(59 days)
Not Found
No
The description focuses on mechanical function (stapling, cutting) and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is a surgical stapler used for cutting and creating anastomoses, which are procedural actions rather than therapeutic interventions aimed at curing or treating a disease.
No
The device is a surgical instrument used for transection, resection, and/or creation of anastomoses, which are therapeutic actions, not diagnostic ones. It performs mechanical actions like stapling and cutting tissue.
No
The device description explicitly states it is a "sterilized and disposable surgical instrument" that "delivers four staggered rows of titanium staples with a knife," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The PANTHER Cutter Stapler is a surgical instrument used directly on tissue within the body during surgical procedures (transection, anastomosis, resection). It physically cuts and staples tissue.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the body. Its function is entirely focused on manipulating tissue in situ.
The description clearly indicates it's a surgical tool used during procedures, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
Product codes
GDW, GAG
Device Description
The proposed device, PANTHER Cutter Stapler, is sterilized and disposable surgical instruments, which is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedure.
It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal and skeletal muscle, gynecologic, urologic, and thoracic
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
Pre-Clinical: No study is included in this submission.
Bench: Bench tests including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance, Maximum Tensile Strength and Force Required to Fire Stapler were conducted to confirm that the proposed devices perform as intended and are substantially equivalent to the predicate devices.
Animal: No animal study is included in this submission.
Clinical: No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three human profiles facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2015
B. J. Zh. F. Panther Medical Equipment Company, Ltd % Ms. Diana Hong Mid-link Consulting Company, Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K152618
Trade/Device Name: PANTHER Cutter Stapler Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: September 1, 2015 Received: September 14, 2015
Dear Ms. 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. 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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name PANTHER Cutter Stapler
Indications for Use (Describe)
The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedures.
☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120
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510(k) Summary
510(k) Submitter
B. J. ZH. F. Panther Medical Equipment Co., Ltd Room 3305A, Floor 3, Building 3, No.208 Block 2 Liza Park, Wangjing Industrial District, Chaoyang District, 100102 Beijing, China Tel: +86-010-80789058 Fax: +86-510-80789028 Email: lina.yun@pantherhealthcare.com
Date Prepared: 10/08/2015
Device Names/Classification
Trade Name: PANTHER Cutter Stapler Common Name: Cutter stapler and reloads
Classification Name: Staple, Implantable; Classification: II; Product Code: GDW; Regulation Number: 21CFR 878.4750 Review Panel: General & Plastic Surgery;
Classification Name: Stapler, Surgical; Classification: II; Subsequent Product Code: GAG; Regulation Number: 21CFR 878.4880 Review Panel: General & Plastic Surgery
Predicate Devices
510(k) Number: K091322 Product Name: CONTOUR™ Curved Cutter Stapler and Reloads
Device Description
The proposed device, PANTHER Cutter Stapler, is sterilized and disposable surgical instruments, which is intended for transection, resection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, and thoracic surgical procedure.
It delivers four staggered rows of titanium staples with a knife that divides the tissue simultaneously
4
between the second and third row of staples. The PANTHER Cutter Stapler may be reloaded and fire no more than 6 times in a single procedure.
Indications for Use
The PANTHER Cutter Stapler is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or general (gastrointestinal and skeletal muscle), gynecologic, urologic, and thoracic surgical procedures.
Differences in Technological Characteristic
The PANTHER Cutter Stapler is identical to the CONTOUR™ Curved Cutter Stapler and Reloads marketed device with respect to technological characteristics. The PANTHER Cutter Stapler has the same intended use, configuration, operation principle, staple height, patient-contact material, sterilization as the predicate device.
Summary of Performance Testing
Pre-Clinical No study is included in this submission. Bench Bench tests including Physical Specification, Closed Staple Height Dimensions, Pressure Resistance, Maximum Tensile Strength and Force Required to Fire Stapler were conducted to confirm that the proposed devices perform as intended and are substantially equivalent to the predicate devices. Animal No animal study is included in this submission. Clinical No clinical study is included in this submission.
Conclusion
Based on performance data, the proposed devices is substantially equivalent to the predicate devices CONTOUR™ Curved Cutter Stapler and Reloads cleared in K091322.