(27 days)
DEN210045-Apollo ESG Sx System, Apollo Revise Sx System
Not Found
No
The description focuses on mechanical components and surgical procedures, with no mention of AI, ML, or image processing for analysis or guidance.
Yes
The device is intended to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty or transoral outlet reduction, which are therapeutic interventions for obesity.
No
The device description indicates that the Apollo ESG NXT System and Apollo REVISE NXT System are used to perform gastric remodelling through the placement of anchor-sutures and locking cinch devices to facilitate weight loss. This describes a therapeutic, rather than a diagnostic, function.
No
The device description explicitly details physical components like a Needle Driver Assembly, Anchor Exchange Device, Tissue Helix, Suture Cinch, and Suture-Anchor Assembly, all made from various materials. It also describes mechanical actions like squeezing a handle and rotating a device. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty" and "enabling transoral outlet reduction as a revision to a previous bariatric procedure." These are surgical procedures performed directly on the patient's body.
- Device Description: The description details a system of instruments used for "gastric remodelling through the placement of anchor-sutures and locking cinch device." This involves physical manipulation of tissue within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health status. IVDs are designed for testing samples in a laboratory or clinical setting.
The device is a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Apollo ESG NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI between 30-50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.
The Apollo REVISE NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with between 30-50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.
Product codes (comma separated list FDA assigned to the subject device)
QTD
Device Description
These devices are used to perform gastric remodelling through the placement of anchor-sutures and locking cinch device. The Apollo ESG NXT system is for intended for endoscopic sleeve gastroplasty (ESG) while the Apollo REVISE NXT device is intended for transoral outlet reduction, as a revision to a previous bariatric procedure. The two device systems differ in terms of the number of anchor-sutures and cinches needed to perform ESG and TORe procedures.
Both systems are comprised of a Needle Driver Assembly and Anchor Exchange Device, and accessories such as the Tissue Helix, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.
The Apollo ESG NXT and Apollo REVISE NXT needle driver assembies are designed to be compatible with single channel endoscopes. The endcap assembly of the needle driver is mounted onto the endoscope using polyester medical tape. The external catheter sheath has two working channels through which the Anchor Exchange and other accessories can operate, independent of the endoscope channel. The needle driver assembly also incorporates a pull string feature that, when pulled, allows the physician to further control the retroflexion capabilities of the endoscope.
The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations. A previously cleared Tissue Helix is provided with Apollo ESG NXT while the NXT Tissue Helix Pro is provided with Apollo REVISE NXT. Both instruments are used for manipulating tissue into the suturing window of the needle driver assembly. These devices also include a matching number of anchor-sutures and cinches to perform the gastroplasty or revision procedure.
The NXT Tissue Helix Pro is used to acquire tissue by rotating the device's handle to to gather tissue onto the exposed exposed helix coil. The acquired tissue is then pulled into proximity of the needle body to complete the stitching operation. Tissue is released by rotating the handle in the opposite direction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric
Indicated Patient Age Range
adult patients
Intended User / Care Setting
trained gastroenterologists or surgeons that perform bariatric procedures
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 Data:
- Performance Testing: Bench testing included suture drag testing, tensile testing, torque load testing, endoscope compatibility, sterility, reliability and bond strength. Additionally, the Tissue Helix Pro device was tested for tissue acquisition reliability.
- Functional Testing: An ex vivo model was utilized, using the same test methods as the predicate to evaluate the device function and intended use.
- Packaging Integrity: Packaging Integrity was confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-21, ASTM D4169-22 and ASTM F88/F88M-21.
- Results: Acceptance criteria were met in each of the studies listed above. The results confirmed equivalency between the subject and predicate devices, and that no new issues of safety or efficacy were raised.
Biocompatibility: Biocompatibility testing and toxicological assessments were performed on subject OverStitch devices in accordance with their risk category requirements, as defined in ISO 10933-1. Testing included cytotoxicity, irritation and skin sensitization, systemic toxicity, and material mediated pyrogenicity.
Clinical Performance Data: The DEN210045 clearance associated with the predicate devices created a special controls. One control was for clinical performance, specifically that the device performs as intended under anticipated conditions of use evaluating weight loss and adverse events. Another control was to ensure physicians were trained on the use of the systems to remodel gastric anatomy. These devices, which use the De Novo clearance devices as predicates, leverage the clinical data presented in that De Novo. The ESG and outlet revisions procedures performed with these devices are the same (same implant placements and the same implants), and training requirements are the same. There is reasonable assurance that the weight loss and adverse events will the equivalent to the predicate.
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.
DEN210045-Apollo ESG Sx System, Apollo Revise Sx System
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
N/A
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 18, 2023
Boston Scientific Inc. James Shene Senior Regulatory Affairs Specialist 1120 South Capital of Texas Hwy Suite 300 Austin, Texas 78746
Re: K232544
Trade/Device Name: Apollo ESG NXT System, Apollo REVISE NXT System Regulation Number: 21 CFR 876.5983 Regulation Name: Endoscopic suturing device for altering gastric anatomy for weight loss Regulatory Class: Class II Product Code: QTD Dated: August 18, 2023 Received: August 22, 2023
Dear James Shene:
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.
1
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 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-reporting-
combination-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,
Glenn B. Bell -S
Glenn B. Bell Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K232544
Device Name Apollo ESG NXT System
Indications for Use (Describe)
The Apollo ESG NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI between 30-50 kg/m2 who have not been able to lose weight, or maintain weight loss, through more conservative measures.
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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Indications for Use
510(k) Number (if known) K232544
Device Name Apollo Revise NXT System
Indications for Use (Describe)
The Apollo REVISE NXT System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with between 30-50 kg/m2 by enabling transoral outlet reduction as a revision to a previous bariatric procedure.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue.
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 (508) 382-4000 www.bostonscientific.com
510(k) Summary
| Owner's Name & Address: | Boston Scientific Coporation
300 Boston Scientific Way
Marlborough, MA 01752 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Shene
Senior Regulatory Affairs Specialist
(512) 852-3793
james.shene@apolloendo.com |
| Date: | September 14, 2023 |
| Trade Name: | Apollo ESG NXTTM System, Apollo REVISE NXTTM System |
| Common Name: | Endoscopic suturing device for altering gastric anatomy for
weight loss |
| Product Code: | QTD |
| Classification: | Class II (21 CFR 876.5983) |
| Classification Name | Endoscopic suturing device for altering gastric anatomy for
weight loss |
| Predicate Devices: | DEN210045-Apollo ESG Sx System, Apollo Revise Sx System |
| Device Description | These devices are used to perform gastric remodelling through
the placement of anchor-sutures and locking cinch device. The
Apollo ESG NXT system is for intended for endoscopic sleeve
gastroplasty (ESG) while the Apollo REVISE NXT device is
intended for transoral outlet reduction, as a revision to a previous
bariatric procedure. The two device systems differ in terms of the
number of anchor-sutures and cinches needed to perform ESG
and TORe procedures.
Both systems are comprised of a Needle Driver Assembly and
Anchor Exchange Device, and accessories such as the Tissue
Helix, Suture Cinch and Suture-Anchor Assembly devices. All
devices are sterile packaged and designed for single use and are
manufactured from various thermoplastic, silicone, stainless steel
and other medical grade materials. |
5
Image /page/5/Picture/0 description: The image shows the logo for Boston Scientific. The logo is in blue and features the words "Boston" on the top line and "Scientific" on the bottom line. The font is a serif font and the letters are all capitalized.
bostonscientific.com
Apollo ESG NXT and Apollo REVISE NXT
The Apollo ESG NXT and Apollo REVISE NXT needle driver assembies are designed to be compatible with single channel endoscopes. The endcap assembly of the needle driver is mounted onto the endoscope using polyester medical tape. The external catheter sheath has two working channels through which the Anchor Exchange and other accessories can operate, independent of the endoscope channel. The needle driver assembly also incorporates a pull string feature that, when pulled, allows the physician to further control the retroflexion capabilities of the endoscope.
The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations. A previously cleared Tissue Helix is provided with Apollo ESG NXT while the NXT Tissue Helix Pro is provided with Apollo REVISE NXT. Both instruments are used for manipulating tissue into the suturing window of the needle driver assembly. These devices also include a matching number of anchor-sutures and cinches to perform the gastroplasty or revision procedure.
NXT Tissue Helix Pro
The NXT Tissue Helix Pro is used to acquire tissue by rotating the device's handle to to gather tissue onto the exposed exposed helix coil. The acquired tissue is then pulled into proximity of the needle body to complete the stitching operation. Tissue is released by rotating the handle in the opposite direction.
Indications for Use: The APOLLO ESG System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss by reducing stomach volume through endoscopic sleeve gastroplasty in adult patients with obesity with BMI 30 -50 kg/m² who have not been able to lose weight, or maintain weight loss, through more conservative measures.
The APOLLO REVISE System is intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI 30 - 50 kg/m² by enabling transoral outlet reduction as a revision to a previous bariatric procedure.
6
Image /page/6/Picture/0 description: The image contains the logo for Boston Scientific. The logo is in blue and features the words "Boston" on the top line and "Scientific" on the bottom line. The font is a serif typeface, and the overall design is clean and professional.
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 (508) 382-4000 www.bostonscientific.com
| Technological Characteristics: | Modifications to design and materials as compared to the predicate device cleared via DEN210045 are as follows:
Apollo ESG NXT and Apollo Revise NXT "MaxFlex" Feature: A new feature, integrated into the needle driver assembly, that incorporates the use of a "pull string" to provide physicians with the ability to further control the retroflexion capabilities of their endoscope. This feature does not need to be used by the physician.Endoscope Attachment Method : The method and materials used to attach the needle driver to the endoscope were updated.Design/Material Modifications: New materials and design modifications were implemented in order to improve product durability and the manufacturability of the device. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NXT Tissue Helix Pro
The design of this tissue helix has been updated to lower catheter stiffness and improve maneuverability. Additionally, the handle interface was updated to allow the device to be controlled entirely by the physician and the helix tip was updated to an electro-cut design. |
| Non-Clinical Performance Data: | Appropriate product testing was performed on the subject device to evaluate conformance to product specifications and equivalence to the predicate devices. Verification and validation for the proposed system of devices was conducted in accordance with written protocols, previously applied to the predicate device. All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility. |
| | Performance Testing
Bench testing included suture drag testing, tensile testing, torque load testing, endoscope compatibility, sterility, reliability and bond strength. Additionally, the Tissue Helix Pro device was tested for tissue acquisition reliability. |
| | Functional Testing
An ex vivo model was utilized, using the same test methods as the predicate to evaluate the device function and intended use. |
| | Packaging Integrity
Packaging Integrity was confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-21, ASTM D4169-22 and ASTM F88/F88M-21. |
| | Acceptance criteria were met in each of the studies listed above. The results confirmed equivalency between the subject and |
predicate devices, and that no new issues of safety or efficacy were raised.
7
Image /page/7/Picture/0 description: The image shows the logo for Boston Scientific. The logo is in blue and features the words "Boston Scientific" stacked on top of each other. The font is a serif typeface, and the overall design is clean and professional.
v.bostonscientific.com
Biocompatibility: Biocompatibility testing and toxicological assessments were performed on subject OverStitch devices in accordance with their risk category requirements, as defined in ISO 10933-1. Testing included cytotoxicity, irritation and skin sensitization, systemic toxicity, and material mediated pyrogenicity.
Clinical Performance Data: The DEN210045 clearance associated with the predicate devices created a special controls. One control was for clinical performance, specifically that the device performs as intended under anticipated conditions of use evaluating weight loss and adverse events. Another control was to ensure physicians were trained on the use of the systems to remodel gastric anatomy. These devices, which use the De Novo clearance devices as predicates, leverage the clinical data presented in that De Novo. The ESG and outlet revisions procedures performed with these devices are the same (same implant placements and the same implants), and training requirements are the same. There is reasonable assurance that the weight loss and adverse events will the equivalent to the predicate.
Basis of Substantial Equivalence: Based on a comparison of indications for use and technological characteristics, the proposed devices have demonstrated substantial equivalence to their predicates.
| | Predicate Apollo ESG Sx and Apollo Revise
Sx (DEN210045) | Apollo ESG NXT and
Apollo Revise NXT |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Indications for Use | The APOLLO ESG System is intended to be
used by trained gastroenterologists or surgeons
that perform bariatric procedures to facilitate
weight loss by reducing stomach volume
through endoscopic sleeve gastroplasty in adult
patients with obesity with BMI 30 -50 kg/m2 who
have not been able to lose weight, or maintain
weight loss, through more conservative
measures.
The APOLLO REVISE System is intended to be
used by trained gastroenterologists or surgeons
that perform bariatric procedures to facilitate
weight loss in adult patients with obesity with
BMI 30 - 50 kg/m2 by enabling transoral outlet
reduction as a revision to a previous bariatric
procedure. | Same, with the revision of the
product name (APOLLO ESG
NXT and APOLLO REVISE
NXT). |
| Endoscope
Compatibility | Compatible with single channel endoscopes
having an outer diameter range of 8.8 to 9.8 mm | Same |
| Working Length | Maximum working length of 110 cm | Same |
| Sterilization Method | EO | Same |
| Shelf Life | 3 years | 1 year |
| Usage | Single-use | Same |
Table 1: Summary Table of Equivalence
8
Image /page/8/Picture/0 description: The image contains the logo for Boston Scientific. The logo is in blue and features the words "Boston Scientific" stacked on top of each other. The font is a serif font, and the overall design is simple and professional.
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 (508) 382-4000 www.bostonscientific.com
| | Predicate Apollo ESG Sx and Apollo Revise
Sx (DEN210045) | Apollo ESG NXT and
Apollo Revise NXT |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|
| Functional
Durability | Validated to perform 8 stitches for each of 8
sutures. | Same |
| Biocompatibility | Tested per ISO 19993. | Same |
| MR Compatibility | Safe with 1.5 and 3 T MR scanners with spatial
field gradient of 2500 Gauss/cm (extrapolated or
less) and SAR of 2.0 W/kg for 15 minutes of
continuous scanning | Same |
| Labeling
(Special Control
from DEN210045) | Labeling must include a summary of clinical
performance testing with the device, including a
discussion of adverse event and clinical benefit
reported as percent total body weight loss; and
shelf-life. | Same |
| Training
(Special Control
from DEN210045) | Training must be provided so that upon
completion of the training program, the user can
use the device correctly to approximate tissue to
alter the gastric anatomy for the purpose of
weight loss with minimal implact to the safety of
the patient. | Same |