(49 days)
No
The document describes a family of disposable scopes for examination and procedures of the anus and rectum. There is no mention of AI, ML, image processing, or any data analysis capabilities that would suggest the use of such technologies. The performance studies focus on sterility, packaging, and materials, not algorithmic performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to perform various diagnostic and therapeutic procedures". Also, the "Device Description" mentions that the devices are designed for "examination and treatment" and "for diagnostic or therapeutic use".
Yes
The "Intended Use" states that the device is for physicians "to perform various diagnostic and therapeutic procedures." Additionally, the "Device Description" explicitly mentions "Diagnostic Anoscopes, Proctoscopes and Rectoscopes."
No
The device description clearly outlines physical components made of plastic, including anoscopes, proctoscopes, rectoscopes, and light sources (external or integrated). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- This device is used in vivo (inside the body) to directly visualize and perform procedures on the anal sphincter, anus, and rectum. It's a medical instrument used for examination and intervention, not for analyzing biological samples.
The description clearly states its purpose is for "physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures". This is consistent with a medical device used for direct examination and intervention within the body.
N/A
Intended Use / Indications for Use
The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures by using additional accessories.
The Indications for Use of disposable Anoscope, Proctoscope, Rectoscope and Lightscope have not been modified with respect to the previous submission (K103647).
Product codes
FER, GCP
Device Description
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope are disposable, sterile rectoscopes, proctoscope and anoscopes with a light source which can be external or integrated on the handle.
The devices are designed for the examination and treatment of anus (anoscopes) and the examination of rectum (proctoscopes and rectoscopes).
The devices consist of plastic anoscopes, proctoscopes for diagnostic or therapeutic use.
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices:
- Diagnostic Anoscopes, Proctoscopes and Rectoscopes
- Surgical Proctoscopes
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope includes both models which require the external light source and models which not require the external light source. In the latter case the light source is integrated on the handle.
The external light source is provided as an accessory of the device family and it can be the THD Shining Light and the THD pen light. Both THD Shining Light and THD pen light have been already approved (K091490).
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
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 Annex 4.2). The design verification tests are listed in the following table.
| Modification | Test Performed | Acceptance Criteria |
|---|---|---|
| Sterility of the products | Validation and effectiveness test | Safety and effectiveness of sterilization method |
| Packaging | Design verification | Product shelf life maintenance |
| Handle materials | Design verification | Safety and effectiveness of the materials |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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JUN - 1 2012
K121/135
Page 1 of 3
THD S.p.A. 510(K) Notification
FAMILY OF DISPOSABLE, STERILE AND NOT STERILE THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
510(k) Summary for the
Family of disposable THD Anoscope, Proctoscope, Rectoscope and Light-scope
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
2.1. General Informațion
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 +39-0542 683803 Telephone: Fax: +39-0542 698456 Email: gbonapace(@isemed.eu
Summary Preparation Date:
- 2.2. Names Device Name:
Classification Name: Product Code: Regulation number:
April 4, 2012
Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope Endoscope and accessories FER/GCP 876.1500
2.3. Predicate Devices
This 510(k) is related to the device modifications of the following devices:
21 Page
1
K 12/135
Page 2 of 3
UF
THD S.p.A. 510(K) NOTIFICATION
FAMILY OF DISPOSABLE, STERILE AND NOT STERILE THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
| Applicant | Device name | 510(k) Number |
|---|---|---|
| THD S.p.A. | Family of THD disposable Anoscope, | K103647 |
| Proctoscope, Rectoscope and Light-scope |
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope and its predicate device are indicated for the same intended use and have the same technological characteristics. Both families include the anoscopes, proctoscope the rectoscopes with the same dimensions and manufactured with the same process.
The differences between the families are that:
- The THD Light-scope devices are now available in sterile condition too. .
- The handle material of the family is ABS Terluran and the cover of the integrated � LED light source is ABS Novodur to replace in both cases ABS Lustran.
2.4. Device Description
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope are disposable, sterile rectoscopes, proctoscope and anoscopes with a light source which can be external or integrated on the handle.
The devices are designed for the examination and treatment of anus (anoscopes) and the examination of rectum (proctoscopes and rectoscopes).
The devices consist of plastic anoscopes, proctoscopes for diagnostic or therapeutic use.
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices:
- Diagnostic Anoscopes, Proctoscopes and Rectoscopes .
- Surgical Proctoscopes o
The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope includes both models which require the external light source and models which not require the external light source. In the latter case the light source is integrated on the handle.
The external light source is provided as an accessory of the device family and it can be the THD Shining Light and the THD pen light. Both THD Shining Light and THD pen light have been already approved (K091490).
2.5. Indications for Use
The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum
2
K121/135
page 3 of 3
THD S.p.A. 510(K) NOTIFICATION
FAMILY OF DISPOSABLE, STERILE AND NOT STERILE THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
and to perform various diagnostic and therapeutic procedures by using additional accessories.
The Indications for Use of disposable Anoscope, Proctoscope, Rectoscope and Lightscope have not been modified with respect to the previous submission (K103647).
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 Annex 4.2). The design verification tests are listed in the following table.
| Modification | Test Performed | Acceptance Criteria |
|---|---|---|
| Sterility of the products | Validation and | |
| effectiveness test | Safety and effectiveness of | |
| sterilization method | ||
| Packaging | Design verification | Product shelf life |
| maintenance | ||
| Handle materials | Design verification | Safety and effectiveness of |
| the materials |
A declaration of conformity with design controls is included in annex 1.1
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 emblem resembling an abstract caduceus or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
THD S.p.a. % Mr. Guido Bonapace, General Manager ISEMED S.R.L. Via Borgo Santa Cristina, 12 Imola (BO) 40026 ITALY
JUN - 1 2012
Re: K121135
Trade/Device Name: Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope Regulation Number: 21 CFR& 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER, GCP Dated: April 4, 2012 Received: April 13, 2012
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 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 801); medical device reporting (reporting of medical
4
Page 2-
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,
Benjamin R. Fisher, Ph.D.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
THD S.p.A. 510(K) NOTIFICATION
FAMILY OF DISPOSABLE, STERILE AND NOT STERILE THD ANOSCOPE, PROCTOSCOPE, RECTOSCOPE AND LIGHT-SCOPE
Indications for Use
510(k) Number (if known): K / 2 / / 3 5
Device Name: Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope
Indications for Use:
The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope I no Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures by using additional accessories.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
CONFIDENTIAL
0(k) Number