(115 days)
No
The description focuses on the mechanical function of the device as an accessory to an endoscope and does not mention any computational or analytical capabilities.
Yes
The device is intended to assist with "endoscopic treatment," which falls under the definition of a therapeutic purpose.
No
Explanation: The device assists with optical visualization, diagnosis, and endoscopic treatment, but it is an accessory to an endoscope and does not perform the diagnostic imaging itself. Its role is to facilitate the endoscope's positioning and visualization, rather than to make a diagnosis.
No
The device description clearly states it is a "single-use, close-fitting sleeve" and mentions physical components like a balloon and overtube, indicating it is a hardware device, not software-only.
Based on the provided information, the Ancora-SB is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Ancora-SB Function: The Ancora-SB is an accessory to an endoscope used inside the body (in the small intestine) to assist with positioning, visualization, diagnosis, and treatment. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly describes a device used for in vivo procedures (inside the body).
- Device Description: The description reinforces its use as an accessory for an endoscope used internally.
Therefore, the Ancora-SB falls under the category of a medical device used for in vivo procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FDA, FED
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small intestine
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)
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.
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.
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
§ 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.
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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
1
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Ancora-SB
Indications for Use (Describe)
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.
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)
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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 and |
| Transplant 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 | Primary
Predicate | Reference
Device |
|---------------|------------------------------------------------------------------------------------------------------------|----------------------|---------------------|
| K071254 | Splinting Tube ST-SB1 (accessory to Small Intestinal
Videoscope 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
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.
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 | ||
| Product | |||
| Codes / | |||
| Regulation | |||
| Number | FDA / 21 CFR 876.1500 | ||
| FED / 21 CFR 876.1500 | Same | FDF / 21 CFR 876.1500 | |
| Intended | |||
| Use | 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. | Same | Single use tube intended to | |
| ensure complete positioning of | |||
| an endoscope in the large | |||
| intestine, and assist with | |||
| optical visualization, diagnosis, | |||
| and endoscopic treatment. | |||
| Device | |||
| Component | |||
| s | 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 | ||
| Balloon | |||
| Outer | |||
| Diameter | 38 mm | 40 mm | 60 mm |
| Balloon | |||
| Injection | |||
| Volume | 43 mL | Same¹ | Unknown |
| Insertion | |||
| Tube | |||
| Maximum | |||
| Insertion | |||
| Width | 15.9 mm | Same | Unknown |
| Insertion | |||
| Tube Inner | |||
| Diameter | 11 mm | Same | Unknown |
| Insertion | |||
| Tube | |||
| Working | |||
| Length | 1,320 mm | Same | 1,300 mm |
| Insertion | |||
| Tube Total | |||
| Length | 1,400 mm | Same | Unknown |
| Air Flow | |||
| Tube | |||
| Length | 3,700 mm | Same | Unknown |
| Materials | Hydrophilic-coated silicone | ||
| Radiopaque material on distal | Same | Hydrophilic-coated extruded | |
| polyurethane | |||
| Subject Device | Primary Predicate Device | Reference Device | |
| Ancora-SB | Splinting Tube ST-SB1 | ||
| (Accessory to Small Intestinal | |||
| Videoscope System) | DiLumen C1, EZ1 and Tool | ||
| Mount | |||
| K071254 | K221452 | ||
| end | Low durometer polyurethane | ||
| (balloon) | |||
| Radiopaque material on distal | |||
| end | |||
| Balloon | Single textured balloon on | ||
| distal end of splinting tube | Single smooth balloon on distal | ||
| end of splinting tube | Single smooth balloon on distal | ||
| end of splinting tube | |||
| Balloon | |||
| Inflation | |||
| Methods | Standard flexible endoscopy | ||
| balloon inflation unit with a set | |||
| pressure of 5.4 (+2.6/-1.8) kPa. | Olympus OBCU delivering set | ||
| inflation pressure of 5.4 (+2.6/- 0) kPa | Integrated manual inflation | ||
| bulb | |||
| Proximal | |||
| End | |||
| Connections | • Endoscope insertion port | ||
| • Fluid/flush port | |||
| • Air/inflation port | Same | Same | |
| Sterilization | |||
| Method | Non-sterile | EO | Same |
| Compatible | |||
| Endoscopes | Any standard endoscope with a | ||
| distal tip outer diameter of 9.0 |
- 9.4 mm and a working length
of 1680 mm or greater | Olympus SIF Type Q180, Q260,
each having outer diameter of
9.2 mm and working length of
2000 mm. | Any standard endoscope with a
distal tip outer diameter of
12.5 – 14.3 mm and a working
length of 1680 mm or greater |
6
^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.