Applied Medical Anoscope

K200021 · Applied Medical Resources · FER · Jan 6, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K200021
• Device Name: Applied Medical Anoscope
• Applicant: Applied Medical Resources
• Product Code: FER · Gastroenterology, Urology
• Decision Date: Jan 6, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Applied Medical Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

Device Story

Applied Medical Anoscope is a single-piece, disposable polycarbonate device designed for transanal access. It features a tapered closed tip for insertion, a handle, and a 32mm lumen channel for instrument passage. Used by physicians in clinical settings to retract the anal sphincter and visualize the anorectal anatomy. Unlike the predicate, it lacks an integrated light channel, relying on external illumination for visualization. The device includes visual centimeter markings for depth reference. It facilitates diagnostic and therapeutic procedures by providing a clear passage for additional surgical accessories. Benefits include safe, disposable access to the anal canal, reducing cross-contamination risks compared to reusable alternatives.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1 (cytotoxicity, intracutaneous irritation, sensitization). Functional performance assessed via computer-aided simulation and compression testing.

Technological Characteristics

Polycarbonate construction; one-piece half-round channel design; 32mm lumen; tapered tip; visual depth markings; sterile, disposable; manual operation; no integrated light source; biocompatible per ISO 10993-1.

Indications for Use

Indicated for patients requiring transanal access to the anal sphincter, anus, and rectum for diagnostic or therapeutic procedures performed by physicians.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Sapimed Self Light Disposable Anoscope (K070913)

Submission Summary (Full Text)

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January 6, 2021

Applied Medical Resources Aeree Lee Senior Manager, Regulatory Affairs 22872 Avenida Empresa Rancho Santa Margarita, CA 92688

Re: K200021

Trade/Device Name: Applied Medical Anoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FER Dated: December 8, 2020 Received: December 9, 2020

Dear Aeree Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K200021

Device Name Applied Medical Anoscope

Indications for Use (Describe)

The Applied Medical Anoscope is intended for transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures using additional accessories.

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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# 510(k) Summary

| 510(K) Submitter: | Applied Medical Resources Corp.<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA, 92688<br>[phone] |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Aeree Lee<br>Senior Manager, Regulatory Affairs<br>Applied Medical Resources Corp.<br>[e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Date of Preparation: | December 8, 2020 |
| Trade Name: | Applied Medical Anoscope |
| Common Name: | Disposable anoscope |
| Classification: | 21 CFR 876.1500, Endoscope & Accessories<br>Device Class: Class II<br>Product Code: FER, Anoscope and Accessories |
| Predicate Device: | Sapimed Self Light Disposable Anoscope, K070913<br>Product Code: FER/GCP<br>The predicate device has not been subject to a design related<br>recall. |
| Device Description: | The Applied Medical Anoscope consists of a one-piece<br>polycarbonate half round channel with a tapered closed tip. The<br>device retracts the anal sphincter and provides access to the<br>anorectal anatomy during transanal procedures. |
| Indications for use: | The Applied Medical Anoscope is intended for transanal use to<br>provide physicians access to the anal sphincter, anus, and<br>rectum and to perform various diagnostic and therapeutic<br>procedures using additional accessories. |

# Comparison of Technological Characteristics with the Predicate Device

The predicate and subject anoscopes are sterile, disposable access devices that are used to examine the anal sphincter, anus and rectum during anorectal procedures. Both devices have:

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- A tapered tip for insertion
- A handle at the proximal end
- A full-length open channel for insertion of accessories ●
- Graduated markers on the circumference

The subject device differs from the predicate as follows:

- o The predicate has a dedicated channel for application of a light source, while the subject device does not. However, the subject device has a 32mm lumen that is sufficiently large for direct visualization. Additionally, an external light source may be used to illuminate the working space.
- . The predicate device has cm markings along the outside surface. The subject device has visual centimeter markings that are not labeled but that may be easily counted by the user.

# Discussion of Performance Testing

# Biocompatibility

Biocompatibility evaluation of the subject device was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." The subject device contacts tissue for less than 24 hours and the material was determined to be biocompatible when evaluated against the following endpoints:

- Cytotoxicity
- Intracutaneous Irritation ●
- Sensitization

# Functional Performance

The anoscope is a simple one-piece device that provides a passage into the anal canal. There are no recognized performance standards for access devices of this kind. Therefore, Applied Medical devised criteria by which to assess safety and efficacy, including a computer-aided simulation and a compression test.

# Conclusion

The Applied Medical Anoscope is substantially equivalent to the predicate Sapimed Disposable Anoscope in design and performance.