(366 days)
Not Found
No
The 510(k) summary describes a simple mechanical device for anatomical access and does not mention any AI/ML terms, image processing, or data-driven performance metrics.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to perform various diagnostic and therapeutic procedures using additional accessories."
Yes
The "Intended Use / Indications for Use" states the device is intended "to perform various diagnostic and therapeutic procedures".
No
The device description clearly states it is a physical, one-piece polycarbonate anoscope, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "transanal use to provide physicians access to the anal sphincter, anus, and rectum and to perform various diagnostic and therapeutic procedures." This describes a device used in vivo (within the body) for examination and procedures, not for testing samples in vitro (outside the body).
- Device Description: The description details a physical instrument used for retraction and access, not a reagent, kit, or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This anoscope is a surgical/examination instrument.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FER
Device Description
The Applied Medical Anoscope consists of a one-piece polycarbonate half round channel with a tapered closed tip. The device retracts the anal sphincter and provides access to the anorectal anatomy during transanal procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal sphincter, anus, and rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
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)
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.
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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,
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information, Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Servicus (301) 443-6740 FF
3
510(k) Summary
| 510(K) Submitter: | Applied Medical Resources Corp.
22872 Avenida Empresa
Rancho Santa Margarita, CA, 92688
(949) 713-8000 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Aeree Lee
Senior Manager, Regulatory Affairs
Applied Medical Resources Corp.
aelee@appliedmedical.com
Tel: (949) 713-8272
Fax: (949) 713-8200 |
| Date of Preparation: | December 8, 2020 |
| Trade Name: | Applied Medical Anoscope |
| Common Name: | Disposable anoscope |
| Classification: | 21 CFR 876.1500, Endoscope & Accessories
Device Class: Class II
Product Code: FER, Anoscope and Accessories |
| Predicate Device: | Sapimed Self Light Disposable Anoscope, K070913
Product Code: FER/GCP
The predicate device has not been subject to a design related
recall. |
| Device Description: | The Applied Medical Anoscope consists of a one-piece
polycarbonate half round channel with a tapered closed tip. The
device retracts the anal sphincter and provides access to the
anorectal anatomy during transanal procedures. |
| 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. |
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:
4
- 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.