(76 days)
Not Found
No
The device description and intended use focus on mechanical stapling and cutting actions, with no mention of AI, ML, or image processing.
Yes
The device is described as a surgical stapler used for creating anastomoses, resecting tissue, and treating hemorrhoids and rectal prolapse, which are all therapeutic interventions.
No
Explanation: The device description and intended use clearly state that the Chex Family of Staplers are used for surgical procedures like resection, transaction, and creation of anastomoses, which are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or detect a disease or condition.
No
The device description clearly details physical, mechanical surgical staplers with handles, staples, and cutting blades, indicating a hardware-based medical device. There is no mention of software as the primary or sole component.
Based on the provided text, the Chex Family of Staplers are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The descriptions of the Chex Staplers clearly state their intended use is for surgical procedures involving the mechanical joining or cutting of tissue within the body.
- The device descriptions focus on the mechanical function of stapling and cutting tissue. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- The performance studies described evaluate the physical and performance characteristics of the staplers in a surgical context, such as strength, closure performance, and clinical outcomes like healing and pain management. These are not typical performance metrics for IVD devices.
Therefore, the Chex Family of Staplers are surgical devices, not IVD devices.
N/A
Intended Use / Indications for Use
The Chex Family of Staplers and there intended uses are as follows:
-
Single Use Curved Intraluminal Circular Stapler
The CHEX™ Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques. -
Circular Stapler for Rectal Prolapse and Hemorrhoid
The CHEX™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position. -
Single Use Reloadable Linear Stapler
The CHEX™ Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures. -
Single Use Reloadable Linear Cutter Stapler
The CHEX™ Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
Product codes
GDW
Device Description
The Chex™ Staplers were 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:
The Chex™ Single Use Curved Intraluminal Circular Stapler places a circular, double staqqered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 25mm, 28mm, or 32mm stapler.
The Chex™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal mucosa above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal mucosa. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.
The Chex™ Disposable Reloadable Linear Stapler places a double staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. The Linear Stapler is available in 30mm, 45mm, 60mm, and 90mm 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.
The Chex™ Linear Cutter Disposable Reloadable Stapler delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 100mm). 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. The use of the instrument with stable buttressing materials, or across a previous staple line, may reduce the number of firings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, rectal mucosa, anorectal wall, abdominal, gynecological, thoracic, pediatric
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)
Each of the four Chex™ Staplers were tested and passed all required biocompatibility testing. Specifically, cytotoxcity, skin irritation, and delayed contact sensitization were conducted in accordance with ISO 10993. Secondly, Frankenman tested each stapler to validate both physical (i.e., appearance, dimensions, stapler compatibility with cartridge, sterility per ISO 11737 and EN 552) and performance characteristics (strength, closure performance). Thirdly, a performance test was conducted comparing the Chex™ Sinqle Use Curved Intraluminal Circular Stapler and the Chex™ Disposable Reloadable Linear Stapler to analogous Ethicon staplers. Based on this test, the design and construction of the Frankenman and Ethicon staplers were determined to be substantially equivalent. Finally, clinical testing of each stapler line produced superior results (in terms of post-operative healing, pain management, anastomotic leakage, and bleeding) as compared to manual suturing and competitors' devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K920752, K062850, K024275, K020804, K001895, K051301, K991030, K030925, K822345, K905106, K801590, K951546
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.
0
K09 0821
Page 1 of 3
510(k) Summary (per 21 CFR 807.92(c))
1. Applicant
JUN 1 0 2009
Frankenman International Limited Suite B, 13/F Wing Tat Commercial Building 121 - 125 Winq Lok Street Sheung Wan, Hong Kong China
Contact Person: Lee Edwards, President-International Business Tel: 852 3106 3035 Fax: 852 3585 0519 E-mail: lee.edwards@frankenman.hk
Date Prepared: March 1, 2009
2. Device Name
Trade Name: Chex™ Family of Surgical Staplers Common/ Usual Name: Staple, Implantable Classification Name: Implantable Staple Regulation Number: 878.4750 Product Code: GDW Classification: II Panel: General & Plastic Surgery
3. Predicate Devices
The Chex™ Family of Surgical Staplers, which include:
- Single Use Curved Intraluminal Circular Stapler, .
- . Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids,
- Single Use Reloadable Linear Stapler and Reloads, and .
- Single Use Reloadable Linear Cutter Stapler and Reloads ♥ are substantially equivalent to:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Name | Company | 510(k) Number | |
| Chex™ Single Use | |||
| Curved Intraluminal | |||
| Circular Stapler | Endopath ILS Endoscopic | ||
| Circular Stapler | Ethicon | K920752 | |
| Chex™ Single Use | |||
| Curved Intraluminal | |||
| Circular Stapler | Autosuture™ Circular EEA | ||
| Surgical Staplers | United States | ||
| Surgical Corp. | |||
| (USSC) | K062850 | ||
| Autosuture™ Premium Plus | |||
| CEEA Disposable Staplers | K024275 | ||
| Autosuture™ Premium Plus | |||
| CEEA Disposable Staplers | K020804 | ||
| K001895 | |||
| Chex™ Single Use | |||
| Circular Stapler for | |||
| Rectal Prolapse and | |||
| Hemorrhoids | Proximate PPH Hemorrhoidal | ||
| Circular Stapler and | Ethicon Endo- | ||
| Surgery, Inc. | K051301 |
Accessories
1
| Subject Device | Predicate Device | | 510(k)
Number |
|--------------------------------------------------------------|--------------------------------------------------------|--------------------------------|------------------|
| | Name | Company | |
| | Hemorrhoidal Circular Stapler
and Accessories | | K991030 |
| | Hemorrhoidal Circular Stapler
and Accessories | | K030925 |
| Chex™ Single Use
Reloadable Linear
Stapler and Reloads | Disposable Linear Stapler
(LSF) | Ethicon | K822345 |
| | Auto Suture™ TA premium™ | USSC | K905106 |
| Chex™ Linear
Cutter Disposable
Reloadable Stapler | Auto Suture™ Disposable
GIA™ Surgical Stapler | USSC | K801590 |
| | Proximate Linear Cutters and
Stapler (not Endopath) | Ethicon Endo-
Surgery, Inc. | K951546 |
4. Intended Use
The Chex Family of Staplers and there intended uses are as follows:
Single Use Curved Intraluminal Circular Stapler .
The CHEX™ Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques.
Circular Stapler for Rectal Prolapse and Hemorrhoid
The CHEX™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surqical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.
Single Use Reloadable Linear Stapler
The CHEX™ Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Single Use Reloadable Linear Cutter Stapler
The CHEX™ Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
5. Description of the Devices
The Chex™ Staplers were 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:
2
K0'90821
Page 3 of 3
The Chex™ Single Use Curved Intraluminal Circular Stapler places a circular, double staqqered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 25mm, 28mm, or 32mm stapler.
The Chex™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal mucosa above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal mucosa. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.
The Chex™ Disposable Reloadable Linear Stapler places a double staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. The Linear Stapler is available in 30mm, 45mm, 60mm, and 90mm 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.
The Chex™ Linear Cutter Disposable Reloadable Stapler delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 100mm). 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. The use of the instrument with stable buttressing materials, or across a previous staple line, may reduce the number of firings.
6. Summary of Performance Data
Each of the four Chex™ Staplers were tested and passed all required biocompatibility testing. Specifically, cytotoxcity, skin irritation, and delayed contact sensitization were conducted in accordance with ISO 10993. Secondly, Frankenman tested each stapler to validate both physical (i.e., appearance, dimensions, stapler compatibility with cartridge, sterility per ISO 11737 and EN 552) and performance characteristics (strength, closure performance). Thirdly, a performance test was conducted comparing the Chex™ Sinqle Use Curved Intraluminal Circular Stapler and the Chex™ Disposable Reloadable Linear Stapler to analogous Ethicon staplers. Based on this test, the design and construction of the Frankenman and Ethicon staplers were determined to be substantially equivalent. Finally, clinical testing of each stapler line produced superior results (in terms of post-operative healing, pain management, anastomotic leakage, and bleeding) as compared to manual suturing and competitors' devices.
7. Safety & Effectiveness
There are no substantial differences between the Chex™ Family of Staplers defined in this 510(k) submission and the predicate devices. They have the same or similar Indications for Use. In addition, the minor differences in technological characteristics do not raise issues of safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2009
Frankenman International Limited % Emergo Group. Incorporated Ms. Jean Asquith Senior Consultant, Regulatory Affairs 1705 South Capitol of Texas Highway, Suite 500 Austin, Texas 78746
Re: K090821
Trade/Device Name: CHEX™ Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: II Product Code: GDW Dated: March 6, 2009 Received: March 30, 2009
Dear Ms. Asquith:
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.
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
4
Page 2-Ms. Jean Asquith
(reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K090821
Device Name: CHEX™ Surgical Staplers
Indications for Use:
The Chex Family of Staplers and there intended uses are as follows:
1. Single Use Curved Intraluminal Circular Stapler
The CHEX™ Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques.
2. Circular Stapler for Rectal Prolapse and Hemorrhoid
The CHEX™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.
3. Single Use Reloadable Linear Stapler
The CHEX™ Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
4. Single Use Reloadable Linear Cutter Stapler
The CHEX™ Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krone for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K990821