Titan SGS

K210278 · Standard Bariatrics · GDW · Apr 28, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210278
• Device Name: Titan SGS
• Applicant: Standard Bariatrics
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Apr 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for transection and resection of gastric tissue.

Device Story

Titan SGS is a single-use, sterile linear cutter for longitudinal transection of gastric tissue during sleeve gastrectomy. Device consists of a stapler (handle, shaft, end effector with 342 preloaded titanium staples) and a cable connecting to a reusable, wall-powered Power Supply Unit. Operated by surgeons in an OR setting; device is inserted laparoscopically via trocar. Surgeon uses trigger to open/close jaws and fire; mechanical linkage drives knife to transect tissue while staples are formed into 'B' shapes in 6 staggered rows. Output is a stapled, transected gastric pouch. Device facilitates sleeve gastrectomy by enabling consistent tissue resection and hemostasis. Benefits include standardized staple line creation and effective tissue management.

Clinical Evidence

Evidence includes a comparative study on 36 excised human stomachs and a multisite clinical study (IDE G200085) enrolling 62 subjects. Results demonstrated that the Titan SGS performs comparably to the predicate device in longitudinal gastric resection, providing reasonable assurance of safety and effectiveness.

Technological Characteristics

Single-use linear cutter; 230 mm end effector; 342 titanium staples in 6 staggered rows; closed staple height 1.2-2.2 mm. Powered by external wall-outlet DC power supply. Mechanical linkage for jaw actuation and firing. Sterilized via gamma radiation (10-6 SAL). Complies with ISO 10993-1 (biocompatibility), ISO 14971 (risk management), IEC 60601-1 (electrical safety), and ISO 11737-2 (sterility).

Indications for Use

Indicated for longitudinal transection of gastric tissue for sleeve gastrectomy pouch creation.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Echelon Flex Power Plus (K140560)

Submission Summary (Full Text)

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April 28, 2021

Standard Bariatrics Alison Sathe Regulatory Affairs 4362 Glendale Milford Rd. Cincinnati, Ohio 45242

# Re: K210278

Trade/Device Name: Titan SGS Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable Staple Regulatory Class: Class II Product Code: GDW, GAG Dated: January 28, 2021 Received: February 1, 2021

# Dear Ms. Sathe:

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

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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 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 ([e-mail]) or phone [phone] 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) K210278

Device Name Titan SGS

Indications for Use (Describe)

The Titan SGS linear cutter is intended for longitudinal transection of gastric tissue for sleeve gastrectory pouch creation.

| 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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Image /page/3/Picture/1 description: The image shows the logo for Standard Bariatrics. The logo consists of a stylized red letter "S" on the left and the words "STANDARD BARIATRICS" in black on the right. The letter "S" is made up of three parallel lines that curve around to form the shape of the letter. The word "STANDARD" is above the word "BARIATRICS", and there is a small trademark symbol to the right of the word "BARIATRICS".

# 510(k) Summary

#### I. Submitter's Information

| Company Name: | Standard Bariatrics, Inc. |
|-----------------|----------------------------------------------------|
| Address: | 4362 Glendale Milford Road<br>Cincinnati, OH 45242 |
| Phone Number: | 513-658-0328 |
| Fax Number: | 513-436-0201 |
| Contact Person: | Alison Sathe |
| Phone Number: | 513-304-7971 |
| Email Address: | [e-mail] |
| Date Prepared: | January 28, 2021 |

#### II. Device Information

| Device Name: | Titan SGS |
|-------------------|---------------------|
| Common Name: | Staple, Implantable |
| Regulatory Class: | Class II |
| Regulation: | 21 CFR 878.4750 |
| Product Code: | GDW |

#### III. Predicate Device:

Echelon Flex Power Plus, K140560, 21CFR 878.4750, Class II, Product Code GDW Ethicon Endo-Surgery, LLC

#### IV. Device Description

The Titan SGS with implantable staples (Titan Stapler) is a single patient use, sterile instrument used for cutting and stapling gastric tissue for sleeve gastrectomy pouch creation. The Titan Stapler is supplied preloaded with staples, fires once and cannot be reloaded.

The Titan Stapler is comprised of three main sections:

- . Stapler: located in the sterile field, it has three main sections
- the handle, which does not contact the patient and is handled by user within the sterile O field,
- the device shaft and end effector which are surgically invasive components, O
- the staples, which are housed in the end effector until they are applied to the tissue O where they are permanently implanted.
- . Cable: permanently attached to the stapler, it is passed from the sterile field to the nonsterile area to connect with the reusable Power Supply Unit, and

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- . Power Supply Unit: which is stored and used in the nonsterile area of the O.R. and powers the stapler opening, closure, and firing
The stapler end effector is 230 mm long and contains 342 staples that are organized in 6 staggered rows, 3 on each side of the cut line. The staples range in closed staple height from 2.2 mm to 1.2 mm. Staples are formed into a traditional 'B' shape: similar to existing devices. As with other powered staylers, the Titan Stapler opens and closes through a simple mechanical linkage housed in the shaft and effector of the device.

The device of the single-use Titan Stapler and a reusable power source which is supplied separately. There are no accessories supplied with the instrument. The Titan Stapler Power Source is designed to supply energy to the Titan Stapler and has a unique receptable port specific to the Titan Stapler.

#### V. Intended Use

Intended for transection and resection of gastric tissue.

#### VI. Indications for Use

The Titan SGS linear cutter is intended for longitudinal transection of gastric tissue for sleeve gastrectomy pouch creation.

#### VII. Technological Characteristics

The technological specifications of Titan Stapler and its predicate have been evaluated to determine equivalence. As detailed on Section 012 - Substantial equivalence of this 510(k) submission, upon reviewing and comparing intended use, design, materials, principle of operation and overall technological characteristics, the Titan Stapler is determined by Standard Bariatrics to be substantially equivalent to existing legally marketed devices (Table 1).

| | Standard Bariatrics'<br>Device | Predicate Device | Determination |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Product Name | Titan SGS | Echelon Flex Powered Plus | N/A |
| 510(k) Holder | Standard Bariatrics | Ethicon Endo-Surgery, LLC | N/A |
| Regulatory Information | | | |
| 510(k) Number | TBD | K140560 | N/A |
| Product Code | GDW | GDW | Same |
| Regulation | 21 CFR 878.4750<br>Implantable Staple | 21 CFR 878.4750<br>Implantable Staple | Same |
| Classification | II | II | Same |
| Design Information | | | |
| Principle of operation | Tissue is placed between<br>jaws of stapler, jaws are<br>closed, stapler is fired by<br>depressing trigger, knife<br>transects tissue as staples<br>are formed in tissue | Tissue is placed between jaws of<br>stapler, jaws are closed, stapler<br>is fired by depressing trigger,<br>knife transects tissue as staples<br>are formed in tissue | Same |

| Table 1: Overview of Substantial Equivalence | | | |
|----------------------------------------------|--|--|--|
|----------------------------------------------|--|--|--|

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| Method of Insertion | Used in laparoscopic<br>applications by insertion<br>through a trocar | Used in laparoscopic<br>applications by insertion<br>through a trocar | Same |
|----------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|-------------|
| Power Source | DC powered - wall outlet | DC powered - battery | Equivalent |
| Staple Shape | B | B | Same |
| Staple Material | Titanium | Titanium Alloy | Equivalent. |
| Closed Staple Height | 1.2 - 2.2 | 1.0-2.3mm | Equivalent |
| Staple Arrangement | 3 staggered rows on each<br>side of cut line | 3 staggered rows on each side of<br>cut line | Same |
| Staple Line Extension<br>Past Cut Line | 1.5 staples (6.0 mm) | 1.5 staples (6.0 mm) | Same |
| Method of Resection | Blade | Blade | Same |
| Method of Activation | Trigger to open/close<br>device jaws and fire | Trigger to open/close device<br>jaws and fire | Same |
| Sterilization | Provided sterile via gamma.<br>10-6 SAL | Provided sterile via gamma. 10-6<br>SAL | Same |

The technological differences between the predicate and subject device do not impact the safety and effectiveness of the subject device as described in Section 012 - Substantial Equivalence.

#### VIII. Performance Data

### Non-Clinical

Performance Testing to evaluate and compare the technological and performance characteristics included bench, animal, and clinical studies.

Pre-determined performance specifications were tested, and validation activites were conducted to demonstrate that the Titan Stapler met the defined criteria. Testing on the subject device included biocompatibility, MR compatibility, usability, Electrical Safety and EMC testing. Animal studies evaluating hemostasis as compared to the predicate device and a survival study were conducted.

Performance evaluation of the Titan Stapler during the design validation and verification was completed by applying methods of internationally recognized standards such as, EN ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and Testing within a risk management process, EN ISO 14971:2012, Medical Devices - Application of Risk Management to Medical Devices, IEC 60601-1:2005/(R)2012, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance, ISO 11737-2:2009, Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process, among others.

The Titan Stapler met acceptance criteria and demonstrated comparable performance to the predicate device for the equivalent indications for use.

### Clinical

A comparative clinical study including 36 subjects at one site was conducted between the Titan Stapler and the predicate device, the Echelon Flex Powered Plus GST System on excised human stomach. Results demonstrated substantially equivalent performance between the two devices for the equivalent indications for use.

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IDE G200085 with protocol title Multisite Study of Titan SGS Stapler in Longitudinal Gastric Resection was developed based on FDA's recommendations (Q200176). The study enrolled 62 subjects at three sites. Results demonstrated that the Titan SGS does not raise any new types of questions and the performance data provided reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.

#### IX. Conclusion

The Titan Stapler has the same intended use as the Echelon Flex Powered Plus GST System. The conclusion drawn from the nonclinical and clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. The design/technological differences do not raise any new types of questions and the performance data provided reasonable assurance of safety and effectiveness to demonstrate substantial equivalence.