The GLA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.

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).

AI/ML Overview

The document describes a 510(k) premarket notification for the GIA™ Stapler with Tri-Staple™ Technology. A 510(k) submission aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving that it meets specific, novel acceptance criteria based on extensive clinical studies typical for novel devices.

Therefore, the "acceptance criteria" here refers to demonstrating that the subject device is substantially equivalent to the predicate device in terms of technological characteristics and performance, without raising new questions of safety or effectiveness. The study performed is a series of non-clinical performance tests.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission focused on substantial equivalence, the "acceptance criteria" are implicitly that the subject device performs comparably to the predicate or reference device in specified non-clinical tests. The document doesn't provide explicit pass/fail criteria with numerical thresholds, but rather outlines the types of tests performed to demonstrate comparable performance.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate/Reference)	Reported Device Performance (Summary from Non-Clinical Tests)
Performance Test (Bench)
- Visual inspection satisfactory	Performed
- IFU walkthrough successful	Performed
- Staple formation on test media comparable	Performed
- Firing force within acceptable range	Performed
- Multi-fire evaluation satisfactory	Performed
Performance Test (Ex-Vivo)
- Burst pressure comparable	Performed
- Pneumostasis comparable	Performed
- Across staple line evaluation comparable	Performed
Performance Test (In-Vivo)
- Hemostasis comparable	Performed
- Staple formation on tissues comparable	Performed
Biocompatibility Tests (per ISO 10993-1 and FDA guidance)
- Cytotoxicity acceptable	Performed
- Sensitization acceptable	Performed
- Intracutaneous irritation acceptable	Performed
- Acute system toxicity acceptable	Performed
- Pyrogenicity acceptable	Performed
Overall 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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for each of the non-clinical tests (bench, ex-vivo, in-vivo, biocompatibility). It only states that these tests "have been performed." The data provenance is not explicitly mentioned, but the submitter (Covidien) has corporate presence in both China (Leo Chen) and the USA (Katherine Y. Choi, U.S. Agent), suggesting the tests could have been conducted in various locations. Given the nature of these tests, they are inherently prospective experiments designed to evaluate device performance under controlled conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to this submission. "Ground truth" established by experts is typically relevant for diagnostic AI/imaging devices where human interpretation is the benchmark. For a surgical stapler, the "ground truth" is defined by objective physical and biological performance metrics (e.g., burst pressure, staple formation, hemostasis) measured in laboratory or animal settings, not by expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no expert adjudication of results in the context of mechanical device performance testing. The results are based on objective measurements and established test procedures.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable. This type of study is used for evaluating diagnostic devices, particularly those involving human interpretation of medical images (e.g., AI in radiology). The GIA™ Stapler is a surgical instrument, not a diagnostic AI device. The submission explicitly states: "No clinical study is deemed necessary since the substantial equivalence has been sufficiently demonstrated by non-clinical studies."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a manual surgical stapler; it is not an algorithm or an AI product, and therefore does not have a "standalone" algorithmic performance. Its performance is intrinsically tied to its mechanical function and human use in a surgical setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

As explained in point 3, the concept of "ground truth" in the diagnostic context is not directly applicable. For this device, the "ground truth" for performance evaluation is based on objective measurements from in-vitro (bench), ex-vivo, and in-vivo (animal) studies, such as:

Physical measurements of staple formation.
Measured firing force.
Burst pressure of stapled tissues.
Assessment of pneumostasis.
Evaluation of hemostasis.
Standardized biocompatibility test results.

8. The sample size for the training set

This is not applicable. The GIA™ Stapler is a mechanical surgical device, not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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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

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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

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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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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

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

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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).

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.

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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™ technologyhas applications in abdominal and thoracicsurgical procedures for resection, transectionand 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 ofOperation	Same as predicate device.	The instruments are activated by sliding thefiring knob forward to a complete stop andImmediately after staple formation, the knifeblade resects the excess tissue, creating alinear anastomosis.
Product Codes	Stapler with Cartridge:GIA60MTS, GIA60XTSCartridge:GIA60MTC, GIA60XTC	Stapler with Cartridge:GIA80MTS, GIA80XTSCartridge:GIA80MTC, GIA80XTC
Staple Rows	Same as predicate device.	3 staggered rows of staples on either side ofthe tissue cut line with different staple height ineach staple row
Instrument HandleType	Same as predicate device.	Single-handle squeeze
Staple CartridgeConfiguration	Same as predicate device.	2 triple rows staples, step-faced cartridge withdifferent 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, 4.0mmBlack cartridge: 4.0mm, 4.5mm, 5.0mm
Anvil	Same as predicate device.	2 triple staggered rows of anvil pocket design
Staple Line Length	60mmSame as reference device (60mm), whichis selected to be the control device in theperformance 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 ofMaterials of Implant(staple) and tissuecutting component(knife)	Same as predicate device.	Staple: Titanium per ASTM F67 Grade IKnife: Stainless SteelAnvil: Stainless Steel
Biocompatibility	Same as predicate device.	Evaluated per ISO 10993-1 series and FDAbiocompatibility 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

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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.

1. Performance Test (Bench)
- Visual inspection ●
- . IFU walkthrough
- . Staple formation on test media
- . Firing force test
- Multi-fire evaluation
1. Performance Test (Ex-Vivo)
- Burst pressure .
- . Pneumostasis
- . Across staple line evaluation
1. Performance Test (In-Vivo)
- Hemostasis test .
- . Staple formation on tissues
1. 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.

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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.

Regulation Number and Section

§ 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.