(168 days)
Not Found
No
The description focuses on the mechanical function of the stapler and does not mention any AI or ML components.
No
Explanation: This device is a surgical stapler used to cut and join tissue, which is a surgical tool rather than a device intended to treat or cure a disease or condition.
No
The device is a surgical stapler used for cutting and joining tissue, not for diagnosing conditions. Its intended use is for "resection, transection and creation of anastomosis" in surgical procedures.
No
The device description clearly describes a physical surgical stapler with mechanical components (staples, cutting mechanism) and mentions materials, sterilization, and shelf life, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis." This describes a surgical tool used directly on tissue within the body during a procedure.
- Device Description: The description details a mechanical stapler that places staples and cuts tissue. This is a surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / 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.
Product codes
GDW, GAG
Device Description
The subject 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™ stapler and cartridges with Tri-Staple™ technology are available in 80 mm staple line length and two staple sizes to accommodate various tissue thicknesses: medium/thick and extra thick. Staplers with medium/thick staple size (purple cartridge) deploy three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the tissue cut line. Staplers with extra thick staple size (black cartridge) deploy three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples on either side of the cut line. Each GIA™ stapler with Tri-Staple™ technology may be reloaded with GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
The subject device GIA™ Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K111825).
The subject device GIA™ stapler™ technology has the same principle operation as the predicate device. The GIA™ Stapler with Tri-Staple™ Technology is a manual single-use device. It is provided sterile (ethylene oxide) with 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K111825).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic surgical procedures Alimentary tract and Thoracic
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 devices.
- Performance Test In-Vitro
- Visual inspection on product, packaging and instruction for use.
- Staple formation on test media
- Firing force test
- Multi-Fire Evaluation
- Performance Test Ex-Vivo
- Burst Pressure
- Pneumostasis
- Across Staple Line Evaluation
- Performance Test In-Vivo
- In vivo safety and efficacy
- Tissue Abrasion
- Hemostasis test
- Staple formation on tissues
- Chronic survival testing.
Above device testing is completed per FDA Guidance "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submission" issued on April 26, 2019 on the finial finished sterilized devices that have been subject to all manufacturing processes.
4. Performance Test Human Factors/Usability per IEC 62366 and FDA Guidance 'Applying Human Factors and Usability Engineering to Medical Devices"
- Human factors evaluation was conducted on the subject device and the predicate device. Based on the results of those studies, the subject device has been found to be safe and effective for the intended users, uses and use environments.
5. Biocompatibility testing has been conducted to meet the requirements of ISO 10993-1 and FDA Guidance 'Use of international Standard ISO 10993-1" issued June 16, 2016 on the final manufactured, packaged and sterilized medical device that have been subject to all manufacturing processes.
- Cytotoxicity test
- Sensitization
- Intracutaneous irritation
- Acute system toxicity
- Pyrogenicity
6. Sterilization assessment per ISO 11135
- Overkill method used for validation
- ETO residual test.
7. Stability/Shelf-life studies
- Accelerated aging test for 5 years shelf life
- Product and packaging functional test
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)
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
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 Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 13, 2020
Covidien Frank Gianelli Senior Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K192720
Trade/Device Name: GIA 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 13, 2019 Received: September 27, 2019
Dear Frank Gianelli:
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); 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,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192720
Device Name
GIATM Stapler with Tri-Staple™ Technology
Indications for Use (Describe)
The GIA™ 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 | | | |
PSC Publishing Services (301) 443-6740 EF
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
3
Image /page/3/Picture/0 description: The image contains the word "COVIDIEN" in a sans-serif font. To the left of the word is a blue square with a white square in the center. A light blue line runs vertically through the white square. The word "COVIDIEN" is in a dark blue color.
K192720 Page 1 of 5
510(k) Summary
Submission Date: Sep 27, 2019
K192720
SUBMITTER INFORMATION:
Sarah Tang Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China
Contact:
Frank Gianelli (U.S. Agent) on behalf of Sarah Tang Covidien 60 Middletown Avenue North Haven, CT 06473, USA Senior Requlatory Affairs Specialist Telephone: (203) 492-5352 Fax: frank.j.gianelli@medtronic.com Email:
Subject Device:
Proprietary/Trade GIA™ Stapler with Tri-Staple™ Technology Name: GIA80MTS, GIA80XTS, GIA80MTC, GIA80XTC Model Numbers: Staple, Implantable Classification Name: 21 CFR 878.4750 Requlations Number: GDW Product Codes: Class II Device Class: General and Plastic Surgery Review Panel: Surgical Staple Common Name:
Predicate Device:
Proprietary/Trade Name: GIATM Stapler with DST™ Technology 510(k) Number: K111825 Classification Name: Staple, Implantable Regulations Number: 21 CFR 878.4750 Product Codes: GDW Device Class: Class II Review Panel: Common Name:
General and Plastic Surgery Surgical Staple
Device Description:
The subject 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™ stapler and cartridges with Tri-Staple™ technology are available in 80 mm staple line length and two staple sizes to accommodate various tissue thicknesses: medium/thick and extra thick. Staplers with medium/thick staple size (purple cartridge) deploy three height-progressive
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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 cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
K192720 Page 2 of 5
510(k) Summary
rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the tissue cut line. Staplers with extra thick staple size (black cartridge) deploy three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples on either side of the cut line. Each GIA™ stapler with Tri-Staple™ technology may be reloaded with GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
The subject device GIA™ Stapler with Tri-Staple™ Technology is manufactured with the same patient contact materials that are utilized within the predicate device (K111825).
The subject device GIA™ stapler™ technology has the same principle operation as the predicate device. The GIA™ Stapler with Tri-Staple™ Technology is a manual single-use device. It is provided sterile (ethylene oxide) with 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K111825).
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 Characteristics:
The subject new device GIA™ stapler with Tri-Staple™ technology is substantially equivalent to the predicate K111825 GIA™ Stapler with DST™ Technology regarding the fundamental stapling technologies employed, intended use and indications for use. Both are single-use manual linear staplers.
The major technical difference between the subject device GIA™ staple™ technology and predicate device GIA™ Stapler with DST™ Technology is the new proposed device is equipped with Tri-Staple™ Technology.
The subject device GIA™ stapler with Tri-Staple™ technology places two triple staggered row of height progressive titanium staples, hence the name "Tri-Staple". The is available in 80mm length. The staplers are offered in 2 cartridge sizes, the purple cartridge deploying three height-progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples is for medium/thick tissue thickness range and the black cartridge deploying three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples is for extra thick tissue thickness range.
The predicate GIA™ Stapler with DST™ Technology deploy two double staggered same-height rows of titanium staples. The length of the staple line is 80mm. The staplers are offered in 2 cartridge sizes, blue cartridge deploying 2 rows of 3.8mm titanium staples is for medium/thick tissue thickness range, green cartridge deploying 2 rows of 4.8mm titanium staples is for extra thick tissue thickness range.
Substantial Equivalent:
The subject devices have the same intended use and indications for use as the predicate devices.
They are similar in fundamental scientific technology in that they are all sterile, single used, handheld, manual surqical instruments equipped with titanium staples intended to have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis. The subject and predicate device are similar in design, materials and are sterilized via ethylene oxide.
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Image /page/5/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white cross in the center, and the word "COVIDIEN" in blue text to the right of the square. The text is in a sans-serif font and is slightly smaller than the square.
K192720 Page 3 of 5
510(k) Summary
The below table further summarizes the similarities and differences between the subject and predicate device.
| Features | Subject Device (K192720) | Predicate Device (K111825) |
|---|---|---|
| GIA™ Stapler with Tri-Staple™ Technology | GIA™ Staplers with DST™ Technology | |
| Manufacturer | Covidien | Covidien |
| Constructional | Image: GIA Stapler with Tri-Staple Technology | Image: GIA Staplers with DST Technology |
| 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. | The GIA™ staplers with DST™ technology and the knifeless stapler have applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis. |
| Operation Method | Manual | Manual |
| Anatomical Site | Alimentary tract and Thoracic | Alimentary tract and Thoracic |
| Surgical Approach | Open surgery | Open surgery |
| Method of Operation | 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: | |
| GIA80MTS, GIA80XTS | ||
| Cartridge: | ||
| GIA80MTC, GIA80XTC | Stapler with Cartridge: | |
| GIA8038S, GIA8048S | ||
| Cartridge: | ||
| GIA8038L, GIA8048L | ||
| Staple Rows | 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 | Single-handle squeeze | Single-handle squeeze |
| Staple Cartridge Configuration | 2 triple rows staples, step-faced cartridge with different staple size in each staple row | 2 double rows staples, flat-faced with same staple size in each staple row |
| Cartridge Color | Purple, Black | Blue, Green |
| Staple Size (open leg height) | Purple cartridge: 3.0mm, 3.5mm 4.0mm | |
| Black cartridge: 4.0mm, 4.5mm 5.0mm | Blue cartridge: 3.8mm | |
| Green cartridge: 4.8mm | ||
| Anvil | 2 triple staggered rows of anvil pocket design | 2 double staggered rows of anvil pocket design |
| Staple Line Length | 80mm | 80mm |
| Staple Material | Titanium per ASTM F67 Grade I | Titanium per ASTM F67 Grade I |
| Features | Subject Device (K192720) | Predicate Device (K111825) |
| Identification of | ||
| Materials of | ||
| Implant (staple) | ||
| and tissue cutting | ||
| component (knife) | 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 | Evaluated per ISO 10993-1 series and | |
| FDA 2016 biocompatibility guidance | Evaluated per ISO 10993-1 series | |
| Audible Feedback | Yes | Yes |
| Knife | Yes. | |
| without knifeless option | Yes | |
| with knifeless option | ||
| Single Use | Yes | Yes |
| Disposable | Yes | Yes |
| Sterile | Ethylene oxide | Ethylene oxide |
| Shelf Life | 5 years | 5 years |
| GIA™ Stapler with Tri-Staple™ Technology | GIA™ Staplers with DST™ Technology |
GIA™ Stapler with Tri-Staple™ Technology
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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 cross in the center, and the word "COVIDIEN" in blue letters to the right of the square. The logo is simple and modern, and the colors are clean and professional.
K192720 Page 4 of 5
510(k) Summary
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 devices.
-
- Performance Test In-Vitro
- Visual inspection on product, packaging and instruction for use .
- Staple formation on test media ●
- . Firing force test
- . Multi-Fire Evaluation
-
- Performance Test Ex-Vivo
- Burst Pressure ●
- . Pneumostasis
- Across Staple Line Evaluation ●
-
- Performance Test In-Vivo
- In vivo safety and efficacy .
- Tissue Abrasion
- Hemostasis test .
- Staple formation on tissues .
- Chronic survival testing .
Above device testing is completed per FDA Guidance " Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submission" issued on April 26, 2019 on the finial finished sterilized devices that have been subject to all manufacturing processes.
-
- Performance Test Human Factors/Usability per IEC 62366 and FDA Guidance 'Applying Human Factors and Usability Engineering to Medical Devices"
- Human factors evaluation was conducted on the subject device and the predicate . device. Based on the results of those studies, the subject device has been found to be
GIA™ Stapler with Tri-Staple™ Technology
7
Image /page/7/Picture/0 description: The image shows the Covidien logo. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
K192720 Page 5 of 5
510(k) Summary
safe and effective for the intended users, uses and use environments.
-
- Biocompatibility testing has been conducted to meet the requirements of ISO 10993-1 and FDA Guidance 'Use of international Standard ISO 10993-1" issued June 16, 2016 on the final manufactured, packaged and sterilized medical device that have been subject to all manufacturing processes.
- . Cytotoxicity test
- . Sensitization
- Intracutaneous irritation .
- Acute system toxicity
- . Pyrogenicity
-
- Sterilization assessment per ISO 11135
- Overkill method used for validation .
- ETO residual test .
-
- Stability/Shelf-life studies
- Accelerated aging test for 5 years shelf life .
- . Product and packaging functional test
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies.