SELF-LIGHT DISPOSABLE ANOSCOPE

K070913 · Sapimed S.P.A. · FER · Aug 10, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K070913
• Device Name: SELF-LIGHT DISPOSABLE ANOSCOPE
• Applicant: Sapimed S.P.A.
• Product Code: FER · Gastroenterology, Urology
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Sapimed Self Light® Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Device Story

Sapimed Self Light Disposable Anoscopes are clear, transparent plastic instruments used for proctological examination and surgical procedures. The device is inserted into the anal canal to provide visualization of the anal sphincter and anus. Illumination is provided by an external coldlight source (GLF 100) or a pen-light. Available in multiple configurations, including standard models for examination, curved models for surgical procedures (e.g., hemorrhoidectomy, sphincterotomy), cone-shaped models with graduated scales, and beak-shaped models with open channels. The device is intended for use by physicians in a clinical setting. By providing a clear view of the surgical or diagnostic site, the device assists the clinician in performing procedures, potentially improving procedural accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Biocompatibility testing was conducted in accordance with ISO 10993 standards. Accelerated aging testing was performed to substantiate a 5-year shelf life.

Technological Characteristics

Disposable, clear transparent plastic anoscopes. Illumination via external coldlight source (GLF 100) or pen-light. Various form factors: standard, curved, cone-shaped with graduated scale, and beak-shaped with open channel. Biocompatibility per ISO 10993. Non-powered, manual instrument.

Indications for Use

Indicated for physician use to examine the anal sphincter and anus 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

• O'Regan Disposable Anoscope (K020702)
• Welch Allyn, Inc. Disposable Anoscope (K810227)
• North EOS Industries Disposable Proctoscope (K954614)

Submission Summary (Full Text)

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K0709/3

### 510(k) Summary

SAPIMED S.P.A. Via Santi 25-Z.I. D4 Scalo

Alessandria, ITALY 15100 Phone [phone]

AUG 1 0 2007

Contact: Mrs. Paola Oddenino

Summary Prepared: February 28, 2007

Trade Name: Sapimed Self Light Disposable Anoscope

Common Name: Disposable Anoscope

Classification Name: Anoscope, Non-Powered Endoscope, AC Powered and Accessories

#### Predicate Device Identification:

CFR21:876.1500 Product Code:FER/GCP Device Class:II Legally Marketed Device: Company Patrick J. O'Regan Welch Allyn, Inc North EOS Industries

Product 510(k) # O'Regan Disposable Anoscope K020702 Model #53110 Disposable Anoscope K810227 EOS Brand Disposable Proctoscope K954614

#### Description:

The Sapimed Self Light ® Disposable Anoscopes are clear, transparent plastic anoscopes in a range of sizes to suit varying clinical needs. Illumination is provided by either coldlight source GLF 100 or pen-light. The anoscopes are provided in the following configurations:

Models A.4018 and 4019 are clear anscopes for a clear and easy rectal examination.

Models A.4023 and 4024 are anoscopes for examination and use in surgical procedures. The Self-Light® Disposable Operating Anoscopes are clear, transparent disposable anoscopes for various proctological procedures. Illumination is provided by either

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coldlight source GLF 100 or pen-light.

Pg 2 of 3

Ro70913

Model A.4081 is an operating anoscopes with a curved shape, transparency and length suitable for open and close hemorrhoiectomy, spincterotomy , coleo/ileo anastamosis, anoplasty, etc.

Model A.4082 Basile's cone shaped operating anoscope has a graduated scale visible on the internal part of the instrument.

ModelA.4083 The Beak is a surgical anoscope with a closed and rounded tip and a fulllength open channel 2-2.5cm wide

## Intended Use:

The Sapimed Self Light® Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

# Predicate Product Comparison Chart:

| Parameter | | | | |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Sapimed<br>Disposable<br>Anoscope | O'Regan<br>Disposable<br>Anoscope | Welch Allyn<br>Disposable<br>Anoscope | North Eos<br>Industries<br>Disposable<br>Proctoscope |
| Product Code | FER | FER | FER | GCP |
| K Number | | K020702 | K810227 | K954614 |
| Common<br>Name | Disposable<br>anoscope | Disposable<br>Anoscope | Disposable<br>anoscope | Disposable<br>proctoscope |
| Intended Use | intended for<br>physician use to<br>examine the anal<br>sphincter and anus,<br>and, using<br>additional<br>accessories, to<br>perform various<br>diagnostic and<br>therapeutic<br>procedures. | intended for<br>physician use to<br>examine the anal<br>sphincter and anus,<br>and, using additional<br>accessories, to<br>perform various<br>diagnostic and<br>therapeutic<br>procedures. | intended for<br>physician use to<br>examine the anal<br>sphincter and anus,<br>and, using additional<br>accessories, to<br>perform various<br>diagnostic and<br>therapeutic<br>procedures. | intended for<br>physician use to<br>examine the anal<br>sphincter and anus,<br>and, using<br>additional<br>accessories, to<br>perform various<br>diagnostic and<br>therapeutic<br>procedures |
| Material | Plastic | Plastic | Plastic | Plastic |

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K 07 0913
Fgj 343

| Single use | | | | |
|------------|---------------------------------------|---------------------------|---------------------------|----------------|
| Packaged | Yes<br>Clean, non-sterile/<br>Sterile | Yes<br>Clean, non sterile | Yes<br>Clean, non-sterile | Yes<br>Sterile |

## Similarities and differences between Self-Light Disposable Anoscope and Predicate Products

The Sapimed disposable anoscopes have a similar intended use, technological

characteristics and mode of operation as the predicate products, both disposable and

reuseable and presents no new questions concerning safety and efficacy.

### Shelf Life

Accelerated aging testing was performed to substantiate an expiration of 5 years.

### Biocompatibility Testing:

ISO10993 standards

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

### AUG 1 0 2007

Sapimed S.P.A. c/o Ms. Yoland Smith Consultant Smith Associates 1676 Village Green, Suite A CROFTON MD 21114

Re: K070913

Trade/Device Name: Self Light® Disposable Anoscope Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FER Dated: June 1, 2007 . Received: June 28, 2007

Dear Ms. Smith:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image is a black and white circular seal. The seal commemorates the FDA's centennial from 1906-2006. The center of the seal contains the letters FDA in a bold, blocky font, with the word "Centennial" written in a cursive font underneath.

Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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/cdrh/industry/support/index.html

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Ko70913 510(k) Number (if known):

Device Name: Self Light® Disposable Anoscope

Indications for Use:

The Sapimed Self Ligh®t Disposable Anoscopes are intended for physician use to examine the anal sphincter and anus, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Prescription Use ﮮ AND/OR (Part 21 CFR 801 Subpart D)

and Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 807 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, Abdominal, | |