(46 days)
Not Found
No
The device description and performance studies focus on mechanical function and equivalence to predicate devices, with no mention of AI/ML technologies or data-driven performance metrics.
Yes
The device, a surgical stapler, is used to facilitate surgical procedures (e.g., creating anastomoses, transecting/resecting tissue, treating hemorrhoidal disease), which are therapeutic interventions.
No
Explanation: The device description states that the PANTHER Staplers are used for surgical procedures to place staples, resect tissue, and create anastomoses. There is no indication that these devices are used to diagnose medical conditions; their function is therapeutic (surgical).
No
The device description clearly outlines physical, sterile, single-patient-use instruments (staplers and accessories) made of titanium, activated by squeezing a handle, and used for surgical procedures involving tissue manipulation and stapling. 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:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the PANTHER Staplers are surgical instruments used to create anastomoses (connections between tissues) and resect or transect tissue during surgical procedures. They are used directly on the patient's body, not on specimens taken from the body.
The device's function is mechanical and surgical, not diagnostic based on analyzing biological samples.
N/A
Intended Use / Indications for Use
The Panther Circular staplers and accessories have 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 PANTHER Hemorrhoidal Circular Stapler and accessories have application throughout the anal to perform surgical treatment of hemorrhoidal disease.
The PANTHER Linear Stapler can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
The PANTHER Linear Cutter Stapler can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
Device Description
The PANTHER Staplers were sterile(ETO), single-patient-use instruments which designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go. Specifics for each stapler include:
PANTHER Circular Stapler: The PANTHER Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. PANTHER Circular Stapler includes 4 series: FCSM, FCSME, FCSMF, and FCSLWBE.
PANTHER Hemorrhoidal Circular Stapler: The PANTHER Hemorrhoidal Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. The Hemorrhoidal Circular Stapler set includes a Hemorrhoidal Circular Stapler, Suture Threader, Circular Anal Dilator and Purse-string Suture Anoscope. PANTHER Hemorrhoidal Circular Stapler includes 4 series: FCSS, FCSSME, FCSSWAE and FCSSWBE.
PANTHER Linear Stapler: The PANTHER Linear Stapler places a double or triple staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. and is available in 30 mm, 45 mm, 60 mm, 75 mm and 90 mm staple line lengths for use in various applications. The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Stapler includes 2 series: FLSL, FLSLE
PANTHER Linear Cutter Stapler: The PANTHER Linear Cutter Staplers place two double staggered rows of titanium staples in organs and tissues to anastomose the internal tissues and simultaneously cut and divide between the two rows during surgical procedures. The PANTHER Linear Cutter Staplers is available in six staple line lengths (55, 60, 75, 80, 100 or110mm). The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Cutter Stapler includes 2 series: SSAA, SSAB.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Alimentary tract, anal canal, abdominal, thoracic, pediatric, gynecological
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)
Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the PANTHER Stapler is substantially equivalent to the predicate devices.
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.
K062850, K030411, K905106, K801590
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
K103470
page 1/3
510(k) Summary (per 2.1 CFR 807.92.(c))
JAN 1 1 2011
1. Applicant
B.J.ZH.F. Panther Medical Equipment Co. Ltd · Room 806, Peking Times Square B, No.103 Huizhongli, Chaoyang District, Beijing, 100101; China
Date Prepared: 11/22/2010
2. Device Name
Trade Name: PANTHER Group of Surgical Staplers Common/Usual Name: Stapler, Implantable Classification Name: Implantable Staple Regulation Number: 878.4750 Product Code: GDW Classification: II Panel: General & Plastic Surgery
3. Predicate Device
The PANTHER Group of Surgical Staplers includes:
- PANTHER Circular stapler *
- PANTHER Hemorrhoidal Circular Stapler .
- PANTHER Linear Stapler .
- PANTHER Linear Cutter Stapler .
are substantially equivalent to:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Name | Company | 510(k) | |
| Number | |||
| PANTHER | |||
| Circular stapler | AutosutureTM EEATM surgical | ||
| Stapler | United States | ||
| Surgical Corp. | |||
| (USSC) | K062850 | ||
| PANTHER | |||
| Hemorrhoidal | |||
| Circular Stapler | PROXIMATE PPH Hemorrhoidal | ||
| Circular Stapler and Accessories | Ethicon | ||
| Endo-Surgery, Inc | K030411 | ||
| PANTHER | |||
| Linear Stapler | AUTO SUTURE(R) TA | ||
| PREMIUM(TM) UROLOGY | |||
| STAPLER | United States | ||
| Surgical Corp. | |||
| (USSC) | K905106 | ||
| PANTHER | |||
| Linear Cutter | |||
| Stapler | AUTO SUTURE DISPOSABLE | ||
| GIA SURG. STAPLER | United States | ||
| Surgical Corp. | |||
| (USSC) | K801590 |
1
Page
2/3
4. Intended Use
The PANTHER Surgical Staplers and there intended uses are as follows:
PANTHER Circular Stapler .
The Panther Circular staplers and accessories have application throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
PANTHER Hemorrhoidal Circular Stapler .
The PANTHER Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
PANTHER Linear Stapler
The PANTHER Linear Stapler can be applied in abdominal, thoracic and pediatric surgical procedures for transection or resection of tissue.
PANTHER Linear Cutter Stapler .
The PANTHER Linear Cutter Stapler can be applied in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
5. Description of the Devices
The PANTHER Staplers were sterile(ETO), single-patient-use instruments which designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go. Specifics for each stapler include:
PANTHER Circular Stapler
The PANTHER Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. PANTHER Circular Stapler includes 4 series: FCSM, FCSME, FCSMF, and FCSLWBE.
PANTHER Hemorrhoidal Circular Stapler
The PANTHER Hemorrhoidal Circular Stapler places a circular, double staggered row of titanium staples in the tissue and resects the excess tissue, thus creating a circular anastomosis. The Hemorrhoidal Circular Stapler set includes a Hemorrhoidal Circular Stapler, Suture Threader, Circular Anal Dilator and Purse-string Suture Anoscope. PANTHER Hemorrhoidal Circular Stapler includes 4 series: FCSS, FCSSME, FCSSWAE and FCSSWBE.
PANTHER Linear Stapler .
The PANTHER Linear Stapler places a double or triple staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. and is available in 30 mm, 45 mm, 60 mm, 75 mm and 90 mm staple line lengths for use in various applications. The instrument may be reloaded during a single procedure but
2
Page 3/3
cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Stapler includes 2 series: FLSL, FLSLE
PANTHER Linear Cutter Stapler .
The PANTHER Linear Cutter Staplers place two double staggered rows of titanium staples in organs and tissues to anastomose the internal tissues and simultaneously cut and divide between the two rows during surgical procedures. The PANTHER Linear Cutter Staplers is available in six staple line lengths (55, 60, 75, 80, 100 or110mm). The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. PANTHER Linear Cutter Stapler includes 2 series: SSAA, SSAB.
6. Summary of Performance Data
Bench testing was performed to verify the PANTHER Stapler's performance to internal specifications. In addition, bench testing was also performed to demonstrate that the PANTHER Stapler is substantially equivalent to the predicate devices.
7. Safety & Effectiveness
There are no substantial differences between the PANTHER Group of Surgical Stablers 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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in black lines. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
B.J.ZH.F. Panther Medical Equipment Co., LTD % Chu Xiaoan Room 1606 Building 1, Jianxiang Yu, No. 209 Bei Si Huan Beijing, China 100083
JAN 1 1 2011
Re: K103470
Trade/Device Name: PANTHER Group of Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW, GAG Dated: November 15, 2010 Received: November 26, 2010
Dear 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
4
Page 2 - Chu Xiaoan
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
A. B. 21
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
JAN 1 1 2011
510(k) Number (if known):
Device Name: PANTHER Group of Surgical Staplers
Indications For Use
510(k) Number (if known):
PANTHER Circular The Panther Circular staplers and accessories have application Stapler throughout the alimentary tract to create end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
PANTHER The PANTHER Hemorrhoidal Circular Stapler and accessories Hemorrhoidal have application throughout the anal to perform surgical Circular Stapler treatment of hemorrhoidal disease.
PANTHER Linear The PANTHER Linear Stapler can be applied in abdominal, Stapler thoracic and pediatric surgical procedures for transection or resection of tissue.
PANTHER Linear The PANTHER Linear Cutter Stapler can be applied in abdominal, Cutter Stapler gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. Prescription Use
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF N.
Nail Kure Bu Mkay
Concurrence of CDRH, Offeg as Ask SPACE
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K103470