(86 days)
Not Found
No
The description focuses on mechanical and electrical components, and there is no mention of AI, ML, or related concepts.
Yes
The device is used for cutting and stapling gastric tissue during sleeve gastrectomy, which is a surgical procedure to treat obesity and related conditions. This procedure is performed to improve a patient's health and quality of life, which aligns with the definition of a therapeutic device.
No
The device is a surgical stapler used for cutting and stapling gastric tissue, not for evaluating or identifying medical conditions.
No
The device description clearly outlines a physical instrument (Stapler, Cable, Power Supply Unit) used for cutting and stapling tissue, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue samples) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Titan SGS Function: The Titan SGS is a surgical instrument used directly on gastric tissue inside the body during a surgical procedure (sleeve gastrectomy). It cuts and staples tissue.
The description clearly indicates a surgical tool used for a procedure, not a device used for laboratory testing of samples.
N/A
Intended Use / Indications for Use
- Intended Use: Intended for transection and resection of gastric tissue.
- Indications for Use: The Titan SGS linear cutter is intended for longitudinal transection of gastric tissue for sleeve gastrectomy pouch creation.
Product codes (comma separated list FDA assigned to the subject device)
GDW, GAG
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
- 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.
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)
- 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. 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.
- Clinical: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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
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 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,
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
2
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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3
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 |
| Cincinnati, OH 45242 | |
| Phone Number: | 513-658-0328 |
| Fax Number: | 513-436-0201 |
| Contact Person: | Alison Sathe |
| Phone Number: | 513-304-7971 |
| Email Address: | alison@regulatorymark.com |
| 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
4
- . 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'
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
Implantable Staple | 21 CFR 878.4750
Implantable Staple | Same |
| Classification | II | II | Same |
| Design Information | | | |
| Principle of operation | Tissue is placed between
jaws of stapler, jaws are
closed, stapler is fired by
depressing trigger, knife
transects tissue as staples
are formed in tissue | Tissue is placed between jaws of
stapler, jaws are closed, stapler
is fired by depressing trigger,
knife transects tissue as staples
are formed in tissue | Same |
| Table 1: Overview of Substantial Equivalence | |||
|---|---|---|---|
| ---------------------------------------------- | -- | -- | -- |
5
| Method of Insertion | Used in laparoscopic
applications by insertion
through a trocar | Used in laparoscopic
applications by insertion
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
side of cut line | 3 staggered rows on each side of
cut line | Same |
| Staple Line Extension
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
device jaws and fire | Trigger to open/close device
jaws and fire | Same |
| Sterilization | Provided sterile via gamma.
10-6 SAL | Provided sterile via gamma. 10-6
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.
6
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.