THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES

K103647 · Thd Spa · FER · Mar 1, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K103647
• Device Name: THD DISPOSABLE ANOSCOPES, PROCTOSCOPES AND RECTOSCOPES
• Applicant: Thd Spa
• Product Code: FER · Gastroenterology, Urology
• Decision Date: Mar 1, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Family of disposable, non-sterile anoscopes, proctoscopes, and rectoscopes; used for examination and treatment of anal sphincter, anus, and rectum. Devices consist of transparent plastic tubes; handle options include standard interface for external light source (THD Shining Light or pen light) or integrated LED light source. Light-scope models feature white tip for improved light focus/visibility; specific rectoscope models include lens without hole or inflation bulb. Operated by physicians in clinical settings. External light source provides illumination; integrated LED handle provides self-contained illumination. Output is visual access to the anal/rectal area for diagnostic or therapeutic intervention. Benefits include improved visualization and disposable design to reduce cross-contamination risk.

Clinical Evidence

Bench testing only. No clinical data provided. Design verification tests included safety and electromagnetic tests for the LED integrated handle, effectiveness tests for the new handle designs, and verification of the white tip and lens modifications.

Technological Characteristics

Disposable transparent plastic anoscopes, proctoscopes, and rectoscopes. Illumination via external light source or integrated LED handle. Features include white tip for light focusing and lens without hole. Connectivity: standalone. Sterilization: non-sterile. Energy source: battery/LED (integrated) or external light source.

Indications for Use

Indicated for physician use to examine the anal sphincter, anus, and rectum, and to perform diagnostic and therapeutic procedures using additional accessories.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Family of THD Disposable anoscopes, proctoscopes and rectoscopes (K091490)

Reference Devices

• THD Shining Light (K091490)
• THD pen light (K091490)

Submission Summary (Full Text)

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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: [phone] Telephone: [phone] Fax: [phone] Email: [e-mail]

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,<br>proctoscopes and rectoscopes | K091490 |

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K108647 Page
2 of 3
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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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<br>without integrated light<br>source | Design verification and<br>effectiveness test | Safety and effectiveness of<br>the device |
| New handle designed with<br>a LED integrated light<br>source | Design verification<br>Safety and electromagnetic<br>tests | Safety and effectiveness of<br>the device |
| White tip in the new<br>anoscope models | Design verification | Safety and effectiveness of<br>the device |
| Lens without hole in the<br>new rectoscope | Design verification | Safety and effectiveness of<br>the device |
| New packaging of<br>rectoscope with inflation<br>bulb | Design verification and<br>effectiveness test | Safety and effectiveness of<br>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

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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

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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 [phone] or [phone] 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

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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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Concurrence of CDRH, Office of Device Evaluation (ODE)

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