Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

Device Description

The Standard Staple-Line Reinforcement (SSLR23) is an implantable device designed to be used with Standard Bariatrics' TITAN SGS23R device (K210278) during laparoscopic surgery to position, clamp, staple, and resect long planes of soft flat tissue and organs, such as the stomach. The SSLR23 device consists of 2 (two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws. The SSLR23 device is single-use and supplied sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Standard Staple-Line Reinforcement (SSLR23)". It describes the device, its intended use, comparison to a predicate device, and a summary of performance testing. However, it does not include information about acceptance criteria and reported device performance in a table format, nor does it detail a study that proves the device meets specific acceptance criteria in the manner requested.

The document states: "Pre-determined performance specifications were evaluated, tested and verification/validation activities were completed to demonstrate that the subject device... met the defined criteria. Testing on the subject device included reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility per applicable parts of ISO 10993-1, Biological evaluation of medical devices. Sterilization and packaging validation activities were also completed to support this submission."

It also explicitly says: "No clinical studies were required to support this 510(k) submission."

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than a detailed study with specific acceptance criteria and performance metrics for a standalone device or comparative effectiveness.

Here's a breakdown of why I cannot fulfill each requested point:

A table of acceptance criteria and the reported device performance: This information is not provided in the document. While it mentions "pre-determined performance specifications were evaluated" and "met the defined criteria", it does not list these criteria or the specific performance results in detail.
Sample sized used for the test set and the data provenance: This is not specified. The document mentions "testing on the subject device" but gives no details about sample sizes or data provenance (country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-driven ground truth establishment for a test set is mentioned. The testing appears to be primarily engineering/laboratory-based.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no adjudication process involving human review of test set results is described.
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: Not applicable. The device is a "Staple-Line Reinforcement" which is a physical surgical mesh, not an AI or imaging device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states that "No clinical studies were required to support this 510(k) submission," implying that the testing was primarily non-clinical (e.g., bench testing, biocompatibility). It doesn't detail standalone performance in a clinical context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated, as the testing described ("reliability, staple-form, burst pressure, hemostasis, as well as applicable biocompatibility, sterilization and packaging validation activities") would likely rely on physical measurements and standardized test methods rather than clinical ground truth sources like pathology or outcomes data.
The sample size for the training set: Not applicable. The device is a physical medical device, not an AI/machine learning algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 06, 2023

Standard Bariatrics, Inc. Trevor Barton Project Manager & Staff Product Development Engineer 4300 Glendale Milford Road Cincinnati. Ohio 45242

Re: K231603

Trade/Device Name: Standard Staple-Line Reinforcement (SSLR23) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OXC Dated: September 5, 2023 Received: September 5, 2023

Dear Trevor Barton:

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 (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

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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" (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.

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For comprehensive regulatory information about medical devices and radiation-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,

Tek N.Lamichhane -S	Digitally signed byTek N. Lamichhane -S
	Date: 2023.10.06
	10:09:02 -04'00'

Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231603

Device Name

Standard Staple-Line Reinforcement (SSLR23)

Indications for Use (Describe)

Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

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)

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Image /page/4/Picture/0 description: The image is a logo for Standard Bariatrics. The logo consists of a red, stylized "S" on the left and the words "STANDARD BARIATRICS" in black on the right. The "S" is made up of three parallel lines that curve around to form the shape of the letter.

510(k) Summary

510(k) Number: K231603

Date Prepared: 06-October-2023

l. Submitter's Information

Company Name Address

Company Phone Number Primary Contact

Standard Bariatrics, Inc. 4300 Glendale Milford Road Cincinnati, OH 45242 USA +1-513-620-7751 Trevor Barton Project Manager & Staff Product Development Engineer 859-962-7619 trevor.barton@teleflex.com

Phone Number Email address

II. Subject Device Information

Device Trade Name Regulatory Class Regulation Number Regulation Name Product Code

Standard Staple-Line Reinforcement (SSLR23) Class II 21 CFR 878.3300 Surgical Mesh OXC - Mesh, Surgical, Absorbable, Staple Line Reinforcement

III. Predicate Device Information

Device Trade Name GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Regulatory Class Class II 21 CFR 878.3300 Regulation Number Regulation Name Surgical Mesh Product Code OXC - Mesh, Surgical, Absorbable, Staple Line Reinforcement FDA clearance K181940

IV. Device Description

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Image /page/5/Picture/0 description: The image is a logo for Standard Bariatrics. The logo features a red, stylized "S" on the left side. To the right of the "S" is the company name, "STANDARD BARIATRICS," in black, bold letters. The letters are slightly shadowed, giving them a three-dimensional appearance.

(two) sheets of GORE® SEAMGUARD® Bioabsorbable Staple Line Reinforcement Material, configured to be used only with TITAN SGS23R and which provides a continuous sheet of Staple-Line Reinforcement for the entire length of the staple-line, up to 23cm in length. The device contains an applicator to aid in the installation of the SSLR23 on the TITAN SGS23R jaws.

The SSLR23 device is single-use and supplied sterile.

V. Indications for Use / Intended Use

INTENDED USE

Intended for staple-line reinforcement of gastric tissue when used with the TITAN Standard Gastric Stapler (SGS23R) during sleeve gastrectomy pouch creation.

INDICATIONS FOR USE

Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.

VI. Comparison of Technological Characteristics with the Predicate Device

The technological characteristics and specifications of Standard Staple-Line Reinforcement (SSLR23) and the predicate device were evaluated to determine substantial equivalence. Upon reviewing and comparing the intended use, materials, design, principles of operall technological characteristics, Standard Bariatrics determined that the subject device is substantially equivalent to the existing legally marketed device. A summary of the evaluation of substantial equivalence is provided below.

	Subject Device	Predicate Device	Equivalence
ProductName	Standard Staple-LineReinforcement (SSLR23)	GORE SEAMGUARD Bioabsorbable Staple LineReinforcement	N/A
Manufacturer	Standard Bariatrics, Inc.	W.L. Gore & Associates, Inc.	N/A
510kinformation	K231603	K181940	N/A
DeviceClassification	II	II	Same
ClassificationName	Surgical Mesh	Surgical Mesh	Same
Regulationand code	878.3300OXC	878.3300OXC	Same
Indicationsfor Use	Standard Staple-LineReinforcement is indicated for usein bariatric procedures in whichgastric tissue transection andresection with staple linereinforcement is needed.	GORE® SEAMGUARD® Bioabsorbable StapleLine Reinforcement is indicated for use insurgical procedures in which soft tissuetransection or resection with staple linereinforcement is needed. It can be used forreinforcement of staple lines duringhysterectomy, lung resection, liver resection,bladder reconstruction, bronchial, bariatric,colon, colorectal, esophagus, gastric,mesentery, pancreas, small bowel, and spleen	Equivalent.The indications of thesubject device arelimited to the TITANSGS23R proceduralindications.
Principle of Operation	Staple line reinforcement insurgical procedures using TITANSGS23R.	procedures. It is also intended to be used forreinforcement of suture lines and staple lines(i.e., occlusion of the left atrial appendageduring open chest procedures) during cardiacsurgery.The GORE SEAMGUARD Bioabsorbable StapleLine Reinforcement Material is to be used withsurgical stapling devices.	Equivalent.Differences toaccommodatedifferent staplercompatibility exist,but the fundamentalmode of operation(staple linereinforcement insurgical procedures)is the same.
Single use	Yes	Yes	Same
Material	GORE SEAMGUARD BioabsorbableStaple Line ReinforcementMaterial (Synthetic bioabsorbablepoly (glycolide: trimethylenecarbonate) copolymer (PGA:TMC))	GORE SEAMGUARD Bioabsorbable Staple LineReinforcement Material (Syntheticbioabsorbable poly (glycolide: trimethylenecarbonate) copolymer (PGA:TMC))	Same
MRCompatibility	MR Safe	MR Safe	Same
StaplerCompatibility	The subject device is comprised ofthe GORE® SEAMGUARD®Bioabsorbable Staple LineReinforcement Materialconfigured to fit StandardBariatrics' Titan SGS23R Stapler(K210278). Subject and predicatedevices possess equivalentfundamental technology.TITAN Standard Gastric Stapler(SGS23R) (K210278)	GORE® SEAMGUARD® Bioabsorbable StapleLine Reinforcement Material Configured forEndoscopic Surgical Staplers, specificallydesigned to fit the geometry of IntuitiveSureForm 60TM (K173721).	Equivalent.Differences inconfiguration forstapler compatibilityare expected.
Sterilization	Gamma Irradiation	Gamma Irradiation	Same
Packaging	Supplied in sterile, poly-foil filmpouches, with an applicator tofacilitate the placement of thedevice onto the jaws of the TITANSGS surgical stapler. Desiccantpacks are included to preservedevice integrity.	Supplied in sterile foil film laminate pouches,with Tyvek® inserts to facilitate placement ofthe reinforcement material onto the staplerjaws.Desiccant paper/pack are included to preservedevice integrity.	Equivalent.Differences inpackaging betweenthe subject andpredicate devicesexist due to devicesize differences forstapler compatibility.

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Image /page/6/Picture/0 description: The image is the logo for Standard Bariatrics. The logo has a red icon on the left that looks like a stylized letter S. To the right of the icon is the company name, "STANDARD BARIATRICS" in black, block letters. The letters are bold and sans-serif.

VII. Summary of Performance Testing

Pre-determined performance specifications were evaluated, tested and verification/validation activities were completed to demonstrate that the subject device, Standard Staple-Line Reinforcement designed to use with Standard Bariatrics' TITAN SGS23R Standard Gastric Stapler (K210278) met the defined criteria. Testing on the subject device included reliability, staple-form, burst pressure, hemostasis, as well as

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Image /page/7/Picture/0 description: The image is a logo for Standard Bariatrics. The logo features a red, stylized "S" on the left side. To the right of the "S" is the company name, "STANDARD BARIATRICS," in black, bold letters. The letters have a slight shadow effect, giving them a three-dimensional appearance.

applicable biocompatibility per applicable parts of ISO 10993-1, Biological evaluation of medical devices. Sterilization and packaging validation activities were also completed to support this submission.

Test results provided in this submission demonstrated that the technological differences between the subject and predicate devices are acceptable and do not raise any new type of questions; furthermore, the performance data provides reasonable assurance of safety and effectiveness of the device when used as intended.

No clinical studies were required to support this 510(k) submission.

VIII. Conclusion

The subject device, Standard Staple-Line Reinforcement (SSLR23), shares the intended use and equivalent indications for use as its predicate device. It is concluded that the different technological characteristics do not raise new types of questions and performance data has provided reasonable assurance to demonstrate substantial equivalence and that the subject device can perform as intended.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.