(127 days)
No
The summary describes a mechanical staple-line reinforcement device and its materials. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is a staple-line reinforcement material used during surgical procedures to strengthen staple lines, not to treat a disease or condition.
No
The device is described as an implantable device used for staple-line reinforcement during surgical procedures, specifically for tissue transection and resection. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "implantable device" consisting of physical sheets of material and an applicator, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for surgical procedures involving gastric tissue transection and resection with staple line reinforcement. This is a surgical device used in vivo (within the body) during a procedure.
- Device Description: The device is described as an implantable device used with a surgical stapler to reinforce a staple line. This is a physical device used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo during a surgical procedure.
N/A
Intended Use / Indications for Use
Standard Staple-Line Reinforcement is indicated for use in bariatric procedures in which gastric tissue transection and resection with staple line reinforcement is needed.
Product codes
OXC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric tissue
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)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
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 by
Tek 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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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4
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
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
5
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 | |
|---|---|---|---|
| Product | |||
| Name | Standard Staple-Line | ||
| Reinforcement (SSLR23) | GORE SEAMGUARD Bioabsorbable Staple Line | ||
| Reinforcement | N/A | ||
| Manufacturer | Standard Bariatrics, Inc. | W.L. Gore & Associates, Inc. | N/A |
| 510k | |||
| information | K231603 | K181940 | N/A |
| Device | |||
| Classification | II | II | Same |
| Classification | |||
| Name | Surgical Mesh | Surgical Mesh | Same |
| Regulation | |||
| and code | 878.3300 | ||
| OXC | 878.3300 | ||
| OXC | Same | ||
| Indications | |||
| for Use | Standard Staple-Line | ||
| Reinforcement is indicated for use | |||
| in bariatric procedures in which | |||
| gastric tissue transection and | |||
| resection with staple line | |||
| reinforcement is needed. | GORE® SEAMGUARD® Bioabsorbable Staple | ||
| Line Reinforcement is indicated for use in | |||
| surgical procedures in which soft tissue | |||
| transection or resection with staple line | |||
| reinforcement is needed. It can be used for | |||
| reinforcement of staple lines during | |||
| hysterectomy, lung resection, liver resection, | |||
| bladder reconstruction, bronchial, bariatric, | |||
| colon, colorectal, esophagus, gastric, | |||
| mesentery, pancreas, small bowel, and spleen | Equivalent. | ||
| The indications of the | |||
| subject device are | |||
| limited to the TITAN | |||
| SGS23R procedural | |||
| indications. | |||
| Principle of Operation | Staple line reinforcement in | ||
| surgical procedures using TITAN | |||
| SGS23R. | procedures. It is also intended to be used for | ||
| reinforcement of suture lines and staple lines | |||
| (i.e., occlusion of the left atrial appendage | |||
| during open chest procedures) during cardiac | |||
| surgery. | |||
| The GORE SEAMGUARD Bioabsorbable Staple | |||
| Line Reinforcement Material is to be used with | |||
| surgical stapling devices. | Equivalent. | ||
| Differences to | |||
| accommodate | |||
| different stapler | |||
| compatibility exist, | |||
| but the fundamental | |||
| mode of operation | |||
| (staple line | |||
| reinforcement in | |||
| surgical procedures) | |||
| is the same. | |||
| Single use | Yes | Yes | Same |
| Material | GORE SEAMGUARD Bioabsorbable | ||
| Staple Line Reinforcement | |||
| Material (Synthetic bioabsorbable | |||
| poly (glycolide: trimethylene | |||
| carbonate) copolymer (PGA:TMC)) | GORE SEAMGUARD Bioabsorbable Staple Line | ||
| Reinforcement Material (Synthetic | |||
| bioabsorbable poly (glycolide: trimethylene | |||
| carbonate) copolymer (PGA:TMC)) | Same | ||
| MR | |||
| Compatibility | MR Safe | MR Safe | Same |
| Stapler | |||
| Compatibility | The subject device is comprised of | ||
| the GORE® SEAMGUARD® | |||
| Bioabsorbable Staple Line | |||
| Reinforcement Material | |||
| configured to fit Standard | |||
| Bariatrics' Titan SGS23R Stapler | |||
| (K210278). Subject and predicate | |||
| devices possess equivalent | |||
| fundamental technology. | |||
| TITAN Standard Gastric Stapler | |||
| (SGS23R) (K210278) | GORE® SEAMGUARD® Bioabsorbable Staple | ||
| Line Reinforcement Material Configured for | |||
| Endoscopic Surgical Staplers, specifically | |||
| designed to fit the geometry of Intuitive | |||
| SureForm 60TM (K173721). | Equivalent. | ||
| Differences in | |||
| configuration for | |||
| stapler compatibility | |||
| are expected. | |||
| Sterilization | Gamma Irradiation | Gamma Irradiation | Same |
| Packaging | Supplied in sterile, poly-foil film | ||
| pouches, with an applicator to | |||
| facilitate the placement of the | |||
| device onto the jaws of the TITAN | |||
| SGS surgical stapler. Desiccant | |||
| packs are included to preserve | |||
| device integrity. | Supplied in sterile foil film laminate pouches, | ||
| with Tyvek® inserts to facilitate placement of | |||
| the reinforcement material onto the stapler | |||
| jaws. | |||
| Desiccant paper/pack are included to preserve | |||
| device integrity. | Equivalent. | ||
| Differences in | |||
| packaging between | |||
| the subject and | |||
| predicate devices | |||
| exist due to device | |||
| size differences for | |||
| stapler 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
7
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.