The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0 - 9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment.

Device Description

The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard endoscope having an outer diameter of 9.0 – 9.4 mm and a working length of 1680 mm or greater. The device is indicated to ensure complete positioning of an endoscope in the small intestine, by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. The device is designed to be used with a Balloon Endoscopy System (BES) which includes a multi-channel endoscope, an endoscopy tower (light source, display monitor, recording equipment, etc.) and a balloon inflation unit (equipment that inflates or deflates by a push button control, inflation is to a stated maximum pressure and the pressure is maintained during active use when inflated).

AI/ML Overview

The provided text is a 510(k) summary for the Ancora-SB device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not describe an acceptance criteria table with reported device performance or a study demonstrating the device meets such criteria using human reader data. Therefore, many of the requested items cannot be extracted from this document as they pertain to clinical or human-in-the-loop performance studies, which are not detailed here.

However, I can extract information regarding non-clinical testing performed to establish safety and effectiveness for substantial equivalence.

Here's a summary of what can be extracted based on the provided document:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria linked to reported exact performance metrics for the device. It lists types of non-clinical tests that were performed to demonstrate safety and equivalence to the predicate device.

2. Sample size used for the test set and the data provenance:

The document describes non-clinical bench testing and an animal study. For these types of studies, standard sample sizes for individual tests are typically used based on engineering principles and regulatory guidelines. The document does not specify these sample sizes. The data provenance is not mentioned beyond stating "GLP animal study" and "bench performance testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the studies described are non-clinical (bench and animal) and do not involve expert interpretation or ground truth establishment in the context of clinical scenarios, human readers, or expert consensus.

4. Adjudication method for the test set:

Not applicable, as this refers to clinical studies with human readers, which are not detailed in this document.

5. 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:

No MRMC comparative effectiveness study is mentioned. This document focuses on non-clinical testing for substantial equivalence. The device does not appear to be an AI-based diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable, as the device is not an algorithm, but a physical accessory to an endoscope. Its performance is evaluated through bench and animal testing, not standalone algorithmic performance.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" would be established by the physical and mechanical properties being measured (e.g., dimensions, force, inflation time) as defined by engineering standards. For the animal study, the "ground truth" would be the observed physiological responses or effects in the animal model. Specific details on how this "ground truth" was established are not provided in the summary.

8. The sample size for the training set:

Not applicable, as this document does not describe an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as this document does not describe an AI/ML device that requires a training set.

Summary of Non-Clinical Testing Performed (from Section: SUMMARY OF NON-CLINICAL TESTING):

The document states that the following non-clinical tests were performed to demonstrate safety and substantial equivalence:

Biocompatibility testing: Per ISO 10993-1, -5, -10, and -23.
Distribution testing: Per ASTM D4169-22.
Shelf-life testing: Per ASTM F1980-21.
Bench performance testing: Including:
- Dimension inspection
- Packaging inspection
- Components and features inspection
- Balloon compatibility and reliability
- Overtube friction force and reliability
- Balloon inflation time
- Balloon anchor force
- Joint strength
GLP animal study.

Conclusion:

"The results of these tests indicate that the Ancora-SB is substantially equivalent to the predicate device."
"Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device."

Summary

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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.

August 31, 2023

Aspero Medical, Inc. % Pierre Bounaud Principal Consultant Ram+ 2251 San Diego Ave, Suite B-257 San Diego, California 92110

Re: K231323

Trade/Device Name: Ancora-SB Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDA, FED Dated: July 31, 2023 Received: July 31, 2023

Dear Pierre Bounaud:

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

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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-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,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231323

Device Name

Ancora-SB

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.

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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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Image /page/3/Picture/0 description: The image shows the logo for Aspero Medical. The logo includes a graphic of three vertical bars of varying heights, followed by the word "aspero" in a bold, sans-serif font. Below the word "aspero" is the word "MEDICAL" in a smaller, blue, sans-serif font. The text "Page 1 of 5" and "K231323" are in the upper right corner of the image.

510(k) Summary

DATE PREPARED

July 31, 2023

MANUFACTURER AND 510(k) OWNER

Aspero Medical, Inc. 320 E. Vine Drive, Suite 101, Fort Collins, CO 80524, USA Telephone: Official Contact: Dr. Mark Rentschler, CEO

REPRESENTATIVE/CONSULTANT

Pierre Bounaud, Ph.D. Allison C. Komiyama, Ph.D., R.A.C. RQM+ Telephone: +1 (412) 816-8139 Email: pbounaud@rqmplus.com akomiyama@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	Ancora-SB
Regulation Name:	Endoscope and accessories
Regulation Number:	21 CFR 876.1500
Class:	II
Product Codes:	FDA, FED
Premarket Review:	OPEQ/OHT3/Renal, Gastrointestinal, Obesity andTransplant Devices (DHT3A)
Review Panel:	Gastroenterology/Urology

PREDICATE DEVICE IDENTIFICATION

The Ancora-SB is substantially equivalent to the following predicates:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate	ReferenceDevice
K071254	Splinting Tube ST-SB1 (accessory to Small IntestinalVideoscope System) / Olympus Medical Systems Corp.	✓
K221452	DiLumen C1, EZ1 and Tool Mount / Lumendi, LLC		✓

The predicate devices have not been subject to a design related recall.

DEVICE DESCRIPTION

The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard endoscope having an outer diameter of 9.0 – 9.4 mm and a working length of 1680

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Image /page/4/Picture/0 description: The image shows the logo for Aspero Medical. The logo has a series of vertical bars of increasing height to the left of the word "aspero" in bold black letters. Below the word "aspero" is the word "MEDICAL" in blue. At the top of the image are the words "Page 2 of 5" and the code "K231323".

mm or greater. The device is indicated to ensure complete positioning of an endoscope in the small intestine, by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment. The device is designed to be used with a Balloon Endoscopy System (BES) which includes a multi-channel endoscope, an endoscopy tower (light source, display monitor, recording equipment, etc.) and a balloon inflation unit (equipment that inflates or deflates by a push button control, inflation is to a stated maximum pressure and the pressure is maintained during active use when inflated).

INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Aspero Medical, Inc. believes that the Ancora-SB is substantially equivalent to the predicate device based on the information summarized here:

The subject device has the same intended use, i.e., it is a single use tube intended to ensure complete positioning of an endoscope in the small intestine, by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment, as the splinting tube ST-SB1 cleared as an accessory in K071254.

The subject device has similar technological characteristics (same operating principle, similar design and dimensions, similar materials). as the splinting tube ST-SB1 cleared as an accessory in K071254. Differences in technological characteristics includes the following:

The silicone balloon of the subject device features a proprietary textured surface . designed to provide stability and advancement of the endoscope. Smooth, round balloons currently on the market, such as the one on the splinting tube ST-SB1, are prone to slippage against the mucosa, reducing the time efficiency of small bowel enteroscopy procedures.
. The Ancora-SB is provided non-sterile. This is similar to the reference device cleared in K221452.

These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.

Table below provides a summary of the technological characteristics of the subject device compared to the predicate and reference devices.

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Image /page/5/Picture/1 description: The image contains the logo for Aspero Medical. The logo consists of a series of vertical bars of varying heights and shades of gray, followed by the word "aspero" in a large, bold, black font. Below "aspero" is the word "MEDICAL" in a smaller, blue font.

	Subject Device	Primary Predicate Device	Reference Device
	Ancora-SB	Splinting Tube ST-SB1	DiLumen C1, EZ1 and Tool
		(Accessory to Small Intestinal	Mount
		Videoscope System)
		K071254	K221452
ProductCodes /RegulationNumber	FDA / 21 CFR 876.1500FED / 21 CFR 876.1500	Same	FDF / 21 CFR 876.1500
IntendedUse	Single use tube intended toensure complete positioning ofan endoscope in the smallintestine, by either oral or analinsertion, and assist withoptical visualization, diagnosis,and endoscopic treatment.	Same	Single use tube intended toensure complete positioning ofan endoscope in the largeintestine, and assist withoptical visualization, diagnosis,and endoscopic treatment.
DeviceComponents	Single Use Splinting Tube Air supply tube assembly Luer adaptor	Small Intestinal Videoscope Single Use Splinting Tube(ST-SB1) Balloon Control Unit(OBCU) Accessories	Sleeve Manual inflation bulb
BalloonOuterDiameter	38 mm	40 mm	60 mm
BalloonInjectionVolume	43 mL	Same¹	Unknown
InsertionTubeMaximumInsertionWidth	15.9 mm	Same	Unknown
InsertionTube InnerDiameter	11 mm	Same	Unknown
InsertionTubeWorkingLength	1,320 mm	Same	1,300 mm
InsertionTube TotalLength	1,400 mm	Same	Unknown
Air FlowTubeLength	3,700 mm	Same	Unknown
Materials	Hydrophilic-coated siliconeRadiopaque material on distal	Same	Hydrophilic-coated extrudedpolyurethane
	Subject Device	Primary Predicate Device	Reference Device
	Ancora-SB	Splinting Tube ST-SB1(Accessory to Small IntestinalVideoscope System)	DiLumen C1, EZ1 and ToolMount
		K071254	K221452
	end		Low durometer polyurethane(balloon)Radiopaque material on distalend
Balloon	Single textured balloon ondistal end of splinting tube	Single smooth balloon on distalend of splinting tube	Single smooth balloon on distalend of splinting tube
BalloonInflationMethods	Standard flexible endoscopyballoon inflation unit with a setpressure of 5.4 (+2.6/-1.8) kPa.	Olympus OBCU delivering setinflation pressure of 5.4 (+2.6/- 0) kPa	Integrated manual inflationbulb
ProximalEndConnections	• Endoscope insertion port• Fluid/flush port• Air/inflation port	Same	Same
SterilizationMethod	Non-sterile	EO	Same
CompatibleEndoscopes	Any standard endoscope with adistal tip outer diameter of 9.0- 9.4 mm and a working lengthof 1680 mm or greater	Olympus SIF Type Q180, Q260,each having outer diameter of9.2 mm and working length of2000 mm.	Any standard endoscope with adistal tip outer diameter of12.5 – 14.3 mm and a workinglength of 1680 mm or greater

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^Volume of air needed to reach the outside diameter specification (40 mm) of the balloon in a commercial splinting tube ST-SB1, as measured by Aspero Medical.

SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety based on current industry standards:

Biocompatibility testing per ISO 10993-1, -5, -10, and -23 ●
Distribution testing per ASTM D4169-22
Shelf-life testing per ASTM F1980-21
Bench performance testing including dimension inspection, packaging inspection, . components and features inspection, balloon compatibility and reliability, overtube friction force and reliability, balloon inflation time, balloon anchor force, and joint strength
GLP animal study .

The results of these tests indicate that the Ancora-SB is substantially equivalent to the predicate device.

CONCLUSION

Based on the testing performed, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for

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Image /page/7/Picture/0 description: The image shows the logo for Aspero Medical. The logo has the word "aspero" in bold black letters, with the word "MEDICAL" in blue letters below it. To the left of the word "aspero" are three vertical bars of varying heights. The text "Page 5 of 5" and "K231323" are in the upper right corner of the image.

use, technological characteristics, and performance characteristics for the proposed Ancora-SB are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.