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.

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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Apollo ESG NXT System and Apollo REVISE NXT System. The study presented here focuses on demonstrating substantial equivalence to a predicate device (DEN210045-Apollo ESG Sx System, Apollo Revise Sx System) rather than proving the device meets acceptance criteria for a new, independent performance claim for an AI/ML-based device.

Therefore, many of the requested elements pertaining to an AI/ML device's acceptance criteria, performance study design (e.g., ground truth establishment, MRMC studies, standalone performance), and expert input are not applicable to this submission, as the fundamental claim is one of equivalence based on similar design, materials, and intended use as a physical medical device.

However, I can extract the information relevant to what types of testing were performed to show this equivalence and where "acceptance criteria were met."

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance (as demonstrated for Substantial Equivalence)

Criteria Category	Acceptance Criteria (Implied by equivalence to predicate & regulatory standards)	Reported Device Performance (Summary from submission)
Functional/Performance	Expected to perform similarly to predicate (e.g., suture drag, tensile strength, torque load, tissue acquisition reliability, endoscope compatibility, functional durability).	- Suture Drag Testing: Performed.\n- Tensile Testing: Performed.\n- Torque Load Testing: Performed.\n- Endoscope Compatibility: Tested and confirmed for single-channel endoscopes with OD range 8.8-9.8 mm (same as predicate).\n- Sterility: Tested.\n- Reliability: Performed.\n- Bond Strength: Performed.\n- Tissue Acquisition Reliability: NXT Tissue Helix Pro specifically tested.\n- Functional Durability: Validated to perform 8 stitches for each of 8 sutures (same as predicate).\n- "MaxFlex" Feature: Integrated into the needle driver, providing enhanced retroflexion control (new feature, demonstrated to function).\n- Endoscope Attachment Method: Updated method and materials, tested for functionality.\n- Design/Material Modifications: New materials and design changes implemented to improve durability and manufacturability, validated through testing.
Biocompatibility	Meet ISO 10933-1 requirements for risk category.	- Biocompatibility Testing: Performed per ISO 10933-1 (cytotoxicity, irritation, skin sensitization, systemic toxicity, material-mediated pyrogenicity) on "OverStitch devices" (presumably refers to the subject devices, as they are part of the OverStitch family and use similar components/materials) – Same as Predicate.
Shelf Life	Established shelf life.	- Shelf Life: Established as 1 year (predicate was 3 years, so this is a difference, but acceptable).
Sterilization	Validated sterilization method.	- Sterilization Method: EO (Ethylene Oxide) – Same as Predicate.
Packaging Integrity	Maintain sterile barrier and protect device during transport/storage.	- Packaging Integrity: Confirmed by repeating testing in accordance with ASTM F2096-11, ASTM F1980-21, ASTM D4169-22, and ASTM F88/F88M-21.
MR Compatibility	Safe for use in specific MR environments.	- 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 as Predicate.
Clinical Performance (Leveraged)	Demonstrate equivalent weight loss outcomes and adverse event profiles to the predicate, with proper training.	- Leverages clinical data from the DEN210045 predicate. The ESG and outlet revision procedures performed with these new devices are stated to be "the same (same implant placements and the same implants)". "There is reasonable assurance that the weight loss and adverse events will be the equivalent to the predicate."

Here's an analysis of the requested elements:

A table of acceptance criteria and the reported device performance
- See table above. The "acceptance criteria" are implied by the need to demonstrate substantial equivalence to the predicate device and adherence to relevant standards for biocompatibility, sterility, etc. The "reported device performance" is a summary of the non-clinical testing performed.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for the bench or functional testing (e.g., number of devices tested for tensile strength, torque, etc.). It states: "Appropriate product testing was performed... All devices were evaluated to their individual functional and reliability requirements, as well as system compatibility."
- The document primarily relies on non-clinical (bench and ex vivo) testing for the current device and leverages existing clinical data from the predicate device (DEN210045).
- Data Provenance: The new testing is likely proprietary, conducted at Boston Scientific facilities or their chosen testing labs. No information is given about the country of origin for the data itself. The clinical data is leveraged from the predicate's De Novo clearance, which would have had its own clinical study details (not provided in this 510(k) summary).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. This is a physical medical device submission, not an AI/ML diagnostic or image analysis device. There is no concept of "ground truth" established by experts in the context of image interpretation or diagnosis for this device's performance claims. The "ground truth" for the device's function (e.g., successful suturing, material integrity) is established through engineering and performance testing against specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, this is not an AI/ML or diagnostic study requiring human expert adjudication of output.
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. This is not an AI-assisted diagnostic or image analysis device, so no MRMC studies were performed. The device is a surgical/endoscopic suturing system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not have an "algorithm only" or a "human-in-the-loop" component in the context of AI/ML performance. Its standalone performance refers to its mechanical and functional reliability as a physical instrument.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the non-clinical testing: The "ground truth" refers to the established engineering specifications and validated test methods (e.g., a specific tensile strength must be met, a specific number of stitches must be capable of being performed successfully).
- For the clinical performance: The document states "These devices, which use the De Novo clearance devices as predicates, leverage the clinical data presented in that De Novo." This implies that the 'ground truth' for clinical efficacy (weight loss) and safety (adverse events) for the predicate device would have been established through its own clinical trials, likely using patient outcomes data. The current submission argues that because the new device performs the "same procedures" with "same implant placements and the same implants," the clinical data from the predicate is applicable.
The sample size for the training set
- Not Applicable. This device is not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no AI/ML training set for this device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K232544

Device Name Apollo ESG NXT System

Indications for Use (Describe)

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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Indications for Use

510(k) Number (if known) K232544

Device Name Apollo Revise NXT System

Indications for Use (Describe)

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.

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"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."

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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 Coporation300 Boston Scientific WayMarlborough, MA 01752
Contact Person:	James SheneSenior Regulatory Affairs Specialist(512) 852-3793james.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 forweight loss
Product Code:	QTD
Classification:	Class II (21 CFR 876.5983)
Classification Name	Endoscopic suturing device for altering gastric anatomy forweight loss
Predicate Devices:	DEN210045-Apollo ESG Sx System, Apollo Revise Sx System
Device Description	These devices are used to perform gastric remodelling throughthe placement of anchor-sutures and locking cinch device. TheApollo ESG NXT system is for intended for endoscopic sleevegastroplasty (ESG) while the Apollo REVISE NXT device isintended for transoral outlet reduction, as a revision to a previousbariatric procedure. The two device systems differ in terms of thenumber of anchor-sutures and cinches needed to perform ESGand TORe procedures.Both systems are comprised of a Needle Driver Assembly andAnchor Exchange Device, and accessories such as the TissueHelix, Suture Cinch and Suture-Anchor Assembly devices. Alldevices are sterile packaged and designed for single use and aremanufactured from various thermoplastic, silicone, stainless steeland other medical grade materials.

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bostonscientific.com

Apollo ESG NXT and Apollo REVISE NXT

NXT Tissue Helix Pro

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.

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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 ProThe 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 TestingBench 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 TestingAn ex vivo model was utilized, using the same test methods as the predicate to evaluate the device function and intended use.
	Packaging IntegrityPackaging 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.

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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 ReviseSx (DEN210045)	Apollo ESG NXT andApollo Revise NXT
Indications for Use	The APOLLO ESG System is intended to beused by trained gastroenterologists or surgeonsthat perform bariatric procedures to facilitateweight loss by reducing stomach volumethrough endoscopic sleeve gastroplasty in adultpatients with obesity with BMI 30 -50 kg/m2 whohave not been able to lose weight, or maintainweight loss, through more conservativemeasures.The APOLLO REVISE System is intended to beused by trained gastroenterologists or surgeonsthat perform bariatric procedures to facilitateweight loss in adult patients with obesity withBMI 30 - 50 kg/m2 by enabling transoral outletreduction as a revision to a previous bariatricprocedure.	Same, with the revision of theproduct name (APOLLO ESGNXT and APOLLO REVISENXT).
EndoscopeCompatibility	Compatible with single channel endoscopeshaving 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

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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 ReviseSx (DEN210045)	Apollo ESG NXT andApollo Revise NXT
FunctionalDurability	Validated to perform 8 stitches for each of 8sutures.	Same
Biocompatibility	Tested per ISO 19993.	Same
MR Compatibility	Safe with 1.5 and 3 T MR scanners with spatialfield gradient of 2500 Gauss/cm (extrapolated orless) and SAR of 2.0 W/kg for 15 minutes ofcontinuous scanning	Same
Labeling(Special Controlfrom DEN210045)	Labeling must include a summary of clinicalperformance testing with the device, including adiscussion of adverse event and clinical benefitreported as percent total body weight loss; andshelf-life.	Same
Training(Special Controlfrom DEN210045)	Training must be provided so that uponcompletion of the training program, the user canuse the device correctly to approximate tissue toalter the gastric anatomy for the purpose ofweight loss with minimal implact to the safety ofthe patient.	Same

Regulation Number and Section

N/A