(22 days)
Not Found
No
The device description and intended use focus on physical examination tools and accessories, with no mention of AI/ML capabilities or data processing.
Yes
The 'Intended Use / Indications for Use' section states that the device is intended for "various diagnostic and therapeutic procedures".
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended "to perform various diagnostic and therapeutic procedures," and the "Device Description" explicitly mentions "Diagnostic Anoscopes, Proctoscopes and Rectoscope."
No
The device description clearly states it consists of transparent plastic anoscope, proctoscope, or rectoscope, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the physical examination of the anal sphincter, anus, and rectum, and for performing diagnostic and therapeutic procedures directly on the patient.
- Device Description: The device is a physical instrument (anoscope, proctoscope, rectoscope) used for visualization and access to these anatomical sites.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health. This device does not involve the analysis of specimens.
Therefore, this device falls under the category of a medical device used for direct examination and procedures on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The family of THD disposable Anoscope, Proctoscope and Rectoscope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
FER/GCP
Device Description
The family of THD Disposable Anoscope, Proctoscope and Rectoscope are designed for the examination and treatment of the anal (anoscope) and recturn (proctoscope and rectoscope) examination. The devices consist of transparent plastic anoscope. proctoscope or rectoscope for diagnostic or therapeutic use.
The family of THD disposable Anoscopes, Proctoscopes and Rectoscope is made by 2 categories of devices:
- . Diagnostic Anoscopes, Proctoscopes and Rectoscope
- . Surgical Proctoscopes
The family of THD disposable Anoscopes, Proctoscopes and Rectoscope consist of the evolution of the family of THD disposable Anoscope and proctoscope previously cleared (K080132).
As in the previous submission, this family is provided with two accessories for illumination the "Shining Light" and the "pen light".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal sphincter, anus, rectum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician use
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 risk analysis method used to assess the impact of the modifications is described in the Annex 4.3 - Risk management plan. The design verification tests were performed as a result of this risk analysis assessment (see attachment 4.2). The design verification tests are listed in the following table.
| Modification | Test Performed | Acceptance Criteria |
|---|---|---|
| Dimensions of the proctoscope | Design verification | Safety and effectiveness of the device |
| Materials of the tip of new size devices | Biocompatibility | Medical Grade material |
| Sterilization of the rectoscopes | Sterilization Validation | See Sterilization Statement (Annex 5.1) |
The test method used are the same as those submitted in the original submission. A declaration of conformity with design controls is included in attachment 1.1
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
THD S.p.A. SPECIAL 510(K) Notification
FAMILY OF THD DISPOSABLE ANOSCOPE, PROCTOSCOPE AND RECTOSCOPE
K 091470
510(k) Summary for the
Pogl જુજ JUN 1 1 2009
THD Anoscope, Proctoscope and Rectoscope
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
2.1. General Information
Submitter:
THD S.p.A. Via dell'Industria, 1 42015 - Correggio (RE) Italy
Establishment Registration Number: 3006680097
Contact Person:
Guido Bonapace ISEMED srl Via Borgo Santa Cristina 12 40026 Imola (BO) Italy Mob.phone: +39-335-5378686 Telephone: +39-051-6527315 +39-051-6284344 Fax: Email: gbonapace@isemed.eu
Summary Preparation Date:
- 2.2. Names Device Name:
Classification Name: Product Code: Regulation number:
May 14, 2009
Family of THD disposable anoscope, proctoscope and rectoscope Endoscope and accessories FER/GCP 876.1500
2.3. Predicate Devices
This Special 510(k) is related to the device modifications of the following devices:
| Applicant | Device name | 510(k) Number |
|---|---|---|
| THD S.p.A. | Family of THD Disposable | |
| anoscope/proctoscope | K080132 |
20 Page
1
THD S.p.A. SPECIAL 510(K) Notification
FAMILY OF THD DISPOSABLE ANOSCOPE, PROCTOSCOPE AND RECTOSCOPE
K.091490
pg 2 of 2
2.4. Device Description
The family of THD Disposable Anoscope, Proctoscope and Rectoscope are designed for the examination and treatment of the anal (anoscope) and recturn (proctoscope and rectoscope) examination. The devices consist of transparent plastic anoscope. proctoscope or rectoscope for diagnostic or therapeutic use.
The family of THD disposable Anoscopes, Proctoscopes and Rectoscope is made by 2 categories of devices:
- . Diagnostic Anoscopes, Proctoscopes and Rectoscope
- . Surgical Proctoscopes
The family of THD disposable Anoscopes, Proctoscopes and Rectoscope consist of the evolution of the family of THD disposable Anoscope and proctoscope previously cleared (K080132).
As in the previous submission, this family is provided with two accessories for illumination the "Shining Light" and the "pen light".
2.5. Indications for Use
The family of THD disposable Anoscope, Proctoscope and Rectoscope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
No changes in the Indications for use was occurred.
2.6. Design Control Activities
The risk analysis method used to assess the impact of the modifications is described in the Annex 4.3 - Risk management plan. The design verification tests were performed as a result of this risk analysis assessment (see attachment 4.2). The design verification tests are listed in the following table.
| Modification | Test Performed | Acceptance Criteria |
|---|---|---|
| Dimensions of the | ||
| proctoscope | Design verification | Safety and effectiveness of |
| the device | ||
| Materials of the tip of new | ||
| size devices | Biocompatibility | Medical Grade material |
| Sterilization of the | ||
| rectoscopes | Sterilization Validation | See Sterilization Statement |
| (Annex 5.1) |
The test method used are the same as those submitted in the original submission. A declaration of conformity with design controls is included in attachment 1.1
21
Page
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
JUN 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
THD Spa % Mr. Guido Bonapace CEO ISEMED S.R.L. Via Borgo Santa Cristina 12 40026 Imola (BO) ITALY
Re: K091490
Trade/Device Name: Family of THD disposable anoscope, proctoscope and rectoscope Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: May 14, 2009 Received: May 20, 2009
Dear Mr. Bonapace:
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
3
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
THD S.p.A.
SPECIAL 510(K) Notification
FAMILY OF THD DISPOSABLE ANOSCOPE, PROCTOSCOPE AND RECTOSCOPE
Indications for Use
510(k) Number (if known): /