(97 days)
K.070913
Not Found
No
The device description and intended use describe a simple mechanical anoscope with no mention of software, image processing, or AI/ML capabilities.
Yes
The intended use explicitly states that the device is used to perform "various diagnostic and therapeutic procedures."
Yes
The device is intended for physician use to examine the anal sphincter and anus, which is a diagnostic activity, and it explicitly states it can be used for "various diagnostic and therapeutic procedures."
No
The device description clearly states it is a physical, disposable anoscope made of transparent plastic, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The EES Slotted Anoscope is a physical instrument used for direct visualization and access to the anal canal. It is used in vivo (within the living body) for examination and procedures, not for testing samples in vitro (outside the living body).
- Intended Use: The intended use clearly states it's for "physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures." This describes a direct medical procedure, not a laboratory test on a sample.
- Device Description: The description details a physical instrument with a body, tip, and slide, designed for insertion and visualization. It doesn't mention any components or processes related to analyzing biological samples.
Therefore, based on the provided information, the EES Slotted Anoscope is a medical device used for examination and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EES Slotted Anoscope is intended for physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes
FER
Device Description
The Ethicon Endo Surgery® Slotted Anoscope consists of a transparent plastic disposable anoscope in sterile condition. The Slotted Anoscope comprises a cylindrical body, with a closed end conical-shaped distal tip and a longitudinal open channel that accommodates a removable slide. The removable slide comprises a longitudinal open channel of 11mm in width. The body of the Slotted Anoscope has an outer diameter (OD) of 34mm. The Slotted Anoscope is a single patient use device.
The transparent characteristics of the material used in the Slotted Anoscope allows for visualization of the tissue in contact with the device in the anal canal. The opening in the removable slide provides access to tissue in the canal. The removal of the slide provides a wider margin of access to the targeted area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal sphincter and anus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K.070913
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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K093894
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510(k) Summary
Company Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, OH 45242
Contact Glenda Marsh QS/RA Senior Project Manager Ethicon Endo-Surgery, Inc. 4545 Creek Road, ML 131 Cincinnati, OH 45242 Telephone: (513) 337-7659 Fax: (513) 337-2860 Email: gmarsh(@its.jnj.com
MAR 2 5 2010
Date Prepared December 16, 2009
New Device Name
Trade Name: Ethicon Endo Surgery® Slotted Anoscope Common or Usual Name: Slotted Anoscope Classification Name: Anoscope and accessories (21 CFR 876.1500, Product Code FER)
Predicate Device
Sapimed Self Light Disposable Anoscope, model A.4083 (K.070913)
The Ethicon Endo Surgery® Slotted Anoscope consists of a Device Description transparent plastic disposable anoscope in sterile condition. The Slotted Anoscope comprises a cylindrical body, with a closed end conical-shaped distal tip and a longitudinal open channel that accommodates a removable slide. The removable slide comprises a longitudinal open channel of 11mm in width. The body of the Slotted Anoscope has an outer diameter (OD) of 34mm. The Slotted Anoscope is a single patient use device.
The transparent characteristics of the material used in the Slotted Anoscope allows for visualization of the tissue in contact with the device in the anal canal. The opening in the removable slide provides access to tissue in the canal. The removal of the slide provides a wider margin of access to the targeted area.
Indications for Use The Ethicon Endo-Surgery® Slotted Anoscope has the same indication statement as the predicate device. The Slotted Anoscope is intended for physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures.
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K093896
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Technological Characteristics The EES Slotted Anoscope device the same technological characteristics to the predicate device in that it consists of a clear, transparent plastic anoscope of cylindrical shape and a closed, rounded (or conical) tip.
The only minor difference between the EES Slotted Anoscope and the predicate device is the width of the open channel (or tissue aperture). The new EES device contains a removable slide that provides the user with the choice of two different widths for the open channel. This difference does not affect the safety or performance characteristics of the new EES device compared to the predicate.
Performance Data Bench testing and preclinical laboratory evaluations were performed to demonstrate that the device performs as intended.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Glenda Marsh QS/RA Senior Project Manager Ethicon Endo-Surgery, Inc 4545 Creek Rd. CINCINNATI OH 45242
MAR 2 5 2010
Re: K093896
Trade/Device Name: Ethicon Endo Surgery® Slotted Anoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: March 4, 2010 Received: March 8, 2010
Dear Ms. Marsh:
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. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 801); medical device reporting (reporting of medical
3
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
093896 510(k) Number (if known):
Device Name:
Ethicon Endo Surgery® Slotted Anoscope
Indications for Use:
The EES Slotted Anoscope is intended for physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Posted November 13, 2003)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K093896 |
|---|---|
| --------------- | --------- |