(78 days)
No
The device description focuses on the physical characteristics and intended use of disposable scopes for examination and procedures, with no mention of AI or ML capabilities.
Yes
The "Intended Use" section explicitly states that the device is intended "to perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" states the device is intended "to perform various diagnostic and therapeutic procedures." Additionally, the "Device Description" explicitly mentions "Diagnostic Anoscopes, Proctocope and Rectoscope" as one of the categories of devices within the family.
No
The device description clearly states it is a family of disposable physical instruments (anoscopes, proctoscopes, rectoscopes) made of transparent plastic, with an integrated or external light source. There is no mention of software as the primary or sole component.
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 anatomical structures (anal sphincter, anus, rectum) and for performing diagnostic and therapeutic procedures. This is a direct examination of the body, not the analysis of samples taken from the body.
- Device Description: The device is a physical instrument (anoscope, proctoscope, rectoscope) used for visualization and access to these anatomical sites. It does not involve the analysis of biological samples like blood, urine, or tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or performing any kind of in vitro test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for direct physical examination and intervention.
N/A
Intended Use / Indications for Use
The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope 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
FER
Device Description
The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope are disposable not sterile rectoscopes, proctoscopes and anoscopes with a light source external or integrated on the handle. The devices are designed for the examination and treatment of the anal (anoscopes) and rectum (proctoscopes and rectoscopes) examination.
The devices consist of transparent plastic anoscope, proctoscope or rectoscope for diagnostic or therapeutic use.
The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices:
- Diagnostic Anoscopes, Proctocope and Rectoscope.
- Surgical Proctoscopes.
The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope include both models which require the external light source and models which not require the external light source, in this case the light source is integrated on the handle. The external light source is provided as accessory of the family and it can be the THD Shining Light and the THD 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
THD S.p.A. SPECIAL 510(K) NOTIFICATION
FAMILY OF THD DISPOSABLE ANOSCOPES PROCTOSCOPES, RECTOSCOPES AND LIGHT-SCOPE
510(k) Summary for the
MAR - 1 2011
Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes 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 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: +39-0542 683803 Fax: +39-0542 698456 Email: gbonapace@isemed.eu
Summary Preparation Date:
- 2.2. Names Device Name:
Classification Name: Product Code: Regulation number:
November 25, 2010
Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope 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 anoscopes, | |
| proctoscopes and rectoscopes | K091490 |
ﻟﻠ
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K108647 Page
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ES
The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope and its predicate device are indicated for the same intended use and have the same teoops and characteristics. Both families include the anoscopes, proctoscope and the rectoscopes manufactured with the same materials and with the same dimensions.
The only difference is that the Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope includes also a group of different models with a different, handle:
- · A type of handle for the use of the devices with an external light source
- · A type of handle with a LED integrated light source
Moreover the new group of devices have the following modification
- The THD Light-scope models have a white tip .
- The THD Light-scope rectoscopes have the lens without hole .
- Some rectoscope models are packaged with a class I device: the inflation bulb .
The modification of the handle consents to manufacture the devices with or without integrated light source. The model without light source are intended to be used with an external light source, which must be fitted on the devices as the previous cleared devices. The models with light source have the same functioning method of the previous cleared device, but they are ready to use for the physician.
The THD Light-scope models are designed with the white tip as the previous cleared rectoscope (K091490). This characteristic improves the light focus to the end of the device with a better visibility of the treated area.
The THD Light-scope rectoscope models with lens without hole are the same of the previous approved rectoscope (K091490), the only difference is that the stopper with lens at the initial part of the rectoscope is manufactured without hole.
2.4. Device Description
The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope are disposable not sterile rectoscopes, proctoscopes and anoscopes with a light source external or integrated on the handle. The devices are designed for the examination and treatment of the anal (anoscopes) and rectum (proctoscopes and rectoscopes) examination.
The devices consist of transparent plastic anoscope, proctoscope or rectoscope for diagnostic or therapeutic use.
· The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices:
- Diagnostic Anoscopes, Proctocope and Rectoscope .
- Surgical Proctoscopes .
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2
FAMILY OF THD DISPOSABLE ANOSCOPES,
PROCTOSCOPES, RECTOSCOPES AND LIGHT-SCOPE
The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope include both models which require the external light source and models which not require the external light source, in this case the light source is integrated on the handle. The external light source is provided as accessory of the family and it can be the THD Shining Light and the THD pen light. The external light source THD Shining Light and the THD pen light have been already approved (K091490).
2.5. Indications for Use
The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope 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 |
|---|---|---|
| New handle designed | ||
| without integrated light | ||
| source | Design verification and | |
| effectiveness test | Safety and effectiveness of | |
| the device | ||
| New handle designed with | ||
| a LED integrated light | ||
| source | Design verification | |
| Safety and electromagnetic | ||
| tests | Safety and effectiveness of | |
| the device | ||
| White tip in the new | ||
| anoscope models | Design verification | Safety and effectiveness of |
| the device | ||
| Lens without hole in the | ||
| new rectoscope | Design verification | Safety and effectiveness of |
| the device | ||
| New packaging of | ||
| rectoscope with inflation | ||
| bulb | Design verification and | |
| effectiveness test | Safety and effectiveness of | |
| the device |
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
3
Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration. 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
THD S.D.A. c/o Mr. Guido Bonapace Regulatory Consultant & General Manager ISEMED S.R.L. Via Borgo Santa Cristina, 12 Imola. BO ITALY 40026
MAR - 1 2011
Re: K103647
· Trade/Device Name: Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope
Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: February 3, 2011 Received: February 7, 2011
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 of medical device-related
4
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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.
http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.
Sincerely yours,
Hubert Lemur MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
THD S.p.A. SPECIAL 510(K) NOTIFICATION
FAMILY OF THD DISPOSABLE ANOSCOPES, PROCTOSCOPES, RECTOSCOPES AND LIGHT-SCOPE
Indications for Use
510(k) Number (if known): K103647
Device Name: Family of THD disposable Anoscope, Proctoscope, Rectoscope, and Light-scope
Indications for Use:
The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic roocant; and
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(21 CFR 801 Subpart C)
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