(82 days)
No
The description focuses on mechanical aspects, staple technology, and manual operation. There is no mention of AI, ML, or any computational decision-making processes.
No
This device is a surgical stapler used for cutting and sealing tissue, which is an operative tool, not a device that directly administers therapy.
No
The device is a surgical stapler used for resecting, transecting, and anastomosing tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines a physical surgical stapler that places titanium staples and cuts tissue. The performance studies also focus on physical characteristics like staple formation, firing force, burst pressure, and biocompatibility, indicating 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 the patient's body during a procedure.
- Device Description: The description details a surgical stapler that places staples and cuts tissue. This is a mechanical surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is a surgical instrument used 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 (comma separated list FDA assigned to the subject device)
GDW
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 subject GIA™ stapler and cartridges with Tri-Staple™ technology are available in 60 mm staple line length and two staple sizes to accommodate tissue thicknesses: medium/thick and extra thick. Staplers for medium/thick tissue (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 for extra thick tissue (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 a GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
The GIA™ Stapler with Tri-Staple™ Technology is manufactured with essentially the same patient contact materials that are utilized within the predicate device (K192720).
The GIA™ stapler with Tri-Staple™ 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 a 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K192720).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
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.
-
- Performance Test (Bench)
- Visual inspection ●
- . IFU walkthrough
- . 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)
- Hemostasis test .
- . Staple formation on tissues
-
- Biocompatibility Tests per ISO 10993-1 and FDA guidance "Use of international Standard ISO 10993-1" issued on September 4, 2020
- Cytotoxicity test .
- Sensitization .
- . Intracutaneous irritation
- Acute system toxicity
- . Pyrogenicity
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
§ 878.4750 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 7, 2020
Covidien Katherine Choi Principal Regulatory Affairs Specialist 60 Middletown Avenue North Haven, Connecticut 06473
Re: K202701
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 Dated: November 6, 2020 Received: November 9, 2020
Dear Katherine Choi:
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/cfpmr/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. 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
Indications for Use
510(k) Number (if known) K202701
Device Name GIATM Stapler with Tri-Staple™ Technology
Indications for Use (Describe)
The GLA™ 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) | ||
|---|---|---|
| Residential Use (18 CCR 91.1 Subpart B) On-Site Construction (18 CCR 91.1 Subpart C) | Residential Use (18 CCR 91.1 Subpart B) | On-Site Construction (18 CCR 91.1 Subpart C) |
| Residential Use (18 CCR 91.1 Subpart B) | ||
| On-Site Construction (18 CCR 91.1 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Date Prepared:
Sep 10, 2020
Submitter:
Leo Chen Covidien Rooms 501, 502, 601, 602, No.3 building No.2388 Chen Hang Road Min Hang District, Shanghai, 201114, China
Contact:
Katherine Y. Choi (U.S. Agent) on behalf of Leo Chen Covidien 60 Middletown Avenue North Haven, CT 06473, USA Principal Regulatory Affairs Specialist Telephone: (917) 841-6315 Fax: (203) 492-5029 katherine.y.choi@medtronic.com Email:
Name of Device:
Proprietary/Trade Name: Model Numbers: Classification Name: Regulations 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 K192720 Staple, Implantable 21 CFR 878.4750 GDW 79 Class II General and Plastic Surgery Surgical Stapler
GIA™ Stapler with Tri-Staple™ Technology
Staple, Implantable
General and Plastic Surgery
21 CFR 878.4750
Surgical Stapler
GDW
Class II
79
GIA60MTS, GIA60XTS, GIA60MTC, GIA60XTC
Reference Device:
Proprietary/Trade Name: 510(k) Number: Classification Name: Regulations Number:
GIA™ Stapler with DST Series™ Technology K111825 Staple, Implantable 21 CFR 878.4750
4
| Product Codes: | GDW |
|---|---|
| FDA Panel Number: | 79 |
| Device Class: | Class II |
| Review Panel: | General and Plastic Surgery |
| Common Name: | Surgical Stapler |
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 subject GIA™ stapler and cartridges with Tri-Staple™ technology are available in 60 mm staple line length and two staple sizes to accommodate tissue thicknesses: medium/thick and extra thick. Staplers for medium/thick tissue (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 for extra thick tissue (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 a GIA™ Cartridge with Tri-Staple™ Technology up to 7 times for a total of 8 firings per instrument.
The GIA™ Stapler with Tri-Staple™ Technology is manufactured with essentially the same patient contact materials that are utilized within the predicate device (K192720).
The GIA™ stapler with Tri-Staple™ 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 a 5-year shelf life, and intended for multiple use during a single procedure, which is the same as the predicate device (K192720).
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 line length 60mm) is substantially equivalent to the predicate device K192720 (staple line length 80mm) 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 K192720. The subject disposable manual linear stapler is available in 60mm staple line length, while, the predicate device is available in 80mm staple line length. The 60mm staple line length, however, is not new; the reference device K111825 offers the same length.
Substantial Equivalence:
The subject new product models have the same intended use and indications for use as the predicate device.
They also have the same fundamental scientific technology in that they are all sterile, single used, hand-held, manual surgical instruments equipped with titanium staples intended to have applications in abdominal and thoracic surgical procedures for resection and creation of anastomosis. The subject and predicate device are the same in design and are sterilized via ethylene oxide, but different in staple line length.
5
The below table further summarizes the similarities and differences between the subject and predicate devices.
| Features | Subject Device | Predicate Device (K192720) |
|---|---|---|
| GIA™ Stapler with Tri-Staple™ Technology | ||
| Manufacturer | Same as predicate device. | Covidien |
| Constructional | ||
| (example) | Image: Subject Device | Image: Covidien |
| Indications for Use | Same as predicate device. | The GIA™ stapler with Tri-Staple™ technology |
| has applications in abdominal and thoracic | ||
| surgical procedures for resection, transection | ||
| and creation of anastomosis. | ||
| Operation Method | Same as predicate device. | Manual |
| Anatomical Site | Same as predicate device. | Alimentary tract and Thoracic |
| Surgical Approach | Same as predicate device. | Open surgery |
| Method of | ||
| Operation | Same as predicate device. | 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: | |
| GIA60MTS, GIA60XTS | ||
| Cartridge: | ||
| GIA60MTC, GIA60XTC | Stapler with Cartridge: | |
| GIA80MTS, GIA80XTS | ||
| Cartridge: | ||
| GIA80MTC, GIA80XTC | ||
| 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 | ||
| Instrument Handle | ||
| Type | Same as predicate device. | Single-handle squeeze |
| Staple Cartridge | ||
| Configuration | Same as predicate device. | 2 triple rows staples, step-faced cartridge with |
| different staple size in each staple row | ||
| Cartridge Color | Same as predicate device. | Purple, Black |
| Staple Size | ||
| (open leg height) | Same as predicate device. | Purple cartridge: 3.0mm, 3.5mm, 4.0mm |
| Black cartridge: 4.0mm, 4.5mm, 5.0mm | ||
| Anvil | Same as predicate device. | 2 triple staggered rows of anvil pocket design |
| Staple Line Length | 60mm | |
| Same as reference device (60mm), which | ||
| is selected to be the control device in the | ||
| performance testing. | 80mm | |
| Staple Material | Same as predicate device. | Titanium per ASTM F67 Grade l |
| Features | Subject Device | Predicate Device (K192720) |
| GIA™ Stapler with Tri-Staple™ Technology | ||
| Identification of | ||
| Materials of Implant | ||
| (staple) and tissue | ||
| cutting component | ||
| (knife) | Same as predicate device. | 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 | ||
| Audible Feedback | Same as predicate device. | Yes |
| Knife | Same as predicate device. | Yes. |
| Single Use | Same as predicate device. | Yes |
| Disposable | Same as predicate device. | Yes |
| Sterile | Same as predicate device. | Ethylene oxide |
| Shelf Life | Same as predicate device. | 5 years |
6
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.
-
- Performance Test (Bench)
- Visual inspection ●
- . IFU walkthrough
- . 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)
- Hemostasis test .
- . Staple formation on tissues
-
- Biocompatibility Tests per ISO 10993-1 and FDA guidance "Use of international Standard ISO 10993-1" issued on September 4, 2020
- Cytotoxicity test .
- Sensitization .
- . Intracutaneous irritation
- Acute system toxicity
- . Pyrogenicity
Clinical performance data - No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies.
7
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 K192720 and does not raise different questions or additional risks of safety and effectiveness than the predicate device.