ethicon Echelon Flex Endopath are similar in technological characteristics, materials, performance, and method of operation. Both devices are intended to mechanically seal and transect tissue by placing two, triple-staggered rows of titanium staples and simultaneously dividing the stapled tissue.
The following technological differences exist between the subject and predicate staplers:
- The subject device has 3 modular components: 1) handle 2) shaft 3) reload. The predicate device has 2 components: 1) handle and shaft 2) reload.
- The subject device requires 5 trigger strokes to complete a firing while the predicate device requires 3 trigger strokes to complete a firing.
- . The compact and long versions of the subject shaft differ in length from the predicate. However, this difference in shaft length does not impact staple formation.
Discussion of Performance Testing Submitted
Evidence of safety and effectiveness of the subject device in support of substantial equivalence was obtained from bench testing, preclinical testing, and biocompatibility testing. No human clinical studies were required to demonstrate the safety and effectiveness of the subject device in support of this premarket notification. A summary of the performance tests used to evaluate the technological and performance characteristics in support of substantial equivalence is presented in Table 5-2. All performance testing acceptance criteria were met.
5
Table 5-1 Bench Tests
| Test | Test Objective |
|---|---|
| Firing Force | To evaluate the input force required to actuate the trigger |
| Leak Test | To evaluate staple line leak pressures |
| Articulation Testing | To evaluate device performance when fully articulated |
| Reinforcement Material | |
| Compatibility | To evaluate device performance with reinforcement material |
| Shelf Life Testing | To evaluate device performance after simulated transit and storage conditions |
| Staple Formation | To evaluate staple formation in media and out of media |
| Formed Staple Height | To measure the formed staple height |
| Radiograph Imaging | To evaluate location and quality of staple formation in media |
| Tissue Compression Evaluation | To evaluate tissue effects associated with application of the device |
| Crossed Staple Line | To evaluate device performance when fired across existing staple line |
Table 5-2 Preclinical Tests
| Test | Test Objective |
|---|---|
| 21-Day Porcine Chronic Survival | |
| Study | To evaluate in vivo device performance including in |
| vivo hemostasis and histopathological evaluations | |
| Acute Porcine In-Vivo Study | To evaluate device performance on high pressure |
| arteries and thin-walled veins |
Biocompatibility Tests
The following biological evaluations were performed in support of substantial equivalence:
- Ethylene Oxide Residual (per ISO 10993-7) ●
- Material Mediated Pyrogenicity (per USP 40-NF 35:) ●
- Cytotoxicity (per ISO 10993-5) ●
- Sensitization (per ISO 10993-10)
- Acute Systemic Toxicity (per ISO 10993-11)
- Intracutaneous Reactivity (per ISO 10993-10)
- Intramuscular Implant Testing (2 week and 13 week, per ISO 10993-6)
A chemical characterization and subsequent toxicological risk assessment (per ISO 10993-18) was performed to evaluate the safety of the implantable staples. Results from the testing were used to assess the following endpoints:
- Reproductive and Developmental Toxicity
6
- Subacute Toxicity .
- Subchronic Toxicity ●
- . Chronic Toxicity
- Genotoxicity
- . Carcinogenicity
Conclusion
Based on the intended use, technological characteristics, and performance testing results, the subject Applied Laparoscopic Linear Cutter is substantially equivalent to the predicate Ethicon Echelon Flex Endopath and does not raise any new issues of safety and efficacy.