(30 days)
Not Found
No
The description focuses on mechanical stapling technology and does not mention any AI or ML components.
No
This device is a surgical stapler used for cutting and joining tissue, not for treating a disease or condition.
No
The device is a surgical stapler used for cutting and dividing tissue and creating anastomoses, which are therapeutic actions, not diagnostic ones.
No
The device description clearly describes a mechanical stapler and accompanying physical loading units, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis." This describes a surgical tool used directly on living tissue within the body.
- Device Description: The description details a surgical stapler that places staples and cuts tissue. This is a mechanical surgical instrument.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The information provided describes a surgical instrument, not a diagnostic device used with biological samples.
N/A
Intended Use / Indications for Use
The reloadable staplers have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
Product codes
GAG, GDW
Device Description
The GIA™ Auto Suture™ Stapler with DST Series™ Technology places two double staggered rows of titanium staples and simultaneously cuts and divides the tissue between the two double rows. The stablers and accompanying single use loading units (SULUs, also referred to as "reloads") are available in 60 mm, and 100 mm lengths. Three staple sizes are available: 2.5 mm, 3.8 mm, and 4.8 mm to accommodate varying tissue thicknesses. The GIA™ stapler may be reloaded with a GIA™ Auto Suture™ Loading Unit with DST Series™ Technology up to 7 times for a total of 8 firings per instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal and thoracic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
The following non-clinical testing was performed to evaluate the labeling changes summarized in this Special 510(k).
-
- Usability Evaluation of Labeling Changes in accordance with IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices;
-
- Staple Line Reinforcement Material Evaluation (Ex-Vivo).
No clinical study has been deemed necessary since 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 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.
May 5, 2022
Covidien Angela Arsdale Senior Manager 60 Middletown Avenue North Haven, Connecticut 06473
Re: K221013
Trade/Device Name: GIA Auto Suture Stapler with DST Series Technology Regulation Number: 21 CFR 878.4740 Regulation Name: Surgical Stapler Regulatory Class: Class II Product Code: GAG, GDW, Dated: April 4, 2022 Received: April 5, 2022
Dear Angela 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 (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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Mark Trumbore Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221013
Device Name
GIATM Auto Suture™ Stapler with DST Series™ Technology
Indications for Use (Describe)
The reloadable staplers have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains 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.
510(k) Summary
| Date Prepared: | April 4, 2022 |
|---|---|
| Submitter: | Robert Zott |
| Covidien | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Senior Regulatory Affairs Specialist | |
| Email: robert.zott@medtronic.com | |
| Name of Device: | |
| Proprietary / | |
| Trade Name: | GIA™ Auto Suture™ Stapler with DST Series™ Technology |
| Model Numbers: | GIA10038L, GIA10038S, GIA10048L, GIA10048S, GIA8038L, |
| GIA8038S, GIA8048L, GIA8048S, GIA6025L, GIA6038L, | |
| GIA6048L, GIA6025S, GIA6038S, GIA6048S | |
| Classification Name: | |
| Regulation Number: | |
| Product Codes: | |
| FDA Panel Number: | |
| Device Class: | |
| Review Panel: | Staple, Implantable |
| 21 CFR 878.4750 / 21 CFR 878.4740 | |
| GDW / GAG | |
| 79 | |
| Class II | |
| General and Plastic Surgery | |
| Common Name: | Surgical Stapler with Implantable Staples |
| Predicate Device: | |
| Proprietary / | |
| Trade Name: | GIA™ Auto Suture™ Stapler with DST Series™ Technology |
| 510(k) Number: | K111825 |
| Classification Name: | Staple, Implantable |
| Regulation Number: | 21 CFR 878.4750 |
| Product Codes: | GDW |
| FDA Panel Number: | 79 |
| Device Class: | Class II |
| Review Panel: | General and Plastic Surgery |
| Common Name: | Surgical Stapler with Implantable Staples |
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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 square inside, and the word "COVIDIEN" in blue text to the right of the square. The text is in a sans-serif font and is all capitalized.
Device Description:
The GIA™ Auto Suture™ Stapler with DST Series™ Technology places two double staggered rows of titanium staples and simultaneously cuts and divides the tissue between the two double rows. The stablers and accompanying single use loading units (SULUs, also referred to as "reloads") are available in 60 mm, and 100 mm lengths. Three staple sizes are available: 2.5 mm, 3.8 mm, and 4.8 mm to accommodate varying tissue thicknesses. The GIA™ stapler may be reloaded with a GIA™ Auto Suture™ Loading Unit with DST Series™ Technology up to 7 times for a total of 8 firings per instrument.
Indications for Use:
The reloadable staplers have applications in abdominal and thoracic surgical procedures for resection, transection and creation of anastomosis.
Technological and Performance Characteristics:
The sled inside of the single use loading unit (SULU), as it travels down the channel along its center, will strike the staple pusher components which, in turn, will push the titanium staples out of the cartridge and through the target tissue with the open legs of the staples striking the anvil of the reload to form B-shaped staples in the tissue. While this action is occurring, the knife bar, as it advances down the reload channel, will divide the tissue between the staple lines that are being formed resulting in two staple lines on either side of the . Directional Stapling Technology (DST™) is a proprietary technology that provides consistent and reliable staple formation by reducing the potential for the staple to twist.
Substantial Equivalence:
The subject device is substantially equivalent in terms of previously-cleared indications, intended use, device design, and the fundamental stapling technology employed. There has been no change in operating principle. Both devices are sterile, single-use, hand-held, manual surgical instruments equipped with titanium staples. The patient contact materials of the subject and predicate devices are substantially equivalent; both are Ethylene Oxide (EtO) sterilized with a 5year shelf life, and both can be fired up to 8 times during a single procedure.
With regard to the previously-cleared indications, the subject device described herein is the version containing a knife blade. Gynecologic, pediatric and pancreatic indications have not been included in this premarket notification.
The Substantial Equivalence Overview Table below summarizes the substantial equivalence between the subject and predicate devices.
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Image /page/5/Picture/0 description: The image features the logo of Covidien, a former global healthcare products company. On the left side of the logo is a square graphic composed of smaller squares in varying shades of blue and white. To the right of the graphic is the company name, "COVIDIEN," written in a bold, sans-serif font, also in blue.
| Features | Subject Device
GIA™ Auto Suture™ Stapler with DST
Series™ Technology | Predicate Device (K111825)
GIA™ Auto Suture™ Stapler with DST
Series™ Technology |
|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Same as predicate device. | Covidien |
| Construction | Image: GIA Auto Suture Stapler with DST Series Technology | Image: GIA Auto Suture Stapler with DST Series Technology |
| Indications for
Use
&
Intended Use | The reloadable staplers have applications in
abdominal and thoracic surgical procedures
for resection, transection and creation of
anastomosis. | The DST Series™ GIA™ Staplers and the DST
Series™ SGIA™ Knifeless Stapler have
applications in abdominal, gynecological,
pediatric and thoracic surgical procedures for
resection, transection and creation of
anastomosis. The SGIA™ Knifeless stapler
may be used for occlusion of the left atrial
appendage in open procedures. They may be
used for transection and resection of pancreas. |
| Contra-
indications | The Contraindication has been modified as
follows:
"The instrument should not be used on
tissues that are necrotic, friable, or have
altered integrity, e.g., ischemic or
edematous tissues." | The IFU in the predicate submission states the
following in the Contraindications:
"The DST Series™ GIA™ Stapler instruments
should not be used on friable or delicate tissue
and/or where the closure of the device might be
destructive to the tissues." |
| Warnings,
Precautions,
and Instructions
for Use | Various labeling edits and additions
based on the Stapling Guidance. | The predicate labeling was cleared prior to the
issuance of the Labeling Guidance. |
| Anatomical Site | Same as predicate device. | Alimentary Tract
Thoracic |
| Surgical
Approach | Same as predicate device. | Open Surgery |
| Method of
Operation | Same as predicate device. | The instrument is activated by sliding the firing
knob forward to a complete stop. Immediately
following staple formation, the knife blade
resects the excess tissue. |
| Features | Subject Device
GIA™ Auto Suture™ Stapler with DST
Series™ Technology | Predicate Device (K111825)
GIA™ Auto Suture™ Stapler with DST
Series™ Technology |
| Product Codes | GIA10038L, GIA10038S, GIA10048L,
GIA10048S, GIA8038L, GIA8038S,
GIA8048L, GIA8048S, GIA6025L, GIA6038L
GIA6048L, GIA6025S, GIA6038S, GIA6048S | GIA10038L, GIA10038S, GIA10048L,
GIA10048S, GIA8038L, GIA8038S, GIA8048L,
GIA8048S, GIA6025L, GIA6038L, GIA6048L,
GIA6025S, GIA6038S, GIA6048S, SGIA6038L,
SGIA6038S |
| Staple Rows | Same as predicate device. | Two staggered rows of staples on either side of
the tissue cut line. |
| Instrument
Handle | Same as predicate device. | Handle is manually squeezed while the firing
knob is pushed forward. |
| Staple Cartridge
Configuration | Same as predicate device. | Two double rows of staples. |
| Cartridge Color
& Open Staple
Heights | Same as predicate device. | White (2.5 mm), Blue (3.8 mm), Green (4.8 mm) |
| Anvil | Same as predicate device. | Two double staggered rows of anvil pocket
design. |
| Staple Line
Length | Same as predicate device. | 60 mm, 80 mm, and 100 mm |
| Identification of
Materials of
Implant (staple)
and tissue
cutting
component
(knife) | Same as predicate device. | Staple: Titanium per ASTM F67 Grade I
Anvil & Knife: Stainless Steel |
| Biocompatibility | Evaluated per ISO 10993-1 series and the
FDA biocompatibility guidance. | Evaluated per ISO 10993-1 series. |
| Audible
Feedback | Same as predicate device. | Audible click heard upon
closure of the device. |
| Knife | Same as predicate device. | Yes. |
| Single Use | Same as predicate device. | Yes |
| Features | Subject Device
GIA™ Auto Suture™ Stapler with DST
Series™ Technology | Predicate Device (K111825)
GIA™ Auto Suture™ Stapler with DST
Series™ Technology |
| Disposable | Same as predicate device. | Yes |
| Sterile | Same as predicate device. | Ethylene Oxide (EtO) |
| Shelf Life | Same as predicate device. | 5 years |
Substantial Equivalence Overview Table
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Image /page/6/Picture/0 description: The image contains the word "COVIDIEN" in blue font. To the left of the word is a blue and white square logo. The logo is made up of smaller squares of different shades of blue and white. The word "COVIDIEN" is in all capital letters.
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Image /page/7/Picture/0 description: The image shows the logo for Covidien. The logo consists of a blue and white square design on the left, followed by the word "COVIDIEN" in blue, sans-serif font. The square design features a grid-like pattern with varying shades of blue and white.
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Image /page/8/Picture/0 description: The image contains the word "COVIDIEN" in blue font. To the left of the word is a blue and white square logo. The logo is a blue square with a white square inside of it. There is a blue line going through the middle of the square.
Testing Performed:
The following non-clinical testing was performed to evaluate the labeling changes summarized in this Special 510(k).
-
- Usability Evaluation of Labeling Changes in accordance with IEC 62366-1 Edition 1.0 2015-02 Medical devices - Part 1: Application of usability engineering to medical devices;
-
- Staple Line Reinforcement Material Evaluation (Ex-Vivo).
No clinical study has been deemed necessary since substantial equivalence has been sufficiently demonstrated by non-clinical studies.
Conclusion:
Based on the supporting data summarized above, Covidien has concluded that the subject device GIA™ Auto Suture™ Stapler with DST Series™ Technology is substantially equivalent to the legally-marketed predicate device K111825 and does not raise different questions or risks regarding safety and effectiveness.