(43 days)
Not Found
No
The device description and performance studies focus on mechanical function and physical characteristics, with no mention of AI or ML.
Yes
Surgical staplers are therapeutic devices as they are used to resect tissue, create anastomoses, and restore normal physiological position, directly treating or managing a condition or injury.
No
Explanation: The device description and intended use clearly state that these are surgical staplers used for cutting, resecting, and anastomosing tissue. They are instruments used during surgical procedures, not for diagnosing conditions.
No
The device description clearly details physical, mechanical staplers with handles, blades, and titanium staples, indicating a hardware-based medical device. There is no mention of software as the primary or sole component.
Based on the provided information, these Frankenman 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Frankenman Staplers clearly indicates they are surgical instruments used on the human body for procedures like creating anastomoses, resecting tissue, and treating hemorrhoids. They are used during surgery, not for testing samples outside the body.
The intended use, device description, and performance studies all point to these being surgical staplers used for mechanical suturing and tissue manipulation during surgical procedures.
N/A
Intended Use / Indications for Use
The indications for use for the Frankenman Family of Staplers include:
Disposable Alimentary Canal Stapler
The Frankenman Disposable Alimentary Canal 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.
Single Use Circular Stapler for Rectal Prolapse and Hemonrhoid
The Frankenman 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.
Disposable Reloadable Linear Stapler and Reloads
The Frankenman Disposable Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Disposable Reloadable Linear Cutter Stapler and Reloads
The Frankenman Disposable Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The Frankenman 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 Frankenman Disposable Alimentary Canal Stapler places a circular, double staggered 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, 28mm, or 32mm stapler.
- The Frankenman 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 Frankenman Disposable Reloadable Linear Stapler places a double(or triple in the case of the LS30-W) 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 Frankenman Disposable Reloadable Linear Cutter 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 101mm). 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 staple 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, anorectal, abdominal, gynecological, thoracic
Indicated Patient Age Range
pediatric
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)
physical (i.e., appearance, dimensions, stapler compatibility with cartridge, sterility per ISO 11737 and EN 552) and performance characteristics (strength, closure performance). In addition, a performance test was conducted comparing the Frankenman Disposable Alimentary Canal Stapler and the Frankenman 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-opera:ive 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): 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.
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
510(k) Summary
(per 21 CFR 807.92(c))
1. Applicant
JUN 2 9 2010
Suzhou Frankenman Medical Equipment Co., Ltd. 88 Jinfeng Road High-new District Suzhou 215011 · · · China
Contact Person: Zhou Tiejun, Office Manager. Tel: 86 512 6878 6125 Fax: 86 512 6808 0025 E-mail: manager@frankenman.com
Date Prepared: April 12, 2010
-
- Device Name
| Trade Name: | Frankenman 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 Frankenman Su: gical Staplers which include:
- Disposable Alimentary Canal Staplers; .
- . Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids;
- . Disposable Reloadable Linear Stapler and Reloads; and
- Disposable Reloadable Linear Cutter Stapler and Reloads; .
are substantially equivalent to the devices listed in Table 1. In fact, the Frankenman Staplers are identical to the Chex Staplers with the exception of the manufacturer and product names as listed on the labeling.
1
510(k) Summary
(per 21 CFR 807.92(c))
1. Applicant
Suzhou Frankenman Medical Equipment Co., Ltd. 88 Jinfeng Road High-new District Suzhou 215011 China
Contact Person: Zhou Tiejun, Office Manager Tel: 86 512 6878 6125 Fax: 86 512 6808 0025 E-mail: manager@frankenman.com
Date Prepared: April 12, 2010
2. Device Name
| Trade Name: | Frankenman 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 Frankenman Surgical Staplers which include:
- Disposable Alimentary Canal Staplers; .
- Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids; .
- Disposable Reloadable Linear Stapler and Reloads; and .
- Disposable Reloadable Linear Cutter Stapler and Reloads; .
are substantially equivalent to the devices listed in Table 1. In fact, the Frankenman Staplers are identical to the Chex Staplers with the exception of the manufacturer and product names as listed on the labeling.
2
| Predicate Device | |||
|---|---|---|---|
| Subject Device | Name | Company | 510(k) Number |
| Disposable Alimentary | |||
| Canal Staplers | Chex™ Single Use Curved | ||
| Intraluminal Circular Stapler | Frankenman™ | ||
| International Limited | K090821 | ||
| Disposable Alimentary | |||
| Canal Staplers | Endopath ILS Endoscopic | ||
| Circular Stapler | Ethicon | K920752 | |
| Single Use Circular | |||
| Stapler for Rectal | |||
| Prolapse and | |||
| Hemorrhoids | Chex™ Single Use Circular | ||
| Stapler for Rectal Prolapse and | |||
| Hemorrhoids | Frankenman™ | ||
| International Limited | K090821 | ||
| Disposable Reloadable | |||
| Linear Stapler and | |||
| Reloads | Chex™ Single Use Reloadable | ||
| Linear Stapler and Reloads | Frankenman™ | ||
| International Limited | K090821 | ||
| Disposable Linear Stapler (LSF) | Ethicon | K822345 | |
| Disposable Reloadable | |||
| Linear Cutter Stapler | |||
| and Reloads | Chex™ Linear Cutter Disposable | ||
| Reloadable Stapler | Frankenman™ | ||
| International Limited | K090821 |
4. Indications for Use
The indications for use for the Frankenman Family of Staplers include:
Disposable Alimentary Canal Stapler �
The Frankenman Disposable Alimentary Canal 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.
. Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid
The Frankenman 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.
. Disposable Reloadable Linear Stapler and Reloads
The Frankenman Disposable Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Disposable Reloadable Linear Cutter Stapler and Reloads .
The Frankenman Disposable Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
3
| Predicate Device | |||
|---|---|---|---|
| Subject Device | Name | Company | 510(k) Number |
| Disposable Alimentary | |||
| Canal Staplers | Chex™ Single Use Curved | ||
| Intraluminal Circular Stapler | Frankenman™ | ||
| International Limited | K090821 | ||
| Endopath ILS Endoscopic | |||
| Circular Stapler | Ethicon | K920752 | |
| Single Use Circular | |||
| Stapler for Rectal | |||
| Prolapse and | |||
| Hemorrhoids | Chex™ Single Use Circular | ||
| Stapler for Rectal Prolapse and | |||
| Hemorrhoids | Frankenman™ | ||
| International Limited | K090821 | ||
| Disposable Reloadable | |||
| Linear Stapler and | |||
| Reloads | Chex™ Single Use Reloadable | ||
| Linear Stapler and Reloads | Frankenman™ | ||
| International Limited | K090821 | ||
| Disposable Linear Stapler (LSF) | Ethicon | K822345 | |
| Disposable Reloadable | |||
| Linear Cutter Stapler | |||
| and Reloads | Chex™ Linear Cutter Disposable | ||
| Reloadable Stapler | Frankenman™ | ||
| International Limited | K090821 |
4. Indications for Use
The indications for use for the Frankenman Family of Staplers include:
Disposable Alimentary Canal Stapler .
The Frankenman Disposable Alimentary Canal 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.
. Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid
The Frankenman 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.
Disposable Reloadable Linear Stapler and Reloads .
The Frankenman Disposable Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Disposable Reloadable Linear Cutter Stapler and Reloads .
The Frankenman Disposable Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
4
Description of the Devices 5.
The Frankenman 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 Frankenman Disposable Alimentary Canal Stapler places a circular, double staggered . 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, 28mm, or 32mm stapler.
- . The Frankenman 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 Frankenman Disposable Reloadable Linear Stapler places a double(or triple in the . case of the LS30-W) 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 Frankenman Disposable Reloadable Linear Cutter 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 101mm). 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 staple buttressing materials, or across a previous staple line, may reduce the number of firings.
6. Summary of Performance Data
Suzhou 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). In addition, a performance test was conducted comparing the Frankenman Disposable Alimentary Canal Stapler and the Frankenman 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 Frankenman 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.
Page 5-3
5
Description of the Devices 5.
The Frankenman 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 Frankenman Disposable Alimentary Canal Stapler places a circular, double staggered 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, 28mm, or 32mm stapler.
- The Frankenman 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 Frankenman Disposable Reloadable Linear Stapler places a double(or triple in the . case of the LS30-W) 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 Frankenman Disposable Reloadable Linear Cutter 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 101mm). 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 staple buttressing materials, or across a previous staple line, may reduce the number of firings.
6. Summary of Performance Data
Suzhou 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). In addition, a performance test was conducted comparing the Frankenman Disposable Alimentary Canal Stapler and the Frankenman 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-opera:ive 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 Frankenman 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.
6
Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle symbol with three curved lines representing the eagle's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Suzhou Frankenman Medical Equipment Co., Ltd % Emergo Group, Inc. Jean Asquith 1705 S. Capital of Texas Highway, Suite 500 Austin, Texas 78746
JUN 2 9 2010
Re: K101378
Trade/Device Name: Frankenman Surgical Staplers Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: April 12, 2010 Received: May 21, 2010
Dear Jean 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 includines for use stated in the enclosure) to legally marketed predicate devices marked 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 Fedral 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, isting 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 misleding.
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 maden wor not not hits incan 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
7
Page 2 - Jean Asquith
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/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 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.
Mark N. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): _ KIOI.378
Device Name: Frankenman Surgical Staplers
Indications for Use:
Frankenman Staplers are indicated as follows:
Disposable Alimentary Canal Stapler .
The Frankenman Disposable Alimentary Canal 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.
Single Use Circular Stapler for Rectal Prolapse and Hemorrhoid .
The Frankenman 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.
Disposable Reloadable Linear Stapler and Reloads The Frankenman Disposable Reloadable Linear Stapler (and Reloads) is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
Disposable Reloadable Linear Cutter Stapler and Reloads The Frankenman Disposable Reloadable Linear Cutter Stapler (and Reloads) has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.
Prescription Use Over-The-Counter Use X AND/OR {Part 21 CFR 801 Subpart D} (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)
Donald Kione for MXM
of Surgical. Onhopedic. storative Devices
510(k) Number: K101378