(119 days)
No
The description focuses on the mechanical function of the stapler and does not mention any AI/ML components or capabilities.
No
The device is a surgical stapler used for cutting and joining tissue, which is a surgical tool rather than a therapeutic device designed to treat a condition.
No
The device is a surgical stapler used for tissue resection, transection, and creating anastomoses. It performs a physical action (cutting and stapling tissue) rather than diagnosing a condition.
No
The device description clearly details a physical surgical stapler with titanium staples, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures (resection, transection, anastomosis) in the abdomen and thorax. This is a surgical tool used directly on tissue within the body.
- Device Description: The description details a mechanical stapler that cuts and staples tissue. This is a surgical instrument, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The GIATM stapler with Tri-Staple™ technology has applications in abdominal 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 GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The GIA™ staplers and cartridges with Tri-Staple™ technology are currently available in 60mm and 80 mm length.
The subject device provides the thin/medium staple size. Staplers for thin/medium tissue (tan) deploy three height-progressive rows of 2.4 mm, 2.7 mm and 3.0 mm titanium staples.
Each GIA™ stapler with Tri-Staple™ technology may be reloaded with a GIAT™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
Both the subject device and the predicate device (K221006) are from the same product family GIA™ Stapler with Tri-Staple™ Technology. The subject device GIATM Stapler with Tri-Staple™ Technology (staple size 2.4mm, 2.7mm, 3.0mm) provides the surgeons a choice of additional staple size selection to best suit the target anatomy.
The subject device is manufactured with essentially the same patient contact materials that are utilized within the predicate device (K221006).
The GIA™ stapler with Tri-Staple™ technology has the same operation principle as the predicate device. The GIA™ Stapler with Tri-Staple™ Technology is a single-use device. It is packaged and sterilized via ETO (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K221006).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal and thoracic (Specifically, Alimentary tract and Thoracic as listed in the comparison table)
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)
Non-clinical performance data - the following testing has been performed to demonstrate substantial equivalence to the predicate device.
-
- Stability Test for single use device
-
- Biocompatibility Test per ISO 10993-1 and FDA guidance "Use of international Standard ISO 10993-1" issued on September 4, 2020
-
- Performance Test (In-Vitro)
-
- Performance Test (Ex-Vivo)
-
- Performance Test (In-Vivo)
-
- Performance Test (Chronic)
-
- Performance Test (Usability)
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies.
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.
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
§ 878.4740 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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 27, 2023
Covidien Angela Van Arsdale Sr. Regulatory Affairs Manager 60 Middletown Avenue North Haven, Connecticut 06473
Re: K231934
Trade/Device Name: GIATM Stapler with Tri-Staple™ Technology Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: September 27, 2023 Received: September 27, 2023
Dear Angela Van Arsdale:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.27
07:50:21 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
GIATM Stapler with Tri-Staple™ Technology
Indications for Use (Describe)
The GIATM stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (JOI) 443-6740 EF
CONFIDENTIAL
GIA™ Stapler with Tri-Staple™ Technology Traditional 510(k)
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Image /page/4/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle in the center and a blue vertical line running through it. To the right of the square is the word "COVIDIEN" in blue, with each letter clearly visible.
510(k) Summary
Date Prepared:
Jun 30, 2023
Submitter:
Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China Principal Regulatory Affairs Specialist Telephone: +86 21 3323 0182 Email: leo.chen@medtronic.com
US Contact:
Angela Van Arsdale Covidien 60 Middletown Avenue North Haven, CT 06473, USA Sr. Regulatory Affairs Manager angela.vanarsdale@medtronic.com Email:
Name of Device:
Proprietarv/Trade Name: Model Numbers: Classification Name: Requlations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
Predicate Device:
Proprietary/Trade Name: 510(k) Number: Classification Name: Regulations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
GIA™ Stapler with Tri-Staple™ Technology K221006 Stapler, Surgical; Staple, Implantable 21 CFR 878.4740, 21 CFR 878.4750 GAG, GDW 79 Class II General and Plastic Surgery Surqical stapler with implantable staples
GIA™ Stapler with Tri-Staple™ Technology
Stapler, Surgical; Staple, Implantable
21 CFR 878.4740, 21 CFR 878.4750
Surgical stapler with implantable staples
General and Plastic Surgery
GAG, GDW
79
Class II
GIA80TMS, GIA60TMS, GIA80TMC, GIA60TMC, GIA60TMC
Reference Device:
Proprietary/Trade Name: 510(k) Number: Classification Name:
GIA™ Stapler with DST Series™ Technology K221013 Stapler, Surgical; Staple, Implantable
CONFIDENTIAL
GIA™ Stapler with Tri-Staple™ Technology Traditional 510(k)
5
Image /page/5/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle inside, bisected by a light blue vertical line. To the right of the square is the word "COVIDIEN" in a bold, blue sans-serif font. The logo is simple and modern, with a focus on the company name.
Requlations Number: Product Codes: FDA Panel Number: Device Class: Review Panel: Common Name:
21 CFR 878.4740. 21 CFR 878.4750 GAG, GDW 79 Class II General and Plastic Surgerv Surgical stapler with implantable staples
Device Description:
The GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and divides tissue between these two triple rows. The GIA™ staplers and cartridges with Tri-Staple™ technology are currently available in 60mm and 80 mm length.
The subject device provides the thin/medium staple size. Staplers for thin/medium tissue (tan) deploy three height-progressive rows of 2.4 mm, 2.7 mm and 3.0 mm titanium staples.
Each GIA™ stapler with Tri-Staple™ technology may be reloaded with a GIAT™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
Both the subject device and the predicate device (K221006) are from the same product family GIA™ Stapler with Tri-Staple™ Technology. The subject device GIATM Stapler with Tri-Staple™ Technology (staple size 2.4mm, 2.7mm, 3.0mm) provides the surgeons a choice of additional staple size selection to best suit the target anatomy.
The subject device is manufactured with essentially the same patient contact materials that are utilized within the predicate device (K221006).
The GIA™ stapler with Tri-Staple™ technology has the same operation principle as the predicate device. The GIA™ Stapler with Tri-Staple™ Technology is a single-use device. It is packaged and sterilized via ETO (ethylene oxide) with a 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K221006).
Indications for Use:
The GIA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
Technological and Performance Characteristics:
The subject device GIA™ stapler with Tri-Staple™ technology (staple size 2.4mm, 2.7mm, 3.0mm) is substantially equivalent to the predicate device K221006 (staple size 3.0mm, 3.5mm, 4.0mm; 4.0mm, 4.5mm, 5.0mm) regarding the fundamental stapling technologies employed, intended use and indications for use. Both are single-use manual linear staplers.
The Tri-Staple™ technology used in the subject device is exactly the same as the predicate device K221006. The subject disposable manual linear stapler is available in staple size 3.0mm, 3.5mm, 4.0mm; 4.0mm, 4.5mm, 5.0mm, while the predicate device is available in staple size 2.4mm, 2.7mm, 3.0mm. That's why a reference device K221013 offering the similar staple size is to be introduced as control device in performance testing.
Substantial Equivalence:
The subject new product models have the same intended use and indications for use as the predicate device.
CONFIDENTIAL
GIA™ Stapler with Tri-Staple™ Technology Traditional 510(k)
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Image /page/6/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white rectangle inside, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
They also have the same fundamental scientific technology in that they are all sterile, single use, hand-held, manual surgical instruments equipped with titanium staples intended to have applications in abdominal and thoracic surgical procedures for resection and creation and creation of anastomosis. The subject and predicate device are essentially the same in design and are sterilized via ethylene oxide, but different in staple size.
The below table further summarizes the similarities and differences between the subject and predicate device.
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| Features | Subject Device | Predicate Device (K221006) | Reference Device (K221013) |
|---|---|---|---|
| GIA™ Stapler with Tri-Staple™ Technology | GIA™ Stapler with DST Series™ Technology | ||
| Manufacturer | Same | Covidien | Covidien |
| Constructional | |||
| (example) | Image: Subject Device | Image: Predicate Device | Image: Reference Device |
| Indications for Use | Same | The GIA™ stapler with Tri-Staple™ technology | |
| has applications in abdominal and thoracic | |||
| surgical procedures for resection, transection | |||
| and creation of anastomosis. | The GIA™ staplers with DST Series™ | ||
| technology have applications in abdominal and | |||
| thoracic surgical procedures for resection, | |||
| transection and creation of anastomosis. | |||
| Operation Method | Same | Manual | Manual |
| Anatomical Site | Same | Alimentary tract and Thoracic | Alimentary tract and Thoracic |
| Surgical Approach | Same | Open surgery | Open surgery |
| Method of | |||
| Operation | Same | The instruments are activated by sliding the | |
| firing knob forward to a complete stop and | |||
| Immediately after staple formation, the knife | |||
| blade resects the excess tissue, creating a | |||
| linear anastomosis. | The instruments are activated by sliding the | ||
| firing knob forward to a complete stop and | |||
| Immediately after staple formation, the knife | |||
| blade resects the excess tissue, creating a | |||
| linear anastomosis. | |||
| Product Codes | Stapler with Cartridge: | ||
| GIA80TMS, GIA60TMS | |||
| Cartridge: | |||
| GIA80TMC, GIA60TMC | Stapler with Cartridge: | ||
| GIA80MTS, GIA80XTS, GIA60MTS, | |||
| GIA60XTS | |||
| Cartridge: | |||
| GIA80MTC, GIA80XTC, GIA60MTC, | |||
| GIA60XTC | Stapler with Cartridge: | ||
| GIA6025S | |||
| Cartridge: | |||
| GIA6025L | |||
| Staple Rows | Same as predicate device. | 3 staggered rows of staples on either side of | |
| the tissue cut line with different staple height in | |||
| each staple row | 2 staggered rows of staples on either side of | ||
| the tissue cut line with same staple height in | |||
| each staple row | |||
| Instrument Handle | |||
| Type | Same | Single-handle squeeze | Single-handle squeeze |
| Features | Subject Device | Predicate Device (K221006) | Reference Device (K221013) |
| GIA™ Stapler with Tri-Staple™ Technology | GIA™ Stapler with DST Series™ Technology | ||
| Staple Cartridge | |||
| Configuration | Same as predicate device. | 2 triple rows staples, step-faced cartridge with different staple size in each staple row | 2 staggered rows of staples, flat-faced with same staple height in each staple row |
| Cartridge Color | Tan | Purple, Black | White |
| Staple Size | |||
| (open leg height) | Tan cartridge: 2.4mm, 2.7mm, 3.0mm | Purple cartridge: 3.0mm, 3.5mm, 4.0mm | |
| Black cartridge: 4.0mm, 4.5mm, 5.0mm | White cartridge: 2.5mm, 2.5mm | ||
| Anvil | Same as predicate device. | 2 triple staggered rows of anvil pocket design | 2 double staggered rows of anvil pocket design |
| Staple Line Length | Same as predicate device. | 80mm, 60mm | 60mm |
| Staple Material | Same | Titanium per ASTM F67 Grade I | Titanium per ASTM F67 Grade I |
| Identification of | |||
| Materials of Implant | |||
| (staple) and tissue | |||
| cutting component | |||
| (knife) | Same | Staple: Titanium per ASTM F67 Grade I | |
| Knife: Stainless Steel | |||
| Anvil: Stainless Steel | Staple: Titanium per ASTM F67 Grade I | ||
| Knife: Stainless Steel | |||
| Anvil: Stainless Steel | |||
| Biocompatibility | Same as predicate device. | Evaluated per ISO 10993-1 series and FDA | |
| biocompatibility guidance | Evaluated per ISO 10993-1 series | ||
| Audible Feedback | Same | Yes | Yes |
| Knife | Same | Yes | Yes |
| Single Use | Same | Yes | Yes |
| Disposable | Same | Yes | Yes |
| Sterile | Same | Ethylene oxide | Ethylene oxide |
| Shelf Life | Same | 5 years | 5 years |
CONFIDENTIAL
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9
Image /page/9/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue square with a white rectangle inside, and the word "COVIDIEN" in blue text to the right of the square. The square is made up of different shades of blue.
Tests performed to evaluate and compare technological and performance characteristics:
Non-clinical performance data - the following testing has been performed to demonstrate substantial equivalence to the predicate device.
-
- Stability Test for single use device
-
- Biocompatibility Test per ISO 10993-1 and FDA guidance "Use of international Standard ISO 10993-1" issued on September 4, 2020
-
- Performance Test (In-Vitro)
-
- Performance Test (Ex-Vivo)
-
- Performance Test (In-Vivo)
-
- Performance Test (Chronic)
-
- Performance Test (Usability)
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies.
Conclusion:
Based upon the supporting data summarized above, we concluded that the subject device GIA™ Stapler with Tri-Staple™ Technology is substantially equivalent to the legally-marketed device K221006 and does not raise different questions or additional risks of safety and effectiveness than the predicate device.