(272 days)
PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The proposed device. PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (SULU) is sterile (ETO), single-patient-use surgical instruments, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two triple-staggered rows. The Endo Linear Cutter Stapler will accommodate any of the reloading unit with staple cartridge lengths of 30mm, 45mm, and 60mm and come in long or compact shaft lengths, and they may be reloaded and fired up to 25 times in a single procedure. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm SULU.
The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.
The provided document is a 510(k) summary for a medical device called "PANTHER Endo Linear Cutter Staplers with Single Use Loading Units." This document's purpose is to demonstrate substantial equivalence to a predicate device, not to present a study proving a device meets specific acceptance criteria for performance as would typically be seen in the context of an AI/ML medical device.
Therefore, the information requested in the prompt, such as acceptance criteria tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document. This document focuses on non-clinical tests to establish substantial equivalence of a physical medical device.
Here's an explanation of what is present and why the requested information isn't:
- Acceptance Criteria and Reported Performance: The document doesn't outline specific, quantifiable acceptance criteria for a "performance study" in the way one might expect for diagnostic accuracy or algorithmic performance. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." It then lists the types of non-clinical tests: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing. The success of these tests implies meeting design specifications for mechanical and material integrity rather than meeting a clinical performance metric.
- Sample Size and Data Provenance for Test Set: Not applicable. The "tests" mentioned are non-clinical, likely involving a number of units of the device for physical, sterility, and integrity evaluations, not patient data.
- Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth for non-clinical physical tests typically involves validated reference standards or established laboratory methods, not expert consensus on clinical data.
- Adjudication Method: Not applicable for non-clinical testing.
- MRMC Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance, which is not relevant to a physical stapler device.
- Standalone Performance: Not applicable. This refers to the performance of an algorithm without human intervention, which is not relevant to a physical stapler device.
- Type of Ground Truth Used: For the non-clinical tests, the ground truth would be based on established engineering and materials science standards, chemical analysis (for endotoxin), and physical integrity assessments, not clinical pathology or outcomes data.
- Sample Size for Training Set: Not applicable. This device is a physical stapler, not an AI/ML algorithm that requires a training set.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of available information related to "testing" as presented:
- Device Tested: PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
- Purpose of Testing: To verify the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device (Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units).
- Types of Non-Clinical Tests Conducted:
- Physical Performance Testing
- Endotoxin Testing
- Package Integrity Testing
- Shelf Life Testing
- Biocompatibility (Cytotoxicity, Irritation, Sensitization) - Compliance with ISO 10993-5 and ISO 10993-10
- Conclusion: The tests led to the conclusion that the device is Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness.
This document describes the regulatory pathway for a surgical stapler, which primarily involves demonstrating equivalence to a previously approved device through non-clinical performance and a comparison of design and materials. It does not contain the kind of detailed clinical study performance data or AI/ML specific criteria requested.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2015
B.j.z.h.f. Panther Medical Equipment Co. Ltd. % Chu Xiaoan Room 1606 Bldg. 1 Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District Beijing, CN 102200
Re: K142577
Trade/Device Name: Panther Endo Linear Cutter Staplers With Single Use Loading Units Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW Dated: September 12, 2014 Received: September 12, 2014
Dear Mr. Chu Xiaoan,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K142577
Device Name
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units
Indications for Use (Describe)
PANTHER Endo Linear Cutter Stapler with Single Use Loading Units has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary (per 2.1 CFR 807.92)
1. Applicant
| B.J.ZH.F. Panther Medical Equipment Co. Ltd. | ||
|---|---|---|
| ROM 805, Ruichuang Mansion, NO.9 Wangjing East, | ||
| Beijing, 102200, China | ||
| Ms. Liu Yu | ||
| 8610-6970402-8039 | ||
| 9/9/2014 | ||
2. Device Name
Trade or Proprietary Name: PANTHER Endo Linear Cutter Stapler with Single Use Loading Units
Common/Usual Name: Surgical Stapler with Implantable Staple Classification Name: Implantable Staple Regulation Number: 878.4750 Product Code: GDW Classification: II Panel: General & Plastic Surgery
3. Predicate Device
3.1 Device
Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units with Staple Line Reinforcement (K 080898)
3.2 Manufacture
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien)
4. Intended Use
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.
5. Description of the Devices
The proposed device. PANTHER Endo Linear Cutter Staplers with Single Use Loading Units (SULU) is sterile (ETO), single-patient-use surgical instruments, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two triple-staggered rows. The Endo Linear Cutter Stapler will accommodate any of the reloading unit with staple cartridge lengths of 30mm, 45mm,
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and 60mm and come in long or compact shaft lengths, and they may be reloaded and fired up to 25 times in a single procedure. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 3.5 mm, 4.0 mm or 4.8mm SULU.
The SULU has two configurations: (1) Straight SULU and (2) Articulating SULU, each of them has various specifications.
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. These tests include: Physical Performance Testing, Endotoxin Testing, Package Integrity Testing, and Shelf Life Testing.
7. Substantially Equivalent (SE) Conclusion
The following table compares the proposed-device to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.
| Features & Description | Subject Device | Predicate Device |
|---|---|---|
| Product Code | GDW | Same |
| Regulation Number: | 878.4750 | Same |
| Class | II | Same |
| Intend for use | PANTHER Endo Linear Cutter Staplerwith Single Use Loading Units (SULU)has applications in abdominal,gynecologic, pediatric and thoracicsurgery for resection, transaction andcreation of anastomosis. They may beused for transection and resection of liversubstance, hepatic vasculature and biliarystructures. | Same |
| Cutting Mechanism | Linear Knife | Same |
| Operation Principle | Manual | Same |
| Safety Mechanism | Green button for preventing frommiss-firing. | Same |
| Staple shape | B-Shaped | Same |
| Closed staple height(mm) | 0.75,1.0, 1.5, 2.0 | Same |
| material | StapleISO 5832-2: Implants for surgery -Metallic materials - Part 2: Unalloyedtitanium | Same |
.Table 1 Product Comparison Table
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| Kinife | Stainless steel | Same |
|---|---|---|
| Stapler | Polymeric materials,surgical grade stainless steels,adhesives, and lubricants | Very Similarly |
| Sterilization | EtO sterilized , SAL: 10-6 | Same |
| Packaging | PET shrink plastic tray and Tyvek®.dialyzed paper | Same |
| Shelf life | 36 months | Same |
| Biocompatibility | Cytotoxicity Compliance with ISO 10993-5 | Same |
| Irritation Compliance with ISO 10993-10 | Same | |
| Sensitization Compliance with ISO10993-10 | Same |
Although there is a little different from the Predicate Device, the staple line reinforcement material (the synthetic absorbable film) on the ENDO GIA TM UNIVERSAL Single Use Loading Units (SULUs), but there are no substantial differences between the PANTHER Endo Linear Cutter Stapler with Single Use Loading Units (SULU) and the predicate devices. They have the same or similar indications for use. In addition, the minor differences in the technological characteristics do not raise issues of safety and effectiveness.
8. Conclusion
The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units, is determined to be Substantially Equivalent (SE) to the predicate device. Autosuture ™ ENDO GIA™ Staplers with ENDO GIA ™ Single Use Loading Units with Staple Line Reinforcement (K 080898), in respect of safety and effectiveness.
§ 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.