(345 days)
The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease.
The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
Disposable Circular Stapler 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 resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm, 28mm, 29mm and 32mm five specifications. The staple is available in 4.5mm and 4.8mm two different heights.
Disposable Endoscopic Linear Cutter Stapler and Unit places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three specifications. Reloads are available in 2.5mm, 4.0mm and 4.8mm four staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.
Disposable Hemorrhoidal Stapler 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 stapler are available in 32mm, 33mm three specifications. The staple size is 3.8mm. It cannot be reloaded.
Disposable Linear Cutter Staplers and Reload places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm five specifications. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 8 times in a single procedure.
The Disposable Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm four specifications for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 8 times in a single procedure.
The provided document is a 510(k) Summary for various disposable staplers and reload devices. It describes non-clinical tests to verify performance but does not include any information about studies involving acceptance criteria related to AI/human reader performance, ground truth establishment by experts, or any MRMC comparative effectiveness studies.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to medical device regulatory submission for staplers, not AI medical devices.
However, I can provide the following based on the Non-Clinical Test Conclusion section:
1. A table of acceptance criteria and the reported device performance
The document mentions several tests and standards the device complies with, which would imply passing these as acceptance criteria. It doesn't provide specific numerical acceptance criteria or performance metrics for each test, but generally states that the device "met all design specifications" and "complies with the following standards".
| Test/Standard | Reported Device Performance (Implied Acceptance) |
|---|---|
| ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process. | Device complies with the standard. |
| ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity. | Device complies with the standard. |
| ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity | Device complies with the standard. |
| USP42-NF37 <85> Bacterial Endotoxins Tests | Device complies with the standard. |
| ASTM F 88/F88M-15 Standard test method for seal strength of flexible barrier materials; | Device complies with the standard. |
| ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration | Device complies with the standard. |
| ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Device complies with the standard. |
| Ex-vivo tissue test (porcine stomach and intestine tissue) - Pressure Rest, Closed Staple Dimension Test, Staple Formation Test, Force Required to Fire Stapler Test. | Test results demonstrated the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. |
| Jugular vein test (porcine model) - Burst pressure, closed staple height and staple formation. | Test results demonstrated the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: The ex-vivo and jugular vein tests were conducted on "porcine stomach and intestine tissue" and a "porcine model," respectively. This indicates animal tissue, not human data. The geographical origin of the tests is within "Beijing Biosis Healing Biological Technology Co., Ltd." in China (derived from company address). The tests are described as non-clinical "conducted to verify," implying prospective testing for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of experts or ground truth establishment for a test set in the context of human interpretation or AI performance studies. The testing is for medical staplers, not an AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of adjudication methods for a test set, as this document refers to physical device testing rather than expert-based assessments of data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document explicitly states: "No clinical study is included in this submission." Furthermore, the device is a surgical stapler, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a surgical stapler, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ex-vivo and jugular vein tests, the "ground truth" would be the direct measurements and observations of the physical performance characteristics (e.g., staple formation, burst pressure, seal strength) as defined by engineering specifications and relevant standards, demonstrated through the "device met all design specifications" claim. This is physical performance testing, not diagnostic accuracy evaluation.
8. The sample size for the training set
Not applicable. The document describes a physical medical device (stapler), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this document does not describe an AI algorithm or a training set.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
May 27, 2021
Beijing Biosis Healing Biological Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K201639
Trade/Device Name: Disposable Circular Stapler, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: June 2, 2020 Received: June 16,2020
Dear Diana Hong:
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/cdrl/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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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.
for Cindy Chowdhury, Ph.D., MBA 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
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Indications for Use
510(k) Number (if known) K210639
Device Name
Disposable Circular Stapler; Disposable Hemorrhoidal Stapler and Reloads; Disposable Linear Cutter Stapler and Reloads; Disposable Endoscopic Linear Cutter Stapler and Reloads
Indications for Use (Describe)
The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, sideto-side anastomoses in both open and laparoscopic surgeries.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoid disease.
The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
| 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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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K201639
-
- Date of Preparation: 05/27/2021
-
- Sponsor Identification
Beijing Biosis Healing Biological Technology Co., Ltd. No.6 Plant West, Valley No.1 Bio-medicine Industry Park, Daxing District, 102600, Beijing, China
Establishment Registration Number: 3016668451
Contact Person: Jiali Zhou Position: RA Tel: +86-10-61252660 Fax: +86-10-61252030 Email: zhoujiali@biosishealing.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
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Identification of Proposed Device 4.
Trade Name:
Disposable Circular Stapler Disposable Hemorrhoidal Stapler Disposable Linear Stapler and Reloads Disposable Linear Cutter Stapler and Reloads Disposable Endoscopic Linear Cutter Stapler and Reloads Common Name: Stapler, Implantable
Regulatory Information Classification Name: Implantable Stapler; Classification: II; Product Code: GDW; Regulation Number: 21CFR 878.4750 Review Panel: General & Plastic Surgery;
Indications for Use:
The Disposable Circular Stapler has application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease.
The Disposable Linear Stapler and Reloads can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
The Disposable Linear Cutter Stapler and Reloads can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
The Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis.
Device Description:
Disposable Circular Stapler 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 resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 25mm, 28mm, 29mm and 32mm five
{5}------------------------------------------------
specifications. The staple is available in 4.5mm and 4.8mm two different heights.
Disposable Endoscopic Linear Cutter Stapler and Unit places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three specifications. Reloads are available in 2.5mm, 4.0mm and 4.8mm four staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 25 times in a single procedure.
Disposable Hemorrhoidal Stapler 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 stapler are available in 32mm, 33mm three specifications. The staple size is 3.8mm. It cannot be reloaded.
Disposable Linear Cutter Staplers and Reload places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm five specifications. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 8 times in a single procedure.
The Disposable Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm four specifications for use in various applications. Two staple sizes (3.5mm and 4.8mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 8 times in a single procedure.
ર . Identification of Predicate Devices
Predicate Device 1 510(k) Number: K103470 Product Name: PANTHER Group of Surgical Staplers
Predicate Device 2 510(k) Number: K142577 Product Name: Panther Endo Linear Cutter Staplers with Single Use Loading Unit
6. 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. The test results demonstrated that the proposed device complies with the following standards:
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-
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk management process.
-
ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity.
- ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and > delayed-type hypersensitivity
- USP42-NF37 <85> Bacterial Endotoxins Tests >
-
ASTM F 88/F88M-15 Standard test method for seal strength of flexible barrier materials;
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ▲ ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Ex-vivo tissue test was conducted on porcine stomach and intestine tissue for both proposed device and predicate device to evaluate the device performance. The test items include Pressure Rest, Closed Staple Dimension Test, Staple Formation Test and Force Required to Fire Stapler Test. Besides tissue test, jugular vein test was conducted on a porcine model to evaluate the device performance in thin tissues. This test was conducted on both proposed device and predicate device for 2.5mm staple height. Burst pressure, closed staple height and staple formation were evaluated in jugular vein test.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device 1 |
|---|---|---|
| K103470 | ||
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Circular Stapler hasapplication throughout the alimentarytract to create end-to-end, end-to-sideand side-to-side anastomoses in bothopen and laparoscopic surgeries | The Panther circular staplers andaccessories have applicationthroughout the alimentary tract tocreate end-to-end, end-to-side andside-to-side anastomoses in bothopen and laparoscopic surgeries |
| Anvil | Anvil | |
| Cartridge | Cartridge | |
| Drivepipe | Drivepipe | |
| Firing Handle | Firing Handle | |
| Main Configuration | Insurance | Insurance |
| Rating Nut | Rating Nut | |
| Staple | Staple | |
| Circular Knife | Circular Knife | |
| Cartridge Cover | Cartridge Cover | |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Circular Knife | Circular Knife |
| Safety Mechanism | Insurance is used for preventing frommis-firing | Insurance is used for preventingfrom mis-firing |
| Specification | 25, 26, 28, 29 and 32mm | 24, 26, 29, 32 and 34mm |
| Staple Height | 4.5 and 4.8mm | 4.5 and 4.8mm |
| Row number of Staple | 2 | 2 |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contactmaterial of stapler | Stainless SteelABSAL6063 | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Item | Proposed Device | Predicate Device 1K103470 |
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Hemorrhoidal Circular Stapler has application throughout the anal canal to perform surgical treatment of hemorrhoid disease | The PANTHER Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical Treatment of hemorrhoidal disease. |
| Main Configuration | AnvilCartridge CoverCartridgeFixed handleFiring HandleRating NutInsuranceStapleCircular Knife | AnvilCartridge CoverCartridgeFixed handleFiring HandleRating NutInsuranceStapleCircular Knife |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Circular Knife | Circular Knife |
| Safety Mechanism | Insurance is used for preventing from mis-firing | Insurance is used for preventing from mis-firing |
| Specification | 32, 33 and 34mm | 31, 32, 33 and 34mm |
| Staple Height | 3.8mm | 3.8mm |
| Row number of Staple | 2 | 2 |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contact material of stapler | Stainless SteelPEABSPC | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
Table 1 Comparison of Disposable Circular Stapler
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| Table 2 Comparison of Disposable Hemorrhoidal Stapler | ||||
|---|---|---|---|---|
| -- | -- | -- | ------------------------------------------------------- | -- |
{9}------------------------------------------------
| Item | Proposed Device | Predicate Device 1K103470 |
|---|---|---|
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Linear Stapler andReloads can be applied inabdominal, thoracic and pediatricsurgical procedures for transectionor resection of tissue. | The PANTHER Linear Staplercan be applied in abdominal,thoracic and pediatric surgicalprocedures for transection orresection of tissue. |
| Main Configuration | AnvilReloading UnitLeft and right sliderRest knobFixed handleFiring handle | AnvilReloading UnitLeft and right sliderRest knobFixed handleFiring handle |
| Operate Principle | Manual | Manual |
| Suture length | 30 mm, 45 mm, 60 mm and 90 mm | 30mm, 45mm, 60mm, 75mm and90mm |
| Staple Height | 3.5mm and 4.8mm | 2.5mm, 3.5mm and 4.8mm |
| Row number ofStaple | Double staggered rows | Double staggered rows |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contactmaterial of stapler | PCStainless SteelPA-757 | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Item | Proposed Device | Predicate Device 1 |
| K103470 | ||
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | The Disposable Linear Cutter Staplerand Reloads can be applied inabdominal, gynecological, pediatricand thoracic surgical proceduresfor resection, transection and creationof anastomosis | The PANTHER Linear CutterStapler can be applied inabdominal, gynecological,pediatric and thoracic surgicalprocedures for resection,transection and creation ofanastomosis. |
| Main Configuration | Push ButtonRotating pinCutting knifeCartridge coverCartridge | Push ButtonRotating pinCutting knifeCartridge coverCartridge |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Linear knife | Linear knife |
| Suture length | 55mm, 60 mm, 75mm, 80 mm and100 mm | 55mm, 60mm, 75mm, 80mm,100mm and 110mm |
| Staple Height | 3.8mm and 4.8mm | 3.8mm and 4.8mm |
| RownumberofStaple | two double staggered mows | two double staggered mows |
| Closed Staple form | B-shape | B-shape |
| Staple material | Titanium | Titanium |
| Patient-contactmaterial of stapler | Stainless SteelPCABSPOMPPA | Unknown |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
| Item | Proposed Device | Predicate Device 2 |
| Product Code | GDW | GDW |
| Regulation No. | 878.4750 | 878.4750 |
| Indication for Use | Disposable Endoscopic Linear Cutter Stapler and Reloads has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis. | PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transaction and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. |
| Main Configuration | Firing rodBarrel shellRotary knobInsurance buttonLeft and right shellCartridge | Firing rodBarrel shellRotary knobInsurance buttonLeft and right shellCartridge |
| Operate Principle | Manual | Manual |
| Cutting Mechanism | Linear Knife | Linear Knife |
| Safety Mechanism | Insurance button for preventing from miss-firing | Insurance button for preventing from miss-firing |
| Suture length | 30mm, 45mm and 60mm | 30mm, 45mm and 60mm |
| Staple Height | 2.5, 3.5, 4.0 and 4.8mm | 2.0, 2.5, 3.5, 4.0 and 4.8mm |
| Row number of Staple | Two, triple-staggered rows | Two, triple-staggered rows |
| Closed Staple form | B-shape | B-shape |
| Staple material | Unalloyed Titanium | Unalloyed Titanium |
| Patient-contact material of stapler | PPAStainless Steel | Stainless steelPolymeric materialsAdhesiveslubricants |
| Sterilization | Ethylene Oxide | Ethylene Oxide |
| Endotoxin Limit | 20EU | 20EU |
| Labeling | Conforms with 21 CFR 801 | Conforms with 21 CFR 801 |
Table 3 Comparison of Disposable Linear Stapler and Reloads
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Table 4 Comparison of Disposable Linear Cutter Stapler and Reloads
{11}------------------------------------------------
{12}------------------------------------------------
-
- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion
§ 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.