(85 days)
Not Found
No
The description details a purely mechanical stapling system with no mention of computational processing, data analysis, or adaptive behavior characteristic of AI/ML.
No.
The device is a surgical stapler used for tissue approximation (closing incisions) during procedures, not for treating or curing a disease or condition.
No
The device is a surgical stapler used for tissue approximation during abdominal and thoracic procedures; it does not collect or analyze any data to diagnose a condition.
No
The device description clearly outlines a mechanical stapling system with physical components (handle, loading units, staples) and does not mention any software functionality.
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 Function: The TA™ Stapler with DST Series™ technology is a surgical instrument used during a surgical procedure to mechanically apply staples to tissue for approximation (closing). It does not analyze or test any biological samples.
- Intended Use: The intended use is for "transection or resection of tissue" and "application of staples for the purpose of tissue approximation." This is a mechanical function performed directly on the patient's tissue, not on a sample outside the body.
The device description clearly outlines a mechanical stapling system used in surgery, which falls under the category of surgical instruments, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The TA™ Stapler with DST Series™ technology is indicated for use in abdominal and thoracic surgical procedures for transection or resection of tissue.
The intended purpose of the device is the application of staples for the purpose of tissue approximation and is limited to the aspect of stapling the tissue to prepare for the transection and resection of tissue.
Product codes
GAG, GDW
Device Description
The TA™ Stapler with DST Series™ Technology with a TA™ Loading Unit with DST Series™ Technology is a modular stapling system indicated for use during transection of tissue during surgical procedures.
The TA™ Stapler is a handheld mechanical stapler handle used to position and deploy TA™ Loading Units, which are staple cartridges containing titanium staples. The TA™ staplers and TA™ Loading Units are supplied sterile. To perform its intended use, the distal shaft of a TA™ Stapler is assembled with a TA™ loading unit. The TA™ Loading Unit is then mechanically activated by the surgeon by squeezing the handle of the TA™ stapler, thereby deploying staggered rows of titanium staples to close incisions in abdominal and thoracic tissue. The TA™ Stapler is reloadable meaning the surgeon can manually remove a fired TA™ Loading Unit and replace it with a new TA™ Loading Unit for subsequent firing in a single patient surgical procedure. The TA™ Stapler can be reloaded up to 7 times for a total of 8 firings per instrument.
The TA™ Staplers with DST Series™ Technology are available with staple line anvil lengths that accommodate 30, 45, 60 and 90 mm length TA™ Loading Units. The TA™ Loading Unit with DST Series™ Technology are available with staple heights of 2.5 mm (white vascular cartridge, 3 rows of staples, 30 mm length only); 3.5 mm (blue cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths); 4.8 mm (green cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths).
The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended to be used by medical professionals qualified in the transportation, preparation, and use of surgical devices. The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal and thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals qualified in the transportation, preparation, and use of surgical devices. ... sterile operating room environment in surgical procedures.
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
Non-clinical performance data – The following studies have been performed to demonstrate substantial equivalence and ensure compliance with the new requirements applical stapler under FDA's Final Order 2021-22041 and the new FDA's quidance titled "Surgical Staplers for Internal use - Labeling Recommendations." (Issued on October 8, 2021):
- Performance testing per 21 CFR 878.4740 (b)(2)(i) such as (A) bench top, ex-vivo, and in-vivo ● pre-clinical testing to evaluate staple formation characteristics in maximum and minimum tissue thickness, (B) measurement of the worst-case deployment pressure of stapler firing force, (C) measurement of staple line strength, and (D) conformation of staple line integrity
- . Acute GLP study performed to evaluate the (E) in-vivo conformation of staple line hemostasis and integrity
To ensure compliance with the new reguirements applical stapler under FDA's Final Order 2021-22041 and the new FDA's guidance titled "Surgical Staplers and Staples for Internal use – Labeling Recommendations." (Issued on October 8, 2021), the following supporting data has been included. When possible, applicable FDA-recognized standards were considered:
- Biocompatibility evaluation conducted in accordance with the FDA's 2020 guidance and ISO ■ 10993-1
- Shelf life/packaging stability
- Usability
MR safety information was not part of K111825: therefore, new testing has been performed per the latest FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" issued on May 20, 2021, and labeling has been updated.
Previously demonstrated compliance for the following aspects remains unimpacted:
- Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility . Assurance Level (SAL) of 10-6
Clinical performance data – No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4740 Surgical stapler.
(a) Surgical stapler for external use.
(1)
Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.(b) Surgical stapler for internal use.
(1)
Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
4 ) Avoidance of use of the stapler on the aorta;(
5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
6 ) Ensuring stapler compatibility with staples; and(
7 ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
August 16, 2023
Covidien Emily Jacobs Principal Biomedical Engineer 60 Middletown Ave. North Haven, Connecticut 06473
Re: K231491
Trade/Device Name: TATM Stapler and Loading Unit with DST Series™ Technology Regulation Number: 21 CFR 878.4740 Regulation Name: Stapler, Surgical Regulatory Class: Class II Product Code: GAG, GDW Dated: May 23, 2023 Received: May 23, 2023
Dear Emily Jacobs:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/6 description: The image shows the text "Mark Trumbore -S" in a simple, sans-serif font. The text is arranged vertically, with "Mark" on the top line and "Trumbore -S" on the bottom line. The background is plain and white.
Digitally signed by Mark Trumbore -S Date: 2023.08.16 13:45:53 -04'00'
Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE:
The TA™ Stapler with DST Series™ technology is indicated for use in abdominal and thoracic surgical procedures for transection or resection of tissue.
The intended purpose of the device is the application of staples for the purpose of tissue approximation and is limited to the aspect of stapling the tissue to prepare for the transection and resection of tissue.
3
510(k) Summary
DATE PREPARED:
May 23rd, 2023
SUBMITTER:
Covidien 60 Middletown Avenue North Haven, CT 06473 USA
CONTACT PERSON:
Emily E. Jacobs, Ph.D. Principal Biomedical Engineer Telephone: (203) 492-8433
IDENTIFICATION OF DEVICE:
| Proprietary/Trade Name: | TA™ Stapler with DST Series™ Technology |
|---|---|
| Classification Name: | Staples, Implantable |
| Regulation Number: | 21 CFR 878.4740 |
| Device Class: | Class II |
| Product Code: | GAG (Primary), GDW (Secondary) |
| Review Panel: | General and Plastic Surgery |
| Common Name: | Surgical Stapler |
PREDICATE DEVICE:
| Predicate | |
|---|---|
| 510(k) Number | K111825 (Oct 25, 2011) |
| Proprietary/Trade Name | TA™ Staplers with DST Series™ Technology and TA™ Loading Units |
| with DST Series™ Technology | |
| Classification Name | Staple, Implantable |
| Regulation Number | 21 CFR 878.4750 |
| Device Class | Class II |
| Product Code | GDW |
| Review Panel | General and Plastic Surgery |
| Common Name | Surgical Stapler |
DEVICE DESCRIPTION:
The TA™ Stapler with DST Series™ Technology with a TA™ Loading Unit with DST Series™ Technology is a modular stapling system indicated for use during transection of tissue during surgical procedures.
The TA™ Stapler is a handheld mechanical stapler handle used to position and deploy TA™ Loading Units, which are staple cartridges containing titanium staples. The TA™ staplers and TA™ Loading Units are supplied sterile. To perform its intended use, the distal shaft of a TA™ Stapler is assembled with a TA™ loading unit. The TA™ Stapler acts as a stapler handle used by the surgeon to insert and position the TA™ Loading Units inside the body via an incision. The TA™ Loading Unit is then mechanically activated by the surgeon by squeezing the handle of the TA™ stapler, thereby deploying staggered rows of titanium staples to close incisions in abdominal and thoracic tissue. The TA™ Stapler is reloadable meaning the surgeon can manually remove a fired TA™ Loading Unit and replace it with a new TA™
4
Loading Unit for subsequent firing in a single patient surgical procedure. The TA™ Stapler can be reloaded up to 7 times for a total of 8 firings per instrument.
The TA™ Staplers with DST Series™ Technology are available with staple line anvil lengths that accommodate 30, 45, 60 and 90 mm length TA™ Loading Units. The TA™ Loading Unit with DST Series™ Technology are available with staple heights of 2.5 mm (white vascular cartridge, 3 rows of staples, 30 mm length only); 3.5 mm (blue cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths); 4.8 mm (green cartridge, 2 rows of staples, 30, 45, 60 and 90 mm lengths).
The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended to be used by medical professionals qualified in the transportation, preparation, and use of surgical devices. The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.
No significant design improvements or changes have been implemented since the predicate K111825, however the indication of use has been updated.
This submission also addresses the new requirements applicable to the surgical stapler under FDA's Final Order 2021-22041 and the new FDA's guidance titled "Surgical Staplers and Staples for Internal use – Labeling Recommendations." (Issued on October 8, 2021). New performance testing has been conducted and included to ensure data reflects the currently manufactured and marketed device.
INDICATIONS FOR USE:
The TA™ Stapler with DST Series™ technology is indicated for use in abdominal and thoracic surgical procedures for transection or resection of tissue.
The intended purpose of the device is the application of staples for the purpose of tissue approximation and is limited to the aspect of stapling the tissue to prepare for the transection and resection of tissue.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are identical to their predicate K111825. No significant design improvements or changes have been made. Key design features such as staple design, staple material, number of staggered staple rows, staple sizes available, stapler handle design and deployment mechanism, and indicated tissue thickness ranges have all remained the same as the predicate.
SUBSTANTIAL EQUIVALENCE:
The TA™ Loading Unit with DST Series™ Technology and TA™ Staplers with DST Series™ Technology are identical to their predicate K111825. No significant design improvements or changes have been made. This submission's purpose is to address the new requirements applical stapler under FDA's Final Order 2021-22041 and the new FDA's guidance titled "Surgical Staplers and Staples for Internal use - Labeling Recommendations." (Issued on October 8, 2021) and provide updated performance testing reflective of the current manufactured and marketed device.
SUMMARY OF STUDIES:
Non-clinical performance data – The following studies have been performed to demonstrate substantial equivalence and ensure compliance with the new requirements applical stapler under FDA's Final Order 2021-22041 and the new FDA's quidance titled "Surgical Staplers for Internal use - Labeling Recommendations." (Issued on October 8, 2021):
5
- Performance testing per 21 CFR 878.4740 (b)(2)(i) such as (A) bench top, ex-vivo, and in-vivo ● pre-clinical testing to evaluate staple formation characteristics in maximum and minimum tissue thickness, (B) measurement of the worst-case deployment pressure of stapler firing force, (C) measurement of staple line strength, and (D) conformation of staple line integrity
- . Acute GLP study performed to evaluate the (E) in-vivo conformation of staple line hemostasis and integrity
To ensure compliance with the new reguirements applical stapler under FDA's Final Order 2021-22041 and the new FDA's guidance titled "Surgical Staplers and Staples for Internal use – Labeling Recommendations." (Issued on October 8, 2021), the following supporting data has been included. When possible, applicable FDA-recognized standards were considered:
- Biocompatibility evaluation conducted in accordance with the FDA's 2020 guidance and ISO ■ 10993-1
- Shelf life/packaging stability
- Usability
MR safety information was not part of K111825: therefore, new testing has been performed per the latest FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" issued on May 20, 2021, and labeling has been updated.
Previously demonstrated compliance for the following aspects remains unimpacted:
- Ethylene oxide (EO) sterilization for the single use devices with a minimum Sterility . Assurance Level (SAL) of 10-6
Clinical performance data – No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated through non-clinical studies.
CONCLUSION:
Based upon the supporting data summarized above, we concluded that the TA™ Staplers with DST Series™ Technology, when used with the TA™ Loading Unit with DST Series™ Technology, are as safe and effective as the legally marketed predicate device, and do not raise different questions of safety and effectiveness than the predicate device.